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What changed in NANOVIRICIDES, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of NANOVIRICIDES, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+503 added−358 removedSource: 10-K (2025-09-29) vs 10-K (2024-09-27)

Top changes in NANOVIRICIDES, INC.'s 2025 10-K

503 paragraphs added · 358 removed · 298 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

202 edited+176 added−40 removed414 unchanged
Biggest changeTime Schedules, Milestones and Development Costs In the upcoming fiscal year, we hope to meet several important milestones towards establishing human proof-of-concept for the Nanoviricides Platform: ● Completion of the final report of the Phase Ia/Ib clinical trial of the API NV-387, as drug products NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. ● File an IND for RSV treatment for Phase I/Phase II human clinical trials for NV-387 as a treatment of RSV infection, and resources permitting, begin human clinical trials for RSV treatment indication.
Biggest changeTime Schedules, Milestones and Development Costs In the upcoming fiscal year, we hope to meet several important milestones towards establishing human effectiveness proof-of-concept for the Nanoviricides Platform: ● Completion and Submission of the final report of the Phase Ia/Ib clinical trial of the API NV-387, as drug products NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies. ● Filing of the Clinical Trial Application for the Evaluation of NV-387 as a Treatment for MPox to ACOREP in DRC ● Initiation of the Phase II NV-387-MPox Clinical Trial ● Top-line Effectiveness’ and Safety/Tolerability in Patients Data from the Phase II NV-387-MPox Clinical Trial ● Completion of the In-Hospital Treatment Part of the Phase II NV-387-MPox Clinical Trial ● Closing of the Phase II NV-387-MPox Clinical Trial, Data Analysis and Initial Reports ● Filing of the Clinical Trial Application for the Evaluation of NV-387 as a Treatment for Viral ARI and Viral SARI in India ● Initiation of the Phase II NV-387-ARI/SARI Clinical Trial ● Top-line effectiveness and Safety/Tolerability in Patients Data from the Phase II NV-387-ARI/SARI Clinical Trial ● Potentially, Completion of the In-Hospital Treatment Part of the Phase II NV-387-MPox Clinical Trial ● Filing of Orphan Drug Designation for NV-387 as a Treatment for MPox in the USA ● Filing of Orphan Drug Designation for NV-387 as a Treatment for Smallpox in the USA ● Filing of Orphan Drug Designation for NV-387 as a Treatment for Measles in the USA ● Pre-IND Application for NV-387 as a Treatment for MPox in the USA ● Pre-IND Application for NV-387 as a Treatment for Smallpox in the USA Page 55 of 107 Table of Contents ● Pre-IND Application for NV-387 as a Treatment for Measles in the USA ● We also plan on filing a Pre-IND application for RSV treatment for Phase II human clinical trials for NV-387 as a treatment of RSV infection, in the USA, in the context of the Phase II ARI/SARI in India, to evaluate how the data can be brought into the USA FDA IND application.
Thus, their mode is complementary to NV-CoV-2 and combination therapy with one of these drugs and NV-CoV-2 may yield substantial benefits. We also note that none of these drugs in development attack the complete lifecycle of the virus as NV-387-Rp is designed to do, to the best of our knowledge.
Thus, their mode is complementary to NV-387 (NV-CoV-2) and combination therapy with one of these drugs and NV-387 may yield substantial benefits. We also note that none of these drugs in development attack the complete lifecycle of the virus as NV-387-Rp is designed to do, to the best of our knowledge.
In various animal models of lethal virus infection challenge, NV-387 was found to lead to substantial increase in survival, compared to even approved drugs where available, indicating potential for successful clinical regulatory development as a treatment for these viruses. Additional criteria studied in these animal models also further bolstered these expectations of potentially successful regulatory development.
In various animal models of lethal virus infection challenge, NV-387 was found to lead to substantial increase in survival, compared to even approved drugs where available, indicating potential for successful clinical regulatory development as a treatment for a number of viruses. Additional criteria studied in these animal models also further bolstered these expectations of potentially successful regulatory development.
Brincidofovir, based on the toxic drug cidofovir, is in development by Chimerix, but certain clinical trials involving brincidofovir have failed to meet the desired end points and have actually shown a greater fatality rate in brincidofovir treated subjects compared to placebo. Foscarnet is also used for VZV and ARN, but its toxicity is high.
Brincidofovir, based on the toxic drug cidofovir, was in development by Chimerix, but certain clinical trials involving brincidofovir have failed to meet the desired end points and have actually shown a greater fatality rate in brincidofovir treated subjects compared to placebo. Foscarnet is also used for VZV and ARN, but its toxicity is high.
NV-387, Phase II-Ready Broad-Spectrum Nanoviricide Drug Development Against Multiple Viruses Our first clinical stage drug candidate, NV-387, has recently completed Phase Ia/Ib human clinical trial for the evaluation of safety and tolerability in healthy subjects.
NV-387, Phase II-Ready Broad-Spectrum Nanoviricide Drug Development Against Multiple Viruses Our first clinical stage drug candidate, NV-387, has completed Phase Ia/Ib human clinical trial for the evaluation of safety and tolerability in healthy subjects.
The general process for FDA approval is as follows: Preclinical Testing The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● Completion of preclinical testing of new pharmaceutical or biological products, generally conducted in the laboratory and in animal studies in accordance with GLP standard, and applicable requirements for the humane use of laboratory animals or other applicable regulations to evaluate the potential efficacy and safety of the product candidate; ● Submission of the results of these studies to the FDA as part of an Investigational New Drug application, which must become effective before clinical testing in humans can begin; ● Manufacturing of investigational medicine under cGMP standard; ● Performance of adequate and well-controlled human clinical trials according to GCPs and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the product candidate for its intended use; ● Submission to the FDA of a new drug application, or NDA, for any new chemical entity drug we seek to market that includes substantive evidence of safety, purity, and potency, or safety and effectiveness from results of nonclinical testing and clinical trials; ● Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product is produced, packaged and distributed, to assess compliance with cGMPs, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● Potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the NDA; and ● FDA review and approval of the NDA.
Page 50 of 107 Table of Contents The general process for FDA approval is as follows: Preclinical Testing The process required by the FDA before a drug or biological product may be marketed in the United States generally involves the following: ● Completion of preclinical testing of new pharmaceutical or biological products, generally conducted in the laboratory and in animal studies in accordance with GLP standard, and applicable requirements for the humane use of laboratory animals or other applicable regulations to evaluate the potential efficacy and safety of the product candidate; ● Submission of the results of these studies to the FDA as part of an Investigational New Drug application, which must become effective before clinical testing in humans can begin; ● Manufacturing of investigational medicine under cGMP standard; ● Performance of adequate and well-controlled human clinical trials according to GCPs and any additional requirements for the protection of human research patients and their health information, to establish the safety and efficacy of the product candidate for its intended use; ● Submission to the FDA of a new drug application, or NDA, for any new chemical entity drug we seek to market that includes substantive evidence of safety, purity, and potency, or safety and effectiveness from results of nonclinical testing and clinical trials; ● Satisfactory completion of an FDA inspection of the manufacturing facility or facilities where the product is produced, packaged and distributed, to assess compliance with cGMPs, to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity; ● Potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the NDA; and ● FDA review and approval of the NDA.
Activity of Oral NV-387 in Lethal Intra-digital Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone We conducted evaluation of activity of NV-387compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus intra-digital footpad infection in mice.
Activity of Oral NV-387 in Lethal Intra-digital Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone We conducted evaluation of activity of NV-387 compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus intra-digital footpad infection in mice.
Anil Diwan, our Founder, President, and Executive Chairman, who owns approximately 90% of the capital stock of TheraCour which itself owns 470,961 shares of the Company’s outstanding common stock and 681,859 shares of the Company’s Series A preferred stock as of June 30, 2024.
Anil Diwan, our Founder, President, and Executive Chairman, who owns approximately 90% of the capital stock of TheraCour which itself owns 470,961 shares of the Company’s outstanding common stock and 681,859 shares of the Company’s Series A preferred stock as of June 30, 2025.
Meeta Vyas Meeta Vyas is the Company’s Chief Financial Officer and is married to Dr. Anil Diwan. Due to her marriage to Dr. Anil Diwan, Meeta Vyas is deemed to be a related party, Employees As of June 30, 2024, the Company had approximately seven full-time employees.
Meeta Vyas Meeta Vyas is the Company’s Chief Financial Officer and is married to Dr. Anil Diwan. Due to her marriage to Dr. Anil Diwan, Meeta Vyas is deemed to be a related party, Employees As of June 30, 2025, the Company had approximately seven full-time employees.
We believe that the data we have collected particularly for the manufacture of NV-387 drug substance and drug products, and the non-clinical studies of NV-387, will enable us to file appropriate IND application(s) to the FDA for the RSV indications.
We believe that the data we have collected particularly for the manufacture of NV-387 drug substance and drug products, and the non-clinical and clinical studies of NV-387, will enable us to file appropriate IND application(s) to the FDA for various indications.
Page 51 of 106 Table of Contents United States Post-Approval Requirements Any products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses, known as off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
United States Post-Approval Requirements Any products for which we receive FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses, known as off-label use, limitations on industry-sponsored scientific and educational activities and requirements for promotional activities involving the internet.
We believe that with the human clinical trials of NV-387, we will be able to accumulate the evidence of human safety and effectiveness that would help us achieve meaningful partnerships with Big Pharma. We are also working on obtaining non-dilutive funding for various programs and projects in our pipeline.
We believe that with the human clinical trials of NV-387, we will be able to accumulate the evidence of antiviral effectiveness in human infections, in addition to human safety and effectiveness, that would help us achieve meaningful partnerships with Big Pharma. We are also working on obtaining non-dilutive funding for various programs and projects in our pipeline.
We anticipate adding business development efforts in the western countries as we further develop NV-387 towards initiation of a Phase II clinical trial. A Phase II clinical trial is designed for the evaluation of effectiveness of a drug for its indication and is considered a “proof-of-concept” in humans that the drug is likely to succeed in regulatory approvals.
We anticipate adding business development efforts in the western countries as we further develop NV-387 into a Phase II clinical trial. A Phase II clinical trial is designed for the evaluation of effectiveness of a drug for its indication and is considered a “proof-of-concept” in humans that the drug is likely to succeed in regulatory approvals.
Page 20 of 106 Table of Contents Activity of NV-387 in Lethal Lung Influenza Infection in Mice - NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to Three Approved Influenza Drugs, and Significantly Increased Protection of Lungs from Virally Induced Damage We evaluated the activity of NV-387 given orally (twice on first day then once daily, 8 days, total 9 doses) in comparison with the three approved drugs, oseltamivir (Tamiflu®, Roche) given orally (twice daily for 8 days), baloxavir (Xofluza®, Shionogi, Roche) given orally as a single dose, and peramivir (Rapivab®, Biocryst) given by tail-vein injection once daily for 8 days.
Activity of NV-387 in Lethal Lung Influenza Infection in Mice - NV-387 Treatment Resulted in Significantly Greater Survival Improvement Compared to Three Approved Influenza Drugs, and Significantly Increased Protection of Lungs from Virally Induced Damage We evaluated the activity of NV-387 given orally (twice on first day then once daily, 8 days, total 9 doses) in comparison with the three approved drugs, oseltamivir (Tamiflu®, Roche) given orally (twice daily for 8 days), baloxavir (Xofluza®, Shionogi, Roche) given orally as a single dose, and peramivir (Rapivab®, Biocryst) given by tail-vein injection once daily for 8 days.
By signing on September 23, 2024, and being effective as of September 20, 2024 the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the “MOU”) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive right of first refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications.
On September 23, 2024, the Company entered into a “Memorandum of Understanding for All Antivirals Drug Development” (the “MOU”) with TheraCour that granted to the Company, a limited, non-assignable, non-sublicensable, exclusive right of first refusal to License to any antiviral drugs in development or to be developed by TheraCour for research and development purposes only, for all as-yet unlicensed viral infection treatment indications.
We have been able to significantly expand the potential indications of viral infections wherein NV-387 could be a drug candidate worthy of pursuing into clinical trials, to include the respiratory viral infections RSV and Influenza, in addition to the coronaviruses, as well as Smallpox/Mpox.
We have been able to significantly expand the potential indications of viral infections wherein NV-387 could be a drug candidate worthy of pursuing into clinical trials, to include the respiratory viral infections RSV and Influenza, in addition to the coronaviruses, as well as Smallpox/Mpox, and now to include Measles virus.
Several antibodies had received EUAs, but all of these have been revoked due to loss of efficacy as new variants emerged. None of the available drugs attack the external circulating virus particles or block the re-infection cycle as NV-CoV-2 is designed to do.
Several antibodies had received EUAs, but all of these have been revoked due to loss of efficacy as new variants emerged. None of the available drugs attack the external circulating virus particles or block the re-infection cycle as NV-387 is designed to do.
It is possible that NV-387 may have similar antiviral effect against many other viruses, something that we plan on continuing to evaluate as our programs advance. This expectation is based on the mechanism of NV-387 in that it mimics sulfated proteoglycan structures associated with host cells that over 90% of human pathogenic viruses are known to use as attachment receptors.
It is possible that NV-387 may have similar antiviral effect against many other viruses, something that we plan on continuing to evaluate as our programs advance. This expectation is based on the mechanism of NV-387 in that it mimics sulfated proteoglycan structures associated with host cells that are used by over 90% of human pathogenic viruses as attachment receptors.
The results are shown in the table below. ​ ​ ​ ​ Survival Lifespan of Lethally Infected Mice – Intra-digital Footpad Infection with Ectromelia Virus Treatment Survival, Days Increase in Survival, Days Increase in Survival, % NV-387, Oral 15 7 88% Tecovirimat (TPOXX), Oral 16 8 100% NV-387-m-T, Oral 19 11 138% Vehicle, Oral 8 0 - ​ In this trial, we found that the activity of NV-387 substantially matched that of tecovirimat, the approved drug for smallpox which was used in the recent MPox epidemics in the West.
The results are shown in the table below. ​ ​ ​ ​ Survival Lifespan of Lethally Infected Mice – Lethal Lung Infection with Ectromelia Virus Treatment Survival, Days Increase in Survival, Days Increase in Survival, % NV-387, Oral 15 7 88% Tecovirimat (TPOXX), Oral 16 8 100% NV-387-m-T, Oral 19 11 138% Vehicle, Oral 8 0 - ​ In this trial, we found that the activity of NV-387 substantially matched that of tecovirimat, the approved drug for smallpox which was used in the recent MPox epidemics in the West.
We believe that such expansions would enable maximization of return on investment (ROI) and maximization of shareholder value. Including the HerpeCide program explained above, we currently have about 11 different drug development programs, attesting to the strength of our platform technology.
We believe that such expansions would enable maximization of ROI and maximization of shareholder value. Including the HerpeCide program explained above, we currently have about 11 different drug development programs, attesting to the strength of our platform technology.
Page 9 of 106 Table of Contents We developed two different oral formulations of NV-387, namely “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies.” The latter is a semi-solid fixed-dose form. The oral syrup enables body-weight-based dose titration as needed for pediatric treatments. Both of these formulations have been evaluated in the Phase Ia/Ib human clinical trial of NV-387.
We developed two different oral formulations of NV-387, namely “NV-CoV-2 Oral Syrup” and “NV-CoV-2 Oral Gummies.” The latter is a semi-solid fixed-dose form. The oral syrup enables body-weight-based dose titration as needed for pediatric treatments. Both of these formulations have been evaluated in the Phase Ia/Ib human clinical trial of NV-387.
Page 26 of 106 Table of Contents The Company has licenses to key patents, patent applications and rights to proprietary and patent-pending technologies related to our compounds, products and technologies (see Table 1), but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.
Page 33 of 107 Table of Contents The Company has licenses to key patents, patent applications and rights to proprietary and patent-pending technologies related to our compounds, products and technologies (see Table 1), but we cannot be certain that issued patents will be enforceable or provide adequate protection or that pending patent applications will result in issued patents.
Both drugs led to approximately 85-100% increase in survival of the animals. Moreover, treatment with an oral co-formulation of NV-387 and tecovirimat together developed by us (that we call NV-387-m-T, “m” for “mixed-in”), led to a significantly increased survival improvement of about 138% compared to either drug given alone.
Both drugs led to approximately 85-100% increase in survival of the animals. Moreover, Page 28 of 107 Table of Contents treatment with an oral co-formulation of NV-387 and tecovirimat together developed by us (that we call NV-387-m-T, “m” for “mixed-in”), led to a significantly increased survival improvement of about 138% compared to either drug given alone.
Chickenpox remains a sporadic epidemic disease despite vaccines. Page 40 of 106 Table of Contents Expansion to additional indications is likely, as we perform further studies. It is likely that some of these drug candidates with variations may be able to address diseases caused by the remaining human herpes viruses, namely EBV, HCMV, HHV-6A, HHV-6B, and HHV-7.
Chickenpox remains a sporadic epidemic disease despite vaccines. Expansion to additional indications is likely, as we perform further studies. It is likely that some of these drug candidates with variations may be able to address diseases caused by the remaining human herpes viruses, namely EBV, HCMV, HHV-6A, HHV-6B, and HHV-7.
Eye Diseases Caused by Herpesviruses (HSV-1, HSV-2, VZV), Ocular Herpes Keratitis, viral Acute Retinal Necrosis (Table 2.H, Drug Modality 2, Modality 3) We believe that we will be able to successfully develop a drug candidate for Ocular Herpes Keratitis (HK) as well. HK is caused by HSV-1 or HSV-2 infection of the external eye.
Eye Diseases Caused by Herpesviruses (HSV-1, HSV-2, VZV), Ocular Herpes Keratitis, viral Acute Retinal Necrosis We believe that we will be able to successfully develop a drug candidate for Ocular Herpes Keratitis (HK) as well. HK is caused by HSV-1 or HSV-2 infection of the external eye.
Further, the treatment of herpes virus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need. We are developing replication-inhibitors addressing this resistance issue as well, that we plan on encapsulating within NV-HHV-1. Page 38 of 106 Table of Contents It is known that many of the human herpesvirus infections produce lifelong latent infections.
Further, the treatment of herpes virus infections caused by acyclovir- and famciclovir- resistant mutants is currently an unmet medical need. We are developing replication-inhibitors addressing this resistance issue as well, that we plan on encapsulating within NV-HHV-1. It is known that many of the human herpesvirus infections produce lifelong latent infections.
A highly effective antiviral that can be injected into the eye infrequently and provides sustained antiviral therapeutic effect over a long period of time for ARN is an unmet medical need. Page 41 of 106 Table of Contents Neonatally acquired herpes virus infections, even when asymptomatic, are thought to have led to ARN as late as age 22.
A highly effective antiviral that can be injected into the eye infrequently and provides sustained antiviral therapeutic effect over a long period of time for ARN is an unmet medical need. Neonatally acquired herpes virus infections, even when asymptomatic, are thought to have led to ARN as late as age 22.
Page 56 of 106 Table of Contents On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
On February 12, 2024, the Company entered into an Amendment to the COVID License Agreement with TheraCour dated September 7, 2021, whereby any further cash milestone payments that would be earned upon milestone event would only become payable upon the Company having sufficient revenues, with only a portion of revenues to be used for satisfying such milestone payments.
We then down-select from the effective drug candidates about five to seven candidates for further development based on a number of considerations including the level (or potency) and spectrum of activity, any likely issues with safety/tolerability, drug stability, pharmacokinetics, pharmacodynamics, ease of manufacturing, ease of formulations, and the desired routes of administration.
We then down-select from the effective drug candidates about five to seven candidates for further development based on a number of Page 20 of 107 Table of Contents considerations including the level (or potency) and spectrum of activity, any likely issues with safety/tolerability, drug stability, pharmacokinetics, pharmacodynamics, ease of manufacturing, ease of formulations, and the desired routes of administration.
This forms a significant and stable part of our long term assets, accounting for over $7.5 million in long term assets post-depreciation and amortization as of June 30, 2024. The replacement cost of these assets was estimated, in April 2024, at $18 million by a third party consultant, which we believe is a low-end estimate.
This forms a significant and stable part of our long term assets, accounting for over $6.8 million in long term assets post-depreciation and amortization as of June 30, 2025. The replacement cost of these assets was estimated, in April 2024, at $18 million by a third party consultant, which we believe is a low-end estimate.
The nanoviricides built using Modality 1 as well as Modality 2 can be employed to add the replication-inhibition capability in this manner. NV-CoV-2-R, our other drug in development for treatment of coronaviruses contains the API NV-387-R. This API is made up of remdesivir encapsulated within the belly of the polymeric micelles of NV-387.
The nanoviricides built using Modality 1 as well as Modality 2 can be employed to add the replication-inhibition capability in this manner. Page 18 of 107 Table of Contents NV-CoV-2-R, our other drug in development for treatment of coronaviruses contains the API NV-387-R. This API is made up of remdesivir encapsulated within the belly of the polymeric micelles of NV-387.
NanoViricides State-of-the-Art Nanomedicines Characterization Lab Supports In-Process QC, Release Testing of Manufactured Drug Substance, Drug Products, as well as R&D We have a state-of-the-art nanomedicines characterization facility in-house in the same campus that has all the capabilities necessary for in-process quality control as well as release testing and quality assurance of our drug products and for supporting our manufacturing operations as well as our R&D operations.
NanoViricides State-of-the-Art Nanomedicines Characterization Lab Supports In-Process QC, Release Testing of Manufactured Drug Substance, Drug Products, as well as R&D We have a state-of-the-art nanomedicines characterization facility in-house in the same campus that has all the capabilities necessary for in-process quality control as well as release testing and quality assurance of our drug products and for supporting our manufacturing Page 21 of 107 Table of Contents operations as well as our R&D operations.
Trademarks The Company currently has no registered trademarks. Corporate Events - Financing We had approximately $4.8 million cash in hand as of June 30, 2024, the end of the reporting period. In addition, in February 2024, we obtained a $2 million financing in the form of a line of credit from Dr. Anil Diwan, our founder, President and Executive Chairman.
Trademarks The Company currently has no registered trademarks. Corporate Events - Financing We had approximately $1.6 million cash in hand as of June 30, 2025, the end of the reporting period. In addition, in February 2024, we obtained a $2 million financing in the form of a line of credit from Dr. Anil Diwan, our founder, President and Executive Chairman.
However, we have no knowledge of the extensive active internal developments at a number of companies in the targeted therapeutics area. Page 27 of 106 Table of Contents TheraCour may obtain patents for the compounds many years before we obtain marketing approval for them.
However, we have no knowledge of the extensive active internal developments at a number of companies in the targeted therapeutics area. Page 34 of 107 Table of Contents TheraCour may obtain patents for the compounds many years before we obtain marketing approval for them.
Further analysis of gross histology as well as micro- histopathology of lungs from the animals treated with NV-387 compared to ribavirin was also conducted. The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all-time points during the study, including at the end of the study.
Page 25 of 107 Table of Contents Further analysis of gross histology as well as micro- histopathology of lungs from the animals treated with NV-387 compared to ribavirin was also conducted. The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all-time points during the study, including at the end of the study.
We reported on these results in a press release dated May 6, 2024. We also studied the effect of NV-387 treatment on the lung mucus index, as well as lung immune cell infiltration in this animal trial. Lung mucus index is a parameter that measures the lung congestion and relates to pneumonia symptoms.
We reported on these results in a press release dated May 6, 2024. Page 26 of 107 Table of Contents We also studied the effect of NV-387 treatment on the lung mucus index, as well as lung immune cell infiltration in this animal trial. Lung mucus index is a parameter that measures the lung congestion and relates to pneumonia symptoms.
When and if we are able to successfully develop products, they would compete with existing products based primarily on: ● efficacy; ● safety; ● tolerability; ● acceptance by doctors; ● patient compliance; ● patent protection; ● ease of use; ● price; Page 46 of 106 Table of Contents ● insurance and other reimbursement coverage; ● distribution; ● marketing; and ● adaptability to various modes of dosing.
When and if we are able to successfully develop products, they would compete with existing products based primarily on: ● efficacy; ● safety; ● tolerability; ● acceptance by doctors; ● patient compliance; ● patent protection; ● ease of use; ● price; ● insurance and other reimbursement coverage; ● distribution; ● marketing; and ● adaptability to various modes of dosing.
Page 11 of 106 Table of Contents NanoViricide Platform Enables Drugs That Can Be Designed To Block the Complete Virus Lifecycle, Thus Enabling Potential Cure for Non-Latency Viruses A nanoviricide is made by chemically covalently linking a “nanomicelle” - a globular polymeric micelle with pendant lipid chains inside - to one or more different small chemical ligands designed to mimic the cellular receptor to which the virus binds.
NanoViricide Platform Enables Drugs That Can Be Designed To Block the Complete Virus Lifecycle, Thus Enabling Potential Cure for Non-Latency Viruses A nanoviricide is made by chemically covalently linking a “nanomicelle” - a globular polymeric micelle with pendant lipid chains inside - to one or more different small chemical ligands designed to mimic the cellular receptor to which the virus binds.
Some viruses use more than one receptor. The nanoviricide platform technology allows use of different ligands on the same nanoviricide drug to be able to attack such difficult viruses. It would be very difficult for a virus to become resistant to a nanoviricide that mimics the virus’ cognate cellular receptor.
The nanoviricide platform technology allows use of different ligands on the same nanoviricide drug to be able to attack such difficult viruses. It would be very difficult for a virus to become resistant to a nanoviricide that mimics the virus’ cognate cellular receptor.
Additionally, we believe that NV-387 may have effectiveness against many other viruses including viruses that do not have current treatments such as Henipaviruses (Hendra and Nipa viruses), many hemorrhagic viruses of interest to the Department of Defense, and others.
Additionally, we believe that NV-387 may have effectiveness against many other viruses including viruses that do not have current treatments such as Henipaviruses (Hendra and Nipa viruses), filoviruses (Ebola and Marburg viruses), other hemorrhagic viruses of interest to the Department of Defense, among others.
Page 24 of 106 Table of Contents Licenses, Patents, Trademarks, Proprietary Rights: Intellectual Property Licenses from TheraCour Our drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. (TheraCour) that enabled creation of drugs engineered specifically to combat viral diseases in humans.
Licenses, Patents, Trademarks, Proprietary Rights: Intellectual Property Licenses from TheraCour Our drug development business model was formed in May 2005 with a license to the patents and intellectual property held by TheraCour Pharma, Inc. (TheraCour) that enabled creation of drugs engineered specifically to combat viral diseases in humans.
While this loads up our initial activities, it is expected to minimize the risk for further drug development towards IND or regulatory filings by making available backup drug candidates with different PK-PD profiles. Our work-plan is expected to reduce certain risks of drug development.
While this loads up our initial activities, it is expected to minimize the risk for further drug development towards IND or regulatory filings by making available backup drug candidates with different PK-PD profiles. Page 56 of 107 Table of Contents Our work-plan is expected to reduce certain risks of drug development.
Page 22 of 106 Table of Contents Activity of Oral NV-387 in Lethal Lung Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone We also conducted evaluation of activity of NV-387 compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus lung infection in mice.
Activity of Oral NV-387 in Lethal Lung Poxvirus Infection in Mice Matched that of Approved Drug Tecovirimat; Activity of Combination of NV-387 and Tecovirimat was Significantly Better than Either Drug Alone We also conducted evaluation of activity of NV-387 compared to the approved drug tecovirimat (TPOXX®, SIGA) in a lethal model of mousepox (ectromelia) virus lung infection in mice.
For example, most cases of viral Acute Retinal Necrosis (ARN), a disease that leads to severe loss of vision and can lead to blindness, have been linked to VZV and HSV-2, with some also associated with HSV-1 or CMV infection of the eye.
For example, most cases of viral Acute Retinal Necrosis (ARN), a disease that leads to severe loss of vision and can lead to blindness, have been Page 45 of 107 Table of Contents linked to VZV and HSV-2, with some also associated with HSV-1 or CMV infection of the eye.
The Fast Track program that is intended to expedite or facilitate the process for reviewing new drug products that treat a serious condition and fill an unmet medical need. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied.
Page 52 of 107 Table of Contents The Fast Track program that is intended to expedite or facilitate the process for reviewing new drug products that treat a serious condition and fill an unmet medical need. Fast Track designation applies to the combination of the product and the specific indication for which it is being studied.
Other Health Care Laws In the event any of proposed products are ever approved for marketing, we may also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments where we may market our product candidates, if approved.
Page 54 of 107 Table of Contents Other Health Care Laws In the event any of proposed products are ever approved for marketing, we may also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments where we may market our product candidates, if approved.
The NYSE-American Exchange requires additional corporate governance, financial and reporting requirements. The Company is fully compliant with the requirements of the NYSE-American regarding requirements for independent board members and board committee compositions. Website Our website address is www.nanoviricides.com. Information on our website is not incorporated by reference herein.
The NYSE-American Exchange requires additional corporate governance, financial and reporting requirements. The Company is fully compliant with the requirements of the NYSE-American regarding requirements for independent board members and board committee compositions. Page 60 of 107 Table of Contents Website Our website address is www.nanoviricides.com. Information on our website is not incorporated by reference herein.
These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. For many of these viruses there are no antivirals available, or the antivirals have limited applicability.
These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, among others. Page 16 of 107 Table of Contents For many of these viruses there are no antivirals available, or the antivirals have limited applicability.
Thus, we have a strong and broad pipeline that is expected to continue to result in highly effective drug candidates against a number of viral diseases. Page 15 of 106 Table of Contents We are now at the stage of clinically harnessing the development of Modality 1 and Modality 2 nanoviricides drugs.
Thus, we have a strong and broad pipeline that is expected to continue to result in highly effective drug candidates against a number of viral diseases. We are now at the stage of clinically harnessing the development of Modality 1 and Modality 2 nanoviricides drugs.
In this animal study, topical treatment with the nanoviricides® anti-VZV compounds significantly reduced the measures of abnormal pain sensations in a rat model of neuropathic pain. The study was conducted at AR BioSystems in Tampa, FL. A characteristic excruciating pain is a debilitating pathology of shingles presentation.
In this animal study, topical treatment with the nanoviricides® anti-VZV compounds significantly reduced the measures of abnormal pain sensations in a rat model of neuropathic pain. The study was conducted at AR BioSystems in Tampa, FL. A characteristic excruciating pain is a debilitating Page 43 of 107 Table of Contents pathology of shingles presentation.
Page 57 of 106 Table of Contents KMPL is owned by the Diwan family, consisting of four siblings and their immediate families. Dr. Diwan has an undivided share in the Diwan family interest in KMPL. The number of shares is not currently available. Consequent to and subsequent to the KMPL COVID License, KMPL is deemed to be a related party.
KMPL is owned by the Diwan family, consisting of four siblings and their immediate families. Dr. Diwan has an undivided share in the Diwan family interest in KMPL. The number of shares is not currently available. Consequent to and subsequent to the KMPL COVID License, KMPL is deemed to be a related party.
Our Plan for Regulatory Development and Commercialization of Our Drugs The above mentioned broad-spectrum antiviral effect of NV-387 as found in animal models of lethal virus challenge infection suggests that NV-387 is eligible for regulatory clinical development as a potential treatment for RSV, Influenza, MPOX, and Smallpox, in addition to Coronaviruses, based on the current data at hand.
The above mentioned broad-spectrum antiviral effect of NV-387 as found in animal models of lethal virus challenge infection suggests that NV-387 is eligible for regulatory clinical development as a potential treatment for RSV, Influenza, MPox and Smallpox, as well as Measles, in addition to Coronaviruses, based on the current data at hand.
The Nanoviricide Platform technology has been designed from the ground up to enable consistent manufacture and control. Thus, the nanoviricide backbone is a “homopolymer” (i.e. it is made up of a single repeating unit or monomer), which enables a naturally uniform structure.
Page 15 of 107 Table of Contents The Nanoviricide Platform technology has been designed from the ground up to enable consistent manufacture and control. Thus, the nanoviricide backbone is a “homopolymer” (i.e. it is made up of a single repeating unit or monomer), which enables a naturally uniform structure.
Our current plan is focused on developing NV-387 for RSV indication to the necessary stage(s) for potential collaborations, followed by similarly developing NV-HHV-1 for shingles and the follow on systemic anti-herpesviruses drug candidate in the HerpeCide program to the necessary stage(s) for fruitful collaborations.
Our current plan is focused on developing NV-387 for MPox indication and for Respiratory Viruses including Influenza and RSV to the necessary stage(s) for potential collaborations, followed by similarly developing NV-HHV-1 for shingles and the follow on systemic anti-herpesviruses drug candidate in the HerpeCide program to the necessary stage(s) for fruitful collaborations.
We are currently not aware of any approved drugs for the treatment of viral diseases of the external eye. Page 47 of 106 Table of Contents The current approved drugs for influenza include the neuraminidase inhibitors Tamiflu, Relenza, and Peramivir, anti-influenza drugs that are sold by Roche, Glaxo SmithKline (GSK), and BioCryst partners, respectively.
We are currently not aware of any approved drugs for the treatment of viral diseases of the external eye. The current approved drugs for influenza include the neuraminidase inhibitors Tamiflu, Relenza, and Peramivir, anti-influenza drugs that are sold by Roche, Glaxo SmithKline (GSK), and BioCryst partners, respectively.
We found that NV-387 demonstrated excellent anti-RSV activity, almost matching the activity of ribavirin as shown in the table below. Ribavirin is the only drug currently approved for treatment of RSV infection.
We found that NV-387 demonstrated excellent anti-RSV activity, almost matching the activity of ribavirin Page 24 of 107 Table of Contents as shown in the table below. Ribavirin is the only drug currently approved for treatment of RSV infection.
Since ribavirin is highly toxic, the activity of NV-387 demonstrated in this study is of great significance. Page 19 of 106 Table of Contents Importantly, NV-387 given orally at approximately twice the total dose of NV-387 given as an injection produced equivalent results in terms of effect on animal survival.
Since ribavirin is highly toxic, the activity of NV-387 demonstrated in this study is of great significance. Importantly, NV-387 given orally at approximately twice the total dose of NV-387 given as an injection produced equivalent results in terms of effect on animal survival.
If we believe that the data from the Phase III clinical trials show an adequate level of safety and effectiveness, we will file a new drug application (NDA) with the FDA seeking approval to sell the drug for a particular use.
Page 51 of 107 Table of Contents If we believe that the data from the Phase III clinical trials show an adequate level of safety and effectiveness, we will file a new drug application (NDA) with the FDA seeking approval to sell the drug for a particular use.
We may perform initial developmental testing by ourselves and through third parties, such as academic labs, government institutions, contract research organizations, for safety and effectiveness, among other tests. The Company may perform further IND-enabling advanced pre-clinical studies using third parties, such as contract research organizations, usually on clinical drug candidates.
We may perform initial developmental testing by ourselves and through third parties, such as academic labs, government institutions, contract research organizations, for safety and effectiveness, among other tests. The Company may perform further IND-enabling advanced pre-clinical studies using third parties, Page 32 of 107 Table of Contents such as contract research organizations, usually on clinical drug candidates.
Page 17 of 106 Table of Contents External CROs for GLP and Non-GLP Animal Model Studies, Regulatory Affairs Support, and Clinical Trials We depend upon external collaborators and Contract Research Organizations (“CROs”) for all of our animal studies that include antiviral efficacy studies, safety and tolerability studies, in both GLP and non-GLP practices.
External CROs for GLP and Non-GLP Animal Model Studies, Regulatory Affairs Support, and Clinical Trials We depend upon external collaborators and Contract Research Organizations (“CROs”) for all of our animal studies that include antiviral efficacy studies, safety and tolerability studies, in both GLP and non-GLP practices.
(KMPL) who sponsored the drug in India, with a local CRO, around September 2022, and KMPL obtained regulatory permission for the clinical trial towards the end of January 2023. The Phase Ia/Ib clinical trial began with the first human dosing in June 2023.
(KMPL) who sponsored the drug in India, with a local CRO, around September 2022, and KMPL obtained regulatory permission for the clinical trial towards the end of January 2023. Page 23 of 107 Table of Contents The Phase Ia/Ib clinical trial began with the first human dosing in June 2023.
The TheraCour technologies and patents required for execution of our work in the licensed fields and licensed products are automatically licensed to us even if such technologies and patents are developed after the license agreements themselves. Page 25 of 106 Table of Contents Patents, Patent Applications, Proprietary Rights Patents and other proprietary rights are essential for our operations.
The TheraCour technologies and patents required for execution of our work in the licensed fields and licensed products are automatically licensed to us even if such technologies and patents are developed after the license agreements themselves. Patents, Patent Applications, Proprietary Rights Patents and other proprietary rights are essential for our operations.
Page 49 of 106 Table of Contents Clinical Trials If the FDA accepts the investigational new drug application, we study the drug in human clinical trials to determine if the drug is safe and effective. These clinical trials involve a time-consuming and costly three-phase process that often overlap, can take many years to compile and are very expensive.
Clinical Trials If the FDA accepts the investigational new drug application, we study the drug in human clinical trials to determine if the drug is safe and effective. These clinical trials involve a time-consuming and costly three-phase process that often overlap, can take many years to compile and are very expensive.
Page 5 of 106 Table of Contents We executed a Memorandum of Understanding (“MOU”) with TheraCour September 23, 2024 effective as of September 20, 2024, subsequent to the reported period, whereby we have obtained a right of first refusal for all antiviral drug developments including unlicensed developments that occur during the course of the Development Activities as specified in our license agreements, and have set out the process of development of drugs for unlicensed viral indications towards completion of appropriate license agreements.
We executed a Memorandum of Understanding (“MOU”) with TheraCour on September 23, 2024, subsequent to the reported period, whereby we have obtained a right of first refusal for all antiviral drug developments including unlicensed developments that occur during the course of the Development Activities as specified in our license agreements, and have set out the process of development of drugs for unlicensed viral indications towards completion of appropriate license agreements.
Moreover, the nanoviricides were long acting. Viral load suppression continued to hold for more than four weeks after stopping HIVCide treatment. We believe that this strong effect and sustained effect together indicate that HIVCide can be developed as a single agent that would provide “Functional Cure” from HIV/AIDS.
Viral load suppression continued to hold for more than four weeks after stopping HIVCide treatment. We believe that this strong effect and sustained effect together indicate that HIVCide can be developed as a single agent that would provide “Functional Cure” from HIV/AIDS.
Page 7 of 106 Table of Contents Our novel nanoviricide class of drug candidates are designed to specifically attack and dismantle enveloped virus particles, by mimicking the host-side features that the virus particle lands on as it infects a host cell.
Our novel nanoviricide class of drug candidates are designed to specifically attack and dismantle enveloped virus particles, by mimicking the host-side features that the virus particle lands on as it infects a host cell.
The results of this trial are shown in the table below. ​ ​ ​ ​ ​ ​ Survival Lifespan of Lethally Infected Mice - Lung Infection with RSV A2 Treatment Survival, Days Increase in Survival, Days Increase in Survival, % NV-387, Oral 22+ (Complete) > 14 > 175% Ribavirin, Oral 14 6 75% Vehicle, Oral 8 0 0% ​ We were pleasantly surprised to find that the increased oral dosing of NV-387 led to complete survival of all of the lethally lung-RSV-infected mice, well beyond the 21 day study length, and they remained healthy until final sacrifice as per protocol at 30 days.
The results of this trial are shown in the table below. ​ ​ ​ ​ ​ ​ ​ Survival Lifespan and Lung Microhistopathology of Lethally Infected Mice - Lung Infection with RSV A2 Treatment Survival, Days Increase in Survival, Days Increase in Survival, % Lung histopathology NV-387, Oral Complete ​ Cured ​ Cured No Lung Damage Ribavirin, Oral 14 6 75% Immune Infiltration, Pneumonia Vehicle, Oral 8 0 0% Immune Infiltration, Pneumonia ​ We were pleasantly surprised to find that the increased oral dosing of NV-387 led to complete survival of all of the lethally lung-RSV-infected mice, well beyond the 21 day study length, and they remained healthy until final sacrifice as per protocol at 30 days.
Page 54 of 106 Table of Contents We intend to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies for further development of NV-387 and other drugs in our pipeline.
We intend to pursue non-diluting funding sources such as government grants and contracts as well as licensing agreements with other pharmaceutical companies for further development of NV-387 and other drugs in our pipeline.
NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris LLP. In consideration for the COVID License Agreement, the Company issued 100,000 shares of the Company’s Series A Preferred Stock upon execution of the agreement in 2021.
NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris LLP. Page 58 of 107 Table of Contents In consideration for the COVID License Agreement, the Company issued 100,000 shares of the Company’s Series A Preferred Stock upon execution of the agreement in 2021.
We would like to continue to further explore the effectiveness of NV-387 against many other important human pathogenic viruses that are known to utilize S-PG attachment receptors. For example, Nipah virus causes sporadic lethal outbreaks in India and Bangladesh in particular.
We intend, subject to financing, to further explore the effectiveness of NV-387 against many other important human pathogenic viruses that are known to utilize S-PG attachment receptors. For example, Nipah virus causes sporadic lethal outbreaks in India and Bangladesh in particular.
Development fees and other costs charged by TheraCour for the years ended June 30, 2024 and 2023 were approximately $2,550,000 and $2,536,000, respectively. At June 30, 2024, approximately $720,000, was due to TheraCour. No royalties are due TheraCour from the Company’s inception through June 30, 2024. TheraCour is affiliated with the Company through Dr.
Development fees and other costs charged by TheraCour for the years ended June 30, 2025 and 2024 were approximately $2,490,000 and $2,550,000, respectively. At June 30, 2025, approximately $584,000, was due to TheraCour. No royalties are due TheraCour from the Company’s inception through June 30, 2025. TheraCour is affiliated with the Company through Dr.
Page 45 of 106 Table of Contents Broad and Expanding Drug Pipeline Enabled by the NanoViricides Platform Technology As can be seen from these extensive lists of drug development programs and targets, we have been making tremendous progress year-over-year in bringing successful anti-viral drugs based on our novel technology platform into human clinical studies.
Broad and Expanding Drug Pipeline Enabled by the NanoViricides Platform Technology As can be seen from these extensive lists of drug development programs and targets, we have been making tremendous progress year-over-year in bringing successful anti-viral drugs based on our novel technology platform into human clinical studies, as permitted by available financing.
Page 12 of 106 Table of Contents In the reported year, we have also reported on the antiviral activity of NV-387 in animal models relevant to Smallpox/Mpox (orthopoxvirus) infections, measured by increase in survival in relevant lethal virus-challenge animal models.
In the reported year, we have also reported on the antiviral activity of NV-387 in animal models relevant to Smallpox/Mpox (orthopoxvirus) infections, measured by increase in survival in relevant lethal virus-challenge animal models.
On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023.
Page 35 of 107 Table of Contents On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023.
These ligands are chemically attached to the base polymer or “nanomicelle,” to create a nanoviricide. When a nanoviricide nanomicelle “sees” a virus particle, several of these ligands associated with the nanomicelle are expected to bind to the virus particle.
These ligands are chemically attached to the base polymer or “nanomicelle,” to create a nanoviricide. Page 14 of 107 Table of Contents When a nanoviricide nanomicelle “sees” a virus particle, several of these ligands associated with the nanomicelle are expected to bind to the virus particle.
Page 21 of 106 Table of Contents The results further indicated that NV-387 treatment resulted in significant reduction in mucus load in the lungs. The extent of mucus in the lung tissue was substantially reduced in the case of NV-387 treatment a positive finding.
The results further indicated that NV-387 treatment resulted in significant reduction in mucus load in the lungs. The extent of mucus in the lung tissue was substantially reduced in the case of NV-387 treatment a positive finding.
Page 3 of 106 Table of Contents NanoViricides Technology Platform in Brief We are a clinical stage company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling a targeted virus, (c) without assistance from the human immune system. a.
Page 3 of 107 Table of Contents NanoViricides Technology Platform Target Product Profile in Brief We are a clinical stage company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling a targeted virus, (c) without assistance from the human immune system. a. Virus Escape Unlikely.
We believe that our approach for improved drug safety is validated by the demonstration of strong relevant results in animal studies of NV-387 for safety and tolerability.
Page 13 of 107 Table of Contents We believe that our approach for improved drug safety is validated by the demonstration of strong relevant results in animal studies of NV-387 for safety and tolerability.
This model emulates the virus infection by transfer of virus via skin abrasion, a mode of infection that has been found to be the dominant mode in Mpox virus epidemics in the West.
This model emulates the virus infection by transfer of virus via skin Page 27 of 107 Table of Contents abrasion, a mode of infection that has been found to be the dominant mode in Mpox virus epidemics in the West.
Page 50 of 106 Table of Contents The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.
The FDA may refuse to file any NDA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeWe also are subject to the following risks and obligations, related to the approval of our products: ● The FDA or foreign regulators may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them. ● If regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution. ● In addition, many foreign countries control pricing and coverage under their respective national social security systems. ● The FDA or foreign regulators may not approve our manufacturing processes or manufacturing facilities. ● The FDA or foreign regulators may change their approval policies or adopt new regulations. ● Even if regulatory approval for any product is obtained, the marketing license will be subject to continual review, and newly discovered or developed safety or effectiveness data may result in suspension or revocation of the marketing license. ● If regulatory approval of the product candidate is granted, the marketing of that product would be subject to adverse event reporting requirements and a general prohibition against promoting products for unapproved or “off-label” uses. ● In some foreign countries, we may be subject to official release requirements that require each batch of the product we produce to be officially released by regulatory authorities prior to its distribution by us. ● We will be subject to continual regulatory review and periodic inspection and approval of manufacturing modifications, including compliance with current GMP regulations.
Biggest changePage 66 of 107 Table of Contents ● The FDA or foreign regulators may change their approval policies or adopt new regulations. ● Even if regulatory approval for any product is obtained, the marketing license will be subject to continual review, and newly discovered or developed safety or effectiveness data may result in suspension or revocation of the marketing license. ● If regulatory approval of the product candidate is granted, the marketing of that product would be subject to adverse event reporting requirements and a general prohibition against promoting products for unapproved or “off-label” uses. ● In some foreign countries, we may be subject to official release requirements that require each batch of the product we produce to be officially released by regulatory authorities prior to its distribution by us. ● We will be subject to continual regulatory review and periodic inspection and approval of manufacturing modifications, including compliance with current GMP regulations.
Our ability to become profitable depends primarily on the following factors: ● our ability to develop drugs, obtain approval for such drugs, and if approved, to successfully commercialize our nanoviricide drug(s); ● our R&D efforts, including the timing and cost of clinical trials; and ● our ability to enter into favorable alliances with third parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.
Our ability to become profitable depends primarily on the following factors: ● our ability to develop drugs, obtain approval for such drugs, and if approved, to successfully commercialize our nanoviricide drug(s); ● our R&D efforts, including the timing and cost of clinical trials; ● our ability to enter into favorable alliances with third parties who can provide substantial capabilities in clinical development, regulatory affairs, sales, marketing and distribution.
Factors affecting our R&D expenses include, but are not limited to: ● the number and outcome of clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number of late-stage clinical studies that we may be required to conduct; ● the number, extent, and outcome of pre-clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number and extent of IND-enabling pre-clinical studies including CMC Studies, Tox Package Studies, and Quality Programs that we may be required to conduct; ● the number of drugs entering into pre-clinical development from research; for example, there is no guarantee that internal research efforts will succeed in generating sufficient data for us to make a positive development decision; ● licensing activities, including the timing and amount of related development funding or milestone payments; for example, we may enter into agreements requiring us to pay a significant up-front fee for the purchase of in-process R&D that we may record as R&D expense; and Page 66 of 106 Table of Contents ● maintenance of our relationship with our licensing partner TheraCour and our rights and obligations under the license agreements, including any conflict, dispute or disagreement arising from our failure to satisfy payment obligations under such agreement, our ability to develop and commercialize the affected product candidate may be adversely affected.
Factors affecting our R&D expenses include, but are not limited to: ● the number and outcome of clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number of late-stage clinical studies that we may be required to conduct; ● the number, extent, and outcome of pre-clinical studies we are planning to conduct; for example, our R&D expenses may increase based on the number and extent of IND-enabling pre-clinical studies including CMC Studies, Tox Package Studies, and Quality Programs that we may be required to conduct; ● the number of drugs entering into pre-clinical development from research; for example, there is no guarantee that internal research efforts will succeed in generating sufficient data for us to make a positive development decision; Page 68 of 107 Table of Contents ● licensing activities, including the timing and amount of related development funding or milestone payments; for example, we may enter into agreements requiring us to pay a significant up-front fee for the purchase of in-process R&D that we may record as R&D expense; and ● maintenance of our relationship with our licensing partner TheraCour and our rights and obligations under the license agreements, including any conflict, dispute or disagreement arising from our failure to satisfy payment obligations under such agreement, our ability to develop and commercialize the affected product candidate may be adversely affected.
If our securities are delisted from trading on the NYSE American and we are not able to list our securities on another exchange or to have them quoted on NASDAQ, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; Page 77 of 106 Table of Contents ● a limited amount of news and analyst coverage for us; and ● a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3 or obtain additional financing in the future).
If our securities are delisted from trading on the NYSE American and we are not able to list our securities on another exchange or to have them quoted on NASDAQ, our securities could be quoted on the OTC Bulletin Board or on the “pink sheets.” As a result, we could face significant adverse consequences including: ● a limited availability of market quotations for our securities; ● a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities; Page 79 of 107 Table of Contents ● a limited amount of news and analyst coverage for us; and ● a decreased ability to issue additional securities (including pursuant to short-form registration statements on Form S-3 or obtain additional financing in the future).
These factors include but are not limited to: ● progress of our products through the regulatory process ● results of preclinical studies and clinical trials; ● announcements of technological innovations or new products by us or our competitors; ● government regulatory action affecting our products or our competitors’ products in both the United States and foreign countries; ● developments or disputes concerning patent or proprietary rights; Page 78 of 106 Table of Contents ● general market conditions for emerging growth and pharmaceutical companies; ● economic conditions in the United States or abroad; ● actual or anticipated fluctuations in our operating results; ● broad market fluctuations; and ● changes in financial estimates by securities analysts.
These factors include but are not limited to: ● progress of our products through the regulatory process ● results of preclinical studies and clinical trials; ● announcements of technological innovations or new products by us or our competitors; ● government regulatory action affecting our products or our competitors’ products in both the United States and foreign countries; ● developments or disputes concerning patent or proprietary rights; Page 80 of 107 Table of Contents ● general market conditions for emerging growth and pharmaceutical companies; ● economic conditions in the United States or abroad; ● actual or anticipated fluctuations in our operating results; ● broad market fluctuations; and ● changes in financial estimates by securities analysts.
Our proposed products are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to: ● the absence of an operating history; ● the lack of commercialized products; Page 60 of 106 Table of Contents ● insufficient capital; ● expected substantial and continual losses for the foreseeable future; ● limited experience in dealing with regulatory issues; the lack of manufacturing experience and limited marketing experience; ● an expected reliance on third parties for the development and commercialization of our proposed products; ● a competitive environment characterized by numerous, well-established and well capitalized competitors; ● reliance on key personnel.
Our proposed products are subject to all of the risks inherent in the establishment of a new business enterprise, including but not limited to: ● the absence of an operating history; ● the lack of commercialized products; ● insufficient capital; ● expected substantial and continual losses for the foreseeable future; ● limited experience in dealing with regulatory issues; the lack of manufacturing experience and limited marketing experience; ● an expected reliance on third parties for the development and commercialization of our proposed products; ● a competitive environment characterized by numerous, well-established and well capitalized competitors; ● reliance on key personnel.
The success of our product candidates will depend on several factors, including the following: ● successfully designing preclinical studies which may be predictive of clinical outcomes; ● successful results from preclinical and clinical studies; ● receipt of marketing approvals from applicable regulatory authorities; ● obtaining and maintaining patent and trade secret protection for future product candidates; ● establishing and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability; and ● successfully commercializing our products, if and when approved, whether alone or in collaboration with others.
The success of our product candidates will depend on several factors, including the following: ● successfully designing preclinical studies which may be predictive of clinical outcomes; ● successful results from preclinical and clinical studies; ● receipt of marketing approvals from applicable regulatory authorities; ● obtaining and maintaining patent and trade secret protection for future product candidates; ● establishing and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability; and Page 67 of 107 Table of Contents ● successfully commercializing our products, if and when approved, whether alone or in collaboration with others.
In addition, any failures by third parties to adequately perform their responsibilities may delay the submission of our proposed products for regulatory approval, impair our ability to deliver our products on a timely basis, increase our costs, or otherwise impair our competitive position. Page 70 of 106 Table of Contents We have limited manufacturing experience.
In addition, any failures by third parties to adequately perform their responsibilities may delay the submission of our proposed products for regulatory approval, impair our ability to deliver our products on a timely basis, increase our costs, or otherwise impair our competitive position. Page 72 of 107 Table of Contents We have limited manufacturing experience.
Termination for default provisions do not permit these recoveries and make us liable for excess costs incurred by the U.S. government in procuring undelivered items from another source. Page 74 of 106 Table of Contents As a U.S. government contractor, we may become subject to periodic audits and reviews.
Termination for default provisions do not permit these recoveries and make us liable for excess costs incurred by the U.S. government in procuring undelivered items from another source. Page 76 of 107 Table of Contents As a U.S. government contractor, we may become subject to periodic audits and reviews.
Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of those intellectual property rights. Page 69 of 106 Table of Contents Thus, it is possible that one or more organizations will hold patent rights to which we will need a license.
Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of those intellectual property rights. Page 71 of 107 Table of Contents Thus, it is possible that one or more organizations will hold patent rights to which we will need a license.
Page 72 of 106 Table of Contents We employ the use of certain chemical and biological agents and compounds that may be deemed hazardous and we are therefore subject to various environmental laws and regulations. Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable.
Page 74 of 107 Table of Contents We employ the use of certain chemical and biological agents and compounds that may be deemed hazardous and we are therefore subject to various environmental laws and regulations. Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable.
Page 76 of 106 Table of Contents The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates. Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.
Page 78 of 107 Table of Contents The successful development of biopharmaceuticals is highly uncertain. A variety of factors including, pre-clinical study results or regulatory approvals, could cause us to abandon development of our drug candidates. Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.
We control the research and work TheraCour performs on our behalf and no costs may be incurred without our prior authorization or approval. Page 71 of 106 Table of Contents We depend on TheraCour and other third parties to perform manufacturing activities effectively and on a timely basis.
We control the research and work TheraCour performs on our behalf and no costs may be incurred without our prior authorization or approval. Page 73 of 107 Table of Contents We depend on TheraCour and other third parties to perform manufacturing activities effectively and on a timely basis.
Our ability to generate revenue depends heavily on: ● demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; ● successful development of our first product candidate in our pipeline; ● our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; ● the successful commercialization of our product candidates; and ● market acceptance of our products.
Our ability to generate revenue depends heavily on: ● demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; Page 62 of 107 Table of Contents ● successful development of our first product candidate in our pipeline; ● our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; ● the successful commercialization of our product candidates; and ● market acceptance of our products.
Page 73 of 106 Table of Contents The Company does not allow a conflicted shareholder, director, or executive officer to vote on matters wherein a conflict may be perceived. The conflicted person or entity is not allowed to nominate an alternate person to vote for them either.
Page 75 of 107 Table of Contents The Company does not allow a conflicted shareholder, director, or executive officer to vote on matters wherein a conflict may be perceived. The conflicted person or entity is not allowed to nominate an alternate person to vote for them either.
Approximately 668,384 shares of our restricted shares of common stock are held by non-affiliates who may avail themselves of the public information requirements and sell their shares in accordance with Rule 144. As a result, some or all of these shares may be sold in accordance with Rule 144 potentially causing the price of the Company’s shares to decline.
Approximately 1,092,000 shares of our restricted shares of common stock are held by non-affiliates who may avail themselves of the public information requirements and sell their shares in accordance with Rule 144. As a result, some or all of these shares may be sold in accordance with Rule 144 potentially causing the price of the Company’s shares to decline.
Page 68 of 106 Table of Contents Efforts of government and third-party payers to contain or reduce the costs of health care may adversely affect our revenues even if we were to develop an FDA approved drug.
Page 70 of 107 Table of Contents Efforts of government and third-party payers to contain or reduce the costs of health care may adversely affect our revenues even if we were to develop an FDA approved drug.
Page 62 of 106 Table of Contents Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance of the successful and timely development of new drugs. Our drug candidates are in their clinical and pre-clinical developmental stages.
Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control. Consequently, we can provide no assurance of the successful and timely development of new drugs. Our drug candidates are in their clinical and pre-clinical developmental stages.
We hope that our drug candidates under development and in clinical trials will address major markets within the anti-viral sector. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities.
We believe that our drug candidates under development and in clinical trials address major markets and unmet medical needs within the anti-viral sector. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities.
Anil Diwan owns approximately 90% of the capital stock of TheraCour, which as of June 30, 2024, owned 3.6% of our common stock, and 681,859 shares of the Company’s Series A preferred stock, and provides the nanomaterials to the Company with which it intends to develop its products and is the holder of the intellectual property rights the Company uses to conduct its operations.
Anil Diwan owns approximately 90% of the capital stock of TheraCour, which as of June 30, 2025, owned 2.8% of our common stock, and 681,859 shares of the Company’s Series A preferred stock, and provides the nanomaterials to the Company with which it intends to develop its products and is the holder of the intellectual property rights the Company uses to conduct its operations.
Page 64 of 106 Table of Contents We can provide no assurance that our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable. The testing, marketing and manufacturing of any product for use in the United States will require approval from the FDA.
We can provide no assurance that our drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable. The testing, marketing and manufacturing of any product for use in the United States will require approval from the FDA.
The sale or the proposed sale of substantial amounts of our common stock in the public markets may adversely affect the market price of our common stock and our stock price may decline substantially. Page 79 of 106 Table of Contents The Company is authorized to issue up to 150,000,000 shares of common stock without additional approval by shareholders.
The sale or the proposed sale of substantial amounts of our common stock in the public markets may adversely affect the market price of our common stock and our stock price may decline substantially. The Company is authorized to issue up to 150,000,000 shares of common stock without additional approval by shareholders.
Management believes that the Company’s cash and cash equivalents balance of approximately $4.8 million, additional capital raised of approximately $1.5 million by ATM sales of our common stock from July 1, 2024 through September 10, 2024, and 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-K.
Management believes that the Company’s cash and cash equivalents balance of approximately $1.6 million, additional capital raised of approximately $1.25 million, by ATM sales of our common stock from July 1, 2025 through September 24, 2025, and 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-K.
This would necessitate implementing staff reductions and operational adjustments that would include reductions in the following business areas: ● research and development programs; ● preclinical studies and clinical trials; material characterization studies, regulatory processes; Page 61 of 106 Table of Contents ● a search for third party marketing partners to market our products for us.
This would necessitate implementing staff reductions and operational adjustments that would include reductions in the following business areas: ● research and development programs; ● preclinical studies and clinical trials; material characterization studies, regulatory processes; ● a search for third party marketing partners to market our products for us.
BioCryst Pharmaceuticals, Inc. has achieved FDA approval for IV Infusions formulations of peramivir, an influenza neuraminidase inhibitor, for the treatment of uncomplicated influenza. Peramivir is approved in Japan and had obtained emergency use authorization in the US. Its effectiveness during multiple clinical trials was found to be severely limited.
Generic competitors include amantadine and rimantadine, both oral. BioCryst Pharmaceuticals, Inc. has achieved FDA approval for IV Infusions formulations of peramivir, an influenza neuraminidase inhibitor, for the treatment of uncomplicated influenza. Peramivir is approved in Japan and had obtained emergency use authorization in the US. Its effectiveness during multiple clinical trials was found to be severely limited.
Even if we have positive results from our preclinical testing of our products, this may not necessarily be predictive of the results from our planned clinical trials in humans.
Because the results of preclinical testing are not necessarily predictive of future results, our products may not have favorable results in our planned clinical trials. Even if we have positive results from our preclinical testing of our products, this may not necessarily be predictive of the results from our planned clinical trials in humans.
At June 30, 2024, shareholders of the Company held 1,330,156 shares of restricted common stock, or approximately 10.1% of the outstanding Common Stock. If we were to file a registration statement including all of these shares, and the registration is allowed by the SEC, these shares would be freely tradable upon the effectiveness of the planned registration statement.
At June 30, 2025, shareholders of the Company held 1,692,259 shares of restricted common stock, or approximately 10.2% of the outstanding Common Stock. If we were to file a registration statement including all of these shares, and the registration is allowed by the SEC, these shares would be freely tradable upon the effectiveness of the planned registration statement.
Page 75 of 106 Table of Contents Our RSV drug does not have any direct competition at present but there are two protective antibodies as well as three vaccines for RSV, although there are no approved treatments other than the highly toxic last-resort drug, ribavirin.
Our RSV drug does not have any direct competition at present but there are two protective antibodies as well as three vaccines for RSV, although there are no approved treatments other than the highly toxic last-resort drug, ribavirin.
Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals.
Page 69 of 107 Table of Contents Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals.
These include brincidofovir, cyclopropavir, valamocyclovir, pritelivir, letermovir, as well as antibodies. Their patient benefit profiles are not known at present. Our anti-influenza drug in development, Flucide, would compete with neuraminidase inhibitors Tamiflu and Relenza, anti-influenza drugs that are sold by Roche and Glaxo SmithKline (GSK), respectively. Generic competitors include amantadine and rimantadine, both oral.
These include brincidofovir, cyclopropavir, valamocyclovir, pritelivir, letermovir, as well as antibodies. Their patient benefit profiles are not known at present. Our Influenza drug candidate would compete with already approved therapies. Our anti-influenza drug in development, Flucide, would compete with neuraminidase inhibitors Tamiflu and Relenza, anti-influenza drugs that are sold by Roche and Glaxo SmithKline (GSK), respectively.
Failure to complete clinical trials or to prove that our drug candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations. We have limited manufacturing expertise and we may have to rely on external manufacturers.
Failure to complete clinical trials or to prove that our drug candidates are safe and effective would have a material adverse effect on our ability to generate revenue and could require us to reduce the scope of or discontinue our operations.
Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability. We have incurred significant operating losses and may not ever be profitable. As of June 30, 2024, we had a cash and cash equivalent balance of $4,797,778.
Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability. We have incurred significant operating losses and may not ever be profitable. As of June 30, 2025, we had a cash and cash equivalent balance of approximately $1.6 million.
We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms.
Page 63 of 107 Table of Contents We will need to raise substantial additional capital in the future to fund our operations and we may be unable to raise such funds when needed and on acceptable terms.
Also, we have incurred significant operating losses since its inception, resulting in an accumulated deficit of $139,374,895 at June 30, 2024. Such losses are expected to continue for the foreseeable future.
Also, we have incurred significant operating losses since its inception, resulting in an accumulated deficit of approximately $149 million at June 30, 2025. Such losses are expected to continue for the foreseeable future.
The regulatory process to obtain approval for drugs for commercial sale involves numerous steps. Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA.
Drugs are subjected to clinical trials that allow development of case studies to examine safety, efficacy, and other issues to ensure that sale of drugs meets the requirements set forth by various governmental agencies, including the FDA.
We have limited experience in drug development, and may not be able to successfully develop any drugs.
Page 64 of 107 Table of Contents We have limited experience in drug development, and may not be able to successfully develop any drugs.
We have estimated a total cash expenditure budget of approximately $7.9 million for the period of July 2024 through October 2025 of which approximately $4.9 million is expected to be spent on research and development for our drug candidates, including completion and reporting of the Phase I clinical trial and preparation for the Phase II clinical trial of our lead drug candidate NV-387 for treatment of RSV, an IND filing for RSV indication, and approximately $3 million is budgeted for general and administrative expenses.
We have estimated a total cash expenditure budget of approximately $11 million for the period of July 2025 through October 2026 of which approximately $7.0 million is expected to be spent on research and development for our drug candidates, including completion and reporting of the Phase I clinical trial. $1 million has been budgeted toward execution of the Phase II clinical trial of our lead drug candidate NV-387 for treatment of MPox, and approximately $3 million is budgeted for general and administrative expenses.
The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict.
The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict. We have limited experience in conducting or supervising clinical trials and must outsource all clinical trials.
In addition 892,625 shares of Series A preferred stock are restricted and convertible into 3,124,188 shares of common stock only upon of a change of control of the Company.
In addition 905,717 shares of Series A preferred stock are restricted and convertible into 3,170,010 shares of common stock only upon of a change of control of the Company.
Page 63 of 106 Table of Contents The process of obtaining FDA approval has historically been costly and time consuming.
The process of obtaining FDA approval has historically been costly and time consuming.
As of June 30, 2024, 1,330,156 of 13,144,055 issued and outstanding shares of the Company’s common stock were restricted securities as defined under Rule 144 of the Securities Act of 1933, as amended (the “Act”) and under certain circumstances may be resold without registration pursuant to Rule 144.
As of June 30, 2025, 1,692,259 of 16,606,832 issued and outstanding shares of the Company’s common stock are restricted securities as defined under Rule 144 of the Securities Act of 1933, as amended (the “Act”) and under certain circumstances may be resold without registration pursuant to Rule 144.
These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for testing, manufacturing and marketing. Our Coronavirus drug candidates would compete with the already approved therapies (either EUA or full approvals) and are subject to the COVID pandemic dissipating.
These factors include the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the ability to obtain government approval for testing, manufacturing and marketing. Our Smallpox drug candidate would compete with the already approved therapies.
Page 59 of 106 Table of Contents ● The Company has no sales or marketing personnel. ● The Company’s collaborative relationships with third parties could cause the Company to expend significant resources and incur substantial business risk with no assurance of financial return. ● The Company may be liable for damages caused by biological and hazardous material. ● The Company depends on senior management and their loss or unavailability could put the Company at a competitive disadvantage. ● There exist conflicts of interest among officers, directors and stockholders. ● Risks relating to dependence on U.S. government contracts. ● Company common stock may be considered “penny stock”. ● Management of the Company has identified a material weakness in internal controls that if not remediated could result in material misstatements in our financial statements.
Additionally, we lack suitable facilities for clinical testing which leads to a reliance on third parties. ● The Company may be unable to attract or retain and motivate skilled personnel which will delay product development programs and research and development efforts. ● The Company has no sales or marketing personnel. ● The Company’s collaborative relationships with third parties could cause the Company to expend significant resources and incur substantial business risk with no assurance of financial return. ● The Company may be liable for damages caused by biological and hazardous material. ● The Company depends on senior management and their loss or unavailability could put the Company at a competitive disadvantage. ● There exist conflicts of interest among officers, directors and stockholders. ● Risks relating to dependence on U.S. government contracts. ● Company common stock may be considered “penny stock”.
We believe that the technology we use to manufacture our products and compounds is proprietary, although some of the generalities are patented or patent-pending. For our products, we may have to disclose all necessary aspects of this technology to contract manufacturers to enable them to manufacture the products and compounds for us.
For our products, we may have to disclose all necessary aspects of this technology to contract manufacturers to enable them to manufacture the products and compounds for us.
Page 67 of 106 Table of Contents We have limited experience in conducting or supervising clinical trials and must outsource all clinical trials. We have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA.
We have limited experience in conducting or supervising clinical trials that must be performed to obtain data to submit in concert with applications for approval by the FDA. The regulatory process to obtain approval for drugs for commercial sale involves numerous steps.
Some of the principal risk factors that make an investment in the Company speculative or risky are summarized as follows: ● Our company is in the developmental stage and has no products approved for commercial sale, no generated revenue, and may never achieve profitability. ● The Company will need to raise substantial additional capital in the future to fund operations. ● Due to the nature of the process involved in the development process of pharmaceuticals, the Company can provide no assurance of the successful and timely development of new drugs. ● The Company must comply with significant and complex government regulations, which may delay or prevent the commercialization of drug candidates. ● The Company can provide no assurance that drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable. ● In the event that regulatory approvals are obtained, drug candidates will be subject to regulatory review.
Page 61 of 107 Table of Contents ● Due to the nature of the process involved in the development process of pharmaceuticals, the Company can provide no assurance of the successful and timely development of new drugs. ● The Company must comply with significant and complex government regulations, which may delay or prevent the commercialization of drug candidates. ● The Company can provide no assurance that drug candidates will obtain regulatory approval or that the results of clinical studies will be favorable. ● In the event that regulatory approvals are obtained, drug candidates will be subject to regulatory review.
As of June 30, 2024, we had 13,144,055 shares of common stock outstanding, 6,862 warrants convertible to 6,862 shares of common stock, and 892,625 shares of Series A preferred stock convertible into 3,124,188 shares of common stock only in the event of a change in control. Large amounts of our common stock will be eligible for resale under Rule 144.
As of June 30, 2025, we had 16,606,832 shares of common stock outstanding, 5,720 warrants convertible to 5,720 shares of common stock, and 905,717 shares of Series A preferred stock convertible into 3,170,010 shares of common stock only in the event of a change in control.
Several H5N1 bird flu, and influenza novel H1N1/2009 vaccines are also in development worldwide. Several companies are developing anti-influenza drugs and vaccines.
Several H5N1 bird flu, and influenza novel H1N1/2009 vaccines are also in development worldwide. A new long-acting biologic drug, CD388 (Cidara) is in late clinical trials for use as an influenza prophylactic (i.e. protection before infection, like vaccines), but not as a therapeutic (i.e. treatment after infection and disease). Several companies are developing anti-influenza drugs and vaccines.
Removed
Additionally, we lack suitable facilities for clinical testing which leads to a reliance on third parties. ● The Company may be unable to attract or retain and motivate skilled personnel which will delay product development programs and research and development efforts.
Added
Some of the principal risk factors that make an investment in the Company speculative or risky are summarized as follows: ● Our company is in the developmental stage and has no products approved for commercial sale, no generated revenue, and may never achieve profitability. ● The Company will need to raise substantial additional capital in the future to fund operations.
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Page 65 of 106 Table of Contents Because the results of preclinical testing are not necessarily predictive of future results, our products may not have favorable results in our planned clinical trials.
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Page 65 of 107 Table of Contents We have limited manufacturing expertise and we may have to rely on external manufacturers. We believe that the technology we use to manufacture our products and compounds is proprietary, although some of the generalities are patented or patent-pending.
Added
We also are subject to the following risks and obligations, related to the approval of our products: ● The FDA or foreign regulators may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them. ● If regulatory approval of a product is granted, the approval may be limited to specific indications or limited with respect to its distribution. ● In addition, many foreign countries control pricing and coverage under their respective national social security systems. ● The FDA or foreign regulators may not approve our manufacturing processes or manufacturing facilities.
Added
Our MPox drug candidate at present does not have any known competition, but at least one drug is currently in a clinical trial. Page 77 of 107 Table of Contents Our Measles drug candidate at present does not have any known competition.
Added
However, the potential market size does not support us committing to regulatory drug development for this purpose without non-dilutive funding from other sources. Our Coronavirus drug candidates would compete with the already approved therapies (either EUA or full approvals) and are subject to the COVID pandemic dissipating.
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Page 81 of 107 Table of Contents Large amounts of our common stock will be eligible for resale under Rule 144.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

1 edited+0 added−0 removed7 unchanged
Biggest changeWe select key third-party service providers based on several factors, including the type of data processed and the nature of services offered, and we oversee such key third-party service providers by conducting vendor diligence upon onboarding and ongoing monitoring, including a review of SOC-1 reports on an annual basis, where applicable.
Biggest changeWe select key third-party service providers based on several factors, including the type of data processed and the nature of services offered, and we oversee such key third-party service Page 82 of 107 Table of Contents providers by conducting vendor diligence upon onboarding and ongoing monitoring, including a review of SOC-1 reports on an annual basis, where applicable.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

1 edited+1 added−0 removed0 unchanged
Biggest changeITEM 3: LEGAL PROCEEDINGS. From time to time, we are a party to legal proceedings arising in the ordinary course of business. We are not currently a party to any legal proceedings that we believe could have a material adverse effect on financial condition or results of operations. ITEM 4: MINE SAFETY DISCLOSURES. Not applicable. PART II
Biggest changeITEM 3: LEGAL PROCEEDINGS. From time to time, we are a party to legal proceedings arising in the ordinary course of business. We are not currently a party to any legal proceedings that we believe could have a material adverse effect on financial condition or results of operations. ITEM 4: MINE SAFETY DISCLOSURES.
Added
Not applicable. ​ Page 83 of 107 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+0 added−1 removed0 unchanged
Biggest changeAs of June 30, 2024, a total of 13,144,055 shares of the Company’s common stock are outstanding and held by 146 shareholders of record. This number of shareholders does not reflect the persons or entities that hold their stock in nominee or street name through various brokerage firms.
Biggest changeThis number of shareholders does not reflect the persons or entities that hold their stock in nominee or street name through various brokerage firms. Of this amount 14,914,573 shares are unrestricted, of which 0 shares are held by affiliates, 1,091,838 shares are restricted securities held by non-affiliates, and the remaining 600,421 shares are restricted securities held by affiliates.
The Company currently intends to retain any earnings for use in its business, and therefore does not anticipate paying dividends in the foreseeable future. ITEM 6: [RESERVED] ​ Page 82 of 106 Table of Contents
These shares may only be sold in accordance with Rule 144. Dividends. The Company has not paid any cash dividends since its inception. The Company currently intends to retain any earnings for use in its business, and therefore does not anticipate paying dividends in the foreseeable future. ITEM 6: [RESERVED] ​ Page 84 of 107 Table of Contents
ITEM 5: MARKET FOR REGISTRANT’S COMMON EQUITY RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our Common Stock is listed on the NYSE-American under the symbol “NNVC”. Page 81 of 106 Table of Contents Number of Shareholders.
ITEM 5: MARKET FOR REGISTRANT’S COMMON EQUITY RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES. Our Common Stock is listed on the NYSE-American under the symbol “NNVC”. Number of Shareholders. As of June 30, 2025, a total of 16,606,832 shares of the Company’s common stock are outstanding and held by 143 shareholders of record.
Removed
Of this amount, 11,813,899 shares are unrestricted, of which 0 shares are held by affiliates, 668,384 shares are restricted securities held by non-affiliates, and the remaining 661,772 shares are restricted securities held by affiliates. These shares may only be sold in accordance with Rule 144. Dividends. The Company has not paid any cash dividends since its inception.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

43 edited+22 added−17 removed35 unchanged
Biggest changeOur liabilities as of June 30, 2024 are approximately $1,359,000, including accounts payable of approximately $376,000 payable to third parties, accounts payable to TheraCour of approximately $720,000, accrued expenses approximately $262,000. The Company has an accumulated deficit at June 30, 2024 of approximately $139,375,000 and net cash used in operating activities of approximately $6,316,000 for the fiscal year then ended.
Biggest changeThe Company has an accumulated deficit at June 30, 2025 of approximately $148,842,000 and net cash used in operating activities of approximately $8,479,000 for the fiscal year then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future.
Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2024.
Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2025.
ITEM 7: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion should be read in conjunction with the information contained in the financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Company’s Annual Report on Form 10-K for the year ended June 30, 2024.
ITEM 7: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion should be read in conjunction with the information contained in the financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Company’s Annual Report on Form 10-K for the year ended June 30, 2025.
Under this shelf registration process, we may, from time to time, sell up to $150 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants and units. Approximately $145 million remains available for sale as of the date of this filing.
Under this shelf registration process, we may, from time to time, sell up to $150 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants and units. Approximately $140 million remains available for sale as of the date of this filing.
Results of Operations The Company is a biopharmaceutical company and does not have any revenue for the years ended June 30, 2024 and June 30, 2023. Comparison of the Year End June 30, 2024 to the Year Ended June 30, 2023 Revenues - The Company is a non-revenue producing entity.
Results of Operations The Company is a biopharmaceutical company and does not have any revenue for the years ended June 30, 2025 and June 30, 2024. Comparison of the Year End June 30, 2025 to the Year Ended June 30, 2024 Revenues - The Company is a non-revenue producing entity.
These sales, if any, would have been made pursuant to the terms of the August 1, 2023 ATM Sales Agreement. On April 5, 2024, the Company entered into a new ATM sales agreement with. E.F.
These sales, if any, would have been made pursuant to the terms of the August 1, 2023 ATM Sales Agreement. On April 5, 2024, the Company entered into a new ATM sales agreement with. E.F. Hutton (now D.
Page 85 of 106 Table of Contents Financings On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023.
Page 87 of 107 Table of Contents Financings On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023.
Page 83 of 106 Table of Contents The Company plans to develop several drugs through the preclinical studies and clinical trial phases with the goal of eventually obtaining approval from the United States Food and Drug Administration (“FDA”) for these drugs.
Page 85 of 107 Table of Contents The Company plans to develop several drugs through the preclinical studies and clinical trial phases with the goal of eventually obtaining approval from the United States Food and Drug Administration (“FDA”) for these drugs.
Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with EF Hutton, the Sales Agent, that became active around April 5, 2024.
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 5, 2024.
Hutton Securities (now EF Hutton, LLC), the sales agent, replacing the prior August 1, 2023 sales agreement, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock having an aggregate offering price of up to $50 million (each such offering an “At-the-Market” or ATM Offering).
Boral Capital), the sales agent, replacing the prior August 1, 2023 sales agreement, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents, shares of common stock having an aggregate offering price of up to $50 million (each such offering an “At-the-Market” or ATM Offering).
Management believes that the Company’s cash and cash equivalents balance of approximately $4.8 million and additional capital raised of approximately $1.5 million by ATM sales of our common stock from July 1, 2024 through September 10, 2024 and 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-K.
Management believes that the Company’s cash and cash equivalents balance of approximately $1.6 million at June 30, 2025, and additional capital raised of approximately $1.25 million by ATM sales of our common stock from July 1, 2025 through September 24, 2025 and 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-K.
As of June 30, 2024, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $39,772,000. This amount has been offset by a full valuation allowance.
As of June 30, 2025, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $42,492,000. This amount has been offset by a full valuation allowance.
The decrease in the Company’s net loss for the year ended June 30, 2024 from the year ended June 30, 2023 of $295,000 is generally attributable to the items discussed above. Research and Development Costs The Company does not maintain separate accounting line items for each project in development.
The increase in the Company’s net loss for the year ended June 30, 2025 from the year ended June 30, 2024 of $1,173,000 is generally attributable to the items discussed above. Research and Development Costs The Company does not maintain separate accounting line items for each project in development.
Herpes Simplex virus infections (HSV-1, HSV-2) and VZV Indications: Cold Sores, Genital Ulcers, Shingles and ARN ​ ​ — ​ ​ 100,000 4 Smallpox/Mpox ​ ​ 150,000 ​ ​ — 5 Influenza ​ ​ 100,000 ​ ​ — ​ Total ​ $ 5,437,297 ​ $ 6,392,414 ​ As many of our programs share a substantial amount of materials as well as laboratory work, we do not maintain project-based accounting of costs at present.
Herpes Simplex virus infections (HSV-1, HSV-2) and VZV Indications: Cold Sores, Genital Ulcers, Shingles and ARN ​ $ 100,000 ​ $ — ​ Total ​ $ 5,549,000 ​ $ 5,437,000 ​ As many of our programs share a substantial amount of materials as well as laboratory work, we do not maintain project-based accounting of costs at present.
General and Administration Expenses - General and administrative expenses increased approximately $528,000 to approximately $3,079,000 for the year ended June 30, 2024 from approximately $2,551,000 for the year ended June 30, 2023. The increase in general and administrative expenses is generally attributable to an increase in professional services including, legal, accounting and investor outreach expenditures.
General and Administration Expenses - General and administrative expenses increased approximately $964,000 to approximately $4,043,000 for the year ended June 30, 2025 from approximately $3,079,000 for the year ended June 30, 2024. The increase in general and administrative expenses is generally attributable to an increase in professional services including, legal, accounting, and investor outreach expenditures.
Net Loss - For the year ended June 30, 2024, the Company had a net loss of approximately $8,294,000, or a basic and fully diluted loss per share of $0.70 compared to a net loss of approximately $8,589,000, or a basic and fully diluted loss per share of $0.74 for the year ended June 30, 2023.
Net Loss - For the year ended June 30, 2025, the Company had a net loss of approximately $9,467,000, or a basic and fully diluted loss per share of $0.63 compared to a net loss of approximately $8,294,000, or a basic and fully diluted loss per share of $0.70 for the year ended June 30, 2024.
These anticipated expenses for the subsequent period commencing on July 1, 2024 can be summarized as follows: 1. Planned costs for remaining activities in the Phase Ia/Ib human clinical trial of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies, including bioanalytical activities and reports. 2.
These anticipated expenses for the subsequent period commencing on July 1, 2025 can be summarized as follows: 1. Planned costs for remaining activities in the Phase 1a/1b human clinical trial of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies, including bioanalytical activities and reports. 2. Planned costs for Phase II clinical trial of evaluation of NV-387 for MPox.
The Company believes that it has several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387.
The Company believes that it has have several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for our broad-spectrum drug NV-387 that is now in progress.
The net proceeds to the Company from the offering was approximately $1,533,000 after placement agent fees and other estimated offering expenses. Liquidity and Capital Reserves As of June 30, 2024, we had approximately $4,798,000 in cash and cash equivalents.
The net proceeds to the Company from the offering was approximately $1.25 million after placement agent fees and other estimated offering expenses. Liquidity and Capital Reserves As of June 30, 2025, we had approximately $1.6 million in cash and cash equivalents.
As such, these budget estimates may not be accurate. In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur.
In addition, the actual work to be performed is not known at this time, other than a broad outline, as is normal with any scientific work. As further work is performed, additional work may become necessary or change in plans or workload may occur. Such changes may have an adverse impact on our estimated budget.
Page 84 of 106 Table of Contents Interest Income - Interest income was approximately $272,000 and approximately $356,000 for the years ended June 30, 2024 and 2023, respectively. Interest income decreased due to lower cash balances.
Page 86 of 107 Table of Contents Interest Income - Interest income was approximately $125,000 and approximately $272,000 for the years ended June 30, 2025 and 2024, respectively. Interest income decreased due to lower cash balances.
In summary, we are developing and sourcing compounds and preparing nano-materials; performing experiments involving preclinical studies using cell cultures and animal models of efficacy and safety, advancing drug candidates against different indications into IND-enabling safety/toxicology studies, and we have advanced our first drug candidate for treatment of COVID into Phase Ia/Ib clinical studies.
In summary, we are developing and sourcing compounds and preparing nano-materials; performing experiments involving preclinical studies using cell cultures and animal models of efficacy and safety, advancing drug candidates against different indications into IND-enabling safety/toxicology studies.
The net proceeds to the Company from the offering was approximately $3,120,000 after placement agent fees and other estimated offering expenses. From July 1, 2024 through September 10, 2024, subsequent to the Company’s fiscal year end, the Company sold 772,836 shares of common stock at an average price of approximately $1.98 per share.
The net proceeds to the Company from the offering was approximately $5,296,000 after placement agent fees and other estimated offering expenses. From July 1, 2025 through September 24, 2025 subsequent to the Company’s fiscal year end, the Company sold 824,535 shares of common stock at an average price of approximately $1.57 per share.
Such changes may have an adverse impact on our estimated budget. Such changes may also have an adverse impact on our projected timeline of drug development. Our strategy is to minimize capital expenditure. We therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous collaborators.
Such changes may also have an adverse impact on our projected timeline of drug development. Our strategy is to minimize capital expenditure. We therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous collaborators. Management further intends to use capital and debt financing, as required, to fund the Company’s operations.
Requirement for Additional Capital As of June 30, 2024 we have a cash balance of approximately $4,798,000 and raised an approximate additional $1.5 through September 10, 2024 through ATM sales of our common stock.
Requirement for Additional Capital As of June 30, 2025 we have a cash balance of approximately $1.6 million and raised an approximate additional $1.25 million through September 24, 2025 through ATM sales of our common stock.
While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary Page 88 of 106 Table of Contents assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures. ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures.
Management further intends to use capital and debt financing, as required, to fund the Company’s operations. There can be no assurance that we will be able to obtain the additional capital resources, non-dilutive financings, grants and contracts, or pharmaceutical partnerships.
There can be no assurance that we will be able to obtain the additional capital resources, non-dilutive financings, grants and contracts, or pharmaceutical partnerships.
These costs include staffing costs for the scientific staff and consulting firms to assist with FDA compliance, as well as material characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and other items related to FDA compliance, as required for development of necessary data.
These costs include staffing costs for the scientific staff and consulting firms to assist with regulatory compliance, as well as material characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and other items related to regulatory compliance, as required for development of necessary data. 3. Similarly, planned costs for Phase II clinical trial of evaluation of NV-387 for Viral ARI/SARI.
As a result substantial doubt exists about the Company’s ability to continue as a going concern. 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.
Page 88 of 107 Table of Contents 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.
The table above represents estimated cost allocations for specific activities in the different programs, with the bulk of common activities reported under the “Pan-coronavirus drug program – NV-387” heading.
The table above represents estimated cost allocations for specific activities in the different programs, with the bulk of common activities reported under the “NV-387 Manufacture, Clinical Trials, R&D” heading.
The licenses granted by TheraCour are for entire set of pathologies that the licensed virus is a causative agent for. The licenses are not for single drug/indication pairs, which is the customary mode of licensing in the pharmaceutical industry.
The licenses are not for single drug/indication pairs, which is the customary mode of licensing in the pharmaceutical industry.
The Company may seek to add additional virus types to its drug pipeline as the Company progresses further. The Company would then need to negotiate with TheraCour or an unrelated party appropriate license agreements to include those of such additional viruses that the Company determines it wants to follow for further development.
The Company would then need to negotiate with TheraCour or an unrelated party appropriate license agreements to include those of such additional viruses that the Company determines it wants to follow for further development. Historically, the Company initiates negotiations for additional licenses when initial exploratory research determines that a viable drug candidate for the targeted field is possible.
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.
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.
This includes budgeted office salaries, legal, accounting, investor relations, public relations, business development, and other costs expected to be incurred by being a public reporting company. As our programs mature and as we are able to move additional drug candidates into human clinical trials we will continue to require additional funding for such activities.
As our programs mature and as we are able to move additional drug candidates into human clinical trials we will continue to require additional funding for such activities.
Page 87 of 106 Table of Contents We believe that as our programs mature towards FDA approval, the Company’s market capitalization should improve substantially, based on market capitalizations of comparable public companies in clinical stages.
We believe that as our programs mature towards FDA approval, the Company’s market capitalization should improve substantially, based on market capitalizations of comparable public companies in clinical stages. However, we cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate.
Historically, the Company initiates negotiations for additional licenses when initial exploratory research determines that a viable drug candidate for the targeted field is possible. We are seeking to add to our existing portfolio of products through our internal discovery pre-clinical development programs and through an in-licensing strategy.
We are seeking to add to our existing portfolio of products through our internal discovery pre-clinical development programs and through an in-licensing strategy. The licenses granted by TheraCour are for entire set of pathologies that the licensed virus is a causative agent for.
Interest Expense - The Company has incurred interest expense of approximately $50,000 and $900 for the years ended June 30, 2024 and June 30, 2023 respectively. The increase in interest expense for the year ended June 30, 2024 is a result of interest expense charged pursuant to the milestone payment note with TheraCour.
Interest Expense - The Company has incurred interest expense of approximately $149 and $50,000 for the years ended June 30, 2025 and June 30, 2024 respectively.
ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements. ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures.
RECENT ACCOUNTING PRONOUNCEMENTS Recently Issued Accounting Pronouncements The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s financial statements.
Research and Development Expenses - Research and development expenses for the year ended June 30, 2024 decreased approximately $955,000, to approximately $5,437,000 from approximately $6,392,000 for the year ended June 30, 2023. This year-to-year decrease is generally attributable to the decrease in license fees, offset by the increase in outside laboratory services.
Research and Development Expenses - Research and development expenses for the year ended June 30, 2025 increased approximately $112,000, to approximately $5,549,000 from approximately $5,437,000 for the year ended June 30, 2024. This year-to-year increase is generally attributable to an increase in outside lab fees related to preparation of the Company’s Phase II clinical trial applications.
However, we cannot provide assurance that our plans will not change or that changed circumstances will not result in the depletion of our capital resources more rapidly than we currently anticipate. The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants.
The Company has limited experience with pharmaceutical drug development. Thus, our budget estimates are not based on experience, but rather based on advice given by our associates and consultants. As such, these budget estimates may not be accurate.
Table : R&D Costs Allocation ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Program June 30, 2024 June 30, 2023 1 Pan-Coronavirus Drug Program (Including COVID) – NV-387 ​ $ 4,937,297 ​ $ 6,092,414 2 RSV ​ ​ 250,000 ​ ​ 200,000 3 HerpeCide™ Program.
Table : R&D Costs Allocation ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Program June 30, 2025 June 30, 2024 1 NV-387 Manufacture, Clinical Trials, R&D ​ $ 4,449,000 ​ $ 3,437,000 2 Smallpox/Mpox ​ $ 400,000 ​ $ 150,000 3 Measles ​ $ 300,000 ​ $ — 4 RSV ​ $ 150,000 ​ $ 250,000 5 Influenza ​ $ 150,000 ​ $ 100,000 3 HerpeCide™ Program.
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 expenses and increased additional paid in capital by approximately $50,000. Income Taxes - There is no provision for income taxes due to ongoing operating losses.
The decrease in interest expense for the year ended June 30, 2025 is a result of the milestone payment interest expense charged pursuant to the milestone payment note with TheraCour for the year ended June 30, 2024. Income Taxes - There is no provision for income taxes due to ongoing operating losses.
Additional milestones include Pre-IND and IND filing to the US FDA for RSV and clinical trial application for Phase II clinical trial of NV-387 for the treatment of RSV infection in adults with the goal towards further regulatory advancement and approval of NV-387 for the treatment of pediatric RSV infection.
Additional milestones we look forward to include: orphan drug designation filing to the US FDA for NV-387 for the treatment of MPox, smallpox and Measles, Pre-IND Application filing to the US FDA for Smallpox/MPox/Orthopoxviruses, and an IND filing to the US FDA, possibly for NV-387 for the treatment of smallpox under the FDA “Animal Rule”.
Removed
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.
Added
The Company has the right of first refusal for any antiviral drugs with TheraCour. The Company may seek to add additional virus types to its drug pipeline as the Company progresses further.
Removed
This Phase Ia/Ib human clinical trial is for evaluating the safety and tolerability of two oral formulations of NV-387, namely (i) NV-CoV-2 Oral Gummies, and (ii) NV-387 Oral Syrup, as described elsewhere, with COVID as the indication.
Added
We have successfully completed Phase Ia/Ib clinical trial for human safety and tolerability of our first drug candidate, NV-387, a broad-spectrum antiviral with multiple virus indications. We are now advancing NV-387 towards multiple indications with different regulatory pathways in a highly cost-effective strategy. We plan on seeking non-dilutive funding for some of the initiatives.
Removed
The safety and tolerability data from this clinical trial is expected to be applicable as Phase Page 86 of 106 Table of Contents Ia/Ib data for other indications of NV-387 as well, including RSV, MPOX, Influenza and others.
Added
The net proceeds to the Company from the offering was approximately $3,120,000 after placement agent fees and other estimated offering expenses. From July 1, 2024 through June 30, 2025, the Company sold 3,351,096 shares of common stock at an average price of approximately $1.65 per share.
Removed
Additionally, we believe that NV-387 qualifies for a Phase II clinical trial for the treatment of MPOX infection in Central African nations under the MEURI protocol of WHO because there is no other treatment available for this epidemic that is declared by the WHO as a public health emergency of international concern (MEURI = Monitored Emergency Use of Unregistered and Investigational Interventions.).
Added
The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706), which became effective on May 22, 2023.
Removed
We plan on initiating the Phase II study for MPOX as soon as feasible if we get the appropriate regulatory clearances.
Added
Our liabilities as of June 30, 2025 are approximately $1.3 million, including accounts payable of approximately $459 thousand payable to third parties, accounts payable to related parties of approximately $821 thousand, and accrued expenses approximately $26 thousand.
Removed
Additionally, we continue towards developing the Pre-IND and IND applications for a Phase IIa clinical trial of NV-387 for the treatment of RSV infection in adults, to be followed by a Phase IIb/III clinical trial of NV-387 for the treatment of RSV infection in hospitalized pediatric patients.
Added
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.
Removed
To this end, we are also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans.
Added
Additional milestones include filing of clinical trial application for Phase II clinical trial of NV-387 for MPox indication, anticipated approval of the application, initiation of the Phase II Clinical Trial, Interim Datasets regarding the Safety and Effectiveness of NV-387 for the treatment of MPox, Completion of the Phase II Clinical Trial for MPox, as well as filing of clinical trial application for Phase II clinical trial of NV-387 for Viral-ARI/SARI indication, anticipated approval of the application, initiation of the Phase II Clinical Trial, interim datasets regarding the safety and effectiveness of NV-387 for the treatment of a multitude of respiratory viral infections, completion of the Phase II Clinical Trial and data analysis with data regarding efficacy of NV-387 in the treatment of Influenza, RSV, Coronavirus, and possibly other respiratory viruses.
Removed
Planned costs for the preparation of regulatory documents for filing an IND with the FDA to enter Phase II clinical trial for NV-387 as treatment of RSV infection in humans.
Added
We plan on preparing the Clinical Trial Application (CTA) for this trial after regulatory submission of the MPox CTA in DRC. We believe we may be able to initiate the Phase II NV-387-Viral-ARI/SARI clinical trial towards the FY2026 third quarter, but majority of the clinical trial is expected to be conducted during the early part of FY2027. 4.
Removed
We believe that we will be eligible to enter Phase II clinical trial for RSV indication based on the preliminary safety and tolerability data from the Phase Ia/Ib clinical trial; 3. Additional R&D Expenditures for RSV Project including regulatory non-clinical studies to enable treatment of children with NV-387. 4. Drug Substance and Drug Product Manufacturing costs, and 5. Corporate overhead.
Added
Additional Non-clinical Safety Toxicology Studies of NV-387 to enable treatment of children with NV-387. 5. Drug Substance and Drug Product Manufacturing costs, and Page 89 of 107 Table of Contents 6. Corporate overhead. This includes budgeted office salaries, legal, accounting, investor relations, public relations, business development, and other costs expected to be incurred by being a public reporting company.
Removed
Management believes that as a result of the management plan, our existing resources and access to the capital markets will permit us to fund planned operations and expenditures for at least one year from the filing of the 10-K.
Added
CRITICAL ACCOUNTING POLICIES AND ESTIMATES Accounting for Research and Devlopment Costs The Company accounts for research and development cost in accordance with Accounting Standards Codification subtopic 730-10, Research and Development (“ASC 730-10”). ASC 730-10, requires research and development costs to be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred.
Removed
CRITICAL ACCOUNTING POLICIES AND ESTIMATES Accounting for Stock Based Compensation – The Company follows the provisions of ASC 718 – Stock Compensation , which requires the measurement of compensation expense for all shared-based payment awards made to employees, non-employee directors, and non-employees including employee stock options.
Added
Third-party research and developments costs are expensed when the contracted work has been performed or as milestone results have been achieved. For the years ended June 30, 2025 and 2024, we incurred approximately $5,549,000 and $5,437,000 respectively for research and development expense which are included in the statements of operations.
Removed
Shared-based compensation expense is based on the grant date fair value estimated in accordance with the provisions of ASC 718 and is generally recognized as an expense over the requisite service period, net of forfeitures. RECENT ACCOUNTING PRONOUNCEMENTS Recently Issued Accounting Pronouncements The Company considers the applicability and Impact of all Accounting Standard Updates (“ASU’s”).
Added
ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities (PBEs) to disclose, in interim and annual reporting periods, additional information about certain expenses in the notes to financial statements. The requirements of ASU 2024-03 apply to all public business entities.
Removed
ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The requirements of this update require disclosure of significant segments expenses and increase the frequency of segment reporting to interim periods. The ASU is effective for all public companies for fiscal years beginning after December 15, 2023 and for interim period beginning after December 15, 2024.
Added
The ASU requires disaggregated disclosure of income statement expenses for public business entities (PBEs). The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements.
Removed
Early adoption is permitted and is applicable to all periods presented in the financial statements unless retrospective application is impracticable.
Added
ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning Page 90 of 107 Table of Contents after December 15, 2027. Early adoption is permitted.
Removed
There have been certain changes in ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40) - Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under GAAP.
Added
Recently Adopted Accounting Standards Segment and Geographic Information The Company adopted Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024.
Removed
The ASU also removes certain settlement conditions that are required for equity-linked contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. The Company adopted this guidance on July 1, 2023 using the modified retrospective method.
Added
This ASU requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), an amount for other segment items by a reportable segment and a description of its composition, and disclosure of the title and position of the CODM.
Removed
The adoption of this standard did not have a material effect on the Company’s financial statements.
Added
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the CODM, or decision making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment: life science.
Added
The life science segment consists of the development of clinical and preclinical product candidates for the development of the Company’s proprietary anti-viral therapies. The Company’s CODM is the President and Executive Chairman of the Board of Directors.
Added
Segment revenue, profit or loss, significant segment expenses and other segment items - The accounting policies of the Company’s single operating and reportable segment are the same as those described in this Summary of Significant Accounting Policies.
Added
The Company’s method for measuring segment profitability includes net income (loss), which the CODM uses to assess performance and make decisions for resource allocation, consistent with the measurement principals for net income (loss) as reported on the Company’s statement of operations.

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