10-Q 1 nbio_10q.htm FORM 10-Q nbio_10q.htm

  

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended December 31, 2018

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ______________ to ______________

 

Commission File Number: 000-55299

 

NASCENT BIOTECH INC

(Exact Name of Registrant as Specified in Its Charter)

  

Nevada

 

45-0612715

(State of Incorporation)

 

(IRS Employer Identification No.)

   

  

601 21st Street Suite 300, Vero Beach, FL

 

32960

(Address of Principal Executive Offices)

 

(Zip Code)

 

(612) 961-5656

(Registrant’s Telephone Number)

 

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed 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) been subject to such filing requirements for the past 90 days. Yes x No ¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files). Yes x No ¨

 

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 large accelerated filer, an accelerated file, non-accelerated filer, or a smaller reporting company.

 

Large accelerated filer

¨

Accelerated filed

¨

Non-accelerated filer

¨

Smaller reporting company

x

 

 

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 ¨ No x

 

As of February 13, 2019, the Registrant had 32,169,598 shares of common stock issued and outstanding.

 

 
 
 
 

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statement (Unaudited)

 

3

 

 

 

 

 

 

Unaudited Consolidated Balance Sheets as of December 31, 2018, and March 31, 2018

 

3

 

 

 

 

 

 

Unaudited Consolidated Statements of Operations for the Three and Nine Months Ended December 31, 2018 and 2017

 

4

 

 

 

 

 

 

Unaudited Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2018 and 2017

 

5

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

6

 

 

 

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

10

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risks

 

12

 

 

 

 

 

Item 4.

Controls and Procedures

 

12

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

13

 

 

 

 

 

Item 1A.

Risk Factors

 

13

 

 

 

 

 

Item 2.

Unregistered Sales of Equity and Use of Proceeds

 

13

 

 

 

 

 

Item 3.

Default upon Senior Securities

 

13

 

 

 

 

 

Item 4.

Mine Safety Information

 

13

 

 

 

 

 

Item 5.

Other Information

 

13

 

 

 

 

 

Item 6.

Exhibits

 

14

 

 

 

 

 

SIGNATURES

 

15

 

 
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PART I – FINANCIAL INFORMATION

ITEM I:  FINANCIAL STATEMENT

 

NASCENT BIOTECH, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

December 31,

2018

 

 

March 31,

2018

 

 

 

 

 

 

 

 

ASSETS

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$ 103,305

 

 

$ 116,994

 

Total current assets

 

 

103,305

 

 

 

116,994

 

 

 

 

 

 

 

 

 

 

Total assets

 

$ 103,305

 

 

$ 116,994

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$ 539,559

 

 

$ 203,373

 

Due to related parties

 

 

55,000

 

 

 

--

 

Total current liabilities

 

 

594,559

 

 

 

203,373

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

594,559

 

 

 

203,373

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 authorized, none issued and outstanding

 

 

--

 

 

 

--

 

Common stock, $0.001 par value; 100,000,000 authorized, 31,139,598 and 27,753,365 issued and outstanding, respectively

 

 

31,140

 

 

 

27,754

 

Additional paid-in capital

 

 

11,976,477

 

 

 

11,350,456

 

Accumulated deficit

 

 

(12,498,871 )

 

 

(11,464,589 )

Total stockholders’ deficit

 

 

(491,254 )

 

 

(86,379 )

Total liabilities and stockholder’ deficit

 

$ 103,305

 

 

$ 116,994

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

 
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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months

 

 

Nine Months

 

 

 

Ended December 31,

 

 

Ended December 31,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expense

 

$ 231,570

 

 

$ 153,192

 

 

$ 857,870

 

 

$ 688,558

 

Research and development

 

 

25,000

 

 

 

410,483

 

 

 

176,439

 

 

 

731,893

 

Loss from operations

 

 

(256,570 )

 

 

(563,675 )

 

 

(1,034,309 )

 

 

(1,420,451 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5

 

 

 

53

 

 

 

27

 

 

 

100

 

Gain on change in fair value of derivative liability

 

 

--

 

 

 

 

 

 

 

--

 

 

 

346

 

Total other income (expense)

 

 

5

 

 

 

53

 

 

 

27

 

 

 

446

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss before income taxes

 

 

(256,565 )

 

 

(563,622 )

 

 

(1,034,282 )

 

 

(1,420,005 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$ (256,565 )

 

$ (563,622 )

 

$ (1,034,282 )

 

$ (1,420,005 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$ (0.01 )

 

$ (0.02 )

 

$ (0.04 )

 

$ (0.06 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding, basic and diluted

 

 

30,600,054

 

 

 

27,160,806

 

 

 

29,503,095

 

 

 

25,500,333

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

 
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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Nine Months Ended

December 31,

 

 

 

2018

 

 

2017

 

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$ (1,034,282 )

 

$ (1,420,005 )

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Change in fair value of derivative liability

 

 

--

 

 

 

(346 )

Stock based compensation – related parties

 

 

96,822

 

 

 

128,172

 

Stock-based compensation

 

 

27,500

 

 

 

7,320

 

Option expense

 

 

28,800

 

 

 

29,430

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

 

336,186

 

 

 

5,441

 

Material held for research and development with alternative future use

 

 

--

 

 

 

234,344

 

Accrued expenses – related parties

 

 

55,000

 

 

 

--

 

License agreement liability

 

 

--

 

 

 

(14,000 )

Net cash used in operating activities

 

 

(489,974 )

 

 

(1,029,644 )

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Common stock issued for exercise of warrants

 

 

83,285

 

 

 

1,928

 

Proceeds from sale of common stock and warrants

 

 

393,000

 

 

 

1,166,063

 

Net cash provided by financing activities

 

 

476,285

 

 

 

1,167,991

 

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

 

(13,689 )

 

 

138,337

 

Cash and cash equivalents – beginning of year

 

 

116,994

 

 

 

129,806

 

Cash and cash equivalents – end of period

 

$ 103,305

 

 

$ 268,143

 

 

 

 

 

 

 

 

 

 

SUPPLEMENT DISCLOSURES:

 

 

 

 

 

 

 

 

Interest paid

 

$ --

 

 

$ --

 

Income taxes paid

 

$ --

 

 

$ --

 

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

 
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NASCENT BIOTECH, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

NOTE 1 – ORGANIZATION AND NATURE OF OPERATIONS

 

Nascent Biotech, Inc. (“Nascent” or the “Company””) was incorporated on March 3, 2014 under the laws of the State of Nevada. The Company is actively developing its primary asset Pritumumab for the treatment of brain cancer and pancreatic cancer. Nascent is also actively researching other cancers that have a high probability of benefiting from the therapeutic effects of Pritumumab because they share a common target. Pritumumab has shown to be very effective at low doses in previous clinical studies in Japan. Nascent is a pre-clinical stage biopharmaceutical company that focuses on biologic drug candidates that are preparing for initial clinical testing for the treatment of brain and pancreatic cancer.

 

On March 31, 2017 the Company filed its IND submission with the Federal Drug Administration (FDA) for clearance to begin Phase I clinical trials. On December 7, 2018 the Company received a letter from the FDA allowing it to use a specific lot of drug substance to begin phase 1 clinical trials. The FDA also requested additional data to remove the partial clinical hold. The Company is in the process of responding to additional data requests from the FDA requiring additional testing of the product and additional materials to answer specific questions from the FDA.

 

On April 1, 2018 the Company adopted ASC 606 (Revenue From Contracts with Customers) which is effective for annual and interim reporting periods after December 15, 2017. As the Company has no revenue during this period there is no impact from adoption.

 

NOTE 2 – BASIS OF PRESENTATION

 

The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles. The Company has elected a fiscal year ending on March 31.

 

The accompanying unaudited interim consolidated financial statements of the Company for the nine months ended December 31, 2018 and 2017 have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information in accordance with Securities and Exchange Commission and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s annual report on Form 10-K for the year ended March 31, 2018. In the opinion of management, the unaudited financial statements have been prepared on the same basis as the annual financial statements and reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the financial position and the results of operations for the interim periods presented herein. The results of operations for the interim periods are not necessarily indicative of the results to be expected for any subsequent quarters or for an entire year.

 

NOTE 3 – GOING CONCERN

 

The Company’s consolidated financial statements are prepared using accounting principles generally accepted in the United States of America applicable to a going concern that contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company had incurred net losses since inception and after the year ended March 31, 2017 in which the Company posted net income from a license sale to a pharmaceutical company in China. The Company has a working capital deficit, no revenue to cover its operating costs and the Company will incur additional expenses in the future developing their product. These factors raise substantial doubt about the company’s ability to continue as a going concern. The Company engages in research and development activities that must be satisfied in cash secured through outside funding. The Company may offer noncash consideration and seek equity lines as a means of financing its operations. If the Company is unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may substantially curtail or terminate its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may dilute the interests of existing stockholders. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 
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NOTE 4 – RELATED PARTY TRANSACTIONS

 

On September 1, 2015, the Company entered into five-year employment contracts with three of its officers and directors. Under the terms of the agreements the Company issued shares of common stock to the officers and directors equaling 11% of the outstanding shares of the Company as of the date of the contracts. As additional future shares are issued, the officers and directors are entitled to additional shares so their aggregate ownership percentage remains at 11% of the outstanding shares of the Company. The following table sets forth the shares earned under these contracts as of December 31, 2018:

 

Officer and Director

 

Initial Share Awards Under the Contracts

 

 

Additional Shares Earned to Maintain Ownership Percentage

 

 

Total Shares Earned

 

President

 

 

1,028,910

 

 

 

528,397

 

 

 

1,557,307

 

Chief Financial Officer

 

 

617,346

 

 

 

317,028

 

 

 

934,374

 

Executive Vice President

 

 

617,346

 

 

 

317,028

 

 

 

934,374

 

Total

 

 

2,263,602

 

 

 

1,162,453

 

 

 

3,426,055

 

 

In addition, if the officers and directors are removed from the Company, they are entitled to receive a cash severance payment per annum for each year of the term of the contract less salary payments received to date of termination. The table below sets forth the annual salary and annual severance amounts per the contracts:

 

Officer and Director

 

Fiscal Year Annualized Compensation Being Paid

 

 

Annual Severance per Contract if Terminated

 

President

 

$ 186,000

 

 

$ 250,000

 

Chief Financial Officer

 

$ 132,000

 

 

$ 180,000

 

Executive Vice President

 

$ 84,000

 

 

$ 140,000

 

Total

 

$ 402,000

 

 

$ 570,000

 

 

During the nine months ended December 31, 2017 the Company issued 514,338 shares of common stock to three officers and a director of the Company with a value of $128,172 for service.

 

During the nine months ended December 31, 2018 the Company issued 373,381 shares of common stock to three officers of the Company with a value of $96,822 for service.

 

During the nine months ended December 31, 2018 the Company paid a related party and Chairman of the Scientific Board $14,000 in consulting fees and accrued $5,000 of the fees. During the same period in 2017 the Company paid $45,000 to the same individual.

 

As of December 31, 2018 the Company accrued $55,000 of compensation earned but not paid to related parties.

 

NOTE 5 – COMMON STOCK

 

During the nine months ended December 31, 2018 the Company issued 1,277,142 shares of common stock to 15 individuals plus 237,747 warrants to eight individuals for $393,000 in cash. The warrants vest immediately and terminate in one year with conversion prices ranging from $0.05-$0.50.

 

During the nine months ended December 31, 2018 the Company issued 1,665,710 shares of common stock for the exercise of 1,665,710 warrants for cash of $83,285.

 

During the nine month period ended December 31, 2018 the Company issued 70,000 shares of common stock of the Company to two individuals with a value of $27,500 for service.

 

During the nine month period ended December 31, 2018 the Company issued 373,381 shares of common stock to three officers of the Company with a value of $96,822 for service.

 

 
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NOTE 6 – OPTIONS

 

During the nine month period ended December 31, 2018, the Company expensed $28,800 related to its option awards. The unrecognized future balance to be expensed over the remaining vesting term of the options is $12,254 as of December 31, 2018.

 

The following sets forth the options granted and outstanding during the nine months ended December 31, 2018:

  

 

 

Options

 

 

Weighted

Average

Exercise

Price

 

 

Weighted

Average

Remaining

Contract

Life

 

 

Number of

Options

Exercisable

 

 

Intrinsic

Value

 

Outstanding at March 31, 2018

 

 

1,365,000

 

 

$ 0.35

 

 

 

7.88

 

 

 

1,236,000

 

 

$ --

 

Granted

 

 

40,000

 

 

 

0.25

 

 

 

9.50

 

 

 

--

 

 

 

--

 

Exercised

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

Outstanding at December 31, 2018

 

 

1,405,000

 

 

$ 0.34

 

 

 

7.19

 

 

 

1,296,000

 

 

$ --

 

  

The weighted average remaining life and intrinsic value of the options as of December 31, 2018, was 7.19 years and zero, respectively.

 

NOTE 7 – WARRANTS

 

During the nine month period ended December 31, 2018, the Company issued 237,747 warrants for cash proceeds (Note 5). Each warrant is exercisable, within one year of the issuance, into one share of the Company’s common stock at $0.05 to $0.50 per share.

 

During the nine month period ended December 31, 2018 sixteen individuals exercised 1,665,710 warrants into 1,665,710 shares of common stock for cash of $83,285. As of December 31, 2018, the Company had total outstanding warrants of 237,747.

 

During the nine months ended December 31, 2018 274,228 warrants expired.

 

The weighted average remaining life and intrinsic value of the warrants as of December 31, 2018, was 0.20 years and zero respectively.

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

 

 

 

 

 

 

 

Exercise

 

 

Contract

 

 

Intrinsic

 

 

 

Warrants

 

 

Price

 

 

Life

 

 

Value

 

Outstanding at March 31, 2018

 

 

1,939,938

 

 

$ 0.09

 

 

 

0.38

 

 

$ 333,133

 

Granted

 

 

237,747

 

 

 

0.20

 

 

 

.87

 

 

 

--

 

Exercised

 

 

(1,665,710 )

 

 

0.05

 

 

 

--

 

 

 

--

 

Expired

 

 

(274,228 )

 

 

(0.35 )

 

 

--

 

 

 

--

 

Outstanding at December 31, 2018

 

 

237,747

 

 

$ 0.20

 

 

 

0.50

 

 

$ 19,273

 

 

 
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NOTE 8 – LICENSE AGREEMENT

 

On September 13, 2016, the Company completed a license agreement with a company based in China to license the Company’s product for production and sales in China. Under the terms of the license agreement the initial payment of $600,000 was made by the licensee on March 30, 2016 to suspend negotiations with other license parties. The $600,000 payment was recorded in the prior year as deferred income. After it became nonrefundable when the license agreement was signed September 13, 2016 and the negotiation suspension period ceased, the Company recorded the revenue. On July 6, 2016, the Company received the balance of the license payment of $2,400,000 less taxes of 10% ($240,000). A payment of $5,000,000 less taxes of 10% will be received when the product is cleared by the China FDA for clinical trial and a payment of $8,000,000 less taxes of 10% upon approval for commercial use within the license territory. In addition, a royalty of 9% of net sales less taxes of 10% will be paid to the Company for a period of 20 years after approval for commercial use.

  

NOTE 9 – COMMITMENTS AND CONTINGENCIES

 

On September 30, 2016, the Company entered a cell line sales agreement with the product manufacturer. Under the terms of the agreement the Company is obligated to make future payments based on the milestones of its achievements. These future payments may be as followed;

 

 

1. $100,000 upon the initiation (first dose/first patient) of the first Phase I clinical trial (or equivalent) of a Product;

 

 

 

 

2. $225,000 upon the initiation (first dose/first patient) of the first Phase III clinical trial (or equivalent) of a Product

 

 

 

 

3. $225,000 payable upon the first Biologics License Application approval (or equivalent) of a product.

 

 

 

 

4. Annual maintenance fee upon completion of phase I manufacturing or the transfer of the cell line from Catalent’s control of $50,000;

 

 

 

 

5. A contingent sales fee upon first commercial sale of a product of 1% of sales or $150,000 whichever is greater payable quarterly.

  

NOTE 10 – SUBSEQUENT EVENTS

 

On January 9, 2019 the Company issued 30,000 shares of common stock to two individuals for service with a value of $5,400.

 

On February 11, 2019 the Company issued 1,000,000 shares of common stock to one individual for cash with a value of $250,000.

 

 
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ITEM 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERTIONS

 

This report contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. The Company’s actual results could differ materially from those set forth on the forward-looking statements because of the risks set forth in our filings with the Securities and Exchange Commission, general economic conditions, and changes in the assumptions used in making such forward looking statements.

 

Nascent Biotech, Inc (“Nascent” or the “Company”) was incorporated on March 3, 2014 under the laws of the State of Nevada. The Company is actively developing its primary asset Pritumumab for the treatment of brain cancer and pancreatic cancer. Nascent is also actively researching other cancers that have a high probability of benefiting from the therapeutic effects of Pritumumab because they share a common target. Pritumumab has shown to be very effective at low doses in previous clinical studies in Japan.

 

Nascent is a pre-clinical stage biopharmaceutical company that develops monoclonal antibodies for the treatment of various forms of cancer. The Company focuses on biologic drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. Nascent currently is developing for the treatment of brain cancer and pancreatic cancer both of which we hold orphan drug status granted by the FDA.

 

Overview

 

The Company is focused on developing pritumumab for the treatment of patients with brain cancer malignancies such as gliomas and astrocytomas. Pritumumab is a monoclonal antibody that has been tested on 249 brain cancer patients and reviewed by the Ministry of Health and Welfare in Japan. The objective of the Phase I and Phase II human clinical trial was to determine the safety of pritumumab in humans and its efficacy in eliminating tumors or reducing tumor size in patients with brain cancer. These clinical trials were conducted at 22 clinical sites within Japan during a 14-year time (1988 to 2002). Except for 17 patients that were treated for a period of four weeks in a Phase I (safety) study (1mg per week dosage), all patients were dosed at 1 mg, either once or twice per week, for 24 weeks, and were evaluated for both safety and efficacy. The sponsor of those trials was the Hagiwara Institute of Health (HIH). Manufacturing of Pritumumab was done by Japan Pharmaceutical Development Company-a pharmaceutical contract manufacturing company, and all pre-clinical development work was performed at HIH. At the end of the Phase II trial, the HIH was approved for expanded Phase III trials in humans; however, the founder of HIH passed away and the clinical development of Pritumumab was suspended. A concern at that time was the ability to manufacture enough pritumumab to continue clinical trials. The product has never been approved for sale in Japan or elsewhere. Current therapeutic strategies for brain cancer include the use of the chemotherapy, surgical intervention or radiation therapy. Because these treatments have marginal outcomes there exists a need to develop safer, more effective drugs. Temodar-the most commonly used Chemotherapeutic drug used to treat brain cancer, is attributed to only median rates of survival and many brain tumors are eligible for surgery. Moreover, even when removed, most brain tumors come back within one year post-operation. Today, with current standards of care, less than 60% of all brain cancer patients will live past the first year after diagnosis, and less than 35% of patients will live to five years. Glioblastoma, a particularly aggressive form of brain cancer that constitutes 42% of ALL brain and other nervous system cancers, has survival rates of 36.5% at 1 year and 5% at 5 years. (SEER Registry Data, September 15th, 2016 (Central Brain Tumor Registry of the United States).

 

On March 31, 2017 the Company filed its IND submission with the Federal Drug Administration (FDA) for clearance to begin Phase I clinical trials. On December 7, 2018 the Company received a letter from the FDA allowing it to use a specific lot of drug substance to begin phase 1 clinical trials. The FDA also requested additional data to remove the partial clinical hold. The Company is in the process of responding to additional data requests from the FDA requiring additional testing of the product and additional materials to answer specific questions from the FDA.

 

 
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Results of Operations

 

The Company recorded zero of revenue during the three and nine month periods ended December 31, 2018, and 2017, respectively.

 

General and administrative expenses for the three and nine month periods ended December 31, 2018 was $231,570 and $857,870 compared to $153,192 and $688,558 in 2017, respectively. This increase in expenses for the nine months ended December 31, 2018 over the same period in 2017 was due to an increase in cost for IND filing of the Company in 2018.

 

Research and development expenses for the three and nine month periods ended December 31, 2018 was $25,000 and $176,439 compared to $410,483 and $731,893 in the same period in 2017, respectively. This decrease in expenses for the three and nine months ended December 31, 2018 over the same period in 2017 reflected decreased testing required in the filing of the IND with the FDA.

 

Total other income incurred in the three and nine month periods ended December 31, 2018 was $5 and $27, compared to other income of $53 and $446 in the same periods in 2017, respectively. Other income consisted of interest income from saving account for all periods plus change in fair value in 2017.

 

For the three and nine month periods ended December 31, 2018, our net loss was $256,565 and $1,034,282 compared to a net loss of $563,622 and $1,420,005 for the same periods in 2017. The difference between the periods relates to lower research and development costs in 2018 offset with higher general and administrative costs preparing the IND in 2018.

 

Liquidity and Capital Resources

 

The Company’s liquidity and capital is dependent on the capital it can raise to continue the Company’s development and testing of its product. The Company projects it must raise approximately $10-15 million to complete its Phase I and Phase II clinical studies.

 

There are no agreements or understandings about future loans by or with the officers, directors, principals, affiliates, or shareholders of the Company. The Company will continue to raise outside capital through loans, equity sales and possible licensing agreements. These factors raise substantial doubt about the company’s ability to continue as a going concern

 

At December 31, 2018, the Company had negative working capital of $491,254. Current assets consist of cash of $103,305. Current liabilities as of the same date were $594,559 consisting of accounts payable of which approximately $320,000 was cost overrun on the IND submission. 

 

Net cash used in operating activities in the nine months period ended December 31, 2018 was $489,974 compared to net cash used of $1,029,644 in the same period in 2017. The variance between the same periods in 2018 and 2017 relates mainly change in accounts payable of $336,186 in 2018.

 

Net cash provided by financing activities for the nine month period ended December 31, 2018 was $476,285 compared to $1,167,991 in the same period in 2017. Cash provided was a result of the conversion of warrants to common stock of $83,285 and from the sale of common stock of $393,000 for the nine months period in 2018.

 

As of December 31, 2018, the Company had total assets of $103,305 and total liabilities of $594,559. Stockholders’ deficit as of December 31, 2018 was $491,254. This compares to a stockholders’ deficit of $86,379 as of March 31, 2018. Liabilities increased in 2018 due mainly to an increase in accounts payable during this period versus the same period in 2017.

 

NEED FOR ADDITIONAL FINANCING:

 

Our current capital needs are estimated to be approximately $10-15 million. This will take us through Phase I/II clinical trials which are scheduled to begin in the fourth quarter 2019.

 

 
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Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements or guarantees of third party obligations at December 31, 2018.

  

Inflation

 

We believe that inflation has not had a significant impact on our operations since inception.

 

ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4: CONTROLS AND PROCEDURES

 

Under the supervision and the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of December 31, 2018, of the effectiveness of the design and operation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Securities Exchange Act of 1934, as amended. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were not effective as of December 31, 2018, Such conclusion reflects the identification of material weakness as follows: (1) lack of accounting proficiency of our chief executive officer who is our sole officer and our principal accounting officer which has resulted in a reliance on part-time outside consultants to perform substantially all of our accounting functions, (2) a lack of adequate segregation of duties and necessary corporate accounting resources in our financial reporting process and accounting function, and (3) lack of control procedures that include multiple levels of review. Until we can remedy these material weaknesses, we have engaged third party consultants and accounting firm to assist with financial reporting.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in our internal control over financial reporting that occurred during the three months ended December 31, 2018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 
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PART II – OTHER INFORMATION

 

ITEM 1: LEGAL PROCEEDINGS

 

None

 

ITEM 1A: RISK FACTORS

 

There have been no material changes to Nascent Biotech’s risk factors as previously disclosed in our most recent Form 10-K filing.

 

ITEM 2: SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

 

During the nine months ended December 31, 2018 the Company issued 1,277,142 shares of common stock to 15 individuals plus 237,747 warrants to eight individuals for $393,000 in cash. The warrants vest immediately and terminate in one year with conversion price from $0.05-$0.50.

 

During the nine months ended December 31, 2018 the Company issued 1,665,710 shares of common stock for the exercise of 1,665,710 warrants for cash of $83,285.

 

During the nine month period ended December 31, 2018 the Company issued 70,000 shares of common stock of the Company to two individuals with a value of $27,500 for service.

 

During the nine month period ended December 31, 2018 the Company issued 373,381 shares of common stock to three officers of the Company with a value of $96,822 for service.

 

ITEM 4: MINE SAFETY INFORMATION

 

None

 

ITEM 5: OTHER INFORMATION

 

None.

 

 
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ITEM 6: EXHIBITS

 

EXHIBIT 31.1

 

Certification of Principal Executive Officer of the Registrant pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

 

EXHIBIT 31.2

 

Certification of Principal Financial Officer of the Registrant pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

EXHIBIT 32.1

 

Certification of Principal Executive Officer of the Registrant pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

EXHIBIT 32.2

 

Certification of Principal Financial Officer of the Registrant pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

101.INS

 

XBRL Instance Document

101.SCH

 

XBRL Taxonomy Extension Schema Document

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 
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SIGNATURE

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

NASCENT BIOTECH, INC.

       
Dated: February 13, 2019 By: /s/ Sean Carrick

 

 

Sean Carrick

 
   

Principal Executive Officer

 

  

 

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