S-1: Nascent Biotech Files for Potential $4.175 Million Offering to Fund Cancer Drug Trials

Nascent Biotech is seeking to raise capital through a share offering to fund Phase 2 clinical trials for its cancer drug, Pritumumab, and cover general administrative expenses.

Summary

• Nascent Biotech Inc., a clinical-stage biopharmaceutical company, has filed a registration statement for a proposed offering.
• The offering includes the potential sale of up to 32,250,000 shares of common stock.
• This comprises 20,000,000 shares offered by the company at a fixed price of $0.15 per share, 1,250,000 shares issuable upon conversion of convertible debentures, and 1,000,000 shares issuable upon exercise of warrants at $0.05 per share.
• Additionally, 10,000,000 shares held by a single shareholder are being registered for potential sale.
• The company intends to use the proceeds from the sale of its shares to fund Phase 2 clinical trials of its drug Pritumumab and for general and administrative expenses.
• The offering is self-underwritten on a best efforts basis, with no minimum number of shares required to be sold.
• Nascent Biotech's common stock is currently quoted on the OTCQB under the symbol NBIO, with the last reported sale price on March 11, 2024, at $0.15.
• The company has a history of operating losses and its auditors have expressed substantial doubt about its ability to continue as a going concern.

Sentiment

Score: 4

Explanation: The document presents a mixed sentiment. While there are positive aspects such as the completion of Phase 1 trials and clearance to begin Phase 2, the company's history of operating losses, going concern doubts, and the high degree of risk associated with the investment contribute to a more cautious outlook.

Positives

• The company has completed Phase 1 clinical trials and is cleared to begin Phase 2 clinical trials for Pritumumab.
• Pritumumab has shown positive therapeutic effect at low doses in previous clinical studies in Japan.
• The company has regained worldwide rights for development and distribution of Pritumumab.
• The US Patent Office issued Patent Number 11028155 to the Company titled Enhanced Delivery of Drug to the Brain on June 8, 2021.
• The US Patent Office issued Patent Number 11492394 to the Company titled Kits and Containers for Treating Vimentin Expressing Tumors on November 8, 2022.

Negatives

• The company has a history of operating losses and no product revenues.
• The company's auditors have expressed substantial doubt about its ability to continue as a going concern.
• The offering price bears no relationship to the company's assets, book value, earnings, or any other customary investment criteria.
• The company is making this offering without the involvement of underwriters or broker-dealers.

Risks

• Investing in the company's common stock involves a high degree of risk.
• The company currently has no product revenues and no products approved for marketing.
• The company will need to raise additional capital to operate its business.
• The outcome of the lengthy and complex process of identifying new compounds and developing new products is inherently uncertain and involves a high degree of risk and cost.
• The company's stock price may be volatile.
• The company may in the future issue additional shares of its common stock which would reduce investors' ownership interests in the company, and which may dilute the share value.
• FINRA sales practice requirements may limit a stockholder's ability to buy and sell the company's stock.
• The company's common stock is currently deemed to be penny stock, which makes it more difficult for investors to sell their shares.

Future Outlook

The company expects to incur substantial losses and negative operating cash flow for the foreseeable future as it commences clinical trials of its drug candidates, which it does not expect will be commercially available for several years, if at all.

Industry Context

The development and commercialization of new products to treat cancer is highly competitive, and the company expects considerable competition from major pharmaceutical, biotechnology and specialty cancer companies.

Comparison to Industry Standards

• The company's potential competitors include, but are not limited to, Genentech, Merk, Roche, Takeda, Array Biopharma and Ambit Biosciences.
• Many of the company's competitors have substantially more resources than the company, including both financially and technically.
• In addition, many of the company's competitors have more experience than the company in clinical development, manufacturing, regulatory and global commercialization.

Related Party Transactions

• On September 1, 2020, the Company entered five-year compensation agreements with two of its officers and directors.
• During the year ended March 31, 2022, two officers and a director converted $128,333 of accrued payables into 2,407,010 shares of common stock.
• During the year ended March 31, 2022, the Company issued 1,513,719 shares of common stock with a value of $110,835 to three related parties for service.
• During the year ended March 31, 2023, the Company issued 3,815,414 shares of common stock with a value of $624,320 to three related parties for services.

Stakeholder Impact

• The offering may dilute the ownership of existing stockholders.
• The company's ability to continue as a going concern is dependent on its ability to complete equity or debt financing activities or to generate profitable operations.
• The company's success is dependent on the successful development and commercialization of its drug candidates.

Next Steps

• The company plans to commence Phase II clinical trials in the United States with Pritumumab in the third calendar quarter of 2023.
• The company will continue to evaluate the application of Pritumumab in the treatment of other unmet ectodomain vimentin positive cancer types such as pancreatic.

Key Dates

Keywords

Pritumumab, clinical trials, biotech, cancer, offering, shares, common stock, Nascent Biotech, FDA