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. As of December 31, 2022 the Company had completed the infusion of final patients in Cohort 5 ending the addition of any new patients in the phase 1 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 is in human clinical trials with a major oncology hospital for brain cancer, both primary and metastatic As of December 31, 2022, the Company had completed dosing of patients in the last cohort of the phase 1 clinical trials. The company is in the process of completing the required protocol and submitting the data to the FDA for approval to commence 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.






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Results of Operations

The Company recorded zero revenue during the three and nine month periods ended December 31, 2022 and $1,000,000 in license payments for the same periods in 2021.

Total operating expenses for the three and nine month periods ended December 31, 2022 was $475,026 and $1,615,936 compared to $369,025 and $1,042,072 for the same periods ended December 31, 2021. Consulting expense for the three and nine month periods ending December 31, 2022 were $246,590 and $883,655 compared to $108,000 and $388,813 for the same periods in 2021. This increase in expenses for the nine month ended December 31, 2022 over the same period in 2021 was due primarily to increased consulting fee of $494,842, 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 nine month periods ended December 31, 2022 was $55,875 and $188,503 compared to $41,000 and $139,531 in the same periods in 2021. Clinical trials costs were $39,627 and $219,155 for the three and nine month periods ended December 31, 2022 compared to $149,487 and $200,192 for same periods in 2021.

Total other expense incurred in the three and nine month periods ended December 31, 2022 was $362,294 and $666,974, compared to other expenses of $33,652 and $21,711 for the same periods in 2021. Other expense in three and nine month periods in 2022 consisted of interest expense of $648,900 and $994,738, original discount interest of zero and $329,390 and finance costs of zero and 5,124 offset by a gain on the change of fair value of $258,462 and $634,118. Other income/expenses in the three months and nine month periods ended December 31, 2021 consisted of income from the change in fair value of $57,703 and $375,585, interest expense of $5,041 and $11,177, original note discount expense of $86,314 and $287,979 and financing costs of zero and $101,150.

For the three and nine month periods ended December 31, 2022, our net loss was $837,320 and $2,282,910 compared to a net income of $597,323 and net loss of $63,783 for the same periods in 2021. The difference between the periods relates to higher consulting costs experienced in 2022 plus higher other expenses, during the nine months period in 2022 verses 2021 plus the license revenue earned in the nine month period ended December 31, 2021 with no income in the same period in 2022.

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 additional funds 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 December 31, 2022, the Company had negative working capital of $1,364,074. Current assets consist of cash of $558,764 and prepaid of $7,083 with current liabilities $1,929,918 consisting of accounts payable and accrued expenses of $387,253, convertible notes, net of discount of $470,171, plus derivative liability of $1,072,494. The decrease in accounts payable and accrued expense was due primarily to the payment of an outstanding payment payable with a manufacturer of $325,000.

Net cash used in operating activities in the nine month period ended December 31, 2022 was $1,400,650 compared to net cash provided of $120,803 in the same period in 2021. The variance between the same periods in 2022 over 2021 relates mainly to a significant loss in 2022 of $2,282,910 compared to $ 63,783 resulting from higher expense in 2022 against revenue of $1,000,000 in 2021 with none in 2022.






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Net cash provided by financing activities for the nine month period ended December 31, 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 December 31, 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 $320,500 for the same period in 2021.

As of December 31, 2022, the Company had total assets of $565,844 and total liabilities of $1,929,918. Stockholders' deficit as of December 31, 2022 was $1,364,074. 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 $470,171 and derivative liability of $1.027,494 compared to zero for both as of March 31, 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 was completed as of December 31, 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 December 31, 2022.





Inflation

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

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