Nascent Biotech Inc. - Quarter Report: 2015 September (Form 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, 2015
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.) | |
8400 Miramar Road/Suite 247 San Diego CA | 92126 | |
(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 ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated file, non-accelerated filer, or a smaller reporting company.
Large accelerated filer | ¨ | Accelerated filed | ¨ |
Non-accelerated filer | ¨ | Smaller reporting company | x |
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 5, 2015, the Registrant had 21,038,902 shares of common stock issued and outstanding.
TABLE OF CONTENTS
PART I – FINANCIAL INFORMATION |
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Item 1. | Financial Statement (Unaudited) |
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| Unaudited Consolidated Balance Sheets as of September 30, 2015 and March 31, 2015 |
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| 3 |
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| Unaudited Consolidated Statements of Operations for the Three And Six Months Ended September 30, 2015 and 2014 |
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| Unaudited Consolidated Statements of Cash Flows for the Six Months Ended September 30, 2015 and 2014 |
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| Notes to Unaudited Consolidated Financial Statements |
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| 6 |
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Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations |
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| 12 |
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Item 3. | Quantitative and Qualitative Disclosures About Market Risks |
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| 14 |
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Item 4. | Controls and Procedures |
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| 14 |
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PART II – OTHER INFORMATION |
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Item 1. | Legal Proceedings |
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| 15 |
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Item 1A. | Risk Factors |
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| 15 |
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Item 2. | Unregistered Sales of Equity and Use of Proceeds |
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| 15 |
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Item 3. | Default upon Senior Securities |
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| 15 |
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Item 4. | Mine Safety Information |
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| 15 |
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Item 5. | Other Information |
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| 15 |
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Item 6. | Exhibits |
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| 16 |
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SIGNATURES |
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| 17 |
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PART I – FINANCIAL INFORMATION
ITEM 1: FINANCIAL STATEMENT
NASCENT BIOTECH, INC
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| September 30, |
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| March 31, 2015 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
| $ | 42,410 |
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| $ | 107,571 |
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Prepaid expenses |
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| 1,566 |
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| 2,066 |
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Total current assets |
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| 43,976 |
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| 109,637 |
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Materials held for research and development with alternative future use |
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| 827,964 |
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| 827,964 |
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Total assets |
| $ | 871,940 |
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| $ | 937,601 |
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LIABILITIES AND STOCKHOLDERS' DEFICIT |
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Current liabilities: |
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Accounts payable and accrued liabilities |
| $ | 1,540,056 |
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| $ | 1,280,938 |
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Accounts payable to related parties |
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| -- |
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| 4,672 |
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License agreement liability |
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| 33,000 |
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| 1,792,650 |
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Derivate liability |
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| 3,236 |
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| 6,330 |
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Total current liabilities |
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| 1,576,292 |
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| 3,084,590 |
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Convertible note payable |
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| -- |
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| 60,000 |
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Total liabilities |
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| 1,576,292 |
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| 3,144,590 |
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Stockholders' deficit: |
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Preferred stock, $0.001par value, 10,000,000 authorized, none issued and outstanding |
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| -- |
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| -- |
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Common stock, $0.001 par value,100,000,000 authorized, 20,961,152 and 17,564,600 issued and outstanding, respectively |
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| 20,961 |
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| 17,564 |
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Additional paid-in capital |
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| 8,571,216 |
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| 4,006,934 |
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Accumulated deficit |
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| (9,296,529 | ) |
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| (6,231,487 | ) |
Total stockholders' deficit |
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| (704,352 | ) |
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| (2,206,989 | ) |
Total liabilities and stockholder deficit |
| $ | 871,940 |
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| $ | 937,601 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
3
NASCENT BIOTECH, INC
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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| Three Months Ended |
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| Six Months Ended |
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| 2015 |
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| 2014 |
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| 2015 |
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| 2014 | |||||
Operating expenses: |
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General and administrative expense |
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| 3,793,858 |
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| 51,710 |
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| 3,954,088 |
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| $ | 113,355 |
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Gain on settlement of license agreement liability |
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| (1,573,650 | ) |
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| -- |
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| (1,573,650 | ) |
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| -- |
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Research and development |
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| 27,371 |
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| 271,330 |
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| 627,422 |
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| 441,330 |
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Loss from operations |
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| (2,247,579 | ) |
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| (323,040 | ) |
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| (3,007,860 | ) |
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| (554,685 | ) |
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Other income (expense): |
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Interest income |
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| 1 |
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| -- |
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| 1 |
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| -- |
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Gain (loss) on change in fair value of derivative liability |
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| 15,483 |
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| (5,048 | ) |
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| 3,094 |
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| (5,048 | ) |
Interest expense |
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| (36,454 | ) |
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| (169 | ) |
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| (60,277 | ) |
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| (433 | ) |
Total other income (expense) |
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| (20,970 | ) |
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| (5,217 | ) |
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| (57,182 | ) |
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| (5,481 | ) |
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Net loss |
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| (2,268,549 | ) |
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| (328,257 | ) |
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| (3,065,042 | ) |
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| (560,166 | ) |
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Net loss per share, basic and diluted |
| $ | (0.12 | ) |
| $ | (0.02 | ) |
| $ | (0.17 | ) |
| $ | (0.05 | ) |
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Weighted average number of shares outstanding, basic and diluted |
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| 18,308,898 |
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| 14,460,567 |
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| 18,064,600 |
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| 10,895,030 |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
4
NASCENT BIOTECH, INC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended | ||||||||
| 2015 |
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| 2014 |
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Cash flows from operating activities: |
| $ | (3,065,042 | ) |
| $ | (560,166 | ) |
Net loss |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Change in fair value of derivative liability |
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| (3,094 | ) |
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| 5,048 |
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Gain on settlement of license agreement liability |
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| (1,573,650 | ) |
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| -- |
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Derivative warrants issued |
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| -- |
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| 1,218 |
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Stock based compensation |
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| 3,667,369 |
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| -- |
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Option expense |
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| 105,310 |
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| -- |
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Changes in operating assets and liabilities: |
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Accounts payable and accrued expenses |
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| 259,118 |
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| 80,750 |
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Accounts payable to related parties |
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| (4,672 | ) |
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| 18,375 |
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License agreement liability |
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| (36,000 | ) |
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| (5,000 | ) |
Prepaid expenses |
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| 500 |
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| (11,000 | ) |
Net cash used in operating activities |
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| (650,161 | ) |
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| (470,775 | ) |
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Cash flows from financing activities: |
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Repayment of convertible note |
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| (60,000 | ) |
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| -- |
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Proceeds from sale of common stock and warrants |
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| 645,000 |
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| 422,500 |
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Net cash provided by financing activities |
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| 585,000 |
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| 422,500 |
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Net decrease in cash |
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| (65,161 | ) |
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| (48,275 | ) |
Cash – beginning of year |
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| 107,571 |
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| 113,832 |
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Cash – end of year |
| $ | 42,410 |
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| $ | 65,557 |
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SUPPLEMENT DISCLOSURES: |
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Interest paid |
| $ | 8,550 |
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| $ | -- |
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Income taxes paid |
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| -- |
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| -- |
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NON-CASH TRANSACTIONS |
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Common stock issued for reverse merger |
| $ | -- |
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| $ | 19,000 |
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Cancellation of common stock |
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| -- |
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| 15,000 |
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Common stock issued for settlement of license agreement liability |
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| 150,000 |
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| -- |
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The accompanying notes are an integral part of these unaudited consolidated financial statements.
5
NASCENT BIOTECH, INC
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 1 – ORGANIZATION AND NATURE OF OPERATIONS
Nascent Biotech, Inc ("Biotech") was incorporated on March 3, 2014 under the laws of the State of Nevada.
On March 21, 2014, Biotech entered into a reverse merger with Nascent Biologics, Inc. exchanging shares on a one for one basis. Nascent Biologics, Inc. was incorporated under the laws of the State of Delaware on July 15, 2008. Biotech issued 3,000,000 shares of common stock for 100% of Nascent Biologics, Inc. common stock. Prior to the share exchange, Biotech had 1,000,200 common shares outstanding. Biotech had $92,415 of net assets at the date of merger. This has been accounted for as a reverse merger and recapitalization where Nascent Biologics is deemed the accounting acquirer.
The net assets of Biotech consisted of the following as of the date of the merger:
Cash |
| $ | 79,915 |
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Prepaid expenses |
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| 15,000 |
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Accounts payable to related party |
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| (2,500 | ) |
Net assets |
| $ | 92,415 |
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On July 15, 2014 Biotech entered into a reverse merger with Jin-En Group International Holding Company (Jin-En). Jin-En issued 7,500,200 shares of its common stock for all the outstanding shares of Nascent Biotech, Inc. In addition, Jin-En cancelled 15,000,000 shares of its common stock. Prior to the merger Jin-En had 22,829,400 shares outstanding. Jin-En changed its name to Nascent Biotech, Inc. Jin-En had $19,000 of net liabilities at the date of the merger.
The net liabilities of Jin-En consisted of the following as of the date of the merger:
Receivable from Biotech |
| $ | 60,000 |
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Accounts payable |
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| (19,000 | ) |
Convertible note payable |
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| (60,000 | ) |
Net liabilities |
| $ | (19,000 | ) |
Nascent Biotech is engaged in the research and development of antibodies for control of certain types of cancer in humans.
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, 2015 and 2014 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, 2015 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.
Certain prior period amounts have been reclassified to conform to current period presentation.
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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, as shown in the accompanying consolidated balance sheets, has a working capital deficit of $1,523,316 as September 30, 2015 and has incurred net losses since inception. The Company does not have a source of revenue to cover its operating costs. These factors raise substantial doubt about the company's ability to continue as a going concern. The Company will engage in research and development activities that must be satisfied in cash secured through outside funding. The Company will offer noncash consideration and seek equity lines as a means of financing its operations. If the Company is unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may substantially curtail or terminate its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may dilute the interests of existing stockholders.
NOTE 4 – RELATED PARTY TRANSACTIONS
On September 25, 2015, the Company paid an accounts payable of $4,672 to a former Officer and Director. As of September 30, 2015 the balance due was zero.
On September 1, 2015 the Company entered into five year employment contracts with three of its officers and directors. Under the terms of the agreements the Company issued shares of common stock to the officers and directors equaling 11% of the outstanding shares of the Company as of the date of the contracts. As additional future shares are issued, the officers and directors are entitled to additional shares so their aggregate ownership percentage remains at 11% of the outstanding shares of the Company. The following table sets forth the shares earned under these contracts during the six months ended September 30, 2015:
Officer and Director |
| Initial Share |
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| Additional Shares Earned to Maintain Ownership Percentage |
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| Total Shares |
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President |
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| 1,028,910 |
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| 17,250 |
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| 1,046,160 |
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Chief Financial Officer |
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| 617,346 |
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| 10,350 |
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| 627,696 |
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Senior Vice President |
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| 617,346 |
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| 10,350 |
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| 627,696 |
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Total |
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| 2,263,602 |
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| 37,950 |
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| 2,301,552 |
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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 |
| Annual Salary |
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| Annual Severance per Contract if Terminated |
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President |
| $ | 72,000 |
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| $ | 250,000 |
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Chief Financial Officer |
| $ | 60,000 |
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| $ | 180,000 |
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Senior Vice President |
| $ | 24,000 |
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| $ | 140,000 |
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Total |
| $ | 156,000 |
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| $ | 570,000 |
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NOTE 5 – LICENSE LIABILITY
The Company holds a license from a third party for certain patents and related material related to Pritumumab. The license allows the Company to develop, manufacture and sell its product worldwide using the patents under the licenses agreement. The license was entered into by Nascent Biologics, Inc. in March 2009 granting rights to the development and certain patents. The license was granted for total consideration of $2,000,000, to be paid in six installment of $300,000 plus a final payment of $200,000 on January 1, 2016. In addition, the license provides the licensor with a royalty of 2% on the sales of the developed product, up to $10,000,000 in sales, and thereafter, a royalty of 1% for all sales over $10,000,000. Prior to the acquisition by the Company, Nascent Biologics allowed 10 patents to expire based on their assessment of the patents and their value relating to the Company's development of its product. Nascent Biologics and the licensor amended the license agreement requiring payments of $333,000 per year from January 1, 2012 through January 1, 2015. Such payments were not made by Nascent Biologic or the Company after the acquisition of Nascent Biologic.
On September 21, 2015 the Company and the licensor amended their agreement where the licensor received a $30,000 cash payment and will receive $1,000 per month for 28 months plus a $5,000 additional payment on the 28th month. In addition the licensor received 200,000 shares of the Company's common stock, plus will receive 1% of net sales of the Company's product up to $1,000,000 in royalties. The fair value of the stock issued was determined to be $150,000 and the transaction resulted in a remaining liability as of September 30, 2015 of $33,000 to be paid over 28 months and a gain on settlement of license agreement liability of $1,573,650.
NOTE 6 – DERIVATIVE LIABILITIES
On May 20, 2014 the Company granted 13,317 common stock warrants for services. The warrants vest immediately, are exercisable at $1.00 per share and expire on May 21, 2017. The Company determined that the warrants were not afforded equity classification because the warrants are not considered to be indexed to the Company's own stock due to the anti-dilution provision. Accordingly, the warrants are treated as a derivative liability and are carried at fair value. The Company estimated the fair value of these derivative warrants at each balance sheet date and the changes in fair value are recognized in earnings in the statement of operations under the caption "loss on change in fair value of derivative liability" until such time as the derivative warrants are exercised or expire. The Company used the Black-Scholes Option Pricing model to estimate the fair value of the derivative liability as of the date of issuance and as of September 30, 2015 using the following key inputs: market price of the Company's common stock $0.10 to $1.51 per share, volatility of 250% and discount rate of 0.13%. The fair value of the derivative liability was determined to be $6,330 as of March 31, 2015 and $3,236 as of September 30, 2015 which resulted in a gain on the change in fair value of derivative liability of $3,094 for the six months ended September 30, 2015.
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.
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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.
Financial assets and liabilities measured at fair value on a recurring basis are summarized below as of September 30, 2015 and March 31, 2015:
| Level 1 |
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| Level 2 |
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| Level 3 |
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| Total |
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As of September 30, 2015: |
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Assets |
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None |
| $ | - |
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| $ | - |
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| $ | - |
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| $ | - |
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Liabilities |
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Derivative liability |
| $ | - |
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| $ | - |
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| $ | 3,236 |
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| $ | 3,236 |
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As of March 31, 2015: |
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Assets |
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None |
| $ | - |
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| $ | - |
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| $ | - |
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| $ | - |
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Liabilities |
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Derivative liability |
| $ | - |
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| $ | - |
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| $ | 6,330 |
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| $ | 6,330 |
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The following table summarizes the change in the fair value of the derivative liability during the six months ended September 30, 2015:
Fair value as of March 31, 2015 |
| $ | 6,330 |
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Additions |
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| -- |
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Transfers in (out) of Level 3 |
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| -- |
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Change in fair value |
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| (3,094 | ) |
Fair value as of September 30, 2015 |
| $ | 3,236 |
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NOTE 7 – COMMON STOCK
During the six month period ended September 30, 2015 the Company issued 645,000 shares of common stock for $645,000 in cash.
On September 21, 2015 the Company issued 200,000 shares of its common stock with a value of $150,000 as part of the settlement of the license agreement liability (see Note 5). The license agreement liability settled totaled $1,723,650 and the fair value of the stock was determined to be $150,000 resulting in a gain of $1,573,650.
During the six months ended September 30, 2015 the Company issued an aggregate of 2,551,552 shares of common stock with a value of $3,667,369 for services and compensation.
9
NOTE 8 – CONVERTIBLE NOTES PAYABLE
On May 5, 2014 Jin-En issued a $60,000 unsecured convertible note bearing interest at 10% per annum. The note was convertible into common stock of the Company at $0.01 per share and matured on May 5, 2019. On September 15, 2015 the Company paid the debt holder in cash $68,550 which included a principal payment of $60,000 and accrued interest of $8,550. As of September 30, 2015 the balance due on the convertible note was zero.
NOTE 9 – OPTIONS
The Company under its 2015 option plan issues options to various officers, directors and consultants. The options vest in equal annual installments over a five year period with the first 20% vested when the options were granted. All of the options are exercisable at a purchase price based on the last trading price of the Company's common stock on the date of grant and have a term of 10 years.
On January 27, 2015 the Company issued 355,000 options with an exercise prices between $0.35 and $0.50 per share to four officers and directors and two consultants of the Company. A volatility of 250%, market price of common stock of $1.25 and a discount rate of 1.81% were used in calculating the fair value of the options using the Black-Scholes Option Pricing Model. The fair value of the options was determined to be $443,069. The fair value is being recognized as stock-based compensation over the vesting period of the options.
On April 1, 2015 the Company granted a consultant to the Company 30,000 options that are exercisable at $0.70 per share. A volatility of 250%, market price of common stock of $1.05 and a discount rate of 1.87% were used in calculating the fair value of the options using the Black-Scholes Option Pricing Model. The fair value of the options was determined to be $31,436. The fair value is being recognized as stock-based compensation over the vesting period of the options.
During the six period ended September 30, 2015, the Company expensed $105,310 related to its option awards. The unrecognized future balance to be expensed over the remaining vesting term of the options is $249,878 as of September 30, 2015.
The following sets forth the options granted and outstanding during the six months ended September 30, 2015:
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| Weighted |
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| Weighted |
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| Average |
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| Average |
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| Remaining |
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| Number of |
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| Exercise |
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| Contract |
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| Options |
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| Intrinsic |
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| Options |
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| Price |
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| Life |
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| Exercisable |
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| Value |
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Outstanding at March 31, 2015 |
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| 355,000 |
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| $ | 0.49 |
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| 9.59 |
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| 71,000 |
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| $ | 72,610 |
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Granted |
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| 30,000 |
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| 0.70 |
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| 9.51 |
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| 6,000 |
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| 4,860 |
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Exercised |
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| -- |
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| -- |
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| -- |
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| -- |
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| -- |
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Outstanding at September 30, 2015 |
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| 385,000 |
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| $ | 0.51 |
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| 9.35 |
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| 77,000 |
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| $ | 77,470 |
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The weighted average remaining life and intrinsic value of the options as of September 30, 2015 was 9.35 years and $77,470, respectively.
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NOTE 10 – WARRANTS
On September 30, 2015 the Company issued 145,000 warrants to 6 shareholders along with 145,000 common shares for aggregate cash proceeds of $145,000. Each warrant is exercisable within two years of the issuance date into one share of the Company's common stock at $0.01 per share. As of September 30, 2015, none of these warrants have been exercised. These are the only warrants outstanding as of September 30, 2015.
The weighted average remaining life and intrinsic value of the warrants as of September 30, 2015 was 1.97 years and $42,050, respectively.
NOTE 11 – MATERIALS HELD FOR RESEARCH AND DEVELOPMENT WITH ALTERNATIVE FUTURE ALTERNATIVE USE
During the year ended March 31, 2015, the Company, through contract manufacturing incurred costs related to the production of 424 grams of Pritumumab, a human monoclonal antibody. The product is being produced for use in research and development. In addition to the use in the brain cancer clinical trials, the Company has also determined the Pritumumab can be used in its current state for pancreatic, breast and lung cancer trials, none of which have commenced. Due to the existence of these alternative future uses, the Company has capitalized the cost of these materials not expected to be used in the brain cancer trials. Of the 424 grams being produced, 110 grams is expected to be used in the brain cancer trials which have already been planned, but have not commenced. The cost of the 110 grams was expensed as research and development during the year ended March 31, 2015. The amount capitalized by the Company as of September 30, 2015 and March 31, 2015 is $827,964 associated with 313 grams. These capitalized costs will be expensed as research and development as the materials are consumed. As of September 30, 2015 and March 31, 2015, the production of the 424 grams was not yet complete. The Company will obtain ownership of the Pritumumab upon payment of all outstanding payables owed to the manufacturer. As of September 30, 2015, the Company had a payable balance of $1,197,936 owed to the manufacturer related to the production of the Pritumumab and other services provided. The Company made payment arrangements on the outstanding invoices with the manufacture but was unable to meet the terms of payment. The Company is in default on the payment of these outstanding invoices.
NOTE 12 – SUBSEQUENT EVENTS
On October 23, 2015 the Company issued 50,000 shares of common stock and 50,000 warrants convertible at $0.01 per share into 50,000 shares of common stock for $50,000 in cash.
On October 26, 2015 15,000 warrants were converted into 15,000 shares of common stock for $150 in cash.
On November 4, 2015 the Company issued 10,000 shares of common stock with a value of $2,750 for service.
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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 as a result 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., a Nevada corporation ("Nascent" or the "Company") was originally incorporated on May 13, 2009 as "Jin-En International Group Holding Company" to operate an online retail fur boutique for the Chinese market. 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. Articles of Exchange were filed with the Nevada Secretary of State describing this transaction. The shareholders of Biologics exchanged their shares in Biologics for shares in Jin-En on a one-to-one ratio, for a total issuance by Jin-En to the Biologics shareholders of an aggregate of 7,500,200 shares. As part of the transaction, the largest Jin-En shareholder returned 15,000,000 shares of Jin-En common shares for cancellation and those shares were returned to the treasury.
Overview
We are a development stage biopharmaceutical company that develops monoclonal antibodies for the treatment of various forms of cancer. We focus 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. We currently own the license rights to a drug candidate, pritumumab which we are developing initially for the treatment of brain cancer patients, as well as metastatic lung cancer patients, and metastatic breast cancer patients.
We are initially primarily focused on developing pritumumab for the treatment of patients with brain cancer malignancies such as glioma and astrocytoma. Pritumumab is a monoclonal antibody that has been tested in Ministry of Health and Welfare approved clinical studies in 249 human brain cancer patients in the nation of 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 period (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 conducted by the Japanese contract research organization, Japan Pharmaceutical Development, 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 abandoned. An issue 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. Currently, therapeutic strategies, such as the use of the chemotherapy drug Temodar, or surgical strategies, are used for the treatment of this cancer. However, there still exists a huge need in the marketplace to develop safer, more effective drugs as Temodar is attributed to only median rates of survival and many brain tumors are eligible for surgery. Moreover, even when removed, many 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. For glioblastoma, a particularly aggressive form of brain cancer that constitutes 42% of ALL brain and other nervous system cancers, the 1 and 5 year survival rates are 36.5% and 5.0%, respectively. Survival rates are taken from the latest SEER Registry Data, published on June 15th, 2015 (Central Brain Tumor Registry of the United States).
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Results of Operations
The Company recorded no revenue during the three and six months ended September 30, 2015 and 2014.
General and administrative expenses for the three and six months ended September 30, 2015 was $3,793,858 and $3,954,088 compared to $51,710 and 113,355 in 2014, respectively. This increase in expenses for the three and six months ended September 30, 2015 over the same period in 2014 was due mainly to the issuance of stock for stock based compensation of $3,676,369 for the six month period ended September 30, 2015.
Research and development expenses for the three and six months ended September 30, 2015 was $27,371 and $627,422 compared to $$271,330 and $441,330 in 2014, respectively. This decrease in expenses for the three months and increase for the six months ended September 30, 2015 over the same period in 2014 reflected the toxically tests and end of the production run for the product to be used in the clinical studies estimated to commence in the first calendar quarter of 2016.
Total other expense incurred in the three and six months ended September 30, 2015 was $20,970 and $57,182, compared to other expense of $5,217 and $5,481 in the same periods in 2014. The major change between 2015 and 2014 was the interest expense of $36,454 and $60,277 in 2015 compared to interest expense of $169 and $433 in the same periods in 2014. Change in fair value derivative liability showed a gain of $15,483 and $3,094 for the three and six months period in 2015 compared to a loss of fair value of $5,048 for both the three and six months periods in 2014.
For the three and six months ended September 30, 2015, our net loss was $2,268,549 and $3, 065,042 compared to a net loss of $328,257 and $560,166 for the same periods in 2014. The increase in 2015 over 2014 is a direct result of the stock based compensation as mentioned in the paragraph above about general and administrative costs.
Liquidity and Capital Resources
The Company's liquidity and capital is dependent on the capital it can raise to continue the Company's development and testing of its product. The Company projects it has significant cash to continue its present operations through December, 2015.
There are no agreements or understandings with regard to 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 and equity sales.
At September 30, 2015, the Company had negative working capital of $1,523,316. Current assets consist of cash of $42,410 and prepaid expenses of $1,566. Current liabilities as of the same date were $1,567,292 consisting of accounts payable of $1,540,056, license liability of $33,000, and derivative liability of $3,236
Net cash used in operating activities in the six months ended September 30, 2015 was $650,161 compared to net cash used of $470,775 in the same period in 2014. The variance between the same periods in 2015 and 2014 relates mainly to the increase in the net loss in 2015 over 2014 of $2,504,876 offset by stock based compensation increase of $3,676,369 and gain on settlement of license agreement liability of $1,573,650
Net cash provided by financing activities for the six months period ended September 30, 2015 was $585,000 compared to $422,500 in the same period in 2014. The total amount of the cash provided was from the sale of common stock of $645,000 offset by repayment of long term debt of $60,000 by the Company as part of its financing activities in 2015 compared to the sale of common stock of $422,500 in 2014.
As of September 30, 2015, the Company had total assets of $871,940 and total liabilities of $1,567,292. Stockholders' deficit as of September 30, 2015 was $704,352 compared to a deficit of $2,206,989 at March 31, 2015. Liabilities decreased in 2015 due mainly to the settlement of the license agreement and retirement of the long term debt.
During the six months ended September 30, 2015, the Company issued an aggregate of 645,000 common shares for cash proceeds of $645,000.
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NEED FOR ADDITIONAL FINANCING:
Our current capital needs through December 31, 2016 is $10 million. This will take us through Phase I/II clinicals.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements or guarantees of third party obligations at September 30, 2015.
Inflation
We believe that inflation has not had a significant impact on our operations since inception.
ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Not applicable.
ITEM 4: CONTROLS AND PROCEDURES
Under the supervision and the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation as of December 31, 2014 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, 2014. 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 are able to 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 six months ended September 30, 2015 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
ITEM 1: LEGAL PROCEEDINGS
None
ITEM 1A: RISK FACTORS
There have been no material changes to Nascent Biotech's risk factors as previously disclosed in our most recent Form 10-K filing.
ITEM 2: SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
During the six months ended September 30, 2015, the Company issued an aggregate of 645,000 common shares for cash proceeds of $645,000.
On October 23, 2015 the Company issued 50,000 shares of common stock and 50,000 warrants convertible at $0.01 per share into 50,000 shares of common stock for $50,000 in cash.
On October 26, 2015 15,000 warrants were converted into 15,000 shares of common stock for $150 in cash.
On November 4, 2015 the Company issued 10,000 shares of common stock with a value of $2,750 for service.
ITEM 3: DEFAULTS UPON SENIOR SECURITIES.
None
ITEM 4: MINE SAFETY INFORMATION
None
ITEM 5: OTHER INFORMATION
None.
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ITEM 6: EXHIBITS
Exhibit No. | Description | |
31 | Certification of Principal Executive Officer and CFO pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
32 | Certification of Principal Executive Officer and CFO Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
16 |
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 5, 2015 | By: | /s/ Sean Carrick |
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| Sean Carrick |
|
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| Principal Executive Officer |
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17