UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly
period ended
Commission File
No.
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of |
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(IRS Employer |
incorporation or organization) |
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Identification No.) |
(Address of principal executive offices)
Registrant’s telephone number, including area code
Peptide Technologies, Inc.
(Former name or former address, if changed since last report.)
Indicate by check mark whether the Registrant (1) has filed all reports required by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days:
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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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.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b–2 of the Exchange Act).
Yes
Securities registered pursuant to Section 12(b) of the Act: None
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
Class |
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Outstanding at February 5, 2024 |
Common stock, $0.001 par value |
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“Explanatory Note Regarding Forward-Looking Statements:”
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:
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our ability to add new customers; |
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the impacts of COVID-19, or other future pandemics on our business, results of operations, financial position and cash flows; |
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the potential benefits of and our ability to maintain our relationships, and establish or maintain future collaborations or strategic relationships or obtain additional funding; |
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our marketing capabilities and strategy; |
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our ability to maintain a cost-effective program; |
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our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; |
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our competitive position, and developments and projections relating to our competitors and our industry; |
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our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and |
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the impact of laws and regulations. |
All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.
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REGENEREX PHARMA, INC.
INDEX TO FORM 10-Q FILING
FOR THE NINE MONTHS ENDED DECEMBER 31, 2023 AND 2022
TABLE OF CONTENTS
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PART I - FINANCIAL INFORMATION |
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Management Discussion & Analysis of Financial Condition and Results of Operations |
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PART II - OTHER INFORMATION |
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CERTIFICATIONS |
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31.1 |
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act |
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31.2 |
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act |
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32.1 |
Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act |
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32.2 |
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act |
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PART I
FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
REGENEREX PHARMA, INC.
BALANCE SHEETS
(UNAUDITED)
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December 31, 2023 |
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March 31, 2023 |
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ASSETS |
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Current Assets |
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Cash and equivalents |
$ |
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$ |
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Prepaid expenses |
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Total Current Assets |
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Website, net of accumulated amortization of $ |
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Furniture and computer equipment, net of accumulated amortization of $ |
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Right of use asset |
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Total Assets |
$ |
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$ |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current Liabilities |
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Accounts payable |
$ |
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$ |
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Related party advances |
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Accrued compensation |
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Other accrued liabilities |
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Current portion of notes payable to shareholder |
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Current portion of notes payable to related parties |
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Current portion of notes payable |
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Current portion of lease liabilities |
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Total Current Liabilities |
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Notes payable to shareholder, net of current portion |
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Notes payable to related parties, net of current portion |
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Notes payable, net of current portion |
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Lease liabilities, net of current portion |
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Total Liabilities |
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Commitments and Contingencies (Note 7) |
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Stockholders’ Deficit |
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Common stock: $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total Stockholders’ Deficit |
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Total Liabilities and Stockholders’ Deficit |
$ |
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The accompanying notes are an integral part of these unaudited financial statements.
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REGENEREX PHARMA, INC.
STATEMENTS OF OPERATIONS
(UNAUDITED)
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Three Months Ended |
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Nine Months Ended |
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December 31, |
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December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating Expenses |
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General and administrative |
$ |
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$ |
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$ |
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$ |
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Research and development |
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Total Operating Expenses |
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Operating Loss |
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Other Income (Expense) |
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Interest expense |
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Foreign currency gain (loss) |
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Total Other Income (Expense) |
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Net Loss |
$ |
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$ |
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$ |
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$ |
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Basic and Diluted Loss per Common Share |
$ |
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$ |
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$ |
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$ |
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Weighted Average Number of Common Shares Outstanding |
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The accompanying notes are an integral part of these unaudited financial statements.
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REGENEREX PHARMA, INC.
STATEMENTS OF CASH FLOWS
(UNAUDITED)
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For the Nine Months Ended |
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December 31, |
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2023 |
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2022 |
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Cash Flows from Operating Activities: |
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Net loss |
$ |
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$ |
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Adjustments to reconcile net loss to cash flows used in operating activities: |
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Depreciation and amortization |
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Foreign currency adjustments |
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Stock-based compensation |
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Research and development |
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Amortization of ROU assets, net of liabilities |
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Changes in operating assets and liabilities: |
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Prepaid expenses |
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Accounts payable and accrued liabilities |
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Net cash used in operating activities |
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Cash Flows from Investing Activities: |
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Purchase of furniture and computer equipment |
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Net cash used in investing activities |
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Cash Flows from Financing Activities: |
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Related party advances |
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Proceeds from notes payable to shareholder |
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Proceeds from notes payable to related parties |
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Partial repayment of note payable to shareholder |
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Partial repayment of note payable to related parties |
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Proceeds from sale of common stock and warrants |
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Net cash provided by financing activities |
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Increase (Decrease) in cash and equivalents |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period |
$ |
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$ |
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Supplemental Cash Flow Information – Cash Paid For: |
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Income Taxes |
$ |
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$ |
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Interest |
$ |
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$ |
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Non-Cash Investing and Financing Activities: |
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Accrued interest converted into note payable |
$ |
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$ |
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Operating lease, ROU asset and liabilities |
$ |
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$ |
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Note payable issued for acquisition of intellectual property |
$ |
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$ |
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The accompanying notes are an integral part of these unaudited financial statements.
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REGENEREX PHARMA, INC.
STATEMENTS OF STOCKHOLDERS’ DEFICIT
(UNAUDITED)
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Common Stock |
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Shares |
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Amount |
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Additional Paid-in Capital |
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Accumulated Deficit |
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Stockholders’ Deficit |
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Balance at March 31, 2022 |
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$ |
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$ |
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$ |
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Net loss |
— |
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Balance at September 30, 2022 |
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$ |
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$ |
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$ |
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Net loss |
— |
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Balance at December 31, 2022 |
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$ |
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$ |
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$ |
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Balance at March 31, 2023 |
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$ |
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$ |
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$ |
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Shares and warrants sold for cash |
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Stock-based compensation |
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Net loss |
— |
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Balance at September 30, 2023 |
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$ |
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$ |
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$ |
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Stock-based compensation |
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Net loss |
— |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited financial statements.
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4 |
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REGENEREX PHARMA, INC.
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 – NATURE OF OPERATIONS
Regenerex Pharma, Inc.,
formerly Peptide Technologies, Inc. (the “Company” or “Regenerex”), was incorporated
in the State of Nevada, United States of America, on
On November
15, 2021, the Company entered into an Asset Purchase Agreement in which the Company
purchased certain intellectual property in exchange for
Risks and Uncertainties
Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding the impacts of COVID-19, or other future pandemics on our business, results of operations, financial position, and cash flows.
The Company has a lack of revenue history and has had a limited history of operations. No revenue has historically been derived from the assets purchased. Regenerex can give no assurance of success or profitability to the Company’s investors.
The wound care healing space is well suited for Home Care service providers that are funded by the US Government. Strategic planning and development will be performed internally by the Company.
NOTE 2 – BASIS OF PRESENTATION OF INTERIM FINANCIAL STATEMENTS
The Company prepares its financial statements in accordance with accounting principles generally accepted in the United States of America. The accompanying interim unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. In our opinion, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.
Operating results for the nine months ended December 31, 2023, are not necessarily indicative of the results that may be expected for the year ending March 31, 2024. Notes to the unaudited interim financial statements that would substantially duplicate the disclosures contained in the audited financial statements for the year ended March 31, 2023, have been omitted. This report should be read in conjunction with the audited financial statements and the footnotes thereto for the fiscal year ended March 31, 2023, included within the Company’s Annual Report on Form 10-K as filed with the Securities and Exchange Commission.
NOTE 3 – GOING CONCERN
These financial
statements have been prepared in conformity with accounting principles generally
accepted in the United States of America (“U.S. GAAP”), which contemplate the
continuation of the Company as a going concern. The Company has incurred losses
from operations, and as of December 31, 2023, it had excess liabilities over
assets of $
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The Company requires significant cash to launch its business and reduce its liabilities. Management’s plans are to actively seek capital to enable the Company to add new products and/or services to ultimately achieve profitability. However, management cannot provide assurance that they can raise sufficient capital and whether the Company will ultimately achieve profitability, become cash flow positive, or raise additional debt and/or equity capital. If the Company is unable to raise additional capital in the near future or meet financing requirements, management expects that the Company will need to curtail operations, seek additional capital on less favorable terms, and/or pursue other remedial measures.
These financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should the Company become unable to continue as a going concern.
NOTE 4 –SIGNIFICANT ACCOUNTING POLICIES
Revenue Recognition
The Company will record revenue under ASC 606 by 1) identifying the contract with the customer 2) identifying the performance obligations in the contract 3) determining the transaction price, 4) allocating the transaction price to the required performance obligations in the contract, and 5) recognizing revenue when or as the companies satisfies a performance obligation.
We expect to generate revenue from home care service providers that are funded by the U.S. Government, State Medicaid Programs, International Health Care Programs, Veteran’s administration, Prison system, Home Health Care Providers, and other applicable Medicare reimbursement models. The Company will defer revenue where the earnings process is not yet complete. To date, no revenue has been generated from the asset acquisition disclosed in Note 1.
Earnings per Share
Earnings per share is reported in accordance with FASB Accounting Standards Codification (“ASC”) Topic 260 “Earnings per Share” which requires dual presentation of basic earnings per share (“EPS”) and diluted EPS on the face of all statements of earnings, for all entities with complex capital structures. Diluted EPS reflects the potential dilution that could occur from common shares issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In certain circumstances, the conversion of these options, warrants and convertible securities are excluded from diluted EPS if the effect of such inclusion would be anti-dilutive. Fully diluted EPS is not provided when the effect is anti-dilutive. When the effect of dilution on loss per share is anti-dilutive, diluted loss per share equals the loss per share.
During the three and nine-months ended December 31, 2023, the Company excluded the outstanding stock warrants
from its calculation of earnings per share, as the warrants would be
anti-dilutive. As at December 31, 2023 and 2022, the Company had common shares
warrants outstanding of
Website
Expenditures related to the
planning and operation of the Company’s website are expensed as incurred. Expenditures
related to the website application
and infrastructure development are capitalized and amortized over the website’s
estimated useful life of three (
Furniture and Computer Equipment
Furniture and computer
equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the
straight-line method over the estimated useful life of three (
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Right of Use Assets and Lease Liabilities
The Company has active operating lease arrangements for office space, production equipment, and production facilities. The Company is required to make fixed minimum rent payments relating to its right to use the underlying leased asset. In accordance with the adoption of ASC 842, the Company recorded right-of-use assets and related lease liabilities for these leases as of December 2023.
The
Company’s lease agreements do not provide an implicit borrowing rate. Therefore, the Company used a benchmark approach
to derive an incremental borrowing rate of
Stock-Based Compensation
Stock-based compensation is measured at the grant date, based on the estimated fair value of the award. Stock-based compensation is recognized as expense over the employee’s requisite vesting period and over the nonemployee’s period of providing goods or services. The fair value of each stock warrant is estimated on the date of grant using the Black-Scholes option valuation model. Share grants are measured based on the fair market value of the underlying stock on the grant date.
Research and Development
We incur research and development costs during the process of researching and developing additional technologies purchased and future manufacturing processes. Our research and development costs consist primarily of the purchase of additional intellectual property that we will use in the development of our planned product. We expense these costs as incurred until the resulting product has been completed, tested, and made ready for commercial use.
Recent Accounting Pronouncements
The Financial Accounting Standards Board issued Accounting Standards Updates (“ASU”) to amend the authoritative literature in the Accounting Standards Codification (“ASC”). There have been a number of ASUs to date that amend the original text of the ASC. The Company believes those updates issued-to-date either (i) provide supplemental guidance, (ii) are technical corrections, (iii) are not applicable to the Company, or (iv) are not expected to have a significant impact on the Company.
NOTE 5 – RELATED PARTY TRANSACTIONS
The Company purchased assets from the Company’s current Chief Executive Officer (“CEO”) and Secretary/Treasurer (see note 6).
On June 10, 2023, the Company has entered into an agreement with Woundcare Labs, LLC, a party related to the CFO and CEO of the company, to lease a plant and to lease equipment in Tennessee (see note 8).
Related Party Advances
The
Company’s former Chief Financial Officer (“CFO”) had advanced the Company
monies for operating expenses; no amounts were advanced during the periods
presented. The advances were due on demand, but no later than June
30, 2023. The related party advances
began to accrue interest at ten (
During the
nine-month periods ended December 31, 2023 and 2022, the Company’s
Chief Financial Officer (“CFO”) and the Company’s Chief Executive Officer (“CEO”)
advanced the Company monies for operating expenses in the amount of $
|
7 |
|
|
The related party advances totaled $
Notes Payable to Related Parties
During
the year ended March 31, 2023, the Company’s CFO and the Company’s CEO advanced
the Company monies for operating expenses in the amount of $
During
the nine-month period ended December 31, 2023, the Company’s CFO and the
Company’s CEO advanced the Company monies for operating expenses in the amount
of $
The
related party notes payable totaled $
Note Payables to Shareholders
As at December 31, 2023 and March 31, 2023, the
Company had various promissory notes with total outstanding principal balances
of $
During the nine months ended December 31, 2023,
notes with principal amounts totaling approximately $
During the nine months ended December 31, 2023, notes
with principal amounts of $
The reissued notes are unsecured, bear interest at 10% per annum, and have revised maturity dates ranging from April 11, 2024, to June 17, 2025.
During the nine-month period ended December 31, 2023,
a shareholder was issued additional one (1) promissory note totaling approximately
$
Accrued interest was
$
NOTE 6 – INTANGIBLE ASSETS AND INTELLECTUAL PROPERTY
On November 15, 2021, the Company entered into an Asset Purchase Agreement in which the Company purchased certain intellectual property in exchange for 150,000,000 shares of the Company’s common stock
and
|
8 |
|
|
On August 17, 2023, the Company entered into an Agreement to Purchase Technology Platforms in which the Company purchased certain intellectual property in exchange for a two million four hundred thousand dollars ($2,400,000) note payable. The intellectual property that was purchased requires further development prior to the product being finalized and produced so it has been expensed as research and development. The note payable is due within twelve (12) months of the date of the agreement and is included in current liabilities. If the Company has not raised a minimum of ten million dollars ($10,000,000) in sales within twelve (12) months of the agreement date, or a maximum of ten million dollars ($10,000,000) in investment, the seller will extend the payment for a further period of twelve (12) months for a 10% payment of the outstanding balance.
The Technology Platforms include but are not limited to:
|
A. |
Proteomic research platforms which include proprietary blends. |
|
B. |
Combination design Techniques |
|
C. |
Patent Pending Proprietary Blends |
|
D. |
Patent Pending Formulas |
|
E. |
Trademarks and all pending Trademarks |
|
F. |
510K USA FDA, information and Know-how for application |
|
G. |
All Clinical trials, (Right to use) |
|
H. |
CE mark (International) |
|
I. |
Regenerex Library formula incorporated in the Wound Healing Technology. |
|
J. |
Wound Healing Technology QBX |
|
K. |
Synthetic Compositions of Cations derived from botanical material in the ash of Red- Oak Bark. |
Products:
|
1. |
Xcellderma over the counter product. |
|
2. |
Accelerex, combination product as a drug device. |
|
3. |
Accelerex in a tube. |
NOTE 7 – COMMITMENTS AND CONTINGENCIES
The Company is not currently involved with and does not have knowledge of any pending or threatened litigation against the Company or any of its officers.
See Note 6 for discussion of the $
NOTE 8 – OPERATING LEASES
On April 1, 2023, the
Company entered into an office lease agreement commencing in May 2023 which
expires on April 30, 2028. Under this
agreement, the monthly rental payments are $
|
9 |
|
|
During the three and nine-month periods ended December 31, 2023, and 2022 the operating lease cost was $55,720 and $0 and $137,171 and $0 respectively and is included in general and administrative expenses in the accompanying financial statements.
NOTE 9 – STOCKHOLDERS’ DEFICIT
The Company has
authorized the issuance of
During the nine
months ended December 31, 2023, the Company issued
During the nine months ended December 31,
2023, the Company issued
The warrant fair values were estimated using a Black Scholes model with a 5-year expected term, risk-free interest rate ranging from 5.19% to 5.54%, a dividend yield of 0%, and a volatility of 80.0%. The risk-free interest rate assumptions for options granted is based upon observed interest rates on the United States government securities appropriate for the expected term of the equity awards.
As of the date of this valuation, the Companies stock was not trading. The volatility was calculated based on comparable public companies. The Company will continue to monitor peer companies and other relevant factors used to measure expected volatility for future equipment award grants, until such time that the Company’s Common Stock has enough market history to use historical volatility.
The dividend yield assumption for equity awards granted is based on Company’s history and expectation of dividend payouts. The Company has never declared or paid any cash dividends on its Common Stock, and the Company does not anticipate paying any cash dividends in the foreseeable future.
The closing stock price of the Company’s
common stock is not available as the Company’s stock is not trading. As a
result, the Board of Directors and management determined the fair value of the
common stock to be $
During the nine-month period ended December
31, 2023, the Company issued
As of December 31, 2023,
NOTE 10 – SUBSEQUENT EVENTS
Subsequent to the nine-month
period ended December 31, 2023, three additional notes to a shareholder that
were originally due in January and February 2024 with a principal amount of approximately
$
|
10 |
|
|
Subsequent to the nine-month
period ended December 31, 2023, one additional note to a shareholder that was
originally due in February 2024 with a principal amount of $
Subsequent to the nine-month
period ended December 31, 2023, we approved the issuance of fifty thousand (
|
11 |
|
|
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
In this Quarterly Report, “Company,” “our company,” “us,” and “our” refer to Regenerex Pharma, Inc., unless the context requires otherwise.
Forward-Looking Statements
The following information contains certain forward-looking statements. Forward-looking statements are statements that estimate the happening of future events and are not based on historical fact. Forward-looking statements may be identified by the use of forward-looking terminology, such as “may,” “could,” “expect,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “possible,” “should,” “continue,” or similar terms, variations of those terms or the negative of those terms. The forward-looking statements specified in the following information have been compiled by our management on the basis of assumptions made by management and considered by management to be reasonable. Our future operating results, however, are impossible to predict and no representation, guaranty, or warranty is to be inferred from those forward-looking statements.
Estimated COVID-19 impacts and uncertainties.
COVID-19 has severely impacted, and is expected to continue to impact, the economies of the U.S. and other countries around the world COVID-19 has created significant public health concerns as well as significant volatility, uncertainty, and economic disruption in every region in which we operate, all of which have adversely affected and may continue to adversely affect our industries and our business operations. Further, financial and credit markets have experienced and may again experience volatility.
Beginning in our first fiscal quarter of 2020, the novel coronavirus known as “COVID-19" began to spread throughout the world, resulting in a global pandemic. The pandemic triggered a significant downturn in global commerce as early as February 2020 and the challenging market conditions have continued throughout the second half of fiscal 2020 through 2021 and into the first half of fiscal 2022 and may continue for an extended period.
COVID-19 continued to affect global economic conditions during the nine months ended December 31, 2023. The Company expects this will continue in the Company’s fourth quarter. The situation surrounding COVID-19 remains fluid, and we are actively managing our response in collaboration with team members and business partners and assessing potential impacts to our financial position and operating results, as well as developments in our business.
Operations and New Developments
On November 15, 2021, the Company entered into an Related Party Asset Purchase Agreement in which the Company purchased certain intellectual property in exchange for 150,000,000 shares of the Company’s common stock and up to $10,000,000 in contingent consideration to be paid at the rate of 15% of all gross revenues received from sales or investment money into the Company, payable on the 15th of the following month, for a period of 60 months.
On August 17, 2023, the Company entered into an Agreement to Purchase Technology Platforms in which the Company purchased certain intellectual property in exchange for a two million four hundred thousand dollars ($2,400,000) interest-free due August 17, 2024. The note payable is due within twelve (12) months of the date of the agreement. If the Company has not raised a minimum of ten million dollars ($10,000,000) in sales within twelve (12) months, or a maximum of ten million dollars ($10,000,000) in investment, the seller will extend the payments for a further period of twelve (12) months for a 10% payment of the outstanding balance.
The Company received all rights and title to proprietary wound healing technologies platforms and formulas involving the application of wound care protocols to treat all wounds, such as diabetic ulcers, pressure ulcers, burns and surgical wounds. These unique products strategically position the Company to enter and capture a high proportionate market share in the U.S.
Currently management is engaged in developing managed care agreements with southeastern states to manage their Medicaid wound care patients. Regenerex would provide our wound care products and protocols which would result in a large savings for the state Medicaid population. The Company is also in the process of negotiating with several distributors in various Middle Eastern countries to provide the Company's products.
|
12 |
|
|
Business of Issuer
The business of Regenerex Pharma, Inc., (the “Company” or “Regenerex Pharma,”), is to develop and market Woundcare Healing products. The Company has three technologies for different types of wound conditions:
|
• |
The first is for closing chronic wounds, |
|
• |
the second is for accelerating closure of acute or surgical wounds, and |
|
• |
the third solves the issue on contamination of all types of wounds including the destruction of biofilms. |
The current product technology provides the Company a number of complete wound care protocols to treat all wounds, such as diabetic ulcers, pressure ulcers, burns and surgical wounds. These unique products strategically position the Company to enter and capture a high proportionate market share in the U.S. and global markets.
Products:
|
1. |
Xcellderma OTC - Liquid Bandage Skin Protectant Xcellderma™ products are sterile wound dressings and are effective for treating diabetic foot ulcers, pressure ulcers, and other chronic wounds. During the last several years, a scientific and medical consensus has emerged that elevated protease levels impede wound healing. QBx™ the active ingredient down regulates the production of certain proteases and matrix metalloproteases, or MMPs, which are protein enzymes that are proven to impede the healing of a majority of chronic wounds. Approximately 80% of chronic wounds display elevated levels of proteases (including MMPs). |
|
2. |
Accelerex Sterile Wound Cream - The first commercially available medical device, Accelerex, is for the treatment of a wide variety of chronic and acute wounds. Accelerex is a custom-designed, FDA and CE approved unit-dose, sterile wound dressing impregnated with an ointment containing QBx. Chronic wounds are generally defined as wounds that have not healed after thirty days of consistent clinical treatment, and include diabetic ulcers, burns, pressure ulcers (bedsores), and venous stasis ulcers. The Company’s broadly enabling technology was discovered from oak bark extract and referred to as QBx™. |
|
3. |
Accelerex Impregnated Sterile Wound Dressing – For use as a wound dressing to manage pressure ulcers (stages I-IV), stasis ulcers, diabetic skin ulcers, skin irritations, cuts, and abrasions. FDA-cleared, prescription-only combination devices that blends the benefits of a would dressing with two drug components. Provides 3 modes of action to help trat acute and chronic wounds.: Protective dressing, moisturizing ointment, and 2 drug components: rubidium chloride and potassium chloride. |
Regenerex System has been shown in many clinical trials to successfully close up to 95% of non-responding chronic wounds within 90 days. The wounds clinically tested had already been subject to current protocols of treatment and failed to heal. Competitive clinical trials indicated there isn’t another System that has the ability to close chronic wounds at these levels and speed. Not only does the System close chronic wounds relatively quickly but it does so at a very reasonable cost.
QBx™ contributes to setting up a suitable environment to allow wounds to close. Other than the products marketed by the Company, there are no products currently available on the market that are successful in healing chronic, non-healing wounds through the down regulation of proteases. Other modern wound dressings such as hydrocolloids and collagens absorb wound fluids, but these dressings do not impact the cellular environment with simple gauze and gauze-like dressings to cover and protect the wound.
Our QBx™ technology is the most efficacious, and clinically proven Chronic wound Care product in the world. Chronic wounds are those that fail to progress through a normal, orderly, and timely sequence of repair. They are not only characterized by delayed healing for weeks, months, or even years, but also by a resistance to treatment with conventional dressings and therapies. They impart a particularly devastating financial and quality-of-life burden on individuals suffering from the wounds and are frustrating for the caregivers and clinicians who attempt to manage, but fail to heal, these wounds.
|
13 |
|
|
Non-healing chronic wounds are thought to be a consequence of factors that affect both the production of new tissue and the elevated destruction of existing tissue. Biochemically, these wounds appear to be stuck in a catabolic, inflammatory phase that is hostile to local growth factors and the activity of fibroblasts and keratinocytes. Increases in matrix metalloproteinases (MMPs) MMP-2 and MMP-9 are of significance in non-healing chronic wounds.
MMPs are a group of zinc-containing proteolytic enzymes that play an important role in the remodeling of the extracellular matrix of wounds. An overproduction of MMPs may result in degradation of the extracellular matrix and inactivation of vital growth factors. A precisely orchestrated balance of MMP production and their natural inhibitors (TIMPs) is needed.
Additionally, it is theorized that wounds stuck in the inflammatory phase persistently overproduce free radicals or reactive oxygen species (ROS). At low concentration and early in the inflammatory phase of wound healing, ROS such as hydrogen peroxide (H2O2), have a positive effect on healing through stimulation of fibroblast proliferation. However, persistent overproduction of ROS is thought to be detrimental to healing. A new treatment strategy has emerged focused upon manipulating the expression of genes which control the endogenous production of MMPs and TIMPs within the local wound environment. Contrary to modalities designed to sequester MMPs and/or act as a competitive substrate for protease activity, this technology strategy relies on delivery of metal ions into the wound to help regulate gene expression for the production of MMPs and TIMPs, thus bringing them into balance. These metal ions are delivered via a polyethylene glycol based, QBx™ ointment, which also contains citric acid to help normalize wound pH and reduce ROS activity. The QBx™ ointment is delivered via a tube or an acetylated regenerated cellulose carrier which allows for the passage of wound drainage and is non-fiber shedding. The entire composition is marketed as our primary wound dressing called Accelerex™.
Approximately 80% of chronic wounds display elevated levels of MMPs. Traditionally, however, these wounds have been managed with simple gauze and gauze-like dressings to cover and protect the wound. Other modern wound dressings such as hydrocolloids and collagens absorb wound fluids, but these dressings do not impact the cellular environment. This void in the treatment regimen offers a unique market advantage. QBx™ contributes to creating a suitable environment to allow wounds to close. These formularies are based on Proteases Down Regulating Technology and provide the System for a comprehensive suite of wound care products focused on the treatment of chronic wounds.
Chronic wounds impose significant costs to the US economy. Chronic wounds are a growing issue in the United States, causing immense patient pain and suffering as well as substantial economic and social cost. Although precise information on the prevalence of chronic wounds in the US is unavailable, it is estimated that, as of 2021, there were more than 8.3 million Americans suffering from chronic wounds. Chronic wounds are generally defined as wounds that have not healed after ninety days of consistent clinical treatment, and include diabetic foot ulcers, pressure ulcers (bedsores), and venous stasis ulcers, however this does not include acute wounds.
The most common chronic wounds are diabetic foot ulcers and pressure ulcers. The increasing number of Americans with diabetes and obesity we well as the aging population will likely cause the number of individuals with chronic wounds to continue to rise. In addition to the immeasurable human benefits of improving treatment outcomes, there would be substantial economic effect. The costs of medical treatment could be expected to decrease, and, as patients are able to return to work sooner, productivity would increase.
Due to the staggering costs associated with chronic wounds in the US, the Affordable Healthcare Act (AHA) is changing how the entire wound care system is reimbursed in the US. Now all four markets segments: hospital, nursing homes, home health, and general wound care clinics are all on paid on a “pay for performance basis.” These cost pressures in the healthcare system are a major issue in the wound care market, with the US government and payors seeking new approaches that address cost constraints and product performance. Home health is now paid on a “diagnostic code” for the wound in single payments removing the risk from the Payee to the Payer. The Company’s first markets will be those segments that are totally “at risk” for single payments to close the wounds. Today, the fastest growing segment in the US wound market is Home Health and Nursing Homes due to the aging population.
|
14 |
|
|
The Company has purchased proprietary wound care formulations, and has entered into an agreement, dated June 10, 2023, with Woundcare Labs, LLC to lease a plant and equipment in Tennessee. We expect to launch our sales initiative during the Company’s first quarter of our fiscal year ending March 31, 2025.
Currently management is engaged in developing managed care agreements with southeastern states to manage their Medicaid wound care patients. Regenerex would provide our wound care products and protocols which would result in a large savings for the state Medicaid population. The Company is also in the process of negotiating with several distributors in various Middle Eastern countries to provide the Company's products. The Company has engaged into an agreement as of June 11, 2023, in the amount of $45,000, with First Forte Consultancy in the UAE to assist in meetings and road shows, introducing potential clients for distribution of the companies wound care product. $22,500 was paid June 15, 2023, and the balance of $22,500 is to be paid after the road shows and meetings are completed, in the Company’s fourth quarter.
Financial Results and Trends
Results of Operations for the Three and Nine Months Ended December 31, 2023 and 2022
At present, the Company has $0 revenue during the nine months ended December 31, 2023, and 2022, respectively. Net loss increased from $49,400 to $263,976 for the three months ended December 31, 2022 to December 31, 2023 and from $91,040 to $3,251,000 for the nine months ended December 31, 2022 to December 31, 2023, due to the purchase of intellectual property which was recorded as research and development expenses due to the nature of the acquired IP, higher payroll expense and higher lease costs.
Liquidity and Capital Resources
The Company requires significant cash to launch its business and reduce its payables. Management’s plans are to actively seek capital to enable the Company to add new products and/or services to ultimately achieve profitability. However, management cannot provide assurance that they can raise sufficient capital and whether the Company will ultimately achieve profitability, become cash flow positive, or raise additional debt and/or equity capital. The Company’s primary sources of liquidity and capital resources have been notes payable, which are not sufficient prospectively. These factors raise substantial doubt about the Company’s ability to continue as a going concern. If the Company is unable to raise additional capital in the near future or meet financing requirements, the Company may need to curtail or alter its plan of operations, seek additional capital on less favorable terms, and/or pursue other remedial measures.
Cash Flow
The following table summarizes, for the periods indicated, selected items in our condensed Statements of Cash Flows:
|
Nine months Ended |
|
|||||
|
December 31, |
|
|||||
|
2023 |
|
|
2022 |
|
||
Net cash (used in) provided by: |
|
|
|
|
|
|
|
Operating activities |
$ |
(393,113 |
) |
|
$ |
(73,140 |
) |
Investing activities |
$ |
(6,299 |
) |
|
$ |
(1,398 |
) |
Financing activities |
$ |
406,133 |
|
|
$ |
73,101 |
|
Operating Activities
Cash used in operating activities was $393,113 and $73,140 for the nine months ended December 31, 2023 and 2022, respectively. The increase in cash used in operating activities was primarily due to an increase in net loss.
|
15 |
|
|
Investing Activities
Cash used in investing activities was $6,299 and $1,398 for the nine months ended December 31, 2023 and 2022. The increase in cash used in investing activities was due to the purchase of furniture and computer equipment.
Financing Activities
Cash provided by financing activities was $406,133 and $73,101 for the nine months ended December 31, 2023 and 2022, respectively. The increase in cash provided by financing activities was primarily due to proceeds from sale of common stocks and warrants and additional notes payable offset by repayment of notes payable.
Off-Balance Sheet Arrangements
None.
|
16 |
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|
WHERE YOU CAN FIND MORE INFORMATION
You are advised to read this Quarterly Report on Form 10-Q in conjunction with other reports and documents that we file from time to time with the SEC. In particular, please read our Registration Statement on Form 10-12G, Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, and Current Reports on Form 8-K that we file from time to time. You may obtain copies of these reports directly from us or from the SEC at the SEC’s Public Reference Room at 100 F. Street, N.E. Washington, D.C. 20549, and you may obtain information about obtaining access to the Reference Room by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains information for electronic filers at its website http://www.sec.gov.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We had no material changes in market risk from those described in “Item 2—Quantitative and Qualitative Disclosures about Market Risk” of our Annual Report on Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
This report includes the certification of our Chief Executive Officer required by Rule 13a-14 of the Securities Exchange Act of 1934 (the “Exchange Act”). See Exhibits 31.1 and 31.2. This Item 4 includes information concerning the controls and control evaluations revered to in those certifications.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s (the “SEC”) rules and forms and that such information is accumulated and communicated to our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.
Under the supervision and with the participation of management, including the principal executive officer and principal financial officer, the Company conducted an evaluation of the effectiveness of internal control over financial reporting. This assessment was based on the framework in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation under the framework in Internal Control – Integrated Framework, management concluded that the Company did not maintain effective internal control over financial reporting as of December 31, 2023, as such term is defined in Exchange Act Rule 13a-15(f).
In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures were designed to provide reasonable assurance that the controls and procedures would meet their objectives.
As required by SEC Rule 13a-15(b), our Chief Executive Officer and Chief Financial Officer need to carry out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2023.
Management’s Report on Internal Control over Financial Reporting
Our Chief Executive Officer and the Chief Financial Officer are responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of our internal control over financial reporting. Internal control over financial reporting (as defined in Rules 13a-15(f) and 15d(f) under the Exchange Act) is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with U.S. GAAP. Internal control over financial reporting includes those policies and procedures that (a) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of assets, (b) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, (c) provide reasonable assurance that receipts and expenditures are being made only in accordance with appropriate authorization of management and the Board of Directors, and (d) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on the financial statements.
|
17 |
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|
In connection with the preparation of this Quarterly Report on Form 10-Q for the quarter ended December 31, 2023, our Chief Executive Officer and Chief Financial Officer have concluded that our internal controls and procedures over financial reporting were not effective and that material weaknesses existed in the following area as of December 31, 2023.
We do not employ full time in-house personnel with the technical knowledge to identify and address some of the reporting issues surrounding complex and non-routine transactions. Management recognized that during the preparation of our Financial Statements, the Company recorded material post close adjustment This situation led to delays in the process and evidenced the need to improve the existent control environment including the experience and knowledge of the team. Management will continue to seek guidance from third-party experts and consultants to gain a thorough understanding of these transactions.
Our management will continue to monitor and evaluate the designation, implementation and effectiveness of our internal controls and procedures and our internal controls over financial reporting on an ongoing basis and is committed to taking further action and implement additional enhancements or improvements, as necessary.
Inherent Limitations on Internal Controls
It should be noted that any system of controls, however well designed and operated, can provide only reasonable and not absolute assurance that the objectives of the control system are met. In addition, the design of any control system is based in part upon certain assumptions about the likelihood of certain events. Limitations inherent in any control system include the following:
|
● |
Judgments in decision-making can be faulty, and control and process breakdowns can occur because of simple errors or mistakes; |
|
|
|
|
● |
Controls can be circumvented by individuals, acting alone or in collusion with others, or by management override; |
|
|
|
|
● |
The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; |
|
|
|
|
● |
Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with associated policies or procedures; and |
|
|
|
|
● |
The design of a control system must reflect the fact that resources are constrained, and the benefits of controls must be considered relative to their costs. |
Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.
|
18 |
|
|
PART II
OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
As of December 31, 2023, the Company is not involved in any material litigation.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS SECURITIES
During the nine months ended December 31, 2023, Regenerex did not sell any unregistered equity securities.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINING SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
There is no information with respect to which information is not otherwise called for by this form.
ITEM 6. EXHIBITS
Exhibits
3.0 |
Articles of Incorporation. Incorporated by reference to the Registrant’s Form 10-12G filed on July 28, 2017. |
|
|
3.1 |
Amended Articles of Incorporation. Incorporated by reference to the Registrant’s Form 10-12G filed on July 28, 2017. |
|
|
3.2 |
Amended Articles of Incorporation. Incorporated by reference to the Registrant’s Form 10-12G filed on July 28, 2017. |
|
|
3.3 |
Corporate Bylaws. Incorporated by reference to the Registrant’s Form 10-12G filed on July 28, 2017. |
|
|
10.1 |
Advance from Shareholder of Regenerex Pharma, Inc. Incorporated by reference to the Registrant’s Form 10-12G filed on July 28, 2017. |
|
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act |
|
|
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act |
|
|
|
Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act |
|
|
|
Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act |
|
19 |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934 the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Registrant |
Regenerex Pharma, Inc. |
|
|
|
|
Date: February 5, 2024 |
By: |
/s/ Gregory Pilant |
|
Gregory Pilant |
|
|
Chief Executive Officer |
|