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

Nascent Biotech, Inc ("Nascent" or the "Company") was incorporated on March 3, 2014 under the laws of the State of Nevada. The Company is actively developing Pritumumab for the treatment of brain cancer and pancreatic cancer. Nascent is also actively researching other cancers that have a high probability of benefiting from the therapeutic effects of Pritumumab because they share a common target.

Nascent is a phase 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. Nascent completed Cohort 4 and open cohort 5 on September 16, 2022 of the phase 1 clinical trials. .One patient has been enrolled into Cohort 5 as of this filing. Once completed, the Company will submit to the FDA for approval to begin phase 2 clinical trials.

In addition, Nascent has begun, in collaboration with academic and corporate partners, to assess the potential for pritumumab to be involved as both a treatment and a vaccine for the SARS-CoV-2 virus.





Overview

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

On March 31, 2017, the Company filed its IND submission with the United States Food and Drug Administration (FDA) for clearance to begin Phase I clinical trials. On December 7, 2018, the Company received a letter from the FDA allowing it to use a specific lot of drug substance to begin phase 1 clinical trials. The Company has commenced human clinical trials with a major oncology hospital for brain cancer, both primary and metastatic. It is now in the final cohort of the phase 1 clinical trial and once completed will submit to the FDA to begin phase 2 Clinical trials.

In May of 2020, Nascent announced a research collaboration to study, both in vitro and in vivo (mouse models), the ability of pritumumab to block the SARS-Cov-2 virus from infecting cells. This notion has been raised by a published article in the scientific literature (Yu et al. Journal of Biomedical Science (2016) 23:14 DOI 10.1186/s12929-016-0234-7), which specifically mentioned cell surface vimentin (the protein to which pritumumab binds selectively) as a potential target in the treatment of conditions related to coronaviruses. These preliminary studies are on-going. Further, in May of 2020, Nascent announced a joint collaboration with Manhattan BioSolutions, Inc 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,






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Results of Operations

The Company recorded zero of revenue during the three and six month periods ended September 30, 2022 and 2021, respectively.

General and administrative expenses for the three and six month periods ended September 30, 2022 was $81,986 and $191,689 compared to $27,461 and $239,323

for the period ended September 30, 2021. Consulting expense for the three and six months periods ending September 30, 2022 were $213,915 and $637,065 compared to $$118,000 and $280,813 for the same period in 2021. This increase in expenses for the six months ended September 30, 2022 over the same period in 2021 was due primarily to increased consulting fee of $356,252, a result of the pricing of the shares issued to management for maintaining the percentage of ownership per their agreements.

Research and development expenses for the three and six month periods ended September 30, 2022 was $75,738 and $132,628 compared to $84,777 and $152,911 in the same period in 2021. Clinical trials costs were $149,592 and $179,528 for the three and six months ended September 30, 2022 with none in the same period in 2021. Clinical had started in 2021 but no cost was incurred during the six months period ended September 30, 2021.

Total other income/expense incurred in the three and six month periods ended September 30, 2022 was income of $375,517 and other expense of $304,680, compared to other income of $19,308 and $11,941 in the same periods in 2021. Other income/expense in three and six month periods in 2022 consisted of interest expense of $275,883 and $345,834, discount interest of 246,724 and $329,390 and finance costs of $5,124 and 5,124 offset by a gain on the change of fair value of $903,240 and $375,656. Other income/expenses in the three months and six months period ended September 30, 2021 consisted of income from the change in fair value of $151,300 and $315,882, interest expense of $$2,630 and $6,136, original note discount expense of $94,466 and $201,665 and financing costs of $35,000 and $101,150.

For the three and six month periods ended September 30, 2022, our net loss was $145,714 and $1,445,590 compared to a net loss of $211,030 and $661,106 for the same periods in 2021. The difference between the periods relates to higher consulting costs and clinical costs experienced in 2022 plus higher other expenses, during the six months period in 2022 verses 2021. For the three months period the higher other income in 2022 over 2021 respectively, impacted the net loss in 2022 over 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 $20-25 million to complete its Phase II clinical studies for both brain and pancreatic cancer.

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, 2022, the Company had negative working capital of $1,187,940. Current assets consist of cash of $1,181,912 and prepaid of $19,083 with current liabilities $2,388,935 consisting of accounts payable and accrued expenses of $764,839, convertible notes, net of discount of $293,140, plus derivative liability of $1,330,956.






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Net cash used in operating activities in the six months period ended September 30, 2022 was $777,502 compared to net cash provided of $221,452 in the same period in 2021. The variance between the same periods in 2022 over 2021 relates mainly to a higher loss in the period ended September 30, 2022 over the same period in 2021.

Net cash provided by financing activities for the six months period ended September 30, 2022 was $1,865,000 compared to net cash used in financing activities of $120,500 in the same period in 2021. Cash provided in the period ended September 30, 2022 was due to warrant conversion of $208,000, net proceeds from convertible notes of $1,932,000, offset by repayment of convertible note of $275,000 compared to proceeds from convertible note of $200,000 offset by repayment of convertible notes of $320,000 for the same period in 2021.

As of September 30, 2022, the Company had total assets of $1,200,995 and total liabilities of $2,388,935. Stockholders' deficit as of September 30, 2022 was $1,187,940. This compares to a stockholders' deficit of $671,476 as of March 31, 2022. Liabilities increased in 2022 mainly as a function of the issuance of convertible notes net of discount of $293,140 and derivative liability of $1,330,956 compared to zero for both in 2021.

NEED FOR ADDITIONAL FINANCING:

The Company is engaged in research and development activities that must be satisfied in cash secured through outside funding. The Company will offer noncash consideration and seek equity lines as a means of financing its operations. If the Company is unable to obtain revenue producing contracts or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may substantially curtail or terminate its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may dilute the interests of existing stockholders.

Our current capital will take us through Phase I clinical trials which is scheduled to be completed in late 2022 and the FDA approval process for Phase 2. It is estimated Phase 2 trials will require an additional $20-25 million for completion of the brain and pancreatic cancer trials.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements or guarantees of third party obligations at September 30, 2022





Inflation

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

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