U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended June 30, 2024

 

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

46-5001940

(State of Incorporation)

(IRS Employer Identification No.)

631 US Hwy 1, Suite 407, North Palm Beach, FL

32408

(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 ☒     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 ☒     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

 

 

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 ☒

 

As of August 14, 2024 the Registrant had, 172,202,165 shares of common stock and no shares of Series A convertible preferred issued and outstanding.

 

 

 

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

Item 1.

Financial Statement (Unaudited)

 

3

 

 

 

 

 

 

 

Unaudited Consolidated Balance Sheets as of June 30, 2024, and audited March 31, 2024

 

3

 

 

 

 

 

 

 

Unaudited Consolidated Statements of Operations for the Three Months Ended June 30, 2024 and 2023

 

4

 

 

 

 

 

 

 

Unaudited Consolidated Statements of Stockholders’ Deficit for the Three Months Ended June 30, 2024 and 2023

 

5

 

 

 

 

 

 

 

Unaudited Consolidated Statements of Cash Flows for the Three Months Ended June 30, 2024 and 2023

 

6

 

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

7

 

 

 

 

 

 

Item 2.

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

 

13

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risks

 

15

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

15

 

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

16

 

 

 

 

 

 

Item 1A.

Risk Factors

 

16

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity and Use of Proceeds

 

16

 

 

 

 

 

 

Item 3.

Default upon Senior Securities

 

16

 

 

 

 

 

 

Item 4.

Mine Safety Information

 

16

 

 

 

 

 

 

Item 5.

Other Information

 

16

 

 

 

 

 

 

Item 6.

Exhibits

 

17

 

 

 

 

 

 

SIGNATURES

 

18

 

 

 
2

Table of Contents

 

PART I – FINANCIAL INFORMATION

 

ITEM: 1 FINANCIAL STATEMENT

  

NASCENT BIOTECH, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

June 30,

2024

 

 

March 31,

2024

 

 

 

(Unaudited)

 

 

(Audited)

 

ASSETS

 

Current assets:

 

 

 

 

 

 

Cash

 

$47,391

 

 

$372,120

 

Prepaid

 

 

180,000

 

 

 

180,000

 

Total current assets

 

 

227,391

 

 

 

552,120

 

 

 

 

 

 

 

 

 

 

Total assets

 

$227,391

 

 

$552,120

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$682,931

 

 

$686,294

 

Convertible note- net of discount

 

 

59,000

 

 

 

122,500

 

Total current liabilities

 

 

741,931

 

 

 

808,794

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

741,931

 

 

 

808,794

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies

 

 

-

 

 

 

-

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 50,000,000 authorized, none issued and outstanding. respectively

 

 

-

 

 

 

-

 

Common stock, $0.001 par value; 500,000,000 authorized, 172,202,165 and 170,594,165 issued and outstanding, respectively

 

 

172,202

 

 

 

170,594

 

Additional paid-in capital

 

 

23,951,105

 

 

 

23,833,189

 

Accumulated deficit

 

 

(24,637,847)

 

 

(24,260,457)

Total stockholders’ deficit

 

 

(514,540)

 

 

(256,674)

Total liabilities and stockholders’ deficit

 

$227,391

 

 

$552,120

 

 

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

 

 
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Table of Contents

  

NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

Consulting

 

$138,920

 

 

$229,362

 

General and administrative expense

 

 

106,084

 

 

 

87,750

 

Clinical trials

 

 

1,032

 

 

 

32,444

 

Manufacturing and filling

 

 

114,626

 

 

 

136,507

 

Research and development

 

 

15,000

 

 

 

25,910

 

Loss from operations

 

 

(375,662)

 

 

(511,973)

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

Interest income

 

 

224

 

 

 

21

 

Change in fair value of derivative

 

 

-

 

 

 

159,444

 

Gain on debt settlement

 

 

-

 

 

 

50,000

 

Interest expense

 

 

(1,952)

 

 

(237,716)

Total other income (expense)

 

 

(1,728)

 

 

(28,250)

 

 

 

 

 

 

 

 

 

Net loss

 

$(377,390)

 

$(540,224)

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$(0.00)

 

$(0.01)

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding, basic and diluted

 

 

170,657,418

 

 

 

139,952,376

 

 

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

 

 
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Table of Contents

  

NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

THREE MONTHS ENDED JUNE 30, 2024 AND 2023

(Unaudited)

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Common stock

 

 

Paid In

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2023

 

 

131,764,348

 

 

$131,764

 

 

$20,194,874

 

 

$(21,622,775)

 

$(1,296,137)

Common stock issued to related parties

 

 

2,235,250

 

 

 

2,235

 

 

 

109,527

 

 

 

-

 

 

 

111,762

 

Common stock issued for convertible debt

 

 

9,537,180

 

 

 

9,537

 

 

 

358,259

 

 

 

-

 

 

 

367,796

 

Common stock issued for service

 

 

100,000

 

 

 

100

 

 

 

5,500

 

 

 

-

 

 

 

5,600

 

Change in derivative at conversion

 

 

 

 

 

 

 -

 

 

 

191,258

 

 

 

 -

 

 

 

191,258

 

Option discount

 

 

--

 

 

 

-

 

 

 

4,911

 

 

 

-

 

 

 

4,911

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

--

 

 

 

-

 

 

 

-

 

 

 

(540,224)

 

 

(540,224)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30,2023

 

 

143,636,778

 

 

$143,636

 

 

$20,864,329

 

 

$(22,162,999)

 

$(1,115,034)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2024

 

 

170,594,165

 

 

$170,594

 

 

$23,833,189

 

 

$(24,260,457)

 

$(256,674)

Common stock issued to related parties

 

 

338,000

 

 

 

338

 

 

 

30,582

 

 

 

-

 

 

 

30,920

 

Common stock issued for convertible debt

 

 

1,270,000

 

 

 

1,270

 

 

 

62,230

 

 

 

-

 

 

 

63,500

 

Option discount

 

 

--

 

 

 

-

 

 

 

25,104

 

 

 

-

 

 

 

25,104

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 -

 

 

 

 -

 

 

 

(377,390)

 

 

(377,390)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30, 2024

 

 

172,202,165

 

 

$172,202

 

 

$23,951,105

 

 

$(24,637,847)

 

$(514,540)

 

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

 

 
5

Table of Contents

 

NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Three Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$(377,390)

 

$(540,224)

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

 

 

 

 

 

 

 

 

Stock based compensation – related parties

 

 

30,920

 

 

 

111,762

 

Stock-based compensation

 

 

-

 

 

 

5,600

 

(Gain) loss in fair value of derivative liability

 

 

-

 

 

 

(159,444)

Debt discount amortization

 

 

-

 

 

 

232,381

 

Gain on debt settlement

 

 

-

 

 

 

(50,000)

Stock option expense

 

 

25,104

 

 

 

4,911

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

 

(3,363)

 

 

218,934

 

Prepaid

 

 

-

 

 

 

13,374

 

Net cash provided by (used in) operating activities

 

 

(324,729)

 

 

(162,706)

 

 

 

 

 

 

 

 

 

Net increase (decrease) in cash

 

 

(324,729)

 

 

(162,706)

Cash -beginning of year

 

 

372,120

 

 

 

172,186

 

Cash -end of period

 

$47,391

 

 

$9,480

 

 

 

 

 

 

 

 

 

 

SUPPLEMENT DISCLOSURES:

 

 

 

 

 

 

 

 

Interest paid

 

$-

 

 

$-

 

Income taxes paid

 

$-

 

 

$-

 

 

 

 

 

 

 

 

 

 

Non-Cash Transactions

 

 

 

 

 

 

 

 

Common stock issued for debt conversion

 

$63,500

 

 

$358,259

 

Retirement of derivative at conversion of debt

 

$-

 

 

$191,258

 

 

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

 

 
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Table of Contents

 

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 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 phase 1 clinical trial 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 United States Food and 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. On March 15, 2021, the Company opened phase1 clinical trials. As of June 30, 2024 the Company had completed the phase 1 clinical trials and was cleared by the FDA to begin phase 2 clinical trials.

 

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 three months ended June 30, 2024 and 2023 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, 2024. 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.

 

Basis of Presentation

 

The Company computes net loss per share in accordance with ASC 260, Earnings per Share, which requires presentation of both basic and diluted loss per share (“EPS”) on the face of the statement of operations. Basic EPS is computed by dividing net loss available to common shareholders (numerator) by the weighted average number of common shares outstanding (denominator) during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period including stock options and warrants, using the treasury stock method, convertible preferred stock, and convertible debt, using the if-converted method. In computing diluted EPS, the average stock price for the period is used in determining the number of shares assumed to be purchased from the exercise of stock options or warrants. Diluted EPS excludes all potentially dilutive common shares if their effect is antidilutive.

 

We have identified the conversion features of certain of our convertible notes payable as derivatives. We estimate the fair value of the derivatives using the Black-Scholes pricing model. We estimate the fair value of the derivative liabilities at the inception of the financial instruments, at the date of conversions to equity and at each reporting date, recording a derivative liability, debt discount, and a gain or loss on change in derivative liabilities as applicable. These estimates are based on multiple inputs, including the market price of our stock, interest rates, our stock price volatility and variable conversion prices based on market prices as defined in the respective agreements. These inputs are subject to significant changes from period to period and to management's judgment; therefore, the estimated fair value of the derivative liabilities will fluctuate from period to period, and the fluctuation may be material.

 

 
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Table of Contents

 

 

Revenue recognition

 

In April 2016, the FASB issued ASU 2016–10 Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. The amendments in this Update do not change the core principle of the guidance in Topic 606. Rather, the amendments in this Update clarify the following two aspects of Topic 606: identifying performance obligations and the licensing implementation guidance, while retaining the related principles for those areas. Topic 606 includes implementation guidance on (a) contracts with customers to transfer goods and services in exchange for consideration and (b) determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The amendments are intended to render more detailed implementation guidance with the expectation to reduce the degree of judgement necessary to comply with Topic 606.

 

ASC Topic 606 prescribes a new five-step model entities should follow in order to recognize revenue in accordance with the core principle. These five steps are:

 

1. Identify the contract(s) with a customer.

2. Identify the performance obligations in the contract.

3. Determine the transaction price.

4. Allocate the transaction price to the performance obligations in the contract.

5. Recognize revenue when (or as) the entity satisfied the performance obligations.

 

The Company implemented the transition using the modified retrospective method of transition. The funds are not earned on milestones that have not been reached per the contract. Based on the cut off treatment of the recognition of revenue per the milestones specific to the license agreements, the Company has determined that there are no adjustments in the value of the revenue recognized from these contracts.

 

The Company has no source of revenue and is in the development stage.

 

Derivative debt

 

In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40). The new ASU eliminates the beneficial conversion and cash conversion accounting models for convertible instruments and supersedes the respective guidance within ASC 470-20 and ASC 740-10-55-51. With the elimination of the cash conversion and beneficial conversion feature models, more instruments will be accounted for as a single instrument rather than having their proceeds allocated between liability and equity accounting units.

 

The amendments in the ASU are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted at the beginning of an entity’s annual fiscal year, but no earlier than fiscal years beginning after December 15, 2020.

 

As of June 30, 2024, the Company’s debt was convertible at a fixed amount, thus the calculation of derivative liability does not apply.

 

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 has a working capital deficit of $514,540 and has incurred losses from operations during the quarter ending June 30, 2024, of $377,390. The Company has 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 five-year employment contracts with three of its officers and directors. One of the officers and director resigned as of September 30, 2020. 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 initially remained at 11% (undated to 18% as noted below) of the outstanding shares of the Company. The agreements were amended on September 1, 2020, as noted below, and the table reflects the amendment to these agreements. The following table sets forth the shares earned under these contracts for the two active officers as of June 30, 2024:

 

Officer and Director

 

Initial Share Awards

Under the Contracts

 

 

Additional Shares Earned to

Maintain Ownership Percentage

 

 

Total Shares Earned

 

President

 

 

1,028,910

 

 

 

14,904,669

 

 

 

15,933,579

 

Chief Financial Officer

 

 

617,346

 

 

 

7,684,673

 

 

 

8,302,019

 

Total

 

 

1,646,256

 

 

 

22,589,342

 

 

 

24,235,598

 

 

On September 1, 2020, the Company entered five-year compensation agreements with two of its officers and directors. Under the terms of the agreements the Company issued shares of common stock to the two senior officers equaling 18% of the outstanding shares of the Company as additional future shares are issued. The officers are entitled to additional future shares, so their aggregate ownership percentage remains at 18% of the future outstanding shares of the Company.

 

Officer and Director

 

Fiscal Year

Annualized

Compensation

Being Paid

 

President

 

$252,000

 

Chief Financial Officer

 

$180,000

 

Total

 

$430,000

 

 

During the three months ended June 30, 2023, two officers and a director were issued 2,235,250 shares of common stock with a value of $111,763 for service.

 

During the three months ended June 30, 2024, two officers and a director were issued 338,000 shares of common stock with a value of $30,920 for service.

 

NOTE 5 – EQUITY

 

Common

 

On July 9, 2020, the Company increased its authorized shares to 550,000,000 consisting of 500,000,000 shares of common stock and 50,000,000 shares of preferred stock all at the par value of $0.001.

 

During the three months ended June 30, 2023, two officers and a director were issued 2,235,250 shares of common stock with a value of $111,763 for service.

 

During the three months ended June 30, 2023, the Company issued 9,537,180 shares of common stock with a value of $367,796 for the conversion of debt and accrued interest.

 

During the three months ended June 30, 2023, the Company issued 100,000 shares of common stock with a value of $5,600 for service.

 

During the three months ended June 30, 2024, the Company issued 1,270,000 shares of common stock with the value of $63,500 for the conversion of convertible debt.

 

During the three months period ended June 30, 2024, the Company issued 338,000 shares of common stock with a value of $30,920 to officers and a director for service.

 

 
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NOTE 6– OPTIONS

 

As of June 30, 2024, the Company recognized $25,104 in option expense leaving a balance of /recognized option expense of $37,569.

 

The following sets forth the options granted and outstanding during the three months ended June 30, 2024:

 

 

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Number of

 

 

 

 

 

 

 

 

 

Exercise

 

 

Contract

 

 

Options

 

 

Intrinsic

 

 

 

Options

 

 

Price

 

 

Life

 

 

Exercisable

 

 

Value

 

Outstanding at March 31, 2024

 

 

930,000

 

 

$0.34

 

 

 

2.81

 

 

 

930,000

 

 

$-

 

Granted

 

 

500,000

 

 

 

0.10

 

 

 

-

 

 

 

--

 

 

 

-

 

Exercised/Forfeited

 

 

(30,000)

 

 

--

 

 

 

--

 

 

 

--

 

 

 

-

 

Outstanding at June 30, 2024

 

 

1,400,000

 

 

$0.28

 

 

 

5.23

 

 

 

1,030,000

 

 

$-

 

 

The weighted average remaining life and intrinsic value of the options as of June 30, 2024, was 5.23 years and zero, respectively.

 

NOTE 7 – WARRANTS

 

On August 31, 2022, the Company issued 750,000 warrants as part of a convertible note issued the same date. The Company used the Black Scholes Pricing model to estimate the fair value of the warrants as of grant date using the following key inputs; market prices of the Company’s stock at date of grant of $0.41 per share, conversion price of $0.60 per share, volatility of 137% and discount of 3.50%. The fair value of the warrants was calculated to be $ 188,760 and was used to allocate the proceeds to the two elements based on the relative fair value of the debt instruments without the warrants and of the warrants at the time of issuance. The portion of the proceeds that were allocated to the warrants of $9,902 is accounted for as paid in capital.

 

On September 2, 2022, the Company issued 250,000 warrants as part of a convertible note issued the same date. The Company used the Black Scholes Pricing model to estimate the fair value of the warrants as of grant date using the following key inputs; market prices of the Company’s stock at date of grant of $0.345 per share, conversion price of $0.60 per share, volatility of 137% and discount of 3.47%. The fair value of the warrants was calculated to be $50,273 and was used to allocate the proceeds to the two elements based on the relative fair value of the debt instruments without the warrants and of the warrants at the time of issuance. The portion of the proceeds were allocated to the warrants of $2,484 is accounted for as paid in capital.

 

The 1,000,000 warrants outstanding contain an anti-dilution clause which become effective if any instrument is issued after the warrant issuance is converted into common stock at a price lower than the warrant conversion price. During the year ended March 31, 2023, the valuation resulted in a deemed dividend from the down round calculation of $550,000 with a recalculated conversion price change to $0.05 per share

 

On January 30, 2024, the Company issued 250,000 warrants as part of purchase, for cash, of 1,000,000 shares of common stock. The warrant expires on January 29, 2027. The Company used the Black Scholes Pricing model to estimate the fair value of the warrants as of grant date using the following key inputs; market prices of the Company’s stock at date of grant of $0.11 per share, conversion price of $0.60 per share, volatility of 158% and discount of 5.20%. The fair value of the warrants was calculated to be $18,280.

 

 
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The weighted average remaining life and intrinsic value of the warrants as of June 30, 2024, was:

 

 

 

 

 

 

Weighted

 

 

Weighted

 

 

 

 

 

 

 

 

 

Average

 

 

Average

 

 

 

 

 

 

 

 

 

Exercise

 

 

Remaining

 

 

Intrinsic

 

 

 

Warrants

 

 

Price

 

 

Contract Life

 

 

Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding as of March 31, 2024

 

 

1,250,000

 

 

$0.16

 

 

 

0.95

 

 

134,500

 

Granted

 

 

-

 

 

 

-

 

 

 

--

 

 

 

-

 

Exercised

 

 

-

 

 

 

-

 

 

 

--

 

 

 

-

 

Expired

 

 

--

 

 

 

-

 

 

 

--

 

 

 

-

 

Outstanding as of June 30, 2024

 

 

1,250,000

 

 

$0.16

 

 

 

0.70

 

 

$38,900

 

 

As of June 30, 2024, there were 1,250,000 warrants outstanding.

 

NOTE 8 - CONVERTIBLE DEBT

 

On December 1, 2023, the Company issued an amended convertible debenture to an unrelated third party under the agreement dated September 2, 2022 (noted in the paragraph above), totaling $250,000. The debenture had an original discount of 10% with no accrued interest and matures on May 30, 2024.  The note is convertible into common stock of the Company at the rate of $0.10 per share. On December 6, 2023, the note holder converted $125,000 of the note into 1,250,000 shares of common stock of the Company. As of March 31, 2024, the outstanding balance of the note was $125,000.

 

On May 30, 2024, the Note was extended to August 31, 2024, with an interest rate of 10% per annum and the conversion rate for an initial conversion was amended to $0.05 per share.  On June 26, 2024, the Company issued 1,270,000 shares of common stock for the conversion of $63,500 of convertible debt.  The balance of the note as of June 30, 2024, was $59,000, net of discount, plus interest.

 

NOTE 9 - FAIR VALUE MEASUREMENTS AND DERIVATIVE LIABILITIES

 

As defined in (Financial Accounting Standards Board ASC 820), fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date (exit price). The Company utilized the market data of similar entities in its industry or assumptions that market participants would use in pricing the asset or liability, including assumptions about risk and the risks inherent in the inputs to the valuation technique. These inputs can be readily observable, market corroborated, or generally unobservable. The Company classifies fair value balances based on the observability of those inputs. FASB ASC 820 establishes a fair value hierarchy that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurement) and the lowest priority to unobservable inputs (level 3 measurement).

 

The three levels of the fair value hierarchy are as follows:

 

Level 1 

Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions for the asset or liability occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Level 1 primarily consists of financial instruments such as exchange-traded derivatives, marketable securities, and listed equities.

 

 

 

Level 2 

Pricing inputs are other than quoted prices in active markets included in level 1, which are either directly or indirectly observable as of the reported date and includes those financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including quoted forward prices for commodities, time value, volatility factors, and current market and contractual prices for the underlying instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace throughout the full term of the instrument, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. Instruments in this category generally include non-exchange-traded derivatives such as commodity swaps, interest rate swaps, options, and collars.

 

 

 

Level 3 

– 

Pricing inputs include significant inputs that are generally less observable from objective sources. These inputs may be used with internally developed methodologies that result in management’s best estimate of fair value

 

As June 30, 2024, the Company believes the amounts reported for cash, payables, accrued liabilities and amounts due to related parties approximate their fair values, due to the nature or duration of these instruments.

 

 
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NOTE 10 –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.

 

As of June 30, 2024, the outstanding balance was $50,000.

 

On March 9, 2020, the Board of Directors of the Company adapted an expense bonus program. Under the program, if an acquisition, merger or change in control is affected, 10% of the value of the transaction will be allocated to pay the expenses of the transaction including but not limited to legal, accounting, transfer fees and other miscellaneous expense. The balance of the fund after expenses will be allocated 20% to directors and 80% to officers and employees of the Company as allocated by the Chief Executive Officer and approved by the Board of Directors.

 

NOTE 11 - SUBSEQUENT EVENTS

 

The Company has evaluated subsequent events to determine events occurring after June 30, 2024, through the date of this filing that would have a material impact on the Company’s financial results or require disclosure and have determined none exist other than those noted above in this footnote.

 

 
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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 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.

 

Nascent is a phase 2 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. Nascent has completed phase 1 clinical trials and has submitted to the FDA to begin to begin phase 2 clinical trials.

 

In addition, Nascent, in collaboration with academic and corporate partners, has asserted the potential for pritumumab to be involved as both a treatment and a vaccine for the SARS-CoV-2 virus (responsible for COVID-19).

 

Overview

 

The Company is focused on developing pritumumab for the treatment of patients with brain cancer malignancies such as gliomas and astrocytomas. 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 United States Food and 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 Company commenced human clinical trials with a major oncology hospital for brain cancer, both primary and metastatic. Phase 1 clinical trials has been completed and clearance has been received to begin phase 2 Clinical trials.

 

In May of 2020, Nascent announced a research collaboration to study, both in vitro and in vivo (mouse models), the ability of pritumumab to block the SARS-Cov-2 virus from infecting cells. This notion has been raised by a published article in the scientific literature (Yu et al. Journal of Biomedical Science (2016) 23:14 DOI 10.1186/s12929-016-0234-7), which specifically mentioned cell surface vimentin (the protein to which pritumumab binds selectively) as a potential target in the treatment of conditions related to coronaviruses. These preliminary studies are on-going. Further, in May of 2020, Nascent announced a joint collaboration with Manhattan BioSolutions, Inc (NY, NY) to employ Manhattan’s platform, based on the recombinant Mycobacterium bovis Bacillus Calmette-Guerin (BCG) vaccine, but engineered to target SARS-CoV-2. BCG is a live non-pathogenic bacterium that stimulates diverse innate and adaptive immune responses and is well-known for its long safety track record as a tuberculosis vaccine. Thus, with these collaborations, Nascent is investigating the potential utility of pritumumab as both a treatment for COVID-19 and a preventive vaccine for COVID-19.

 

 
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Results of Operations

 

The Company recorded zero of revenue during the three-month periods ended June 30, 2024, and 2023, respectively.

 

General and administrative expenses for the three-month periods ended June 30, 2024, was $106,084 compared to $87,850 for the period ended June 30, 2023. Consulting expense for the three months periods ending June 30, 2024, was $138,920 compared to $229,362 for the same period in 2023. This decrease in expenses for the three months ended June 30, 2024, over the same period in 2023 was due primarily to decreased consulting fee of $90,442 from the pricing of the shares issued to management for maintaining the percentage of ownership per their agreements, plus lower product filling cost of $114,626 for the three months period ended June 30, 2024, verses $136,507 in the same period in 2023.

 

Research and development expenses for the three-month periods ended June 30, 2024, was $15,000 compared to $25,910 in the same period in 2023. Clinical trials costs were $1,032 for the three months ended June 30, 2024, with $32,444 in the same period in 2023. Phase 1 clinical trials ended during the period ended in April 2023 meaning further costs were minimal until we start the phase 2 clinical trials.

 

Total other expense incurred in the three-month periods ended June 30, 2024, was $1,728, compared to other expense of $28,250 in the same period in 2023. Other expense in 2023 consisted of interest expense of $1,952 and interest income of $224. Other expenses in the three months period ended June 30, 2023, consisted of change in fair value of $159,444, gain on debt settlement of $50,000, interest expense of $237,716 and interest income of $21.

 

For the three-month periods ended June 30, 2024, our net loss was $377,390 compared to a net loss of $540,224 for the same periods in 2023. The difference between the periods was due primarily to a net positive change in fair value in the three months period ended June 30, 2024, of $159,444, lower interest expense of $235,764, offset by a gain on debt settlement of $50,000 in the same period in 2023.

 

Liquidity and Capital Resources

 

The Company’s liquidity and capital is dependent on the capital it can raise to continue the Company’s testing and clinical trials of its product. The Company projects it must raise approximately $15-20 million to complete its 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

 

As of June 30, 2024, the Company had negative working capital of $514,540. Current assets consist of cash of $47,391 and prepaid of $180,000 with current liabilities $741,931 consisting of accounts payable and accrued expense of $682,931 and convertible notes, net of discount of $59,000.

 

Net cash used in operating activities in the three months period ended June 30, 2024, was $324,729 compared to net cash used of $162,706 in the same period in 2023. The variance between the same periods in 2024 and 2023 relates mainly to a lower loss, offset by the gain in fair value, debt discount and gain on debt settlement in the same period in 2023.

 

As of June 30, 2024, the Company had total assets of $227,391 and total liabilities of $741,931. Stockholders’ deficit as of June 30, 2024, was $514,540. This compares to a stockholders’ deficit of $256,674 as of March 31, 2024. Liabilities decreased in 2024 mainly as a function of lower convertible notes, net of discount and no derivative liability.

 

NEED FOR ADDITIONAL FINANCING:

 

The Company is engaged in research and development activities that must be satisfied in cash secured through outside funding. The Company will 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.

 

 
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Our current capital needs are estimated to be approximately $15 million. This will take us through Phase II clinical trials which is scheduled to begin in late 2024.

 

Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements or guarantees of third-party obligations as of June 30, 2024

 

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 June 30, 2024, 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 June 30, 2024. 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 June 30, 2024, 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: UNREGISERED SALES OF EQUITY AND USE OF PROCEEDS.

 

During the three months ended June 30, 2024, the Company issued 1,270,000 shares of common stock with the value of $63,500 for the conversion of convertible debt.

 

During the three months period ended June 30, 2024, the Company issued 338,000 shares of common stock with a value of $30,920 to officers and a director for service.

 

ITEM 3: DEFAULT ON SENIOR SECURITIES

 

None

 

ITEM 4: MINE SAFETY INFORMATION

 

None

 

ITEM 5: OTHER INFORMATION

 

None.

 

 
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ITEM 6: EXHIBITS

 

Exhibit No.

 

Description

 

 

 

31

 

Certification of Principal Executive Officer and CFO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

32

 

Certification of Principal Executive Officer and CFO Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

101.INS

 

Inline XBRL Instance Document (the instance document does not appear in the Interactive Date File because its XBRL tags are embedded within the Inline XBRL document).

 

 

 

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document.  

 

 

 

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document.   

 

 

 

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document.    

 

 

 

101.LAB

 

Inline XBRL Taxonomy Extension Labels Linkbase Document.   

 

 

 

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document.    

 

 

 

104

 

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). 

 

 
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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: August 14, 2024

By:

/s/ Sean Carrick

 

 

Sean Carrick

 
  

Principal Executive Officer

 
    

 

 
18