Quarterly Report (10-q)

Date : 11/18/2019 @ 6:20PM
Source : Edgar (US Regulatory)
Stock : Nascent Biotech Inc (QB) (NBIO)
Quote : 0.117  -0.001 (-0.85%) @ 9:00PM

Quarterly Report (10-q)

 

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended September 30, 2019

 

OR

 

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

 

For the transition period from ______________ to ______________

 

Commission File Number: 000-55299

 

 

NASCENT BIOTECH INC

(Exact Name of Registrant as Specified in Its Charter)

 
 

Nevada

 

45-0612715

(State of Incorporation)

 

(IRS Employer Identification No.)

 

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 x     No ¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated file, non-accelerated filer, or a smaller reporting company.

 

Large accelerated filer

¨

Accelerated filed

¨

Non-accelerated filer

x

Smaller reporting company

x

 

 

Emerging Growth Company

x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

 

As of November 18, 2019, the Registrant had 33,772,970 shares of common stock issued and outstanding.

 

 
 
 
 

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statement (Unaudited)

 

 

 

 

 

 

 

Consolidated Balance Sheets as of September 30, 2019 (unaudited) and March 31, 2019

 

3

 

 

 

 

 

 

Unaudited Consolidated Statements of Operations for the Three and Six Months Ended September 30, 2019 and 2018

 

4

 

 

 

 

 

 

Unaudited Consolidated Statements of Stockholders’ Deficit for the Six Months Ended September 30, 2019 and 2018

 

5

 

 

 

 

 

 

Unaudited Consolidated Statements of Cash Flows for the Six Months Ended September 30, 2019 and 2018

 

6

 

 

 

 

 

 

Notes to Unaudited Consolidated Financial Statements

 

7

 

 

 

 

 

Item 2.

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

 

11

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risks

 

13

 

 

 

 

 

Item 4.

Controls and Procedures

 

13

 

 

 

 

 

PART II – OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

14

 

 

 

 

 

Item 1A.

Risk Factors

 

14

 

 

 

 

 

Item 2.

Unregistered Sales of Equity and Use of Proceeds

 

14

 

 

 

 

 

Item 3.

Default upon Senior Securities

 

14

 

 

 

 

 

Item 4.

Mine Safety Information

 

14

 

 

 

 

 

Item 5.

Other Information

 

14

 

 

 

 

 

Item 6.

Exhibits

 

15

 

 

 

 

 

SIGNATURES

 

16

 

 

 
2
 
 

 

PART I – FINANCIAL INFORMATION

 

ITEM: 1 FINANCIAL STATEMENT

 

NASCENT BIOTECH, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

September 30,

2019

 

 

March 31,

2019

 

 

 

(Unaudited)

 

 

 

ASSETS

Current assets:

 

 

 

 

 

 

Cash

 

$ 5,471

 

 

$ 131,472

 

Total current assets

 

 

5,471

 

 

 

131,472

 

 

 

 

 

 

 

 

 

 

Total assets

 

$ 5,471

 

 

$ 131,472

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$ 676,907

 

 

$ 525,636

 

Due to related parties

 

 

129,710

 

 

 

88,000

 

Total current liabilities

 

 

806,617

 

 

 

613,636

 

 

 

 

 

 

 

 

 

 

Total liabilities

 

 

806,617

 

 

 

613,636

 

 

 

 

 

 

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 authorized, 110,000 Series A and none issued and outstanding, respectively

 

 

110

 

 

--

 

Common stock, $0.001 par value; 100,000,000 authorized, 33,772,970 and 32,646,635 issued and outstanding, respectively

 

 

33,774

 

 

 

32,647

 

Additional paid-in capital

 

 

12,604,060

 

 

 

12,318,685

 

Accumulated deficit

 

 

(13,439,090 )

 

 

(12,833,496 )

Total stockholders’ deficit

 

 

(801,146 )

 

 

(482,164 )

Total liabilities and stockholder’ deficit

 

$ 5,471

 

 

$ 131,472

 

 

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

 

 
3
 
Table of Contents

 

NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

Three Months Ended

 

 

Six Months

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expense

 

$ 228,667

 

 

$ 298,512

 

 

$ 473,618

 

 

$ 626,300

 

Research and development

 

 

98,861

 

 

 

39,500

 

 

 

127,653

 

 

 

151,439

 

Loss from operations

 

 

(327,528 )

 

 

(338,012 )

 

 

(601,271 )

 

 

(777,739 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1

 

 

 

14

 

 

 

6

 

 

 

22

 

Interest expense

 

 

(4,329 )

 

 

--

 

 

 

(4,329 )

 

 

--

 

Total other income (expense)

 

 

(4,328 )

 

 

14

 

 

 

(4,323 )

 

 

22

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$ (331,856 )

 

$ (337,998 )

 

$ (605,594 )

 

$ (777,717 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$ (0.01 )

 

$ (0.01 )

 

$ (0.02 )

 

$ (0.03 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares outstanding, basic and diluted

 

 

33,572,695

 

 

 

29,773,807

 

 

 

33,176,663

 

 

 

28,950,329

 

 

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

 

 
4
 
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NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT

SIX MONTHS ENDED SEPTEMBER 30, 2019 AND 2018

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

Total Stockholders’

 

 

 

Preferred Stock

 

 

Common Stock

 

 

Paid-In

 

 

Accumulated

 

 

Equity

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For Three Months Ended September 30, 2018

 

Balance at June 30, 2018

 

 

 

 

 

 

 

 

28,543,295

 

 

 

28,544

 

 

 

11,543,696

 

 

 

(11,904,308 )

 

 

(332,068 )

Common stock issued for warrants

 

 

--

 

 

 

--

 

 

 

1,304,996

 

 

 

1,305

 

 

 

63,945

 

 

 

--

 

 

 

65,250

 

Common stock issued for stock and warrants

 

 

--

 

 

 

--

 

 

 

465,714

 

 

 

466

 

 

 

162,534

 

 

 

--

 

 

 

163,000

 

Common stock issued to related parties for service

 

 

--

 

 

 

--

 

 

 

218,852

 

 

 

218

 

 

 

41,363

 

 

 

--

 

 

 

41,581

 

Option discount

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

9,600

 

 

 

--

 

 

 

9,600

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

(337,998 )

 

 

(227,998 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

 

--

 

 

 

--

 

 

 

30,532,857

 

 

$ 30,533

 

 

$ 11,821,138

 

 

$ (12,242,306 )

 

$ (390,635 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For Six Months Ended September 30, 2018

Balance at March 31, 2018

 

 

--

 

 

 

--

 

 

 

27,753,365

 

 

$ 27,754

 

 

$ 11,350,456

 

 

$ (11,464,589 )

 

$ (86,379 )

Common stock and warrants issued for cash

 

 

--

 

 

 

--

 

 

 

737,142

 

 

 

737

 

 

 

257,263

 

 

 

--

 

 

 

258,000

 

Common stock issued to related parties for service

 

 

--

 

 

 

--

 

 

 

306,640

 

 

 

306

 

 

 

85,170

 

 

 

--

 

 

 

85,476

 

Common stock issued for warrant exercise

 

 

--

 

 

 

--

 

 

 

1,665,710

 

 

 

1,666

 

 

 

81,619

 

 

 

--

 

 

 

83,285

 

Common stock issued for service

 

 

--

 

 

 

--

 

 

 

70,000

 

 

 

70

 

 

 

27,430

 

 

 

--

 

 

 

27,500

 

Option expense

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

19,200

 

 

 

--

 

 

 

19,200

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

(777,717 )

 

 

(777,717 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2018

 

 

--

 

 

 

--

 

 

 

30,532,857

 

 

$ 30,533

 

 

$ 11,821,138

 

 

$ (12,242,306 )

 

$ (390,635 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For Three Months Ended September 30, 2019

 

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 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

For Six Months Ended September 30, 2019

 

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

 

 

--

 

 

 

--

 

 

 

165,372

 

 

 

166

 

 

 

29,075

 

 

 

--

 

 

 

29,241

 

Common stock issued for warrant exercise

 

 

--

 

 

 

---

 

 

 

21,427

 

 

 

21

 

 

 

1,050

 

 

 

--

 

 

 

1,071

 

Common stock issued for service

 

 

--

 

 

 

--

 

 

 

300,000

 

 

 

300

 

 

 

47,000

 

 

 

--

 

 

 

47,300

 

Preferred shares issued for cash

 

 

110,000

 

 

 

110

 

 

 

--

 

 

 

--

 

 

 

109,890

 

 

 

--

 

 

 

110,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

(605,594 )

 

 

(605,594 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at September 30, 2019

 

 

110,000

 

 

$ 110

 

 

 

33,772,970

 

 

$ 33,774

 

 

$ 12,604,060

 

 

$ (13,439,090 )

 

$ (801,146 )

 

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

 

 
5
 
Table of Contents

 

NASCENT BIOTECH, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

 

 

Six Months Ended

September 30,

 

 

 

2019

 

 

2018

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$ (605,594 )

 

$ (777,717 )

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

76,541

 

 

 

112,976

 

Option expense

 

 

--

 

 

 

19,200

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

 

151,271

 

 

 

262,434

 

Due to related parties

 

 

140,710

 

 

 

35,000

 

Net cash used in operating activities

 

 

(237,072 )

 

 

(348,107 )

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Common stock issued for exercise of warrants

 

 

1,071

 

 

 

83,285

 

Proceeds from the sale of preferred shares for cash

 

 

110,000

 

 

 

--

 

Proceeds from sale of common stock and warrants

 

 

--

 

 

 

258,000

 

Net cash provided by financing activities

 

 

111,071

 

 

 

341,285

 

 

 

 

 

 

 

 

 

 

Net decrease in cash

 

 

(126,001 )

 

 

(6,822 )

Cash -beginning of year

 

 

131,472

 

 

 

116,994

 

Cash -end of period

 

$ 5,471

 

 

$ 110,172

 

 

 

 

 

 

 

 

 

 

SUPPLEMENT DISCLOSURES:

 

 

 

 

 

 

 

 

Interest paid

 

$ --

 

 

$ --

 

Income taxes paid

 

$ --

 

 

$ --

 

 

 

 

 

 

 

 

 

 

Non Cash Transactions

 

 

 

 

 

 

 

 

Common stock issued for accrued expenses- related party

 

$ 99,000

 

 

$ --

 

 

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

 

 
6
 
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 its primary asset Pritumumab for the treatment of brain cancer and pancreatic cancer. Nascent is also actively researching other cancers that have a high probability of benefiting from the therapeutic effects of Pritumumab because they share a common target. Pritumumab has shown to be very effective at low doses in previous clinical studies in Japan. Nascent is a pre-clinical stage biopharmaceutical company that focuses on biologic drug candidates that are preparing for initial clinical testing for the treatment of brain and pancreatic cancer.

 

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

 

On July 10, 2019 the Company filed an amended articles of Incorporation designating 1,500,000 shares of preferred stock as Series A Convertible preferred shares convertible into common stock.

 

On August 9, 2019 the Company signed a contract for clinical phase 1 studies with west coast clinic.

 

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 six months ended September 30, 2019 and 2018 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, 2019. 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.

 

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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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. The following table sets forth the shares earned under these contracts as of September 30, 2019:

 

Officer and Director

 

Initial Share Awards Under the Contracts

 

 

Additional Shares Earned to Maintain Ownership Percentage

 

 

Total Shares Earned

 

President

 

 

1,028,910

 

 

 

681,476

 

 

 

1,710,386

 

Chief Financial Officer

 

 

617,346

 

 

 

411,693

 

 

 

1,029,039

 

Executive Vice President

 

 

617,346

 

 

 

411,693

 

 

 

1,029,039

 

Total

 

 

2,263,602

 

 

 

1,504,862

 

 

 

3,768,464

 

 

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

 

Officer and Director

 

Fiscal Year Annualized Compensation Being Paid

 

 

Annual Severance per Contract if Terminated

 

President

 

$ 186,000

 

 

$ 250,000

 

Chief Financial Officer

 

$ 132,000

 

 

$ 180,000

 

Executive Vice President

 

$ 84,000

 

 

$ 140,000

 

Total

 

$ 402,000

 

 

$ 570,000

 

 

During the six month period ended September 30, 2018 the Company issued 306,640 shares of common stock to three officers of the Company with a value of $85,476 for service.

 

During the six month period ended September 30, 2018 the Company paid a related party and Chairman of the Scientific Board $12,000 in consulting fees and accrued $3,000 of the fees. During the same period in 2017 the Company paid $30,000 to the same individual.

 

During the six month period ended September 30, 2018 the Company accrued $32,000 in fees due to officers of the Company.

 

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.

 

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.

 

 
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During the six months ended September 30, 2019 the Company issued 165,372 shares of common stock to three officers and a director for service with a value of $29,241.

 

During the six month period ended September 30, 2019 the Company paid the related parties (three officers and directors) $59,000 in consulting fees in cash and accrued $120,710 of the consulting fees for a total of $179,710. In addition $6,209 in expenses were accrued for the related parties.

 

During the six months period ended September 30, 2019, Company paid $4,000 plus had an outstanding accrual of $9,000 with a related party and Chairman of the Scientific Board. During the same period in 2018, Company paid the same related party $9,000 in consulting fees and accrued $6,000 of the fees.

 

NOTE 5 – EQUITY

 

Preferred Stock

 

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) the equitant of 70% of the lowest closing price for the 20 days prior to the conversion of the preferred shares and accumulates 7% interest annually.

 

Common Stock

 

During the six months ended September 30, 2018 the Company issued 737,142 shares of common stock plus 237,747 warrants to eight individuals for $258,000 in cash. The warrants vest immediately and terminate in one year with conversion price from $0.05-$0.50.

 

During the six months ended September 30, 2018 the Company issued 1,665,710 shares of common stock for the conversion of 1,665,710 warrants with a value of $83,285.

 

During the six month period ended September 30, 2018 the Company issued 70,000 shares of common stock of the Company to two individuals with a value of $27,500 for service.

 

During the six month period ended September 30, 2018 the Company issued 306,640 shares of common stock to three officers of the Company with a value of $85,476 for service.

 

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.

 

During the six months period ended September 30, 2019 Company issued 300,000 shares of common stock to two entities with a value of $47,300 for service.

 

During the six months ended September 30, 2019, the Company issued 165,372 shares of common stock to three officers and a director for service with a value of $29,241.

 

NOTE 6 – OPTIONS

 

As of September 30, 2019 there was no option expenses recognized by the Company and the balance of unrecognized option expense was zero.

 

 
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The following sets forth the options granted and outstanding during the six months ended September 30, 2019:

 

 

 

 

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

 

 

 

6.80

 

 

 

1,397,000

 

 

$ --

 

Granted

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

Exercised

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

 

 

--

 

Outstanding at September 30, 2019

 

 

1,405,000

 

 

$ 0.34

 

 

 

6.55

 

 

 

1,397,000

 

 

$ --

 

  

The weighted average remaining life and intrinsic value of the options as of September 30, 2019, was 6.55 years and zero, respectively.

 

NOTE 7 – WARRANTS

 

During the six month period ended September 30, 2018, the Company issued 237,747 warrants with each warrant is exercisable, within one year of the issuance, into one share of the Company’s common stock at $0.05 to $0.50 per share.

 

During the six month period ended September 30, 2018 seventeen individual exercised 1,665,710 warrants into 1,665,710 shares of common stock with a value of $83,285 in cash. As of September 30, 2018, the Company had total outstanding warrants of 511,975.

 

During the six months ended September 30, 2019 two individuals exercised 21,427 warrants into 21,427 shares of common stock for cash of $1,071. As of September 30, 2019 the Company had a total of 109,276 warrants outstanding.

 

During the six months ended September 30, 2019 216,320 warrants expired.

 

The weighted average remaining life and intrinsic value of the warrants as of September 30, 2019 was zero.

 

 

 

 

 

 

 

 

 

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 September 30, 2019

 

 

--

 

 

$ 0.00

 

 

 

0.00

 

 

$ --

 

 

NOTE 8 – 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 September 30, 2019 $100,000 was due for the annual maintenance fee.

 

NOTE 9 - SUBSEQUENT EVENT

 

On November 14, 2019 an Officer and Director of the Company advanced the Company $10,000. The advance is on demand and bears no interest.

 

 
10
 
Table of Contents

 

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.

 

Overview

 

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

 

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

 

 
11
 
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Results of Operations

 

The Company recorded zero of revenue during the three and six month periods ended September 30, 2019, and 2018, respectively.

 

General and administrative expenses for the three and six month periods ended September 30, 2019 was $228,667 and $473,618 compared to $298,512 and $626,300 in 2018. This decrease in expenses for the six months ended September 30, 2019 over the same period in 2018 was due to a lower cost for IND filing of the Company in 2019.

 

Research and development expenses for the three and six month periods ended September 30, 2019 was $98,861 and $127,653 compared to $39,500 and $151,439 in the same period in 2018. This decrease in expenses for the six months ended September 30, 2019 over the same period in 2018 reflected decreased testing required in the filing of the IND with the FDA.

 

Total other expense incurred in the three and six month periods ended September 30, 2019 was $4,328 and 4,323, compared to other income of $14 and $22 in the same periods in 2018. Other expense consisted of interest expense from preferred shares and payables.

 

For the three and six month periods ended September 30, 2019, our net loss was $331,856 and $605,594 compared to a net loss of $337,998 and $777,717 for the same periods in 2018. The difference between the periods relates to lower research and development costs in 2019 along with lower general and administrative costs preparing the IND in 2019 compared to the same period in 2018.

 

Liquidity and Capital Resources

 

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

 

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

 

At September 30, 2019, the Company had negative working capital of $801,146. Current assets consist of cash of $5,471. Current liabilities as of the same date were $806,617 consisting of accounts payable of $676,907 of which approximately $350,000 was cost overrun on the IND submission plus due to related parties of $129,710.

 

Net cash used in operating activities in the six months period ended September 30, 2019 was $237,072 compared to net cash used of $348,107 in the same period in 2018. The variance between the same periods in 2019 and 2018 relates mainly to a lower loss in the six months period ended September 30, 2019 over the same period in 2018.

 

Net cash provided by financing activities for the six months period ended September 30, 2019 was $111,071 compared to $341,285 in the same period in 2018. Cash provided was a result of the conversion of warrants to common stock of $1,071 and from the sale of convertible preferred stock for $110,000 in 2019 compared to warrant conversion of $83,285 and the sale of common stock and warrants of $258,000 in the same period in 2018

 

As of September 30, 2019, the Company had total assets of $5,471 and total liabilities of $806,617. Stockholders’ deficit as of September 30, 2019 was $801,146. This compares to a stockholders’ deficit of $482,164 as of March 31, 2019. Liabilities increased in 2019 due mainly to an increase in accounts payable and due to related parties during this period versus the same period in 2018 but was partly offset by the conversion by two related parties of $99,000 due the related parties converted to common stock.

 

NEED FOR ADDITIONAL FINANCING:

 

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

 

 
12
 
Table of Contents

 

Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements or guarantees of third party obligations at September 30, 2019.

 

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, 2019, 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 September 30, 2019, 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 September 30, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

 
13
 
Table of Contents

 

PART II – OTHER INFORMATION

 

ITEM 1: LEGAL PROCEEDINGS

 

None

 

ITEM 1A: RISK FACTORS

 

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

 

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

 

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.

 

During the six months period ended September 30, 2019 Company issued 300,000 shares of common stock to two entities with a value of $47,300 for service.

 

During the six months ended September 30, 2019, 2019 the Company issued 165,372 shares of common stock to three officers and a director for service with a value of $29,241.

 

ITEM 3: DEFAULT ON SENIOR SECURITIES

 

None

 

ITEM 4: MINE SAFETY INFORMATION

 

None

 

ITEM 5: OTHER INFORMATION

 

None.

 

 
14
 
Table of Contents

 

ITEM 6: EXHIBITS

 

Exhibit No.

 

Description

 

31.1

 

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

 

31.2

 

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

 

 

 

32.1

 

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

 

 

 

32.2

 

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

 

 
15
 
Table of Contents

 

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: November 18, 2019 By: /s/ Sean Carrick

 

 

Sean Carrick  
    Principal Executive Officer  

 

 

16

 

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