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 December 31, 2020

 

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.)
6330 Nancy Ridge Dr. Suite 105, San Diego CA		92121
(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 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). 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 February 9, 2021 the Registrant had 97,059,154 shares of common stock and 110,710 shares of Series A convertible preferred shares issued and outstanding.

 

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION
Item 1.	Financial Statement (Unaudited)		3
	Unaudited Consolidated Balance Sheets as of December 31, 2020, and March 31, 2020		3
	Unaudited Consolidated Statements of Operations for the Three and Nine Months Ended December 31, 2020 and 2019		4
	Unaudited Consolidated Statements of Stockholders’ Deficit for the Three and Nine Months Ended December 31, 2020 and 2019		5
	Unaudited Consolidated Statements of Cash Flows for the Nine Months Ended December 31, 2020 and 2019		6
	Notes to Unaudited Consolidated Financial Statements		7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		16
Item 3.	Quantitative and Qualitative Disclosures About Market Risks		18
Item 4.	Controls and Procedures		18
PART II – OTHER INFORMATION
Item 1.	Legal Proceedings		19
Item 1A.	Risk Factors		19
Item 2.	Unregistered Sales of Equity and Use of Proceeds		19
Item 3.	Default upon Senior Securities		19
Item 4.	Mine Safety Information		19
Item 5.	Other Information		19
Item 6.	Exhibits		19
SIGNATURES			20

 

2

 

PART I – FINANCIAL INFORMATION

 

ITEM: 1 FINANCIAL STATEMENT

 

NASCENT BIOTECH, INC.

CONSOLIDATED BALANCE SHEETS

 

		December 31, 2020				March 31, 2020
		(Unaudited)				(Audited)
ASSETS
Current assets:
Cash		$	54,672			$	3,218
Prepaid			18,313				--
Total current assets			72,985				3,218
Total assets		$	72,985			$	3,218
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable and accrued liabilities		$	761,598			$	852,664
Convertible note- net of discount			109,792				88,815
Derivative liability			226,186				603,836
Note payable			--				50,000
Due to related parties			207,333				1,283,607
Total current liabilities			1,304,909				2,878,922
Total liabilities			1,304,909				2,878,922
Commitments and contingencies			--				--
Stockholders’ deficit:
Preferred stock, $0.001 par value, 50,000,000 authorized, 250,000 and 60,000 issued and outstanding			250				60
Common stock, $0.001 par value; 500,000,000 authorized, 91,330,154 and 44,890,262 issued and outstanding, respectively			91,330				44,890
Additional paid-in capital			16,855,917				13,916,995
Accumulated deficit			(18,179,421	)			(16,837,649	)
Total stockholders’ deficit			(1,231,924	)			(2,875,704	)
Total liabilities and stockholders’ deficit		$	72,985			$	3,218

 

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

 

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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THREE AND NINE MONTHS ENDED DECEMBER 31.

(Unaudited)

 

		Three Months								Nine Months
		2020				2019				2020				2019
Operating expenses:
Consulting		$	409,111			$	181,290			$	1,129,846			$	494,300
General and administrative expense			91,923				62,107				260,106				249,625
Research and development			53,903				124,925				277,338				255,578
Loss from operations			(554,937	)			(368,232	)			(1,667,290	)			(969,503	)
Other income (expense):
Interest income			1				--				4				6
Change in fair value			(73,810	)			--				556,220				--
Financing costs			(31,356	)			--				(34,356	)			--
Debt discount interest			(4,423	)			--				(4,423	)			--
Interest expense			(54,981	)			(1,920	)			(201,927	)			(6,249	)
Total other income (expense)			(164,570	)			(1,920	)			325,518				(6,249	)
Net loss		$	(719,507	)		$	(370,152	)		$	(1,341,772	)		$	(975,746	)
Net loss per share, basic and diluted		$	(0.01	)		$	(0.01	)		$	(0.02	)		$	(0.03	)
Weighted average number of shares outstanding, basic and diluted			76,566,884				33,828,331				64,027,487				33,419,628

  

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

 

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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

THREE AND NINE MONTHS ENDED DECEMBER 31, 2020 AND 2019

(Unaudited)

																		Additional								Total
		Preferred Shares								Common Stock								Paid-In				Accumulated				Stockholders’
		Shares				Amount				Shares				Amount				Capital				Deficit				(Deficit)
Balance at March 31, 2019			--			$	--				32,646,635			$	32,647			$	12,318,685			$	(12,833,496	)		$	(482,164	)
Common stock issued related parties for AP settlement			--				--				639,536				640				98,360				---				99,000
Common stock issued to related parties for service			--				--				137,872				138				25,583				--				25,721
Common stock issued for warrant exercise			--				--				21,427				21				1,050				--				1,071
Common stock issued for service			--				--				50,000				50				9,500				--				9,550
Net loss			--				--				--				--				--				(273,738	)			(273,738	)
Balance at June 30, 2019			--				--				33,495,470				33,496				12,453,178				(13,107,234	)			(620,560	)
Common stock issued for service			--				--				250,000				250				37,500				--				37,750
Common stock issued to related parties for service			--				--				27,500				28				3,492				--				3,520
Preferred shares issued for cash			110,000				110				--				--				109,890				--				110,000
Net loss			--								--				--				--				(331,856	)			(331,856	)
Balance at September 30, 2019			110,000				110				33,772,970				33,774				12,604,060				(13,439,090	)			(801,146	)
Common Stock issued for cash			--				--				150,000				150				14,850				--				15,000
Common stock issued for service-related parties			--				--				207,900				207				20,582				--				20,789
Common stock issued for related parties debt			--				--				1,830,000				1,830				181,170				--				183,000
Net loss			--				--				--				--				--				(370,152	)			(370,152	)
Balance at December 31, 2019			110,000			$	110				35,960,870			$	35,961			$	12,820,662			$	(13,809,242	)		$	(952,509	)
Balance at March 31, 2020			60,000			$	60				44,890,262			$	44,890			$	13,916,995			$	(16,837,649	)		$	(2,875,704	)
Common stock issued for related parties for service			--				--				2,007,000				2,007				188,908				--				190,915
Common stock issued for AP- related parties			--				--				13,831,101				13,831				1,374,041				--				1,387,872
Common stock issued for AP settlement			--				--				35,715				36				4,964				--				5,000
Common stock issued for service		----					--				677,000				677				84,763				--				85,440
Common stock issued for preferred shares			(60,000	)			(60	)			1,352,529				1,354				11,717				--				13,011
Net loss			--				--				--				--				--				(203,971	)			(203,971	)
Balance at June 30, 2020			--				--				62,793,607				62,795				15,581,388				(17,041,620	)			(1,397,437	)
Preferred stock issued for cash			640,000				640				--				--				639,360				--				640,000
Preferred stock issued for debt			100,000				100				--				--				99,900				--				100,000
Common stock issued for service			--				--				728,572				728				43,423				--				44,151
Common stock issued for service – related parties			--				--				918,115				918				63,350				--				64,268
Common stock issued for convertible debt			--				--				2,677,397				2,677				147,323				--				150,000
Common stock issued for accounts payable			--				--				63,000				63				6,237				--				6,300
Net loss			--				--				--				--				--				(418,294	)			(418,294	)
Balance at September 30, 2020			740,000				740				67,180,691				67,181				16,580,981				(17,495,914	)			(811,012	)
Common stock issued for service			--				--				245,902				246				14,754				--				15,000
Common stock issued for service- related parties			--				--				4,784,460				4,784				219,244				--				224,028
Common stock issued for convertible debt			--				--				1,304,782				1,305				48,262				--				49,567
Common stock issued for conversion of preferred shares			(490,000	)			(490	)			17,814,319				17,814				(7,324	)			--				10,000
Net loss			--				--				--				--				--				(719,507	)			(719,507	)
Balance at December 31, 2020			250,000			$	250				91,330,154			$	91,330			$	16,855,917			$	(18,179,421	)		$	(1,231,924	)

 

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

 

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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

		Nine Months Ended December 31,
		2020				2019
Cash flows from operating activities:
Net loss		$	(1,341,772	)		$	(975,746	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation – related parties			479,212				50,030
Stock-based compensation			144,591				47,300
(Gain) loss in fair value of derivative liability			(566,220	)			--
Debt discount expense			178,652				--
Financing cost			34,356				--
Changes in operating assets and liabilities:
Accounts payable and accrued expenses			(60,650	)			314,162
Prepaid			(18,313	)			--
Due to related parties			311,598				308,530
Net cash used in operating activities			(838,546	)			(255,724	)
Cash flows from financing activities:
Common stock issued for exercise of warrants			--				1,071
Proceeds from the sale of preferred shares for cash			640,000				110,000
Proceeds from the sale of common stock for cash			--				15,000
Proceeds from convertible notes			200,000				--
Proceeds from notes payable			50,000				--
Net cash provided by financing activities			890,000				126,071
Net decrease in cash			51,454				(129,653	)
Cash -beginning of year			3,218				131,472
Cash -end of period		$	54,672			$	1,819
SUPPLEMENT DISCLOSURES:
Interest paid		$	--			$	--
Income taxes paid		$	--			$	--
Non Cash Transactions
Common stock issued for conversion of preferred shares		$	23,560			$	--
Common stock issued for accrued expenses- related party		$	1,387,872			$	282,000
Common stock issued for accounts payable		$	11,300			$	--
Common stock issued for convertible debt		$	199,567			$	--
Preferred shares issued for notes payable		$	100,000			$	--

   

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.

 

In July, 2014, Jin-En entered into an Exchange Agreement with an entity formerly known as Nascent Biotech, Inc., a Nevada corporation which is now known as Nascent Biologics, Inc. (“Biologics”). As part of the Exchange Agreement, Jin-En changed its name to “Nascent Biotech Inc.” and the entity formerly known as “Nascent Biotech, Inc.”, changed its name to Nascent Biologics, Inc. and became the Company’s wholly owned subsidiary.

 

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 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. Due to the low potency testing of the initial lot, this drug substance will not be used in the clinical trials.

 

On October 30, 2020, the Company filed additional data requests and additional testing of the product and additional materials to answer specific questions from the FDA to remove the partial clinical hold.

 

On December 7, 2020, the Company received full clinical clearance from the FDA to begin phase 1 clinical trials on brain cancer patients. Trials are open and scheduled to begin in February 2021, subject to the required financing being received.

 

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 and nine months ended December 31, 2020 and 2019 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, 2020. 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.

 

Principles of Consolidation

 

The accompanying consolidated financial statements include the accounts of Nascent Biotech, Inc. and its wholly-owned subsidiary Nascent Biologics, Inc. All intercompany accounts and transactions have been eliminated.

 

Recent Accounting Pronouncements

 

In February 2016, the FASB issued ASU No. 2016-02, Leases. The main provisions of ASU No. 2016-02 require management to recognize lease assets and lease liabilities for all leases. ASU 2016-02 retains a distinction between finance leases and operating leases. The classification criteria for distinguishing between finance leases and operating leases are substantially similar to the classification criteria for distinguishing between capital leases and operating leases in the previous release’s guidance. The result of retaining a distinction between finance leases and operating leases is that under the lessee accounting model, the effect of leases in the statement of comprehensive income and the statement of cash flows is largely unchanged from previous U.S. GAAP. The amendments in this ASU are effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements and related disclosures.

 

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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.

 

Stock-Based Compensation

 

The Company accounts for stock-based compensation in accordance with the fair value recognition provision of the Financial Accounting Standards Board(“FASB”) Accounting Standards Codification (“ASC”) No 718. The Company issues restricted stock to employees and consultants for their services. Cost of these transactions are measured at fair value of the equity instrument issued at the date of grant. These shares are considered fully vested and the fair market value is recognized as the expense in the period granted. The Company recognized consulting expense and a corresponding increase to the additional paid in capital related to the stock issued for services. For agreements requiring future services the consulting expense is to be recognized ratably over the requisite service period.

 

Fair Value of Financial Instruments

 

The Company’s financial instruments consist of cash and cash equivalents, accounts payable and accrued expenses and shareholder loans. The carrying amount of these financial instruments approximates fair value due either to length of maturity or interest rates that approximate prevailing market rates unless otherwise disclosed in these financial statements.

 

Financial assets and liabilities recorded at fair value in our condensed consolidated balance sheets are categorized based upon a fair value hierarchy established by GAAP, which prioritizes the inputs used to measure fair value into the following levels:

 

Level 1– Quoted market prices in active markets for identical assets or liabilities at the measurement date.

 

Level 2– Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable and can be corroborated by observable market data.

 

Level 3– Inputs reflecting management’s best estimates and assumptions of what market participants would use in pricing assets or liabilities at the measurement date. The inputs are unobservable in the market and significant to the valuation of the instruments.

 

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

 

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The following table summarizes the change in the fair value of the derivative liabilities during the three and nine months ended December 31, 2020:

 

		Level 1				Level 2				Level 3
Fair value of derivative liability as of March 31, 2020		$	--			$	--			$	603,836
Change in fair value at initial issuance											295,126
Change in fair value due to conversion of debt											(106,556	)
Change in fair value of the derivative			--				--				(566,220	)
Balance at December 31, 2020		$	--			$	--			$	226,186

 

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 and has incurred losses from operations. 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.

 

NOTE 4 - RELATED PARTY TRANSACTIONS

 

On September 1, 2015, the Company entered 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.

 

On September 1, 2020. the Company renewed the compensation agreements for the Officers of the Company. The agreements set out the compensation as noted in the table below and increased the non-dilutive ownership for the President to 12% and CFO to 6%.

 

The following table sets forth the shares earned under these contracts as of December 31, 2020:

 

Officer and Director		Initial Share Awards Under the Contracts				Additional Shares Earned to Maintain Ownership Percentage				Total Shares Earned
President			1,028,910				5,209,869				6,238,779
Chief Financial Officer			617,346				2,837,523				3,454,869
Executive Vice President (1)			617,346				1,267,553				1,884,899
Total			2,263,602				9,314,945				11,578,547

__________ 

(1) Effective September 30, 2020 the Executive Vice President left the employment of the Company and maintains a consulting agreement on a as needed basis.

 

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During the year ended March 31, 2020 the Board of Directors amended the compensation plan so that the total amount per the officer agreements allow for the accrual of the full amount due each officer per their contract. The table below sets forth the annual amounts per the contracts:

 

Officer and Director		Fiscal Year Annualized Compensation Being Paid
President		$	250,000
Chief Financial Officer		$	180,000
Executive Vice President (1)		$	140,000
Total		$	570,000

________ 

(1) Effective September 30, 2020 the Executive Vice President left the employment of the Company and maintains a consulting agreement on a as needed basis.

 

On July 11, 2019, an officer and director of the Company advanced the Company $10,000. The advance was on demand and bears no interest. On July 26, 2019, the Company repaid the $10,000 advance to the officer and director of the Company.

 

During the nine months ended December 31, 2019 an officer and director of the Company advanced the Company $37,620, $4,250 in cash and $33,370 in payment of accounts payable bills.

 

On December 30, 2019, three officers and directors and the chairman of the Scientific Board of the Company converted $282,000 of accrued fees into 2,469,536 shares of common stock at $0.10- $0.1548 per share.

 

During the nine months ended December 31, 2019, the Company issued 373,272 shares of common stock to three officers and a director for service with a value of $50,030.

 

On December 31, 2019, an officer and director of the Company advanced the Company $14,000 in payment of accounts payable bills

 

During the nine month period ended December 31, 2019 the Company paid the related parties (three officers and directors) $59,000 in consulting fees in cash and accrued $170,000 of the consulting fees for a total of $179,710. In addition $6,209 in expenses were accrued for the related parties.

 

During the nine months ended December 31, 2020 four officers and directors were issued 7,709,575 shares of common stock with a value of $479,212 for service.

 

During the nine months period ended December 31, 2020 three officers of the Company converted $1,387,872 of accrued compensation into 13,831,101 shares of common stock of the Company.

 

During the nine month period ended December 31, 2019 the Company paid the related parties (three officers and directors) $89,000 in consulting fees in cash and accrued $193,333 of the consulting fees for a total of $282,333. In addition $14,000 in expenses were accrued for the related parties.

 

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 officers and directors equaling 18% of the outstanding shares of the Company as additional future shares are issued. The officers and directors are entitled to additional future shares so their aggregate ownership percentage remains at 18% of the future outstanding shares of the Company. In addition, the officers ae entitled to future bonuses including a signing bonus totaling $170,000 which was accrued during the period ending December 31, 2020 plus additional bonuses based on their performance.

 

Officer and Director		Fiscal Year Annualized Compensation Base Being Paid				Non-dilutive shares percentage
President		$	252,000				12	%
Chief Financial Officer		$	180,000				6	%
Chief Operation Officer		$	162,000				--
Total		$	594,000				18	%

 

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NOTE 5 - EQUITY

 

Preferred

 

On July 25, 2019, the Company issued 110,000 shares of series A convertible preferred to one entity with a value of $110,000 for cash. Each share of series A preferred is convertible after 180 days to four shares of common stock or at the lowest of: (i) the fixed conversion price; (ii) or 70% of the lowest closing price for the 20 days prior to the conversion of the preferred shares.

 

During the nine months period ended December 31, 2020 the Company issued 740,000 shares of Series A preferred stock and 3,700,000 warrants; 640,000 for $640,000 in cash and $100,000 for debt. The stock is convertible into common stock at 10 cents per share or 50% of the lowest trading price, whichever is lower 5 days prior to conversion. The Company has the right to convert the shares nine months after the issuance. The warrants are convertible at $0.15 per share within two years of issuance. In addition the Company agreed to filing an S-1 by September 21, 2020 for the common stock to be converted and the underlying common shares for the warrants. The S-1 has not been filed.

 

During the nine months ended December 31, 2020 the Company issued 17,714,319 shares of common stock for the conversion of 490,000 shares of preferred stock and $8,400 in interest.

 

Common

 

On June 5, 2019, two officers and directors of the Company converted $99,000 of accrued fees into 639,536 shares of common stock at $0.1548 per share.

 

During June 2019, two warrant holders exercised 21,427 warrants for common stock at $0.05 per share for cash of $1,071.

 

On December 11, 2019, the Company issued 150,000 shares of common stock with a value of $15,000 for cash.

 

During the nine months period ended December 31, 2019 Company issued 300,000 shares of common stock to two entities with a value of $47,300 for service.

 

On December 30, 2019, three officers and directors and the chairman of the Scientific Board of the Company converted $282,000 of accrued fees into 2,469,536 shares of common stock at $0.10-$0.1548 per share.

 

During the nine months ended December 31, 2019 the Company issued 373,272 shares of common stock to three officers and a director for service with a value of $50,030.

 

During the nine months ended December 31, 2020 the Company issued 98,715 shares of common stock with a value of $11,300 for settlement of accounts payable.

 

During the nine months ended December 31, 2020 the Company issued 1,651,474 shares of common stock with a value of $144.591 for service.

 

During the nine months ended December 31, 2020 the Company issued 19,166,848 shares of common stock for the conversion of 550,000 shares of preferred stock.

 

During the nine months ended December 31, 2020 three officers and a director were issued 7,709,575 shares of common stock with a value of $479,212 for service.

 

During the nine months ended December 31, 2020, the Company issued 3,982,179 shares of common stock for the conversion of $199,566 of convertible debt and fees.

 

During the nine months period ended December 31, 2020 three officers of the Company converted $1,387,872 of accrued compensation into 13,831,101 shares of common stock of the Company.

 

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NOTE 6 - OPTIONS

 

As of December 31, 2019 there was no option expenses recognized by the Company and the balance of unrecognized option expense was zero.

 

The following sets forth the options granted and outstanding during the nine months ended December 31, 2020:

 

		Options				Weighted Average Exercise Price				Weighted Average Remaining Contract Life				Number of Options Exercisable				Intrinsic Value
Outstanding at March 31, 2019			1,405,000			$	0.34				5.80				1,405,000			$	--
Granted			--				--				--				--				--
Exercised			--				--				--				--				--
Outstanding at December 31, 2020			1,405,000			$	0.34				5.05				1,405,000			$	--

   

The weighted average remaining life and intrinsic value of the options as of December 31, 2020, was 5.05 years and zero, respectively.

 

NOTE 7 - WARRANTS

 

During the nine months ended December 31, 2019 two individuals exercised 21,427 warrants into 21,427 shares of common stock for cash of $1,071.

 

During the nine months ended December 31, 2019 216,320 warrants expired.

 

During the nine months period ended December 31, 2020 the Company granted 3,700,000 warrants to four entities as part of the issuance of 740,000 Series A convertible preferred shares. The warrants expire in two years and convertible into common stock at $0.15 per share.

 

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 common stock at dates of grant between $0.08-0.110 per share, conversion price of $0.15, volatility of 312.5%-314.49% and discount rate of 0.14-0.16%. Based on the fair value of the common stock of $437,000 and recalculated value of the warrants of $349,605 the fair value of the warrants was calculated to be 41 % of the total value or $303,000. During the period ended December 31, 2020 the valuation did not result in a deemed dividend from the down round calculation.

 

As of December 31, 2020 the Company outstanding warrants totaled 3,700,000.

 

										Weighted
						Weighted				Average
						Average				Remaining
						Exercise				Contract				Intrinsic
		Warrants				Price				Life				Value
Outstanding at March 31, 2019			237,747			$	0.20				0.25			$	18,470
Granted			--				--				--				--
Exercised			(21,427	)			0.05				--				--
Expired			(216,320	)			(0.05	)			--				--
Outstanding at March 31, 2020			--				--				--				--
Granted			3,700,000				0.15				2.0				--
Exercised			--				--				--				--
Expired			--				--				--				--
Outstanding at December 31, 2020			3,700,000			$	0.15				1.60			$	--

   

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NOTE 8 - CONVERTIBLE DEBT

 

On December 31, 2019, the Company signed a guaranteed interest rate of 7% Convertible note for $161,250 with an OID of $11,250. The note was funded on January 3, 2020. The note is convertible into common stock of the Company after 180 days at the rate of 60% of the lowest trading price for twenty days prior to conversion or $0.078 whichever is lower. The note may be repaid to the issuer within 180 days from issuance at variable premium rates of 115% to 135% above face value calculated on the outstanding face value of the note plus guaranteed interest.

 

On May 7, 2020, The Company issued an 8% $50,000 one year convertible note. The note is convertible into common stock at the lesser of $0.20 per share or 80% of the lowest closing bid five days prior to conversion.

 

On July 7, 2020, $50,000 of the one year convertible note payable was converted into 50,000 shares of series A preferred

 

On October 28, 2020, the Company issued a $82,500 convertible note with an OID of $7,500. The note matures on October 28,2021 and bears fixed interest of 10%. After 180 days the note may be converted into common stock of the Company at a 35% discount to the lowest trading price during the 20 days prior to conversion.

 

On November 12, 2020, the Company issued a $138,000 convertible note with an OID of $10,000. The note matures on October 28,2021 and bears interest at 10% per annum. After 180 days the note may be converted into common stock of the Company at $0.04 per share or a 30% discount to the VWAP during the 20 days prior to conversion. The initial derivative was calculated using risk free interest of .18%, volatility of 212% and expected life of .50 years.

 

During the nine months ended December 31, 2020, the Company issued 2,677,397 shares of common stock for the conversion of $150,000 of convertible debt leaving a principal balance of $11,250.

 

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 December 31, 2020, 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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The following table represents the change in the fair value of the derivative liabilities during the nine months ended December 31, 2020:

 

		Level 1				Level 2				Level 3
Fair value of derivative liability as of March 31, 2020		$	--			$	--			$	603,836
Change in fair value at initial issuance											295,126
Change in fair value due to conversion of debt											(106,556	)
Change in fair value of the derivative			--				--				(566,220	)
Balance at December 31 2020		$	--			$	--			$	226,186

 

The estimated fair value of the derivative liabilities at December 31, 2020 was calculated using the Binomial Lattice pricing model with the following assumptions:

 

Risk-free interest rate			.18	%
Expected life in years			0.25
Dividend yield			0	%
Expected volatility			208.00	%

 

NOTE 10 - NOTE PAYABLE

 

On March 25, 2020, the Company issued a secured note with face value of $50,000. The note matures on July 24, 2020 and bears interest at 7% per annum. In the event of a default the obligation increase to 150% of the outstanding balance and the interest rate increases to 12%. On July 7, 2020 , the $50,000 note payable was converted into 50,000 shares of Series A preferred shares. The interest on the note was forgiven.

 

NOTE 11 - 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 December 31, 2020 $178,000 was due for the annual maintenance fee plus interest.

 

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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 allocation 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.

 

On October 30, 2020, the Company signed a term sheet with Alpha Holdings, Inc (Alpha) whereby Alpha, subject to a definitive agreement agreeable to both parties will invest US $ 5,000,000 in the Company. The term sheet outlines the terms of the agreement with a projected closure by December 31, 2020 for an initial investment of $2,500,000 and an additional investment of $2,500,000 on about April 30, 2021. The investment will be in the Company’s common stock to be priced at a low of nine cents per share and a high of 10 cents per share subject to a 90 day weighted average pricing before closing. Upon completion of the $5,000,000 investment Alpha may elect a majority of the board of directors of the Company. The Company has determined that Alpha was treating this as an acquisition and not investment requiring control of the board of directors. the Company determined in the best interest of all shareholders to terminate it discussions with Alpha Holdings, Inc

 

NOTE 12 - SUBSEQUENT EVENTS

 

On January 14, 2021, the Company converted 93,428 shares of preferred stock plus interest of $3,171 to 4,200,000 shares of common stock.

 

On January 14, 2021, the S-1 filed by the Company registering 26,300,000 shares of common stock and the underlying shares for 3,700,000 warrants became effective.

 

On February 1, 2021, the Company converted 45,870 shares of preferred stock into 1,529,000 shares of common stock.

 

The Company has evaluated subsequent events to determine events occurring after December 31, 2020 through February 8, 2020 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 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 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.

 

In addition, Nascent has begun collaboration with academic and corporate partners, to assess 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 15^th, 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 FDA also requested additional data to remove the partial clinical hold. On December 7, 2020, the Company received full clinical clearance from the FDA to begin phase 1 clinical trials on brain cancer patients. Trials are open and scheduled to begin in February 2021, subject to the required financing being received. The Company has an arrangement with a major oncology hospital to commence human clinical trials, first for brain cancer, both primary and metastatic.

 

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 and nine month periods ended December 31, 2020 and 2019, respectively.

 

General and administrative expenses for the three and nine month periods ended December 31, 2020 was $91,926 and $260,107 compared to $62,107 and $ 249,625 in 2019. Consulting expense for the three and nine months periods ending December 31, 2020 was $409,111 and $1,129,846 compared to $181,290 and $494,300 for the same period in 2019. This increase in expenses for the three and nine months ended December 31, 2020 over the same period in 2019 was due to higher consulting fees offset by higher research and development in 2020 over 2019.

 

Research and development expenses for the three and nine month periods ended December 31, 2020 was $53,902 and $277,338 compared to $124,925 and $255,578 in the same period in 2019 This increase in expenses for the nine months ended December 31, 2020 over the same period in 2019 reflected increased testing required in the filing with the FDA to remove the partial hold on the IND .

 

Total other income-expense incurred in the three and nine month periods ended December 31, 2020 was other expense of $164,567 for the three months period and other income of 4325,518 for the nine months period, compared to other expense of $1,920 and $6,249 in the same periods in 2019. Other income in 2020 consisted of a gain on the change of fair value of $556,220 offset by interest expense of $201,927 and finance costs of $34,356.

 

For the three and nine month periods ended December 31, 2020, our net loss was $719,507 and $1,341,772 compared to a net loss of $370,152 and $975,746 for the same periods in 2019. The difference between the periods relates to higher general and administrative and consulting cost offset by the change in fair value in 2020 over 2019.

 

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 $2 million to complete its Phase I and $15 million to complete 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, 2020, the Company had working capital of $1,231,924 Current assets consist of cash and prepaid of $72,985 and current liabilities $1,304,909 consisting of accounts payable and accrued expense of $761,598 convertible notes, net of discount, of $109,792, due related parties of $207,333 plus derivative liability of $226,186.

 

Net cash used in operating activities in the nine months period ended December 31, 2020 was $838,546 compared to net cash used of $255,724 in the same period in 2019. The variance between the same periods in 2020 and 2019 relates mainly to a higher loss in the nine months period ending December 31, 2020 over the same period in 2019 offset by the change in derivative liability and decrease in accounts payable and accrued expenses with a due to related parties increase.

 

Net cash provided by financing activities for the nine months period ended December 31, 2020 was $890,000 compared to $126,071 in the same period in 2019. Cash provided was a result of a note payable of $50,000, convertible notes of $200,000 and the issuance of preferred shares for cash of $640,000 in 2020 compared to the conversion of warrants of $1,017 and the sale of preferred shares of $110,000 in 2019.

 

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As of December 31, 2020, the Company had total assets of $72,985 and total liabilities of $1,304,909 Stockholders’ deficit as of December 31, 2020 was $1,231,924. This compares to a stockholders’ deficit of $2,875,704 as of March 31, 2019. Liabilities decreased in 2020 mainly to the conversion of related party accrued compensation into common stock plus lower derivative liability and the payment of accounts payable verses March 31, 2020.

 

NEED FOR ADDITIONAL FINANCING:

 

Our current capital needs are estimated to be approximately $17 million of which $2 million for phase I trials and $15 million for phase II trials. This will take us through Phase I/II clinical trials which are scheduled to begin in February, 2021.

 

Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements or guarantees of third party obligations at December 31, 2020

 

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 September 30, 2020, 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, 2020 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 nine months ended December 31, 2020 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 nine months ended December 31, 2020 the Company issued 98,715 shares of common stock with a value of $11,300 for settlement of accounts payable.

 

During the nine months ended December 31, 2020 the Company issued 1,651,474 shares of common stock with a value of $133,591 for service.

 

During the nine months ended December 31, 2020 the Company issued 19,166,848 shares of common stock for the conversion of 550,000 shares of preferred stock.

 

During the nine months ended December 31, 2020 three officers and a director were issued 7,709,575 shares of common stock with a value of $479,212 for service.

 

During the nine months ended December 31, 2020, the Company issued 3,982,179 shares of common stock for the conversion of $199,566 of convertible debt and fees.

 

During the nine months period ended December 31, 2020 three officers of the Company converted $1,387,872 of accrued compensation into 13,831,101 shares of common stock of the Company.

 

ITEM 3: DEFAULT ON SENIOR SECURITIES

 

None

 

ITEM 4: MINE SAFETY INFORMATION

 

None

 

ITEM 5: OTHER INFORMATION

 

None.

 

ITEM 6: EXHIBITS

 

Exhibit No.		Description
31.1		Section 302 Certification under Sarbanes-Oxley Act of 2002 of the Principal Executive Officer
31.2		Section 302 Certification under Sarbanes-Oxley Act of 2002 of the Principal Financial Officer and Principal Accounting Officer
32.1		Section 906 Certification under Sarbanes-Oxley Act of 2002 of the Principal Executive Officer
32.2		Section 906 Certification under Sarbanes-Oxley Act of 2002 of the Principal Financial Officer and Principal Accounting Officer

 

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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 9, 2021	By:	/s/ Sean Carrick
		Sean Carrick
		Principal Executive Officer

 

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