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 is in Cohort 4 of the
phase 1 clinical trials. Once completed, the Company may 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 (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 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 stages of the
phase 1 clinical trial and once completed with 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 (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 zero of revenue during the three month periods ended June
30, 2022 and 2021, respectively.
General and administrative expenses for the three month periods ended June 30,
2021 was $224,790 compared to $109,703 for the period ended June 30, 2022.
Consulting expense for the three months periods ending June 30, 2021 was
$162,813 compared to $423,150 for the same period in 2022. This increase in
expenses for the three months ended June 30, 2022 over the same period in 2021
was due primarily to increased consulting fee of $260,337 from the pricing of
the shares issued to management for maintaining the percentage of ownership per
their agreements.
Research and development expenses for the three month periods ended June 30,
2021 was $55,206 compared to $56,890 in the same period in 2022. Clinical trials
costs were $29,936 for the three months ended June 30, 2022 with none in the
same period in 2021. Clinical had just started in the three months ended June
30, 2021, so no cost was incurred until after the period ended.
Total other expense incurred in the three month periods ended June 30, 2021 was
$7,267, compared to other expense of $680,197 in the same period in 2022. Other
expense in 2021 consisted of interest expense of $3,506 discount interest of
$107,199 and finance costs of $66,150 from pay off convertible notes offset by a
gain on the change of fair value of $164,582. Other expenses in the three months
period ended June 30, 2022 consisted of change in fair value of $527,584,
interest expense of $69,950 and original note discount of $82,666.
For the three month periods ended June 30, 2021, our net loss was $450,076
compared to a net loss of $1,161,931 for the same periods in 2022. The
difference between the periods relates to higher consulting costs plus higher
other expenses, due primarily to a net change in fair value in the three months
period ended June 30, 2022 of $596,171 from the same period 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 $15-20 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 June 30, 2022, the Company had negative working capital of $1,436,792.
Current assets consist of cash of $145,575 and prepaid of $37,750 with current
liabilities $1,620,117 consisting of accounts payable of $702,816, convertible
notes, net of discount of $64,887, plus derivative liability of $835,914 and due
related parties of $16,500.
Net cash provided by operating activities in the three months period ended June
30, 2021 was $487,905 compared to net cash used of $343,839 in the same period
in 2022. The variance between the same periods in 2021 and 2022 relates mainly
to a higher loss, most of it other expenses, in the period ended June 30, 2022
over the same period in 2021.
Net cash used in financing activities for the three months period ended June 30,
2021 was $220,500 compared to net cash provided by financing activities of
$395,000 in the same period in 2022. Cash provided in the period ended June 30,
2022 was due to the conversion of warrants for a net of $148,000 and net
proceeds from a convertible note of $247,000.
As of June 30, 2022, the Company had total assets of $183,575 and total
liabilities of $1,620,117. Stockholders' deficit as of June 30, 2022 was
$1,436,792. 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 a
note for $64,887, net of discount and derivative liability of $835,914.
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 needs are estimated to be approximately $15-20 million. This
will take us through Phase II clinical trials which is scheduled to begin in
late 2022 subject to the completion of phase 1 and FDA approval to proceed to
phase 2.
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Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements or guarantees of third party
obligations at June 30, 2022
Inflation
We believe that inflation has not had a significant impact on our operations
since inception.
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