News & Events zu NanoViricides, Inc (NNVC)NNVCNanoViricides, Inc

Company Receives Approval for NV-387 Vaccine Clinical Trial

The company said, "In the fiscal year 2026, we have achieved a substantial level of accomplishments. We have focused on regulatory advancement of our broad spectrum antiviral drug NV- 387. We received approval for Phase II clinical trial to evaluate the safety and efficacy of NV-387 Oral Gummies for the treatment of Mpox in September, 2025, from the regulatory agency ACOREP in the Democratic Republic of Congo. Unfortunately, the MPox Clade I epidemic that led WHO to declare a Public Health Emergency of International Concern in August, 2024, had substantially abated in the Kinshasa region. We therefore chose a remote site where Mpox cases were still prevalent. We had to upgrade the facilities at this site including patient isolation facilities as well as laboratory facilities significantly to enable conducting the clinical trial there. This Phase II clinical trial began enrollment at the end of September, 2026. Meanwhile, in May 2026, WHO declared a PHEIC for the Ebola Bundibugyo virus disease outbreak that had just begun in the Ituri province. There is no approved treatment nor an approved vaccine for this virus. Moreover, this Bundibugyo virus differs significantly from previous Bundibugyo viruses that caused outbreaks, as well as from other Ebola viruses. Subsequent to the reporting period, in July, 2026, we applied for regulatory approval to conduct a Phase II clinical trial to evaluate he safety and efficacy of NV-387 Oral Gummies for the treatment of Ebola virus disease. In August, 2026, we received the approval for this Phase II clinical trial of NV-387 from ACOREP in DRC. This Phase II clinical trial also began enrollment at the end of September, 2026 at an Ebola Treatment Center in Ituri province. The current Ebola outbreak in DRC is rapidly growing. As of September 23, 2026, there have been 7,890 confirmed cases, 3,799 confirmed deaths, and 1,966 confirmed recoveries in DRC, according to the WHO daily report i. In comparison, as of August 14, 2026, there were reported 4,945 confirmed cases and 2,325 confirmed deaths due to this virus. The crude fatality rate is about 48%, but the probability of an infected person dying is estimated at 67%ii. In addition, we also began our efforts towards US FDA regulatory approvals for NV-387. We applied for an Orphan Drug Designation of NV-387 as a Treatment for Measles in February, 2026. Subsequently, we also applied for a Rare Pediatric Disease Drug designation for NV-387 as a pediatric Measles treatment. The US FDA approved the ODD and the RPDD designation for NV-387 as a treatment of Measles in May and June, 2026, respectively. In addition, we have continued process development work for the manufacture of NV-387. We have also worked on improved formulations of the NV-387 oral gummies. Thus, we have made significant achievements towards regulatory approvals for NV-387 in the reported year."

Company Reports Cash Assets of Approximately $2.79M

The company said, "We reported that, as of June 30, 2026, we had cash and cash equivalent current assets balance of approximately $2.79M. In addition, we reported approximately $6.4M in Net Property and Equipment assets. The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT, where we manufacture our clinical trial drug substance and drug products, thus producing substantial savings as compared to working with an external manufacturer. The total current liabilities were approximately $1.19M. In comparison, as of June 30, 2025, we had cash and cash equivalent balance of approximately $1.67M, P&E assets of approximately $6.83M, and total current liabilities of approximately $1.31M. The net cash utilized in the reported period for operating activities was approximately $7.7M, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, Clinical Trial Application for Phase II Clinical Trial of NV-387 as a Treatment for MPox in DRC, and R&D and preparatory work including cGMP manufacture of the drug substance for the Phase II clinical trial of NV-387 for treatment of MPox. We raised approximately $7.1M in sale of equity and warrants in registered direct offerings, and $1.91M from sale of common stock in ATM equity offering, for a total financing of approximately $9.01M during the reported period. Subsequent to the reporting period, in July, we raised approximately $3.8M in gross proceeds from a registered direct offering comprising common stock and warrants to a single investor. Further, our founder, Dr. Anil Diwan has provided a line of credit of $3M to the Company. We have not yet drawn on the LOC. As such, we reported that we do not have sufficient funding in hand as of now to continue operations through September 30, 2027, for our planned objectives. As a result substantial doubt exists about the Company's ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the "At-The-Market" agreement that became active around July 17, 2026. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so."