NANOVIRICIDES, INC.

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 development of safe and well tolerated drugs.

Current wording

Phase I human clinical trial of NV-387 to evaluate safety and tolerability in healthy subjects 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

Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response.

Current wording

A nanoviricide drug is designed to complete the task of destroying the virus particle, without requiring assistance from a functioning immune system of the patient. Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response. Vaccines require healthy immune system so that appropriate antibody-generating memory cells can be created, stored, and deployed in case of infection later. Antibodies used as drugs decorate the virus particle and require a healthy immune system to handle the virus-antibody complexes thus formed.

Previous wording

These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine technology platform. After decades of development, this novel nanoviricide technology is now advancing through clinical stages towards regulatory approvals.

Current wording

These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine technology platform.

Previous wording

Clinical Stage Lead Drug NV - 387

Current wording

Revolutionary Broad-Spectrum Antiviral - Clinical Stage Lead Drug NV-387

Previous 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.

Current wording

Our clinical stage 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

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 wording

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.

Previous wording

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 wording

We believe that the potential relatively rapid regulatory path for NV-387 would be enabled by any of its indications that are eligible for “Orphan Drug” status in the USA. Generally speaking, an Orphan Drug is a drug for a disease that has less than 200,000 incidence rate annually, or for a specific bio-terrorism agent such as smallpox. Based on our animal model studies to date, we have identified three different treatment indications that are orphan drug indications for NV-387, namely: (i) NV-387 for the treatment of Measles, (ii) NV-387 for the treatment of MPox, and (iii) NV-387 for the treatment of smallpox. Orphan Drug Designation for these cases would enable several benefits.

Previous wording

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 wording

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 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).

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

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 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.

Previous 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.

Current wording

3 The Measles vaccine, a live attenuated strain developed circa 1968, continues to be in use, even as the Measles 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

Humanized mice were required for the animal model because Measles virus only infects humans, and specifically uses hSLAM as the cognate receptor for cell entry, while using the ubiquitous HSPG for congregation next to cells. The mice had human hSLAM (aka hCD150) gene knocked-in, and also had their interferon responses deleted (hSLAM+k.i., IfnAR-/- transgenic mice on C57BL/6

Current wording

Humanized mice were required for the animal model because Measles virus only infects humans, and specifically uses hSLAM as the cognate receptor for cell entry, while using the ubiquitous HSPG for congregation next to cells. The mice had human hSLAM (aka hCD150) gene knocked-in, and also had their interferon responses deleted (hSLAM+k.i., IfnAR-/- transgenic mice on C57BL/6 Background). NV-387 mimics the portions on HSPG that viruses bind to, including the Measles virus, and thereby is designed to attack and engulf the virus particle via lipid-lipid mixing and destroying the virus particle’s ability to infect cells.

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

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 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.

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

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 Platform technology. The technology also enables us to develop nasal sprays and bronchial aerosols. We plan to develop the appropriate formulations as necessary.

Previous wording

During the three months ended September 30, 2025, we have focused on preparing regulatory documentation in accordance with the requirements for the Phase II MPox clinical trial of NV-387 in DRC under the regulatory agency ACOREP as requested by them. We also performed certain non-clinical studies to further elucidate mechanism of action of NV-387.

Current wording

During the three months ended December 31, 2025, we have focused on preparing regulatory documentation in accordance with the requirements for the Phase II MPox clinical trial of NV-387 in DRC under the regulatory agency ACOREP as requested by them. We have now submitted almost all of the documents constituting a clinical trial application, in a “rolling review”-like process to the DRC regulatory agency, ACOREP.

Previous 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.

Current wording

We had previously 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

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.

Current wording

As of December 31, 2025, we had cash and cash equivalents of $5,150,580, prepaid expenses of $145,985 and net property and equipment of $6,656,439. Accounts payable and accrued expenses were $1,195,925, inclusive of accounts payables to related parties of $929,232. Stockholders’ equity was $11,071,715 at December 31, 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.

Previous 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.

Current wording

During the six month period ended December 31, 2025, we used approximately $3.6 million in cash toward operating activities. This was substantially less than the prior one year ago period 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 in the prior one year ago period.

Previous wording

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

Current wording

Revenues The Company is a biopharmaceutical company and did not have any revenue for the three and six month periods ended December 31, 2025 and 2024.

Previous 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.

Current wording

Research and Development Expenses* –*Research and development expenses for the three months ended December 31, 2025 decreased $37,702 to $1,118,649 from $1,156,351 for the three months ended December 31, 2024. Research and development expenses for the six months ended December 31, 2025 decreased $977,727 to $2,111,715 from $3,089,442 for the six months ended December 31, 2024. The decrease in research and development expenses for the three months ended December 31, 2025 is due to a decrease in outside lab fees and clinical trial costs. The decrease in research and development expenses for the six months ended December 31, 2025 is due to a decrease in outside lab fees that were required for a Phase II Clinical Trial Application in 2024, and not required in 2025.

Previous 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.

Current wording

General and Administration Expenses* –*General and administrative expenses for the three months ended December 31, 2025 increased $211,825 to $1,114,525 from $902,700 for the three months ended December 31, 2024. General and administrative expenses for the six months ended December 31, 2025 decreased $219,299 to $1,918,144 from $2,137,443 for the six months ended December 31, 2024. The increase in general and administrative expenses for the three months ended December 31, 2025 is due to an increase in professional fees associated with investor outreach expense. The decrease in general and administrative expenses for the six months ended December 31, 2025 is due to a decrease in professional fees associated with investor outreach expense. From time to time the Company investor outreach strategies change, with occasional changes in expenditures.

Previous 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.

Current wording

Interest Income* –*Interest income for the three months ended December 31, 2025 decreased $19,254 to $12,455 from $31,709 for the three months ended December 31, 2024. Interest income for the six months ended December 31, 2025 decreased $48,650 to $24,082 from $72,732 for the six months ended December 31, 2024. The decrease in interest income for the three and six months ended December 31, 2025 is due to a lower interest bearing balance during the period and lower interest rates during the current three and six month period compared to the prior period.

Previous 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.

Current wording

Net Loss* –*For the three months ended December 31, 2025, the Company had a net loss of $(2,220,719) or $(0.11) per share compared to a net loss of $(2,027,491) or $(0.14) per share for the three months ended December 31, 2024. For the six months ended December 31, 2025, the Company had a net loss of $(4,005,777) or $(0.22) per share compared to a net loss of $(5,154,302) or $(0.36) per share for the six months ended December 31, 2024. The increase in the net loss for the three months ended December 31, 2025, and decrease in the net loss for the six months ended December 31, 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 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.

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 December 31, 2025 of approximately $152.8 million and a net loss of approximately $4.0 million and net cash used in operating activities of approximately $3.6 million for the six 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 December 31, 2025, the Company had available cash and cash equivalents of approximately $5.2 million. The Company’s liabilities at December 31, 2025 were approximately $1.2 million. The Company raised approximately $664,000, net of offering expenses, from ATM sales of our common stock during the current period from October 1, 2025 through December 31, 2025. Additionally, the Company successfully raised capital worth approximately $5.4 million net of expenses in a Registered Direct Offering of common stock and a Private Placement of Series A 2-year and Series B 5.5 year common stock warrants, exercisable into common stock at $1.75 and $2.00, respectively, from a single investor. 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. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Previous 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.

Current wording

Management believes that as these various 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.

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 is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.

Current wording

Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, as well as debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.

Previous wording

Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with D. Boral Capital, the Sales Agent, that became active around April 15, 2024. However, we cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.

Current wording

Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with D. Boral Capital, the Sales Agent.

Previous wording

We have not entered into any off-balance sheet arrangements during the nine months ended September 30, 2025.

Current wording

We have not entered into any off-balance sheet arrangements during the three months ended December 31, 2025.