UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
_____________________
FORM
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
______________________
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(Exact name of registrant as specified in its charter) |
| 7389 | ||
| (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer Identification Number) |
| incorporation or organization) | Classification Code Number) |
_______________________
(
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
________________________
Attn: David R. Koos
Chief Executive Officer
REGEN BIOPHARMA, INC.
4700 Spring Street, Suite 304
La Mesa, CA 91942
Tel: 619-702-1404
(Name, address, including zip code, and telephone number, including area code, of agent for service)
_________________________
Copies to:
Law Offices of William Aul
1600 Hotel Circle North
Suite 207
San Diego, CA 92108
Tel: 619 497 2555
CALCULATION OF REGISTRATION FEE
| Title of Each Class of Securities To Be Registered | Amount To Be Registered | Proposed Maximum Offering Price Per Share | Proposed Maximum Aggregate Offering Price | Aggregate Amount of Registration Fee | ||||||||||||
| Common Stock, par value $0.0001 per share | 1,000,000 | $ | 2.00 | $ | 2,000,000 | $ | 220.40 | |||||||||
Approximate date of commencement of proposed sale to the public: As soon as practicable after the registration statement becomes effective.
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated Filer ☐ | Accelerated Filer ☐ |
| Smaller
reporting company | |
| (Do not check if a smaller reporting company) | Emerging
growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file an amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
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Information contained herein is subject to completion or amendment. A registration statement relating to these securities has been filed
with the Securities and Exchange Commission. These securities may not be sold nor may offers to buy be accepted prior to the time the
registration statement becomes effective. This prospectus shall not constitute an offer to sell or a solicitation of an offer to buy
nor shall there by any sale of these securities in any State in which such offer, solicitation, or sale would be unlawful prior to registration
or qualification under the securities laws of any such State.these securities in any State in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the securities laws of any such State.
SUBJECT TO COMPLETION, DATED APRIL 13, 2023
REGEN BIOPHARMA, INC.
1,000,000 Shares of Common Stock
You may only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provide you with different information. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than the common stock offered by this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any common stock in any circumstances in which such offer or solicitation is unlawful. Neither the delivery of this prospectus nor any sale made in connection with this prospectus shall, under any circumstances, create any implication that there has been no change in our affairs since the date of this prospectus is correct as of any time after its date.
This is a public offering of the Common Shares of Regen Biopharma, Inc.. We are offering 1,000,000 Common Shares at $2.00 per share (the “Shares”), in a best effort, direct public offering, by our officers and directors for the Company.
There is no minimum proceeds threshold for the offering. The offering will terminate within ninety days from the date of this prospectus. The Company will retain all proceeds received from the shares sold in this offering. The Company has not made any arrangements to place the proceeds in an escrow or trust account. Any proceeds received in this offering may be immediately used by the Company in its sole discretion. There are no minimum purchase requirements for each investor. All proceeds retained by the Company may not be sufficient to continue operations.
THIS INVESTMENT INVOLVES A HIGH DEGREE OF RISK. BEFORE INVESTING, YOU SHOULD CAREFULLY READ THIS PROSPECTUS AND, PARTICULARLY, THE RISK FACTORS SECTION, BEGINNING ON PAGE 12.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is _____, 2023.
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Contents
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PROSPECTUS SUMMARY
This summary highlights certain information contained elsewhere in this prospectus. Because it is a summary, it may not contain all of the information that is important to you. Before investing in our common stock, you should read this entire prospectus carefully, especially the sections entitled “Risk Factors” beginning on page 12 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 94 , as well our financial statements and related notes included elsewhere in this prospectus. In this prospectus, the terms “Regen Biopharma, Inc.” “Regen ” “Company,” “we,” “us” and “our” refer to Regen Biopharma , Inc.. In this prospectus, the terms “KCL Therapeutics, Inc.” and “KCL” refer to KCL Therapeutics , Inc.( a wholly owned subsidiary of Regen Biopharma, Inc.
ABOUT US
We were incorporated April 24, 2012 under the laws of the State of Nevada. We intend to engage primarily in the development of regenerative medical applications which we intend to license, develop internally or acquire outright from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
The Company has the following therapies in development:
HemaXellarate : HemaXellarate is a cellular composition of autologous stromal vascular fraction derived from adipose tissue. HemaXellarate contains endothelial progenitor cells as well as mesenchymal stem cells. Once re-infused into the patient, the patient’s bone marrow is regenerated and begins to function normally.
dCellVax: dCellVax is comprised of autologous dendritic cells which have been treated with an siRNA inhibitor of indoleamine-2,3-dioxygenase (IDO), an immunosuppressive enzyme. By inhibiting this enzyme in these dendritic cells, the patient’s cells can now attack cancers, particularly breast cancer.
tCellVax: Immune cells are removed from the patient, treated with siRNA to inhibit NR2F6 and the cells re-infused to the patient. Now that the inhibitor protein is blocked, the immune system is very activated and kills tumors. siRNA is a double-stranded RNA molecule that is non-coding and is a powerful tool in drug targeting and therapeutics development as it is used to modulate gene expression through transcriptional or translational repression. The NR2F6 nuclear receptor has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) and cancer stem cell differentiator.
DiffronC: This drug uses our proprietary siRNA in vivo to inhibit cancer growth and activate T cells. The siRNA targets NR2F6. T cells are part of the immune system and develop from stem cells in the bone marrow.
DuraCar: DuraCar is comprised of CAR-T cells which have been treated with an shRNA targeting the gene NR2F6. By inhibiting NR2F6, we expect our DuraCar cells to have greater efficacy and persistence than conventional CAR-T cells and create a new, optimal way to manufacture CAR-T cells. We are currently in pre-clinical testing of this drug. Chimeric antigen receptor T cells ( CAR-T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy. Chimeric antigen receptors are receptor proteins that have been engineered to give T cells the new ability to target a specific antigen.
Small molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. We are currently in pre-clinical testing of these drugs.
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As of April 10, 2023 we have not licensed any existing therapies which may be marketed. On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to Regen one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
he abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly within the 14 trading days prior to issuance.
Pursuant to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The Agreement may be terminated by Regen:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to Regen with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property ( “License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years from April 7, 2021.
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The License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized by the immune system.
As consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) | pay to Regen a nonrefundable fee of $55,000 no later than April 20,2021 |
| (b) | pay to Regen royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter. |
| (c) | pay to Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment. |
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
On April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby KCL granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from April 7, 2021.
As consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) | pay to KCL a nonrefundable fee of Fifty Thousand common shares of Oncology Pharma, Inc. no later than April 20,2021 |
| (b) | pay to KCL royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter. |
| (c) | pay to KCL ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which KCL receives payment. |
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
Zander and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics Inc.
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Both Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”) in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval would be granted.
The stockholders’ equity section of the Company contains the following classes of capital stock :
As of April 10, 2023
Common stock, $ 0.0001 par value; 5, 800,000,000 shares authorized:3,381,366 shares issued and outstanding.
Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 34 shares issued and outstanding as of April 10, 2023, 540,000,000 is designated Series A Preferred Stock of which 409,551 shares are outstanding as of April 10, 2023, 60,000,000 is designated Series M Preferred Stock of which 29,338 shares are outstanding as of April 10, 2023 and 20,000 is designated Series NC Preferred Stock of which 15,007 shares are outstanding as of April 10 ,2023.
Our common stock is traded on the OTC Pink Market under the symbol “RGBP” and our Series A Preferred stock is traded on the OTC Pink Market under the symbol “RGBPP”. No public market currently exists for any other equity securities of the Company.
At December 31, 2022 (unaudited) | ||||
| Selected Balance Sheet Information: | ||||
| Cash | $ | 40,741 | ||
| Current assets | 191,528 | |||
| Total assets | $ | 414,108 | ||
| Current liabilities | $ | 5,298,935 | ||
| Total liabilities | 5,298,935 | |||
| Total stockholders’ equity (deficit) | $ | (4,884,8274 | ) | |
Retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
For the three months ended December 31, 2022 (unaudited) | For the three months ended December 31, 2021 (unaudited) | |||||||
| Selected Statement of Operations Information: | ||||||||
| (unaudited) | ||||||||
| Revenues | $ | 59,065 | $ | 59,065 | ||||
| Total operating expenses | (522,931 | ) | (165,487 | ) | ||||
| Operating income (loss) | (463,867 | ) | (106,422 | ) | ||||
| Net income (loss) to common shareholders | $ | 1,448,439 | $ | 2,391,062 | ||||
| Basis and diluted earnings (loss) per common share | $ | 0.43 | $ | 0.001 | ||||
| Weighted average common shares outstanding basic and diluted | 3,360,540 | 3,004,636 | ||||||
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
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| For the year ended September 30, 3033 | For the year ended September 30, 2021 | |||||||
| Selected Statement of Operations Information: | ||||||||
| Revenues | 235,517 | $ | 171,194 | |||||
| Total operating expenses | (575,122 | ) | (319,317 | ) | ||||
| Operating income (loss) | (200,771 | ) | (371,964 | ) | ||||
| Net income (loss) to common shareholders | 2,227,034 | $ | (6,765,233 | ) | ||||
| Basis and diluted earnings (loss) per common share | 0.712 | $ | (0.000 | ) | ||||
| Weighted average common shares outstanding basic and diluted | 3,135,846 | 2,007,696 | ||||||
All
stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as
of March 6, 2023
As of December 31, 2022 we had Cash of $40,741 and as of September 30, 2022 we had cash of $51,204. The decrease in cash of approximately 20% is primarily attributable to cash expended in the operation of the Company’s business offset by .receipt by the Company of $150,000 in accrued license fees ( related party) due.
As of December 31, 2022 we had Accounts Receivable, Related Party of $131,698 and as of September 30, 2022 we had Accounts Receivable, Related Party of $ 295,466. The decrease of approximately 48% is primarily attributable to receipt by the Company of $150,000 in accrued license fees ( related party) due offset by accrual of $27,425 of minimum royalties and anniversary fees pursuant to a license granted to Zander Therapeutics, Inc. by Regen Biopharma, Inc. during the quarter ended December 31, 2022.
As of December 31, 2022 we had Prepaid Expenses of $14,089 and as of September 30, 2022 we had prepaid expenses of $20,945. The decrease in Prepaid Expenses of approximately 33% is attributable to the recognition of expenses incurred over the three months ended December 31, 2022 resulting from an agreement to provide Research and Development services which was prepaid during the quarter ended September 30, 2021. The term of the agreement is from July 1, 2021 to July 1, 2023. The total consideration due of $55,000 was paid to the contractor as of July 1, 2021 and is being expensed over the term of the agreement. .
As of September 30, 2022 we had Prepaid Rent of $10,000 and as of December 31, 2022 we had Prepaid Rent of $0. The decrease in Prepaid Rent of 50% is attributable to $10,000 of rental expenses prepaid to BST Partners (an entity under common control with the Company) during the quarter ended September 30, 2022 of which $5,000 was expensed during the quarter ended December 31, 2022.
As of September 30, 2022 we had Accounts Payable of $28,799 and as of December 31, 2022 we had Accounts Payable of $31,039. The increase in Accounts Payable of approximately 8% is primarily attributable to expenses of $1,730 of patent related legal expenses as well as $510 of Transfer Agent fees incurred during the quarter ended December 31, 2022.
As of September 30, 2022 we had Accrued Interest Payable of $689,785 and as of December 31, 2022 we had Accrued Interest Payable of $301,363. The decrease in Accrued Interest Payable of approximately 56% is attributable to the issuance of equity securities of the Company during the quarter ended December 31,2022 in satisfaction of $405,631 of interest accrued but unpaid on Convertible Notes issued by the Company offset by additional interest accrued but unpaid during the quarter ended December 31, 2022 on Notes Payable and Convertible Notes Payable.
As of September 30, 2022 we had a Derivative Liability of $3,551,793 and as of December 31, 2022 we had a Derivative Liability of $1,435, 949. The decrease in Derivative Liability of approximately 60% is attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $350,000 outstanding as of December 31, 2022.
As of December 31, 2022 we had total Convertible Notes Payable of $509,880 and as of September 30, 2022 we had total Convertible Notes Payable of $1,272,340. The decrease in total Convertible Notes Payable of approximately 60 % is attributable to the conversion of $761,500 of convertible indebtedness into shares of the Company’s Series A Preferred Stock as well as the derecognition of $1,000 of convertible indebtedness.
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Revenues from continuing operations were $59,065 for the three months ended December 31, 2022 and $59,065 for the same period ended 2021. $27,425 of revenue from related parties recognized during the three months ended December 31, 2022 and December 31, 2021 consisted of $24,932 related to an anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and $2,493 of minimum royalties recognized during the three months ended December 31, 2021 and 2022 respectively pursuant to the same license. $31,640 of revenue recognized during the three months ended December 31, 2021 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $31,640 of revenue was recognized during the quarter ended December 31, 2022 pursuant to those same licenses.
With regards to the aforementioned license granted to Zander On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
The Company recognized an Operating Loss of $463,867 during the three months ended December 31, 2022 whereas the Company recognized an Operating Loss of $106,422 for the same period ended 2021. The Company recognized a Net Loss of $2,644,980 for the three months ended December 31, 2021 whereas the Company recognized a Net Income of $1,635,730 for the same period ended 2022. The larger Operating Loss recognized during the three months ended December 31 , 2022 as compared to the same period ended 2021 is primarily attributable to material increases in Research and Development expenses and consulting expenses incurred during the period ended 2022 as compared to the same period ended 2021. With regard to Net Income contributing factors to greater Net Income being recognized during the three months ended December 31, 2021 as compared to the same period ended 2021 include:
| (1) | greater operating losses incurred during the three months ended December 31, 2022 |
| (2) | Recognition of Derivative Income of $2,964,939 during the quarter ended December 31, 2021 as opposed to $2,115,806 of Derivative Income recognized during the quarter ended December 31, 2022 |
| (3) | The recognition of a $62,700 gain on derecognition of Accounts Payable during the quarter ended December 31, 2021 for which recovery is barred by the statute of limitations imposed under California Code of Civil Procedure §337. |
Revenues from continuing operations were $235,517 for the twelve months ended September 30, 2022 and $171,194 for the same period ended 2021. $110,000 of revenue from related parties recognized during the years ended September 30, 2021 and September 30, 2022 consisted of $100,000 related to an anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and $10,000 of minimum royalties recognized during the twelve months ended September 30 2021 and 2022 respectively pursuant to the same license. $61,194 of revenue recognized during the year ended September 30, 2021 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $125,517 of revenue was recognized during the year ended September 30, 2022 pursuant to those same licenses.
With regards to the aforementioned license granted to Zander On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
The Company recognized an Operating Loss of $200,771 during the year ended September 30, 2021 whereas the Company recognized an Operating Loss of $339,605 for the same period ended September 30, 2022. The Company recognized a Net Loss of $6,765,233 for the twelve months ended September 30, 2021 whereas the Company recognized a Net Income of $2,443,531 for the same period ended 2022. Contributing factors to the difference between the periods were the recognition of a Derivative Income of $3,340,683 during the period ended 2022 as opposed to the recognition of Derivative Losses of $4,264,975 during the period ended 2021, the recognition during the fiscal year ended September 30, 2021 of an $800,000 expense related to a legal settlement during the year ended September 30,2021 and recognition of $632, 094 of unrealized losses on sales of Investment Securities as well as $524,960 of realized losses on sales of Investment Securities during the year ended September 30,2021.
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EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT
As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act.
An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company:
| • | we are permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations; |
| • | we are exempt from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002; |
| • | we are permitted to provide less extensive disclosure about our executive compensation arrangements; and |
| • | we are not required to give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements. |
We may take advantage of these provisions for up to five years subsequent to the effective date of this registration statement or such earlier time that we are no longer an emerging growth company. We will cease to be an emerging growth company upon the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1 billion, (ii) December 31 of the fiscal year that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter and we have been publicly reporting for at least 12 months or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three-year period.
We hereby elect to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1).
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SUMMARY OF THIS OFFERING
| Newly issued common stock being registered pursuant to the Public Offering: | 1,000,000 shares of common stock | |
| Primary Offering price: | $2.00 per share | |
| Primary Offering period: | From the date of this prospectus until ninety days after | |
| Number of Common Shares Outstanding After the Offering: | ||
| Market for the common stock: | Our shares of common stock are currently quoted on the OTC Markets Pink under the symbol “RGBP”. | |
| Use of proceeds: | See “Use of Proceeds” beginning on page 20 for a more detailed explanation of how the proceeds from the Direct Public Offering will be used. | |
| Risk Factors: | See “Risk Factors” beginning on Page 12 and the other information in this Prospectus for a discussion of the factors you should consider before deciding to invest in shares of our common stock. | |
| Subscriptions: | Subscriptions
are to be made payable to: Regen Biopharma, Inc. |
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RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully consider the risks described below as well as other information provided to you in this prospectus, including information in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline, and you may lose all or part of your investment. The following discussion and analysis should be read in conjunction with the other financial information and consolidated financial statements and related notes appearing in this prospectus.
Risks Related to our Business:
THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S ABILITY TO CONTINUE AS A GOING CONCERN.
Our auditor’s report dated November 15, 2022 expresses an opinion that substantial doubt exists as to whether we can continue as an ongoing concern. Because obtaining investment capital is not certain, we may not have the funds necessary to continue our operations. Our ability to meet our operating needs depends in large part on our ability to secure third party financing. We cannot provide any assurances that we will be able to obtain financing.
THE COMPANY DOES NOT CURRENTLY OWN OR OPERATE ANY LABORATORY OR MANUFACTURING FACILITIES, THE COMPANY CAN PROVIDE NO ASSURANCE THAT THE USAGE OF SUCH FACILITIES CAN BE OBTAINED ON TERMS FAVORABLE TO THE COMPANY
The Company does not currently own or operate any laboratory or manufacturing facilities. As a result, we plan to outsource certain functions, tests and services to Contract Research Organizations (“CROs”) and collaborators as well as outsourcing manufacturing to collaborators and/or contract manufacturers. We also plan to engage a CRO to run all aspects of preclinical studies and clinical trials on our behalf. There is no assurance that such individuals or organizations will be able to provide the functions, tests, or services as agreed upon or in a quality fashion or on terms favorable to the Company. Any failure to do so could cause us to suffer significant delays in the development of our products.
WE ARE IN THE EARLY STAGES OF DEVELOPING OUR PRODUCTS, THE EFFECTIVENESS OF WHICH ARE UNPROVEN.
The Company is currently in the early stage of developing its products. No assurance can be given that the Company’s products will prove effective for their intended purpose or otherwise that any of our work will result in any commercially viable product.
COMPETITORS WITH MORE RESOURCES MAY FORCE US OUT OF BUSINESS.
In the event that we have sufficient financial resources, we anticipate that we will compete with many large and well-established companies. Aggressive pricing by our competitors or the entrance of new competitors into our markets could reduce our revenue and profit margins and otherwise result in significant financial losses that could result in insolvency or bankruptcy.
WE MAY NOT BE ABLE TO ATTAIN PROFITABILITY WITHOUT SIGNIFICANT ADDITIONAL FINANCING WHICH MAY BE UNAVAILABLE.
We have negative equity as of December 31, 2022, minimal working capital and no clear plan to raise additional capital. To date, have funded our operations with minimal financial resources, and we have not generated sufficient cash from operations to be profitable or to maintain sufficient inventory. Unless we are successful in generating sufficient revenues to finance operations as a going concern while also achieving profitability and positive cash flow, we may experience liquidity and solvency problems. Such liquidity and solvency problems may force us to cease operations if additional financing is not available.
| 12 |
WE MAY NOT BE ABLE TO RAISE ADDITIONAL CAPITAL ON ACCEPTABLE TERMS.
We are aware that our business may require significant capital in the future each year and for many years even if we can implement our business plans. Even if we are successful in implementing our business plan, any person who acquires our Common Stock or our Preferred Stock will likely suffer significant and immediate dilution or otherwise become subordinate to the rights and claims of creditors. In addition, any financing that we obtain may not be available on terms favorable to us, or at all. Our ability to obtain additional funding will be subject to various factors, including market conditions, our operating performance, lender and investor sentiment and our ability to incur additional debt or equity financing in compliance with other contractual restrictions which may arise. These factors may make the timing, amount, terms and conditions of additional financings unattractive. Our inability to raise capital could impede our growth. Any person who acquires our securities should be prepared to lose all of their investment.
WE RELY ON HIGHLY SKILLED PERSONNEL AND, IF WE ARE UNABLE TO RETAIN OR MOTIVATE KEY PERSONNEL OR HIRE QUALIFIED PERSONNEL, WE MAY NOT BE ABLE TO GROW EFFECTIVELY.
Our
performance largely depends on the talents and efforts of highly skilled individuals. Competition in our industry for qualified employees
is intense. In addition, our compensation arrangements may not always be successful in attracting new employees and retaining and
motivating our existing employees. Our continued ability to compete effectively depends on our ability to attract new employees
and to retain and motivate our existing employees.
THE COMPANY DOES NOT MAINTAIN CERTAIN INSURANCE, INCLUDING ERRORS AND OMISSIONS INSURANCE.
The Company has limited capital and, therefore, does not currently have a policy of insurance against liabilities arising out of the negligence of its officers and directors and/or deficiencies in any of its business operations. Even assuming that the Company obtained insurance, there is no assurance that such insurance coverage would be adequate to satisfy any potential claims made against the Company, its officers and directors, or its business operations or products. Any such liability which might arise could be substantial and may exceed the assets of the Company.
WE MAY HAVE DIFFICULTY IN ATTRACTING AND RETAINING MANAGEMENT AND OUTSIDE INDEPENDENT MEMBERS TO OUR BOARD OF DIRECTORS AS A RESULT OF THEIR CONCERNS RELATING TO THEIR INCREASED PERSONAL EXPOSURE TO LAWSUITS AND STOCKHOLDER CLAIMS BY VIRTUE OF HOLDING THESE POSITIONS IN A PUBLICLY-HELD COMPANY.
We are aware that directors and management of publicly-traded corporations are increasingly concerned with the extent of their personal exposure to lawsuits and stockholder claims, as well as governmental and creditor claims which may be made against them, particularly in view of recent changes in securities laws imposing additional duties, obligations and liabilities on management and directors. Due to these perceived risks, directors and management are also becoming increasingly concerned with the availability of directors’ and officers’ liability insurance to pay on a timely basis the costs incurred in defending such claims. We currently do not carry directors’ and officers’ liability insurance. Directors’ and officers’ liability insurance has recently become much more expensive and difficult to obtain. If we are unable to provide directors’ and officers’ liability insurance at affordable rates or at all, it may become increasingly more difficult to attract and retain qualified outside directors to serve on our board of directors. We may lose potential independent board members and management candidates to other companies that have greater directors’ and officers’ liability insurance to insure them from liability or to companies that have revenues or have received greater funding to date which can offer more lucrative compensation packages. The fees of directors are also rising in response to their increased duties, obligations and liabilities as well as increased exposure to such risks. As a company that is in the early stages of development and which has limited resources, we will have a more difficult time attracting and retaining management and outside independent directors than a more established company due to these enhanced duties, obligations and liabilities.
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IN THE FUTURE WE MAY BE SUBJECT TO INTELLECTUAL PROPERTY RIGHTS CLAIMS, WHICH ARE COSTLY TO DEFEND, COULD REQUIRE US TO PAY DAMAGES AND COULD LIMIT OUR ABILITY TO SELL SOME OF OUR PRODUCTS.
Although we have not been subject to any intellectual property litigation or infringement claims, we may be in the future, which could cause us to incur significant expenses to defend such claims, divert management’s attention or prevent us from manufacturing, selling or using some aspect of our products. If we chose or are forced to settle such claims, we may be required to pay for a license to certain rights, paying royalties on both a retrospective and prospective basis, and/or cease our manufacturing and sale of certain products that are alleged to be infringing. Future infringement claims against us by third parties may adversely impact our business, financial condition and results of operations.
WE MAY BE SUBJECT TO VARIOUS FORMS OF LITIGATION INCLUDING, BUT NOT LIMITED TO, CLASS ACTION LAWSUITS, WHICH ARE COSTLY TO DEFEND, COULD REQUIRE US TO PAY DAMAGES AND COULD LIMIT OUR ABILITY TO SELL SOME OF OUR PRODUCTS.
Companies have been the target of class action lawsuits and other proceedings alleging, among other things, violations of federal and state workplace and employment laws. Proceedings of this nature, if successful, could result in our payment of substantial damages.
Our results of operations may be adversely affected by legal or governmental proceedings brought by or on behalf of employees or consumers. In recent years, a number of companie, have been subject to lawsuits, including class action lawsuits, alleging violations of federal and state law. A number of these lawsuits have resulted in the payment of substantial awards by the defendants. Although we are not currently a party to any class action lawsuits, we could incur substantial damages and expenses resulting from lawsuits, which would increase the cost of operating the business and decrease the cash available for other uses.
WE ARE SUBJECT TO NUMEROUS LAWS AND REGULATIONS, FAILURE TO COMPLY WITH THOSE LAWS AND REGULATIONS MAY ADVERSELY IMPACT OUR BUSINESS.
Products we are currently developing and which may be developed by us would be highly regulated. We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the Food and Drug Administration (FDA) in the United States and regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our product candidates in the United States until we receive approval of a New Drug Application (NDA) or a Biologic License Application (BLA), as applicable, from the FDA.
In the United States, NDAs and BLAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs and BLAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of a NDA or BLA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval. Regulators of other jurisdictions, such as the European Medicines Agency (EMA) , a European Union agency for the evaluation of medicinal products, have their own procedures for approval of product candidates. Even in the event that a product is approved, the FDA or the EMA, as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.
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NO ASSURANCE CAN BE GIVEN THAT ANY PRODUCT IN DEVELOPMENT OR WHICH MAY BE PUT INTO DEVELOPMENT WILL SUCCESFULLY COMPLETE ANY CLINICAL TRIALS.
Clinical trials involving new drugs and biologics are commonly classified into three phases. Each phase of the drug approval process is treated as a separate clinical trial and the drug-development process usually advances through all four phases over many years. Each phase exposes greater number of subjects to the drug and each phase builds on existing safety and efficacy information. Phase 1 trials are designed to assess the safety and tolerability of a drug or biologic. Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase III trials are aimed at being the definitive assessment of how effective the drug or biologic is, in comparison with current treatment and to provide an adequate basis for physician labeling. If the drug or biologic successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.
The Company’s plan is to engage primarily in the development of regenerative medical applications up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
We have yet to complete a successful clinical trial of any product under development and no assurance can be made that any product under development will successfully complete a clinical trial.
THE COMPANY CAN PROVIDE NO ASSURANCE THAT IT WILL BE ABLE TO SELL OR LICENSE ANY PRODUCT UNDER DEVELOPMENT OR WHICH WE MAY DEVELOPIN THE FUTURE.
The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. We can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.
WE HAVE NOT OBTAINED PATENT PROTECTION FOR MUCH OF OUR INTELLECTUAL PROPERTY.
The Company has not obtained patent protection on much of its intellectual property. Although the Company plans on attempting to obtain patents on its products and services, there can be no assurance that the Company can obtain effective protection against unauthorized duplication or the introduction of substantially similar products.
LIABILITY OF DIRECTORS FOR BREACH OF DUTY OF CARE IS LIMITED. OUR BYLAWS INDEMNIFY MEMBERS OF OUR BOARD OF DIRECTORS, OUR OFFICERS, EMPLOYEES, AND AGENTS AND PERSONS WHO FORMERLY HELD SUCH POSITIONS, AND THE LEGAL REPRESENTATIVES OF ANY OF THEM, TO THE FULLEST EXTENT LEGALLY PERMISSIBLE UNDER THE GENERAL CORPORATION LAW OF THE STATE OF NEVADA AGAINST ANY OR ALL EXPENSE, LIABILITY AND LOSS REASONABLY INCURRED IN DEFENDING A CIVIL OR CRIMINAL ACTION, SUIT OR PROCEEDING TO WHICH ANY SUCH PERSON SHALL HAVE BECOME SUBJECT BY REASON OF HIS HAVING HELD SUCH A POSITION OR HAVING ALLEGEDLY TAKEN OR OMITTED TO TAKE ANY ACTION IN CONNECTION WITH SUCH POSITION.
According to Nevada law (NRS 78.138(7)), all Nevada corporations limit the liability of directors and officers, including acts not in good faith. Our stockholders’ ability to recover damages for fiduciary breaches may be reduced by this statute. In addition our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.
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DEPENDENCE ON DAVID R. KOOS, WITHOUT WHOSE SERVICES COMPANY BUSINESS OPERATIONS COULD CEASE.
At this time, the sole officer and director of the Company is David R. Koos, who is wholly responsible for the development and execution of our business. Mr. Koos is not party to an employment agreement with us. If Mr. Koos should choose to leave us for any reason before we have hired additional personnel our operations may fail. Even if we are able to find additional personnel, it is uncertain whether we could find qualified management who could develop our business along the lines described herein or would be willing to work for compensation the Company could afford. Without such management, the Company could be forced to cease operations and investors in our common stock or other securities could lose their entire investment. David Koos is not party to an employment agreement with the Company.
LIABILITY OF DIRECTORS FOR BREACH OF DUTY OF CARE IS LIMITED.
According to Nevada law (NRS 78.138(7)), all Nevada corporations limit the liability of directors and officers, including acts not in good faith. Our stockholders’ ability to recover damages for fiduciary breaches may be reduced by this statute.
EVENTS OUTSIDE OF OUR CONTROL, INCLUDING PUBLIC HEALTH CRISES SUCH AS THE COVID-19 PANDEMIC, COULD NEGATIVELY AFFECT OUR BUSINESS AND OUR OPERATING RESULTS.
A public health crisis such as the COVID-19 pandemic may cause us to experience disruptions that could severely impact our business including interruptions in preclinical studies due to restricted or limited operations at laboratory facilities, interruption or delays in the operations of the FDA or other regulatory authorities, which may impact review and approval timelines and interruption of, or delays in receiving, supplies for productions of our product candidates from our third party suppliers due to staffing shortages, production slowdowns or stoppages and disruptions in delivery system.
While we are not currently conducting any clinical trials in the event of a public health crisis during a time when we are in the process of conducting one or more clinical trials such trials may be adversely impacted due to:
| • | delays or difficulties in enrolling patients in our clinical trials; |
| • | delays or difficulties in clinical trial site activities, including difficulties in recruiting clinical trial staff; |
| • | diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials; |
| • | interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures (i.e., those that are deemed non-essential), which may impact the integrity of subject data and clinical study endpoints; |
THERE IS NO FIRM COMMITMENT TO PURCHASE THE SHARES OF COMMON STOCK BEING OFFERED.
This is a best efforts, no minimum offering of shares of our common stock being conducted solely by certain members of our management. There is no commitment by anyone to purchase any of the shares being offered. We cannot give any assurance that any or all of the shares will be sold. There is no minimum and we will retain any amount of proceeds received from the sale of the shares. As this offering is a best efforts financing, there is no assurance that this financing will be completed or that any future financing will be affected. Investors assume additional risk on whether the offering will be fully subscribed and to what extent the Company will be able to utilize the proceeds as intended in the event that the offering is not fully subscribed.
| 16 |
Risks Related to an Investment in Our Common Stock
WE DO NOT PLANT TO PAY CASH DIVIDENDS IN THE FORESEEABLE FUTURE.
We currently intend to retain all future earnings for use in the operation and expansion of our business. We do not intend to pay any cash dividends in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them. There is no assurance that stockholders will be able to sell shares when desired or that any continuous and liquid trading market will develop or, if it does develop, that it will be sustained for any period of time and at a level that will allow a stockholder an opportunity to sell any shares of our common stock in any amount at any time.
OUR COMMON STOCK IS QUOTED ON THE OTC PINK MARKET WHICH MAY HAVE AN UNFAVORABLE IMPACT ON OUR STOCK PRICE AND LIQUIDITY.
Our common stock is quoted on the OTC Pink Market . The OTC Pink Market is a significantly more limited market than the New York Stock Exchange or NASDAQ system. The quotation of our shares on the OTC Pink Market may result in a less liquid market available for existing and potential stockholders to trade shares of our common stock, could depress the trading price of our common stock and could have a long-term adverse impact on our ability to raise capital in the future.
PENNY STOCK” RULES MAY MAKE BUYING OR SELLING OUR COMMON STOCK DIFFICULT.
Trading in our securities is subject to the “penny stock” rules. The SEC has adopted regulations that generally define a penny stock to be any equity security that has a market price of less than $5.00 per share, subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than prior customers and accredited investors, must, prior to the sale, make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to execute the transaction. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. Broker-dealers who sell penny stocks to certain types of investors are required to comply with the Commission’s regulations concerning the transfer of penny stocks. These regulations require broker- dealers to:
| • | Make a suitability determination prior to selling a penny stock to the purchaser; |
| • | Receive the purchaser’s written consent to the transaction; and |
| • | Provide certain written disclosures to the purchaser. |
These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.
WE ARE REGISTERING AN AGGREGATE OF 1,000,000 SHARES OF COMMON STOCK. THE SALE OF SUCH SHARES COULD DEPRESS THE MARKET PRICE OF OUR COMMON STOCK.
We are registering an aggregate of 1,000,000 shares of common stock under the registration statement of which this prospectus forms a part. The sale of these shares into the public market could depress the market price of our common stock.
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CONCENTRATED CONTROL RISKS; SHAREHOLDERS COULD BE UNABLE TO CONTROL OR INFLUENCE KEY CORPORATE ACTIONS OR EFFECT CHANGES IN THE COMPANY’S BOARD OF DIRECTORS OR MANAGEMENT
Our sole officer and director, David R. Koos, has voting power over 503_ shares of our common stock, 122,221 of our Series A Preferred stock, 34 shares of our Series AA Preferred Stock , 7,667 shares of our Series M Preferred Stock and 15,007 shares of our Series NC Preferred stock representing approximately 58.5% of the voting control of the Company as of April 10, 2023. Mr. Koos therefore has the power to make many major decisions regarding our affairs, including decisions regarding whether or not to issue stock and for what consideration. In addition, due to Mr. Koos voting power, investors in this offering will have limited control over matters requiring approval by our security holders, including the election of directors, whether or not to sell all or substantially all of our assets and for what consideration and whether or not to authorize more stock for issuance or otherwise amend our charter or bylaws.
OUR DIRECTOR HAS THE RIGHT TO AUTHORIZE THE ISSUANCE OF ADDITIONAL SHARES OF OUR COMMON STOCK AND CHANGE THE AMOUNT AND TYPE OF AUTHORIZED PREFERRED STOCK.
Our sole director, within the limitations and restrictions contained in our articles of incorporation and without further action by our stockholders, has the authority to issue shares of our existing authorized common stock and also to change the amount and type of our authorized capital stock. Any such action would also likely and significantly reduce the value of our existing Common Stock.
BECAUSE WE HAVE ELECTED TO DEFER COMPLIANCE WITH NEW OR REVISED ACCOUNTING STANDARDS PURSUANT TO SECTION 102(b)(1) OF THE JOBS ACT OUR FINANCIAL STATEMENT DISCLOSURE MAY NOT BE COMPARABLE TO SIMILAR COMPANIES.
We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of our election, our financial statements may not be comparable to companies that comply with public company effective dates. .
LIKELIHOOD OF IMMEDIATE AND SUBSTANTIAL DILUTION.
We
anticipate that we may need to raise additional capital to implement our business plan. At present we have not had any definitive discussions
with any venture capital, angel investors, FINRA-registered broker dealers, or other persons regarding the extent of their interest in
investing into the Company. Since we are an early-stage company with no track record of generating revenues, positive cash flow, or profitability,
there can be no guarantee that we will raise the additional capital that we anticipate that we will need to raise or, if we are successful
in raising any such additional capital that we can do so on a reasonable and timely basis, in sufficient amounts and on terms that are
reasonable in light of our present circumstances. For these and other reasons, any person who acquires our Common Stock is likely to
incur immediate and substantial dilution with respect to the book value of the Company’s common stock offered hereby.
FUTURE ISSUANCE OF COMMON STOCK RELATED TO CONVERTIBLE NOTES PAYABLE AND ACCRUED INTEREST ON CONVERTIBLE NOTES PAYABLE MAY HAVE
A DILUTING FACTOR ON EXISTING AND FUTURE SHAREHOLDERS.
As of February 10, 223 the Company has outstanding an aggregate of $769,361 of convertible debt and accrued interest on convertible debt. Of that aggregate amount $569,799 is convertible into common or Series A preferred shares of the Company at various discounts from the market price of the Company’s publicly traded shares. It is the Company’s belief that shares issuable to the holders of $569,799 of combined convertible debt and accrued interest on convertible debt may be resold pursuant to the safe harbor provisions of Rule 144. It is the Company’s intent to use $350,000 of the proceeds of this offering to satisfy principal indebtedness convertible into into common or Series A preferred shares of the Company at various discounts from the market price of the Company’s publicly traded shares. however in the event that the Company realizes less than $350,00 from this offering or in the event that convertible noteholders do not agree to the satisfaction of principal but not of interest accrued then no convertible debt will be satisfied.
| 18 |
WE DO NOT CURRENTLY INTEND TO REGISTER OUR COMMON SHARES UNDER THE SECURITIES AND EXCHANGE ACT OF 1934 (“EXCHANGE ACT”). OUR REPORTING OBLIGATIONS UNDER SECTION 15(D) OF THE EXCHANGE ACT MAY BE SUSPENDED AUTOMATICALLY IF WE HAVE FEWER THAN 300 HOLDERS OF RECORD ON THE FIRST DAY OF OUR FISCAL YEAR AFTER THE YEAR OF EFFECTIVENESS OF THE REGISTRATION STATEMENT FILED PURSUANT TO THE SECURITIES ACT OF 1933 OF WHICH THIS PROSPECTUS CONSTITUTES PART .
We will become subject to the Exchange Act reporting requirements under Section 15(d) upon effectiveness of the current registration statement for at least one year after effectiveness. Our obligation to file reports under Section 15(d) of the Exchange Act will be automatically suspended if, on the first day of any fiscal year, other than a fiscal year in which a registration statement under the Securities Act has gone effective, we have fewer than 300 holders of record. In such an event, we may cease providing periodic reports and current or periodic information, including operational and financial information
WE DO NOT CURRENTLY INTEND TO REGISTER OUR COMMON SHARES UNDER THE SECURITIES AND EXCHANGE ACT OF 1934 (“EXCHANGE ACT”). UNLESS WE REGISTER A CLASS OF OUR SECURITIES PURSUANT TO SECTION 12 OF THE EXCHANGE ACT, WE WILL ONLY BE SUBJECT TO THE PERIODIC REPORTING OBLIGATIONS IMPOSED BY SECTION 15(D) OF THE EXCHANGE ACT WHICH MAY LIMIT THE INFORMATION ON THE COMPANY AVAILABLE TO SHAREHOLDERS.
We do not currently intend to register our common shares under the Securities and Exchange act of 1934 ( “Exchange Act”). Unless we register a class of our securities pursuant to Section 12 of the Exchange Act, we will only be subject to the periodic reporting obligations imposed by Section 15(d) of the Exchange Act. Accordingly, we will not be subject to the proxy rules, short-swing profit provisions, going-private regulation, beneficial ownership reporting, and the majority of the tender offer rules and the reporting requirements of the Exchange Act. Accordingly, shareholders may have access to less information regarding the activities of the Company and its officers and directors than they otherwise may have if a class of the Company’s securities was registered under the Exchange Act.
FORWARD LOOKING STATEMENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION CONTAINED IN THIS PROSPECTUS
This prospectus contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales, profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,” “should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,” “continuing,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend” or the negative of these words or other variations on these words or comparable terminology. These statements may be found under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” as well as in this prospectus generally. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this prospectus generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these forward-looking statements.
The forward-looking statements speak only as of the date on which they are made, and, except to the extent required by federal securities laws, we undertake no obligation to publicly update any forward-looking statements, whether as the result of new information, future events, or otherwise.
| 19 |
USE OF PROCEEDS
We want to raise a maximum of $2,000,000 in this offering. We are requiring no minimum offering proceeds threshold. The table below summarizes how we will utilize the proceeds of this offering, including in the event that the Company raises less than the full amount expected ($2,000,000). The actual amount of proceeds realized may differ from the amounts summarized below.
The amounts set forth above are estimates by management for the allocations of the net proceeds of this offering based upon the current state of our business operations, our business plan and current economic and industry conditions.
| If
10% ($200,000) |
If
25% ($500,000} |
If
50% ($1,000,000) |
If 75% ($1,500,000) | If 100% ($2,000,000) | ||||||||||||||||
| Satisfaction of Convertible Debt | $ | 0 | $ | 350,000 | $ | 350,000 | $ | 350,000 | $ | 350,000 | ||||||||||
| DCell Vax Studies and Investigational New Drug Preparation | $ | 0 | $ | 0 | $ | 600,000 | $ | 0 | $ | 600,000 | ||||||||||
| Car-T Program In Vitro Studies and Pre Clinical Animal Studies | $ | 0 | $ | 0 | $ | 0 | $ | 750,000 | $ | 750,000 | ||||||||||
| TCell VaxProgram IND enabling Studies IND preparation | $ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| DiffronC
Program In Vitro Experiments, Pre-Clinical Animal Studies,IND Enabling Studies, and IND Preparation |
$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| General Corporate Purposes | $ | 200,000 | $ | 150,000 | $ | 50,000 | $ | 400,000 | $ | 250,000 | ||||||||||
DETERMINATION OF OFFERING PRICE
The shares are being offered at $2.00 per share which equals 94 % of the closing price per share of the common shares of the Company on the OTC Pink Market as of March 20, 2023.
PLAN OF DISTRIBUTION
Up to 1,000,000 shares of our common stock(“Shares”) will be sold through our sole director and officer David R. Koos, who may be considered an underwriter as that term is defined in Section 2(a) (11). Mr. Koos will not receive any commission in connection with the sale of Shares, although we may reimburse her for direct expenses incurred by her in connection with the offer and sale of the Shares.
Shares may be purchased by completing and executing a subscription agreement and delivering it to our offices with payment in full for all common shares one wishes to purchase. A copy of the form of that subscription agreement is attached as an exhibit to our registration statement of which this prospectus is a part. A subscription shall not become effective until accepted by us.
| 20 |
DILUTION
The following unaudited table illustrates the dilution on a per share of common stock basis under the scenarios of the Company achieving the sale of 10%, 25%, 50%, 75% and 100% of this offering*:
| If 10% of | If 25% of | If 50% of | If 75% of | If 100% of | ||||||||||||||||
| shares sold | shares sold | shares sold | shares sold | shares sold | ||||||||||||||||
| Book value per share before offering | $ | (1.285 | ) | $ | (1.285 | ) | $ | (1.285 | ) | $ | (1.285 | ) | $ | (1.285 | ) | |||||
| Book value per share after offering | $ | (1.20 | ) | $ | (1.08 | ) | $ | (0.90 | ) | $ | (0.74 | ) | $ | (0.60 | ) | |||||
| Net increase to original shareholders | $ | 0.085 | $ | 0.20 | $ | 0.38 | $ | 0.54 | $ | 0.685 | ||||||||||
| Decrease in investment to new shareholders | $ | (3.2 | ) | $ | (3.08 | ) | $ | (2.90 | ) | $ | (2.74 | ) | $ | (2.60 | ) | |||||
| Dilution percentage to new shareholders | 160 | % | 154 | % | 145 | % | 137 | % | 130 | % | ||||||||||
* Based on book value as of 12/31/2022
DESCRIPTION OF SECURITIES TO BE REGISTERED
The Company is registering for sale 1,000,000 shares of our common stock .
The par value of our common stock is $0.0001. There are 5,800,000,000 shares authorized and 3,381,366 shares issued and outstanding as of April 10, 2023.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any
voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out
of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Our common shareholders are entitled to dividends if and when declared by the Board of Directors and in accordance with the Company’s
Bylaws as well as the laws of the State of Nevada.
OUR OTHER CLASSES AND SERIES OF SECURITIES BESIDES COMMON SHARES
The Company also has the following classes and series of stock authorized and outstanding.
Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 34 shares issued and outstanding as of April 10 , 2023 739,000,000 is designated Series A Preferred Stock of which 409,551 shares are outstanding as of April 10 ,2023 60,000,000 is designated Series M Preferred Stock of which 29,338 shares are outstanding as of April 10, 2023 and 20,000 is designated Series NC Preferred Stock of which 15,007 shares are outstanding as of April 10,2023.
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
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Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”). The Certificate of Designation was amended effective March 6, 2023 to establish that with respect to each matter submitted to a vote of stockholders of the Corporation each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven (7).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
The Board of Directors of the Company have authorized 739,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one . Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
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On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to
each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number
of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise
required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single
class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
On March 26, 2021 Regen Biopharma, Inc. ( “Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”). The Certificate of Designation was amended effective March 6, 2023 to establish that with respect to each matter submitted to a vote of stockholders of the Corporation each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times three hundred and thirty four (334)
The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
Our common stock is traded on the OTC Pink Market under the symbol “RGBP” and our Series A Preferred stock is traded on the OTC Pink Market under the symbol “RGBPP”. No public market currently exists for any other equity securities of the Company.
Our Transfer Agent is:
Nevada Agency and Transfer Company
50 West Liberty Street, Suite 880
Reno NV 89501
Tel: 775-322-0626
Fax: 775-322-5623
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INTERESTS OF NAMED EXPERTS AND COUNSEL
No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the common stock was employed on a contingency basis, or had, or is to receive, in connection with the offering, a substantial interest, direct or indirect, in the registrant or any of its parents or subsidiaries. Nor was any such person connected with the registrant or any of its parents or subsidiaries as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.
The audited financial statements of the Company included in this prospectus and in the registration statement have been audited by BF Borgers CPA PC
William Aul, our independent legal counsel, has provided an opinion on the validity of our common stock.
BUSINESS
We were incorporated April 24, 2012 under the laws of the State of Nevada. We intend to engage primarily in the development of regenerative medical applications which we intend to license, develop internally or acquire outright from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
As of September 7, 2022 we have not licensed any existing therapies which may be marketed.
Patents and Patent Applications:
The following is a list of intellectual property (“IP”) controlled by either Regen Biopharma, Inc. ( the “Company”) or KCL Therapeutics (“KCL”). KCL is a wholly owned subsidiary of the Company.
IP which has been granted patent protection by the United States Patent and Trademark Office (“USPTO”)
GENE SILENCING OF THE BROTHER OF THE REGULATOR OF IMPRINTED SITES (BORIS)
Provides methods and compositions useful for inhibiting expression of the gene encoding the transcription factor, Brother of the Regulatory of Imprinted Sites (BORIS) by RNA interference. Methods of the present invention can be used to silence BORIS in cancer cells, which results in apoptosis and may be useful as for treating cancer in mammals. The methods of the invention directed to cancer therapy can be used alone or in combination with standard cancer treatments such as surgery, radiation, chemotherapy, and immunotherapy.
Patent No: 8263571
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METHODS AND MEANS OF GENERATING IL-17 ASSOCIATED ANTITUMOR EFFECTOR CELLS BY INHIBITION OF NR2F6 INHIBITION
Means, methods, and compositions of matter useful for generation of cancer inhibitory effector cells producing interleukin-17 (IL-17). In one embodiment a cellular population is obtained, said cellular population is exposed to agents capable of inhibiting NR2F6, whereby said inhibition of NR2F6 results in upregulation of IL-17 production, said upregulation of IL-17 production associated with acquisition of anti-tumor activity.
Patent No : 11,053,503
METHODS OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND
Compositions of matter, protocols and methods of screening test compounds to identifying agonists and antagonists of the orphan nuclear receptor NR2F6 by measuring the ability of a test compound to occupy the active site of NR2F6, in the presence of a reference compound.
Patent No: 10,088,485
MODULATION OF NR2F6 AND METHODS AND USES THEREOF
The application provides methods of modulating NR2F6 in a cell or animal in need thereof by administering an effective amount of a NR2F6 modulator
Patent No: 9091696
“UNIVERSAL DONOR CHECKPOINT INHIBITOR SILENCED/GENE EDITED CORD BLOOD KILLER CELLS”
The invention encompasses compositions of matters, cells, and treatment protocols useful for induction of anticancer responses in a patient suffering from cancer. In one embodiment the invention provides the use of NR2F6 silencing or gene editing in cord blood cells possessing anti-tumor activity in order to induce potentiated killer cells suitable for therapeutic use. In one embodiment said allogeneic cord blood killer cells are administered to initiate a cascade of antitumor immune responses, with initially responses mediated by allogeneic killer cells, and followed by endogenous immune responses.
Patent No: 11,141,471 B2
ANTIGEN SPECIFIC MRNA CELLULAR CANCER VACCINES
Antigen specific cancer vaccines in which immunogenic epitopes are produced intracellularly by administration of modified mRNA encoding said immunogenic epitopes. In one embodiment of the invention, said modified mRNA encodes peptides derived from the protein survivin. By directly inducing gene expression of the antigens to which an immune response is desired, immunogenic peptides are generated intracellularly, thus allowing for a wider repertoire of epitopes to be presented to the adaptive immune system, which augments likelihood of successful induction of immunity.
Patent No. 11,090,332
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METHOD OF CANCER TREATMENT USING SIRNA SILENCING
Comprises administering to a subject one or more siRNA constructs capable of inhibiting the expression of an immunosuppressive molecule. The invention also provides siRNA constructs and compositions.
Patent No: 8389708
SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS.
Patent No. 11,324,719
The invention relates to compounds useful to alteration of NR2F6 activity.
Active Patent Applications:
ENHANCED DENDRITIC CELL IMMUNE ACTIVATION BY COMBINED INHIBITION OF NR2F6 WITH CANNIBIDIOL;
Application Number 17035955
REDUCTION OF POST-SURGERY CANCER METASTASIS BY COMBINATION OF CANNABIDIOL AND NR2F6 INHIBITION.
Application Number 17037284
SUPPRESSION OF PATHOLOGICAL ANGIOGENESIS BY INHIBITION OF NR2F6
Application Number 17087386
STIMULATION OF T REGULATORY CELLS BY CANNABIDIOL AS A MEANS OF TREATING ARTHRITIS AND AUTOIMMUNITY
Application Number 17010720
SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS
Application Number 15820324
SMALL MOLECULE MODULATORS OF NR2F6 ACTIVITY.
Application Number 15652967
NR2F6 INHIBITED CHIMERIC ANTIGEN RECEPTOR CELLS
Application Number 15351414
COMBINATION THERAPY OF SOLID TUMORS USING CHIMERIC ANTIGEN RECEPTOR CELLS REPRESENTING ADAPTIVE AND INNATE IMMUNITY
Application Number 63400740
ENHANCEMENT OF CHIMERIC ANTIGEN RECEPTOR T CELL EFFICACY BY DEDIFFERENTIATION
Application Number 63396419
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AUGMENTATION OF SURVIVIN MODIFIED MRNA VACCINE EFFICACY USING DENDRITIC CELLS
Application Number 63391889
Treatment of Liver Cancer through Embolization Depot Delivery of BORIS Gene Silencing Agents
Application Number US-2017166896-A1
Immune Modulation by TLR Activation for Treatment of Filovirus Infections Including Ebola
Application Number US-2016151469-A1
Stimulation of Immunity to Tumor Specific and Endothelial Specific Proteins by in vivo DC Attraction and Maturation
Application Number US-2016074489-A1
Cells, Compositions, and Treatment Methods for Stimulation of Hematopoiesis
Application Number US-2015037303-A1
Cancer Therapy by ex vivo Activated Autologous Immune Cells
Application Number US-2014065096-A1
Acceleration of Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells
Application Number US-2013309210-A1
License Agreements:
On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to Regen one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
The abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly within the 14 trading days prior to issuance.
Pursuant to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).
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Zander is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The Agreement may be terminated by Regen:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to Regen with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property ( “License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years from April 7, 2021.
The License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized by the immune system.
As consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) | pay to Regen a nonrefundable fee of $55,000 no later than April 20,2021 |
| (b) | pay to Regen royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter. |
| (c) | pay to Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment. |
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
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In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
On April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby KCL granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from April 7, 2021.
As consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:
| (a) | pay to KCL a nonrefundable fee of Fifty Thousand common shares of Oncology Pharma, Inc. no later than April 20,2021 |
| (b) | pay to KCL royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter. |
| (c) | pay to KCL ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which KCL receives payment. |
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
Zander and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics Inc.
Both Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”) in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval would be granted.
Principal Products and Services
The Company has begun development of HemaXellerate, a cellular therapy designed to heal damaged bone marrow. HemaXellerate is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based in previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).
Adipose tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic vessels and which play a vital role in angiogenesis (the physiological process through which new blood vessels form from pre-existing vessels).
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The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.
The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan designation for HemaXellerate.
On December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body, treated with siRNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.
The dendritic cells that are treated with the IDO-blocking RNA become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO in the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene-silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to last one year, with tumor assessment before therapy and at 6 and 12 months.
On May 12, 2021 the “Company executed a consulting agreement with Biotech Research Group Corporation, an FDA Specialist Group and Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s inactive Investigational New Drug applications (INDs) #15376 (HemaXellerate) and #16200 (dCellVax) filed with the United States Food and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical trials.
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tCellVax is intended to be a therapy where immune cells are removed from the cancer patient, treated with siRNA which inhibits NR2F6 and the cells re-infused to the patient. NR2F6 normally acts as a brake on the ability of various immune cells from being activated. The immune cells that are treated with the NR2F6-blocking siRNA become highly activated and can efficiently kill tumors. . The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing safety and feasibility of the dCellVax gene-silenced immune cell immunotherapy for treating patients with solid tumors that are metastatic or not able to be removed surgically. The proposed trial will recruit 25 patients with metastatic cancer and will involve 3 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to last one year, with tumor assessment before therapy and at 6 and 12 months.
DiffronC: NR2F6 is a transcription factor that is present in many cells in the body, including immune cells but also highly expressed in certain solid tumors. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. The Company has developed a proprietary drug that is based on shRNA technology, which prevents NR2F6 from being expressed. By inhibiting the expression of NR2F6, immune cells that are treated with the NR2F6-blocking shRNA become highly activated and can efficiently kill tumors and tumors that have NR2F6 suppressed begin to differentiate. . We are currently in pre-clinical testing of this drug to optimize its delivery in vivo.
DuraCar: DuraCar is a new cellular therapy being developed by the Company. It is comprised of CAR-T cells which have been treated with an shRNA targeting the gene NR2F6. CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that have been modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor. These CAR-T cells are then re-infused back into the patient. The CAR-T cells then home in directly on the tumor because they have been given the tumor-specific address via the CAR. While CAR-T cells are very effective in treating leukemias, they are not effective at treating most solid tumors. The reason for this is believed to be that the CAR-T cells are “turned-off” by the physical environment surround solid tumors. By inhibiting NR2F6, we expect our DuraCar cells to have greater efficacy and persistence than conventional CAR-T cells and create a new, optimal way to manufacture CAR-T cells. We are currently in pre-clinical testing of this drug.
Small molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. By inhibiting the function of NR2F6 using small molecules, immune cells that are treated with the NR2F6-blocking agents, similar to using the shRNA approach, should become highly activated and efficiently kill tumors. In addition, tumors that have NR2F6 blocked by using these small molecules should begin to differentiate. Conversely, activating NR2F6 is expected to suppress the immune system. This ability to suppress the immune system can be very useful for treating autoimmune disorders. We are currently in pre-clinical testing of these drugs.
Research Conducted
The Company has begun development of HemaXellerate, a cellular therapy designed to heal damaged bone marrow. HemaXellerate is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based in previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).
Adipose tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic vessels and which play a vital role in angiogenesis (the physiological process through which new blood vessels form from pre-existing vessels).
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The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.
The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan designation for HemaXellerate.
On December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
The costs to perform this Phase I clinical trial is estimated to be approximately $5,000,000 and it is estimated to take 1 year to complete.
The company is developing another cell therapy product termed dCellVax. dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body, treated with siRNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.
The dendritic cells that are treated with the IDO-blocking RNA become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO in the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene-silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to cost $5,000,000 and last one year, with tumor assessment before therapy and at 6 and 12 months.
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On May 12, 2021 the “Company executed a consulting agreement with Biotech Research Group Corporation, an FDA Specialist Group and Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s inactive Investigational New Drug applications (INDs) #15376 (HemaXellerate) and #16200 (dCellVax) filed with the United States Food and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical trials.
Another cell therapy that focuses on a different mechanism of action than dCellVax is tCellVax. tCellVax is intended to be a therapy in which immune cells are removed from the cancer patient, treated with siRNA which inhibits NR2F6 and the cells re-infused to the patient. NR2F6 normally acts as a brake on the ability of various immune cells from being activated. The immune cells that are treated with the NR2F6-blocking siRNA become highly activated and can efficiently kill tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing safety and feasibility of the dCellVax gene-silenced immune cell immunotherapy for treating patients with solid tumors that are metastatic or not able to be removed surgically. The proposed trial will recruit 25 patients with metastatic cancer and will involve 3 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to cost $5,000,000 and last one year, with tumor assessment before therapy and at 6 and 12 months.
DiffronC: NR2F6 is a transcription factor that is present in many cells in the body, including immune cells but also highly expressed in certain solid tumors. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. The Company has developed a proprietary drug that is based on shRNA technology, which prevents NR2F6 from being expressed. By inhibiting the expression of NR2F6, immune cells that are treated with the NR2F6-blocking shRNA become highly activated and can efficiently kill tumors and tumors that have NR2F6 suppressed begin to differentiate. . We are currently in pre-clinical testing of this drug to optimize its delivery in vivo. The two main risks associated with this drug development plan is that the NR2F6 siRNA is not effective at inhibiting NR2F6 expression or that this inhibition will not result in immune cells with enhanced tumoricidal activity.
DuraCar: DuraCar is a new cellular therapy being developed by the Company. It is comprised of CAR-T cells which have been treated with an shRNA targeting the gene NR2F6. CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that have been modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor. These CAR-T cells are then re-infused back into the patient. The CAR-T cells then home in directly on the tumor because they have been given the tumor-specific address via the CAR. While CAR-T cells are very effective in treating leukemias, they are not effective at treating most solid tumors. The reason for this is believed to be that the CAR-T cells are “turned-off” by the physical environment surround solid tumors. By inhibiting NR2F6, we expect our DuraCar cells to have greater efficacy and persistence than conventional CAR-T cells and create a new, optimal way to manufacture CAR-T cells. We have engaged two contract research organizations to advance our pre-clinical testing of this drug. Pre-clinical testing includes design and construction of the relevant plasmids, efficient transfection of T cells, assessment of the expression levels of the siRNA directed at NR2F6 and measurement of its effectiveness at inhibition of NR2F6 expression. Then, these cells will be analyzed for enhanced tumor-killing activity. The two main risks associated with this drug development plan is that the NR2F6 siRNA is not effective at inhibiting NR2F6 expression or that this inhibition will not result in a T cell with enhanced tumoricidal activity. Successful completion of these pre-clinical experiments will significantly de-risk the project.
Small Molecule Drugs: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. By inhibiting the function of NR2F6 using small molecules, immune cells that are treated with the NR2F6-blocking agents, similar to using the shRNA approach, should become highly activated and efficiently kill tumors. In addition, tumors that have NR2F6 blocked by using these small molecules should begin to differentiate. Conversely, activating NR2F6 is expected to suppress the immune system. This ability to suppress the immune system can be very useful for treating autoimmune disorders. We are currently in pre-clinical testing of these drugs.
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Distribution methods of the products or services:
It is anticipated that Regen and /or KCL will enter into licensing and/or sublicensing agreements with outside entities in order that Regen and/or KCL may obtain royalty income on the products and services which it may develop and commercialize.
Competitive business conditions and Regen’s competitive position in the industry and methods of competition
We have yet to achieve significant revenues or profits. The pharmaceutical and biologics industries in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.
We intend to be competitive by utilizing the services and advice of individuals that we believe have expertise in their field in order that we can concentrate our resources on projects in which products and services in which we have the greatest potential to secure a competitive advantage may be developed and commercialized . The Company’s intent is to enter into nonemployee consulting agreements with individuals who we believe have a high level of expertise in their professional fields and who have agreed to provide counsel and assistance to us in (a) determining the viability of proposed projects (b) obtaining financing for projects and (c) obtaining the resources required to initiate and complete a project in the most cost effective and rapid manner.
Sources and availability of raw materials and the names of principal suppliers
The supplies and materials required to conduct our operations are available through a wide variety of sources and may be obtained through a wide variety of sources.
Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.
The US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics.
Our domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals, an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans.
Phase I
Phase 1 trials are designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses usually are a fraction of the dose that causes harm in animal testing and involve a small group of healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have end-stage disease and lack other treatment options.
Phase II
Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II trials are performed on larger groups.
Phase III
Phase III trials are aimed at being the definitive assessment of how effective the product is in comparison with current best standard treatment and to provide an adequate basis for physician labeling. Phase III trials may also be conducted for the purposes of (i) “label expansion” (to show the product works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing or (ii) to obtain additional safety data, or to support marketing claims for the product.
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On occasion Phase IV (Post Approval) trials may be required by the FDA. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.
All phases, must be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans. Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application (“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict the export of therapeutic products for clinical use prior to NDA or BLA approval.
Even after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in FDA-ordered product recall, or in FDA-imposed limitations on permissible
The FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced in compliance with Current Good Manufacturing Practices (“cGMP”) . The FDA also regulates the content of advertisements used to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.
Sales of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval
Amount spent during the fiscal year ended September 30, 2021 on research and development activities
During the fiscal year ended September 30, 2021 we expended $36,704 on research and development activities.
Costs and effects of compliance with environmental laws (federal, state and local)
Regen has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.
Number of total employees and number of full-time employees
As of September 1, 2022 the Company has 1 full time employee.
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PROPERTIES
The Company currently occupies 2,320 square feet of office space at 4700 Spring Street, Suite 304, La Mesa, California 91942. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet the aforementioned office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022. BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
LEGAL PROCEEDINGS
There are no material pending legal proceedings to which the Company is a party or of which any of the Company’s property is the subject.
MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
The par value of our common stock is $0.0001. There are 5,800,000,000 shares authorized and 3,381,366 shares issued and outstanding as of April 10, 2023
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any
voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out
of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Our common shareholders are entitled to dividends if and when declared by the Board of Directors and in accordance with the Company’s
Bylaws as well as the laws of the State of Nevada.
The Company also has the following classes and series of stock authorized and outstanding.
Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 34 shares issued and outstanding as of April 10, 2023 , 739,000 is designated Series A Preferred Stock of which 409,551 shares are outstanding as of April 10, 2023 , 60,000,000 is designated Series M Preferred Stock of which 29,338 shares are outstanding as of April 10,2023 and 20,000 is designated Series NC Preferred Stock of which 15,007 shares are outstanding as of April 10, 2023
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
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Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven (7). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
The Board of Directors of the Company have authorized 540,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one . Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
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If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to
each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number
of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise
required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single
class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
On March 26, 2021 Regen Biopharma, Inc. ( “Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”).
The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 500,000. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
Our common stock is traded on the OTC Pink Market operated by OTC Markets Group under the symbol “RGBP” and our Series A Preferred stock is traded on the OTC Pink Market under the symbol “RGBPP”. No public market currently exists for any other equity securities of the Company.
We had approximately 454 holders of record of our common stock as of March 20, 2023.
We have never paid any cash dividends on our common stock. We currently anticipate that we will retain all future earnings for use in our business. Consequently, we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends in the future will depend upon our results of operations, as well as our short term and long-term cash availability, working capital, working capital needs, and other factors as determined by our Board of Directors. Currently, except as may be provided by applicable laws, there are no contractual or other restrictions on our ability to pay dividends if we were to decide to declare and pay them.
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Below is the range of high and low bid information for our common equity for each quarter within the last two fiscal years. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.
All stock prices have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| October 1, 2021 to September 30, 2022 | HIGH | LOW | ||||||
| First Quarter | $ | 53.23 | $ | 12.23 | ||||
| Second Quarter | $ | 24.18 | $ | 8.21 | ||||
| Third Quarter | $ | 16.72 | $ | 5.13 | ||||
| Fourth Quarter | $ | 19.70 | $ | 5.52 | ||||
| October 1, 2020 to September 30, 2021 | HIGH | LOW | ||||||
| First Quarter | $ | 4.48 | $ | .30 | ||||
| Second Quarter | $ | 7.31 | $ | .89 | ||||
| Third Quarter | $ | 122.23 | $ | 2.98 | ||||
| Fourth Quarter | $ | 121.64 | $ | 18.66 | ||||
Below is the range of high and low bid information for our common equity for each quarter for which interim financial statements are included in this document. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.
All stock prices have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| October 1, 2022 to December 31, 2022 | HIGH | LOW | ||||||
| First Quarter | $ | 10.89 | $ | 5.89 | ||||
On April 10, 2023 the closing price of the common shares was $1.92 per share.
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FINANCIAL STATEMENTS
| REGEN BIOPHARMA , INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| As of | As of | |||||||
| December
31, 2022 (Unaudited) | September 30, 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | $ | ||||||
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| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | ||||||||
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| Accrued payroll taxes | ||||||||
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| Convertible Notes Payable Less unamortized discount | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||
| Total Current Liabilities | ||||||||
| Long Term Liabilities: | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||
| Total Long Term Liabilities | ||||||||
| Total Liabilities | ||||||||
| STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Common Stock ($ par value) 500,000,000 shares authorized; authorized and issued and outstanding as of September 30,2022 and shares issued and outstanding as of December 31, 2022. | ||||||||
| Preferred Stock, par value, authorized as of September 30,2022 and December 31, 2022 respectively | ||||||||
| Series A Preferred authorized as of December 31, 2022 and authorized as of September 30, 2022; and outstanding as of September 30,2022 and December 31, 2022 respectively | ||||||||
| Series AA Preferred $ par value authorized and and outstanding as of September 30, 2022 and December 31,2022 respectively. | ||||||||
| Series M Preferred $ par value authorized and outstanding as of December 31, 2022 and authorized and outstanding as of September 30, 2022 | ||||||||
| Series NC Preferred $ par value authorized and outstanding as of December 31, 2022 and September 30,2022 respectively | ||||||||
| Additional Paid in capital | ||||||||
| Contributed Capital | ||||||||
| Retained Earnings (Deficit) | ( | ) | ( | ) | ||||
| Total Stockholders' Equity (Deficit) | ( | ) | ( | ) | ||||
| TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT) | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
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| REGEN BIOPHARMA , INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (Unaudited) | ||||||||
| Quarter Ended December 31, 2022 | Quarter Ended December 31, 2021 | |||||||
| REVENUES | ||||||||
| Revenues | $ | $ | ||||||
| Revenues, Related Party | ||||||||
| TOTAL REVENUES | ||||||||
| COST AND EXPENSES | ||||||||
| Research and Development | ||||||||
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| Consulting and Professional Fees | ||||||||
| Rent | ||||||||
| Total Costs and Expenses | ||||||||
| OPERATING INCOME (LOSS) | $ | ( | ) | $ | ( | ) | ||
| OTHER INCOME & (EXPENSES) | ||||||||
| Interest Income | ||||||||
| Interest Expense | ( | ) | ( | ) | ||||
| Interest Expense attributable to Amortization of Discount | ( | ) | ||||||
| Penalties | ||||||||
| Unrealized Gain ( Loss) on sale of Investment Securities | ( | ) | ||||||
| Gain(Loss) on sale of Investment Securities | ||||||||
| Gain (Loss) on derecognition of Accounts Payable | ||||||||
| Derivative Income (Expense) | ||||||||
| Financing Fees | ||||||||
| Legal Settlement | ||||||||
| Gain (Loss) on Extinguishment Convertible Debt | ( | ) | ||||||
| TOTAL OTHER INCOME (EXPENSE) | ||||||||
| NET INCOME (LOSS) | $ | $ | ||||||
| NET INCOME (LOSS) attributable to common shareholders | $ | $ | ||||||
| BASIC AND FULLY DILUTED EARNINGS (LOSS) PER SHARE | $ | $ | ||||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||
The Accompanying Notes are an Integral Part of These Financial Statements
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
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REGEN BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY ( DEFICIT)
(unaudited)
Quarters Ended December 31, 2021 and December 31, 2022
| Series A Preferred | Series AA Preferred | Series NC Preferred | Common | Series M Preferred | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Retained Earnings | Contributed Capital | Total | ||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2021 | Balance September 30, 2021 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11-04-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11-04-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12-10-2021 | Shares issued for Debt | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 12-10-2021 | Shares issued for Interest | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended December 31,2021 | Net Loss for the Quarter Ended December 31,2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31, 2021 | Balance December 31, 2021 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2022 | Balance September 30, 2022 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | 10/25/2022 | Preferred Shares Issued for Nonemployee Services | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Debt | 11-11-2022 | Preferred Shares Issued for Debt | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Interest | 11-11-2022 | Preferred Shares Issued for Interest | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares Issued For Interest | 11-11-2022 | Common Shares Issued For Interest | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | 12-05-2022 | Preferred Shares Issued for Nonemployee Services | $ | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income for the Quarter ended December 31, 2022 | Net Income for the Quarter ended December 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31, 2022 | Balance December 31, 2022 | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| 42 |
| REGEN BIOPHARMA , INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| (Unaudited) | ||||||||
| Quarter Ended | Quarter Ended | |||||||
| December 31, 2022 | December 31, 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net Income (loss) | $ | $ | ||||||
| Adjustments to reconcile net Income to net cash | ||||||||
| Common Stock issued for Expenses | ||||||||
| Preferred Stock issued as compensation | ||||||||
| Increase (Decrease) in Interest expense attributable to amortization of Discount | ||||||||
| Increase (Decrease) in Accounts Payable | ( | ) | ||||||
| (Increase) Decrease in Accounts Receivable | ( | ) | ||||||
| Increase (Decrease) in accrued Expenses | ||||||||
| (Increase) Decrease in Prepaid Expenses | ||||||||
| Increase(Decrease) in Contributed Capital | ||||||||
| Increase ( Decrease) in Derivative Expense | ( | ) | ( | ) | ||||
| Increase ( Decrease) in Unearned Income | ( | ) | ( | ) | ||||
| Increase ( Decrease) in Penalties | ||||||||
| (Increase( Decrease in Notes Receivable | ||||||||
| (Increase( Decrease in Accrued Interest Receivable | ( | ) | ||||||
| Securities accepted as compensation | ||||||||
| (Gain) Loss on forgiveness of Debt | ( | ) | ||||||
| Increase (Decrease) in Loss on Sale of Investment Securities | ||||||||
| Unrealized Loss(Gain) on Investment Securities | ||||||||
| Net Cash Provided by (Used in) Operating | ||||||||
| Net Cash Provided by (Used in) Operating | $ | ( | ) | $ | ( | ) | ||
| CASH FLOWS FROM INVESTMENT ACTIVITIES | ||||||||
| Increase(Decrease) in Sale of Investment Securities | ||||||||
| Net Cash Provided By Investment Activities | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | 0 | 0 | ||||||
| (Decrease) in Notes Payable | ||||||||
| Increase (Decrease) in Convertible Notes Payable | ( | ) | ||||||
| Net Cash Provided by (Used in) Financing Activities | ( | ) | ||||||
| Net Increase (Decrease) in Cash | $ | ( | ) | $ | ( | ) | ||
| Cash at Beginning of Period | $ | $ | ||||||
| Cash at End of Period | $ | $ | ||||||
| Supplemental Disclosure of Noncash investing and financing activities: | ||||||||
| Common shares Issued for Debt | $ | $ | ||||||
| Preferred Shares Issued for Debt | $ | $ | ||||||
| Cash Paid for Interest | $ | $ | ||||||
| Common shares Issued for Interest | $ | $ | ||||||
| Preferred Shares issued for Interest | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
| 43 |
REGEN BIOPHARMA, INC.
Notes to Condensed Consolidated Financial Statements
As of December 31, 2022
These Notes have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company was organized April 24, 2012 under the laws of the State of Nevada
The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The Company is currently engaged in actively identifying small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune disease.
The Company is in the early stages of development of its proposed products and therapies. The Company will be required to obtain approval from the FDA in order to market any of The Company’s products or therapies. No approval has been granted by the FDA for the marketing and sale of any of the Company’s products and therapies and no assurance may be given that any of the Company’s products or therapies will be granted such approval. The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The Company can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.
A. BASIS OF ACCOUNTING
The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.
B. PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of KCL Therapeutics, Inc., a Nevada corporation and wholly owned subsidiary of Regen. Significant inter-company transactions have been eliminated.
The Company analyzes the conversion feature of Convertible Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change. The Company values the embedded derivative using the Black-Scholes pricing model.
The Black Scholes pricing model used to determine the Derivative Liability on convertible notes issued by the Company in which an embedded derivative is recognized as of December 31, 2022 utilized the following inputs:
| Risk Free Interest Rate | % | |||
| Expected Term | () – () Yrs | |||
| Expected Volatility | % | |||
| Expected Dividends | ||||
| 44 |
H. INCOME TAXES
The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.
The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of December 31, 2021 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.
The
Company generated a deferred tax credit through net operating loss carry forward. However, a valuation allowance of
Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.
The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, “Earnings Per Share”, which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.
Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.
J. ADVERTISING
Costs
associated with advertising are charged to expense as incurred. Advertising expenses were $
K. NOTES RECEIVABLE
Notes receivable are stated at cost, less impairment, if any.
| 45 |
L. REVENUE RECOGNITION
Sales of products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically met upon the prepayment or invoicing and shipment of products.
The Company determines the amount and timing of royalty revenue based on its contractual agreements with intellectual property licensees. The Company recognizes royalty revenue when earned under the terms of the agreements and when the Company considers realization of payment to be probable. Where royalties are based on a percentage of licensee sales of royalty-bearing products, the Company recognizes royalty revenue by applying this percentage to the Company’s estimate of applicable licensee sales. The Company bases this estimate on an analysis of each licensee’s sales results. Where warranted, revenue from licensees for contractual obligations such as License Initiation Fees are recognized upon satisfaction of all conditions required to be satisfied in order for that revenue to have been earned by the Company.
M. INTEREST RECEIVABLE
Interest receivable is stated at cost, less impairment, if any.
NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS
In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-10, which eliminated certain financial reporting requirements of companies previously identified as “Development Stage Entities” (Topic 915). The amendments in this ASU simplify accounting guidance by removing all incremental financial reporting requirements for development stage entities. The amendments also reduce data maintenance and, for those entities subject to audit, audit costs by eliminating the requirement for development stage entities to present inception-to-date information in the statements of income, cash flows, and shareholder equity. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued (public business entities) or made available for issuance (other entities). Upon adoption, entities will no longer present or disclose any information required by Topic 915. The Company has adopted this standard.
As of the fiscal year ending September 30, 2019 the Company has adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606). The guidance in this Update supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific guidance throughout the Industry Topics of the Codification.
The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer. Step 2: Identify the performance obligations in the contract. Step 3: Determine the transaction price. Step 4: Allocate the transaction price to the performance obligations in the contract. Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation.
In June 2014, FASB issued Accounting Standards Update (ASU) No. 2014-12 Compensation — Stock Compensation (Topic 718), Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. A performance target in a share-based payment that affects vesting and that could be achieved after the requisite service period should be accounted for as a performance condition under Accounting Standards Codification (ASC) 718, Compensation — Stock Compensation. As a result, the target is not reflected in the estimation of the award’s grant date fair value. Compensation cost would be recognized over the required service period, if it is probable that the performance condition will be achieved. The guidance is effective for annual periods beginning after 15 December 2015 and interim periods within those annual periods. Early adoption is permitted. The Company has reviewed the applicable ASU and has not, at the current time, quantified the effects of this pronouncement, however it believes that there will be no material effect on the consolidated financial statements.
| 46 |
In August 2014, FASB issued Accounting Standards Update (ASU) No. 2014-15 Preparation of Financial Statements – Going Concern (Subtopic 205-40), Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Under generally accepted accounting principles (GAAP), continuation of a reporting entity as a going concern is presumed as the basis for preparing financial statements unless and until the entity’s liquidation becomes imminent. Preparation of financial statements under this presumption is commonly referred to as the going concern basis of accounting. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting in accordance with Subtopic 205-30, Presentation of Financial Statements—Liquidation Basis of Accounting. Even when an entity’s liquidation is not imminent, there may be conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern. In those situations, financial statements should continue to be prepared under the going concern basis of accounting, but the amendments in this Update should be followed to determine whether to disclose information about the relevant conditions and events. The amendments in this Update are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company will evaluate the going concern considerations in this ASU, however, at the current period, management does not believe that it has met the conditions which would subject these financial statements for additional disclosure.
On January 31, 2013, the FASB issued Accounting Standards Update [ASU] 2013-01, entitled Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities. The guidance in ASU 2013-01 amends the requirements in the FASB Accounting Standards Codification [FASB ASC] Topic 210, entitled Balance Sheet. The ASU 2013-01 amendments to FASB ASC 210 clarify that ordinary trade receivables and receivables in general are not within the scope of ASU 2011-11, entitled Disclosure about Offsetting Assets and Liabilities, where that ASU amended the guidance in FASB ASC 210. As those disclosures now are modified with the ASU 2013-01 amendments, the FASB ASC 210 balance sheet offsetting disclosures now clearly are applicable only where reporting entities are involved with bifurcated embedded derivatives, repurchase agreements, reverse repurchase agreements, and securities borrowing and lending transactions that either are offset using the FASB ASC 210 or 815 requirements, or that are subject to enforceable master netting arrangements or similar agreements. ASU 2013-01 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.
On February 28, 2013, the FASB issued Accounting Standards Update [ASU] 2013-04, entitled Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date. The ASU 2013-04 amendments add to the guidance in FASB Accounting Standards Codification [FASB ASC] Topic 405, entitled Liabilities and require reporting entities to measure obligations resulting from certain joint and several liability arrangements where the total amount of the obligation is fixed as of the reporting date, as the sum of the following:
The amount the reporting entity agreed to pay on the basis of its arrangement among co-obligors.
Any additional amounts the reporting entity expects to pay on behalf of its co-obligors.
While early adoption of the amended guidance is permitted, for public companies, the guidance is required to be implemented in fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments need to be implemented retrospectively to all prior periods presented for obligations resulting from joint and several liability arrangements that exist at the beginning of the year of adoption. The adoption of ASU 2013-04 is not expected to have a material effect on the Company’s operating results or financial position.
| 47 |
On April 22, 2013, the FASB issued Accounting Standards Update [ASU] 2013-07, entitled Liquidation Basis of Accounting. With ASU 2013-07, the FASB amends the guidance in the FASB Accounting Standards Codification [FASB ASC] Topic 205, entitled Presentation of Financial Statements. The amendments serve to clarify when and how reporting entities should apply the liquidation basis of accounting. The guidance is applicable to all reporting entities, whether they are public or private companies or not-for-profit entities. The guidance also provides principles for the recognition of assets and liabilities and disclosures, as well as related financial statement presentation requirements. The requirements in ASU 2013-07 are effective for annual reporting periods beginning after December 15, 2013, and interim reporting periods within those annual periods. Reporting entities are required to apply the requirements in ASU 2013-07 prospectively from the day that liquidation becomes imminent. Early adoption is permitted. The adoption of ASU 2013-07 is not expected to have a material effect on the Company’s operating results or financial position.
In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-01, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, the ASU clarifies guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The new standard is effective for fiscal years and interim periods beginning after December 15, 2017, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted except for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company adopted ASU 2016-01 as of the fiscal year ending September 30, 2019.
In August 2020, FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity; Own Equity (“ASU 2020-06"), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from GAAP separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company has adopted ASU 2020-06 as of the Fiscal Year ending September 30, 2022.
A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies. Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.
NOTE 3. GOING CONCERN
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company generated
net losses of $
Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise.
| 48 |
NOTE 4. NOTES PAYABLE
(a) RELATED PARTY
| As of December 31, 2022 | ||||
| David Koos | $ | |||
| Total: | $ | |||
$
NOTE 5. CONVERTIBLE NOTES PAYABLE
On
March 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(b) For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2") a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(c) For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3") a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0 .10% ( one tenth of one percent)of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
| 49 |
“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of December 31, 2022 $
.
On April 6, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or$150 per share (whichever is greater).
(b) For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2") a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(c) For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3") a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
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The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0 .10% ( one tenth of one percent) of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of December 31 , 2022 $
On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The
Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into
fully paid and non- assessable shares of Common Stock and/or Series A Preferred Stock, as such Stock exists on the Issue Date, or any
shares of capital stock or other securities of the Company into which such Stock shall hereafter be changed or reclassified at a conversion
price of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
As
of December 31, 2022 $
On May 5, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iii) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $75 per share.
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The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of December 31, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
December 20, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”).
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of December 31, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
October 3, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”).
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of December 31, 2022, $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
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Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of December 31, 2022,
Zander and Regen are under common control. Zander Therapeutics, Inc. is the sole licensee of Regen’s NR2F6 intellectual property for veterinary applications.
NOTE 6. RELATED PARTY TRANSACTIONS
On June 23, 2015 the Company entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to The Company one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
The abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander.
Pursuant to the Agreement, Zander shall pay to The Company royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant to the Agreement, Zander will pay The Company ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which The Company receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to The Company minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The Agreement may be terminated by The Company:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
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The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to The Company with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to The Company with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On December 16, 2019 Zander Therapeutics, Inc. (“Zander”), KCL Therapeutics, Inc. (“KCL”) and Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) whereby:
1) Zander shall return for cancellation 194,285,714 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired by Zander through conversion of $340,000 of principal indebtedness of a $350,000 convertible note payable issued by Regen to Zander. Subsequent to this event the principal amount due to Zander by Regen pursuant to the Convertible Note shall be $350,000 which shall be applied pursuant to the Agreement.
2) A $35,000 one time charge due to Zander by Regen (“One Time Charge”) shall be applied pursuant to the Agreement.
3) $75,900 of principal indebtedness due to Regen by Zander and $4,328 of accrued but unpaid interest due by Regen to Zander shall be applied pursuant to the Agreement.
No actions were taken by any of the parties to enforce the terms of the Agreement.
On April 15, 2021 the Agreement was amended as follows so that the material terms and conditions shall be:
a) Zander shall not return the Conversion shares for cancellation and the principal indebtedness of the aforementioned convertible note shall not reflect such return
b) As of December 16, 2019 all principal and accrued interest payable by Regen to Zander on that date resulting from Promissory Notes issued by Regen to Zander shall be credited towards amounts due by Zander pursuant to that agreement, as amended, entered into by and between Zander and Regen on June 23, 2015 (“License Agreement”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen for non-human veterinary therapeutic use for a term of fifteen years and that License Assignment And Consent agreement entered into by and between Regen, KCL and Zander on December 17, 2018 whereby Regen transferred and assigned to KCL all rights, duties, and obligations of Regen under the License Agreement and KCL agreed to assume such duties and obligations thereunder and be bound to the terms of the License Agreement with respect thereto.
Zander and Regen are under common control.
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On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of December 31, 2022, $
On October 8,2021 the Company entered into an agreement with Dr. Brian Koos, MD PhD whereby Dr. Brian Koos would provide services to the Company consisting of :
a) Reviewing existing publications on research being conducted on Checkpoint NR2F6.
b) Identifying the most promising applications for the Company’s technology
c) Drafting a “white paper” on results for 1(b)
d) Making introductions to known experts in appropriate fields identified in 1(b).
Dr. Brian Koos is to be paid compensated $117,000 as total consideration for performing the abovementioned tasks. During the quarter ended December 31, 2021 Dr. Brian Koos was paid the amount of $80,275 and during the quarter ended March 31, 2022 Dr. Brian Koos was paid $36,975. Dr. Brian Koos is the brother of David Koos the Chairman and Chief Executive Officer of the Company.
As
of December 31, 2022 the Company is indebted to David R. Koos the Company’s sole officer and director in the amount of $. $
During the quarter ended December 31, 2021 the Company paid $5,000 of rental expenses to the landlord of BST Partners as consideration to BST Partners for use of office space. BST Partners is controlled by David R. Koos the Chairman and Chief Executive Officer of the Company.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022.
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
NOTE 7. ACCOUNTS RECEIVABLE, RELATED PARTY
Accounts Receivable due from Related Party as of December 31, 2022 consists solely of amounts earned by the Company not yet paid resulting from the Company’s license agreement with KCL Therapeutics (See Note 6).
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NOTE 8. STOCKHOLDERS’ EQUITY
The stockholders’ equity section of the Company contains the following classes of capital stock as of December 31, 2022:
Common stock, $ 0 par value; shares authorized: shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Preferred Stock, $ par value, shares authorized of which is designated as Series AA Preferred Stock: shares issued and outstanding as of December 31, 2022, is designated Series A Preferred Stock of which shares are outstanding as of December 31, 2022, is designated Series M Preferred Stock of which shares are outstanding as of December 31, 2022, and is designated Series NC stock of which shares are outstanding as of December 31, 2022. .
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven (7). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
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The Board of Directors of the Company have authorized 739,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one . Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to
each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number
of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise
required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single
class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
On March 26, 2021 Regen Biopharma, Inc. ( “Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”).
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The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 334. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
NOTE 9. INVESTMENT SECURITIES, RELATED PARY
On June 11, 2018 Regen Biopharma, Inc. was paid a property dividend consisting of of the common shares of Zander Therapeutics, Inc.
On November 29, 2018 the Company accepted shares of the Series M Preferred stock of Zander Therapeutics, Inc. in satisfaction of prepaid rent and accrued interest owed to the Company collectively amounting to $.
On December 31,2022 the Company revalued of the common shares of Zander Therapeutics, Inc. and shares of the Series M Preferred stock of Zander Therapeutics, Inc. based on the following inputs:
| Fair Value of Intellectual Property | $ | |||
| Prepaid Expenses | ||||
| Due from Employee | ||||
| Note Receivable | ||||
| Accrued Interest Receivable | ||||
| Investment Securities | ||||
| Convertible Note Receivable | ||||
| Accounts Payable | ||||
| Notes Payable | ||||
| Accrued Expenses Related Parties | ||||
| Notes Payable Related Party | ||||
| Accrued Expenses | ||||
| Enterprise Value | ||||
| Less: Total Debt | ( | ) | ||
| Portion of Enterprise Value Attributable to Shareholders | ||||
| Fair Value Per Share | $ |
The abovementioned constitute the Company’s sole related party investment securities as of December 31 , 2022.
As of December 31, 2022:
| 470,588 Common Shares of Zander Therapeutics, Inc. | ||||||||||||||
| Basis | Fair Value | Total Unrealized Gains |
Net Unrealized Gain or (Loss) realized during the quarter ended December 31,2022 | |||||||||||
| $ | $ | $ | $ | |||||||||||
| 725,000 Series M Preferred of Zander Therapeutics, Inc. | ||||||||||||||
| Basis | Fair Value | Total Unrealized Gain | Net Unrealized Gain or (Loss) realized during the quarter ended December 31 , 2022 | |||||||||||
| $ | $ | $ | $ | |||||||||||
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NOTE 10. STOCK TRANSACTIONS
On October 25, 2022 the Company issued Series A preferred shares as consideration for nonemployee services
On
November 11, 2022 the Company issued Series A preferred shares in satisfaction of $
On
November 11, 2022 the Company issued common shares in satisfaction of $
On December 5, 2022 the Company issued Series A preferred shares as consideration for nonemployee services.
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Regen Biopharma, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Regen Biopharma, Inc. (the “Company”) as of September 30, 2022 and 2021 and the related consolidated statements of operations, shareholders’ equity, and cash flows for the two years in the period ended September 30, 2022, and the related notes and schedules (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of September 30, 2022 and 2021, and the results of its operations and its cash flows for the two years in the period ended September 30, 2022 and 2021, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Matter
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has suffered recurring losses from operations that raises substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provide a reasonable basis for our opinion.
Critical Audit Matter
Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
We determined that there are no critical audit matters.
/S BF Borgers CPA PC
BF Borgers CPA PC (PCAOB ID 5041)
We have served as the Company’s auditor since 2019
Lakewood, CO
November 15, 2022
| 62 |
| REGEN BIOPHARMA , INC. | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| As of | As of | |||||||
| September 30, 2022 | September 30, 2021 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | $ | ||||||
| Accounts Receivable, Related Party | ||||||||
| Note Receivable, Related Party | ||||||||
| Accrued Interest Receivable | ||||||||
| Prepaid Expenses | ||||||||
| Prepaid Rent | ||||||||
| Total Current Assets | ||||||||
| OTHER ASSETS | ||||||||
| Investment Securities | ||||||||
| Investment Securities, Related Party | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | ||||||||
| Notes Payable | ||||||||
| Accrued payroll taxes | ||||||||
| Accrued Interest | ||||||||
| Accrued Rent | ||||||||
| Accrued Payroll | ||||||||
| Other Accrued Expenses | ||||||||
| Bank Overdraft | ||||||||
| Due to Investor | ||||||||
| Unearned Income | ||||||||
| Derivative Liability | ||||||||
| Convertible Notes Payable Less unamortized discount | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||
| Total Current Liabilities | ||||||||
| Long Term Liabilities: | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||
| Total Long Term Liabilities | ||||||||
| Total Liabilities | ||||||||
| STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Common Stock ($ par value) 500,000,000 shares authorized; authorized and issued and outstanding as of September 30,2022 and authorized and shares issued and outstanding as of September 30 ,2021. | ||||||||
| Preferred Stock, par value, authorized as of September 30,2022 and September 30,2021 respectively | ||||||||
| Series A Preferred authorized as of September 30,2021 and authorized as of September 30, 2022; 293,053 and outstanding as of September 30,2022 and September 30, 2021 respectively. | ||||||||
| Series AA Preferred $ par value authorized and and outstanding as of September 30, 2022 and September 30,2021 respectively. | ||||||||
| Series M Preferred $ par value authorized and outstanding as of September 30, 2021 and authorized and outstanding as of September 30, 2022. | ||||||||
| Series NC Preferred $ par value authorized and outstanding as of September 30, 2021 and September 30, 2022 respectively | ||||||||
| Additional Paid in capital | ||||||||
| Contributed Capital | ||||||||
| Retained Earnings (Deficit) | ( | ) | ( | ) | ||||
| Total Stockholders' Equity (Deficit) | ( | ) | ( | ) | ||||
| TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT) | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| 63 |
| REGEN BIOPHARMA , INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| Year Ended September 30 | Year Ended September 30 | |||||||
| 2022 | 2021 | |||||||
| REVENUES | ||||||||
| Revenues | $ | $ | ||||||
| Revenues, Related Party | ||||||||
| TOTAL REVENUES | $ | |||||||
| COST AND EXPENSES | ||||||||
| Research and Development | ||||||||
| Research and Development, Related Party | ||||||||
| General and Administrative | ||||||||
| Consulting and Professional Fees | ||||||||
| Rent | ||||||||
| Total Costs and Expenses | ||||||||
| OPERATING INCOME (LOSS) | $ | ( | ) | $ | ( | ) | ||
| OTHER INCOME & (EXPENSES) | ||||||||
| Interest Income | ||||||||
| Interest Expense | ( | ) | ( | ) | ||||
| Interest Expense attributable to Amortization of Discount | ( | ) | ( | ) | ||||
| Penalties | ( | ) | ||||||
| Unrealized Gain ( Loss) on sale of Investment Securities | ( | ) | ||||||
| Gain(Loss) on sale of Investment Securities | ( | ) | ( | ) | ||||
| Gain (Loss) on derecognition of Accounts Payable | ||||||||
| Derivative Income (Expense) | ( | ) | ||||||
| Financing Fees | ( | ) | ||||||
| Legal Settlement | ( | ) | ||||||
| Gain (Loss) on Extinguishment Convertible Debt | ( | ) | ||||||
| TOTAL OTHER INCOME (EXPENSE) | ( | ) | ||||||
| NET INCOME (LOSS) | $ | $ | ( | ) | ||||
| NET INCOME (LOSS) attributable to common shareholders | $ | $ | ( | ) | ||||
| BASIC AND FULLY DILUTED EARNINGS (LOSS) PER SHARE | $ | ( | ) | |||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| 64 |
REGEN BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY ( DEFICIT)
(audited)
Years ended September 30, 2021 and September 30, 2022
| Series A Preferred | Series AA Preferred | Series NC Preferred | Common | Series M Preferred | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Retained Earnings | Contributed Capital | Total | |||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2020 | Balance September 30, 2020 | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/28/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 10/28/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11-06-2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 11-06-2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12-11-2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12-11-2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/16/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/16/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Fees | 12/16/2020 | Shares issued for Fees | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/16/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/16/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/17/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/17/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/17/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/17/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/23/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/23/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/31/2020 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares Issued For Interest | 12/31/2020 | Shares Issued For Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Additions to Contributed Capital Quarter ended 12/31/2020 | Additions to Contributed Capital Quarter ended 12/31/2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss Quarter Ended December 31,2020 | Net Loss Quarter Ended December 31,2020 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31, 2020 | Balance December 31, 2020 | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 1/28/2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 2/23/2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 2/24/2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 2/24/2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 03-02-2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 03-02-2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 03-09-2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 03-09-2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 03-12-2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 03-12-2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 3/18/2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 3/18/2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for debt | 3/31/2021 | shares issued for debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| shares issued for interest | 3/31/2021 | shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Additions to Contributed Capital Quarter ended 3/31/2021 | Additions to Contributed Capital Quarter ended 3/31/2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income for the Quarter Ended March 31,2021 | Net Income for the Quarter Ended March 31,2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance March 31, 2021 | Balance March 31, 2021 | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 04-12-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 04-12-2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares issued for Services | 4/13/2021 | Preferred Shares issued for Services | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/13/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/13/2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/13/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/13/2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/15/2021` | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/15/2021` | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/15/2021` | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/15/2021` | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/15/2021` | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/15/2021` | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/16/2021` | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/16/2021` | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/21/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/21/2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/28/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 4/28/2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 05-03-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 05-03-2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 05-05-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for interest | 05-05-2021 | Shares issued for interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 5/18/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Contributed Capital Quarter Ended June 30, 2021 | Contributed Capital Quarter Ended June 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended June 30,2021 | Net Loss for the Quarter Ended June 30,2021 | ( |
) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance June 30, 2021 | Balance June 30, 2021 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/16/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 7/16/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/22/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 7/22/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 08-02-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 09-10-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 09-10-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 9/30/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 9/30/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 9/30/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 9/30/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 9/30/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 9/30/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 9/30/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended September 30,2021 | Net Loss for the Quarter Ended September 30,2021 | ( |
) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2021 | Balance September 30, 2021 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10-01-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10-01-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11-04-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11-04-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12-10-2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 12-10-2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended December 31,2021 | Net Loss for the Quarter Ended December 31,2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31,2021 | Balance December 31,2021 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 3/28/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 3/28/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended March 31, 2022 | Net Loss for the Quarter Ended March 31, 2022 | ( |
) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance March 31, 2022 | Balance March 31, 2022 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 04-05-2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 04-05-2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 04-08-2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 04-08-2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 5/16/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 06-08-2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income for the Quarter Ended June 30, 2022 | Net Income for the Quarter Ended June 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance June 30, 2022 | Balance June 30, 2022 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/15/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 7/15/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/20/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Expenses | 08-04-2022 | Shares issued for Expenses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended September 30, 2022 | Net Loss for the Quarter Ended September 30, 2022 | ( |
) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2022 | Balance September 30, 2022 | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
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| REGEN BIOPHARMA , INC. | ||||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| Year Ended | Year Ended | |||||||
| September 30, 2022 | September 30, 2021 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net Income (loss) | $ | $ | ( | ) | ||||
| Adjustments to reconcile net Income to net cash | ||||||||
| Common Stock issued for Expenses | ||||||||
| Preferred Stock issued as compensation | ||||||||
| Increase (Decrease) in Interest expense attributable to amortization of Discount | ||||||||
| Increase (Decrease) in Accounts Payable | ( | ) | ( | ) | ||||
| (Increase) Decrease in Accounts Receivable | ( | ) | ( | ) | ||||
| Increase (Decrease) in accrued Expenses | ||||||||
| (Increase) Decrease in Prepaid Expenses | ( | ) | ||||||
| Increase(Decrease) in Contributed Capital | ||||||||
| Increase ( Decrease) in Derivative Expense | ( | ) | ||||||
| Increase ( Decrease) in Unearned Income | ( | ) | ||||||
| Increase ( Decrease) in Penalties | ||||||||
| (Increase( Decrease in Notes Receivable | ( | ) | ||||||
| (Increase( Decrease in Accrued Interest Receivable | ( | ) | ||||||
| Securities accepted as compensation | ( | ) | ||||||
| Gain( Loss) on forgiveness of Debt | ( | ) | ||||||
| Increase (Decrease) in Loss on Sale of Investment Securities | ||||||||
| Unrealized Loss(Gain) on Investment Securities | ( | ) | ||||||
| Net Cash Provided by (Used in) Operating | ||||||||
| Net Cash Provided by (Used in) Operating | $ | ( | ) | $ | ( | ) | ||
| CASH FLOWS FROM INVESTMENT ACTIVITIES | ||||||||
| Increase(Decrease) in Sale of Investment Securities | ||||||||
| Net Cash Provided By Investment Activities | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| (Decrease) in Notes Payable | ||||||||
| Increase (Decrease) in Convertible Notes Payable | ( | ) | ||||||
| Net Cash Provided by (Used in) Financing Activities | ( | ) | ||||||
| Net Increase (Decrease) in Cash | $ | ( | ) | $ | ||||
| Cash at Beginning of Period | $ | $ | ||||||
| Cash at End of Period | $ | $ | ||||||
| Supplemental Disclosure of Noncash investing and financing activities: | ||||||||
| Common shares Issued for Debt | $ | $ | ||||||
| Preferred Shares Issued for Debt | $ | $ | ||||||
| Cash Paid for Interest | $ | $ | ||||||
| Common shares Issued for Interest | $ | $ | ||||||
| Preferred Shares issued for Interest | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements.
All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
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REGEN BIOPHARMA, INC.
Consolidated Financial Statements
As of September 30, 2022
These Notes have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company was organized April 24, 2012 under the laws of the State of Nevada
The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The Company is currently engaged in actively identifying small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune disease.
The Company is in the early stages of development of its proposed products and therapies. The Company will be required to obtain approval from the FDA in order to market any of The Company’s products or therapies. No approval has been granted by the FDA for the marketing and sale of any of the Company’s products and therapies and no assurance may be given that any of the Company’s products or therapies will be granted such approval. The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The Company can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.
A. BASIS OF ACCOUNTING
The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.
B. PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of KCL Therapeutics, Inc., a Nevada corporation and wholly owned subsidiary of Regen. Significant inter-company transactions have been eliminated.
The Company analyzes the conversion feature of Convertible Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change. The Company values the embedded derivative using the Black-Scholes pricing model.
The Black Scholes pricing model used to determine the Derivative Liability on convertible notes issued by the Company in which an embedded derivative is recognized as of September 30, 2022 utilized the following inputs:
| Risk Free Interest Rate | % | |||
| Expected Term | () – () Yrs | |||
| Expected Volatility | % | |||
| Expected Dividends |
H. INCOME TAXES
The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.
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The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2021 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.
The
Company generated a deferred tax credit through net operating loss carry forward. However, a valuation allowance of
Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.
The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, “Earnings Per Share”, which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.
Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.
J. ADVERTISING
Costs
associated with advertising are charged to expense as incurred. Advertising expenses were $
K. NOTES RECEIVABLE
L. REVENUE RECOGNITION
Sales of products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically met upon the prepayment or invoicing and shipment of products.
The Company determines the amount and timing of royalty revenue based on its contractual agreements with intellectual property licensees. The Company recognizes royalty revenue when earned under the terms of the agreements and when the Company considers realization of payment to be probable. Where royalties are based on a percentage of licensee sales of royalty-bearing products, the Company recognizes royalty revenue by applying this percentage to the Company’s estimate of applicable licensee sales. The Company bases this estimate on an analysis of each licensee’s sales results. Where warranted, revenue from licensees for contractual obligations such as License Initiation Fees are recognized upon satisfaction of all conditions required to be satisfied in order for that revenue to have been earned by the Company.
M. INTEREST RECEIVABLE
Interest receivable is stated at cost, less impairment, if any.
NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS
In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-10, which eliminated certain financial reporting requirements of companies previously identified as “Development Stage Entities” (Topic 915). The amendments in this ASU simplify accounting guidance by removing all incremental financial reporting requirements for development stage entities. The amendments also reduce data maintenance and, for those entities subject to audit, audit costs by eliminating the requirement for development stage entities to present inception-to-date information in the statements of income, cash flows, and shareholder equity. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued (public business entities) or made available for issuance (other entities). Upon adoption, entities will no longer present or disclose any information required by Topic 915. The Company has adopted this standard.
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As of the fiscal year ending September 30, 2019 the Company has adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606). The guidance in this Update supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific guidance throughout the Industry Topics of the Codification.
The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer. Step 2: Identify the performance obligations in the contract. Step 3: Determine the transaction price. Step 4: Allocate the transaction price to the performance obligations in the contract. Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation.
In June 2014, FASB issued Accounting Standards Update (ASU) No. 2014-12 Compensation — Stock Compensation (Topic 718), Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. A performance target in a share-based payment that affects vesting and that could be achieved after the requisite service period should be accounted for as a performance condition under Accounting Standards Codification (ASC) 718, Compensation — Stock Compensation. As a result, the target is not reflected in the estimation of the award’s grant date fair value. Compensation cost would be recognized over the required service period, if it is probable that the performance condition will be achieved. The guidance is effective for annual periods beginning after 15 December 2015 and interim periods within those annual periods. Early adoption is permitted. The Company has reviewed the applicable ASU and has not, at the current time, quantified the effects of this pronouncement, however it believes that there will be no material effect on the consolidated financial statements.
In August 2014, FASB issued Accounting Standards Update (ASU) No. 2014-15 Preparation of Financial Statements – Going Concern (Subtopic 205-40), Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Under generally accepted accounting principles (GAAP), continuation of a reporting entity as a going concern is presumed as the basis for preparing financial statements unless and until the entity’s liquidation becomes imminent. Preparation of financial statements under this presumption is commonly referred to as the going concern basis of accounting. If and when an entity’s liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting in accordance with Subtopic 205-30, Presentation of Financial Statements—Liquidation Basis of Accounting. Even when an entity’s liquidation is not imminent, there may be conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern. In those situations, financial statements should continue to be prepared under the going concern basis of accounting, but the amendments in this Update should be followed to determine whether to disclose information about the relevant conditions and events. The amendments in this Update are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company will evaluate the going concern considerations in this ASU, however, at the current period, management does not believe that it has met the conditions which would subject these financial statements for additional disclosure.
On January 31, 2013, the FASB issued Accounting Standards Update [ASU] 2013-01, entitled Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities. The guidance in ASU 2013-01 amends the requirements in the FASB Accounting Standards Codification [FASB ASC] Topic 210, entitled Balance Sheet. The ASU 2013-01 amendments to FASB ASC 210 clarify that ordinary trade receivables and receivables in general are not within the scope of ASU 2011-11, entitled Disclosure about Offsetting Assets and Liabilities, where that ASU amended the guidance in FASB ASC 210. As those disclosures now are modified with the ASU 2013-01 amendments, the FASB ASC 210 balance sheet offsetting disclosures now clearly are applicable only where reporting entities are involved with bifurcated embedded derivatives, repurchase agreements, reverse repurchase agreements, and securities borrowing and lending transactions that either are offset using the FASB ASC 210 or 815 requirements, or that are subject to enforceable master netting arrangements or similar agreements. ASU 2013-01 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.
On February 28, 2013, the FASB issued Accounting Standards Update [ASU] 2013-04, entitled Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date. The ASU 2013-04 amendments add to the guidance in FASB Accounting Standards Codification [FASB ASC] Topic 405, entitled Liabilities and require reporting entities to measure obligations resulting from certain joint and several liability arrangements where the total amount of the obligation is fixed as of the reporting date, as the sum of the following:
The amount the reporting entity agreed to pay on the basis of its arrangement among co-obligors.
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Any additional amounts the reporting entity expects to pay on behalf of its co-obligors.
While early adoption of the amended guidance is permitted, for public companies, the guidance is required to be implemented in fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments need to be implemented retrospectively to all prior periods presented for obligations resulting from joint and several liability arrangements that exist at the beginning of the year of adoption. The adoption of ASU 2013-04 is not expected to have a material effect on the Company’s operating results or financial position.
On April 22, 2013, the FASB issued Accounting Standards Update [ASU] 2013-07, entitled Liquidation Basis of Accounting. With ASU 2013-07, the FASB amends the guidance in the FASB Accounting Standards Codification [FASB ASC] Topic 205, entitled Presentation of Financial Statements. The amendments serve to clarify when and how reporting entities should apply the liquidation basis of accounting. The guidance is applicable to all reporting entities, whether they are public or private companies or not-for-profit entities. The guidance also provides principles for the recognition of assets and liabilities and disclosures, as well as related financial statement presentation requirements. The requirements in ASU 2013-07 are effective for annual reporting periods beginning after December 15, 2013, and interim reporting periods within those annual periods. Reporting entities are required to apply the requirements in ASU 2013-07 prospectively from the day that liquidation becomes imminent. Early adoption is permitted. The adoption of ASU 2013-07 is not expected to have a material effect on the Company’s operating results or financial position.
In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-01, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, the ASU clarifies guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The new standard is effective for fiscal years and interim periods beginning after December 15, 2017, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted except for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company adopted ASU 2016-01 as of the fiscal year ending September 30, 2019.
In August 2020, FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity; Own Equity (“ASU 2020-06"), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from GAAP separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company has adopted ASU 2020-06 as of the Fiscal Year ending September 30, 2022.
A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies. Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.
NOTE 3. GOING CONCERN
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company generated
net losses of $
Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise.
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NOTE 4. NOTES PAYABLE
(a) RELATED PARTY
| As of September 30, 2022 | ||||
| David Koos | $ | |||
| Total: | $ | |||
$
NOTE 5. CONVERTIBLE NOTES PAYABLE
On
March 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(b) For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2") a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or ten cents per share (whichever is greater).
(c) For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3") a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or ten cents per share (whichever is greater).
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0 .10% ( one tenth of one percent)of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of September 30, 2022 $
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On
April 6, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(b) For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2") a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(c) For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3") a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0 .10% ( one tenth of one percent) of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
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“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of September 30 , 2022 $
On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The
Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into
fully paid and non- assessable shares of Common Stock and/or Series A Preferred Stock, as such Stock exists on the Issue Date, or any
shares of capital stock or other securities of the Company into which such Stock shall hereafter be changed or reclassified at a conversion
price of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
.
As of September 30, 2022 $
On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock and/or Series A Preferred Stock, as such Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Stock shall hereafter be changed or reclassified at a conversion price of $18.75 per share.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
As
of September 30, 2022 $
On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000
for consideration consisting of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock and/or Series A Preferred Stock, as such Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Stock shall hereafter be changed or reclassified at a conversion price of $0.0125 per sha
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
As
of September $
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March
13, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $75 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note.
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and
Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit
limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion
features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The
embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement
period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the
change.
The Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $184,615 was recognized by the Company as of September 30, 2022.
On
March 31, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for
consideration consisting of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $75 per share.
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The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In
the event part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity
Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note. As of September
30 ,2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
April 19, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $75 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30 , 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
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The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On May 5, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iii) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $75 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
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On
June 26, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
| 77 |
On
September 25, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party.
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
| 78 |
On October 3, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022, $
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The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
October 16, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
November 1, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On November 1, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
December 20, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As of September 30, 2022 $100,000 of the principal amount of the Note remains outstanding.
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
February 28, 2018 (“Issue date”) the Company issued a two Convertible Notes (“Notes”) in the aggregate face amount
of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of these Notes, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Notes in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the notes, or if the Lender chooses not to convert the remaining amount of the notes into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Notes into Common shares of the Company. The warrants shall have a strike price of $37.50 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Notes on or prior to the close of business on the three (3) month anniversary of the date that the Notes shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Notes, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Notes
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On July 11, 2018 the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
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Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $15 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note.
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of September 30, 2022,
Zander and Regen are under common control. Zander Therapeutics, Inc. is the sole licensee of Regen’s NR2F6 intellectual property for veterinary applications.
On
July 19, 2019 the Company issued a convertible promissory note in the face amount of $
$
the payment of $5,000 of legal fees.
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The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is July 19, 2020. The Note may be converted into the common stock of Regen at a price per share ( “Conversion Price”) equivalent to 60% of the lowest Trading price of the common stock of the Company as reported on the National Quotations Bureau OTC Markets exchange upon which the Company’s shares are traded or any exchange upon which the Common Stock of the Company may be traded in the future , for the twenty prior trading days including the day upon which a Notice of Conversion is received by the Company or its transfer agent. . In no event shall the Holder be allowed to effect a conversion if such conversion, along with all other shares of Company common stock beneficially owned by the Holder and its affiliates would exceed 9.9% of the outstanding shares of the Common Stock of the Company.
The proceeds from the issuance of the Note are to be allocated as follows:
$30,592 will be utilized to retire the outstanding balance of a $75,000 note issued by the Company on August 15, 2018 to One44 capital, LLC and $22,877 will be allocated to the Company’s accountants and auditors to bring the Company current with regards to the Company’s quarterly reporting requirements under the Securities and Exchange Act of 1934.
The Note may be prepaid with the following penalties:
| Time Period | Payment Premium | |
| <=60 days after note issuance | 125% of the sum of principal plus accrued interest | |
| >60 days <= 120 days after note issuance | 135% of the sum of principal plus accrued interest | |
| >120 days <=180 days after note issuance | 140% of the sum• of principal plus accrued• interest |
This Note may not be prepaid after the 180th day.
As
of September 30, 2022 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
NOTE 6. RELATED PARTY TRANSACTIONS
On June 23, 2015 the Company entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to The Company one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
The abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander.
Pursuant to the Agreement, Zander shall pay to The Company royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
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Pursuant to the Agreement, Zander will pay The Company ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which The Company receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to The Company minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The Agreement may be terminated by The Company:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to The Company with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to The Company with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On December 16, 2019 Zander Therapeutics, Inc. (“Zander”), KCL Therapeutics, Inc. (“KCL”) and Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) whereby:
1) Zander shall return for cancellation 194,285,714 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired by Zander through conversion of $340,000 of principal indebtedness of a $350,000 convertible note payable issued by Regen to Zander. Subsequent to this event the principal amount due to Zander by Regen pursuant to the Convertible Note shall be $350,000 which shall be applied pursuant to the Agreement.
2) A $35,000 one time charge due to Zander by Regen (“One Time Charge”) shall be applied pursuant to the Agreement.
3) $75,900 of principal indebtedness due to Regen by Zander and $4,328 of accrued but unpaid interest due by Regen to Zander shall be applied pursuant to the Agreement.
No actions were taken by any of the parties to enforce the terms of the Agreement.
On April 15, 2021 the Agreement was amended as follows so that the material terms and conditions shall be:
a) Zander shall not return the Conversion shares for cancellation and the principal indebtedness of the aforementioned convertible note shall not reflect such return
b) As of December 16, 2019 all principal and accrued interest payable by Regen to Zander on that date resulting from Promissory Notes issued by Regen to Zander shall be credited towards amounts due by Zander pursuant to that agreement, as amended, entered into by and between Zander and Regen on June 23, 2015 (“License Agreement”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen for non-human veterinary therapeutic use for a term of fifteen years and that License Assignment And Consent agreement entered into by and between Regen, KCL and Zander on December 17, 2018 whereby Regen transferred and assigned to KCL all rights, duties, and obligations of Regen under the License Agreement and KCL agreed to assume such duties and obligations thereunder and be bound to the terms of the License Agreement with respect thereto.
Zander and Regen are under common control.
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On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of September 30, 2021, $
On October 8,2021 the Company entered into an agreement with Dr. Brian Koos, MD PhD whereby Dr. Brian Koos would provide services to the Company consisting of :
a) Reviewing existing publications on research being conducted on Checkpoint NR2F6.
b) Identifying the most promising applications for the Company’s technology
c) Drafting a “white paper” on results for 1(b)
d) Making introductions to known experts in appropriate fields identified in 1(b).
Dr. Brian Koos is to be paid compensated $117,000 as total consideration for performing the abovementioned tasks. During the quarter ended December 31, 2021 Dr. Brian Koos was paid the amount of $80,275 and during the quarter ended March 31, 2022 Dr. Brian Koos was paid $36,975. Dr. Brian Koos is the brother of David Koos the Chairman and Chief Executive Officer of the Company.
As
of September 30, 2022 the Company is indebted to David R. Koos the Company’s sole officer and director in the amount of $. $
During the quarter ended December 31, 2021 the Company paid $5,000 of rental expenses to the landlord of BST Partners as consideration to BST Partners for use of office space. BST Partners is controlled by David R. Koos the Chairman and Chief Executive Officer of the Company.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022.
BST
Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
On August 8, 2022
the Company sold 18,200 common shares of Oncology Pharma, Inc. to Zander Therapeutics, Inc. for consideration consisting of $25,000 cash.
NOTE 7. ACCOUNTS RECEIVABLE, RELATED PARTY
Accounts Receivable due from Related Party as of September 30, 2022 consists solely of amounts earned by the Company not yet paid resulting from the Company’s license agreement with KCL Therapeutics (See Note 6).
NOTE 8. STOCKHOLDERS’ EQUITY
The stockholders’ equity section of the Company contains the following classes of capital stock as of September 30 2022:
Common stock, $ 0 par value; shares authorized: shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
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On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Preferred Stock, $ par value, shares authorized of which is designated as Series AA Preferred Stock: shares issued and outstanding as of September 30, 2022, is designated Series A Preferred Stock of which 293,053 shares are outstanding as of September 30, 2022, is designated Series M Preferred Stock of which shares are outstanding as of September 30, 2022, and is designated Series NC stock of which shares are outstanding as of September 30, 2022. .
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven ( 7). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
The Board of Directors of the Company have authorized 540,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one . Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
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On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to
each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number
of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise
required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single
class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
On March 26, 2021 Regen Biopharma, Inc. ( “Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”).
The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 334. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
NOTE 9. INVESTMENT SECURITIES, RELATED PARY
On June 11, 2018 Regen Biopharma, Inc. was paid a property dividend consisting of 470,588 of the common shares of Zander Therapeutics, Inc.
On November 29, 2018 the Company accepted 725,000 shares of the Series M Preferred stock of Zander Therapeutics, Inc. in satisfaction of prepaid rent and accrued interest owed to the Company collectively amounting to $13,124.
On September 30,2022 the Company revalued 470,588 of the common shares of Zander Therapeutics, Inc. and 725,000 shares of the Series M Preferred stock of Zander Therapeutics, Inc. based on the following inputs:
| Fair Value of Intellectual Property | $ | |||
| Prepaid Expenses | ||||
| Due from Employee | ||||
| Note Receivable | ||||
| Accrued Interest Receivable | ||||
| Investment Securities | ||||
| Convertible Note Receivable | ||||
| Accounts Payable | ||||
| Notes Payable | ||||
| Accrued Expenses Related Parties | ||||
| Notes Payable Related Party | ||||
| Accrued Expenses | ||||
| Enterprise Value | ||||
| Less: Total Debt | ( | ) | ||
| Portion of Enterprise Value Attributable to Shareholders | ||||
| Fair Value Per Share | $ |
The abovementioned constitute the Company’s sole related party investment securities as of September 30, 2022.
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As of September 30, 2022:
470,588 Common Shares of Zander Therapeutics, Inc.
| Basis | Fair Value | Total Unrealized Gains | Net Unrealized Gain or (Loss) realized during the quarter ended September 30,2022 | |||||||||||
| $ | $ | $ | $ | |||||||||||
725,000 Series M Preferred of Zander Therapeutics, Inc.
| Basis | Fair Value | Total Unrealized Gain | Net Unrealized Gain or (Loss) realized during the quarter ended September 30, 2022 | |||||||||||
| $ | $ | $ | $ | |||||||||||
NOTE 10. INVESTMENT SECURITIES
During the quarter ended June 30, 2021 the Company was paid 50,000 common shares of Oncology Pharma, Inc. pursuant to an agreement entered into by and between KCL Therapeutics, Inc. ( a wholly owned subsidiary of the Company) and Oncology Pharma, Inc. whereby Oncology Pharma, Inc. was granted a license for the development and commercialization of certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from April 7, 2021.
During the quarter ended June 30, 2021 of the aforementioned common shares were sold to an unrelated party for $ cash.
During the quarter ended September 30, 2021 of the aforementioned common shares were sold to an unrelated party for $ cash.
During
the quarter ended September 30, 2022 of the aforementioned common shares were sold to Zander Therapeutics, Inc. ( company under
common control with Regen) for consideration consisting of $
NOTE 11. INCOME TAXES
As of September 30, 2022
| Deferred tax assets: | ||||
| Net operating tax carry forwards | $ | |||
| Other | ( | ) | ||
| Gross deferred tax assets | ||||
| Valuation allowance | ( | ) | ||
| Net deferred tax assets | $ | ( | ) | |
As
of September 30 2021 the Company has a Deferred Tax Asset of $
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Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. The achievement of required future taxable income is uncertain.
A corporation is considered to undergo “an ownership change” if, as a result of changes in the stock ownership by “5-percent shareholders” or as a result of certain reorganizations, the percentage of the corporation’s stock owned by those 5-percent shareholders increases by more than 50 percentage points over the lowest percentage of stock owned by those shareholders at any time during the prior three-year testing period. Five-percent shareholders are persons who hold 5% or more of the stock of a corporation at any time during the testing period as well as certain groups of shareholders (based typically on whether they acquired their shares in a single offering or exchange transaction) who are not individually 5-percent shareholders.
As the Company will require cash infusions in order to implement its business plan, and as it is probable, although not guaranteed, that such funding needs may be met through the sale of equity securities to “5-percent shareholders”, the Company recognized a valuation allowance equal to the deferred Tax Asset and the Company recorded a valuation allowance reducing all deferred tax assets to 0.
NOTE 11. STOCK TRANSACTIONS
On
October 1, 2021 the Company issued common shares in satisfaction of $
On
October 1, 2021 the Company issued shares of Series A Preferred stock in satisfaction of $
On
October 29, 2021 the Company issued common shares in satisfaction of $
On
November 4 , 2021 the Company issued common shares in satisfaction of $
On
November 24, 2021 the Company issued common shares in satisfaction of $
On
December 10 2021 the Company issued shares of Series A Preferred stock in satisfaction of $
On March
28, 2022 the Company issued common shares in satisfaction of $
On
April 5, 2022 the Company issued common shares in satisfaction of $
On
April 8, 2022 the Company issued common shares in satisfaction of $
On
May 16, 2022 the Company issued common shares in satisfaction of $
On
June 8, 2022 the Company issued common shares in satisfaction of $
On
July 15 2022 the Company issued common shares in satisfaction of $
On
July 20, 2022 the Company issued common shares in satisfaction of $
On August 4, 2022 the Company issued common shares pursuant to contractual obligations imposed by a previously issued convertible note which has now been fully converted.
NOTE 12. SUBSEQUENT EVENTS
On October 25, 2022 the Company issued shares of its Series A Preferred Stock as consideration for social media services to be rendered.
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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Critical Accounting Policies
Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards that have different effective dates for public and private companies. We have elected to take advantage of this extended transition period, and thus, our financial statements may not be comparable to those of other reporting companies.
As of December 31, 2022 we had Cash of $40,741 and as of September 30, 2022 we had cash of $51,204. The decrease in cash of approximately 20% is primarily attributable to cash expended in the operation of the Company’s business offset by .receipt by the Company of $150,000 in accrued license fees ( related party) due.
As of December 31, 2022 we had Accounts Receivable, Related Party of $131,698 and as of September 30, 2022 we had Accounts Receivable, Related Party of $ 295,466. The decrease of approximately 48% is primarily attributable to receipt by the Company of $150,000 in accrued license fees ( related party) due offset by accrual of $27,425 of minimum royalties and anniversary fees pursuant to a license granted to Zander Therapeutics, Inc. by Regen Biopharma, Inc. during the quarter ended December 31, 2022.
As of December 31, 2022 we had Prepaid Expenses of $14,089 and as of September 30, 2022 we had prepaid expenses of $20,945. The decrease in Prepaid Expenses of approximately 33% is attributable to the recognition of expenses incurred over the three months ended December 31, 2022 resulting from an agreement to provide Research and Development services which was prepaid during the quarter ended September 30, 2021. The term of the agreement is from July 1, 2021 to July 1, 2023. The total consideration due of $55,000 was paid to the contractor as of July 1, 2021 and is being expensed over the term of the agreement. .
As of September 30, 2022 we had Prepaid Rent of $10,000 and as of December 31, 2022 we had Prepaid Rent of $0. The decrease in Prepaid Rent of 50% is attributable to $10,000 of rental expenses prepaid to BST Partners (an entity under common control with the Company) during the quarter ended September 30, 2022 of which $5,000 was expensed during the quarter ended December 31, 2022.
As of September 30, 2022 we had Accounts Payable of $28,799 and as of December 31, 2022 we had Accounts Payable of $31,039. The increase in Accounts Payable of approximately 8% is primarily attributable to expenses of $1,730 of patent related legal expenses as well as $510 of Transfer Agent fees incurred during the quarter ended December 31, 2022.
As of September 30, 2022 we had Accrued Interest Payable of $689,785 and as of December 31, 2022 we had Accrued Interest Payable of $301,363. The decrease in Accrued Interest Payable of approximately 56% is attributable to the issuance of equity securities of the Company during the quarter ended December 31,2022 in satisfaction of $405,631 of interest accrued but unpaid on Convertible Notes issued by the Company offset by additional interest accrued but unpaid during the quarter ended December 31, 2022 on Notes Payable and Convertible Notes Payable.
As of September 30, 2022 we had a Derivative Liability of $3,551,793 and as of December 31, 2022 we had a Derivative Liability of $1,435, 949. The decrease in Derivative Liability of approximately 60% is attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $350,000 outstanding as of December 31, 2022.
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As of December 31, 2022 we had total Convertible Notes Payable of $509,880 and as of September 30, 2022 we had total Convertible Notes Payable of $1,272,340. The decrease in total Convertible Notes Payable of approximately 60 % is attributable to the conversion of $761,500 of convertible indebtedness into shares of the Company’s Series A Preferred Stock as well as the derecognition of $1,000 of convertible indebtedness.
Revenues from continuing operations were $59,065 for the three months ended December 31, 2022 and $59,065 for the same period ended 2021. $27,425 of revenue from related parties recognized during the three months ended December 31, 2022 and December 31, 2021 consisted of $24,932 related to an anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and $2,493 of minimum royalties recognized during the three months ended December 31, 2021 and 2022 respectively pursuant to the same license. $31,640 of revenue recognized during the three months ended December 31, 2021 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $31,640 of revenue was recognized during the quarter ended December 31, 2022 pursuant to those same licenses.
With regards to the aforementioned license granted to Zander On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
The Company recognized an Operating Loss of $463,867 during the three months ended December 31, 2022 whereas the Company recognized an Operating Loss of $106,422 for the same period ended 2021. The Company recognized a Net Loss of $2,644,980 for the three months ended December 31, 2021 whereas the Company recognized a Net Income of $1,635,730 for the same period ended 2022. The larger Operating Loss recognized during the three months ended December 31 , 2022 as compared to the same period ended 2021 is primarily attributable to material increases in Research and Development expenses and consulting expenses incurred during the period ended 2022 as compared to the same period ended 2021. With regard to Net Income contributing factors to greater Net Income being recognized during the three months ended December 31, 2021 as compared to the same period ended 2021 include:
| (1) | greater operating losses incurred during the three months ended December 31, 2022 |
| (2) | Recognition of Derivative Income of $2,964,939 during the quarter ended December 31, 2021 as opposed to $2,115,806 of Derivative Income recognized during the quarter ended December 31, 2022 |
| (3) | The recognition of a $62,700 gain on derecognition of Accounts Payable during the quarter ended December 31, 2021 for which recovery is barred by the statute of limitations imposed under California Code of Civil Procedure §337. |
As of December 31, 2022 we had $40,741 in cash on hand and current liabilities of $5,298,935. We feel we will not be able to satisfy our cash requirements over the next twelve months and shall be required to seek additional financing.
As of December 31, 2022 the Company was not party to any binding agreements which would commit Regen to any material capital expenditures.
As of September 30, 2021 we had Cash of $727,162 and as of September 30, 2022 we had cash of $51,204. The decrease in cash of approximately 93% is primarily attributable to the payment of $218,529 in satisfaction $94,537 of convertible indebtedness and $28,973 of accrued interest on convertible indebtedness as well as funds expended in operation of the Company’s business.
As of September 30, 2021 we had Accounts Receivable, Related Party of $213,192 and as of September 30, 2022 we had Accounts Receivable, Related Party of $ 295,466. The increase of approximately 19% is attributable to the accrual during the quarter ended December 31, 2021 of $27,425 of minimum royalties and anniversary fees pursuant to a license granted to Zander Therapeutics, Inc. by Regen Biopharma, Inc. , the accrual during the quarter ended March 31,2022 of $27,425 of minimum royalties and anniversary fees pursuant to a license granted to Zander Therapeutics, Inc. by Regen Biopharma, Inc. the accrual during the quarter ended June 30,2022 of $27,425 of minimum royalties and anniversary fees pursuant to a license granted to Zander Therapeutics, Inc. by Regen Biopharma, Inc. offset by the paying down by licensee of $41,193 of fees accrued yet unpaid due to the Company during the quarter ended September 30, 2022.
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As of September 30, 2021 we had Prepaid Expenses of $48,144 and as of September 30, 2022 we had prepaid expenses of $20,945. The decrease in Prepaid Expenses of approximately 56.4% is attributable to the recognition of expenses incurred over the twelve months ended September 30, 2022 resulting from an agreement to provide Research and Development services which was prepaid during the quarter ended September 30, 2021. The term of the agreement is from July 1, 2021 to July 1, 2023. The total consideration due of $55,000 was paid to the contractor as of July 1, 2021 and is being expensed over the term of the agreement.
As of September 30, 2022 we had Notes Receivable, Related Party of $0 and as of September 30, 2021 we had Notes Receivable, Related Party of $ 5,396. As of September 30, 2022 we had Accrued Interest Receivable, Related Party of $0 and as of September 30, 2021 we Accrued Interest Receivable, Related Party of $230. The decrease is attributable to the payment in cash by Zander Therapeutics, Inc.( an entity under common control with the Company) during the quarter ended September 30, 2022 of the principal balance and accrued interest there of a promissory note issued by Zander Therapeutics, Inc. to the Company during the quarter ended June 30, 2021.
As of September 30, 2022 we had Investment Securities (Not Related Party) of $0 and as of September 30, 2021 we had Investment Securities (Not Related Party) of $198,006. The decrease in Investment Securities (Not Related Party) is attributable to the sale by the Company of 18,300 common shares of Oncology Pharma, Inc. during the year ended September 30, 2022.
As of September 30, 2022 we had Prepaid Rent of $10,000 and as of September 30, 2021 we had Prepaid Rent of $0. The increase in Prepaid Rent is primarily attributable to $10,000 of rental expenses prepaid to BST Partners (an entity under common control with the Company) during the quarter ended September 30, 2022.
As of September 30, 2022 we had Investment Securities (Related Party) of $222,580 and as of September 30, 2021 we had Investment Securities ( Related Party) of $19, 969. During the fiscal year ended September 30, 2022 the Company revalued its owned shares of Zander Therapeutics, Inc. resulting in the recognition of an increase in fair value of 1014.65% as compared to September 30, 2021.
As of September 30, 2022 we had Accounts Payable of $28,799 and as of September 30, 2021 we had Accounts Payable of $91,498. The decrease in Accounts Payable of approximately 69% is primarily attributable to the derecognition of $62,700 of payables for which recovery is barred by the statute of limitations imposed under California Code of Civil Procedure §337.
As of September 30, 2022 we had Accrued Interest Payable of $689,785 and as of September 30, 2021 we had Accrued Interest Payable of $954,861. The decrease in Accrued Interest Payable of approximately 28% is primarily attributable to
(a) the conversion during the quarter ended December 31, 2021 of $298,964 of interest accrued but unpaid on Convertible Notes issued by the Company and the satisfaction of $28,973 of interest accrued but unpaid in cash,
(b) the conversion during the quarter ended March 31, 2022 of $39,708 of interest accrued but unpaid on Convertible Notes issued by the Company ,
(c) the conversion of during the quarter ended June 30, 2022 of $3,201 of interest accrued but unpaid on Convertible Notes issued by the Company
(d) the conversion of during the quarter ended September 30, 2022 of $32,950 of interest accrued but unpaid on a Convertible Note issued by the Company
offset by additional interest accrued but unpaid during the year ended September 30, 2022 on Notes Payable and Convertible Notes Payable.
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As of September 30, 2021 we had Notes Payable of $1,429,179 and as of September 30, 2022 we had Notes Payable of $710. The decrease in Notes Payable of 99.9% is primarily attributable to the reclassification of a Note in the principal amount of $1,500,000 (net of unamortized Original Issue Discount) as a Convertible Note Payable. Such reclassification occurred as a result of the Company’s failure to make a required payment such failure triggering the conversion feature. The aforementioned $1,500,000 Note has been satisfied as of September 30, 2022.
As of September 30, 2021 we had total Convertible Notes Payable of $2,152,811 and as of September 30, 2022 we had total Convertible Notes Payable of $1,272,340. The decrease in total Convertible Notes Payable of 40.98 % is attributable to the following:
| (a) | The satisfaction of $785,964 of principal convertible indebtedness through the issuance of equity securities during the quarter ended December 31, 2021 |
| (b) | The settlement of $94,537 of principal convertible indebtedness through cash payments during the quarter ended December 31, 2021 |
| (c) | The reclassification during the quarter ended March 31, 2022 of $1,724, 960 (net of unamortized discount and including a $300,000 penalty incurred due to the failure by the Company to make a required payment to the lender) of principal indebtedness as convertible debt. |
| (d) | The conversion during the quarter ended March 31, 2022 of $48,420 of principal convertible indebtedness |
| (e) | The conversion during the quarter ended June 30, 2022 of $1,438,378 of principal convertible indebtedness |
| (f) | The conversion during the quarter ended September 30, 2022 of $313,202 of principal convertible indebtedness offset by the recognition of $71,607 Amortization of Discount recognized during the fiscal year ended September 30, 2022. |
As of September 30, 2022 we had a Derivative Liability of $3,551,793 and as of September 30, 2021 we had a Derivative Liability of $6,892,477. The decrease in Derivative Liability of approximately 48% is attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $962,500 outstanding as of September 30, 2022.
As of September 30, 2022 we had a Unearned Income of $1,718,290 and as of September 30, 2021 we had a Unearned Income of $1,843,806. Unearned Income represents that portion of $1,905,000 of license fees paid during the quarter ended June 30, 2021 to be recognized as revenue over the 15 year term of the licenses granted in accordance with ASC 606. The decrease of 6% is attributable to the recognition by the Company of $125,517 of licensing revenue over the year ended September 30, 2022.
Revenues from continuing operations were $235,517 for the twelve months ended September 30, 2022 and $171,194 for the same period ended 2021. $110,000 of revenue from related parties recognized during the years ended September 30, 2021 and September 30, 2022 consisted of $100,000 related to an anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and $10,000 of minimum royalties recognized during the twelve months ended September 30 2021 and 2022 respectively pursuant to the same license. $61,194 of revenue recognized during the year ended September 30, 2021 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $125,517 of revenue was recognized during the year ended September 30, 2022 pursuant to those same licenses.
With regards to the aforementioned license granted to Zander On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
The Company recognized an Operating Loss of $200,771 during the year ended September 30, 2021 whereas the Company recognized an Operating Loss of $339,605 for the same period ended September 30, 2022. The Company recognized a Net Loss of $6,765,233 for the twelve months ended September 30, 2021 whereas the Company recognized a Net Income of $2,443,531 for the same period ended 2022. Contributing factors to the difference between the periods were the recognition of a Derivative Income of $3,340,683 during the period ended 2022 as opposed to the recognition of Derivative Losses of $4,264,975 during the period ended 2021, the recognition during the fiscal year ended September 30, 2021 of an $800,000 expense related to a legal settlement during the year ended September 30,2021 and recognition of $632, 094 of unrealized losses on sales of Investment Securities as well as $524,960 of realized losses on sales of Investment Securities during the year ended September 30, 2021.
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As of September 30, 2022 we had $51,204 in cash on hand and current liabilities of $8,595,461 such liabilities materially consisting of Accounts Payable, Notes Payable, Convertible Notes Payable , Derivative Liability Recognized, Unearned Income and Accrued Expenses. We feel we will not be able to satisfy our cash requirements over the next twelve months and shall be required to seek additional financing.
As of September 30, 2022 the Company was not party to any binding agreements which would commit Regen to any material capital expenditures.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
During our most two most recent fiscal year there have been no changes in or disagreements with our independent registered public accountant.
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
Management and Directors:
David R. Koos
David R. Koos has served as Chairman of the Board of Directors, Chief Executive Officer, Secretary, and Treasurer since April 24, 2012 until his resignation in January 22, 2020.
David R. Koos has served as Acting Chief Financial Officer of the Company for the period beginning April 24, 2012 and ending February 11, 2015.
On March 23, 2021 David R. Koos was appointed Chairman and Sole Director of Regen Biopharma, Inc. On March 23, 2021 David R. Koos was appointed Chief Executive Officer, President, Secretary and Treasurer of Regen Biopharma, Inc.
On March 23, 2021 David R. Koos was appointed Chairman and Sole Director of KCL Therapeutics, Inc. On March 23, 2021 David R. Koos was appointed Chief Executive Officer, President, Secretary and Treasurer of KCL Therapeutics, Inc.
KCL Therapeutics, Inc. is a wholly owned subsidiary of Regen Biopharma, Inc.
Education:
DBA - Finance (December 2003)
Atlantic International University
Ph.D. - Sociology (September 2003)
Atlantic International University
MA - Sociology (June 1983)
University of California - Riverside, California
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Five Year Employment History:
David R. Koos, 62 has served as Chairman of the Board of Directors, Chief Executive Officer, President, Secretary and Treasurer of SYBLEU INC., a biotechnology company, from June 12, 2020 to December 13, 2022. David R. Koos served as Chief Financial Officer of SYBLEU INC. from June 12, 2020 to July 21, 2020. On March 23, 2021 David R. Koos assumed the position of sole officer and director of Zander Therapeutics, Inc., a biotechnology company.
| Position: | Company Name: | Employment Dates: | ||
| Chairman, President, Chief Executive Officer, Secretary, Acting Chief Financial Officer, Principal Accounting Officer | Entest Group, Inc. | June 19, 2009 to November 28, 2018 | ||
| Chairman, President, Chief Executive Officer, Secretary, Chief Financial Officer, Principal Accounting Officer | Entest BioMedical, Inc.( a California corporation) | August 22,2008 to the Present | ||
| Chairman and CEO | Regen BioPharma, Inc. | April 24, 2012 to January 22,2020 | ||
| Acting CFO | Regen BioPharma, Inc. | April 24, 2012 to February 11, 2015 | ||
| President | Regen BioPharma, Inc. | May 29, 2013 to October 9, 2013 | ||
| Chairman, CEO | Zander Therapeutics, Inc. | February 2017 to January 22,2020 | ||
| Sole Officer and Director | Cell Source Research, Inc. | March 24, 2003 to the Present | ||
| Chairman, President, CEO and Acting CFO | Bio-Matrix Scientific Group, Inc. | June 14, 2006 (Chairman) to July 31;2019 June 19, 2006 (President, CEO and Acting CFO); June 19, 2006 (Secretary) to July 31, 2019 | ||
| Chairman & CEO | BST Partners Inc. (A California Corporation) | November 30, 2018 to the Present | ||
| Chairman & CEO | BST Partners Inc. (A Wyoming Corporation) | March 17, to 2017 to the Present |
TRANSACTIONS WITH RELATED PERSONS
On June 23, 2015 the Company entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to The Company one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.
The abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander.
Pursuant to the Agreement, Zander shall pay to The Company royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant to the Agreement, Zander will pay The Company ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which The Company receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to The Company minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
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The Agreement may be terminated by The Company:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to The Company with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to The Company with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On December 16, 2019 Zander Therapeutics, Inc. (“Zander”), KCL Therapeutics, Inc. (“KCL”) and Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) whereby:
1) Zander shall return for cancellation 194,285,714 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired by Zander through conversion of $340,000 of principal indebtedness of a $350,000 convertible note payable issued by Regen to Zander. Subsequent to this event the principal amount due to Zander by Regen pursuant to the Convertible Note shall be $350,000 which shall be applied pursuant to the Agreement.
2) A $35,000 one time charge due to Zander by Regen (“One Time Charge”) shall be applied pursuant to the Agreement.
3) $75,900 of principal indebtedness due to Regen by Zander and $4,328 of accrued but unpaid interest due by Regen to Zander shall be applied pursuant to the Agreement.
No actions were taken by any of the parties to enforce the terms of the Agreement.
On April 15, 2021 the Agreement was amended as follows so that the material terms and conditions shall be:
| a) | Zander shall not return the Conversion shares for cancellation and the principal indebtedness of the aforementioned convertible note shall not reflect such return |
| b) | As of December 16, 2019 all principal and accrued interest payable by Regen to Zander on that date resulting from Promissory Notes issued by Regen to Zander shall be credited towards amounts due by Zander pursuant to that agreement, as amended, entered into by and between Zander and Regen on June 23, 2015 (“License Agreement”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen for non-human veterinary therapeutic use for a term of fifteen years and that License Assignment And Consent agreement entered into by and between Regen, KCL and Zander on December 17, 2018 whereby Regen transferred and assigned to KCL all rights, duties, and obligations of Regen under the License Agreement and KCL agreed to assume such duties and obligations thereunder and be bound to the terms of the License Agreement with respect thereto. |
Zander and Regen are under common control.
On September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $350,000 (“Note”) to Zander Therapeutics, Inc. (“Zander”). Consideration for the Note consisted of $350,000. A onetime interest charge of 10% of the principal amount shall be applied to the principal amount of the Note. The Note is due and payable 24 months from the effective date.
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As of September 1, 2022, $10,000 of the principal amount of the Note remains outstanding.
During the quarter ended June 30, 2021 Zander Therapeutics, Inc. issued a promissory note in the amount of $5,396 to the Company as consideration for expenses of Zander Therapeutics Inc., paid by the Company. The Note is payable on demand of the Holder and bears simple interest at 10% per annum.
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On October 8,2021 the Company entered into an agreement with Dr. Brian Koos, MD PhD whereby Dr. Brian Koos would provide services to the Company consisting of :
| a) | Reviewing existing publications on research being conducted on Checkpoint NR2F6. |
| b) | Identifying the most promising applications for the Company’s technology |
| c) | Drafting a “white paper” on results for 1(b) |
| d) | Making introductions to known experts in appropriate fields identified in 1(b). |
Dr. Brian Koos is to be paid compensated $117,000 as total consideration for performing the abovementioned tasks. During the quarter ended December 31, 2021. Dr. Brian Koos was paid the amount of $80,275 and during the quarter ended March 31, 2022 Dr. Brian Koos was paid $36,975. Dr. Brian Koos is the brother of David Koos the Chairman and Chief Executive Officer of the Company.
As of September 1, 2022 the Company is indebted to David R. Koos the Company’s sole officer and director in the amount of $227. $227 lent to the Company by Koos is due and payable at the demand of the holder and bear simple interest at a rate of 15% per annum.
During the quarter ended December 31, 2021 the Company paid $5,000 of rental expenses to the landlord of BST Partners as consideration to BST Partners for use of office space. BST Partners is controlled by David R. Koos the Chairman and Chief Executive Officer of the Company.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022.
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
CORPORATE GOVERNANCE
Code of Ethics
On September 25, 2013 we adopted a Code of Ethics pursuant to Section 406 of the Sarbanes-Oxley Act of 2002.
Director Independence
Audit Committee and Audit Committee Financial Expert
The members of the Company’s board of Directors may not be considered independent. The Company is not a “listed company” under Securities and Exchange Commission (“SEC”) rules and is therefore not required to have an audit committee comprised of independent directors. The Company does not currently have an audit committee, however, for certain purposes of the rules and regulations of the SEC and in accordance with the Sarbanes-Oxley Act of 2002, the Company’s Board of Directors is deemed to be its audit committee and as such functions as an audit committee and performs some of the same functions as an audit committee including: (1) selection and oversight of our independent accountant; (2) establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls and auditing matters; and (3) engaging outside advisors. The Board of Directors has determined that its member is able to read and understand fundamental financial statements and has substantial business experience that results in that member’s financial sophistication. Accordingly, the Board of Directors believes that its member has the sufficient knowledge and experience necessary to fulfill the duties and obligations that an audit committee would have.
Nominating and Compensation Committees
The Company does not have standing nominating or compensation committees, or committees performing similar functions. The board of directors believes that it is not necessary to have a compensation committee at this time because the functions of such committee are adequately performed by the board of directors. The board of directors also is of the view that it is appropriate for the Company not to have a standing nominating committee because the board of directors has performed and will perform adequately the functions of a nominating committee. The Company is not a “listed company” under SEC rules and is therefore not required to have a compensation committee or a nominating committee.
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Shareholder Communications
There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. There are no specific, minimum qualifications that the board of directors believes must be met by a candidate recommended by the board of directors. Currently, the entire board of directors decides on nominees, on the recommendation of any member of the board of directors followed by the board’s review of the candidates’ resumes and interview of candidates. Based on the information gathered, the board of directors then makes a decision on whether to recommend the candidates as nominees for director. The Company does not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.
Because the Chief Executive Officer of the Company is also the Chairman of the Board of Directors of the Company, the Board of Directors has determined not to adopt a formal methodology for communications from shareholders on the belief that any communication would be brought to the Board of Directors’ attention by virtue of the co-extensive capacities of the Chairman of the Board of Directors.
EXECUTIVE COMPENSATION
| Name and Principal Position | Year | Salary ($) |
Bonus ($) |
Option Awards ($) |
Non
Equity Incentive Plan Compensation ($) |
Nonqualified
Total Deferred Compensation Earnings ($) | ||||||||||||||||||
| David
Koos Chairman, and CEO |
From October 1, 2020 to September 30, 2021 | $ | 0 | 1 | 0 | 0 | 0 | |||||||||||||||||
| Name and Principal Position | Year | Salary ($) |
Bonus ($) |
Option Awards ($) |
Non
Equity Incentive Plan Compensation ($) |
Nonqualified
Total Deferred Compensation Earnings ($) | ||||||||||||||||||
| David
Koos Chairman, and CEO |
From October 1, 2021 to September 30, 2022 | $ | 0 | 0 | 0 | 0 | 0 | |||||||||||||||||
There is a balance of $467,161 of salary accrued but unpaid due to David Koos.
Employment Agreements
Currently neither the Company nor the Company’s wholly owned subsidiary is party to any employment agreement.
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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following table sets forth information known to the Company with respect to the beneficial ownership of each class of the Company’s capital stock as of April 10, 2023 for (1) each person known by the Company to beneficially own more than 5% of each class of the Company’s voting securities, (2) each executive officer, (3) each of the Company’s directors and (4) all of the Company’s executive officers and directors as a group.
Based on 3,381,366 shares issued and outstanding as of April 10, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | ||||||
| Common | David R. Koos | 504 | * | 0.01 | % | ||||
| c/o Regen Biopharma, Inc. | |||||||||
| 4700 Spring Street St 304 | |||||||||
| La Mesa CA 91942* | |||||||||
| Common | All Officers and Directors as a Group | 504* | 0.01 | % | |||||
| *includes 4 shares held by BMXP Holdings Shareholder’s Business Trust and 2 shares held by the AFN Trust | |||||||||
Based on 409,551 shares issued and outstanding as of April 10, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series A Preferred | David R. Koos | 30.10 | % | |||||||
| c/o Regen Biopharma, Inc. | 122,221 | |||||||||
| 4700 Spring Street St 304 | ||||||||||
| Series A Preferred | Zander Therapeutics, Inc. | 105,204 | 25.90 | % | ||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series A Preferred | RGBP HOLDINGS LLC | 40,949 | 10.87 | % | ||||||
| 9962 S CLYDE PLACE HIGHLANDS RANCH, CO 80129 | ||||||||||
| Series A Preferred | All Officers and Directors as a Group | 122,221 | 30.10 | % | ||||||
| * Includes 1 share held by BMXP Holdings Shareholder’s Business Trust, 17,013 shares held by BST Partners, 105, 204 shares held by Zander Therapeutics, Inc. and 1 share held by the AFN Trust |
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Based on 29,338 shares outstanding as of April 10, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series M Preferred | David R. Koos | 7,667 | 26.14 | % | ||||||
| c/o Regen Biopharma, Inc | ||||||||||
| 4700 Spring Street, Suite 304, | ||||||||||
| La Mesa, California 91942 | ||||||||||
| Series M Preferred | Todd S. Caven | 6,667 | 22.73 | % | ||||||
| 8578 TERRACEVIEW LANE NORTH | ||||||||||
| MAPLE GROVE, MN 55311 | ||||||||||
| Series M Preferred | Roger Formisano | 2,001 | 6.82 | % | ||||||
| 4124 N. 64th Street | ||||||||||
| Scottsdale, AZ 85251 | ||||||||||
| Series M Preferred | Robert D. Hopkins | 2,001 | 6.82 | % | ||||||
| 11642 N. 40th Place | ||||||||||
| Phoenix, AZ 85028 | ||||||||||
| Series M Preferred | Harry Lander | 6,667 | 22.73 | % | ||||||
| 50 SUTTON PLACE SOUTH | ||||||||||
| APT. 6A | ||||||||||
| NEW YORK, NY 10022 | ||||||||||
| Series M Preferred | Jean-Pierre Millon | 4,001 | 13.64 | % | ||||||
| 3908 E. San Miguel Ave | ||||||||||
| Paradise Valley, AZ 85253 | ||||||||||
| Series M Preferred | All Officers and Directors as a Group | 7,667 | 26.14 | % | ||||||
based on 334 shares outstanding as of April 10, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series AA Preferred | David R. Koos | |||||||||
| c/o Regen Biopharma, Inc. | 334 | 100 | % | |||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series AA Preferred | All Officers and Directors as a Group | 334 | 100 | % |
based on 15,007 shares outstanding as of April 10, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series NC Preferred | David R. Koos | |||||||||
| c/o Regen Biopharma, Inc. | 15,007 | 100 | % | |||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series NC Preferred | All Officers and Directors as a Group | 15,007 | 100 | % |
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AVAILABLE INFORMATION
We have filed a registration statement on Form S-1 under the Securities Act of 1933 with the Securities and Exchange Commission with respect to the shares of our common stock offered through this prospectus. This prospectus is filed as a part of that registration statement and does not contain all of the information contained in the registration statement and exhibits. We refer you to our registration statement and each exhibit attached to it for a more complete description of matters involving us, and the statements we have made in this prospectus are qualified in their entirety by reference to these additional materials. You may inspect the registration statement and exhibits and schedules filed with the Securities and Exchange Commission at the Commission’s principal office in Washington, D.C. Copies of all or any part of the registration statement may be obtained from the Public Reference Section of the Securities and Exchange Commission, 100 F Street NE, Washington, D.C. 20549. Please call the Commission at 1-800-SEC-0330 for further information on the operation of the public reference rooms. The Securities and Exchange Commission also maintains a web site at http://www.sec.gov that contains reports, proxy statements and information regarding registrants that file electronically with the Commission. In addition, we will file electronic versions of our annual and quarterly reports on the Commission’s Electronic Data Gathering Analysis and Retrieval, or EDGAR System. Our registration statement and the referenced exhibits can also be found on this site as well as our quarterly and annual reports. We will not send the annual report to our shareholders unless requested by the individual shareholders.
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DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES.
Under applicable provisions of the Nevada Revised Statutes, we can indemnify our directors and officers against liabilities they may incur in such capacities, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”). Our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is therefore unenforceable.
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1,000,000 Shares of
Common Stock
SYBLEU INC.
PROSPECTUS
______2023
No dealer, salesperson or other person has been authorized to give any information or to make any representations other than those contained in this prospectus in connection with the offering made by this prospectus, and, if given or made, such information or representations must not be relied upon as having been authorized by our Company or the Distributing Security Holder. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than those specifically offered hereby or an offer to sell or a solicitation of an offer to buy any of these securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation. Except where otherwise indicated, this prospectus speaks as of the effective date of the registration statement. Neither the delivery of this prospectus nor any sale hereunder shall under any circumstances create any implication that there has been no change in the affairs of our Company since the date hereof.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Other Expenses of Issuance and Distribution
The estimated expenses of this offering in connection with the issuance and distribution of the securities being registered, all of which are to be paid by the Registrant, are as follows:
| Securities and Exchange Commission Filing Fee | $ | 220.40 | ||
| Accountant’s Fees | $ | 5,500 | ||
| Total | $ | 5,720.40 |
INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 78.138 of the Nevada Revised Statutes(“NRS”), provides that a director or officer will not be individually liable unless it is proven that (i) the director’s or officer’s acts or omissions constituted a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud or a knowing violation of the law.
Section 78.7502 of NRS permits a company to indemnify its directors and officers against expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with a threatened, pending or completed action, suit or proceeding if the officer or director (i) is not liable pursuant to NRS 78.138 or (ii) acted in good faith and in a manner the officer or director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding, had no reasonable cause to believe the conduct of the officer or director was unlawful.
Section 78.751 of NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending a civil or criminal action, suit or proceeding as they are incurred and in advance of final disposition thereof, upon receipt of an undertaking by or on behalf of the officer or director to repay the amount if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified by the company. Section 78.751 of NRS further permits the company to grant its directors and officers additional rights of indemnification under its articles of incorporation or bylaws or otherwise.
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Section 78.752 of NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf of any person who is or was a director, officer, employee or agent of the company, or is or was serving at the request of the company as a director, officer, employee or agent of another company, partnership, joint venture, trust or other enterprise, for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability and expenses.
Our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.
RECENT SALES OF UNREGISTERED SECURITIES
Retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
Quarter ended December 31, 2022
On October 25, 2022 the Company issued 6,667 Series A preferred shares as consideration for nonemployee services
On November 11, 2022 the Company issued 105126 Series A preferred shares in satisfaction of $761,500 of convertible indebtedness and $380,262 of accrued interest on convertible indebtedness.
On November 11, 2022 the Company issued 11,279 common shares in satisfaction of $25,639 of accrued interest on convertible indebtedness.
On December 5, 2022 the Company issued 1,112 Series A preferred shares as consideration for nonemployee services.
Fiscal Year Ended September 30, 2022
On October 1, 2021 the Company issued 67,812 common shares in satisfaction of $425,000 of convertible indebtedness and $154,991 of accrued interest on convertible indebtedness.
On October 1, 2021 the Company issued 3914 shares of Series A Preferred stock in satisfaction of $50,000 of convertible indebtedness and $23,369 of accrued interest on convertible indebtedness.
On October 29, 2021 the Company issued 17,165 common shares in satisfaction of $140,000 of convertible indebtedness and $54,000 of accrued interest on convertible indebtedness.
On November 4 , 2021 the Company issued 5,751 common shares in satisfaction of $50,000 of convertible indebtedness and $69,012 of accrued interest on convertible indebtedness.
On November 24, 2021 the Company issued 51,570 common shares in satisfaction of $95,964 of convertible indebtedness and $36,967 of accrued interest on convertible indebtedness.
On December 10 2021 the Company issued 950 shares of Series A Preferred stock in satisfaction of $25,000 of convertible indebtedness and $10,625 of accrued interest on convertible indebtedness.
On March 28, 2022 the Company issued 10,667 common shares in satisfaction of $48,420 of convertible indebtedness and $39,708 of accrued interest on convertible indebtedness.
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On April 5, 2022 the Company issued 26,667 common shares in satisfaction of $218,617 of convertible indebtedness and $1,701 of accrued interest on convertible indebtedness.
On April 8, 2022 the Company issued 66,666 common shares in satisfaction of $550,161 of convertible indebtedness and $1,500 of accrued interest on convertible indebtedness.
On May 16, 2022 the Company issued 66,667 common shares in satisfaction of $334,800 of convertible indebtedness.
On June 8, 2022 the Company issued 66,667 common shares in satisfaction of $334,800 of convertible indebtedness.
On July 15 2022 the Company issued 33,333 common shares in satisfaction of $132,650 of convertible indebtedness and $32,950 of accrued interest on convertible indebtedness.
On July 20, 2022 the Company issued 36343 common shares in satisfaction of $180,552 of convertible indebtedness.
On August 4, 2022 the Company issued 4,667 common shares pursuant to contractual obligations imposed by a previously issued convertible note which has now been fully converted.
Fiscal Year Ended September 30, 2021
Quarter ended December 31, 2020
Issuance of Common Shares:
On October 28, 2020 the Company issued 53,377 common shares in satisfaction of $3,752 of convertible indebtedness and $1,452 of accrued interest on convertible indebtedness.
On November 6, 2020 the Company issued 55,956 common shares in satisfaction of $3,900 of convertible indebtedness and $1,555 of accrued interest on convertible indebtedness.
On December 11, 2020 the Company issued 58,013 common shares in satisfaction of $7,300 of convertible indebtedness and $3,142 of accrued interest on convertible indebtedness.
On December 16, 2020 the Company issued 4,231 common shares in satisfaction of $429 of convertible indebtedness, $129 in fees and $236 of accrued interest on convertible indebtedness.
On December 16, 2020 the Company issued 58,773 common shares in satisfaction of $4,030 of convertible indebtedness and $1,700 of accrued interest on convertible indebtedness.
On December 17, 2020 the Company issued 55,478 common shares in satisfaction of $8,200 of convertible indebtedness and $1,786 of accrued interest on convertible indebtedness.
On December 23, 2020 the Company issued 72,296 common shares in satisfaction of $16,000 of convertible indebtedness and $3,250 of accrued interest on convertible indebtedness.
On December 31, 2020 the Company issued 78,558 common shares in satisfaction of $5,330 of convertible indebtedness and $2,329 of accrued interest on convertible indebtedness.
Issuance of Series A Preferred Shares:
On December 17, 2020 the Company issued 21,586 shares of Series A Preferred stock in satisfaction of $13,000 of convertible indebtedness and $8,046 of accrued interest on convertible indebtedness.
Quarter ended March 31, 2021
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Issuance of Common Shares:
On January 28, 2021 the Company issued 57,266 common shares in satisfaction of $5,154 of convertible indebtedness.
On February 23, 2021 the Company issued 58,666 common shares in satisfaction of $4,400 of accrued interest on convertible indebtedness.
On February 24, 2021 the Company issued 55,173 common shares in satisfaction of $30,000 of convertible indebtedness and $4,758 of accrued interest on convertible indebtedness.
On March 2, 2021 the Company issued 79,513 common shares in satisfaction of $5,260 of convertible indebtedness and $2,492 of accrued interest on convertible indebtedness.
On March 9,2021 the Company issued 50,666 common shares in satisfaction of $3,457 of convertible indebtedness and $441 of accrued interest on convertible indebtedness.
On March 20,2021 the Company issued 75,000 common shares in satisfaction of $1,000 of convertible indebtedness and $5,750 of accrued interest on convertible indebtedness.
On March 18, 2021 the Company issued 46,667 common shares in satisfaction of $3,415 of convertible indebtedness and $84 of accrued interest on convertible indebtedness.
On March 31, 2021 the Company issued 26,667 common shares in satisfaction of $1926 of convertible indebtedness and $74 of accrued interest on convertible indebtedness.
Quarter Ended June 30,2021
Issuance of Common Shares
On April 12, 2021 the Company issued 56,666 common shares in satisfaction of $3111 of convertible indebtedness and $49 of accrued interest on convertible indebtedness.
On April 13, 2021 the Company issued 21,979 common shares in satisfaction of $3,510 of convertible indebtedness and $1508 of accrued interest on convertible indebtedness.
On April 13, 2021 the Company issued 55,757 common shares in satisfaction of $19,000 of convertible indebtedness and $4736 of accrued interest on convertible indebtedness.
On April 15, 2021 the Company issued 190,830 common shares in satisfaction of $12,866 of convertible indebtedness and $3,876 of accrued interest on convertible indebtedness.
On April 16, 2021 the Company issued 47,171 common shares in satisfaction of $47,000 of convertible indebtedness and $8,189 of accrued interest on convertible indebtedness.
On April 21, 2021 the Company issued 109,209 common shares in satisfaction of $7655 of convertible indebtedness and $2,264 of accrued interest on convertible indebtedness.
On April 28, 2021 the Company issued 19,189 common shares in satisfaction of $22,000 of convertible indebtedness and $3,905 of accrued interest on convertible indebtedness.
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On May 3, 2021 the Company issued 22,008 common shares in satisfaction of $1,416 of convertible indebtedness and $729 of accrued interest on convertible indebtedness.
On May 5, 2021 the Company issued 18,502 common shares in satisfaction of $1,187 of convertible indebtedness and $616 of accrued interest on convertible indebtedness.
On May 18, 2021 the Company issued 22,515 common shares in satisfaction of $2,026 of convertible indebtedness.
Quarter ended September 30, 2021.
Issuance of Common Shares
On July 16, 2021 the Company issued 132,293 common shares in satisfaction of $500 of convertible indebtedness and $19,344 of accrued interest on convertible indebtedness .
On July 22, 2021 the Company issued 133,333 common shares in satisfaction of $10,000 of convertible indebtedness and $10,000 of accrued interest on convertible indebtedness .
On August 2, 2021 the Company issued 66,667 common shares in satisfaction of $10,000 of convertible indebtedness.
On September 10 , 2021 the Company issued 1,280 common shares in satisfaction of $35,000 of convertible indebtedness and $12,993 of accrued interest on convertible indebtedness .
On September 30, 2021 the Company issued 46,667 common shares in satisfaction of $4,200 of convertible indebtedness.
Issuance of Series A Preferred Shares:
On September 30, 2021 the Company issued 11,901 shares of Series A Preferred stock in satisfaction of $140,000 of convertible indebtedness and $68,535 of accrued interest on convertible indebtedness.
Fiscal Year ended September 30, 2020
October 29, 2019 the Company issued 16,169 common shares in satisfaction of $10,000 of convertible indebtedness and $1,641 of accrued interest on convertible indebtedness.
On October 29, 2019 the Company issued 12,984 common shares in satisfaction of $4,907 of convertible indebtedness and $1,422 of accrued interest on convertible indebtedness.
On November 5, 2019 the Company issued 19,479 common shares in satisfaction of $9,000 of convertible indebtedness and $1,518 of accrued interest on convertible indebtedness.
On November 5, 2019 the Company issued 18,667 common shares in satisfaction of $5,775 of convertible indebtedness and $2,625 of accrued interest on convertible indebtedness.
On November 5, 2019 the Company issued 20,370 common shares in satisfaction of $11,000 of convertible indebtedness .
On November 27, 2019 the Company issued 24,335 common shares in satisfaction of 2785 accrued interest on convertible indebtedness and $500 in fees.
On December 3, 2019 the Company issued 24,076 common shares in satisfaction of $5,500 of convertible indebtedness and $1,000 accrued interest on convertible indebtedness.
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On December 4, 2019 the Company issued 24,362 common shares in satisfaction of $6,090 of convertible indebtedness and $1,035 accrued interest on convertible indebtedness .
On December 5, 2019 the Company issued 27,948 common shares in satisfaction of $7,456 of convertible indebtedness .
On December 6, 2019 the Company issued 27,949 common shares in satisfaction of $907 of convertible indebtedness and $2,365 accrued interest on convertible indebtedness .
On December 10, 2019 the Company issued 33,153 common shares in satisfaction of $5,878 of convertible indebtedness .
On December 13, 2019 the Company issued 34,810 common shares in satisfaction of $2,266 of convertible indebtedness and $366 of accrued interest on convertible indebtedness and $500 in fees.
On December 13, 2019 the Company issued 34,800 common shares in satisfaction of $3,132 of convertible indebtedness.
On December 16, 2019 the Company issued 33,173 common shares in satisfaction of $5,470 of convertible indebtedness and $988 of accrued interest on convertible indebtedness.
On December 19, 2019 the Company issued 28,000 common shares in satisfaction of $3,280 of convertible indebtedness
On December 20, 2019 the Company issued 39,960 common shares in satisfaction of $3,280 of convertible indebtedness and $616 of accrued interest on convertible indebtedness.
On December 20, 2019 the Company issued 39,933 common shares in satisfaction of $3,594 of convertible indebtedness.
On December 23, 2019 the Company issued 39,938 common shares in satisfaction of $942 of convertible indebtedness, $354 of accrued interest on convertible indebtedness and $500 in fees.
On January 2, 2020 the Company issued 46,457 common shares in satisfaction of $3,763 of convertible indebtedness.
On January 2, 2020 the Company issued 47,195 common shares in satisfaction of $1,104 of convertible indebtedness , 524 of accrued interest on convertible indebtedness and $500 in fees.
On January 23, 2020 the Company issued 28,024 common shares in satisfaction of $202 of convertible indebtedness , $558 of accrued interest on convertible indebtedness and $500 in fees.
Issuance of Series A Preferred Shares:
On May 12, 2020 the Company issued 3,493 Series A Preferred shares in satisfaction of $3,000 of convertible indebtedness and $1,426 of accrued interest on convertible indebtedness.
On July 1, 2020 the Company issued 7736 Series A Preferred shares in satisfaction of $5,000 of convertible indebtedness and $2,542 of accrued interest on convertible indebtedness.
On August 7, 2020 the Company issued 11,033 Series A Preferred shares in satisfaction of $7,000 of convertible indebtedness and $3,757 of accrued interest on convertible indebtedness.
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Issuance of non publicly traded securities
Issuance of Series M Preferred Shares:
On November 15, 2019 the Company issued 2,666 Series M Preferred shares as consideration for services.
On November 18, 2019 the Company issued 1,333 Series M Preferred shares as consideration for services.
Issuance of Series NC Preferred Shares
On April 13, 2021 the Company issued 7 Series NC Preferred shares to its Chief Executive Officer David Koos as consideration for services.
On March 17,2023 the Company issued 15,000 Series NC Preferred shares to its Chief Executive Officer David Koos in satisfaction of $10,050 of salaries accrued yet unpaid.
Issuance of Convertible Notes
On September 17,2021 the Company issued a promissory note in the principal amount of $1,500,000 ( “Note”) of which $75,000 was retained by the Holder through an Original Issue Discount (“OID”) for due diligence and origination related to this transaction and Thirty-five Thousand Dollars $35,000 was remitted by the Holder, at the instance and on behalf of the Company, directly to Holder’s counsel for documentation preparation fees resulting in net consideration paid to the Company of $1,390,000.
The Note carries “Guaranteed Interest” on the principal amount at the rate of 5% per annum for the ten-month term of this Note for an aggregate Guaranteed Interest $62,500 all of which Guaranteed Interest shall be deemed earned as of September 17, 2021.
The Principal Amount and the Guaranteed Interest shall be due and payable in five equal monthly payments of $312,500 commencing on March 17, 2022 and continuing on the 17th day of each month thereafter until paid in full not later than July 18, 2022 (the “Maturity Date”).
Solely
following an Event of Default (as such term is defined in the Note) the Note shall become convertible, in whole or in part, into shares
of Common Stock at the option of the Holder. The conversion price of the Note is 90% of the lowest per-share Trading Price per share.
Trading Price is defined as the lowest daily VWAP for the 20 Trading Days preceding a Conversion Date. VWAP is defined as the dollar
volume-weighted average price for the common shares as reported by Bloomberg.
$800,000 of the proceeds received as consideration
for the abovementioned Note was utilized to satisfy a settlement agreement entered into by and between the Company and ChemDiv, Inc.
Principal and interest due on the Note have been satisfied and no longer are an obligation of the Company.
All the abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
With the exception of securities eligible for public resale pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended, a legend was placed on the certificate that evidences the securities stating that the securities have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the securities.
With regard to all securities sold for cash consideration described above cash proceeds received from sale were utilized by Regen for general corporate purposes unless otherwise indicated.
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EXHIBITS
| 114 |
UNDERTAKINGS
The Registrant hereby undertakes the following:
(a)(1) To file, during any period in which it offers or sells securities, a post-effective amendment to this registration statement to:
(i) include any Prospectus required by Section 10(a)(3) of the Securities Act;
(ii) reflect in the Prospectus any facts or events which, individually or together, represent a fundamental change in the information in the registration statement, but notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) include any additional or changed material information of the plan of distribution.
For (2) determining liability under the Securities Act, treat each post-effective amendment as a new registration statement of the securities offered, and the offering of the securities at that time to be the initial bona fide offering.
File a (3) post-effective amendment to remove from registration any of the securities that remain unsold at the end of the offering.
(b) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the provisions described under Item 24 above, or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification relative to alleged Securities Act violations (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person, the Registrant will submit to a court of appropriate jurisdiction the question of whether such indemnification is against public policy and will be governed by the final adjudication of such issue.
(c) That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.
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Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this registration statement to be signed on
its behalf by the undersigned, thereunto duly authorized in the City of La Mesa, State of California, on April 13th, 2023.
| REGEN BIOPHARMA, INC. | |
| By: | /s/ David R. Koos |
| David R. Koos, | |
Chief Executive Officer, Principal Executive Officer | |
| April 13, 2023 | |
| By: | /s/ David R. Koos |
| David R. Koos | |
| Principal Accounting Officer | |
| April 13, 2023 | |
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, AS AMENDED, THIS REGISTRATION STATEMENT ON FORM S-1 HAS BEEN SIGNED BY OR ON BEHALF OF THE FOLLOWING PERSONS IN THE CAPACITIES AND ON THE DATES INDICATED:
| Signature | Title | Date |
| /s/ David R. Koos | Principal Executive Officer | April 13, 2023 |
| David R. Koos | ||
| /s/ David R. Koos | Principal Accounting Officer | April 13, 2023 |
| David R. Koos | ||
| /s/ David R. Koos | Director | April 13, 2023 |
| David R. Koos | ||
| /s/ David R. Koos | Principal Financial Officer | April 13, 2023 |
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Exhibit 99.1
DIRECT OFFERING SUBSCRIPTION AGREEMENT
The undersigned (the “Subscriber”), desires to become a holder of shares of common stock (the “Shares”) of REGEN BIOPHARMA, INC, a Nevada corporation (the “Company”), having its principal place of business located at 4700 Spring Street, St 304, La Mesa, California 91942
Accordingly, the Subscriber hereby agrees as follows:
1. Subscription.
1.1 The Subscriber hereby subscribes for and agrees to accept from the Company that number of Shares set forth in Section 10 of this Subscription Agreement (the “Agreement”), in consideration of $2.00 per Share. This offer to purchase is submitted in accordance with and subject to the terms and conditions described in this Agreement. The Subscriber acknowledges that the Company reserves the right, in its sole and absolute discretion, to accept or reject this subscription and the subscription will not be binding until accepted by the Company in writing.
1.2 The closing of the subscription (the “Closing”) shall occur immediately upon: (a) receipt and acceptance by the Company of a properly completed and executed Agreement; and (b) receipt of all funds for the subscription of Shares hereunder.
2. Purchase Procedure. The Subscriber acknowledges that, in order to subscribe for Shares, Subscriber shall deliver to the Company the full purchase price for the Shares subscribed for in the amount set forth in Section 10, either by cashier’s check made payable to the Company or by wire transfer of immediately available funds in accordance with wire transfer instructions provided by the Company.
3. Representations and Acknowledgements of Subscriber. By executing this Agreement, the Subscriber makes the following representations, declarations, acknowledgements and warranties to the Company, with the intent and understanding that the Company will rely thereon:
3.1 Such Subscriber acknowledges the public availability of the Company's current prospectus (the "Prospectus"). This Prospectus is made available in the Company's Registration Statement on Form S-1 (File No. 333- ), declared effective by the Securities and Exchange Commission on __________ __, 2023. This Prospectus sets forth the terms and conditions of the offering of Shares (the “Offering”) and the risks associated therewith are described.
3.2 All information herein concerning the Subscriber is correct and complete as of the date hereof and as of the date of Closing.
3.3 If the Subscriber is purchasing the Shares in a fiduciary capacity for another person or entity, including without limitation a corporation, partnership, trust or any other entity, the Subscriber has been duly authorized and empowered to execute this Subscription Agreement and all other subscription documents. Upon request of the Company, the Subscriber will provide true, complete and current copies of all relevant documents creating the Subscriber, authorizing its investment in the Company and/or evidencing the satisfaction of the foregoing.
4. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of California, without regard to principles of conflicts of law. Any action to enforce this Agreement shall be brought in the state courts located in San Diego County, State of California.
5. Counterparts; Severability. This Agreement may be executed in one or more counterparts. If any provision of this Agreement shall be held invalid or unenforceable in any jurisdiction, such invalidity or unenforceability shall not affect the validity or enforceability of the remainder of this Agreement or the validity or enforceability of this Subscription Agreement in any other jurisdiction.
6. Persons Bound. This Agreement shall, except as otherwise provided herein, inure to the benefit of and be binding on the Company and its successors and assigns and on each Subscriber and his, her or its respective heirs, legal representatives and successors and assigns, as the case may be.
7. Section Headings.
The section headings contained in this Agreement are inserted for purposes of convenience of reference only and shall not affect the meaning or interpretation of this Agreement.
8. Notices. Any notice or other communication required or permitted hereunder shall be in writing and shall be delivered personally or sent by national recognized overnight courier, to the address of each party set forth in this Agreement.
9. CERTIFICATION. THE SUBSCRIBER CERTIFIES THAT SUBSCRIBER HAS READ THIS ENTIRE SUBSCRIPTION AGREEMENT AND THAT EVERY STATEMENT MADE BY THE SUBSCRIBER HEREIN IS TRUE AND COMPLETE.
10. Ownership Information.
Please print here the number of Shares to be purchased, the Purchase Price and the exact name(s) in which the Shares will be registered.
| Number of Shares Purchased: |
| Purchase Price @ $2.00 per Share: $ |
| Purchaser Name(s): | |
_____Single Person
_____Husband and Wife, as community property
_____Joint Tenants (with right of survivorship)
_____Tenants in Common
_____Corporation or other organization
_____A Partnership
_____IRA
_____Tax-Qualified Retirement Plan
_____Trust
(i) Trustee(s)/Custodian |
(ii) Trust Date |
(iii) Name of Trust |
(iv) For the Benefit of: |
_____ Other:
(Please explain)
| Social Security or Tax I.D.: |
Street Address (If P.O. Box, include address for surface delivery if different than residence)
_______________________________________________________________________________________________
City ________________________________
State ________________________________
Zip Code ________________________________
Email address ________________________________
Telephone Numbers:
| Home: | ( ) |
| Cell: | ( ) |
| 1 |
Subscriber Signature Page
The undersigned, desiring to subscribe for the number of Shares of the Company as is set forth above, acknowledges that he/she has received and understands the terms and conditions of the Subscription Agreement attached hereto and that he/she does hereby agree to all the terms and conditions contained therein.
IN WITNESS WHEREOF, the undersigned has hereby executed this Subscription Agreement as of the date set forth below.
| Date and Signatures. | Dated: _________________ 2023 | |
| Signature(s) | Print Purchaser Name (s) | |
(Each co-owner or joint owner must sign – names must be signed exactly as listed under “Purchaser Name(s)”)
Company Counterpart Signature Page
ACCEPTED:
REGEN BIOPHARMA, INC.
| By: | Dated: ___________________, 2023 | ||
| Name: | |||
| Title |
| 2 |
Exhibit 23.2
LAW OFFICES OF
WILLIAM M. AUL
ATTORNEY AT LAW
1660 Hotel Circle North, Suite 207
San Diego, CA 92108
Email: Bill@Aullaw.net
April 7, 2023
Board of Directors
Regen Biopharma, Inc.
4700 Spring Street, Suite 304
La Mesa, California 91942
Dear Dr. Koos:
In my capacity as counsel for Regen Biopharma, Inc., a Nevada corporation (the “Company”), I have participated in the corporate proceedings relative to the authorization by the Company for the issuance of a maximum of One Million (1,000,000) shares of the Company’s common stock (par value $0.0001) (the “Subject Shares”) pursuant to the resolutions duly adopted by the Company’s Board of Directors and described in the Company’s Registration Statement on Form S-1 under the Securities Act of 1933 (the “Registration Statement”). I have also participated in the preparation and filing of the Registration Statement.
Based upon the foregoing and upon my examination of originals (or copies certified to my satisfaction) of such corporate records of the Company and other documents as I have deemed necessary as a basis for the opinions hereinafter expressed, and assuming the accuracy and completeness of all information supplied me by the Company, having due regard for the legal considerations which I deem relevant, I am of the opinion that:
(1) The Company is a corporation duly organized and validly existing under the laws of the State of Nevada;
(2) The Company has taken all requisite corporate action and all action required by the laws of the State of Nevada with respect to the authorization, issuance and sale of the Subject Shares to be issued pursuant to the Registration Statement;
(3) The Subject Shares, when issued pursuant to the Registration Statement, will be validly issued, fully paid and non-assessable.
I hereby further consent to the use of this opinion as an exhibit to the Registration Statement and to the references to myself in the Registration Statement.
Yours very truly,
/s/ William M. Aul
WILLIAM M. AUL
EXHIBIT 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation in this Form S-1 of our report dated November 15, 2022, relating to the financial statements of Regen Biopharma, Inc. as of September 30, 2022 and 2021 and to all references to our firm included in this registration statement.
Certified Public Accountants
Lakewood, CO
April 10, 2023
Exhibit 14.1
POLICY ON ETHICS AND BUSINESS CONDUCT
Regen Biopharma Inc. , Inc. is committed to always doing the right thing. This is why we have an ethics and compliance program and why we publish this Code of Ethics. The Code is specifically designated to be a part of an effective program to prevent and detect violations of law and moral values.
The values embodied by the Regen Biopharma , Inc. Code of Ethics are meant to guide the business decisions of the Company.
This Code of Ethics will apply to all officers, directors, and employees of the Company.
Code Of Ethics
| 1. | We will always be honest and truthful. |
| 2. | We will adhere to the letter and spirit of all applicable laws, rules, and regulations. |
| 3. | We will handle all actual and apparent conflicts of interest between personal and professional dealings in an ethical manner. |
| 4. | All public filings will contain full, fair, accurate, timely, and understandable disclosure. |
| 5. | All public communications will include full, fair, accurate, timely, and understandable disclosure. |
| 6. | All employees will promptly report to the Board of Directors any violations of this Code. |
| 7. | All employees will be held accountable for adherence to this Code. We will protect employees who report violations of this Code from unfair and undue repercussion by those accused. |
| 8. | We will promote and sustain a work environment that fosters mutual respect, openness, and individual integrity. |
| 9. | We will provide high quality products and services. |
Adopted September 25, 2013
/s/David Koos
David Koos
Chairman and CEO
/s/Thomas Ichim
Thomas Ichim
Director
Exhibit 10.10
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| 6 |
Exhibit 10.9
CONVERTIBLE PROMISSORY NOTE
FOR VALUE RECEIVED, Regen BioPharma, Inc., a Nevada corporation (the “Issuer” of this Security) issues this Security and promises to pay to Zander Therapeutics, Inc., a Nevada corporation, or its Assignees (the “Investor”) the Principal Sum along with the Interest Rate and any other fees according to the terms herein. This Note will become effective only upon both of execution by both parties and delivery of the payment of Consideration by the Investor (the “Effective Date”).
The Principal Sum is $350,000 (three hundred fifty thousand US dollars) plus accrued and unpaid interest and any other fees. The Consideration is $350,000 (three hundred fifty thousand US dollars (there exists a $0 original issue discount, "OID"). The Maturity Date is twenty four months after the Effective Date and is the date upon which the Principal Sum of this Note, as well as any unpaid interest and other fees, shall be due and payable. The Investor may extend any Maturity Date in its sole discretion in increments of up to three months at any time before or after any Maturity Date. The Maturity Date shall automatically be deemed extended unless the Investor provides notice to the Issuer that it is not or has not extended the Maturity Date, which notice the Investor may provide at any time before or after the Maturity Date.
1. Interest and Repayment. A one-time Interest charge of 10% shall be applied to the Principal Sum. The Interest is in addition to the OID, and that OID remains payable regardless of time and manner of payment by the Issuer. The Issuer may not repay any payment of Consideration after its Effective Date prior to its Maturity Date without written approval from the Investor.
2. Conversions. The Investor has the right, at any time after the Effective Date, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of the Issuer as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. Conversion notices may be delivered to the Issuer by method of the Investor’s choice (including but not limited to email, facsimile, mail, overnight courier, or personal delivery), and all conversions shall be cashless and not require further payment from the Investor. If no objection is delivered from the Issuer to the Investor regarding any variable or calculation of the conversion notice within 24 hours of delivery of the conversion notice, the Issuer shall have been thereafter deemed to have irrevocably confirmed and irrevocably ratified such notice of conversion and waived any objection thereto. The Issuer shall deliver the shares from any conversion to the Investor (in any name directed by the Investor) within 3 (three) business days of conversion notice delivery. The Investor, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to the Issuer (under the Investor’s and the Issuer’s expectations that any returned conversion amounts will tack back to the original date of the Note).
3. Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion (In the case that conversion shares are not deliverable by DWAC an additional 10% discount will apply; and if the shares are ineligible for deposit into the DTC system and only eligible for Xclearing deposit an additional 5% discount shall apply; in the case of both an additional cumulative 15% discount shall apply). Notwithstanding the foregoing, if an Issuer default or breach of terms occurs among any of the agreements between the parties, regardless of whether the Investor provides notice of such default or breach and regardless of whether such default or breach is cured or remedied, the Conversion Price shall automatically become the greater of $0.0001 or 40% of the lowest trade price in the 25 trading days previous to the conversion (In the case that conversion shares are not deliverable by DWAC an additional 10% discount will apply; and if the shares are ineligible for deposit into the DTC system and only eligible for Xclearing deposit an additional 5% discount shall apply; in the case of both an additional cumulative 15% discount shall apply) In no event , however, shall the Conversion Price be less than $0.0001 .
4. Piggyback Registration Rights. The Issuer shall include on the next registration statement the Issuer files with SEC (or on the subsequent registration statement if such registration statement is withdrawn) all shares issuable upon conversion of this Note (the “Registrable Securities”). Failure to do so will result in liquidated damages of 10% of the outstanding principal balance of this Note being immediately due and payable to the Investor at its election in the form of cash payment or addition to the balance of this Note.
5. Terms of Future Financings. So long as this Note is outstanding, upon any issuance by the Issuer or any of its subsidiaries of any security with any term more favorable to the holder of such security or with a term in favor of the holder of such security that was not similarly provided to the Investor in this Note, such term, at the Investor’s option, shall become a part of the transaction documents with the Investor. The types of terms contained in another security that may be more favorable to the holder of such security include, but are not limited to, terms addressing conversion rights, conversion discounts, conversion lookback periods, interest rates, original issue discounts, and warrant coverage. The Issuer shall notify the Investor of such additional or more favorable term, including the applicable issuance price, or applicable reset price, exchange price, conversion price, exercise price and other pricing terms, and, at any time while this Note is outstanding, the Investor may request of the Issuer and/or its transfer agent (and they will provide) a schedule of all issuances since the Effective Date of this Note of shares of Series A Preferred stock or of securities entitling the holder thereof to acquire shares of Series A Preferred stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, shares of Series A Preferred stock of the Issuer.
6. Default. Each of the following are an event of default under this Note: (i) the Issuer shall fail to pay any principal under the Note when due and payable (or payable by conversion) thereunder; or (ii) the Issuer shall fail to pay any interest or any other amount under the Note when due and payable (or payable by conversion) thereunder; or (iii) the Issuer shall breach or fail to honor any other term of this Note, any term under any other document related to this Note, or any other written agreement between the Issuer and the Investor (collectively, the “Transaction Documents”), or (iv) the Issuer shall become insolvent or generally fails to pay, or admits in writing its inability to pay, its debts as they become due, subject to applicable grace periods, if any; or (v) the Issuer shall make a general assignment for the benefit of creditors; or (vi) the Issuer shall file a petition for relief under any bankruptcy, insolvency or similar law (domestic or foreign); or (vii) an involuntary proceeding shall be commenced or filed against the Issuer; or (viii) the Issuer’s Series A Preferred stock has an offering price of $0.0001 on its principal trading market at any time; or (ix) the Issuer’s market capitalization (the number of shares of Series A Preferred stock issued and outstanding multiplied by the price per share of Series A Preferred stock) is less than $200,000 at any time or decreases to less than 50% of the market capitalization on the Effective Date; or (x) the price per share of the Issuer’s Series A Preferred stock decreases to less than 50% of the price per share on the Effective Date; or (xi) the Issuer shall lose its status as “DTC Eligible” or the Issuer’s shareholders shall lose the ability to deposit (either electronically or by physical certificates, or otherwise) shares into the DTC System (xii) the Issuer shall become delinquent in its filing requirements as a fully-reporting issuer registered with the SEC.
7. Acceleration. In the event of any default, the outstanding principal amount of this Note, plus accrued but unpaid interest, liquidated damages, fees and other amounts owing in respect thereof through the date of acceleration (the “Note Balance”), shall become, at the Investor’s election, immediately due and payable in cash at the Mandatory Default Amount. The Mandatory Default Amount means the Investor’s choice of (this choice may be made at any time without presentment, demand, or notice of any kind): (i) the Note Balance divided by the Conversion Price on the date of the default multiplied by the closing price on the date of the default; or (ii) the Note Balance divided by the Conversion Price on the date the Mandatory Default Amount is either (a) demanded or (b) paid in full, whichever has a lower Conversion Price, multiplied by the closing price on the date the Mandatory Default Amount is either (a) demanded or (b) paid in full, whichever has a higher closing price; or (iii) 150% of the Note Balance. In connection with such acceleration described herein, the Investor need not provide, and the Issuer hereby waives, any presentment, demand, protest or other notice of any kind, and the Investor may immediately and without expiration of any grace period enforce any and all of its rights and remedies hereunder and all other remedies available to it under applicable law. Such acceleration may be rescinded and annulled by the Investor at any time prior to payment hereunder and the Investor shall have all rights as a holder of the note until such time, if any, as the Investor receives full payment pursuant to this Section 9. No such rescission or annulment shall affect any subsequent event of default or impair any right consequent thereon.
8. Right to Specific Performance and Injunctive Relief. Nothing herein shall limit the Investor’s right to pursue any other remedies available to it at law or in equity including, without limitation, a decree of specific performance and/or injunctive relief. In this regard, the Issuer hereby agrees that the Investor will be entitled to obtain specific performance and/or injunctive relief with respect to the Issuer’s failure to timely deliver shares of Series A Preferred Stock upon conversion of the Note as required pursuant to the terms hereof or the Issuer’s obligations regarding the reservation of shares and its transfer agent, including the use, termination, replacement or resignation of the transfer agent and the obligation to deliver an irrevocable instruction and share reservation letter with any subsequent transfer agent. The Issuer agrees that, in such event, all requirements for specific performance and/or preliminary and permanent injunctive relief will be satisfied, including that the Investor would suffer irreparable harm for which there would be no adequate legal remedy. The Issuer further agrees that it will not object to a court or arbitrator granting or ordering specific performance or preliminary and/or permanent injunctive relief in the event the Investor demonstrates that the Issuer has failed to comply with any obligation herein. Such a grant or order may require the Issuer to immediately issue shares to the Investor pursuant to a Conversion Notice and/or require the Issuer to immediately satisfy its obligations regarding the reservation of shares and its transfer agent, including the use, termination, replacement or resignation of the Issuer’s transfer agent and the obligation to deliver an irrevocable instruction and share reservation letter with any subsequent transfer agent. The Issuer further expressly waives any right to any bond in connection with any temporary or preliminary injunction.
9. No Shorting. The Investor agrees that so long as this Note from the Issuer to the Investor remains outstanding, the Investor will not enter into or effect “short sales” of the Series A Preferred Stock or hedging transaction which establishes a net short position with respect to the Series A Preferred Stock of the Issuer. The Issuer acknowledges and agrees that upon delivery of a conversion notice by the Investor, the Investor immediately owns the shares of Series A Preferred Stock described in the conversion notice and any sale of those shares issuable under such conversion notice would not be considered short sales.
10. Assignability. The Issuer may not assign this Note. This Note will be binding upon the Issuer and its successors and will inure to the benefit of the Investor and its successors and assigns and may be assigned by the Investor to anyone without the Issuer’s approval.
11. Governing Law, Legal Proceedings, and Arbitration. This Note will be governed by, construed and enforced in accordance with the substantive laws of the State of California (including any rights to specific relief provided for under California statutes), without regard to the conflict of laws principles thereof. The parties hereby warrant and represent that the selection of CALIFORNIA law as governing under this Note (i) has a reasonable nexus to each of the Parties and to the transactions contemplated by the Note; and (ii) does not offend any public policy of Nevada, CALIFORNIA or of any other state, federal, or other jurisdiction.
Any action brought by either party against the other arising out of or related to this Note, or any other agreements between the parties, shall be commenced only in the state or federal courts of general jurisdiction located in SAN DIEGO County, in the State of CALIFORNIA, except that all such disputes between the parties shall be subject to alternative dispute resolution through binding arbitration at the Investor’s sole discretion and election (regardless of which party initiates the legal proceedings). The parties agree that, in connection with any such arbitration proceeding, each shall submit or file any claim which would constitute a compulsory counterclaim within the same proceeding as the claim to which it relates. Any such claim that is not submitted or filed in such proceeding shall be waived and such party will forever be barred from asserting such a claim. Both parties and the individuals signing this Note agree to submit to the jurisdiction of such courts or to such arbitration panel, as the case may be.
If the Investor elects alternative dispute resolution by arbitration, the arbitration proceedings shall be conducted in San Diego County and administered by the American Arbitration Association in accordance with its Commercial Arbitration Rules and Mediation Procedures in effect on the Effective Date of this Note, except as modified by this agreement. The Investor’s election to arbitrate shall be made in writing, delivered to the other party, and filed with the American Arbitration Association. The American Arbitration Association must receive the demand for arbitration prior to the date when the institution of legal or equitable proceedings would be barred by the applicable statute of limitations, unless legal or equitable proceedings between the parties have already commenced, and the receipt by the American Arbitration Association of a written demand for arbitration also shall constitute the institution of legal or equitable proceedings for statute of limitations purposes. The parties shall be entitled to limited discovery at the discretion of the arbitrator(s) who may, but are not required to, allow depositions. The parties acknowledge that the arbitrators’ subpoena power is not subject to geographic limitations. The arbitrator(s) shall have the right to award individual relief which he or she deems proper under the evidence presented and applicable law and consistent with the parties’ rights to, and limitations on, damages and other relief as expressly set forth in this Note. The award and decision of the arbitrator(s) shall be conclusive and binding on all parties, and judgment upon the award may be entered in any court of competent jurisdiction. The Investor reserves the right, but shall have no obligation, to advance the Issuer’s share of the costs, fees and expenses of any arbitration proceeding, including any arbitrator fees, in order for such arbitration proceeding to take place, and by doing so will not be deemed to have waived or relinquished its right to seek the recovery of those amounts from the arbitrator, who shall provide for such relief in the final award, in addition to the costs, fees, and expenses that are otherwise recoverable. The foregoing agreement to arbitrate shall be specifically enforceable under applicable law in any court having jurisdiction thereof.
12. Delivery of Process by the Investor to the Issuer. In the event of any action or proceeding by the Investor against the Issuer, and only by the Investor against the Issuer, service of copies of summons and/or complaint and/or any other process which may be served in any such action or proceeding may be made by the Investor via U.S. Mail, overnight delivery service such as FedEx or UPS, email, fax, or process server, or by mailing or otherwise delivering a copy of such process to the Issuer at its last known attorney as set forth in its most recent SEC filing.
13. Attorney Fees. If any attorney is employed by either party with regard to any legal or equitable action, arbitration or other proceeding brought by such party for enforcement of this Note or because of an alleged dispute, breach, default or misrepresentation in connection with any of the provisions of this Note, the prevailing party will be entitled to recover from the other party reasonable attorneys' fees and other costs and expenses incurred, in addition to any other relief to which the prevailing party may be entitled.
14. Notices. Any notice required or permitted hereunder (including Conversion Notices and demands for arbitration) must be in writing and either personally served, sent by facsimile or email transmission, or sent by overnight courier. Notices will be deemed effectively delivered at the time of transmission if by facsimile or email, and if by overnight courier the business day after such notice is deposited with the courier service for delivery.
| Issuer: | Investor: | |
| /s/ David R. Koos | /s/ David R. Koos | |
| David R. Koos | David R. Koos | |
| Regen Biopharma, Inc. | Zander Therapeutics, Inc. | |
| Chief Executive Officer | Chief Executive Officer | |
| Date: 09/30/2018 | Date: 09/30/2018 |
[Signature Page to Convertible Promissory Note]
Exhibit 10.8
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EXHIBIT 10.7
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Exhibit 10.6
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CALCULATION OF REGISTRATION FEE
| Title of Each Class of Securities To Be Registered | Amount To Be Registered | Proposed Maximum Offering Price Per Share | Proposed Maximum Aggregate Offering Price | Aggregate Amount of Registration Fee | ||||||||||||
| Common Stock, par value $0.0001 per share | 1,000,000 | $ | 2.00 | $ | 2,000,000 | $ | 220.40 | |||||||||
Exhibit 10.5
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Exhibit 10.4
AGREEMENT BY AND BETWEEN KCL THERAPEUTICS, INC. AND ONCOLOGY PHARMA INC.
THIS LICENSE AGREEMENT, including the exhibits referred to herein and attached hereto (the “Agreement”), effective as of April 7, 2021 (the “Effective Date”), is made and entered into by and between KCL Therapeutics, Inc., a Nevada corporation and wholly owned subsidiary of Regen BioPharma Inc. (“Licensor”) and Oncology Pharma, Inc., a Nevada corporation (“Licensee”). Licensor and Licensee may be referred to in this Agreement each as a “Party” or collectively as the “Parties.”
RECITALS
A. Licensor owns or has the right to grant rights and licenses to the intellectual property described in Exhibit A (“License IP”).
B. Licensee desires to obtain from Licensor an exclusive right and license for the development and commercialization of the License IP for the treatment in humans of colon cancer and
C. Licensor is willing to grant such right and license to Licensee.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Licensor and Licensee hereby agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meanings indicated:
"Affiliate” shall mean any entity that is controlled by, controls, or is under common control with Licensee at any time during the Term. For such purpose the term “control” means (a) direct or indirect ownership of more than fifty percent (50%) of the voting interest in the entity in question, or more than fifty percent (50%) interest in the income of the entity in question; provided, however, that if local law requires a minimum percentage of local ownership of greater than fifty percent (50%), control will be established by direct or indirect beneficial ownership of one hundred percent (100%) of the maximum ownership percentage that may, under such local law, be owned by foreign interests; or (b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).
“Field” shall mean therapeutic uses related to treatment in humans of colon cancer.
“Improvements” shall mean any development, discovery or invention that is conceived, reduced to practice or otherwise developed by or on behalf of a Party, whether or not patentable, that is a modification, improvement or enhancement to, and is dominated by the claims of, the Patent Rights.
“Licensed Product” shall mean (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to this Agreement.
“Patent Rights” shall mean any and all rights which would be granted under any Patents which may issue on the applications listed in Exhibit A that claim an Improvement dominated by the claims of one or more of the patent rights described in (a) above, each to the extent that they are applicable to the Field.
“Commercialization” or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
“Develop” or “Development” shall mean pre-clinical and clinical research and development activities, including toxicology and other pre-clinical development efforts, stability testing, process development, pre-formulation, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical pharmacology, clinical studies (including without limitation Clinical Trials), regulatory affairs, and regulatory approval and clinical study regulatory activities.
“Term” shall mean fifteen years from the Effective Date.
“Quarter” means each of the four (4) thirteen (13) week periods; (i) commencing on January 1 of any calendar year.
“Net Sales” shall mean the means the gross invoiced amount, and/or the monetary equivalent of any other consideration actually received by Licensee and/or its Sublicensees, for the transfer of a Licensed Product, less any of the following items that are itemized on the relevant invoice or which Licensee can demonstrate have been actually paid or credited with respect to such transfer:
(a) outbound shipping, storage, packing and insurance expenses;
(b) distributor discounts;
(c) allowance for doubtful accounts or uncollectible accounts receivable;
(d) amounts repaid or credited as a result of rejections, defects, or returns, provided that such rejected, defective or returned Licensed Products are not re-transferred; and
(e) sales and other excise taxes (excluding VAT), tariffs, export license fees and duties paid to a governmental entity.
Sales commissions are not deductible. If Licensee or Sublicensee determines the resale price for subsequent transfers of Licensed Product, then Net Sales will be calculated based on the resale invoiced amount. If Licensee or Sublicensees sell the Licensed Products with any other goods or services, Net Sales will be calculated based on the mutually agreeable fair market value of the Licensed Products. Net Sales accrue at the first of delivery or invoice. Notwithstanding the foregoing, “Net Sales” shall not include amounts (i) for any Licensed Product furnished to a third party for which payment (other than the cost of the Licensed Product) is not intended to be received, including, but not limited to, Licensed Products used in Clinical Trials and Licensed Products distributed as promotional and free goods.
“First Commercial Sale” shall mean, with respect to each Licensed Product, the first sale of such Licensed Product by Licensee or its Affiliates or sublicensees to a third party for which payment has been received in any country in the Territory after all applicable required regulatory approvals have been granted by the applicable regulatory authority in such country.
“Territory” shall mean worldwide.
2. LICENSES
2.1. Grant of Rights. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee an exclusive, royalty-bearing right and license, in the Field in the Territory, including the right to grant sublicenses, to make, have made, use, develop, commercialize, offer for sale, have sold, and import Licensed Products. Licensee acknowledges that Licensor is not the sole entity granted patent protection by the US Patent and Trademark Office with regard to the License IP and the Grant of Rights pursuant to this Section 2.1 does not prevent Richard Alexander Wells or any entity authorized by Richard Alexander Wells (“Wells Entities”) from making, using, importing, selling or offering for sale products developed independently by the Wells Entities from the License IP.
2.2. Sublicense Rights. Licensee shall have the right, subject to Licensor’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, to sublicense the rights granted under Section 2.1 (Grant of Rights) to an Affiliate or a third party pursuant to a written sublicense agreement; PROVIDED, in the event of any sublicense of rights by Licensee hereunder, (i) full copies of the final sublicense are provided to Licensor, (ii) such sublicense shall be subject to the terms and conditions of this Agreement that, by their terms, are applicable to such sublicense, (iii) the sublicense by Licensee hereunder shall not relieve Licensee of its obligations under this Agreement, and (iv) Licensee shall remain responsible to Licensor for the performance or nonperformance of any such sublicensee hereunder.
2.3. Rights to Licensee Improvements. Any Improvement made by or on behalf of Licensee after the Effective Date (“Licensee Improvement”) shall be owned by Licensee. Licensee hereby grants Licensor first right of refusal on any intellectual property developed from this license agreement.
2.4. No Other Rights. Except as expressly provided herein, no right, title, or interest is granted whether by implication, estoppel, reliance, or otherwise, by Licensor to Licensee in, to or under the License IP. All rights with respect to technology, patents or other intellectual property rights that are not specifically granted herein are reserved;
3. PAYMENTS AND RELATED OBLIGATIONS
3.1. License Fees. In partial consideration for the rights and license granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor:
3.1.1. a non-refundable, upfront payment Fifty Thousand shares of Oncology Pharma, Inc. common stock (50,000 shares of ONPH) as a license initiation fee both of which must be paid no later than April 20, 2021 such payment to be made to Regen Biopharma, Inc., a Nevada corporation and the parent of the Licensor.
3.1 Royalty Payments:
3.1.1. In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor royalties equal to five percent (5%) of the Net Sales of any Licensed Products in a Quarter.
3.1.2 Royalty Term. The obligation of Licensee to pay royalties to Licensor pursuant to Section 3..1 shall commence on the date of the First Commercial Sale of a Licensed Product and continue, until expiration of the Term.
3.1.3. Sublicensee Payments. Licensee will pay Licensor ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Licensor receives payment in accordance with Section 3.1.1
3.1.4 Licensee shall pay all royalties due and payable on Net Sales in each (i) within sixty (60) days after the last day of each Quarter in which the applicable Net Sales underlying such royalties were billed or invoiced by Licensee (ii) in the case of a sublicensee, within thirty (30) days after the sublicensee or its Affiliate remits payment to Licensee.
3.1.5 Taxes. To the extent a withholding tax obligation is imposed by a governmental authority upon a royalty or other payment due and payable by Licensee to Licensor, Licensee or a sublicensee, as the case may be, shall be entitled to withhold from such payment the amount, if any, of any tax assessed against Licensor and to be withheld, provided that such tax is only for the account of Licensor and evidence of the payment of such tax is promptly provided to Licensor. Licensee, or the sublicensee, as the case may be, shall pay the amount of such tax to the proper taxing authority as required and shall be entitled to deduct the amount of such tax from the payment to be made by Licensee to Licensor. Licensee shall advise Licensor of any tax payment made for the benefit of Licensor pursuant to this Section 3.1.5 (Taxes) and provide, or request a sublicensee to provide, Licensor copies of tax receipts for all taxes paid and deducted from the payment due and payable to Licensor, together with copies of all pertinent communications from or with governmental authorities with respect thereto. At Licensor’s reasonable request and at Licensor’s reasonable expense, Licensee shall reasonably assist Licensor in any effort by Licensor in claiming any exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force, and in minimizing the amount required to be so withheld or deducted.
3.1.6 Interest. Any payment due and payable to Licensor under the terms and conditions of this Agreement, including, without limitation, any royalty payment, made by Licensee after the date such payment is due and payable shall bear interest as of the day after the date such payment was due and payable and shall continue to accrue such interest until such payment is made at an annualized rate equal to 10%.
3.1.7 Records and Reports
Commencing on first commercial transfer of Licensed Product, Licensee will deliver to Licensor within 30 days after the end of each calendar quarter (each, a "Reporting Period") a written report that has been signed by an authorized official of Licensee. Each report will set forth a full accounting of any amounts due Licensor, including the information necessary or desirable to calculate the amount of (a) the continuing royalty payments due under Section 3 for the Reporting Period on a country-by-country basis; (b) the licensing remuneration received during the Reporting Period, or if there were no gross sales/Net Sales or licensing revenue, Licensee will provide a short written statement to Licensor stating that fact.
3.1.8 Audit Rights
Licensee shall permit an independent public accountant designated by Licensor and reasonably acceptable to Licensee, to have access, no more than once in each calendar year during the Term and no more than twice during the three (3) calendar years following the expiration or termination of this Agreement, during regular business hours and upon at least sixty (60) days written notice, to Licensee’s records and books to the extent necessary to determine the accuracy of Net Sales reported, and payments made, by Licensee to Licensor within the three (3) year period immediately preceding such an audit. The independent public accountant shall be under a confidentiality obligation to Licensee to disclose to Licensor only (a) the accuracy of Net Sales reported and the basis for royalty and other payments made to Licensor under this Agreement and (b) the difference, if any, such reported and paid amounts vary from amounts determined as a result of the audit. If such examination results in a determination that Net Sales or payments have been misstated, over or under paid amounts due shall be paid promptly to the appropriate Party. If Net Sales are understated by greater than ten percent (10%), the fees and expenses of such accountant shall be paid by Licensee; otherwise the fees and expenses of such accountant shall be paid by Licensor. All matters reviewed by such independent public accountant shall be deemed Confidential Information of Licensee and shall be subject to Section 6 (Confidentiality). Licensee shall use commercially reasonable efforts to reserve the right to conduct audits of its sublicensees in a comparable manner to this Section 3.2.8 and if requested by Licensor shall appoint an independent public accountant to conduct such audit, at Licensor’s expense, unless the Net Sale of sublicensee are understated by greater than 10 percent (10%), in which case Licensee shall ensure that the fees and expenses of such accountant shall be paid by the sublicensee. Licensee shall provide Licensor with a copy of all audit reports of sublicensees under this Section 3.2.8, such reports shall be deemed Confidential Information of Licensee and shall be subject to Section 6(Confidentiality).
3.1.9 Licensee shall commence Development of Licensed Products no later than that date which is nine months subsequent to the Effective Date.
4. PATENT MATTERS
4.1 Licensor shall have the right, but not the obligation, to prosecute and maintain all Patents to be issued pertaining to the Patent applications licensed in Exhibit A at its cost and expense. Licensor shall keep licensee reasonably apprised of all relevant actions regarding the status of such patents.
4.2 Each Party shall notify the other Party of any infringement of any intellectual property rights with regard to the License IP or a Licensed Product by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party. Licensor shall have has sole responsibility and control of legal action relating to claims of infringement with respect to the Licensed Technology.
4.3 Licensor shall have the first right, but not an obligation, to initiate, maintain and control, at Licensor’s expense, legal action against any infringement of intellectual property rights relating to the Licensed Technology by a third party in the Field.
4.4 In any suit, proceeding or dispute involving infringement of any intellectual property rights relating to the License IP in the Field, the Parties shall provide each other with reasonable cooperation shall make available to each other , at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.
5. REPRESENTATIONS AND WARRANTIES
5.1 Each Party hereby is duly organized, validly existing and in good standing under the laws of their respective jurisdiction. Each Party has the full right and power to enter into and perform its obligations under this Agreement and each has duly authorized, executed and delivered this Agreement which is binding upon, and enforceable against, each Party in accordance with its terms.
Nothing in this Agreement shall be construed as a representation made, or warranty given, by Licensor that (i) that any patent will issue based upon any pending patent application with regard to the License IP or (ii) that the use of any license granted hereunder or the use of the License IP will not infringe the patent or proprietary rights of any third party.
Nothing in this Agreement shall be construed as a representation made, or warranty given by the Licensor regarding merchantability or fitness for a particular purpose of the License IP.
Nothing in this Agreement shall be construed as a representation made, or warranty given, by Licensor that the manufacture, use, sale, offer for sale or importation of the Licensed Products will not infringe the patent or proprietary rights of any third party.
6. CONFIDENTIALITY
6.1. Confidential Information. The Parties may provide Confidential information to each other, including but not limited to each Party’s know-how, invention disclosures, proprietary materials and/or technologies, economic information, business or research strategies, trade secrets and material embodiments thereof. As used herein, “Confidential Information” means any information of a confidential and proprietary nature disclosed by a Party to this Agreement to the other Party (i) in written form marked “confidential” or (ii) in oral form if summarized in a writing marked “confidential” delivered to the receiving Party within thirty (30) days after the oral disclosure.
6.2. Confidentiality and Non-Use. The recipient of a disclosing Party’s Confidential Information shall maintain such Confidential Information in confidence, and shall disclose such Confidential Information only to its employees, agents, consultants, Affiliates, licensors, sublicensees, attorneys, accountants, investors, potential acquirors and advisors who have a reasonable need to know such Confidential Information and who are bound by obligations of confidentiality and non-use no less restrictive than those set forth herein and for whom each Party shall be responsible for any breach of this Section 6. The recipient of the disclosing Party’s Confidential Information shall use such Confidential Information solely to exercise its rights and perform its obligations under this Agreement (including, without limitation, the right to use and disclose such Confidential Information in regulatory applications and filings), unless otherwise mutually agreed in writing. The recipient of the other Party’s Confidential Information shall take the same degree of care that it uses to protect its own confidential and proprietary information of a similar nature and importance (but in any event no less than reasonable care).
6.3. Exclusions. Confidential Information shall not include information that: (a) is in the recipient’s possession prior to receipt from the disclosing Party as established by documentary proof; (b) is or becomes, through no fault of the recipient or its Affiliates or sublicensees hereunder, publicly known (as shown by the recipient’s written record); (c) is furnished to the recipient by a third party without breach of a duty to the disclosing Party; (d) is independently developed by the recipient without use of, application of or access to the disclosing Party’s Confidential Information; or (e) is required to be disclosed under applicable law, but only for the sole purpose of and solely to the extent required by such law, and provided that the recipient, to the extent possible, shall give the disclosing Party prior written notice of the proposed disclosure and cooperate fully with the disclosing Party to minimize the scope of any such required disclosure, to the extent possible and in accordance with applicable law.
6.4. Termination. All obligations of confidentiality and non-use imposed under this Section 6 (Confidentiality) shall expire five (5) years after the date of disclosure of such information under this Agreement.
7. TERMINATION OTHER THAN EXPIRATION OF TERM
7.1 If a Party commits a material breach of this Agreement (“Defaulting Party”), the other Party may notify the Defaulting Party in writing of such failure. If the Defaulting Party does not make a written objection as to whether a material breach has occurred or fails to cure such material breach within ten (10) days of the receipt of the foregoing notice from the other Party then the other Party may terminate this Agreement.
7.2 Licensor may terminate this Agreement if Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory within five years of the date that patent protection has been granted by the United States Patent and Trademark Office to Licensor with regard to the License IP or Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory for any twelve (12) month period after Licensee’s, its Affiliate’s, or its sub licensee’s First Commercial Sale of a Licensed Product, unless (i) such failure to sell Licensed Product is the result of (a) a recall, suspension of regulatory approval or clinical hold by a regulatory authority such as the U.S. Food and Drug Administration or foreign equivalent in the Territory, (b) a voluntary recall and/or suspension of Licensed Product sales by Licensee, its Affiliate, or its sublicensee, based on reasonable concerns for patient safety, or (d) a force majeure ( Section 8).
7.3. Licensor may terminate this Agreement if the License Initiation Fee required pursuant to 3.1.1. of this Agreement is not paid by April 20, 2021.
7.4 Licensee may terminate this Agreement if as of a date that is five years subsequent to the Effective Date of this Agreement a patent has not been granted by the United States patent and Trademark Office to Licensor with regard to that License IP
7.5 Licensee may terminate this Agreement if any of the License IP has not been granted Patent protection by the United States Patent and Trademark Office as of a date which is three years subsequent to the Effective Date .
7.6 Licensee may terminate this Agreement if a patent that has been granted by the United States Patent and Trademark Office to Licensor with regard to any of the License IP is terminated.
7.7 Licensee agrees that, in the event of termination of this Agreement pursuant to 7.1., 7.2, 7.3, 7.4, 7.5, or 7.6 of this Agreement Licensor shall be under no obligation to refund any amounts paid to Licensor by Licensee pursuant to this Agreement.
8. FORCE MAJEURE
8.1 Neither Party shall be held responsible for any delay or failure in performance hereunder caused by strikes, embargoes, unexpected government requirements, including civil or military authorities, acts of God, earthquake, or by the public enemy or other causes reasonably beyond such Party’s control and without such Party’s fault or negligence; provided that the affected Party notifies the unaffected Party as soon as reasonably possible, and resumes performance hereunder as soon as reasonably possible following cessation of such force majeure event; and provided further that no such delay or failure in performance shall continue for more than twelve (12) months.
9. LOSS OF EXCLUSIVITY
9.1 In the event Development pursuant to 3.1.9 shall not have commenced by the required date the rights and license granted pursuant to Section 2 shall be nonexclusive from that date forward.
10. NOTICES
10.1 Notices. Any notice, report, communication or consent required or permitted by this Agreement shall be in writing and shall be sent (a) by prepaid registered or certified mail, return receipt requested, (b) by overnight express delivery service by a nationally recognized courier, or (c) via confirmed facsimile or telecopy, followed within five (5) days by a copy mailed in the preceding manner, addressed to the other Party at the address shown below or at such other address for which such Party gives notice hereunder. Such notice will be deemed to have been given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered.
If to Licensor:
KCL Therapeutics Inc.
C/O Regen Biopharma, Inc.
711 S. Carson Street, Suite 4
Carson City, Nevada 89791
USA
Attn: David R. Koos, CEO
FAX: 619.330.2328
If to Licensee:
Oncology Pharma, Inc.
One Sansome Street
Suite 3500
San Francisco CA 94104
USA
Attn: George Malasek, CEO
FAX:
11. INDEMNIFICATION
11.1 Licensee will indemnify, defend and hold harmless Licensor, its directors, officers, employees, , agents, and consultants ("Licensor Indemnitees") from and against all claims, liabilities, demands, damages, costs, expenses (including attorney fees and costs) and losses, including (a) for death, personal injury, illness and property damage arising from or relating in any way to this Agreement, including the Licensed Products; (b) the use or misuse of the License IP and/or Licensed Products by or on behalf of Licensee, sublicensees, their customers, suppliers, independent contractors and other third persons; (c) the design, manufacture, distribution, storage, sale, import and/or use of any Licensed Products or other products or processes developed in connection with or arising out of the License IP; and (d) Licensee's and/or sublicensees' negligence and willful malfeasance. Licensor will reasonably cooperate with Licensee, at Licensee's expense, in the defense of such action; provided that under no circumstances will Licensee or any party acting on its behalf make any admissions of fault or impose any material obligation on Licensor indemnitees, including with respect to the License IP.
11.2 Licensee will maintain general and product liability insurance with deductibles and minimum limits of liability in amounts commensurate with industry standards and sufficient to satisfy its obligation hereunder, including Section 10.1. Evidence of insurance will be provided to Licensor upon request.
12. ASSIGNMENT
12.1 Licensor has the right to assign its License IP and this Agreement to any successor or assign.
13. Independent Contractor; No Agency.
13.1 Neither Party will be deemed to be the employee, representative, agent, joint venturer or partner of the other Party for any purpose. Neither Party has the authority to obligate or bind the other, or to incur any liability on behalf of the other, nor to direct the employees of the other.
14. GOVERNING LAW, VENUE, AND WAIVER OF JURY TRIAL.
14.1 All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in California for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or inconvenient venue for such proceeding. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
15 SEVERABILITY
15.1 The terms and conditions of this Agreement are severable. If any term or condition of this Agreement is rendered invalid or unenforceable by any law or regulation, or declared null and void by any court of competent jurisdiction, that part will be reformed, if possible, to conform to law, and if reformation is not possible, that part will be deleted in such jurisdiction only and the remainder of the terms and conditions of this Agreement as well as the invalid or unenforceable term or condition in all jurisdictions where valid and enforceable will remain in full force and effect, unless enforcement of this Agreement without the invalid or unenforceable term or condition would be grossly inequitable under the circumstances or would frustrate the primary purpose of this Agreement.
16 WAIVER
16.1 Failure by either Party to enforce a term of this Agreement will not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the Parties.
17 MODIFICATION
17.1 This Agreement may not be altered, amended or modified in any way except by a writing signed by both Parties.
18. ENTIRE AGREEMENT
18.1 The Parties acknowledge that this Agreement, together with the exhibit attached hereto, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements and writings in respect hereto.
| LICENSOR (KCL THERAPEUTICS, INC.) | LICENSEE (ONCOLOGY PHARMA, INC.) |
| By: /s/ David R. Koos | By: /s/ George Malasek |
| David R. Koos | George Malasek |
| Chairman & CEO | Inerim CEO |
| 1 |
Exhibit A.
| Title | Country | Application Number | Date Granted | Patent Number |
| Small Molecule Modulators of NR2F6 Activity | United States | 15652967 | ||
| Small Molecule Agonists and Antagonists of NR2F6 Activity in Humans | United States | 15820324 | ||
| SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY | PCT | PCT/US18/62287 | ||
| Modulation of NR2F6 and methods and uses thereof | United States | 13/652,395 | 07/28/2015 | 9091696 |
| NR2F6 Inhibited Chimeric Antigen Receptor Cells | United States | 15351414 | ||
| SMALL MOLECULE MODULATORS OF NR2F6 ACTIVITY | United States | 15364111 | ||
| METHODS OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND | United States | 14852623 | 10/02/2018 | 10,088,485 |
| Methods and Means of Generating IL-17 Associated Antitumor Effector Cells by Inhibition of NR2F6 Inhibition | United States | 15431681 |
| 2 |
Exhibit 10.3
AGREEMENT BY AND BETWEEN REGEN BIOPHARMA, INC. AND ONCOLOGY PHARMA INC.
THIS LICENSE AGREEMENT, including the exhibits referred to herein and attached hereto (the “Agreement”), effective as of April 7, 2021 (the “Effective Date”), is made and entered into by and between Regen BioPharma, Inc., a Nevada corporation (“Licensor”) and Oncology Pharma, Inc., a Nevada corporation (“Licensee”). Licensor and Licensee may be referred to in this Agreement each as a “Party” or collectively as the “Parties.”
RECITALS
A. Licensor owns or has the right to grant rights and licenses to the intellectual property described in Exhibit A (“License IP”).
B. Licensee desires to obtain from Licensor an exclusive right and license for the development and commercialization of the License IP for the treatment in humans of pancreatic cancer and
C. Licensor is willing to grant such right and license to Licensee.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Licensor and Licensee hereby agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meanings indicated:
"Affiliate” shall mean any entity that is controlled by, controls, or is under common control with Licensee at any time during the Term. For such purpose the term “control” means (a) direct or indirect ownership of more than fifty percent (50%) of the voting interest in the entity in question, or more than fifty percent (50%) interest in the income of the entity in question; provided, however, that if local law requires a minimum percentage of local ownership of greater than fifty percent (50%), control will be established by direct or indirect beneficial ownership of one hundred percent (100%) of the maximum ownership percentage that may, under such local law, be owned by foreign interests; or (b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).
“Field” shall mean therapeutic uses related to treatment in humans of pancreatic cancer.“Improvements” shall mean any development, discovery or invention that is conceived, reduced to practice or otherwise developed by or on behalf of a Party, whether or not patentable, that is a modification, improvement or enhancement to, and is dominated by the claims of, the Patent Rights.
“Licensed Product” shall mean (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to this Agreement.
“Patent Rights” shall mean any and all rights which would be granted under any Patents which may issue on the applications listed in Exhibit A that claim an Improvement dominated by the claims of one or more of the patent rights described in (a) above, each to the extent that they are applicable to the Field.
“Commercialization” or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
“Develop” or “Development” shall mean pre-clinical and clinical research and development activities, including toxicology and other pre-clinical development efforts, stability testing, process development, pre-formulation, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical pharmacology, clinical studies (including without limitation Clinical Trials), regulatory affairs, and regulatory approval and clinical study regulatory activities.
“Term” shall mean fifteen years from the Effective Date.
“Quarter” means each of the four (4) thirteen (13) week periods; (i) commencing on January 1 of any calendar year.
“Net Sales” shall mean the means the gross invoiced amount, and/or the monetary equivalent of any other consideration actually received by Licensee and/or its Sublicensees, for the transfer of a Licensed Product, less any of the following items that are itemized on the relevant invoice or which Licensee can demonstrate have been actually paid or credited with respect to such transfer:
(a) outbound shipping, storage, packing and insurance expenses;
(b) distributor discounts;
(c) allowance for doubtful accounts or uncollectible accounts receivable;
(d) amounts repaid or credited as a result of rejections, defects, or returns, provided that such rejected, defective or returned Licensed Products are not re-transferred; and
(e) sales and other excise taxes (excluding VAT), tariffs, export license fees and duties paid to a governmental entity.
Sales commissions are not deductible. If Licensee or Sublicensee determines the resale price for subsequent transfers of Licensed Product, then Net Sales will be calculated based on the resale invoiced amount. If Licensee or Sublicensees sell the Licensed Products with any other goods or services, Net Sales will be calculated based on the mutually agreeable fair market value of the Licensed Products. Net Sales accrue at the first of delivery or invoice. Notwithstanding the foregoing, “Net Sales” shall not include amounts (i) for any Licensed Product furnished to a third party for which payment (other than the cost of the Licensed Product) is not intended to be received, including, but not limited to, Licensed Products used in Clinical Trials and Licensed Products distributed as promotional and free goods.
“First Commercial Sale” shall mean, with respect to each Licensed Product, the first sale of such Licensed Product by Licensee or its Affiliates or sublicensees to a third party for which payment has been received in any country in the Territory after all applicable required regulatory approvals have been granted by the applicable regulatory authority in such country.
“Territory” shall mean worldwide.
2. LICENSES
2.1. Grant of Rights. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee an exclusive, royalty-bearing right and license, in the Field in the Territory, including the right to grant sublicenses, to make, have made, use, develop, commercialize, offer for sale, have sold, and import Licensed Products.
2.2. Sublicense Rights. Licensee shall have the right, subject to Licensor’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, to sublicense the rights granted under Section 2.1 (Grant of Rights) to an Affiliate or a third party pursuant to a written sublicense agreement; PROVIDED, in the event of any sublicense of rights by Licensee hereunder, (i) full copies of the final sublicense are provided to Licensor, (ii) such sublicense shall be subject to the terms and conditions of this Agreement that, by their terms, are applicable to such sublicense, (iii) the sublicense by Licensee hereunder shall not relieve Licensee of its obligations under this Agreement, and (iv) Licensee shall remain responsible to Licensor for the performance or nonperformance of any such sublicensee hereunder.
2.3. Rights to Licensee Improvements. Any Improvement made by or on behalf of Licensee after the Effective Date (“Licensee Improvement”) shall be owned by Licensee. Licensee hereby grants Licensor first right of refusal on any intellectual property developed from this license agreement.
2.4. No Other Rights. Except as expressly provided herein, no right, title, or interest is granted whether by implication, estoppel, reliance, or otherwise, by Licensor to Licensee in, to or under the License IP. All rights with respect to technology, patents or other intellectual property rights that are not specifically granted herein are reserved;
3. PAYMENTS AND RELATED OBLIGATIONS
3.1. License Fees. In partial consideration for the rights and license granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor:
3.1.1. a non-refundable, upfront payment Fifty Five Thousand Dollars ($55,000 USD) as a license initiation fee which must be paid no later than April 20, 2021
3.1 Royalty Payments:
3.1.1. In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor royalties equal to five percent (5%) of the Net Sales of any Licensed Products in a Quarter.
3.1.2 Royalty Term. The obligation of Licensee to pay royalties to Licensor pursuant to Section 3..1 shall commence on the date of the First Commercial Sale of a Licensed Product and continue, until expiration of the Term.
3.1.3. Sublicensee Payments. Licensee will pay Licensor ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Licensor receives payment in accordance with Section 3.1.1
3.1.4 Licensee shall pay all royalties due and payable on Net Sales in each (i) within sixty (60) days after the last day of each Quarter in which the applicable Net Sales underlying such royalties were billed or invoiced by Licensee (ii) in the case of a sublicensee, within thirty (30) days after the sublicensee or its Affiliate remits payment to Licensee.
3.1.5 Taxes. To the extent a withholding tax obligation is imposed by a governmental authority upon a royalty or other payment due and payable by Licensee to Licensor, Licensee or a sublicensee, as the case may be, shall be entitled to withhold from such payment the amount, if any, of any tax assessed against Licensor and to be withheld, provided that such tax is only for the account of Licensor and evidence of the payment of such tax is promptly provided to Licensor. Licensee, or the sublicensee, as the case may be, shall pay the amount of such tax to the proper taxing authority as required and shall be entitled to deduct the amount of such tax from the payment to be made by Licensee to Licensor. Licensee shall advise Licensor of any tax payment made for the benefit of Licensor pursuant to this Section 3.1.5 (Taxes) and provide, or request a sublicensee to provide, Licensor copies of tax receipts for all taxes paid and deducted from the payment due and payable to Licensor, together with copies of all pertinent communications from or with governmental authorities with respect thereto. At Licensor’s reasonable request and at Licensor’s reasonable expense, Licensee shall reasonably assist Licensor in any effort by Licensor in claiming any exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force, and in minimizing the amount required to be so withheld or deducted.
3.1.6 Interest. Any payment due and payable to Licensor under the terms and conditions of this Agreement, including, without limitation, any royalty payment, made by Licensee after the date such payment is due and payable shall bear interest as of the day after the date such payment was due and payable and shall continue to accrue such interest until such payment is made at an annualized rate equal to 10%.
3.1.7 Records and Reports
Commencing on first commercial transfer of Licensed Product, Licensee will deliver to Licensor within 30 days after the end of each calendar quarter (each, a "Reporting Period") a written report that has been signed by an authorized official of Licensee. Each report will set forth a full accounting of any amounts due Licensor, including the information necessary or desirable to calculate the amount of (a) the continuing royalty payments due under Section 3 for the Reporting Period on a country-by-country basis; (b) the licensing remuneration received during the Reporting Period, or if there were no gross sales/Net Sales or licensing revenue, Licensee will provide a short written statement to Licensor stating that fact.
3.1.8 Audit Rights
Licensee shall permit an independent public accountant designated by Licensor and reasonably acceptable to Licensee, to have access, no more than once in each calendar year during the Term and no more than twice during the three (3) calendar years following the expiration or termination of this Agreement, during regular business hours and upon at least sixty (60) days written notice, to Licensee’s records and books to the extent necessary to determine the accuracy of Net Sales reported, and payments made, by Licensee to Licensor within the three (3) year period immediately preceding such an audit. The independent public accountant shall be under a confidentiality obligation to Licensee to disclose to Licensor only (a) the accuracy of Net Sales reported and the basis for royalty and other payments made to Licensor under this Agreement and (b) the difference, if any, such reported and paid amounts vary from amounts determined as a result of the audit. If such examination results in a determination that Net Sales or payments have been misstated, over or under paid amounts due shall be paid promptly to the appropriate Party. If Net Sales are understated by greater than ten percent (10%), the fees and expenses of such accountant shall be paid by Licensee; otherwise the fees and expenses of such accountant shall be paid by Licensor. All matters reviewed by such independent public accountant shall be deemed Confidential Information of Licensee and shall be subject to Section 6 (Confidentiality). Licensee shall use commercially reasonable efforts to reserve the right to conduct audits of its sublicensees in a comparable manner to this Section 3.2.8 and if requested by Licensor shall appoint an independent public accountant to conduct such audit, at Licensor’s expense, unless the Net Sale of sublicensee are understated by greater than 10 percent (10%), in which case Licensee shall ensure that the fees and expenses of such accountant shall be paid by the sublicensee. Licensee shall provide Licensor with a copy of all audit reports of sublicensees under this Section 3.2.8, such reports shall be deemed Confidential Information of Licensee and shall be subject to Section 6(Confidentiality).
3.1.9 Licensee shall commence Development of Licensed Products no later than that date which is nine months subsequent to the Effective Date.
4. PATENT MATTERS
4.1 Licensor shall have the right, but not the obligation, to prosecute and maintain all Patents to be issued pertaining to the Patent applications licensed in Exhibit A at its cost and expense. Licensor shall keep licensee reasonably apprised of all relevant actions regarding the status of such patents.
4.2 Each Party shall notify the other Party of any infringement of any intellectual property rights with regard to the License IP or a Licensed Product by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party. Licensor shall have has sole responsibility and control of legal action relating to claims of infringement with respect to the Licensed Technology.
4.3 Licensor shall have the first right, but not an obligation, to initiate, maintain and control, at Licensor’s expense, legal action against any infringement of intellectual property rights relating to the Licensed Technology by a third party in the Field.
4.4 In any suit, proceeding or dispute involving infringement of any intellectual property rights relating to the License IP in the Field, the Parties shall provide each other with reasonable cooperation shall make available to each other , at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.
5. REPRESENTATIONS AND WARRANTIES
5.1 Each Party hereby is duly organized, validly existing and in good standing under the laws of their respective jurisdiction. Each Party has the full right and power to enter into and perform its obligations under this Agreement and each has duly authorized, executed and delivered this Agreement which is binding upon, and enforceable against, each Party in accordance with its terms.
Nothing in this Agreement shall be construed as a representation made, or warranty given, by Licensor that (i) that any patent will issue based upon any pending patent application with regard to the License IP or (ii) that the use of any license granted hereunder or the use of the License IP will not infringe the patent or proprietary rights of any third party.
Nothing in this Agreement shall be construed as a representation made, or warranty given by the Licensor regarding merchantability or fitness for a particular purpose of the License IP.
Nothing in this Agreement shall be construed as a representation made, or warranty given, by Licensor that the manufacture, use, sale, offer for sale or importation of the Licensed Products will not infringe the patent or proprietary rights of any third party.
6. CONFIDENTIALITY
6.1. Confidential Information. The Parties may provide Confidential information to each other, including but not limited to each Party’s know-how, invention disclosures, proprietary materials and/or technologies, economic information, business or research strategies, trade secrets and material embodiments thereof. As used herein, “Confidential Information” means any information of a confidential and proprietary nature disclosed by a Party to this Agreement to the other Party (i) in written form marked “confidential” or (ii) in oral form if summarized in a writing marked “confidential” delivered to the receiving Party within thirty (30) days after the oral disclosure.
6.2. Confidentiality and Non-Use. The recipient of a disclosing Party’s Confidential Information shall maintain such Confidential Information in confidence, and shall disclose such Confidential Information only to its employees, agents, consultants, Affiliates, licensors, sublicensees, attorneys, accountants, investors, potential acquirors and advisors who have a reasonable need to know such Confidential Information and who are bound by obligations of confidentiality and non-use no less restrictive than those set forth herein and for whom each Party shall be responsible for any breach of this Section 6. The recipient of the disclosing Party’s Confidential Information shall use such Confidential Information solely to exercise its rights and perform its obligations under this Agreement (including, without limitation, the right to use and disclose such Confidential Information in regulatory applications and filings), unless otherwise mutually agreed in writing. The recipient of the other Party’s Confidential Information shall take the same degree of care that it uses to protect its own confidential and proprietary information of a similar nature and importance (but in any event no less than reasonable care).
6.3. Exclusions. Confidential Information shall not include information that: (a) is in the recipient’s possession prior to receipt from the disclosing Party as established by documentary proof; (b) is or becomes, through no fault of the recipient or its Affiliates or sublicensees hereunder, publicly known (as shown by the recipient’s written record); (c) is furnished to the recipient by a third party without breach of a duty to the disclosing Party; (d) is independently developed by the recipient without use of, application of or access to the disclosing Party’s Confidential Information; or (e) is required to be disclosed under applicable law, but only for the sole purpose of and solely to the extent required by such law, and provided that the recipient, to the extent possible, shall give the disclosing Party prior written notice of the proposed disclosure and cooperate fully with the disclosing Party to minimize the scope of any such required disclosure, to the extent possible and in accordance with applicable law.
6.4. Termination. All obligations of confidentiality and non-use imposed under this Section 6 (Confidentiality) shall expire five (5) years after the date of disclosure of such information under this Agreement.
7. TERMINATION OTHER THAN EXPIRATION OF TERM
7.1 If a Party commits a material breach of this Agreement (“Defaulting Party”), the other Party may notify the Defaulting Party in writing of such failure. If the Defaulting Party does not make a written objection as to whether a material breach has occurred or fails to cure such material breach within ten (10) days of the receipt of the foregoing notice from the other Party then the other Party may terminate this Agreement.
7.2 Licensor may terminate this Agreement if Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory within five years of the date that patent protection has been granted by the United States Patent and Trademark Office to Licensor with regard to the License IP or Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory for any twelve (12) month period after Licensee’s, its Affiliate’s, or its sub licensee’s First Commercial Sale of a Licensed Product, unless (i) such failure to sell Licensed Product is the result of (a) a recall, suspension of regulatory approval or clinical hold by a regulatory authority such as the U.S. Food and Drug Administration or foreign equivalent in the Territory, (b) a voluntary recall and/or suspension of Licensed Product sales by Licensee, its Affiliate, or its sublicensee, based on reasonable concerns for patient safety, or (d) a force majeure ( Section 8).
7.3. Licensor may terminate this Agreement if the License Initiation Fee required pursuant to 3.1.1. of this Agreement is not paid in readily available funds by April 20, 2021.
7.4 Licensee may terminate this Agreement if as of a date that is five years subsequent to the Effective Date of this Agreement a patent has not been granted by the United States patent and Trademark Office to Licensor with regard to that License IP
7.5 Licensee may terminate this Agreement if any of the License IP has not been granted Patent protection by the United States Patent and Trademark Office as of a date which is three years subsequent to the Effective Date .
7.6 Licensee may terminate this Agreement if a patent that has been granted by the United States Patent and Trademark Office to Licensor with regard to any of the License IP is terminated.
7.7 Licensee agrees that, in the event of termination of this Agreement pursuant to 7.1., 7.2, 7.3, 7.4, 7.5, or 7.6 of this Agreement Licensor shall be under no obligation to refund any amounts paid to Licensor by Licensee pursuant to this Agreement.
8. FORCE MAJEURE
8.1 Neither Party shall be held responsible for any delay or failure in performance hereunder caused by strikes, embargoes, unexpected government requirements, including civil or military authorities, acts of God, earthquake, or by the public enemy or other causes reasonably beyond such Party’s control and without such Party’s fault or negligence; provided that the affected Party notifies the unaffected Party as soon as reasonably possible, and resumes performance hereunder as soon as reasonably possible following cessation of such force majeure event; and provided further that no such delay or failure in performance shall continue for more than twelve (12) months.
9. LOSS OF EXCLUSIVITY
9.1 In the event Development pursuant to 3.1.9 shall not have commenced by the required date the rights and license granted pursuant to Section 2 shall be nonexclusive from that date forward.
10. NOTICES
10.1 Notices. Any notice, report, communication or consent required or permitted by this Agreement shall be in writing and shall be sent (a) by prepaid registered or certified mail, return receipt requested, (b) by overnight express delivery service by a nationally recognized courier, or (c) via confirmed facsimile or telecopy, followed within five (5) days by a copy mailed in the preceding manner, addressed to the other Party at the address shown below or at such other address for which such Party gives notice hereunder. Such notice will be deemed to have been given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered.
If to Licensor:
Regen Biopharma, Inc.
711 S. Carson Street, Suite 4
Carson City, Nevada 89791
USA
Attn: David R. Koos, CEO
FAX: 619.330.2328
If to Licensee:
Oncology Pharma, Inc.
One Sansome Street
Suite 3500
San Francisco CA 94104
USA
Attn: George Malasek, CEO
FAX:
11. INDEMNIFICATION
11.1 Licensee will indemnify, defend and hold harmless Licensor, its directors, officers, employees, , agents, and consultants ("Licensor Indemnitees") from and against all claims, liabilities, demands, damages, costs, expenses (including attorney fees and costs) and losses, including (a) for death, personal injury, illness and property damage arising from or relating in any way to this Agreement, including the Licensed Products; (b) the use or misuse of the License IP and/or Licensed Products by or on behalf of Licensee, sublicensees, their customers, suppliers, independent contractors and other third persons; (c) the design, manufacture, distribution, storage, sale, import and/or use of any Licensed Products or other products or processes developed in connection with or arising out of the License IP; and (d) Licensee's and/or sublicensees' negligence and willful malfeasance. Licensor will reasonably cooperate with Licensee, at Licensee's expense, in the defense of such action; provided that under no circumstances will Licensee or any party acting on its behalf make any admissions of fault or impose any material obligation on Licensor indemnitees, including with respect to the License IP.
11.2 Licensee will maintain general and product liability insurance with deductibles and minimum limits of liability in amounts commensurate with industry standards and sufficient to satisfy its obligation hereunder, including Section 10.1. Evidence of insurance will be provided to Licensor upon request.
12. ASSIGNMENT
12.1 Licensor has the right to assign its License IP and this Agreement to any successor or assign.
13. Independent Contractor; No Agency.
13.1 Neither Party will be deemed to be the employee, representative, agent, joint venturer or partner of the other Party for any purpose. Neither Party has the authority to obligate or bind the other, or to incur any liability on behalf of the other, nor to direct the employees of the other.
14. GOVERNING LAW, VENUE, AND WAIVER OF JURY TRIAL.
14.1 All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in California for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or inconvenient venue for such proceeding. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
15 SEVERABILITY
15.1 The terms and conditions of this Agreement are severable. If any term or condition of this Agreement is rendered invalid or unenforceable by any law or regulation, or declared null and void by any court of competent jurisdiction, that part will be reformed, if possible, to conform to law, and if reformation is not possible, that part will be deleted in such jurisdiction only and the remainder of the terms and conditions of this Agreement as well as the invalid or unenforceable term or condition in all jurisdictions where valid and enforceable will remain in full force and effect, unless enforcement of this Agreement without the invalid or unenforceable term or condition would be grossly inequitable under the circumstances or would frustrate the primary purpose of this Agreement.
16 WAIVER
16.1 Failure by either Party to enforce a term of this Agreement will not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the Parties.
17 MODIFICATION
17.1 This Agreement may not be altered, amended or modified in any way except by a writing signed by both Parties.
18. ENTIRE AGREEMENT
18.1 The Parties acknowledge that this Agreement, together with the exhibit attached hereto, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements and writings in respect hereto.
| LICENSOR (KCL THERAPEUTICS, INC.) | LICENSEE (ONCOLOGY PHARMA, INC.) |
| By: /s/ David R. Koos | By: /s/ George Malasek |
| David R. Koos | George Malasek |
| Chairman & CEO | Inerim CEO |
| 1 |
EXHIBIT A
ANTIGEN SPECIFIC MRNA CELLULAR CANCER VACCINES
| 2 |
Exhibit 10.2
LICENSE ASSIGNMENT AND CONSENT AGREEMENT
THIS LICENSE ASSIGNMENT AND CONSENT AGREEMENT (this ”Agreement”), is entered into as of December 17, 2018, by and among Zander Therapeutics, Inc. ( “Licensee”), Regen Biopharma, Inc. (“Licensor”) and KCL Therapeutics, Inc. (“Assignee”)
WHEREAS, Licensor has assigned to Assignee all right title and interest to the intellectual property listed in Exhibit A to this Agreement (“Assigned Properties”)
WHEREAS, Licensor and Licensee are parties to that certain License Agreement dated June 23, 2015, as amended , granting Licensee an exclusive worldwide right and license for the development and commercialization for non-human veterinary therapeutic use of certain intellectual property of the Licensor (the “Original License”);
WHEREAS, Licensor wished to assign, and Assignee wishes to assume, effective as of December 12, 2018 (the “Effective Date”), all rights, duties and obligations of Licensor under the Original License with respect to the Assigned Properties and Licensee wishes to consent to such assignment;
THEREFORE, IT IS AGREED
Effective as of December 12, 2018 , Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Original License with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Original License with respect thereto. This Agreement and the rights, duties, and obligations under the Original License assigned and transferred hereunder shall serve as the agreement between Assignee and Licensee with respect to the Assigned Properties. Accordingly, Assignee and Licensee agree that, upon such assignment, transfer, and assumption, each of Assignee and Licensee shall be entitled to enforce the applicable terms of the Original License against the other under this Agreement.
GOVERNING LAW,VENUE, And WAIVER OF JURY TRIAL.
All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in California for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or inconvenient venue for such proceeding. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
SEVERABILITY.
If any provision of this Agreement shall be held invalid or unenforceable, such invalidity or unenforceability shall attach only to such provision and shall not in any manner affect or render invalid or unenforceable any other severable provision of this Agreement, and this Agreement shall be carried out as if any such invalid or unenforceable provisions were not contained herein.
WAIVER
Failure by either Party to enforce a term of this Agreement will not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the Parties.
MODIFICATION
This Agreement may not be altered, amended or modified in any way except by a writing signed by both Parties.
ENTIRE AGREEMENT
The Parties acknowledge that this Agreement, together with the exhibits attached hereto, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements and writings in respect hereto.
| Licensor | Licensee | Assignee | |||
| By: | /s/ David R. Koos | By: | /s/ David R. Koos | By: | /s/ David R. Koos |
| Name: | David R. Koos | Name: | David R. Koos | Name: | David R. Koos |
| Its: | Chairman & CEO | Its: | Chairman & CEO | Its: | Chairman & CEO |
| 1 |
EXHIBIT A
| 1) | U.S. Provisional Application No. 62/363,588 entitled SMALL MOLECULE MODULATORS OF NR2F6 ACTIVITY, filed July 18 th. 2016: |
| 2) | U.S. Non-Provisional Application No. 15/652,967 entitled SMALL MOLECULE MODULA TORS OF NR2F6 ACTIVITY, filed on July I 8 111, 2017; |
| 3) | U.S. Non-Provisional Application No. 15/820,324 entitled SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS, filed on November 21st, 2017; |
| 4) | U.S. Non-Provisional Application No. 16/008,526 entitled SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY, filed on June 14th, 2018 |
| 5) | U.S. Non-Provisional Application No. 15/351,4 I 4 entitled NR2F6 INHIBITED CHIMERIC ANTIGEN RECEPTOR CELLS, filed on November 14th, 2016 |
| 6) | U.S. Non-Provisional Application No. 13/652,395 entitled MODULATION OF NR2F6 AND METHODS AND USES THEREOF, filed on October 15 th, 2012; now US Patent No. 9,091,696, issued July 28th , 2015; and |
| 6) | U.S. Non-Provisional Application No. 14/852,623 entitled METHODS OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND, filed on September 13 th, 2015, now US Patent No. 10,088,485, issued October 2nd, 2018; |
| 2 |
Exhibit 10.1
AGREEMENT BY AND BETWEEN REGEN BIOPHARMA, INC. AND ZANDER THERAPEUTICS, INC.
THIS LICENSE AGREEMENT, including the exhibits referred to herein and attached hereto (the “Agreement”), effective as of June 23, 2015 (the “Effective Date”), is made and entered into by and between Regen BioPharma Inc., an Nevada corporation (“Licensor”) and Zander Therapeutics Inc., a Nevada corporation (“Licensee”). Licensor and Licensee may be referred to in this Agreement each as a “Party” or collectively as the “Parties.”
RECITALS
A. Licensor owns or has the right to grant rights and licenses to the intellectual property described in Exhibit A (“License IP”).
B. Licensee desires to obtain from Licensor an exclusive right and license for the development and commercialization of the License IP for non-human veterinary therapeutic use; and
C. Licensor is willing to grant such right and license to Licensee.
NOW, THEREFORE, in consideration of the mutual covenants and obligations set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Licensor and Licensee hereby agree as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the meanings indicated:
1.1.1 "Affiliate” shall mean any entity that is controlled by, controls, or is under common control with Licensee at any time during the Term. For such purpose the term “control” means (a) direct or indirect ownership of more than fifty percent (50%) of the voting interest in the entity in question, or more than fifty percent (50%) interest in the income of the entity in question; provided, however, that if local law requires a minimum percentage of local ownership of greater than fifty percent (50%), control will be established by direct or indirect beneficial ownership of one hundred percent (100%) of the maximum ownership percentage that may, under such local law, be owned by foreign interests; or (b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).
1.1.2 “Field” shall mean the use of Licensed Technology in the veterinary Non Human Field for therapeutic purposes.
1.1.3 “Improvements” shall mean any development, discovery or invention that is conceived, reduced to practice or otherwise developed by or on behalf of a Party, whether or not patentable, that is a modification, improvement or enhancement to, and is dominated by the claims of, the Patent Rights.
1.1.4 “Licensed Product” shall mean any product sold by or on behalf of Licensee, its Affiliates or its sublicensees under the applicable sublicense agreement, the manufacture, use or sale of which would infringe a Valid Claim within the Patent Rights in the country of such manufacture, use or sale but for the license granted herein.
1.3 “Licensor Know-How” shall mean any and all technical and scientific information, owned or controlled by Licensor as of the Effective Date and at any time during the Term to the extent that such information relates to the Licensed Technology as applicable to the Field, including, for example, ideas, discoveries, knowledge, know-how, data processes, procedures, methods, techniques, protocols, formulae, trade secrets, inventions (whether or not patentable), research tools, formulations, other physical, chemical or biological information, including without limitation improvements to such information.
1.4 “Patent Rights” shall mean any and all rights which would be granted under any Patents which may issue on the applications listed in Exhibit A and all Patents hereafter filed, owned or controlled by Licensor that claim an Improvement dominated by the claims of one or more of the patent rights described in (a) above, each to the extent that they are applicable to the Field.
1.5 “Commercialization” or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
1.6 “Develop” or “Developments” shall mean pre-clinical and clinical research and development activities, including toxicology and other pre-clinical development efforts, stability testing, process development, pre-formulation, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical pharmacology, clinical studies (including without limitation Clinical Trials), regulatory affairs, and regulatory approval and clinical study regulatory activities.
1.7 “Term” shall mean 15 years.
1.8 “Quarter” means each of the four (4) thirteen (13) week periods; (i) commencing on January 1 of any calendar year.
1.9 “Net Sales” shall mean the gross amount billed or invoiced by Licensee , its Affiliate, or its sublicensees (“Seller”) in U.S. dollars for the final end-user sale or other disposition of Licensed Products, less the following deductions (to the extent such deductions are not already deducted from the amount billed or invoiced and to the extent such deductions are not otherwise recovered or reimbursed):
(a) actual amounts, net of recoveries, of any discounts, charge backs, rebates, allowances for bad debts or uncollectible amounts (provided that such amounts have been formally designated as such in accordance with Seller’s internal accounting procedures, consistently applied) and allowances actually taken;
(b) sales, use, value added and excise taxes, import and customs duties, tariffs, and any other similar government charges, taxes, duties or tariffs, directly imposed against gross sales and to the extent actually paid by or charged to the account of the Seller;
(c) freight, insurance, packaging and insurance costs and other transportation charges to the extent included in the sales price;
(d) amounts corresponding to usual and customary retroactive price reductions actually taken, and
(e) amounts corresponding to credits, allowances or deductions for returns, or rejected or damaged goods, defects, recalls, commissions, stocking allowances, or marketing and promotional expenses.
Notwithstanding the foregoing, “Net Sales” shall not include amounts (i) for any Licensed Product furnished to a third party for which payment (other than the cost of the Licensed Product) is not intended to be received, including, but not limited to, Licensed Products used in Clinical Trials and Licensed Products distributed as promotional and free goods or (ii) from sales or other dispositions of Licensed Products between Licensee and any of its Affiliates or between Licensee or any of its Affiliates and a sublicensee, unless such Affiliate or sublicensee, as the case may be, is an end-user of such Licensed Product.
1.13 “First Commercial Sale” shall mean, with respect to each Licensed Product, the first sale of such Licensed Product by Licensee or its Affiliates or sublicensees to a third party for which payment has been received in any country in the Territory after all applicable required regulatory approvals have been granted by the applicable regulatory authority in such country.
1.14 “Territory” shall mean worldwide rights
2. LICENSES
2.1. Grant of Rights. Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee an exclusive, royalty-bearing right and license, in the Field in the Territory, including the right to grant sublicenses, under the Licensed Technology, to Develop, make, have made, use, Commercialize, offer for sale, have sold, and import Licensed Products.
2.2. Sublicense Rights. Licensee shall have the right, subject to Licensor’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, to sublicense the rights granted under Section 2.1 (Grant of Rights) to an Affiliate or a third party pursuant to a written sublicense agreement; PROVIDED, in the event of any sublicense of rights by Licensee hereunder, (i) full copies of the final sublicense are provided to Licensor, (ii) such sublicense shall be subject to the terms and conditions of this Agreement that, by their terms, are applicable to such sublicense, (iii) the sublicense by Licensee hereunder shall not relieve Licensee of its obligations under this Agreement, and (iv) Licensee shall remain responsible to Licensor for the performance or nonperformance of any such sublicensee hereunder.
2.3. Rights to Licensor Improvements. Any Improvement made by or on behalf of Licensor after the Effective Date which is available to be licensed shall be automatically included in the Licensed Technology licensed to Licensee in Section 2.1 (Grant of Rights).
2.4. Rights to Licensee Improvements. Any Improvement made by or on behalf of Licensee after the Effective Date (“Licensee Improvement”) shall be owned by Licensee. Licensee hereby grants Licensor first right of refusal on any intellectual property developed from this license agreement.
2.5. No Other Rights. Except as expressly provided herein, no right, title, or interest is granted whether by implication, estoppel, reliance, or otherwise, by Licensor to Licensee in, to or under the Licensed Technology. All rights with respect to technology, patents or other intellectual property rights that are not specifically granted herein are reserved;
3. PAYMENTS AND RELATED OBLIGATIONS
3.1. License Fees. In partial consideration for the rights and license granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor:
3.1.1. a one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee on June 23, 2015, which must be paid within 90 days of the date due and
3.1.2. an annual non-refundable payment of one hundred thousand US dollars ($100,000) on the first anniversary of the Effective Date of this Agreement and each subsequent anniversary.
The payments specified in Section 3.1 may be paid in cash or common stock of the Licensee or in common stock of Licensee’s Parent (Entest BioMedical Inc.) accordance with Section 3.2.
3.2. Issue of Common Stock Equivalent to Cash. The payments identified in Sections 3.1 and 3.2 as payable in cash or common stock may be paid in cash or newly issued common stock of the Licensee or in common stock of Licensee’s Parent (Entest BioMedical Inc.) at the Licensee’s discretion valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly within the 14 trading days prior to issuance.
3.3 Royalty Payments.
3.3.1. In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights), Licensee shall pay to Licensor royalties equal to four percent (4%) of the Net Sales of any Licensed Products in a Quarter.
3.3.2 Royalty Term. The obligation of Licensee to pay royalties to Licensor pursuant to Section 3.3.1 shall commence on the date of the First Commercial Sale of a Licensed Product and continue, until expiration of the Term.
3.3.3. Sublicensee Payments. Licensee will pay Licensor ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Licensor receives payment in accordance with Section 3.3.1
3.3.4 Minimum Annual Royalties. In partial consideration for the rights and licenses granted pursuant to Section 2.1 (Grant of Rights),Licensee shall pay to Licensor minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of the Effective Date. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period pursuant to Clause 3.3 below do not exceed ten thousand US dollars ($10,000).
3.3.5 Licensee shall pay all royalties due and payable on Net Sales in each (i) within sixty (60) days after the last day of each Quarter in which the applicable Net Sales underlying such royalties were billed or invoiced by Licensee (ii) in the case of a sublicensee, within thirty (30) days after the sublicensee or its Affiliate remits payment to Licensee.
3.3.6 Taxes. To the extent a withholding tax obligation is imposed by a governmental authority upon a royalty or other payment due and payable by Licensee to Licensor, Licensee or a sublicensee, as the case may be, shall be entitled to withhold from such payment the amount, if any, of any tax assessed against Licensor and to be withheld, provided that such tax is only for the account of Licensor and evidence of the payment of such tax is promptly provided to Licensor. Licensee, or the sublicensee, as the case may be, shall pay the amount of such tax to the proper taxing authority as required and shall be entitled to deduct the amount of such tax from the payment to be made by Licensee to Licensor. Licensee shall advise Licensor of any tax payment made for the benefit of Licensor pursuant to this Section 3.3.6 (Taxes) and provide, or request a sublicensee to provide, Licensor copies of tax receipts for all taxes paid and deducted from the payment due and payable to Licensor, together with copies of all pertinent communications from or with governmental authorities with respect thereto. At Licensor’s reasonable request and at Licensor’s reasonable expense, Licensee shall reasonably assist Licensor in any effort by Licensor in claiming any exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force, and in minimizing the amount required to be so withheld or deducted.
3.3.7 Interest. Any payment due and payable to Licensor under the terms and conditions of this Agreement, including, without limitation, any royalty payment, made by Licensee after the date such payment is due and payable shall bear interest as of the day after the date such payment was due and payable and shall continue to accrue such interest until such payment is made at an annualized rate equal to 10%.
3.3.8 Records and Reports. All payments made to Licensor hereunder shall be accompanied by a written statement setting forth in reasonable detail the calculation thereof, including, for example, in the case of royalty payments, the gross amount billed or invoiced by Licensee, its Affiliates or its sublicensees for sale or other disposition of Licensed Products on a country-by-country basis in the local currency, itemized deductions against such gross amount in accordance with Section 1.12 (Net Sales), Net Sales on a country-by-country basis, and, if applicable, the exchange rate utilized to convert a local currency to US dollars and these reports are due within 30 days of each Quarter. Licensee shall maintain complete and accurate records sufficient to enable accurate calculation of royalties and other payments due Licensor hereunder. Such records and books of account shall be preserved by Licensee for a period of seven (7) years after the end of the period covered by such records and books of account, which obligation shall survive expiration or termination of this Agreement. Licensee shall use commercially reasonable efforts to ensure that its sublicensees provide reports and keep records in a manner consistent with this Section 3.3.8 Licensee shall provide reports received from sublicensees to Licensor with the applicable payment and such reports shall be deemed Confidential Information of Licensee and shall be subject to Section 6 (Confidentiality).
3.3.9 Audit Rights Licensee shall permit an independent public accountant designated by Licensor and reasonably acceptable to Licensee, to have access, no more than once in each calendar year during the Term and no more than twice during the three (3) calendar years following the expiration or termination of this Agreement, during regular business hours and upon at least sixty (60) days written notice, to Licensee’s records and books to the extent necessary to determine the accuracy of Net Sales reported, and payments made, by Licensee to Licensor within the three (3) year period immediately preceding such an audit. The independent public accountant shall be under a confidentiality obligation to Licensee to disclose to Licensor only (a) the accuracy of Net Sales reported and the basis for royalty and other payments made to Licensor under this Agreement and (b) the difference, if any, such reported and paid amounts vary from amounts determined as a result of the audit. If such examination results in a determination that Net Sales or payments have been misstated, over or under paid amounts due shall be paid promptly to the appropriate Party. If Net Sales are understated by greater than ten percent (10%), the fees and expenses of such accountant shall be paid by Licensee; otherwise the fees and expenses of such accountant shall be paid by Licensor. All matters reviewed by such independent public accountant shall be deemed Confidential Information of Licensee and shall be subject to Section 9 (Confidentiality). Licensee shall use commercially reasonable efforts to reserve the right to conduct audits of its sublicensees in a comparable manner to this Section 3.3.9 and if requested by Licensor shall appoint an independent public accountant to conduct such audit, at Licensor’s expense, unless the Net Sale of sublicensee are understated by greater than 10 percent (10%), in which case Licensee shall ensure that the fees and expenses of such accountant shall be paid by the sublicensee. Licensee shall provide Licensor with a copy of all audit reports of sublicensees under this Section 3.3.9, such reports shall be deemed Confidential Information of Licensee and shall be subject to Section 9(Confidentiality).
4. PATENT MATTERS
4.1 Licensor shall have the right and the obligation to prosecute and maintain all Patents to be issued pertaining to the Patent applications licensed in Exhibit A at its cost and expense. Licensor shall keep licensee reasonably apprised of all relevant actions regarding the status of such patents. All intellectual property licensed under this agreement shall be for veterinary purposes only.
4.2 Each Party shall notify the other Party of any infringement of any intellectual property rights with regard to the Licensed Technology or a Licensed Product by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party. Licensor shall have has sole responsibility and control of legal action relating to claims of infringement with respect to the Licensed Technology.
4.3 Licensor shall have the first right, but not an obligation, to initiate, maintain and control, at Licensor’s expense, legal action against any infringement of intellectual property rights relating to the Licensed Technology by a third party in the Field.
4.4 Cooperation. In any suit, proceeding or dispute involving infringement of any intellectual property rights relating to the Licensed Technology in the Field, the Parties shall provide each other with reasonable cooperation shall make available to each other , at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.
5. REPRESENTATIONS AND WARRANTIES
5.1 Each Party hereby is duly organized, validly existing and in good standing under the laws of their respective jurisdiction. Each Party has the full right and power to enter into and perform its obligations under this Agreement and each has duly authorized, executed and delivered this Agreement which is binding upon, and enforceable against, each Party in accordance with its terms. To the best knowledge of each Party there is no action at law or in equity, no arbitration proceeding and no action, proceeding, complaint or investigation before or by any federal, foreign, state or local government or regulatory commission, agency or other administrative or regulatory body or authority pending or threatened against or affecting either Party its officers, directors, business or affairs that will affect the set over of the Assigned Patent and the equitable consideration, as stated herein.
6. CONFIDENTIALITY
6.1. Confidential Information. The Parties may provide Confidential information to each other, including but not limited to each Party’s know-how, invention disclosures, proprietary materials and/or technologies, economic information, business or research strategies, trade secrets and material embodiments thereof. As used herein, “Confidential Information” means any information of a confidential and proprietary nature disclosed by a Party to this Agreement to the other Party (i) in written form marked “confidential” or (ii) in oral form if summarized in a writing marked “confidential” delivered to the receiving Party within thirty (30) days after the oral disclosure.
6.2. Confidentiality and Non-Use. The recipient of a disclosing Party’s Confidential Information shall maintain such Confidential Information in confidence, and shall disclose such Confidential Information only to its employees, agents, consultants, Affiliates, licensors, sublicensees, attorneys, accountants, investors, potential acquirors and advisors who have a reasonable need to know such Confidential Information and who are bound by obligations of confidentiality and non-use no less restrictive than those set forth herein and for whom each Party shall be responsible for any breach of this Section 9. The recipient of the disclosing Party’s Confidential Information shall use such Confidential Information solely to exercise its rights and perform its obligations under this Agreement (including, without limitation, the right to use and disclose such Confidential Information in regulatory applications and filings), unless otherwise mutually agreed in writing. The recipient of the other Party’s Confidential Information shall take the same degree of care that it uses to protect its own confidential and proprietary information of a similar nature and importance (but in any event no less than reasonable care).
6.3. Exclusions. Confidential Information shall not include information that: (a) is in the recipient’s possession prior to receipt from the disclosing Party as established by documentary proof; (b) is or becomes, through no fault of the recipient or its Affiliates or sublicensees hereunder, publicly known (as shown by the recipient’s written record); (c) is furnished to the recipient by a third party without breach of a duty to the disclosing Party; (d) is independently developed by the recipient without use of, application of or access to the disclosing Party’s Confidential Information; or (e) is required to be disclosed under applicable law, but only for the sole purpose of and solely to the extent required by such law, and provided that the recipient, to the extent possible, shall give the disclosing Party prior written notice of the proposed disclosure and cooperate fully with the disclosing Party to minimize the scope of any such required disclosure, to the extent possible and in accordance with applicable law.
6.4. Termination. All obligations of confidentiality and non-use imposed under this Section 6 (Confidentiality) shall expire five (5) years after the date of disclosure of such information under this Agreement.
7. TERMINATION
7.1 If a Party commits a material breach of this Agreement (“Defaulting Party”), the other Party may notify the Defaulting Party in writing of such failure. If the Defaulting Party does not make a written objection as to whether a material breach has occurred or fails to cure such material breach within ninety (90) days of the receipt of the foregoing notice from the other Party then the other Party may terminate this Agreement.
7.2 Licensor may terminate this Agreement if Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory by ten years or Licensee, its Affiliate, or its sublicensee, has not sold any Licensed Product anywhere in the Territory for any twelve (12) month period after Licensee’s, its Affiliate’s, or its sub licensee’s First Commercial Sale of a Licensed Product, unless (i) such failure to sell Licensed Product is the result of (a) a recall, suspension of regulatory approval or clinical hold by a regulatory authority such as the U.S. Food and Drug Administration or foreign equivalent in the Territory, (b) a voluntary recall and/or suspension of Licensed Product sales by Licensee, its Affiliate, or its sublicensee, based on reasonable concerns for patient safety, or (d) a force majeure ( Section 8).
7.3 Licensee may terminate this Agreement with regard to any of the License IP described in Exhibit A if by five years a patent has not been granted by the United States patent and Trademark Office to Licensor with regard to that License IP
7.4 Licensee may terminate this Agreement with regard to any of the License IP described in Exhibit A if a patent that has been granted by the United States patent and Trademark Office to Licensor with regard to that License IP is terminated .
8. FORCE MAJEURE
8.1 Neither Party shall be held responsible for any delay or failure in performance hereunder caused by strikes, embargoes, unexpected government requirements, including civil or military authorities, acts of God, earthquake, or by the public enemy or other causes reasonably beyond such Party’s control and without such Party’s fault or negligence; provided that the affected Party notifies the unaffected Party as soon as reasonably possible, and resumes performance hereunder as soon as reasonably possible following cessation of such force majeure event; and provided further that no such delay or failure in performance shall continue for more than twelve (12) months.
9. NOTICES
9.1 Notices. Any notice, report, communication or consent required or permitted by this Agreement shall be in writing and shall be sent (a) by prepaid registered or certified mail, return receipt requested, (b) by overnight express delivery service by a nationally recognized courier, or (c) via confirmed facsimile or telecopy, followed within five (5) days by a copy mailed in the preceding manner, addressed to the other Party at the address shown below or at such other address for which such Party gives notice hereunder. Such notice will be deemed to have been given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered.
If to Licensor:
Regen BioPharma, Inc.
4700 Spring Street
Suite 304
La Mesa CA 91942
USA
Attn: David R. Koos, CEO
Facsimile: 619.330.2328
If to Licensee:
Zander Therapeutics, Inc.
4700 Spring Street
Suite 304
La Mesa CA 91942
USA
Attn: David R. Koos, CEO
Facsimile: 619.330.2328
10 GOVERNING LAW,VENUE, And WAIVER OF JURY TRIAL.
10.1 All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of California, without regard to the principles of conflicts of law thereof. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in California for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or inconvenient venue for such proceeding. If either party shall commence an action or proceeding to enforce any provisions of this Agreement, then the prevailing party in such action or proceeding shall be reimbursed by the other party for its attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such action or proceeding.
11 SEVERABILITY.
11.1 If any provision of this Agreement shall be held invalid or unenforceable, such invalidity or unenforceability shall attach only to such provision and shall not in any manner affect or render invalid or unenforceable any other severable provision of this Agreement, and this Agreement shall be carried out as if any such invalid or unenforceable provisions were not contained herein.
12 WAIVER
12.1 Failure by either Party to enforce a term of this Agreement will not be deemed a waiver of future enforcement of that or any other term in this Agreement or any other agreement that may be in place between the Parties.
13 MODIFICATION
13.1 This Agreement may not be altered, amended or modified in any way except by a writing signed by both Parties.
14. ENTIRE AGREEMENT
14.1 The Parties acknowledge that this Agreement, together with the exhibits attached hereto, sets forth the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements and writings in respect hereto.
| LICENSOR (REGEN BIOPHARMA INC.) | LICENSEE (ZANDER THERAPEUTICS INC.) |
| By: /s/ David Koos | By: /s/ David Koos |
| David R. Koos | David R. Koos |
| Chairman & CEO | Chairman & CEO |
| 1 |
Exhibit A
| Title | Country | Application # | Application Type |
Application Filing Date | ||||
| Antigen Specific mRNA Cellular Cancer Vaccines | United States | 62165116 | Provisional | 05/21/2015 | ||||
| ACCELERATION OF HEMATOPOIETIC RECONSTITUTION BY... | United States | 13/897,735 | Utility | 05/20/2013 | ||||
| CELLS, COMPOSITIONS, AND TREATMENT METHODS FOR STIMULATION OF HEMATOPOIESIS | United States | 13/957,427 | Utility | 08/01/2013 | ||||
| CANCER THERAPY BY EX VIVO ACTIVATED AUTOLOGOUS IMMUNE CELLS | United States | 13/957,431 | Utility | 08/02/2013 | ||||
| Stimulation of Immunity to Tumor Specific and Endothelial Specific Proteins by In Vivo DC Attractio | United States | 62/050,418 | Provisional | 09/15/2014 | ||||
| Methods and Compositions for treatment of cancer by inhibition of NR2F6 | United States | 14/571,262 | Utility | 12/15/2014 | ||||
| Treatment of Myelodysplastic Syndrome by Inhibition of NR2F6 | United States | 14/572,574 | Utility | 12/16/2014 | ||||
| Treatment of Myelodysplastic Syndrome by Inhibition of NR2F2 | United States | 14/588,374 | Utility | 12/31/2014 | ||||
| Methods and Compositions for treatment of cancer by inhibition of NR2F2 | United States | 14/588,373 | Utility | 12/31/2014 | ||||
| Modulation of Hematopoietic Stem Cell Differentiation | United States | 14/595,078 | 01/12/2015 |
| 2 |
Exhibit 5.1
LAW OFFICES OF
WILLIAM M. AUL
ATTORNEY AT LAW
1660 Hotel Circle North, Suite 207
San Diego, CA 92108
Email: Bill@Aullaw.net
April 7, 2023
Board of Directors
Regen Biopharma, Inc.
4700 Spring Street, Suite 304
La Mesa, California 91942
Dear Dr. Koos:
In my capacity as counsel for Regen Biopharma, Inc., a Nevada corporation (the “Company”), I have participated in the corporate proceedings relative to the authorization by the Company for the issuance of a maximum of One Million (1,000,000) shares of the Company’s common stock (par value $0.0001) (the “Subject Shares”) pursuant to the resolutions duly adopted by the Company’s Board of Directors and described in the Company’s Registration Statement on Form S-1 under the Securities Act of 1933 (the “Registration Statement”). I have also participated in the preparation and filing of the Registration Statement.
Based upon the foregoing and upon my examination of originals (or copies certified to my satisfaction) of such corporate records of the Company and other documents as I have deemed necessary as a basis for the opinions hereinafter expressed, and assuming the accuracy and completeness of all information supplied me by the Company, having due regard for the legal considerations which I deem relevant, I am of the opinion that:
(1) The Company is a corporation duly organized and validly existing under the laws of the State of Nevada;
(2) The Company has taken all requisite corporate action and all action required by the laws of the State of Nevada with respect to the authorization, issuance and sale of the Subject Shares to be issued pursuant to the Registration Statement;
(3) The Subject Shares, when issued pursuant to the Registration Statement, will be validly issued, fully paid and non-assessable.
I hereby further consent to the use of this opinion as an exhibit to the Registration Statement and to the references to myself in the Registration Statement.
Yours very truly,
/s/ William M. Aul
WILLIAM M. AUL
Exhibit 3(ii)
BY-LAWS
OF
REGEN BIOPHARMA INC
A NEVADA CORPORATION
ARTICLE ONE
OFFICES
Section 1.1 Registered Office – the registered office of this corporation shall be in the County of Carson City, State of Nevada
Section 1.2 Other Offices – The Corporation may also have offices at such other places both within and without the State of Nevada as the Board of Directors may from time to time or the business of the corporation may require.
ARTICLE TWO
MEETINGS OF STOCKHOLDERS
Section 2.1 Place – All annual meetings of the stockholders shall be held at registered office of the corporation or at such other place within or without the State of Nevada as the directors shall determine. Special meetings of the stockholders may be held at such time and place within or without the State of Nevada as shall be stated in the notice of the meeting, or in a duly executed waiver of notice thereof.
Section 2.2 Annual Meetings – The annual meeting of the stockholders of the corporation shall be held on such date and at such time as designated from time to time for the purpose or electing directors of the corporation and to transact all business as may properly come before the meeting. If the election of the directors is not held on the day designated herein for any annual meeting of the stockholders, or at any adjournment thereof, the president shall cause the election to be held at a special meeting of the stockholders as soon thereafter as is convenient.
Section 2.3 Special Meetings – Special meetings of the stockholders, for any purpose or purposes, unless otherwise prescribed by statute or by the Articles of Incorporation, may be called by the CEO or the Secretary by resolution of the Board of Directors or at the request in writing of stockholders owning a majority in amount of the entire capital stock of the corporation issued and outstanding and entitled to vote. Such requests shall state the purpose of the purposed meeting.
Section 2.4 Notice of Meetings – Notice of meetings shall be in writing and signed by the President or other officer or by such person or persons as the directors shall designate. Such notice shall state the purpose or purposes of which the meeting is called and the time and place, which may be within or without this state, where it is to be held. A copy of such notice shall either be personally delivered to or shall be mailed to each stockholder of record entitled to vote at such meetings not less than 10 days and not more than 60 days before such meeting. If mailed, it shall be directed to a stockholder as his address as it appears upon the records of the corporation and upon such mailing of any such notice, the service shall be complete and the time of the notice shall begin to run from the date upon which such notice is deposited in the mail for transmission to such stockholder. Personal delivery of any such notice to any officer of a corporation or association or to any member of a partnership shall constitute delivery of such notice of the meeting to the transferee.
Section 2.5 Purpose of Meetings – Business transacted at any special meeting of stockholders shall be limited to the purpose stated in the notice.
Section 2.6 Quorum – The holders of a majority of the stock issued and outstanding and entitled to vote there at, present in person or represented by proxy, shall constitute a quorum at all meetings of stockholders for the transaction of business except as otherwise provided by statute or by the Articles of Incorporation. If, however, such quorum shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote there at, present in person or represented by proxy, shall have power to adjourn the meeting from time to time, without notice other than announcement at the , until a quorum shall be present or represented, any business may be transacted which might have been transacted at the meeting as originally notified.
Section 2.7 Voting – When a quorum is present or represented at any meeting, the vote of the holders of a majority of the stock having voting power present in person or represented by proxy shall be sufficient to elect directors or to decide any questions brought before such meeting, unless the question is one upon which by express provision of the statutes or of the Articles of Incorporation, a different vote is required in which case such express provision shall govern and control the decision of such question.
Section 2.8 Share Voting – Each stockholder of record of the corporation shall be entitled at each meeting of stockholders to one vote for each share of stock standing in his name on the books of the corporation unless such series of stock held by that stockholder shall have been fixed by resolution of the Board of Directors a number of votes per share not equal to one in which case that stockholder shall be entitled to that number of votes so fixed by resolution for each share of stock standing in his name on the books of the corporation ..
Section 2.9 Proxy – At the meeting of the shareholders any stockholder may be presented and vote by a proxy or proxies appointed by an instrument in writing. In the event that any such instrument in writing shall designate two or more persons to act as proxies, a majority of such persons present at the meeting, or, if only one shall be present, then that one shall have and may exercise all of the powers conferred by such written instrument upon all of the persons so designated unless the instrument shall otherwise provide. No proxy or power of attorney to vote shall be used to vote at a meeting of the stockholders unless it shall have been filed with the secretary of the meeting when required by the inspectors of election. All questions regarding the qualification of voters, the validity of proxies and the acceptance or rejection of votes shall be decided by the inspectors of election who shall be appointed by the Board of Directors, or if not so appointed, then by the presiding officer of the meeting.
Section 2.10 Written Consent in Lieu of Meeting – Any action which may be taken by the vote of the stockholders at a meeting may be taken without a meeting if authorized by a written consent of stockholders holding at least a majority of the voting power, unless the provisions of the statutes or of the Articles of Incorporation require a greater proportion of voting power to authorization such action in which case such greater proportion of written consents shall be required.
ARTICLE THREE
DIRECTORS
Section 3.1 Powers – The business of the corporation shall be managed by its Board of Directors, which may exercise all such powers of the corporation and do all such lawful acts and things as are not by statute or by the Articles of Incorporation or by these Bylaws directed or required to be exercised or done by the stockholders.
Section 3.2 Number, Tenure, and Qualification. Except as otherwise provided herein, the Board of Directors of the corporation shall consist of at least one (1) and no more than fifteen (15) persons, who shall be elected at the annual meeting of the stockholders of the corporation and who shall hold office for one (1) year or until his or her successor or successors are elected and qualify.
Section 3.3 Resignation. Any director may resign effective upon giving written notice to the Chairman of the Board of Directors, the CEO or the secretary of the corporation, unless the notice specified at a later time for effectiveness of such resignation. If the Board of Directors accepts the resignation of a director tendered to take effect at a future date, the Board of Directors or the stockholders may elect a successor to take office when the resignation becomes effective.
Section 3.4 Change in Number. Subject to the limitations of the laws of the State of Nevada or the Articles of Incorporation, the number of directors may be changed from time to time by resolution adopted by the Board of Directors.
Section 3.5 Removal.
(a) The Board of Directors of the corporation, by majority vote, may declare vacant the office of a director who has been declared incompetent by an order of a court of competent jurisdiction, convicted of a felony, suspected of misfeasance, malfeasance, immoral acts or otherwise brings disrespect or undue negative impact upon the corporation.
(b) Any director may be removed from office, with or without cause, by the vote or written consent of stockholders representing not less than fifty percent of the issued and outstanding voting capital stock of the corporation.
Section 3.6 Vacancies A vacancy in the Board of Directors because of death, resignation, removal, change in the number of directors, or otherwise may be filled by the stockholders at any regular or special meeting or any adjourned meeting thereof or the remaining director(s) or the affirmative vote of a majority thereof. Each successor so elected shall hold office until the next annual meeting of stockholders or until a successor shall have been duly elected and qualified.
Section 3.7 Reduction in Number. No reduction of the number of directors shall have the effect of removing any director prior to the expiration of his term of office.
ARTICLE FOUR
MEETINGS OF THE BOARD OF DIRECTORS
Section 4.1 Place – Regular meetings of the Board of Directors shall be held at any place within or without the State which has been designated from time to time be resolution of the Board or by written consent of all members of the Board. In the absence of such designation regular meetings shall be held at the registered office of the corporation. Special meetings of the Board may be held either at a place so designated or at the registered office.
Section 4.2 First Meeting – The first meeting of each newly elected Board of Directors shall be immediately following the adjournment of the meeting of stockholders and at the place thereof. No notice of such a meeting shall be necessary to the directors in order legally to constitute the meeting, provided a quorum be present. In the event such meeting is not so held, the meeting may be held at such time and place as shall be specified in a notice given as herein after provided for special meetings of the Board of Directors.
Section 4.3 Regular Meetings – Regular meetings of the Board of Directors may be held without call or notice at such a time and at such a place as shall from time to time be fixed and determined by the Board of Directors.
Section 4.4 Special Meetings – Special meetings of the Board of Directors may be called by the Chairman or the CEO.
Written notice of the time and place of special meetings shall be delivered personally to each director, or sent to each director by mail or by other form of written communication, charges prepaid, addressed to him at his address as it is shown upon the records or if not readily ascertainable, at the place in which the meeting of the directors are regularly held. In case such notice is mailed it shall be deposited in the United States mail at least forty-eight (48) hours prior to the time of the holding of the meeting. In case such notice is delivered as above provided, it shall be so delivered at least at least twenty-four (24) hours prior to the time of holding of the meeting. Such mailing or delivery as above provided shall be due, legal and personal notice to such director.
Section 4.5 Notice – Notice of the time and place of holding an adjourned meeting need not be given to the absent directors if the time and place be fixed at the meeting adjourned.
Section 4.6 Waiver – The transactions of any meeting of the Board of Directors, however called and noticed or wherever held, shall be as valid as though had a meeting duly held after regular call and notice, if a quorum be present, and if, either before or after the meeting, each of the directors not present signs a written waiver of notice, or a consent to holding such meeting, or an approval of the minutes thereof. All such waivers, consents or approvals shall be filed with the corporate records or made a part of the minutes of the meeting.
Section 4.7 Quorum – A Majority of the authorized number of directors shall be necessary to constitute a quorum for the transaction of business, except to adjourn as here in after provided. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the Board of Directors, unless a greater number is required by law or by the Articles of Incorporation. Any action of a majority, although not a regularly called meeting, and the record thereof, if assented to in writing by all of the other members of the Board shall be as valid and effective in all respects as if passed by the Board in regular meeting.
Section 4.8 Adjournment – A quorum of the directors may adjourn any directors meeting to meet again at a stated day and hour; provided, however, that in the absence of a quorum, a majority of the directors present at any directors meeting, either regular or special, may adjourn from time to time until the time fixed for the next regular meeting of the Board.
Section 4.9 Meetings of the Board of Directors may be held through the use of a conference telephone or similar communications equipment such as email, instant messaging or similar communication so long as all members participating in such meeting can communicate with one another at the time of such meeting. Participation in such a meeting constitutes presence in person at such meeting. Each person participating in the meeting shall sign the minutes thereof, which may be in counterparts. Approval of said meeting may be accomplished via email or fax.
Section 4.10 Board Decisions. The affirmative vote of a majority of the directors present at a meeting at which a quorum is present shall be the act of the Board of Directors.
ARTICLE FIVE
COMMITTEES OF DIRECTORS
Section 5.1 Power to Designate – The Board of Directors may, by resolution adopted by a majority of the whole Board, designate one or more committees of the Board of Directors, each committee to consist of one or more of the directors of the corporation which, to the extent provided in the resolution, shall have and may exercise the power of the Board of Directors in the management of the business and affairs of the corporation and may have power to authorize the seal of the corporation to be affixed to all papers which may require it. Such committees shall have such name or names as may be determined from time to time by the Board of Directors. The members of any such committee present at any meeting and not disqualified from voting may, whether or not they constitute a quorum, unanimously appoint another member of the Board of Directors to act at the meeting in the meeting in the place of any absent or disqualified member. At meetings of such committees, a majority of the members or alternate members shall constitute a quorum for the transaction of business, and the act of a majority of the members or alternate members at any meeting at which there is a quorum shall be the act of the committee.
Section 5.2 Regular Minutes – The committees shall keep regular minutes of their proceedings and report the same to the Board of Directors.
Section 5.3 Written Consent – Any action required or permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a meeting if a written consent thereto is signed by all members of the Board of Directors or of such committee, as the case may be, and such written consent is filed with the minutes of proceedings of the Board or committee.
ARTICLE SIX
COMPENSATION OF DIRECTORS
Section 6.1 Compensation – The directors may be paid their expenses of attendance at each meeting of the Board of Directors and may be paid a fixed sum for attendance at each meeting of the Board of Directors or a stated salary as director. No such payment shall prelude any director from serving the corporation in any other capacity and receiving compensation therefore. Members of special or standing committees may be allowed like reimbursement and compensation for attending committee meetings.
ARTICLE SEVEN
NOTICES
Section 7.1 Notice – Notices to directors and stockholders shall be in writing and delivered personally or mailed to the directors or stockholders at their addresses appearing on the books of the corporation. Notice by mail shall be deemed to be given at the time when the same shall be mailed. Notice to directors may also be given by telegram.
Section 7.2 Consent – Whenever all parties entitled to vote at any meeting, whether of directors or stockholders, consent, either by a writing on the records of the meeting or filed with the secretary, or by presence at such meeting and oral consent entered on the minutes, or by taking part in the deliberations at such meeting without objection, the doings of such meetings shall be as valid as if they had occurred at a meeting regularly called and noticed, and at such meeting any business may be transacted which is not excepted from written consent or to the consideration of which no objection for want of notice is made at the time, and if any meeting be irregular for want of notice or of such consent, provided a quorum was present at such a meeting, the proceedings of said meeting may be ratified and approved and rendered likewise valid and the irregularity of defect therein waived by a writing signed by all parties having the right to vote at such meeting; and such consent or approval of stockholders may be proxy or attorney, but all such proxies and powers of attorney must be in writing.
Section 7.3 Waiver of Notices – Whenever any notice whatsoever is required to be given under the provisions of the statutes, of the Articles of Incorporation or of these Bylaws, a waiver thereof in writing, signed by the person or persons entitled to said notice, whether before or after the time stated therein, shall be deemed equivalent thereto.
ARTICLE EIGHT
OFFICERS
Section 8.1 Appointment of Officers – The officers of the Corporation shall be chosen by the Board of Directors and shall be Chief Executive Officer, a Secretary and a Treasurer. Any person may hold two or more offices.
Section 8.2 Time of Appointment – The Board of Directors at its first meeting after each annual meeting of stockholders shall choose a Chairman of the Board who shall be a director, and shall choose a Chief Executive Officer, a Secretary and a Treasurer, none of whom need be directors.
Section 8.3 Additional Officers – The Board of Directors may appoint such other officers and agents as it shall deem necessary who shall hold their offices for such terms and shall exercise such powers and perform such duties as shall be determined from time to time by the Board of Directors.
Section 8.4 Salaries – The salaries and compensation of all officers of the corporation shall be fixed by the Board of Directors.
Section 8.5 Vacancies, Removals, Resignations –Any officer or agent elected or appointed by the Board of Directors may be removed by it with or without cause. Any office may resign at any time upon written notice to the corporation without prejudice to the rights, if any, of the corporation under contract to which the resigning officer is a party. Any vacancy in any office because of death, resignation, removal or otherwise may be filled by the Board of Directors for the unexpired term or such office.
Section 8.6 Chairman of the Board – The Chairman of the Board shall preside at meetings of the stockholders and the Board of Directors, and shall see that orders and resolutions of the Board of Directors are carried into effect.
Section 8.7 Vice-Chairman of the Board – The Vice-Chairman shall, in the absence or disability of the Chairman of the Board, perform the duties and exercise the powers of Chairman of the Board and shall perform such other duties as the Board of Directors may from time to time prescribe.
Section 8.8 Chief Executive Officer – The Chief Executive Officer (also referred to in these Bylaws as the CEO) of the corporation shall be deemed the general manager and executive officer of the corporation subject to the supervision and control of the Board of Directors, and shall direct the corporate affairs, with full power to execute all resolutions and orders of the Board of Directors not especially entrusted to some other officer of the corporation. The CEO, or his designee, shall perform such other duties as shall be prescribed by the Board of Directors. Unless otherwise ordered by the Board of Directors, the CEO, or his designee shall have the full power and authority on behalf of the corporation to attend, act and vote at meetings of the stockholders of any corporation in which the corporation may hold stock and, at such meetings, shall possess and may exercise any and all rights and powers incident to the ownership of such stock. The Board of Directors, by resolution from time to time, may confer like powers on any person or persons in place of the CEO to represent the corporation for these purposes.
Section 8.9 Secretary – The Secretary shall act under the direction of the CEO. Subject to the direction of the CEO he shall attend all meetings of the Board of Directors and all meetings of the stockholders and record the proceedings. He shall perform like duties for the standing committees when required. He shall give, or cause to be given, notice of all meetings of the stockholders and special meetings of the Board of Directors, and shall perform such other duties as may be required by the CEO or the Board of Directors.
Section 8.10 Treasurer – The Treasurer shall act under the direction of the CEO. Subject to the direction of the CEO he shall have custody of the corporate funds and securities and shall keep full and accurate accounts of receipts and disbursements in books belonging to the corporation and shall deposit all monies and other valuable effects in the name and to the credit of the corporation in such depositories as may be designated by the Board of Directors. He shall disburse the funds as may be ordered by the CEO or the Board of Directors, taking proper vouchers for such disbursements, and shall render to the CEO and the Board of Directors, at its regular meetings, or when the Board of Directors so requires, an account of all his transactions as Treasurer and of the financial condition of the corporation.
Section 8.11 Surety – If required by the Board of directors, he shall give the corporation a bond in such sum surety or sureties as shall be satisfactory to the Board of Directors for the faithful performance of the duties of his office and for the restoration to the corporation, in case of his death, resignation, retirement or removal from office, of all books, papers, vouchers, money and other property of whatever kind in his possession or under his control belonging to the corporation.
ARTICLE NINE
CERTIFICATES OF STOCK
Section 9.1 Share Certificates – Every stockholder shall be entitled to have a certificate signed by the President or a Vice-President and the Treasurer or an Assistant Treasurer, or the Secretary of the corporation, certifying the number of shares owned by him in the corporation. If the corporation shall be authorized to issue more than one class of stock or more than one series of any class, the designations, preferences and relative participating, optional or other special restrictions of such rights, shall be set forth in full or summarized on the face or back of the Certificate which the corporation shall issue to represent such stock.
Section 9.2 Transfer Agents – if a certificate is signed (a) by a transfer agent other than the corporation or its employees or (b) by a registrar other than the corporation or its employees, the signatures of the officers of the corporation may be facsimiles. In case any officers who has signed or who’s facsimile signature has been placed upon a certificate shall cease to be such officer before such certificate is issued, such certificate may be issued with the same effect as though the person had not ceased to be such officer. The seal of the corporation, or a facsimile thereof, may, but need not be, affixed to the certificate of stock.
Section 9.3 Lost or Stolen Certificates – The Board of Directors may direct a new certificate or certificates to be issued in place of any certificate theretofore issued by the corporation alleged to have been lost or destroyed upon the making of an affidavit to the fact by the person claiming the certificate of stock to be lost or destroyed. When authorizing such issue of a new certificate or certificates, the Board of Directors may, in its discretion and as a condition precedent to the issue thereof, require the owner of such lost or destroyed certificate or certificates or his legal representative, to advertise the same in such a manner as it shall require and/or give the corporation a bond in such sum as it may direct as indemnity against any claim that may be made against the corporation with respect to the certificate alleged to have been lost or destroyed.
Section 9.4 Share Transfers – upon surrender to the corporation or the transfer agent of the corporation of a certificate for shares duly endorsed or accompanied by a proper evidence of succession, assignment or authority to transfer, it shall be the duty of the corporation, if it is satisfied that all provisions of the laws and regulations applicable to the corporation regarding transfer and ownership of shares have been complied with, to issue a new certificate to the person entitled thereto, cancel the old certificate and record the transaction upon its books.
Section 9.5 Voting Shareholder – The Board of Directors may fix in advance a date not exceeding sixty (60) days nor less than ten (10) days preceding the date of any meeting of stockholders, or the date for the payment of any dividend, or date for the allotment of rights, or the date when any change or conversion or exchange of capital stock shall go into effect, or a date in connection with obtaining the consent of stockholders for any purpose, as a record date for determination of the stockholders entitled to receive payment of any such meeting, and any adjournment thereof, or entitlement to receive payment of any such dividend, or to give such consent, and in such case, such stockholders, and only such stockholders as shall be stockholder of record on the date so fixed, shall be entitled to notice of and to vote at such a meeting, or any adjournment thereof, or to receive payment of such dividend, or to receive such allotment of rights, or to exercise such rights, or to give such consent, as the case may be, notwithstanding any transfer of any stock on the books of the corporation after any such record date fixed as foresaid.
Section 9.6 Shareholders Record – The corporation shall be entitled to recognize the person registered on its books as the owner of shares to be the exclusive owner for all purposes including voting and dividends, and the corporation shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have expressed or other notice thereof, except as otherwise provided by the laws of Nevada.
Section 9.7 Notwithstanding any other provision in these By-Laws, the Corporation may adopt a system of issuance, recordation and transfer of its shares by electronic or other means not involving any issuance of certificates, including provisions for notice to purchasers in substitution for any required statements on certificates.”
ARTICLE TEN
GENERAL PROVISIONS
Section 10.1 Dividends – Dividends upon the capital stock of the corporation, subject to the provisions of the Articles of Incorporation, if any, may be declared by the Board of Directors at any regular or special meeting, pursuant to law. Dividends may be paid in cash, in property or in shares of the capital stock, subject to the provisions of the Articles of Incorporation.
Section 10.2 Reserves – Before payment of any divided, there may be set aside out of any funds of the corporation available for dividends such sum or sums as the directors from time to time, in their absolute discretion, think proper as a reserve or reserves to meet contingencies, or for equalizing dividends or for repairing or maintaining any property of the corporation or for such other purpose as the directors shall think conductive to the interest of the corporation, and the directors may modify or abolish any such reserve in the manner in which it was created.
Section 10.3 Checks – All checks or demands for money and notes of the corporation shall be signed by such officer or officers or such other person or persons as the Board of Directors may from time to time designate.
Section 10.4 Fiscal Year – The fiscal year end of the corporation shall be September 30.
Section 10.5 Corporate Seal – The Corporation may or may not have a corporate seal, as may from time to time be determined by resolution of the Board of Directors. If a corporate seal is adopted, it shall have inscribed thereon the name of the Corporation and the words “Corporate Seal” and “Nevada”. The seal may be used by causing it or a facsimile thereof to be impressed or affixed or in any manner reproduced.
ARTICLE ELEVEN
INDEMNIFICATION
Every person who was or is a party or is threatened to be made party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact that he or a person of whom he is the legal representative is or was a director or officer of the corporation or is or was serving at the request of the corporation or for its benefit as a director or officer of another corporation, or as its representative in a partnership, joint venture, trust or other enterprise, shall be indemnified and held harmless to the fullest extent legally permissible under the General Corporation Law of the State of Nevada from time to time against all expense, liability and loss (including attorney’s fees, judgments, fines and amounts paid or to be paid in settlement) reasonably incurred in defending a civil or criminal action, suit or proceeding must be paid by the corporation as they are incurred and in advance of the final disposition of the action, suit or proceeding upon receipt of an undertaking by or on behalf of the director or officer to repay the amount if it is ultimately determined by a court of competent jurisdiction that he is not entitled to be indemnified by the corporation. Such a right of indemnification shall be a contract right which may be enforced in any manner desired by such person. Such right of indemnification shall not be exclusive of any other right which such directors, officers or representatives may have or hereafter acquire and, without limiting the generality of such statement, they shall be entitled to their respective rights of indemnification under any bylaw, agreement, vote of stockholders, provision of law or otherwise, as well as their rights under this Article.
The Board of Directors may cause the corporation to purchase and maintain insurance on behalf of any person who is or was a director or officer of the corporation, or is or was serving at the request of the corporation as a director or officer of another corporation, or as its representative in a partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred in any such capacity or arising out of such status, whether or not the corporation would have the power to indemnify such person.
The Board of Directors may from time to time adopt further Bylaws with respect to indemnification and may amend these and such Bylaws to provide at all times the fullest indemnification permitted by the General Corporate Law of the State of Nevada.
ARTICLE TWELVE
AMENDMENTS
Section 12.1 By Shareholder – The Bylaws may be amended by a majority vote of all the stock issued and outstanding and entitled to vote at any annual or special meeting of the stockholders, provided notice of intention to amend shall have been contained in the notice of the meeting.
Section 12.2 By Board of Directors – The Board of Directors by a majority vote of the whole Board at any meeting may amend these Bylaws, including Bylaws adopted by the stockholders, but the stockholders may from time to time specify particular provisions of the Bylaws which shall not be amended by the Board of Directors.
APPROVED AND ADOPTED this 1st day of May, 2012.
/s/ David Koos
Secretary
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CERTIFICATE OF SECRETARY
I hereby certify that I am the Secretary of Regen Biopharma Inc and that the foregoing Bylaws, consisting of 14 pages, constitute the code of Bylaws of Regen Biopharma Inc, as duly adopted at a regular meeting of the Board of Directors of the corporation held May 1, 2012.
IN WITNESS WHEREOF, I have hereunto subscribed my name this 1st day of May, 2012.
/s/ David Koos
Secretary
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Exhibit 3(i)(9)
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| 4 |
Exhibit 3(i)8
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Exhibit 3(i)7
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Exhibit 3(i)6
CERTIFICATE OF DESIGNATIONS
OF THE
NONCONVERTIBLE SERIES NC PREFERRED STOCK
OF
REGEN BIOPHARMA, INC.
(“CORPORATION”)
(PURSUANT TO NRS 78.1955)
Section 1 Designation and Amount.
The shares of this series of preferred stock will be designated as Nonconvertible Series NC Preferred Stock (the “Series NC Preferred”) which series shall consist of Twenty Thousand (20,000) shares having a par value of $.0001 per share
Section 2. Voting Rights.
(a) Voting. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times Five Hundred Thousand (500,000).
(b) Class Vote. Except as otherwise required by law, holders of Common Stock, other series of Preferred issued by the Corporation, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Section 3. Dividends.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
Section 4. Rights on Liquidation.
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to the Corporation’s stockholders, a ratable share in the assets of the Corporation.
Exhibit 3(i)5
CERTIFICATE OF DESIGNATIONS
OF THE
SERIES M PREFERRED STOCK
OF
REGEN BIOPHARMA, INC.
(“CORPORATION”)
(PURSUANT TO NRS 78.1955)
Section 1. Designation and Amount.
The shares of this series of preferred stock will be designated as Series M Preferred Stock (the “Series M Preferred”) which series shall consist of Three Hundred Million (300,000,000) shares having a par value of $.0001 per share.
Section 2. Voting Rights.
(a) Voting. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series M Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one (1).
(b) Class Vote. Except as otherwise required by law, holders of Common Stock, other series of Preferred issued by the Corporation, and Series M Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Section 3. Dividends.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore.
Section 4. Rights on Liquidation.
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to the Corporation’s stockholders, a ratable share in the assets of the Corporation.
Exhibit 3(i)4
CERTIFICATE OF DESIGNATIONS
OF THE
SERIES AA PREFERRED STOCK
OF
REGEN BIOPHARMA, INC.
(“CORPORATION”)
(PURSUANT TO NRS 78.1955)
Section 1 Designation and Amount.
The shares of this series of preferred stock will be designated as Series AA Preferred Stock (the “Series AA Preferred”) which series shall consist of six hundred thousand (600,000) shares having a par value of $.0001 per share
Section 2. Voting Rights.
(a) Voting. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times Ten Thousand (10,000).
(b) Class Vote. Except as otherwise required by law, holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Section 3. Dividends.
The holders of Series AA Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
Section 4. Rights on Liquidation.
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Series AA Preferred Stock shall receive, out of assets legally available for distribution to the Corporation’s stockholders, a ratable share in the assets of the Corporation.
Exhibit 3(i)(3)
CERTIFICATE OF DESIGNATIONS OF THE SERIES A PREFERRED STOCK OF REGEN BIOPHARMA, INC.
(“CORPORATION”)
(PURSUANT TO NRS 78.1955)
Section 1. Designation and Amount.
The shares of this series of preferred stock will be designated as Series A Preferred Stock (the “Series A Preferred”) which series shall consist of ninety million (90,000,000) shares having a par value of $.0001 per share.
Section 2. Voting Rights.
(a) Voting. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one (1).
(b) Class Vote. Except as otherwise required by law, holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Section 3. Dividends.
| (a) | Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Corporation (the “Board”) out of funds of the Corporation legally available therefore, non-cumulative cash dividends of $0.01 per quarter. |
| (b) | In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock. |
Section 4. Rights on Liquidation.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
Exhibit 3(i)2
Exhibit 3(i)
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