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NANOVIRICIDES, INC.

For the period ended Sep 30, 2025. Filed Nov 14, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 14, 2025

NNVC$1.32+2.3%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-03-31; filed 2025-05-15.

0001410578-25-001336

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-14.

0001104659-25-112608

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 283 previous paragraphs and 325 current paragraphs.

223 unchanged; 27 reworded; 70 added; 29 removed; 4 previous and 5 current paragraphs rearranged.

Tables are not compared: 7 previous and 19 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (70)

Current report

These viruses include the “triple-threat” respiratory viral infections of (i) Coronaviruses, (ii) RSV, (iii) Influenza viruses; enabling us to envision that NV-387 would be likely effective against almost all respiratory viral infections, based on its design and its observed activity in animal models.

Current report

These robust results also provide us with confidence that NV-387 will be effective against any variant of bird flu H5N1 that may become successful in person-to-person transmission and thereby may cause an endemic or a pandemic. H5N1 is thought to be a single mutation away from acquiring these capabilities. H5N1 resistance to Tamiflu has emerged in the past, and would likely emerge again. Xofluza, a recently approved influenza drug, is readily escaped by Influenza viruses. Rapivab, an injectable drug that is in the same class as Tamiflu, is also escaped by viral mutations.

Current report

In contrast, NV-387 poses a very low likelihood of viral escape, if any. Moreover, orally given NV-387 was substantially superior to these approved drugs in a direct comparison in an animal model of lethal influenza infection.

Current report

In addition, NV-387 was also found to be highly effective against orthopoxvirus infection animal models which provide support for moving it forward towards licensure for its use in the treatment of (iv) Smallpox (caused by Variola virus), an important bioterrorism threat; as well as for evaluation as a treatment for (v) MPox (caused by the Monkeypox virus, MPXV), an important emerging threat.

Current report

Further, the same drug NV-387 was found to be highly active against (vi) Measles virus in a humanized mouse model of lethal Measles virus infection.

Current report

The reason for such exceedingly broad-spectrum activity of NV-387 lies in the design of the drug. All of these distinctly different viruses utilize HSPG (heparan sulfate proteoglycans) for cell infection; so do H5N1, H7N9, the highly pathogenic influenza viruses, and even the Measles virus. In fact, it is well known that over 90-95% of human pathogenic viruses all utilize either HSPG or similar, related Sulfated Proteoglycans (“SPG”) as the initial attachment sites to be able to infect human cells. NV-387 mimics the key features of SPG that are required for the virus binding. No matter how much a virus mutates, it continues to use SPG for initial attachment.

Current report

NV-387, a Single Drug, Meets Many Unmet Medical Needs in Viral Diseases

Current report

NV-387, based on relevant animal model studies, and based on safety and tolerability observed in a Phase I human clinical trial, can fulfill these glaring gaps in pandemic preparedness for current and emerging threats, as well as for potential bioterrorism threats.

Current report

Thus, NV-387, as a single drug, is responding to several unmet medical needs in viral infectious diseases at once.

Current report

Possible Rapid Regulatory Paths, Non-Dilutive Funding, and Potential Revenues for NV-387

Current report

We believe that the potential relatively rapid regulatory path for NV-387 is the FDA Animal Rule based approval of NV-387 as a Treatment for Smallpox.

Current report

Such licensure, if obtained, could drive acquisition of the drug by the US government, worth hundreds of millions of dollars in revenues, and this could afford the fastest revenue path for the Company. As an example, Tecovirimat (TPOXX) acquisition contracts have been ranging at about $150 million per year.

Current report

In addition, there is a strong likelihood that the Biomedical Advanced Research and Development Agency (BARDA) of the US Government could finance development of NV-387 as a smallpox therapeutic in the near future as we further advance the regulatory development of NV-387 in the USA in non-dilutive funding.

Current report

Phase II Clinical Trial of NV-387 as Treatment of MPox in the Democratic Republic of Congo (DRC), Africa

Current report

We began working with the local regulatory agency in DRC, namely ACOREP, circa February 2025. After initial due diligence from them, the Ethics Committee of ACOREP agreed that NV-387 was worth evaluating as a treatment for MPox and gave us a go-ahead

Current report

with a preliminary approval for a potential Phase II clinical trial in April, 2025. Since then we have been providing technical documents to ACOREP as parts of the clinical trial application, in what would be considered an informal “rolling review” of sorts. After all of the questions having been resolved, we received a final approval for starting a Phase II clinical trial from ACOREP at the end of October, 2025. This approval requires us to fulfill certain conditions and provide certain final documentation. We are currently working on completing these last set of requests. (see below).

Current report

Phase II Clinical Trial of NV-387 as Treatment of Viral Acute and Severe-Acute Respiratory Infections (V-ARI and V-SARI) in India

Current report

US FDA Engagement and Regulatory Development Plan for NV-387

Current report

Our objective is to bring the data from the clinical trials external to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA. As discussed earlier, NV-387 has certain orphan disease as well as bioterrorism related indications. We believe some of these applications qualify for orphan drug designations. Therefore, we first plan to file the appropriate Orphan Drug Designations (ODD) for the following three treatments:

Current report

We believe that the ODD’s will provide several benefits that would accelerate the NV-387 program towards regulatory licensure. These include frequent FDA meetings and rapid decision-making. Additionally, the economic benefits include certain tax credits for R&D costs, waiver of certain PDUFA fees, and a seven year exclusivity for marketing the drug for the licensed indication.

Current report

Assuming an ODD is granted, we plan on following up with further US FDA engagements by filing pre-IND applications:

Current report

We also plan to seek a Pediatric Investigation Plan (“PIP”) Meeting with the US FDA at an appropriate time, particularly since Measles generally affects mostly children. RSV, another indication of NV-387, primarily affects neonates, infants and very young children. We plan on performing pediatric-use-related non-clinical studies in accordance with the FDA inputs.

Current report

We believe that the pre-IND Meeting for NV-387 for the Treatment and Prophylaxis of MPox will enable us to file an IND for a Phase II/III registrational clinical trial for licensure of the drug for MPox. We plan on leveraging the MPox Phase II clinical trial for this purpose.

Current report

We believe that the pre-IND Meeting for NV-387 for the Treatment and Prophylaxis of Smallpox will enable us to file an IND for a Phase II/III registrational clinical trial for licensure of the drug for Smallpox. We may be able to leverage the MPox Phase II clinical trial data as one of the model studies emulating smallpox infection.

Current report

At present there is no economic model or business case for development of a drug for Measles. We plan on engaging Measles drug development in full force if it is supported by non-dilutive grants and contracts funding. Measles may be eligible for a traditional tradeable Priority Review Voucher (PRV) issuance from the FDA. If so, the potential trade value of a PRV, currently at or above $150 Million, would provide enticement for us to develop NV-387 for Measles.

Current report

We believe that the planned Phase II Viral ARI/SARI Clinical Trial will provide us with substantial actionable data on the safety and effectiveness of NV-387 in treating at least Influenza, RSV, COVID, and provide further information in the utility of NV-387 against many other respiratory viruses including hMPV, Enteroviruses, Adenoviruses, Rhinoviruses, etc.

Current report

We plan on being able to initiate an IND under the US FDA for use of NV-387 as the treatment of RSV in pediatric patients, based on the Phase II datasets.

Current report

Monkeypox is an emerging disease that has become endemic to Central and Western Africa. Potential epidemics across the world can occur as the virus spills over via travel and then takes hold in other regions.

Current report

Monkeypox virus (MPXV) is freely communicable between humans but requires close contact. MPXV is in the same type of viruses as the Smallpox virus (Variola) and the corresponding vaccine virus (Vaccinia). MPox disease caused by MPXV is far less severe and has a low case fatality rate compared to Smallpox (CFR MPXV Clade I ~9% to ~1.5%, Clade II <0.3%. CFR Variola ~30%).

Current report

MPox has led to two WHO declarations of Public Health Emergency of International Concern (PHEIC).

Current report

The first WHO PHEIC declaration was made in 2022 and lasted approximately one year. It was driven by the emergence of an epidemic of MPox Clade II in Western Africa and its further spread into European countries and then to the USA. MPox Clade II is now endemic in all of these regions.

Current report

The second WHO PHEIC declaration was made in August, 2024, and was closed in September, 2025, although the Africa CDC has continued the Public Health Emergency of Continental Security (PHECS) declaration of MPox because cases have continued and the outbreak has continued to spread into new regions and neighboring countries. This current outbreak is caused by MPox Clade Ia and Clade Ib. MPox Clade Ib in particular has substantially greater morbidity and higher case fatality rate (at about 1.5%) as compared to MPox Clade IIa or Clade IIb. Clade I also disproportionately affects children whereas Clade II remains primarily limited to adults, which is traceable to differences in the communicability of these two clades.

Current report

In the Western World, MPox Clade II has become endemic but has remained limited primarily to Men-having-Sex-with-Men (MSM) population, communicated by sexual contact. A smallpox vaccine called Jynneos was found to be effective in generating antibodies that protect against MPXV Clade II. CDC has recommended it in this MSM population as well as for immunocompromised persons with risky sexual behaviors and persons with HIV.

Current report

Recently three new MPox Clade I cases in unconnected persons were found in California that were not associated with travel to Africa, and community spread of MPox Clade I is suspected to be occurring in California, bringing the USA even closer to a potential epidemic from this MPox variant (https://www.usatoday.com/story/news/health/2025/10/17/california-mpox-strain-cases/86748970007/).

Current report

Thus, although the current threat level is low, MPox Clade I could result in becoming an endemic virus in the USA.

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Removed paragraphs (29)

Previous report

The Company has initiated work towards evaluating the effectiveness of NV-387 in a humanized animal model of Measles virus infection.

Previous report

The Company has initiated work to begin Phase II clinical trials to evaluate safety and effectiveness of NV-387 treatment in MPox patients (see below).

Previous report

MPox caused by Clade 1 and 1b variants is currently a pandemic emergency in the African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. A less pathogenic variant, MPox Clade 2, has spread across the globe and caused a widespread epidemic in May 2022 in the Western world that has now become endemic.

Previous report

In addition, the Company is planning clinical trials towards the approval of NV-387 for the treatment of RSV infection in pediatric patients in the US.

Previous report

To this effect, the Company has engaged a Contract Research Organization (CRO) to help with conducting the MPox clinical trial of NV-387 in countries in the central African region. Trial sites have also been identified already. The Company is preparing a clinical trial application for the MPox Phase II clinical trial for submission to the appropriate regulatory agencies in DRC (Democratic Republic of Congo) and in Uganda. Recently, the Company has received approval from the regional ethics committee in the DRC for conducting a Phase II clinical trial to evaluate the effectiveness of NV-387 as a treatment for MPox infections.

Previous report

MPox caused by Clade Ia and Ib variants is continuing as a pandemic emergency in the Central African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. WHO declared MPox outbreak in 2024 a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, and maintains that the outbreak status still meets the PHEIC definition (https://www.who.int/news/item/17-03-2025-third-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-upsurge-of-mpox-2024). Clade Ib is more transmissible than Clade I and Clade II, and is also causing more pediatric infections (https://www.who.int/news/item/14-08-2024-who-director-general-declares-MPox-outbreak-a-public-health-emergency-of-international-concern).

Previous report

A less pathogenic variant, MPox Clade II, particularly Clade IIb, has spread across the globe. The Clade II MPox virus caused a widespread epidemic in May 2022 in the Western world, and has now become endemic. It continues to cause cases in the USA every year as per May 2025 report of WHO on MPox outbreak global trends (https://worldhealthorg.shinyapps.io/mpx_global/).

Previous report

There is no drug currently available for the treatment of MPox. A drug, tecovirimat (TPOXX®, SIGA) was approved by US FDA under the “Animal Rule” for the treatment of Smallpox (and MPox). However, it failed in a large clinical trial as a treatment of the MPox Clade 1/1b infections, with no statistical improvement observed in comparison to the standard of care (NIH/NIAID Press Release,

Previous report

CDC notes that “MMR vaccination is the best way to prevent measles and its complications,” and that “those who cannot or prefer not to get vaccinated, risk of measles infection and severe illness.”

Previous report

Measles incidence rates are increasing worldwide. The need for an effective therapeutic cannot be over-emphasized.

Previous report

NV-387 is anticipated to be effective against Measles virus. This is because of its broad-spectrum activity against viruses that use HSPG to infect cells. Measles virus belongs to the same class as RSV (paramyxoviruses), and uses HSPG for causing infection.

Previous report

We believe that NV-387 has sufficient non-clinical and clinical data that it can be used in severe Measles cases under specific US FDA provisions related to investigator-initiated clinical trial in one or few patients that can provide preliminary information.

Previous report

During the three months ended March 31, 2025, we have focused on preparing regulatory documentation that will be necessary for primarily (i) a Phase II MPox clinical trial of NV-387, and (ii) a Phase II RSV clinical trial of NV-387.

Previous report

Phase II Clinical Trial for the Treatment of MPox with NV-387

Previous report

We are in the process of developing a Phase II clinical trial application for submission to a regulatory agency in the Central African region, for the treatment of MPox infection with NV-387. To this end we have retained a CRO to help us with the execution of the clinical trial.

Previous report

Our CRO has already engaged one clinical trial site as of this reporting, and we are working on an additional site.

Previous report

Importantly, we have recently received an approval to proceed to a Phase II clinical trial for MPox from the Regional Ethics Committee in the Democratic Republic of Congo (DRC), based on the non-clinical data on safety and efficacy, as well as the safety and tolerability data from a draft report of the Phase I clinical trial of NV-387.

Previous report

This clears the path for us to submit a Phase II Clinical Trial Application (CTA) for the use of NV-387 for the treatment of MPox disease (caused by MPXV infection) to the DRC regulatory agency.

Previous report

We are now completely focused on preparing the Phase II MPox CTA for NV-387.

Previous report

During the reported quarter, we have initiated a program for the development of NV-387 as an antiviral treatment for Measles virus infection. We have acquired a Measles virus in our BSL2 Virology lab and we have grown it in cell cultures in a small quantity sufficient for initial animal studies.

Previous report

We have completed designing an experiment for the evaluation of NV-387 as a treatment for Measles virus infection in an animal model. Measles virus is host restricted and requires the use of humanized hCD150 (h-SLAP) mice for this work. These mice are grown only on order and take several weeks for delivery. We have already commissioned this animal model study.

Previous report

If the animal model study is successful, we plan on opening an IND with the US FDA for a Phase II clinical trial for the evaluation of NV-387 as a treatment of measles virus. We plan on seeking non-dilutive grant support for development of NV-387 as a treatment for Measles virus.

Previous report

We already have the supporting data required for such an IND as summarized below.

Previous report

Interest Expense* –* There was no interest expense incurred during the three months ended March 31, 2025 and March 31 2024. Interest expense decreased $49,659 to $149 for the nine months ended March 31, 2025 from $49,808 for the nine months ended March 31, 2024. The decrease in interest expense for the nine months ended March 31, 2025 is a result of cancellation of the milestone payment note with TheraCour during the nine month period ended March 31, 2024. The interest charged pursuant to the milestone payment note was cancelled by TheraCour on October 27, 2023. The cancellation of the note interest reduced accrued expense and increased additional paid in capital by $49,808.

Previous report

funds by mortgaging its existing fully owned campus and cGMP manufacturing facilities in Shelton, CT, in order to free up a portion of the fixed capital for use as liquid working capital. These facilities were recently valued at $12 to $15 million by industry experts. However, there is no guarantee that we will be able to raise funds on reasonable terms acceptable to us, or at all.

Previous report

In addition, Management continues to adjust its planned expenditures, activities, and programs, in accordance with budgetary constraints and in accordance with its expectations of obtaining additional financing. Management is also taking steps for seeking to license NV-387 to potential partners. Such licenses, if effected, would result in an initial payment at signing, milestone payments as the program advances, and royalty payments from future sales. We do not currently have a licensed partner other than KMPL and there is no guarantee that we can enter into such licensing agreement that provides substantial cash value to us.

Previous report

Management is actively exploring additional required funding through debt or equity financing pursuant to its plan. To cover the shortfall, we intend to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies in addition to equity-based financing. There can be no assurance that we will be able to obtain such additional capital resources or that such financing will be on terms that are favorable to us. We cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of the capital resources more rapidly than we currently anticipate. The accompanying unaudited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.

Previous report

We do not anticipate any major capital costs going forward in the near future. We intend to seek collaborations to develop NV-387 drug further towards approvals by FDA as well as international regulatory authorities.

Previous report

Excluding those sold under the ATM, all of the securities referred to above were issued without registration under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506(b) of Regulation D promulgated thereunder. None of the foregoing securities as well as common stock issuable upon conversion or exercise of such securities, have been registered under the Securities Act or any other applicable laws and are deemed restricted securities, and unless so registered may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.
Reworded paragraphs (27)

Previous wording

As used in this report “Safety”, “Efficacy”, “Effectiveness” and related terms refer to the results of the Company’s research studies and these statements have not been evaluated by regulatory bodies including the US FDA that have the authority for the purpose of commercial use of the drugs.

Current wording

As used in this report “Safety”, “Efficacy”, “Effectiveness” and related terms refer to the results of the Company’s research studies and these statements have not been evaluated by regulatory bodies including the Food and Drug Administration (“US FDA”) that have the authority for the purpose of commercial use of the drugs.

Previous wording

As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Phase I human clinical trial of NV-387 was completed with no adverse events meeting or exceeding safety and tolerability objectives of the trial. In non-clinical IND-enabling studies NV-387 as well as NV-HHV-1 have been found to be extremely good in terms of their effects on animal physiology, clinical and blood chemistry, as well as no organ-specific negative findings. These clinical and non-clinical findings validate our nanoviricide platform as being capable of clinically relevant drug development.

Current wording

As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Phase I human clinical trial of NV-387 was completed with no adverse events meeting or exceeding safety and tolerability objectives of the trial. In non-clinical IND-enabling studies NV-387 as well as NV-HHV-1 have been found to be extremely good in terms of their effects on animal physiology, clinical and blood chemistry, as well as no organ-specific negative findings. These clinical and non-clinical findings validate our nanoviricide platform as being capable of clinically relevant development of safe and well tolerated drugs.

Previous wording

The Company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model trials for the treatment of Coronaviruses, RSV, Influenza viruses as well as Smallpox and MPox, and the Company has predicted it to be active against all influenza viruses including bird flu H5N1 and H7N9, as well as against the Measles virus. All of these distinctly different viruses utilize HSPG (heparan sulfate proteoglycans) for cell infection; so do H5N1, H7N9, the highly pathogenic influenza viruses, and even the Measles virus.

Current wording

The Company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung viral infection animal model trials for the treatment of an extremely broad and wide variety of viruses.

Previous wording

A Phase I clinical trial of (i) NV-387 Oral Syrup and (ii) NV-387 Oral Gummies formulations to evaluate Safety and Tolerability in healthy human subjects was completed with the discharge and final visit of the last subject at the end of December, 2023. There were no reported adverse events, and there were no drop-outs in this clinical trial of 72 subjects. Thus, the drug NV-387, in both of the oral formulations studied, namely oral syrup and oral gummies (a soft solid form that dissolves in the mouth), is deemed to be safe and well tolerated and can be further advanced into Phase II clinical trials, as per communications with the Data Safety and Monitoring Board (DSMB) an independent expert review committee commissioned for this clinical trial. We are awaiting a final report of the clinical trial. This statement regarding safety and tolerability will be evaluated, after we submit the final Phase I report, by the regulatory agency.

Current wording

NV-387 has completed a Phase I human clinical trial for safety and tolerability in healthy subjects that was sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (“KMPL”). This Phase I clinical trial of (i) NV-387 Oral Syrup and (ii) NV-387 Oral Gummies formulations to evaluate Safety and Tolerability in healthy human subjects was completed with the discharge and final visit of the last subject at the end of December, 2023. There were no reported adverse events, and there were no drop-outs in this clinical trial of 72 subjects. Thus, the drug NV-387, in both of the oral formulations studied, namely oral syrup and oral gummies (a soft solid form that dissolves in the mouth), is deemed to be safe and well tolerated and can be further advanced into Phase II clinical trials, as per communications with the Data Safety and Monitoring Board (DSMB) an independent expert review committee commissioned for this clinical trial. We are awaiting a final report of the clinical trial. This statement regarding safety and tolerability will be evaluated, after we submit the final Phase I report, by the regulatory agency.

Previous wording

The Company is also in discussions with experts regarding a Phase II clinical trial for the evaluation of the effectiveness of NV-387 in the treatment of ARI and SARI of Viral origin (ARI = Acute Respiratory Infection and SARI = Severe Acute Respiratory Infection). The design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections (see below).

Current wording

We are in discussions with experts regarding a Phase II clinical trial for the evaluation of the effectiveness of NV-387 in the treatment of ARI and SARI of Viral origin (ARI = Acute Respiratory Infection and SARI = Severe Acute Respiratory Infection). The design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections (see below).

Previous wording

In addition to NV-387, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans to progress NV-HHV-1 into human clinical trials, and further develop the HerpeCide TM program after the Phase II clinical trial of NV-387 for RSV, MPox, ARI/SARI, and possibly for multiple other indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.

Current wording

In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.

Previous wording

The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored the NV-CoV-2 (NV-387) into Phase Ia/Ib human clinical trial, to study the safety and tolerability of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies formulations of the API NV-387 in healthy human subjects, described earlier. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive from KMPL a royalty of 70% calculated as the percentage of final invoiced sales less the cost of sales and goods sold to unaffiliated third parties.

Current wording

The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored the NV-CoV-2 (NV-387) into Phase Ia/Ib human clinical trial, to study the safety and tolerability of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies formulations of the API NV-387 in healthy human subjects, described earlier. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available

Previous wording

August 15, 2024, at https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo). Even so, SIGA Technologies, Inc. had, for TPOXX, approximately $146 million of outstanding procurement orders, out of which there was $122 million of procurement orders from the U.S. Government alone in the third quarter ended September 2024, according to its financial report (SIGA press release dated November 7, 2024). Overall, SIGA has received procurement orders for tecovirimat from US Government alone for over $250 million in 2023-2024, illustrative of the market size of an effective drug against poxviruses (www.siga.com, various press releases).

Current wording

TPOXX (tecovirimat), a drug approved for Smallpox under the USA FDA Animal Rule, failed in clinical trials against MPox Clade II as well as MPox Clade I to show effectiveness more than the standard of care (NIH/NIAID Press Release, August 15, 2024, at https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo). Even so, SIGA Technologies, Inc. had, for TPOXX, approximately $146 million of outstanding procurement orders, out of which there was $122 million of procurement orders from the U.S. Government alone in the third quarter ended September 2024, according to its financial report (SIGA press release dated November 7, 2024). Overall, SIGA has received procurement orders for tecovirimat from US Government alone for over $250 million in 2023-2024, illustrative of the market size of an effective drug against poxviruses (www.siga.com, various press releases). Notably, these procurements reflect replenishments and not initial stocking. The initial stocking orders would be substantially larger. This clearly illustrates the strong market size and demand for a Smallpox/Mpox drug.

Previous wording

Measles Virus and NV-387 - A Drug to Respond to Current Measles Outbreak – Highly Likely to be Effective

Current wording

Measles Virus and NV-387 - A Drug to Respond to Current Measles Outbreak – Effective in Humanized Animal Model

Previous wording

Vaccination rates for MMR vaccines in particular have fallen across the world, primarily because of loss of public faith in the communications regarding vaccines, compulsion during the COVID pandemic, as well supported belief that the side effects of vaccines have not been systematically captured and reported, and that, instead, there has been a strong bias in the health community to avoid associating side effects with the use of vaccines. The US Secretary of Health has begun revising the policies in order to perform more thorough evaluations of vaccines especially since vaccines are to be used in the entire population, unlike treatments that are used only in affected patients.

Current wording

Vaccination rates for MMR vaccines in particular have fallen across the world, primarily because of loss of public faith in the communications regarding vaccines, compulsion during the COVID pandemic, and well supported belief that the side effects of vaccines have not been systematically captured and reported, and that, instead, there has been a strong bias in the health community to avoid associating side effects with the use of vaccines.

Previous wording

There is no antiviral approved for the treatment of Measles virus, an urgent and unmet medical need. CDC fact sheet says that ribavirin is not approved for Measles, although it has been used in some patients, and that clinical data is lacking regarding its effectiveness. Ribavirin may be used only under an emergency use IND filing with the US FDA.

Current wording

There is no antiviral drug approved for the treatment of Measles virus, an urgent and unmet medical need. The CDC has updated the Measles treatment overview fact sheet for health care providers to include recommendations for the use of vitamin A, antibiotics, and inhaled steroids, under the supervision of clinician, to treat measles. CDC fact sheet says that ribavirin is not approved for Measles, although it has been used in some patients, and that clinical data is lacking regarding its effectiveness. Ribavirin may be used only under an emergency use IND filing with the US FDA.

Previous wording

In particular, Measles is the most communicable disease known to man, and “herd immunity” that is required for elimination of Measles from the population, requires 95% of the population to be vaccinated. An increasing portion of the population is becoming incapable of generating full immunity upon vaccination because of immune system compromise, auto-immune diseases, severe allergies, chronic health issues such as diabetes and obesity, and advanced age. There is also personal reluctance for the risk that one’s own child may be affected by a major side effect even as documented rates of side effects are small. There are also communities with religious prohibition for using vaccines. Therefore, reaching 95% vaccination rate is becoming an ever distant goal.

Current wording

3 The Measles vaccine, a live attenuated strain developed circa 1968, continues to be in use, even as the Measle virus itself has changed significantly. The vaccine was originally found to be 95% protective, which means 5% of the fully vaccinated persons could still get measles, called a “vaccine breakthrough” infection. At least 95% of the population needs to be vaccinated to confer “population immunity” or “herd immunity” which can be roughly defined as blocking person-to-person spread of the virus. This high percentage required is a result of the extremely contagious and persistent nature of the Measles virus. However, immune-compromised subjects do not benefit well from any vaccines. The percentage of such subjects that do not benefit fully from vaccination has been estimated at about 7-10% of the US population, and is rising due to chronic diseases, auto-immunity, inflammation, diabetes, obesity, as well as environmental factors that have led to increase in cancer rates in younger population in the USA. Analysis of post-elimination Measles cases in the USA have led to vaccine breakthrough rates estimated at 11-13% rather than the historically used value of 5% (J. Leung et al. Measles Cases in the US, 2001–2022 • CID 2025;80(3):663–72. https://doi.org/10.1093/cid/ciae470). There is also personal reluctance for the risk that one’s own child may be affected by a major side effect even as documented rates of side effects are small. There are also communities with religious prohibition for using vaccines. Therefore, reaching 95% vaccination rate is becoming an ever distant goal. Thus, there is an urgent need for a Measles drug to treat persons that get sick.

Previous wording

RSV causes severe infections primarily in infants and young children, persons over age 60 and immune-compromised persons.

Current wording

RSV causes severe infections primarily in infants and young children, persons over age of 60 and immune-compromised persons.

Previous wording

Our non-clinical programs are designed to minimize the risk of failure of our drug candidates in clinical trials. Specifically, we perform evaluation of antiviral activity in lethal studies in direct comparison with known approved drugs if available, and choose drug candidates that show at least comparable or superior activity to the approved ones. We employ lethal infection studies so that the survival time is a clear indicator of the antiviral activity, and can be used to rank relative activity of drug candidates. We believe our success rate of drug approval would be substantially better than industry averages because of the features of our nanoviricides platform technology and the de-risking strategies we employ in drug development.

Current wording

Our non-clinical programs are designed to minimize the risk of failure of our drug candidates in clinical trials. Specifically, we perform evaluation of antiviral activity in lethal studies in direct comparison with known approved drugs if available, and choose drug candidates that show at least comparable or superior activity to the approved ones. We employ lethal infection studies so that the survival time is a clear indicator of the antiviral activity, and can be used to rank relative activity of drug candidates. We believe our success rate of drug

Previous wording

We believe we have demonstrated that we can rapidly develop different types of formulations for different routes of administration, such as injectable, skin cream, lotion, gel, and even oral, because of the inherent strength of the flexible and tailorable Nanoviricide Platform technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.

Current wording

We believe we have demonstrated that we can rapidly develop different types of formulations for different routes of administration, such as injectable, skin cream, lotion, gel, and even oral, because of the inherent strength of the flexible and tailorable Nanoviricide

Previous wording

Further, we have continued to increase the scale of manufacture of NV-387 in our cGMP-compliant facility, effectively doubling the prior batch size, in preparation for supplying the drug products for the Phase II clinical trials. We believe this scale will be sufficient for a Phase II clinical trial for MPox or for a Phase II clinical trial for RSV. We will commission additional batches as we engage into additional clinical trials.

Current wording

We completed manufacture of the NV-387 drug substance batch for the Phase II MPox clinical trial. As we engaged in this manufacturing batch, we have continued to increase the scale of manufacture of NV-387 in our cGMP-compliant facility, effectively doubling the prior batch size. We will commission additional batches as we engage into additional clinical trials.

Previous wording

We are currently executing the production program for Phase II clinical supply of NV-387 drug products. We have improved the NV-387 drug product formulations with organoleptic considerations (i.e. taste, flavor, feel and smell). We have ordered additional custom equipment, made in the USA, for the gummies blister-pack filling and sealing operation that is expected to be delivered soon.

Current wording

We have improved the NV-387 drug product formulations with organoleptic considerations (i.e. taste, flavor, feel and smell). We have installed additional custom equipment, made in the USA, for the gummies blister-pack filling and sealing operation that is required for the manufacture of the drug product for the Phase II MPox clinical trial and beyond.

Current wording

Our Current Priorities – Measles, MPox, Smallpox, H5N1, and RSV

Previous wording

As of March 31, 2025, we had cash and cash equivalents of $2,542,590, prepaid expenses of $184,716 and net property and equipment of $6,982,750. Accounts payable and accrued expenses were $1,198,911, inclusive of accounts payables to related parties of $813,477 and accrued expenses of $32,616. Stockholders’ equity was $8,833,049 at March 31, 2025. In comparison, as of June 30, 2024, we had $4,797,778 in cash and cash equivalents, prepaid expenses of $172,742 and $7,512,463 of net property and equipment. Our liabilities at June 30, 2024 were $1,358,776 including accounts payable of $376,270 payable to third parties and accounts payable to related parties of $720,039, and accrued expenses of $262,467, of which $227,435 was due to a related party.

Current wording

As of September 30, 2025, we had cash and cash equivalents of $1,125,711, prepaid expenses of $126,855 and net property and equipment of $6,787,456. Accounts payable and accrued expenses were $1,182,386, inclusive of accounts payables to related parties of $901,143 and accrued expenses of $26,300. Stockholders’ equity was $7,174,694 at September 30, 2025. In comparison, as of June 30, 2025, we had $1,558,564 in cash and cash equivalents, prepaid expenses of $112,146 and $6,833,891 of net property and equipment. Our liabilities at June 30, 2025 were $1,306,519 including accounts payable of $459,094 payable to third parties and accounts payable to related parties of $821,456, and accrued expenses of $25,969.

Previous wording

During the nine month period ended March 31, 2025, we used approximately $6.8 million in cash toward operating activities. This was substantially greater than for the nine months ended March 31, 2024 primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II.

Current wording

During the three month period ended September 30, 2025, we used approximately $1.6 million in cash toward operating activities. This was substantially less than for the three months ended September 30, 2024 primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II.

Previous wording

Revenues The Company is a biopharmaceutical company and did not have any revenue for the nine month period ended March 31, 2025.

Current wording

Revenues The Company is a biopharmaceutical company and did not have any revenue for the three month period ended September 30, 2025.

Previous wording

Research and Development Expenses* –* Research and development expenses for the three months ended March 31, 2025 increased $67,590 to $1,282,251 from $1,214,661 for the three months ended March 31, 2024. Research and development expenses for the nine months ended March 31, 2025 increased $116,488 to $4,371,693 from $4,255,205 for the nine months ended March 31, 2024. The increase in research and development expenses for the three and nine months ended March 31, 2025 is due to an increase in outside lab fees and clinical trial costs.

Current wording

Research and Development Expenses*–*Research and development expenses for the three months ended September 30, 2025 decreased $940,025 to $993,066 from $1,933,091 for the three months ended September 30, 2024. The decrease in research and development expenses for the three months ended September 30, 2025 is due to a decrease in outside lab fees previously required for clinical studies.

Previous wording

General and Administration Expenses* –* General and administrative expenses for the three months ended March 31, 2025 increased $273,163 to $966,905 from $693,742 for the three months ended March 31, 2024. General and administrative expenses for the nine months ended March 31, 2025 increased $1,234,804 to $3,104,349 from $1,869,545 for the nine months ended March 31, 2024. The increase in general and administrative expenses for the three and nine months ended March 31, 2025 is due to an increase in professional fees associated with investor outreach.

Current wording

General and Administration Expenses*–* General and administrative expenses for the three months ended September 30, 2025 decreased $431,124 to $803,619 from $1,234,743 for the three months ended September 30, 2024. The decrease in general and administrative expenses for the three months ended September 30, 2025 is due to a decrease in professional fees associated with investor outreach.

Previous wording

Interest Income* –* Interest income for the three months ended March 31, 2025 decreased $21,554 to $32,373 from $53,927 for the three months ended March 31, 2024. Interest income for the nine months ended March 31, 2025 decreased $131,293 to $105,106 from $236,399 for the nine months ended March 31, 2024. The decrease in interest income for the three and nine months ended March 31, 2025 is due to a lower interest bearing balance during the period and lower interest rates during the current three and nine month period compared to the prior periods.

Current wording

Interest Income*–*Interest income for the three months ended September 30, 2025 decreased $29,396 to $11,627 from $41,023 for the three months ended September 30, 2024. The decrease in interest income for the three ended September 30, 2025 is due to a lower interest bearing balance during the period and lower interest rates during the current three month period compared to the prior period.

Previous wording

Net Loss* –*For the three months ended March 31, 2025, the Company had a net loss of $(2,216,783) or $(0.14) per share compared to a net loss of $(1,854,476) or $(0.16) per share for the three months ended March 31, 2024. For the nine months ended March 31, 2025, the Company had a net loss of $(7,371,085) or $(0.50) per share compared to a net loss of $(5,938,159) or $(0.51) per share for the nine months ended March 31, 2024. The increase in the net loss for the three and nine months ended March 31, 2025 is generally attributable to the factors discussed above.

Current wording

Net Loss*–* For the three months ended September 30, 2025, the Company had a net loss of $(1,785,058) or $(0.10) per share compared to a net loss of $(3,126,811) or $(0.23) per share for the three months ended September 30, 2024. The decrease in the net loss for the three months ended September 30, 2025 is generally attributable to the factors discussed above.

Previous wording

The Company’s condensed financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the condensed financial statements, the Company has an accumulated deficit at March 31, 2025 of approximately $146.7 million and a net loss of approximately $7.4 million and net cash used in operating activities of approximately $6.8 million for the nine months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of March 31, 2025, the Company had available cash and cash equivalents of approximately $2.5 million. The Company’s liabilities at March 31, 2025 were approximately $1.2 million. Management believes that the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern.

Current wording

The Company’s condensed financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the condensed financial statements, the Company has an accumulated deficit at September 30, 2025 of approximately $150.6 million and a net loss of approximately $1.8 million and net cash used in operating activities of approximately $1.6 million for the three months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of September 30, 2025, the Company had available cash and cash equivalents of approximately $1.1 million. The Company’s liabilities at September 30, 2025 were approximately $1.2 million. Management believes that the Company’s existing resources, along with additional capital raised of approximately $6 million through a combination of At the Market (ATM) sales and a separate registered direct offering, as described in Note 11 to the financial statements, between October 1, 2025 through November 12, 2025, and the Company’s including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous wording

The ability of the Company to continue as a going concern is dependent upon controlling its overall expenses and identifying and securing additional financing. Management has considered several options for financing working capital as well as to obtain additional funds that will be needed for future human clinical trials. Management believes that we will be achieving several important milestones, including release of the Phase I clinical trial final report, a Phase II clinical trial application to evaluate safety and efficacy of NV-387 as a treatment for MPox, execution of this Phase II clinical trial, top-line results from the same, and further regulatory developments progressing NV-387 as cited elsewhere in this report, in the ensuing year. Management believes that as it achieves these milestones, there would be improvement in the liquidity of the Company’s stock, and that would improve our ability to raise funds on the public markets at terms that may be more favorable to the terms we are offered at present. Management believes that it has on-going access to the capital markets under an “At-The-Market” (ATM) agreement with D. Boral Capital (Formerly EF Hutton LLC) that became active around April 5, 2024. Management believes that the Company’s stock is currently undervalued in contrast to its asset value, based on the potential of NV-387 alone. Management believes that as our investor outreach program expands and bears fruit, this deviation should be lessened, enabling access to public markets for equity funding at reasonable valuations. In addition, Management plans to solicit

Current wording

As these milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present.
Rearranged current paragraphs (5)

Current report — wording carried from elsewhere

In addition to NV-387, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans to progress NV-HHV-1 into human clinical trials, and further develop the HerpeCide TM program after the Phase II clinical trial of NV-387 for MPox, Measles, ARI/SARI, RSV, and possibly for multiple other indications, including Influenzas.

Current report — wording carried from elsewhere

for regulatory filings in other territories of the world. Upon commercialization, the Company will receive from KMPL a royalty of 70% calculated as the percentage of final invoiced sales less the cost of sales and goods sold to unaffiliated third parties.

Current report — wording carried from elsewhere

The US Secretary of Health has begun revising the policies in order to perform more thorough evaluations of vaccines especially since vaccines are required to be used in the entire population, unlike treatments that are used only in affected patients.

Current report — wording carried from elsewhere

approval would be substantially better than industry averages because of the features of our nanoviricides platform technology and the de-risking strategies we employ in drug development.

Current report — wording carried from elsewhere

Platform technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.
Rearranged previous paragraphs (4)

Previous report — wording carried elsewhere

NV-387 has completed a Phase I human clinical trial for safety and tolerability in healthy subjects that was sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (“KMPL”). As topline results of this clinical trial, there were no reported adverse events at all doses studied, and there were no drop-outs either, observations that are indicative that NV-387 was well tolerated by the healthy subjects in this clinical trial. These results of the Phase I clinical trial are consistent with the results of safety/tolerability studies in animals conducted in support of the clinical trial application. We are awaiting the final clinical trial study report from this clinical trial.

Previous report — wording carried elsewhere

Notably, these procurements reflect replenishments and not initial stocking. The initial stocking orders would be substantially larger. This clearly illustrates the strong market size and demand for a Smallpox/Mpox drug.

Previous report — wording carried elsewhere

Measles virus cases have been increasing in the USA year over year and in 2025 there have been over 935 confirmed cases and 3 deaths as of May 1, 2025 (https://www.cdc.gov/measles/data-research/index.html). The CDC has updated the Measles treatment overview fact sheet for health care providers to include recommendations for the use of vitamin A, antibiotics, and inhaled steroids, under the supervision of clinician, to treat measles.

Previous report — wording carried elsewhere

As of March 31, 2025 we had $2,542,590 in cash and cash equivalents.