NanoViricides, Inc. (NNVC): Business Model Canvas [Dec-2025 Updated]

You're looking past the hype to see how NanoViricides, Inc. (NNVC) actually plans to make money from its unique antiviral science, and frankly, the business model is a classic clinical-stage biotech blueprint. It all boils down to validating the proprietary Nanoviricide® Technology-especially with lead candidate NV-387 in Phase II-while managing a significant cash burn, evidenced by that recent $6 million equity raise in November 2025. We'll map out how they intend to transition from heavy Research and Development (R&D) spending, which was $3.09 million for the six months ending December 31, 2024, to securing those crucial out-licensing deals with major pharmaceutical partners. Dive in below to see the full structure.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Key Partnerships

You're looking at the core relationships that fuel NanoViricides, Inc.'s pipeline progression as of late 2025. These aren't just names on a slide; they represent critical dependencies for moving NV-387 and other candidates forward. Honestly, the financial health of the company right now is tied directly to how well these external relationships execute.

TheraCour Pharma Inc.

This is the foundation. NanoViricides, Inc. built its entire platform on the technology and know-how from TheraCour Pharma Inc., a relationship established back in 2005. You need to know the terms of this arrangement because it dictates future revenue sharing.

License Scope	Worldwide exclusive, sub-licensable, field licenses to technology for several drugs in perpetuity
Key Licensed Fields (Perpetual)	HIV/AIDS, HBV, HCV, Rabies, HSV-1 and HSV-2, VZV, Influenza, Dengue, JEV, West Nile Virus, Ebola/Marburg, and certain Coronaviruses
Intended Future Licenses	RSV, Poxviruses, and/or Enteroviruses, contingent on successful initial research
Royalty Obligation	15% of net sales upon commercialization

The license is to entire fields, not specific compounds, which is a key structural detail. If onboarding takes 14+ days, churn risk rises.

Karveer Meditech Pvt. Ltd. (KMPL)

Karveer Meditech Pvt. Ltd. acts as the clinical development sponsor in India, specifically for the COVID drug candidates NV-CoV-2 and NV-CoV-2-R. This collaboration is structured around a specific territory and cost-sharing model.

• Exclusive license granted to Karveer Meditech Pvt. Ltd. for development and commercialization of NV-CoV-2 and NV-CoV-2-R in the Territory of India.
• Karveer agreed to sponsor the Phase I and Phase II clinical trials for these candidates in India.
• The Phase I trial for NV-387, using the same oral formulations, concluded in April 2024.

Here's the quick math on the financial split for those specific Indian commercial sales:

Reimbursement to KMPL	All direct and indirect costs plus a 30% fee on those costs
Royalty to NanoViricides, Inc.	70% of any invoiced commercial sales to unaffiliated third parties
Minimum Royalties/Fees	None specified

Clinical Research Organizations (CROs)

To execute the critical Phase II trial for NV-387 targeting MPox Clade I in the Democratic Republic of Congo (DRC), NanoViricides, Inc. engaged a CRO. This is a major near-term operational dependency.

• Ethics Committee (CNES) approval in the DRC was secured in May 2025.
• Regulatory Agency ACOREP approval to start the Phase II trial was received on November 10, 2025.
• The trial is planned to evaluate 60 patients in the Phase 2b portion.
• The CRO subsequently engaged the Medical Hospital at the University of Kinshasa as the study site.

Aagami, Inc.

Aagami, Inc. is retained as a consulting firm to actively seek out pharma collaborations for NanoViricides, Inc. No specific financial terms or engagement metrics are publicly available as of late 2025.

Institutional Investors

The recent capital raise provided a necessary cash infusion to support ongoing development efforts. This was a single-investor transaction.

Gross Proceeds Raised	Approximately $6 million
Closing Date	On or about November 12, 2025
Purchase Price Per Share/Equivalent	$1.68 per share
Shares Sold (Common Stock or Equivalents)	3,571,429 shares
Warrant Exercise Prices	Series A: $1.75; Series B: $2.00
Cash Balance Impact (Net)	Added approximately $6.1 million as of November 12, 2025
Additional Funding Access	Available line of credit of $3 million from Dr. Anil Diwan

The gross proceeds are designated for working capital and general corporate purposes. Finance: draft 13-week cash view by Friday.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Key Activities

You're focused on the core engine driving NanoViricides, Inc. right now, which is clearly centered on pushing NV-387 through critical clinical milestones while maintaining the infrastructure to support it. Here's the breakdown of the Key Activities as of late 2025.

Advancing NV-387 into Phase II trials for MPox and Viral ARI/SARI

The immediate priority is getting the MPox Phase II trial running in the Democratic Republic of Congo (DRC). NanoViricides, Inc. received approval to start the Phase II Clinical Trial of NV-387 for MPox from the regulatory agency ACOREP in the DRC as of November 10, 2025. You're looking at a CTA filing anticipated in the fourth quarter of 2025 to initiate the trial near the end of 2025 or early 2026. This is a dual-stage, adaptive protocol designed to enroll approximately 80 patients in total.

The initial Phase IIa portion is quite lean, comparing standard of care (SOC) against NV-387 plus SOC in just 10 patients per arm, with dosing over six days. Success here guides Phase IIb, which expands to up to 60 more patients in a 2:1 treatment-to-control ratio. Remember, NV-387 showed preclinical survival improvement of approximately 75% over SOC in animal models, and the combination therapy showed a 112% improvement. Also, NanoViricides, Inc. is planning a separate Phase II trial for Viral Acute and Severe Acute Respiratory Infections (V-ARI and V-SARI) using mostly the same CTA.

R&D on pipeline candidates: NV-HHV-1 (pan-herpesvirus) and NV-HIV-1

While NV-387 is the lead, the platform is clearly yielding other advanced candidates. NV-HHV-1, the pan-herpesvirus drug, awaits its turn behind NV-387 in the clinical pipeline. It has shown activity against HSV-1, HSV-2, and VZV, with expected activity against CMV, HHV-6, and HHV-8. The topical skin cream formulation for Shingles has completed certain IND-enabling non-clinical studies. The market potential for the broader HerpeCide program is estimated to be in excess of $10Bn.

For NV-HIV-1, the anti-HIV drug candidate, the data shows strong efficacy in the SCID-hu-Thy-Liv animal model of HIV infection. Honestly, it demonstrated effectiveness superior to the triple-drug combination HAART therapy in that model.

Here are the key pipeline candidates and their status:

• NV-387: Phase II planning for MPox and V-ARI/SARI
• NV-HHV-1 (Topical): Completed IND-enabling non-clinical studies
• NV-HHV-1 (Systemic): In development, behind NV-387
• NV-HIV-1: Strong efficacy in SCID-hu-Thy-Liv animal model

cGMP-compatible manufacturing of drug substances at Shelton, CT facility

NanoViricides, Inc. has a major asset in its fully owned, mortgage-free, multi-kilogram-scale cGMP-capable manufacturing facility in Shelton, CT. This facility is key because it enables the production of clinical drug substance batches, like the one already manufactured for the NV-387 Phase II trial. The physical asset value is significant, as Net Property and Equipment (P&E) was reported at $6.78 Million as of September 30, 2025, out of total assets of $8.36 Million.

This pilot plant is designed for flexibility and scale, which is a real advantage for time and cost savings in development. It's equipped with specific cleanroom environments:

Cleanroom Suite	Classification
Suites for injectables and other operations	Class 100 (ISO 5)
Suites for injectables and other operations	Class 1,000 (ISO 6)
Suites for injectables and other operations	Class 10,000 (ISO 7)

The company believes this capacity is sufficient for initial marketing upon drug approval, potentially enabling early revenues of about $100MM to $500MM per year. The building itself is an 18,000ft² structure.

Securing non-dilutive funding via government grants and contracts (e.g., BARDA)

You know that cash is tight, with net cash utilized of approximately $1.59 Million in the quarter ending September 30, 2025, and the company reporting it doesn't have sufficient funding through February 14, 2026. Therefore, the pursuit of non-dilutive funding is a critical activity. NanoViricides, Inc. explicitly plans on seeking non-dilutive grants and contracts for NV-387 development targeting Smallpox under the US FDA Animal Rule. Success in the MPox Phase II trial is seen as a major catalyst, potentially leading to development funding from BARDA. Furthermore, the company believes successful regulatory developments could lead to possible direct US Government acquisition contracts worth hundreds of millions of dollars per year if NV-387 is approved for a stockpiled agent.

Investor outreach and presenting at partnering summits (e.g., November 2025)

Keeping the capital runway open requires active engagement. Dr. Diwan presented at the Spartan Capital Investor Conference 2025 on November 3rd, 2025, in New York City. The company also held its Annual Shareholders Meeting on Saturday, November 8th, 2025, in Stamford, CT. This outreach is reflected in the financials; General & Administrative (G&A) expenditure rose 31% to $4.0 Million in FY25, driven by increased investor outreach activity.

Financially, the company raised approximately $1.25 Million net in an At-the-Market (ATM) offering during the three months ending September 30, 2025. As of September 27, 2025, there were approximately 17,431,000 shares of common stock issued and outstanding. Still, the burn rate is real, with operating costs for FY25 hitting $9.6 Million. You also have that $3 million line of credit from management as a backstop. Finance: draft 13-week cash view by Friday.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Key Resources

You're looking at the core assets that power NanoViricides, Inc.'s entire operation right now. These aren't abstract concepts; they are tangible IP, physical plants, and the cash needed to keep the lights on and the trials moving. Honestly, for a clinical-stage biotech, the IP and the facility are what separate them from a pure research outfit.

Proprietary Nanoviricide® Technology and Patent Portfolio

The foundation of NanoViricides, Inc. is the Nanoviricide® Technology, which is based on intellectual property, technology, and proprietary know-how licensed from TheraCour Pharma, Inc. This platform is designed to create first-in-class broad-spectrum antiviral drugs by mimicking conserved attachment receptors on host cells, which over 90% of viruses are known to use. The company claims this approach allows their agents to bind and dismantle virus particles, potentially binding to as many as 90-95% of known viruses.

The scope of the Patent Portfolio is defined by the worldwide exclusive perpetual licenses NanoViricides, Inc. holds from TheraCour Pharma, Inc. for specific targeting mechanisms in perpetuity for several human viral diseases. You need to know exactly what is covered:

• Human Immunodeficiency Virus (HIV/AIDS)
• Hepatitis B Virus (HBV)
• Hepatitis C Virus (HCV)
• Rabies
• Herpes Simplex Virus (HSV-1 and HSV-2)
• Varicella-Zoster Virus (VZV)
• Influenza and Asian Bird Flu Virus
• Dengue viruses
• Japanese Encephalitis virus
• West Nile Virus
• Ebola/Marburg viruses
• Certain Coronaviruses

The company also intends to obtain licenses for RSV, Poxviruses, and/or Enteroviruses based on successful initial research.

Lead Drug Candidate NV-387

NV-387 is the lead drug candidate, a broad-spectrum antiviral that NanoViricides, Inc. plans to develop for multiple indications. It has successfully completed a Phase I human clinical trial in India, covering both single ascending dose (Phase 1a) and multiple ascending dose (Phase 1b) parts in healthy subjects.

As of late 2025, the focus is squarely on advancing NV-387 into Phase II human clinical trials. Specifically, in May 2025, NanoViricides, Inc. received ethics approval in the Democratic Republic of Congo (DRC) to proceed with a Phase II clinical trial of NV-387 for Mpox clade I. The company is also planning another Phase II trial for Viral ARI and SARI (acute and severe-acute viral respiratory infections).

Physical Assets: cGMP Manufacturing Campus

A major, defintely tangible asset is the fully owned cGMP-capable manufacturing campus in Shelton, CT, located at 1 Controls Drive. This facility is a significant differentiator because it is fully owned by the Company with no mortgage or debt. The initial investment for the construction was $20 million.

The physical footprint includes approximately 18,000 square feet dedicated to office, laboratory, and cGMP-capable drug manufacturing space. This pilot plant is a flexible, multi-product asset capable of supplying drug product for all of NanoViricides, Inc.'s programs through human clinical trials. Management believes this capability enables substantial time and cost savings and is capable of production for initial marketing, estimating potential early revenues upon drug approval of about $100MM to $500MM per year.

Here's a quick look at the facility's scale and ownership:

Asset Detail	Metric/Value
Ownership Status	Fully Owned, No Mortgage or Debt
Size	Approximately 18,000 square feet
Capability	cGMP-capable manufacturing for drug substance and drug product
Estimated Initial Investment	$20 million
Potential Initial Annual Revenue Capacity	$100MM to $500MM

Cash and Equivalents

Liquidity is always a key resource to track. As of the requested baseline date, NanoViricides, Inc. reported $3,958,052 (or $3.96 million) in cash and cash equivalents on December 31, 2024.

However, you need the latest picture for late 2025. The Quarterly Report for the fiscal quarter ending September 30, 2025, shows a cash balance of roughly $2.54 million at quarter-end, following a net cash utilization from operations of about -$1.99 million for that quarter. During that same Q3 2025 quarter, the company raised approximately $1.25 Million net of commission in an At-the-Market offering. To be fair, the company reported in November 2025 that based on budgeting, they did not have sufficient funding in hand to continue operations through February 14, 2026, for their planned objectives.

The cash position trend, in millions USD, is illustrative:

• Cash & Equivalents as of June 30, 2024: $4.8 million
• Cash & Equivalents as of September 30, 2025: Approximately $2.54 million
• Cash & Equivalents as of September 30, 2025 (Balance Sheet report): $1.56 million (FY 2025 period ending Sep 30, 2025)

Finance: draft 13-week cash view by Friday.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Value Propositions

The core value proposition for NanoViricides, Inc. (NNVC) centers on its lead candidate, NV-387, which is engineered to overcome the fundamental limitations of existing antiviral treatments.

Broad-Spectrum Efficacy: NV-387 targets multiple viruses (RSV, Flu, MPox, Coronaviruses).

NV-387 has demonstrated high effectiveness across several major viral threats in relevant animal models. This capability positions it as a platform solution rather than a single-indication drug.

Virus Target Category	Specific Viruses Mentioned	Preclinical Model Efficacy
Respiratory Viruses (Tripledemic)	RSV, Influenza A, Coronaviruses	Highly effective in respective lethal animal models of lung infection.
Orthopoxviruses	MPox (Monkeypox), Smallpox (Ectromelia virus)	Excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses.
Other Significant Threats	Measles virus	Excellent effectiveness in a humanized (hCD150+ knock-in) mouse model.

Viral Escape Prevention: Novel mechanism traps and dismantles virus particles.

The mechanism of action is designed to prevent viral evolution away from the drug. Viruses are unlikely to escape NV-387 because the drug mimics host structures that viruses require for infection.

• NV-387 emulates binding to sulfated proteoglycans, a characteristic viruses cannot easily evolve past.
• The platform targets heparan sulfate proteoglycans (HSPG), a common receptor site used by over 90% of human pathogenic viruses.
• The drug is designed to attack the virus particle and destroy it by fooling the virus to enter the NV-387 nanomicelle, thereby reducing viral load.

Empirical Treatment Potential: NV-387 for Viral ARI/SARI without specific virus identification.

If successful in human trials, NV-387 could fundamentally change how acute respiratory infections are managed. This mirrors the broad-spectrum utility seen with antibiotics.

A planned Phase II clinical trial is for the evaluation of NV-387 as a first line therapy for Viral Acute or Severe Acute Respiratory Infections (Viral ARI/SARI). Success would allow prescription based on symptoms alone, without waiting for specific virus identification testing. The potential market size for this empiric therapy is estimated to be well over $20 Billion. For context, the RSV market alone is valued at about US$3 billion.

Superior Preclinical Data: Outperformed Tamiflu/Xofluza in lethal animal models.

Preclinical results show a clear advantage over existing standard-of-care antivirals in head-to-head lethal challenge studies.

• Against RSV animal studies, NV-387 resulted in complete cure.
• In Influenza A/H3N2 lethal lung infection animal models, NV-387 was found to be substantially superior to both Tamiflu and Xofluza.
• In one preclinical experiment, NV-387 increased survival by 88% compared to the control (vehicle).

Oral Delivery Formulation: Successful Phase I with oral syrup and gummy forms.

The drug has successfully passed initial human safety testing in two distinct oral formats, showing excellent tolerability.

The Phase I clinical trial for the drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, was completed successfully in healthy subjects. This trial included both single ascending dose (Phase 1a) and multiple ascending dose (Phase 1b) arms. There were no reported adverse events at any of the dosage levels given. The company had $2,542,590 in cash at the end of Q3 2025. The market capitalization as of late 2025 was $21.96 million.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Customer Relationships

You're managing a clinical-stage biotech where customer relationships are less about direct sales and more about strategic partnerships, regulatory navigation, and investor confidence to fund the long road to revenue. Here's how NanoViricides, Inc. (NNVC) structures its external engagements as of late 2025.

Direct Business Development: High-touch engagement with potential pharma licensees

NanoViricides, Inc. operates on a foundation of licensing its platform technology, which was established in 2005. This high-touch approach involves securing agreements for specific virus application verticals. The core relationship here is with TheraCour Pharma, Inc., from which NanoViricides, Inc. holds broad, exclusive, sub-licensable, field licenses. Upon any successful commercialization, NanoViricides, Inc. is obligated to pay 15% of net sales to TheraCour. This royalty structure is a key term.

The company actively seeks out licensing and collaboration opportunities, presenting its pipeline at industry events. For instance, President and Executive Chairman Anil R. Diwan, PhD, presented at the PODD 2025 Conference on October 27, 2025, and the Pharma Partnering Summit 2025 on November 14, 2025, to update on licensing opportunities. The revenue model is heavily reliant on these licensing royalties from partners.

Specific regional agreements define the engagement model:

• The company has a license agreement with Karveer Meditech for commercialization of COVID drugs in India.
• Under this deal, NanoViricides, Inc. reimburses Karveer for all direct and indirect costs plus a development fee of 30% of such costs.
• Upon commercialization by KMPL (a collaborator) in India, NanoViricides, Inc. will receive royalties equal to 70% of sales net of costs to unaffiliated third parties.

Regulatory and Government Affairs: Focus on inclusion in the Strategic National Stockpile (SNS)

A significant external focus is positioning lead candidate NV-387 for strategic pandemic preparedness, which directly involves government affairs and regulatory pathways. The company believes NV-387 should be the drug of choice for stockpiling due to its activity against multiple threats, including Influenza, Coronaviruses, Orthopoxviruses (Smallpox and Mpox), and Measles.

NanoViricides, Inc. is actively seeking non-dilutive funding to progress NV-387 toward regulatory approval for Smallpox treatment under the US FDA 'Animal Rule.' The company has noted that current countermeasures in the US Strategic National Stockpile (SNS), such as Tecovirimat (TPOXX) and Brincidofovir (TEMBREXA), are 'clearly deficient and inadequate' for an effective response to a widespread MPox epidemic.

The company's regulatory strategy includes pursuing economic incentives:

Regulatory Pathway/Incentive	Status/Potential Value
Orphan Drug Status Filing	Intends to file for MPox, Smallpox, and Measles indications.
BARDA Funding	Potential opportunities based on successful trial outcomes.
Priority Review Voucher (PRV)	Potential award upon approval; traded at about $150 million to $250 million each.

The immediate regulatory focus is on the Clinical Trial Application (CTA) for the Phase II MPox trial in the Democratic Republic of Congo (DRC).

Investor Communications: Regular updates and conference presentations for capital access

Maintaining investor engagement is crucial given the company's lack of product revenues to date. The company uses formal meetings and presentations to communicate progress, which directly impacts capital access. As of November 26, 2025, the Current Market Cap stood at $21.06M, with an Average Trading Volume of 260,737.

Key recent communications include:

• Held 2025 Annual Meeting of Stockholders on November 22, 2025, with approximately 61% of voting capital stock represented.
• Filed Quarterly Report on Form 10-Q for the quarter ending September 30, 2025, on November 14, 2025.
• Reported approximately $8.36 Million in total Assets as of September 30, 2025.
• Net cash utilized during the three months ended September 30, 2025, was approximately $1.59 Million.
• Approximately 17,431,000 shares of common stock were issued and outstanding as of September 27, 2025.

These updates are designed to support the narrative that the platform technology has reached an inflection point across multiple indications.

Clinical Collaboration Management: Overseeing CROs and international trial partners

Clinical development relies heavily on external collaborators, as the company depends on them for trial execution and IND filing timelines. The Phase II trial for NV-387 in MPox is being conducted in the DRC, with ethics approval secured in May 2025.

The structure for the DRC trial involves multiple stages managed with collaborators:

• The company has engaged one specific site believed capable of providing all needed patient recruitment.
• Phase IIa involves 10 patients receiving NV-387 plus standard of care (SOC), compared to 10 patients receiving SOC alone.
• Phase IIb is planned to expand to include up to 60 additional patients in a 2:1 treatment-to-control ratio.
• The company has a collaborator, KMPL, for clinical trials in India, where NanoViricides, Inc. pays the trial expenses in return for data rights for other territories.
• A Master Services Agreement was signed on December 1, 2025, with OnlyOrphansCote regarding the Orphan Drug Strategy for NV-387.

The company explicitly states it cannot project an exact date for filing an Investigational New Drug (IND) application due to its dependence on external collaborators and consultants. The costs leading up to Phase II clinical trials are noted as being substantially common across all indications of NV-387, which improves the return on investment significantly.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Channels

You're looking at how NanoViricides, Inc. (NNVC) plans to get its nanoviricides to market as of late 2025. Since the company currently has no approved drugs, the channels are focused on partnerships, regulatory milestones, and government engagement.

Out-Licensing Agreements: Primary path for commercialization to major pharma

The core commercialization strategy for NanoViricides, Inc. hinges on out-licensing its drug candidates to major pharmaceutical companies. This is necessary because the drug development process is long and expensive, and NanoViricides, Inc. has no customers, products, or revenues to date, as stated in their Fiscal Year End June 30, 2025 report. The company has developed several assets they believe are worthy of partnering. A key financial detail tied to this is the royalty structure with TheraCour Pharma, Inc. (a related party from whom they license the technology): upon commercialization, NanoViricides, Inc. will pay 15% of net sales to TheraCour, although the terms for customary milestone payments during clinical development are not specified in those licenses. Furthermore, for the clinical trial in India, NanoViricides, Inc. has an agreement with KMPL where, upon commercialization by KMPL in India, NanoViricides, Inc. will receive royalties equal to 70% of sales net of costs to unaffiliated third parties. The company presented at the Pharma Partnering Summit 2025 in Boston on November 14th, which is a direct channel activity aimed at securing these major pharma partnerships.

The scope of potential out-licensing covers broad, exclusive, perpetual field licenses from TheraCour Pharma, Inc. for indications including:

• Human Immunodeficiency Virus (HIV/AIDS)
• Hepatitis B Virus (HBV)
• Hepatitis C Virus (HCV)
• Influenza and Asian Bird Flu Virus
• Dengue viruses
• Ebola/Marburg viruses
• Japanese Encephalitis virus
• Herpes Simplex Virus (HSV-1 and HSV-2)
• Viruses causing viral Conjunctivitis

Regulatory Filings: Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions

Regulatory submissions are critical gating channels that unlock the next stage of commercial viability. NanoViricides, Inc. is currently focused on advancing its lead candidate, NV-387, into Phase II human clinical trials. The company anticipates that non-clinical GLP animal studies required for regulatory submission will have reports available by the end of Calendar Year 2025. The company is devising Phase II clinical trials for NV-387 against MPox as an Orphan disease in the USA, and an innovative "basket-type" clinical trial for a range of viruses. For the MPox indication, NanoViricides, Inc. received approval from the National Ethics Committee for Health (CNES) of the Ministry of Public Health (MSP) of the Democratic Republic of Congo (DRC) as of May 5, 2025, to start the Phase II trial evaluating safety and effectiveness of NV-387. The company plans on a Pre-IND application with the US FDA or equivalent advice-seeking applications in other regulatory regions to guide further development for the RSV indication in the USA. Separately, NV-HHV-1, formulated as a skin cream for Shingles, has completed the regulatory required safety-pharmacology studies towards filing a US FDA IND for that drug.

Key regulatory/clinical status points as of late 2025:

Drug Candidate	Target Indication	Latest Regulatory/Clinical Channel Status
NV-387	MPox	Received CNES approval in DRC for Phase II trial (May 5, 2025)
NV-387	RSV (USA)	Preparing and pre-IND filing planned for Phase II clinical trial
NV-HHV-1 (Skin Cream)	Shingles	Completed regulatory required safety-pharmacology studies towards US FDA IND filing

Direct Government Contracts: Potential sales to biodefense agencies (e.g., BARDA)

Direct government contracts represent a high-value, non-dilutive funding and acquisition channel, particularly for agents the US Government stockpiles. NanoViricides, Inc. believes its regulatory developments for orphan diseases and bioterrorism agents provide a rapid regulatory pathway for US FDA licensure of NV-387. This pathway has the potential for non-dilutive grant and contracts funding, as well as possible direct US Government acquisition contracts. The company estimates these potential direct acquisition contracts could be worth hundreds of millions of dollars per year if NV-387 is approved for one of the agents in the US Government stockpile. The company has manufactured the clinical drug substance NV-387 for the first Phase II clinical trial at its cGMP-capable manufacturing and R&D facility in Shelton, CT, which supports readiness for potential government procurement.

Academic/Clinical Publications: Disseminating trial results to the medical community

Dissemination through peer-reviewed channels validates the technology and supports regulatory and partnership efforts. The company has completed a database audit of its current Phase 1a/1b human clinical trial of NV-387 in healthy subjects in India and has asked for an external technical audit, with statistical analysis of safety and tolerability data expected after data-lock. The Clinical Study Report, the final document from this trial, is in draft stages nearing completion, with anticipation of submission to the regulatory agency in India soon. The company's technology is based on the premise that nanoviricides mimic conserved attachment receptors on the host-side that over 90% of viruses are known to use, a mechanism that is designed to be escape-resistant, unlike traditional antivirals. The company's market capitalization as of November 2025 was $25.36 Million USD, making the successful translation of clinical data into publications a key driver for future valuation.

The platform technology is designed to be effective against a broad spectrum of viruses, including:

• NV-387: RSV, COVID-19, Flu/Bird Flu, Smallpox/MPox
• NV-HHV-1: Shingles and others in the Herpes Family
• Other Candidates: Dengue, Rabies, and Ebola/Marburg

Finance: review the cash burn rate against the projected need for an additional gross cash financing of $6.25 Million to fund planned objectives through February 14, 2026.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Customer Segments

You're looking at the customer segments for NanoViricides, Inc. (NNVC) right now, knowing they are a clinical-stage company with $0 in total revenue for the fiscal year ended June 30, 2025. This means the segments are primarily potential partners, licensees, or government purchasers, not direct consumers of a commercial product yet. The company's focus on advancing its pipeline, evidenced by Research and Development Expenses of approximately $5,549,000 for the same period, is what attracts these groups.

The core of NanoViricides, Inc. (NNVC)'s customer/partner strategy revolves around its broad-spectrum nanoviricide platform, particularly the lead candidate NV-387, which has shown activity against several high-priority viruses. The current market capitalization stands at $21.96 million as of late 2025.

Customer Segment	Primary Interest/Need	Relevant NanoViricides, Inc. (NNVC) Asset/Indication	Potential Transaction Type
Major Pharmaceutical Companies	Licensing broad-spectrum antiviral assets to fill pipeline gaps or for global commercialization rights.	NV-387 for RSV, Influenza, Coronaviruses, Smallpox/Mpox, Measles virus.	Out-licensing deals, milestone payments, royalties.
Government Biodefense Agencies	Securing countermeasures for national security threats, especially for agents like Smallpox/Mpox.	NV-387's demonstrated activity against Smallpox/Mpox in animal models.	Direct procurement contracts, BARDA-style funding/contracts.
Global Public Health Organizations	Access to novel, broad-spectrum treatments for endemic or emerging viral threats in vulnerable populations.	Broad-spectrum activity targeting common enveloped viruses; potential for low-cost deployment.	Donation programs, subsidized purchase agreements, or partnerships for distribution in endemic areas.
Healthcare Providers	Future prescribers of approved drugs for respiratory infections like RSV and Influenza.	Approved oral formulations of NV-387 for respiratory infections.	Prescription volume driving future revenue streams (post-approval).

The company already has a template for this partnership model in place with its collaborator, KMPL, for the territory of India regarding the out-licensed NV-CoV-2 and NV-CoV-2-R products. This structure sets a precedent for how NanoViricides, Inc. (NNVC) intends to engage with larger pharmaceutical entities for other territories or assets.

• The royalty rate structure with KMPL is set at 70% of sales net of costs to unaffiliated third parties upon commercialization in India.
• Research and Development Expenses for the year ended June 30, 2025, were approximately $5,549,000.
• Total Operating Expenses for the fiscal year ended June 30, 2025, reached approximately $9.59 million.
• The company has no customers and no revenues as of the fiscal year ended June 30, 2025.
• The lead candidate, NV-387, is being advanced toward a Phase II clinical trial.

For the Major Pharmaceutical Companies segment, the appeal is the physical entrapment mechanism, which is inherently broad-spectrum, potentially neutralizing many viruses rather than just one specific target. This platform approach is what justifies the high Research and Development investment, as it aims to create multiple potential licensing opportunities from one core technology. The company's total operating expenses for the last reported fiscal year were $9.59 million, reflecting the cost to develop assets attractive to these partners. It's definitely a partnership-driven model at this stage.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Cost Structure

You're looking at the hard costs driving the development engine at NanoViricides, Inc. (NNVC) as of late 2025. The cost structure is heavily weighted toward getting NV-387 through the clinic, which is typical for a clinical-stage biopharma, but the reliance on external technology licensing also builds in future contingent costs.

Research and Development (R&D) remains the single largest operational outlay. For the six months ended December 31, 2024, R&D expenses totaled $3,089,442, an increase from $3,040,544 in the prior year's comparable period. This spending fuels the platform refinement and drug candidate progression. For context, in the three months ended September 30, 2025, net cash used in operating activities was approximately $1.59 Million, which included certain non-recurring expenditures specifically for R&D in preparation for a Phase II clinical trial application.

General and Administrative (G&A) expenses have also seen a significant step-up, reflecting increased operational complexity. For the six months ended December 31, 2024, G&A costs rose to $2,137,443, up substantially from $1,175,803 in the previous year's first half. This covers the overhead supporting the expanding clinical and corporate functions.

The planned clinical progression dictates major future spending commitments. NanoViricides, Inc. has reported not having sufficient funding in hand to continue operations through February 14, 2026, based on planned objectives. These objectives directly translate to cost centers:

• Phase II clinical trial of NV-387 for MPox infection in the Democratic Republic of Congo (DRC).
• Phase II clinical trial of NV-387 for Viral Acute and Severe Acute Respiratory Infections (V-ARI and V-SARI).
• Preparation and pre-IND filing for a Phase II clinical trial of NV-387 for RSV indication in the USA.

Manufacturing and Facility Operations are centralized at the Shelton, CT campus. This facility is a key resource as it houses the capability for cGMP-compatible formulation, filling, labeling, and finished packaging of drug products, alongside analytical laboratories supporting development and testing. Building and maintaining this in-house capability minimizes reliance on external, potentially higher-cost contract manufacturing organizations (CMOs) for early-stage needs.

Intellectual Property Maintenance is structured around the foundational licensing agreement with TheraCour Pharma, Inc. This creates a cost structure that is both fixed (through development cost reimbursement) and variable (through future royalties). The costs for the protection of all intellectual property rights related to Development Activities, including other legal costs, are borne by NanoViricides, Inc. as part of the Development Costs paid to TheraCour. Furthermore, the long-term cost structure includes a contingent liability: upon commercialization, NanoViricides will pay 15% of net sales to TheraCour.

Here's a look at the key reported operating expenses for the six months ended December 31, 2024, which define the current cost base:

Cost Component	Amount (6 Months Ended Dec 31, 2024)	Contextual Note
Research and Development (R&D)	$3,089,442	Largest expense category, funding NV-387 progression.
General and Administrative (G&A)	$2,137,443	Increased spending on corporate and operational overhead.
Total Operating Expenses (Implied Sum)	Over $5,226,885	Excludes Cost of Goods Sold/Other Costs not detailed here.
Net Loss	$5,154,302	Resulting loss for the six-month period.

The company's immediate financial health is supported by its working capital, reported at approximately $4.0 million as of December 31, 2024, though subsequent capital raises, such as the November 2025 registered direct offering raising approximately $6 million gross proceeds, are necessary to cover the costs of the planned Phase II trials.

NanoViricides, Inc. (NNVC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of NanoViricides, Inc. (NNVC) as of late 2025. Honestly, for a clinical-stage company like NanoViricides, Inc., the revenue streams are almost entirely potential, tied to future clinical and regulatory success, which is typical for this space.

Current Revenue Status

As of late 2025, NanoViricides, Inc. is operating as a pre-revenue entity. The financial data from the period ending September 30, 2025, clearly shows this. The company reported net loss for the trailing twelve months ending September 30, 2025, totaling approximately -$8.1 Million. Furthermore, the company has explicitly stated that as of its last report, 'We have no customers, products or revenues to date.'

Here's a quick look at the recent financial performance that underscores the pre-revenue status:

Metric	Amount as of September 30, 2025
Trailing Twelve Months Net Loss	-$8.13 Million
Q3 2025 Net Loss	-$1.79 Million
Cash and Cash Equivalents (Sept 30, 2025)	Approximately $1.25 Million

Future Milestone Payments

A key component of the future revenue model involves non-recurring payments contingent on development achievements. NanoViricides, Inc. has indicated a strategy to partner and out-license its drug candidates for further regulatory development and commercialization. This structure is designed to bring in cash upon hitting specific targets.

• Potential for initial license fees upon deal signing.
• Payments triggered by development success milestones.
• Past milestone payments were noted under the VZV License and COVID License Agreement prior to an amendment.

Future Licensing Fees/Royalties

Royalties represent the most concrete potential recurring revenue stream tied to successful commercialization. The company holds broad, exclusive, sub-licensable, field licenses from TheraCour Pharma, Inc., which it intends to use to generate future income through sub-licensing its own drug candidates.

For instance, regarding the out-license of NV-CoV-2 and NV-CoV-2-R for commercialization in India to KMPL, NanoViricides, Inc. is set to receive a significant percentage:

• Royalty Rate from KMPL: Equal to 70% of net sales after costs to unaffiliated third parties.

Government Grants and Contracts

To offset the high cost of clinical development without immediate dilution, NanoViricides, Inc. actively seeks non-diluting funding. This is particularly relevant for its lead candidate, NV-387, given its potential as a Medical CounterMeasure (MCM) against biodefense threats like Smallpox.

The company has been pursuing this avenue:

• Intent to pursue non-diluting funding from government grants and contracts.
• Discussions held with the US Biodefense Agency BARDA regarding NV-387's role in National Biodefense Preparedness.
• Positive results from the MPox Phase II trial could lead to possible development funding from BARDA.

Equity Financing

Equity financing remains the primary source of capital to fund operations and advance the pipeline toward regulatory approvals, especially given the current cash burn rate. You saw a major infusion in late 2025.

The November 2025 offering was a significant capital raise event:

Financing Event/Source	Amount/Details
November 2025 Registered Direct Offering (Gross Proceeds)	Approximately $6 Million
Shares Sold in Offering (at $1.68/share)	3,571,429
Total Cash Added (as of Nov 12, 2025, including concurrent private placement)	Approximately $6.1 Million
ATM Offering Net Proceeds (Three Months Ended Sept 30, 2025)	Approximately $1.25 Million
Available Line of Credit from Founder	$3 Million

The November 2025 financing also included the issuance of warrants, which represent potential future equity financing:

• Series A Warrants: Exercise price of $1.75 per share.
• Series B Warrants: Exercise price of $2.00 per share.

Finance: draft 13-week cash view by Friday.