NANOVIRICIDES, INC.

NanoViricides, Inc.

Business focus

NanoViricides is a clinical-stage biotechnology company developing antiviral drugs using a platform called nanoviricides. The platform produces host-mimetic, direct-acting polymeric micelles with surface ligands that bind enveloped viruses and employ a "bind-engulf-destroy" mechanism to inhibit reinfection and, in some modalities, disrupt intracellular replication.

Lead programs and pipeline

• NV-387 (broad-spectrum antiviral)
  • Active pharmaceutical ingredient (API) for two oral formulations: NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies.
  • Phase Ia/Ib human trial in healthy subjects completed; final Phase I report expected to be submitted.
  • Phase II trials in Mpox (Monkeypox) and Ebola are planned or underway in the Democratic Republic of Congo (DRC).
  • Additional potential indications include acute and severe respiratory infections (ARI/SARI), measles, RSV, influenza, orthopoxviruses (Mpox/Smallpox biodefense), and pediatric RSV.
  • Variants: NV-387-R (remdesivir encapsulated inside the nanoviricide for intracellular replication inhibition), NV-387-Rp and NV-387-Ribvp (ribavirin-encapsulated variants).
• NV-CoV-2 and NV-CoV-2-R
  • NV-CoV-2: NV-387 as the active antiviral in oral formulations.
  • NV-CoV-2-R: NV-387 with remdesivir encapsulated for combined external antiviral action and intracellular replication inhibition.
• NV-HHV-1 (HerpeCide)
  • HVEM-mimetic nanoviricide targeting herpesviruses; developed as a skin cream for shingles (VZV) with IND-enabling safety data. Systemic HSV-1/HSV-2 indications are under development.
• Other programs
  • Preclinical and exploratory programs include NV-HIV-1 (HIVCide), dengue, Ebola/Marburg, and other viral targets.

Manufacturing, facilities, and capabilities

• Owned, integrated facility in Shelton, Connecticut, totaling about 18,000 square feet of office, laboratory, and cGMP-capable manufacturing space.
• In-house API synthesis for NV-387 and production of drug products (oral syrup, oral gummies, skin creams) at multi-kilogram batch scale.
• In-house formulation, filling, labeling, finishing, and analytical laboratories.
• BSL-2 virology lab for in vitro testing and capability to study pseudovirions for BSL-2 work, with controlled arrangements for higher-containment considerations.
• cGMP-capable clean rooms supporting injectable, oral, and topical products.
• Facility capacity designed to support manufacturing sufficient for roughly 1,000 patients per batch; current NV-387 batch up to approximately 6 kg of API and scalable to about 10 kg per batch.

Intellectual property and licensing

• Licenses from TheraCour Pharma, Inc. (affiliated with founder Dr. Anil Diwan) that provide worldwide exclusive rights across a broad range of antiviral targets and virus families, including HIV, HBV, HCV, HSV-1/HSV-2, influenza, dengue, Ebola/Marburg, VZV, and coronaviruses.
• Licenses cover ligands, polymer backbones, formulations, chemistry, and manufacturing processes; TheraCour also performs development activities under the agreements.
• Royalty and milestone structure: NanoViricides pays TheraCour a 15% royalty on net sales and may incur milestone-based payments in certain licensed fields; the arrangement was amended in 2024 to defer cash milestones until sufficient revenue is achieved.
• Other arrangements:
  • KMPL (Karveer Meditech Private Limited, India): exclusive license in India to develop and sponsor NV-387 and NV-CoV-2 programs; NanoViricides receives 70% of sales net of costs to unaffiliated parties from KMPL’s commercialization in India.
  • Memorandum of Understanding with TheraCour (September 23, 2024) granting NanoViricides a right of first refusal on antiviral drug developments by TheraCour, with development and milestone handling aligned to the 2024 amendment.
• Patent portfolio: TheraCour-origin patents and provisional applications underpin the platform, including PCT families on self-assembling amphiphilic polymers and anti-COVID agents; the filing references more than 61 patents globally across related technologies.

Commercial strategy

• The company intends to pursue partnerships, co-development, or licensing with larger pharmaceutical companies, with potential upfront fees, milestones, and royalties as components of its model.
• KMPL in India is a commercial example of geography-specific licensing and revenue-sharing. Additional collaborations and non-dilutive funding opportunities, including government biodefense programs, are being pursued.

Financial snapshot (highlights as of June 30, 2026)

• Cash and liquidity
  • Cash and cash equivalents: approximately $2.8 million.
  • Line of credit: up to $3 million from founder Dr. Anil R. Diwan (undrawn as of 6/30/2026); maturity extended to March 31, 2027.
  • Recent financings: multiple equity financings including at-the-market offerings, registered direct offerings, and private placements between January and July 2026, with examples including net proceeds around $1.9M from a July 2025 ATM and $5.4M from a November 2025 registered direct and PIPE.
• Operating activity and accumulated results
  • Cash used in operating activities: about $7.7 million for the year ended June 30, 2026 (down from approximately $8.5 million in 2025).
  • Accumulated deficit: approximately $157 million.
• Other items
  • No royalties payable to TheraCour as of June 30, 2026.
  • Full-time employees: approximately 7 as of June 30, 2026; the company uses external contractors and CROs for regulatory filings, GLP/non-GLP studies, and clinical trial activities.
  • The company disclosed substantial doubt about its ability to continue as a going concern given operating losses, reliance on external financing, and the current liquidity position.

Corporate and governance

• Public listing: NYSE American (ticker: NNVC).
• Headquarters and facility: 1 Controls Drive, Shelton, Connecticut (owned).
• Website: http://www.Nanoviricides.com

Regulatory status and clinical development

• NV-387: pursuing Phase II Mpox and Ebola trials in the DRC under local regulatory approvals (ACOREP), with interim safety and efficacy datasets expected.
• Measles program: NV-387 is being prepared for a Measles Phase II protocol, with discussions of Orphan Drug and Rare Pediatric Disease designations and potential eligibility for a Priority Review Voucher if approved in the U.S.
• ARI/SARI and pediatric RSV/Influenza: described as potential basket-type Phase II programs to assess efficacy across multiple respiratory viruses within a single trial framework.

Market and competitive context

• NV-387 is positioned as a broad-spectrum antiviral with a mechanism intended to reduce the risk of viral resistance relative to many vaccines, antibodies, and small-molecule antivirals.
• The company highlights biodefense applications (Mpox, Smallpox via Animal Rule), government funding opportunities, and commercial markets for influenza, RSV, and other respiratory viruses.
• The competitive landscape includes existing antivirals and biologics; the company is pursuing partnerships and funding to advance development and commercialization.

Notes: All figures and statements reflect information from the company filing as of June 30, 2026.