NNVC — what changed in the latest 10-K

Text added vs the prior filing · source: 10-K · 2026-09-28

• Our first clinical stage drug candidate, NV-387, has completed Phase Ia/Ib human clinical trial for the evaluation of safety and tolerability in healthy subjects. NV-387 is the active ingredient in the two drug product formulations labeled “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies” that we de…

• Two Phase II clinical trials, (i) NV-387 Oral Gummies for the Treatment of Mpox (Monkeypox) and (ii) NV-387 Oral Gummies for the Treatment of Ebola are about to start in the DRC; both under respective regulatory approvals from the local agency, Autorité Congolaise de Réglementation Pharmaceutique (“…

• Additionally, (iii) The Viral ARI clinical trial will provide information on the effectiveness of NV-387 treatment on a number of viral infections including Influenzas, RSV, Coronaviruses, hMPV, and others, in a single clinical trial.

• If successful, the Viral ARI and Viral SARI clinical trials could lead to NV-387 becoming the world’s first empiric antiviral treatment, i.e. a broad-spectrum antiviral that a physician could prescribe at first visit, akin to how bacterial infections are treated with broad-spectrum antibiotics, afte…

• If the Measles program is successful, the Company would be eligible for a Priority Review Voucher (PRV) from the US FDA. Recently, PRVs have been sold for about $200-220 million1. A PRV, if issued to us, and sold by us, could bring cash to the Company even prior to revenues from commercialization of…

Text removed vs the prior filing · source: 10-K · 2025-09-29

• NV-387, Phase II-Ready Broad-Spectrum Nanoviricide Drug Development Against Multiple Viruses

• Our first clinical stage drug candidate, NV-387, has completed Phase Ia/Ib human clinical trial for the evaluation of safety and tolerability in healthy subjects. NV-387 is the active ingredient in the two drug product formulations labeled “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies” that we de…

• NV-387 is a uniquely broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies of Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox, and most recently, even in a humanized mice model for Measles. These distinct t…

• NV-387 is designed to mimic the essential, invariant, feature of S-PG onto which the virus lands first as it infects a human cell. Thus, NV-387 is designed to interfere at the earliest possible step before the virus can even infect a cell. Over 90% of human pathogenic viruses are known to use sulfat…

• This extremely broad antiviral spectrum of NV-387 is reminiscent of the broad antibacterial spectrum of antibiotics such as penicillin and we believe NV-387 could revolutionize the treatment of viral infections the same way that penicillin revolutionized the treatment of bacterial infections.

Text added vs the prior filing · source: 10-K · 2026-09-28

• We have estimated a total cash expenditure budget of approximately $12.3 million for the fifteen month period of July 2026 through October 2027 of which approximately $8.2 million is expected to be spent on research and development, that includes the Phase II clinical trial of NV-387 for the treatme…

• Our Ebola drug candidate at present does not have any known competition, but at least two drugs are currently in a clinical trial.

• among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.

• sale of substantial amounts of our common stock in the public markets may adversely affect the market price of our common stock and our stock price may decline substantially.

• The Company is authorized to issue up to 150,000,000 shares of common stock without additional approval by shareholders. As of June 30, 2026, we had 23,008,308 shares of common stock outstanding, 8,480,768 warrants convertible to 8,480,768 shares of common stock, and 918,809 shares of Series A prefe…

Text removed vs the prior filing · source: 10-K · 2025-09-29

• We believe we have sufficient funds on hand to complete the remaining tasks of the Phase I clinical trial and obtain a completed clinical study report, and to develop and file a Phase II clinical trial application to evaluate use of NV-387 for the treatment of RSV infection.

• We have estimated a total cash expenditure budget of approximately $11 million for the period of July 2025 through October 2026 of which approximately $7.0 million is expected to be spent on research and development for our drug candidates, including completion and reporting of the Phase I clinical …

• The Company is authorized to issue up to 150,000,000 shares of common stock without additional approval by shareholders. As of June 30, 2025, we had 16,606,832 shares of common stock outstanding, 5,720 warrants convertible to 5,720 shares of common stock, and 905,717 shares of Series A preferred sto…

• providers by conducting vendor diligence upon onboarding and ongoing monitoring, including a review of SOC-1 reports on an annual basis, where applicable.

Text added vs the prior filing · source: 10-K · 2026-09-28

• Income Taxes - There is no provision for income taxes due to ongoing operating losses. As of June 30, 2026, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $43,421,000. This amount has been offset …

• Net Loss - For the year ended June 30, 2026, the Company had a net loss of approximately $8,219,000, or a basic and fully diluted loss per share of $0.41 compared to a net loss of approximately $9,467,000, or a basic and fully diluted loss per share of $0.63 for the year ended June 30, 2025. The dec…

• General R&D, Manufacturing including clinical trial batches, and Phase I clinical trial related

• On April 15, 2024, the Company entered into an ATM sales agreement with E.F. Hutton Securities (now D.Boral Capital), the Sales Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agent, shares of common stock having an aggregate offering price of up t…

• “SEC”), which registration statement was declared effective by the SEC on June 15, 2026. Under this shelf registration process, we may, from time to time, sell shares of common stock, shares of preferred stock, debt securities, warrants and units.

Text removed vs the prior filing · source: 10-K · 2025-09-29

• Interest Expense- The Company has incurred interest expense of approximately $149 and $50,000 for the years ended June 30, 2025 and June 30, 2024 respectively. The decrease in interest expense for the year ended June 30, 2025 is a result of the milestone payment interest expense charged pursuant to …

• Income Taxes - There is no provision for income taxes due to ongoing operating losses. As of June 30, 2025, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $42,492,000. This amount has been offset …

• Net Loss - For the year ended June 30, 2025, the Company had a net loss of approximately $9,467,000, or a basic and fully diluted loss per share of $0.63 compared to a net loss of approximately $8,294,000, or a basic and fully diluted loss per share of $0.70 for the year ended June 30, 2024. The inc…

• On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023. Under this shelf registration process, we may, from …

• On or about August 1, 2023, the ATM Sales Agreement that we previously had with EF Hutton, division of Benchmark Investments, LLC and B. Riley Securities, Inc., taken together as the Sales Agent, was amended to name EF Hutton as the only sales agent (the “Agent”) and to remove B. Riley as a sales ag…