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NanoViricides, Inc. Has Filed its Annual Report: Broad-spectrum Antiviral NV-387 Is In Phase II Clinical Trials

NNVC
  • NanoViricides, Inc. filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026, with the SEC on September 28, 2026.
  • The company received regulatory approval in September 2025 from ACOREP in the Democratic Republic of Congo (DRC) for a Phase II clinical trial of NV-387 Oral Gummies for Mpox, which began enrollment in September 2026 after facility upgrades.
  • Following a WHO Public Health Emergency of International Concern declaration for the Ebola Bundibugyo virus in May 2026, NanoViricides obtained ACOREP approval in August 2026 for a Phase II trial of NV-387 for Ebola, which also started enrollment in September 2026.
  • The DRC Ebola outbreak reached 7,890 confirmed cases with 3,799 deaths by September 23, 2026, resulting in a crude fatality rate of approximately 48% and an estimated infection fatality rate of 67%.
  • The US FDA granted Orphan Drug Designation (ODD) in May 2026 and Rare Pediatric Disease Drug (RPDD) designation in June 2026 for NV-387 as a treatment for Measles.
  • NV-387 Oral Gummies are positioned as a potential medical countermeasure for Mpox, Ebola, Marburg, Measles, Smallpox, RSV, Influenza, and other respiratory viral infections.
  • Financial data for the period ending June 30, 2026, shows cash and cash equivalents of $2.79 million, net property and equipment of $6.40 million, and total current liabilities of $1.19 million.
  • The company utilized $7.70 million in net cash for operating activities and raised $9.01 million through equity offerings during the fiscal year.
  • Subsequent to the reporting period, the company raised an additional $3.8 million via a registered direct offering in July 2026.
  • Founder Dr. Anil Diwan provided a $3 million line of credit, but the company reported substantial doubt regarding its ability to continue as a going concern through September 30, 2027, due to insufficient funding.
  • Upcoming milestones include commissioning enrollment for Phase II trials for Mpox and Ebola, pursuing orphan drug designations for these indications, and filing IND applications for Smallpox treatment under the Animal Rule.
  • Preclinical animal studies demonstrated that oral NV-387 was superior to existing treatments for Influenza, RSV, COVID-19, Orthopoxviruses, and Measles.
  • The company's technology utilizes nanoviricides that mimic host binding sites to prevent viral escape, distinguishing it from vaccines and traditional small molecule drugs.