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

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

Nascent is a phase 1 clinical stage biopharmaceutical company that develops monoclonal antibodies for the treatment of various forms of cancer. The Company focuses on biologic drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seek to further develop those drug candidates for commercial use. Nascent currently is developing for the treatment of brain cancer and pancreatic cancer both of which we hold orphan drug status granted by the FDA.

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





Overview

The Company is focused on developing pritumumab for the treatment of patients with brain cancer malignancies such as gliomas and astrocytomas. Current therapeutic strategies for brain cancer include the use of the chemotherapy, surgical intervention or radiation therapy. Because these treatments have marginal outcomes there exists a need to develop safer, more effective drugs. Temodar-the most commonly used Chemotherapeutic drug used to treat brain cancer, is attributed to only median rates of survival and many brain tumors are eligible for surgery. Moreover, even when removed, most brain tumors come back within one-year post-operation. Today, with current standards of care, less than 60% of all brain cancer patients will live past the first year after diagnosis, and less than 35% of patients will live to five years. Glioblastoma, a particularly aggressive form of brain cancer that constitutes 42% of ALL brain and other nervous system cancers, has survival rates of 36.5% at 1 year and 5% at 5 years. (SEER Registry Data, September 15th, 2016) (Central Brain Tumor Registry of the United States).

On March 31, 2017, the Company filed its IND submission with the United States Food and Drug Administration (FDA) for clearance to begin Phase I clinical trials. On December 7, 2018, the Company received a letter from the FDA allowing it to use a specific lot of drug substance to begin phase 1 clinical trial. The Company has commenced human clinical trials with a major oncology hospital for brain cancer, both primary and metastatic. As of December 17, 2021, the Company completed the second cohort of patients in the dose escalation trial for determining toxicity of the drug and opened cohort 3 enrollment for the phase 1 dose escalation trial.

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






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Results of Operations

The Company recorded revenue of $1,000,000 during the three and nine month periods ended December 31, 2021 and zero revenue for the three and nine months periods ended December 31, 2020. The revenue was from payments due at specific milestones per the license agreement.

Operating income (loss) for the three and nine month periods ended December 31, 2021 was net income of $630,975 and net loss of $42,072 compared to net losses of $554,937 and $1,667,290 for the same periods in 2020. Expenses decreased for the three and nine months ended December 31, 2021 over the same period in 2020 due primarily to an annual license fee and dosing fees of $150,000 and higher consulting costs for the same periods in 2020 over 2021. Consulting expense for the three and nine months periods ending December 31, 2021 was $108,000 and $388,813 compared to $409,111 and $1,129,846 for the same period in 2020. Research and development expense of $190,487 and $343,398 for the three and nine months periods ending December 31, 2021 were incurred compared to $53,903 and $277,338 in the same periods in 2020. Research and development, increases in the periods ended December 31, 2021 over 2020 were due to the phase 1 clinical trials beginning in 2021.

Total other income and expense incurred in the three and nine month periods ended December 31, 2021 was expense of $33,652 and $21,712, compared to other expense of $164,570 and other income of $325,518 in the same periodn 2020. Other expense in 2021 consisted of a gain on the change of fair value of $373,585 offset by interest expense of $97,491 discount interest of $201,665 and finance costs of $101,150 plus a gain on debt settlement of $5,000 from settling payments of accounts payable.

For the three and nine month periods ended December 31, 2021, the Company had net income was $597,323 for the three months and a net loss for the nine months of $63,783, compared to net losses of $719,507 and $1,341,772 for the same periods in 2020. The lower net loss for the nine months ended December 31, 2021 compared to the same period in 2020 was due to the license fee income of $1,000,000 in 2021.

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 II clinical studies.

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

At December 31, 2021, the Company had negative working capital of $447,990. Current assets consist of cash of $1,737 and accounts receivable of $750,000 with current liabilities $1,199,727 consisting of accounts payable of $788,834, convertible notes, net of discount of $165,435 plus derivative liability of $95,238 and due related parties of $150,220.






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Net cash provided (used) by operating activities in the nine months period ended December 31, 2021 was net cash used $120,803 compared to net cash provided of $838,546 in the same period in 2020. The variance between the same periods in 2021 and 2020 was due primarily to a loss of $1,341,772 for the nine months ended December 31,2020 compared to a net loss of $63,783 during the same period in 20201. Other significant impacts on the difference between 2021 and 2020 included stock based compensation of $623,803 during the nine months ended December 31, 2020 compared to $66,966 during the same period in 2021, gain on fair value of $566,220 in 2020 compared to a gain of fair value of $373,585 in 2021, a decrease in due related parties from $311,598 in 2020 to $50,335 in 2021 and an change of accounts payable and accrued expense to $135,055 in 2021 compared to a reduction of $60,650 in accounts payable and accrued expenses in 2020.

Net cash used in financing activities for the nine months period ended December 31, 2021 was $120,500 compared to net cash provided by financing activities of $890,000 in the same period in 2020. Cash used was a function of the repayment of three convertible notes totaling $320,500 in the nine months period ended December 31, 2021 offset by proceed from a convertible note of $200,000.

As of December 31, 2021, the Company had total assets of $751,737 and total liabilities of $1,199,727. Stockholders' deficit as of December 31, 2021 was $447,990. This compares to a stockholders' deficit of $472,505 as of March 31, 2021. Liabilities decrease in 2in the nine months periods ended December 31, 2021021 was due to the lower derivative liability offset by an increase in accounts payable and accrued expense.

NEED FOR ADDITIONAL FINANCING:

Our current capital needs are estimated to be approximately $10-15 million. This will take us through Phase II clinical trials which is scheduled to begin in mid-year 2022 subject to the completion of phase 1 and FDA approval to proceed to phase 2.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements or guarantees of third party obligations as of December 31, 2021.





Inflation

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

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