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What changed in NANOVIRICIDES, INC.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of NANOVIRICIDES, INC.'s 2023 and 2024 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 2024 report.

+615 added−571 removedSource: 10-K (2024-09-27) vs 10-K (2023-10-13)

Top changes in NANOVIRICIDES, INC.'s 2024 10-K

615 paragraphs added · 571 removed · 360 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

254 edited+207 added−163 removed195 unchanged
Biggest changeInjectable Solution, for Injection or Infusion ● Moderate to Severe Shingles ● Moderate to Severe Chickenpox ● Hospitalized or with Urgent Risk of Hospitalization Pre-Clinical D 5 NV-HHV-1 Oral Gummies ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized Pre-Clinical E 6 Oral Syrup ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized ● Patients that require drug titration Pre-Clinical E 7 ​ Injectable Solution, for Injection or Infusion ● Post-Herpetic Neuralgia (PHN) ● Hospitalized or with Urgent Risk of Hospitalization Pre-Clinical E ​ Page 35 of 95 Table of Contents HSV-1 Program; NanoViricides Drug Products in Development (Modalities #2, #3) (Table 2.D) ​ Table 2.D.
Biggest changeC 2 NV-HHV-1 Oral Gummies ● Mild to Moderate Shingles with More Extensive Body Coverage ● Mild to Moderate Chickenpox ● Non-hospitalized Pre-Clinical C 3 Oral Syrup (Systemic Drug In Development) ● Mild to Moderate Shingles ● Mild to Moderate Chickenpox ● Non-hospitalized ● Patients that require drug titration (i.e. specified mg/Kg dosing, as with younger pediatric populations); with or without co-morbidities Pre-Clinical D 4 Injectable Solution, for Injection or Infusion (Systemic Drug In Development) ● Moderate to Severe Shingles ● Moderate to Severe Chickenpox ● Hospitalized or with Urgent Risk of Hospitalization Pre-Clinical D 5 NV-HHV-1 Oral Gummies ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized Pre-Clinical E 6 Oral Syrup (Systemic Drug In Development) ● Post-Herpetic Neuralgia (PHN) ● Non-hospitalized ● Patients that require drug titration Pre-Clinical E 7 Injectable Solution, for Injection or Infusion (Systemic Drug In Development) ● Post-Herpetic Neuralgia (PHN) ● Hospitalized or with Urgent Risk of Hospitalization Pre-Clinical E ​ Page 36 of 106 Table of Contents Shingles and associated pain, post-herpetic neuralgia (PHN) Shingles is caused by re-activation of the chickenpox virus that most humans acquire in childhood.
Several companies have advanced drug candidates for the management of COVID-19. Remdesivir, an antiviral drug, has received full approval, but requires repeated infusions and has limited clinical effectiveness. Oral Molnupiravir (Merck and Ridgeback) has received EUA but it has very poor effectiveness and well-known risks of mutagenicity, and is not widely used.
Several companies have advanced drug candidates for the management of COVID-19. Remdesivir, an antiviral drug, has received full approval, but requires repeated infusions and has limited clinical effectiveness. Oral Molnupiravir (Merck and Ridgeback) has received EUA, but it has very poor effectiveness and has well-known risks of mutagenicity, and is not widely used.
Its use in persons not listed is considered off-label, and recent clinical report has shown that it has no benefits relative to placebo treatment in these groups. Also in a certain percentage of cases Paxlovid has been shown to cause viral resurgence after achieving COVID-negative status upon treatment.
Its use in persons not listed is considered off-label, and a recent clinical report has shown that it has no benefits relative to placebo treatment in these groups. Also in a certain percentage of cases Paxlovid has been shown to cause viral resurgence after achieving COVID-negative status upon treatment.
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. This 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. Our work-plan is expected to reduce certain risks of drug development.
Based on our pre-clinical study data, and based on our own studies of approved drugs in the COVID-19 space, we believe that we have a very high probability that NV-CoV-2 would be demonstrated to be a highly effective and safe drug for the treatment of most if not all Coronavirus infections including SARS-CoV-2 (COVID-19) as well as seasonal coronaviruses, in most if not all segments of the human population including pediatric, geriatric, immune-compromised, and other high risk as well as low risk populations.
Based on our pre-clinical study data, and based on our own studies of approved drugs in the COVID-19 space, we believe that we have a very high probability that NV-CoV-2 would be demonstrated to be a highly effective and safe drug for the treatment of most if not all Coronavirus infections including SARS-CoV-2 (COVID-19) as well as seasonal coronaviruses, in most if not all segments of the human population including pediatric, geriatric, immune-compromised, and other high risk and low risk populations.
Out-Licensing to Karveer Meditech Private Limited, India On March 27, 2023 we entered into a License Agreement with Karveer wherein we granted to Karveer a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India.
Out-Licensing to Karveer Meditech Private Limited, India (KMPL) On March 27, 2023 we entered into a license agreement with KMPL wherein we granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID in patients in India.
Remdesivir is a broad-spectrum antiviral agent that has been approved for COVID and has shown strong pre-clinical activity against many RNA viruses. Its clinical activity is limited by its rapid metabolism in the bloodstream. NV-387 holds remdesivir like in a bottle and releases it slowly, thus limiting the metabolism and enhancing the pharmacokinetics and thereby the effectiveness of remdesivir.
Remdesivir is a broad-spectrum antiviral agent that has been approved for COVID-19 and has shown strong pre-clinical activity against many RNA viruses. Its clinical activity is limited by its rapid metabolism in the bloodstream. NV-387 holds remdesivir like in a bottle and releases it slowly, thus limiting the metabolism and enhancing the pharmacokinetics and thereby the effectiveness of remdesivir.
Nanoviricides Platform Has Enabled Industry-Leading Orally Available Nanomedicines And Multiple Routes of Administration We found that unlike almost all other nanomedicine platforms, our nanoviricide NV-387, the active pharmaceutical ingredient (API) of NV-CoV-2, demonstrated strong antiviral activity when administered orally in multiple animal models.
Nanoviricides Platform Has Enabled Industry-Leading Orally Available Nanomedicines And Multiple Routes of Administration We found that unlike almost all other nanomedicine platforms, our nanoviricide NV-387, the active pharmaceutical ingredient (API) of NV-CoV-2, demonstrated strong activity when administered orally in multiple animal models.
In particular, the Agency agreed that the Company’s strategy for drug substance and drug product acceptance criteria is adequate. The Agency further agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate. The FDA also stated that the proposed design of the IND-opening human clinical studies appears reasonable at this time.
In particular, the FDA agreed that the Company’s strategy for drug substance and drug product acceptance criteria is adequate. The FDA further agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate. The FDA also stated that the proposed design of the IND-opening human clinical studies appears reasonable at this time.
In order to speed up nanoviricide drug development, save on costs, and ensure quality, we have set up our own manufacturing facility that can scale from discovery qualities of a few grams to clinical trials quantities of a few kilograms.
In order to speed up nanoviricide drug development, save on costs, and ensure quality, we have set up our own manufacturing facility that can scale from discovery quantities of a few grams to clinical trials quantities of a few kilograms.
If our studies are successful, we would be more confident in further developing our Coronavirus, RSV, HerpeCide as well as other program drug candidates and may be in a position to re-engage our highly valuable drug programs including HIVCide and FluCide.
If our studies are successful, we would be more confident in further developing our, RSV, FluCide, HerpeCide as well as other program drug candidates and may be in a position to re-engage our highly valuable drug programs including HIVCide.
There is a shingles vaccine approved for adults age 60 and above which is also available for adults younger than that. Acyclovir-based oral drugs, such as valacyclovir (Valtrex®), are available as systemic therapy for shingles. Intravenous acyclovir is also employed for treatment of various VZV indications. However, VZV is substantially less sensitive to (val)acyclovir than is HSV-1.
There is a shingles vaccine approved for adults aged 60 and above which is also available for adults younger than that. Acyclovir-based oral drugs, such as valacyclovir (Valtrex®), are available as systemic therapy for shingles. Intravenous acyclovir is also employed for treatment of various VZV indications. However, VZV is substantially less sensitive to (val) acyclovir than is HSV-1.
If the FDA designates a drug as a breakthrough therapy, the drug is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, potentially beginning at Phase 1 and organizational commitment involving senior managers regarding the development of the drug to ensure that the development program and the design of the clinical trials is as efficient as practicable.
If the FDA designates a drug as a breakthrough therapy, the drug is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, potentially beginning at Phase I and organizational commitment involving senior managers regarding the development of the drug to ensure that the development program and the design of the clinical trials is as efficient as practicable.
We then down-select from the effective drug candidates about five to seven candidates for further development based on a number of considerations including level 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 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.
In addition, the nanoviricide can carry additional active pharmaceutical ingredients (APIs), which may be chosen to affect the intracellular virus life cycle. Thus, the nanoviricide platforms enables construction of complete virus-killing nanomachines that block the virus from entering the cell as well as that block further production of the virus inside the cell.
In addition, the nanoviricide can carry additional active pharmaceutical ingredients (APIs), which may be chosen to affect the intracellular virus life cycle. Thus, the nanoviricide platform enables construction of complete virus-killing nanomachines that block the virus from entering the cell as well as that block further production of the virus inside the cell.
We then choose some of the select polymers and attach the selected antiviral ligands chemically to the polymer providing a library of antiviral nanoviricides. We then evaluate these antivirals in cell cultures against the target viruses. We further evaluate selected antiviral ligands from this screen in animal model studies.
We then choose some of the select polymers and attach the selected antiviral ligands chemically to the polymer to create a library of antiviral nanoviricides. We then evaluate these antivirals in cell cultures against the target viruses. We further evaluate selected antiviral ligands from this screen in animal model studies.
If we believe that the data from the Phase 3 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.
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.
This is likely because it is well known that even repeated application of acyclovir-class of drugs in some patients leads to reduction in the breakout frequency or recurrence of herpe labilis (“cold sores”) caused by HSV-1.
This is likely because it is well known that even repeated application of acyclovir-class of drugs in some patients leads to reduction in the breakout frequency or recurrence of herpes labilis (“cold sores”) caused by HSV-1.
Phase 3 clinical trials are long-term, involve a significantly larger population, are conducted at numerous sites in different geographic regions and are carefully designed to provide reliable and conclusive data regarding the safety and benefits of a drug.
Phase III clinical trials are long-term, involve a significantly larger population, are conducted at numerous sites in different geographic regions and are carefully designed to provide reliable and conclusive data regarding the safety and benefits of a drug.
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, 2023 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, 2024, the Company had approximately seven full-time employees.
Thereafter, on February 15, 2010, we entered into an Additional License Agreement with TheraCour granting the Company the exclusive licenses for technologies developed by TheraCour for the additional virus types for Dengue viruses (DENV), Japanese Encephalitis (JEV), West Nile Virus (WNV), viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes Keratitis, and Ebola/Marburg viruses.
Thereafter, on February 15, 2010, we entered into an TheraCour-Nanoviricides Additional License Agreement (“Additional License Agreement”) with TheraCour granting the Company the exclusive licenses for technologies developed by TheraCour for the additional virus types for Dengue viruses (DENV), Japanese Encephalitis (JEV), West Nile Virus (WNV), viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes Keratitis, and Ebola/Marburg viruses.
Regulatory Review and Approval Process in India The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drug Controller General of India (DCGI) heads CDSCO.
Regulatory Review and Approval Process in India The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drug Controller General of India (DCGI) heads CDSCO.
In consideration, Karveer will be reimbursed by us for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30)% of such costs and applicable taxes.
In consideration, KMPL will be reimbursed by us for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes.
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.
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.
Karveer has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and is acting as clinical trials manager for such clinical trials. Karveer is in the process of establishing a manufacturing plant for some of those medicines.
KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and is acting as clinical trials manager for such clinical trials. KMPL is in the process of establishing a manufacturing plant for some of those medicines.
In consideration, Karveer will be reimbursed by the Company for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes.
In consideration, KMPL will be reimbursed by the Company for all direct and indirect costs incurred for the clinical trials and development activities with a customary clinical trials manager fee of thirty (30%) of such costs and applicable taxes.
HSV-1, HSV-2, Ocular Herpes Keratitis We believe that a skin cream for the control of HSV-1 “cold sores” (herpes labialis, and recurrent herpes labialis or RHL) is another drug candidate that may be close to entering human clinical trials. We have already achieved strong success in animal studies against HSV-1, as discussed above.
We believe that a skin cream for the control of HSV-1 “cold sores” (herpes labialis, and recurrent herpes labialis or RHL) is another drug candidate that may be close to entering human clinical trials. We have already achieved strong success in animal studies against HSV-1, as discussed above.
We will not make any upfront cash payments to TheraCour and we have agreed to the following milestone payments to TheraCour: 100,000 shares of the Company’s Series A Convertible Preferred Stock, par value $0.00001 per share (the “Series A Preferred Stock”) upon the execution of the Agreement; 50,000 shares of Series A Preferred Stock after the grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase 1 Clinical Trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase 2A Clinical Trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase 1 or its equivalent; 100,000 shares of Series A Preferred Stock after the initiation of Phase 3 clinical trials or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A Preferred Stock, no later than six (6) months after the completion of Phase 3 Clinical Trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase 2 Clinical Trials or its equivalent.
We will not make any upfront cash payments to TheraCour and we have agreed to the following milestone payments to TheraCour: 100,000 shares of the Company’s Series A preferred stock, par value $0.00001 per share (the “Series A preferred stock”) upon the execution of the Agreement; 50,000 shares of Series A preferred stock after the grant of the approval of Licensee’s Investigational New Drug (IND) Application, or its equivalent; cash payments of $1,500,000 after the initiation of Phase I clinical trials or its equivalent; $2,000,000 after the completion of Phase I clinical trials or its equivalent for at least one product within twelve (12) months from the date of the acceptance of the IND; $2,500,000 no later than six (6) months after the completion of Phase IIA clinical trials or its equivalent for at least one product within twenty (24) months from the date of the completion of Phase I or its equivalent; 100,000 shares of Series A preferred stock after the initiation of Phase III clinical trials or its equivalent; and, at TheraCour’s option, $5,000,000 in cash or 500,000 shares of Series A preferred stock, no later than six (6) months after the completion of Phase III clinical trials or its equivalent for at least one product within thirty-six (36) months from the completion of Phase II clinical trials or its equivalent.
We will not be undertaking socially important programs such as the development of an anti-Zika virus drug candidate, or continuation of our efforts in developing anti-Ebola drug candidate, unless non-dilutive funding for such efforts becomes available. At present we have not applied for any grants for these programs.
We will not be undertaking socially important programs such as the development of an anti-Zika virus drug candidate, or continuation of our efforts in developing anti-Ebola drug candidate, unless non-dilutive funding for such efforts becomes available. At present we have not applied for any grants for these programs. Table 2.I.
This is firstly because the nanoviricides based on mimicking attachment receptors are broad-spectrum in nature, capable of antiviral effect against not just a specific virus type or subtype, strain or variant, but entire families of viruses (as defined in the virus classification system), and secondly, because, no matter how much a virus mutates or changes, its binding to the cellular receptor does not change.
This is firstly because the nanoviricides based on mimicking attachment receptors are broad-spectrum in nature, capable of antiviral effect against not just a specific virus type or subtype, strain or variant, but entire families of viruses (as defined in the virus classification system), and secondly, because, no matter how much a virus mutates or changes, its binding to the host-side receptor(s) does not change.
Karveer shall provide NanoViricides with all reports of the clinical trials and the Company has the rights to use such reports for further advancement of the drug candidates with regulatory authorities outside India.
KMPL shall provide NanoViricides with all reports of the clinical trials and the Company has the rights to use such reports for further advancement of the drug candidates with regulatory authorities outside India.
After the Coronavirus and RSV programs clinical trials are in progress, we plan on completing an effective clinical trial plan for our Shingles drug candidate to reengage human clinical trials for the shingles treatment program. All of these studies are dependent on external collaborators providing available time slots for us.
After the RSV program clinical trials are in progress, we plan on completing an effective clinical trial plan for our Shingles drug candidate to reengage human clinical trials for the shingles treatment program. All of these studies are dependent on external collaborators providing available time slots for us.
To assist in the analysis of the terms of the CoV Agreement, we commissioned research reports on Coronavirus drug market sizes for the Coronavirus antiviral field from an independent consulting agency, Nanotech Plus, LLC. Additionally, we obtained business analysis and valuation reports for potential licensing terms for a coronavirus drug from an independent consultant.
To assist in the analysis of the terms of the COVID License Agreement, we commissioned research reports on Coronavirus drug market sizes for the Coronavirus antiviral field from an independent consulting agency, Nanotech Plus, LLC. Additionally, we obtained business analysis and valuation reports for potential licensing terms for a coronavirus drug from an independent consultant.
Upon commercial sales of any resulting approved drugs, Karveer will pay the Company a royalty of seventy (70)% percent of the final invoiced sales less costs to unaffiliated third parties. Diwan, our Founder, President and Executive Chairman, is a passive investor in Karveer. His ownership interest does not provide him with control or significant influence over Karveer.
Upon commercial sales of any resulting approved drugs, KMPL will pay the Company a royalty of seventy (70%) percent of the final invoiced sales less costs to unaffiliated third parties. Dr. Anil Diwan, our Founder, President and Executive Chairman, is a passive investor in KMPL. His ownership interest does not provide him with control or significant influence over KMPL.
Karveer shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India.
KMPL shall provide NanoViricides with all reports of the clinical trials and the Company can use such reports for further advancement of the drug candidates with regulatory authorities outside India.
The market size for severe cases of shingles may be approximately one billion dollars. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur every year in the USA alone.
The market size for severe cases of shingles may be approximately one billion dollars. These estimates take into account the Shingrix® vaccine as well as existing vaccines. About 500,000 to 1 million cases of shingles occur every year in the U.S. alone.
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 40 of 95 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; Page 46 of 106 Table of Contents ● insurance and other reimbursement coverage; ● distribution; ● marketing; and ● adaptability to various modes of dosing.
The Company also issued 50,000 shares of the Company’s Series A preferred shares upon the grant of an IND to perform clinical trials which are being sponsored by our licensee and collaborator Karveer in India, in April 2023.
The Company also issued 50,000 shares of the Company’s Series A preferred stock upon the grant of an IND to perform clinical trials which are being sponsored by our licensee and collaborator KMPL in India, in April 2023.
We anticipate that once our first drug goes successfully through Phase 1 and Phase 2 clinical trials thereby proving our capabilities and our Nanoviricides Platform technology, the Company, assuming it acquires the necessary financings, could enter a phase of exponential growth and rapid clinical development of additional candidates thereby transforming the way viral infections are treated.
We anticipate that once our first drug goes successfully through Phase I and Phase II clinical trials thereby proving our capabilities and our Nanoviricides Platform technology, the Company, assuming it acquires the necessary financings, could enter a phase of exponential growth and rapid clinical development of additional candidates thereby transforming the way viral infections are treated.
Related Parties TheraCour Pharma, Inc. Pursuant to an exclusive license agreement we entered into with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies.
Pursuant to an exclusive license agreement we entered into with TheraCour, the Company was granted exclusive licenses for technologies developed by TheraCour for the virus types: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus, Herpes Simplex Virus (HSV-1 and HSV-2), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies.
The CoV Agreement provides that the Manufacturing and Supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements.
The COVID License Agreement provides that the manufacturing and supply agreement would be on customary and reasonable terms, on a cost-plus basis, using a market rate based on then-current industry standards, and include customary backup manufacturing rights, as with prior agreements.
Our Contact Information Our principal executive offices are currently located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137 (voice mail). We can be contacted by email at info@nanoviricides.com .
Our Contact Information Our principal executive offices are currently located at 1 Controls Drive, Shelton, Connecticut 06484 and our telephone number is (203) 937-6137 (voicemail). We can be contacted by email at info@nanoviricides.com .
We are a clinical stage company with our first drug in Phase 1a/1b clinical trial and several additional drug candidates in various stages of pre-clinical development, including IND-filing stage and late stage IND-enabling non-clinical studies. We have no customers, products or revenues to date, and may never achieve revenues or profitable operations.
We are a clinical stage company with our first drug in Phase Ia/Ib clinical trial and several additional drug candidates in various stages of pre-clinical development, including IND-filing stage and late stage IND-enabling non-clinical studies. We have no customers, products or revenues to date, and may never achieve revenues or profitable operations.
On or about August 1st, 2023, the ATM Sales Agreement was amended to name EF Hutton, division of Benchmark Investments, LLC as the only sales agent (the “Agent”) and to remove B. Riley Securities, Inc. as a sales agent.
On or about August 1, 2023, our ATM Sales Agreement was amended to name EF Hutton, division of Benchmark Investments, LLC as the only sales agent (the “Agent”) and to remove B. Riley Securities, Inc. as a sales agent.
We believe that with the human clinical trials in our coronavirus program, 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 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.
Karveer has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials.
KMPL has engaged in further drug development in India including sponsoring of drug candidates for human clinical trials in India and has acted as clinical trials manager for such clinical trials.
The Nanoviricides Platform enables using mimics of one or more cellular receptors attached into a single nanoviricide drug. Thus this platform has the capability of mimicking both the CD4 binding site and the CCR5 binding site of HIV on one nanoviricide, which is expected to enable the most effective drug against HIV.
Another important HIV cognate receptor is CCR5. The Nanoviricides Platform enables using mimics of one or more cellular receptors attached into a single nanoviricide drug. Thus, this platform has the capability of mimicking both the CD4 binding site and the CCR5 binding site of HIV on one nanoviricide, which is expected to enable the most effective drug against HIV.
In case of a health emergency, applications may be processed in an expedited timeframe and approvals for commercial use of the drug may be provided at the end of Phase 2 with requirements for further data collection. Normally, the new drug approval application would be submitted after completion of a Phase 3 clinical trial.
In case of a health emergency, applications may be processed in an expedited timeframe and approvals for commercial use of the drug may be provided at the end of Phase II with requirements for further data collection. Normally, the new drug approval application would be submitted after completion of a Phase III clinical trial.
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.
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.
Therefore, NV-HHV-1 is likely to be a potential pan-herpesviridae nature of our anti-HSV drug candidates is expected to enable several anti-herpesviral indications. HSV-1 primarily affects skin and mucous membranes causing “cold sores”. HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases.
Therefore, NV-HHV-1 is likely to be a potential pan-herpesviridae nature of our anti-HSV drug candidates is expected to enable several anti-herpes viral indications. HSV-1 primarily affects skin and mucous membranes causing “cold sores.” HSV-2 primarily affects skin and mucous membranes leading to genital herpes. HSV-1 infection of the eye causes herpes keratitis that can lead to blindness in some cases.
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.
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.
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.
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.
On March 27, 2023 the Company entered into a License Agreement with Karveer, wherein the Company granted to Karveer a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID-19 in patients in India (“Karveer COVID License”).
Karveer Meditech, Private Limited (KMPL) On March 27, 2023 the Company entered into a License Agreement with KMPL, wherein the Company granted to KMPL a limited, non-transferable, exclusive license for the use, sale, or offer of sale in India of the Company’s two clinical test drug candidates titled as NV-CoV-2 and NV-CoV-2-R for the treatment of COVID-19 in patients in India (“KMPL COVID License”).
While our first drug candidate, NV-CoV-2, is now in human clinical trials, and another one, NV-HHV-1, is awaiting to go into the clinic, over the years we have developed more than ten drug candidates that, we believe, can be rapidly moved into the clinical stage, from nearly forty different antiviral drug development programs.
While our first drug candidate, NV-387, is now in human clinical trials, and another one, NV-HHV-1, is awaiting to go into the clinic, over the years we have developed more than ten drug candidates that, we believe, can be rapidly moved into the clinical stage, for nearly forty different antiviral drug development programs.
Management’s beliefs are based on results of pre-clinical cell culture studies, ex vivo tissue-based studies (e.g. human skin patch or a culture model), and in vivo animal studies using small animals. Drug Development Plan We intend to perform the regulatory filings and own all the regulatory licenses for the drugs we are currently developing.
Our beliefs are based on results of pre-clinical cell culture studies, ex vivo tissue-based studies (e.g. human skin patch or a culture model), in vivo animal studies using small animals, and Phase I human clinical trials. Drug Development Plan We intend to perform the regulatory filings and own all the regulatory licenses for the drugs we are currently developing.
These three phases, which are themselves subject to considerable regulation, are as follows: ● Phase 1. The drug is given to a small number of healthy human subjects or patients to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion. ● Phase 2.
These three phases, which are themselves subject to considerable regulation, are as follows: ● Phase I. The drug is given to a small number of healthy human subjects or patients to test for safety, dose tolerance, pharmacokinetics, metabolism, distribution and excretion. ● Phase II.
Drug products, i.e. different dose levels of the skin cream, were made at scales of 3-5kg batches. We have conducted a Pre-IND Meeting with the FDA regarding NV-HHV-1 as treatment for Shingles rash, and received a response from the FDA in May, 2019.
Drug products, i.e. different dose levels of the skin cream, were made at scales of 3-5kg batches. Page 35 of 106 Table of Contents We have conducted a Pre-IND Meeting with the FDA regarding NV-HHV-1 as treatment for Shingles rash, and received a response from the FDA in May 2019.
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.
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.
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 eleven different drug development programs, attesting to the strength of our platform technology.
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.
If our human clinical studies in COVID-19 program are not successful, we will have to develop additional drug candidates and perform further studies, or further advance our other programs, for example RSV, VZV, HSV-1 or HSV-2 drug candidates, into human clinical trials.
If our human clinical trials RSV program are not successful, we will have to develop additional drug candidates and perform further studies, or further advance our other programs, for example, Influenza, VZV, HSV-1 or HSV-2 drug candidates, into human clinical trials.
Nanoviricides Represent the Next Generation Development Beyond Immunotherapeutics Our nanoviricide technology relies on copying the human cell-surface receptor to which the virus binds, and making small chemicals that are called “ligands” that will bind to the virus in the same fashion as the attachment receptor or the cognate receptor (see below).
Nanoviricides Represent the Next Generation Development Beyond Classical Immunotherapeutics (Antibodies and Vaccines) Our nanoviricide technology relies on copying the human cell-surface receptor to which the virus binds, and making small chemicals that are called “ligands” that will bind to the virus in the same fashion as the host side attachment receptor or the cognate receptor (see below).
Page 42 of 95 Table of Contents FDA Approval Process The FDA must “license” a drug before it can be sold in the United States. Other countries have similar regulatory processes, and most are being harmonized under the ICH guidelines (ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
FDA Approval Process The FDA must “license” a drug before it can be sold in the United States. Other countries have similar regulatory processes, and most are being harmonized under the ICH guidelines (ICH stands for The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).
These safety results are in agreement with histopathological observations in the human skin organ culture model studies. Page 25 of 95 Table of Contents We manufactured NV-HHV-1 in a cGMP-compliant manner at our own facility for its IND-enabling GLP Safety/Toxicology study. The drug substance, or active pharmaceutical ingredient (API) was produced at approximately 1Kg-scale.
These safety results are in agreement with histopathological observations in the human skin organ culture model studies. We manufactured NV-HHV-1 in a cGMP-compliant manner at our own facility for its IND-enabling GLP Safety/Toxicology study. The drug substance, or active pharmaceutical ingredient (API) was produced at approximately 1Kg-scale.
An effective therapy for patients with severe shingles continues to be an unmet need. Page 26 of 95 Table of Contents NV-HHV-1 Skin Cream is intended for topical (dermal) application directly onto the shingles rash. It is expected to be useful in mild to moderate cases with limited body coverage of the rash in non-hospitalized patients.
An effective therapy for patients with severe shingles continues to be an unmet need. NV-HHV-1 Skin Cream is intended for topical (dermal) application directly onto the shingles rash. It is expected to be useful in mild to moderate cases with limited body coverage of the rash in non-hospitalized patients.
As and when needed, management plans to continue to raise additional funds for our continuing drug development efforts from public markets. However, there can be no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us. Page 19 of 95 Table of Contents Investor Outreach We have retained Tradigital, Inc. as our investor relations firm.
As and when needed, management plans to continue to raise additional funds for our continuing drug development efforts from public markets. However, there can be no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us. Investor Outreach We have retained Tradigital, Inc. as our investor relations firm.
Page 44 of 95 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.
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 46 of 95 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.
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.
Further, the Company’s common stock is listed on the NYSE-American. 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. Website Our website address is www.nanoviricides.com. Information on our website is not incorporated by reference herein.
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.
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.
Page 27 of 95 Table of Contents Of these, the shingles indication program has resulted in the clinical drug candidate NV-HHV-1, for which we are in the process of clinical trial design and clinical site selection, which will be a part of the IND application. Our HerpeCide™ program has matured towards multiple drug indications.
Of these, the shingles indication program has resulted in the clinical drug candidate NV-HHV-1, for which we are in the process of clinical trial design and clinical site selection, which will be a part of the IND application. Our HerpeCide™ program has matured towards multiple drug indications.
We intend to distribute these drugs via subcontracts with distributor companies or in partnership arrangements. We plan to market these drugs either on its own or in conjunction with marketing partners. We also plan to actively pursue co-development, as well as other licensing agreements with other pharmaceutical companies, both in the USA as well as internationally.
We intend to distribute these drugs via subcontracts with distributor companies or in partnership arrangements. We plan to market these drugs either on our own or in conjunction with marketing partners. We also plan to actively pursue co-development, as well as other licensing agreements with other pharmaceutical companies, both in the US and internationally.
We believe that once we have revenues from commercialization of our first drug or from partnership, we will be able to engage in further speeding up the development of programs in Tables 2.C through 2.G.
We believe that once we have revenues from commercialization of our first drug or from partnership, we will be able to engage in further speeding up the development of programs in Tables 2.D through 2.I.
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 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.
We note as a risk factor that these resource constraints may cause further delays in our estimated timelines. We have taken on the most important risk in nanomedicines, that of enabling cGMP manufacture, with consistent product from batch to batch, "head on" so to speak.
We note as a risk factor that these resource constraints may cause further delays in our estimated timelines. We have taken on the most important risk in nanomedicines, that of enabling cGMP manufacture, to achieve consistent product from batch to batch, “head on” so to speak.
Formulation is Inherent in the Design Aspect of a Nanoviricide Since developing our API NV-387 in the COVID drug development program, development of its formulations, injectable, infusion, inhalation, oral syrup, and oral gummies (semi-solid form) was relatively quick, accomplished within months, including formulation design and scale-up with cGMP manufacturing considerations.
Formulation is Inherent in the Design Aspect of a Nanoviricide Since developing our lead clinical drug candidate API NV-387, development of its formulations, injectable, infusion, inhalation, oral syrup, and oral gummies (semi-solid form) was relatively quick, accomplished within months, including formulation design and scale-up with cGMP-compliance manufacturing considerations.
NanoViricides was represented by McCarter & English, LLP while TheraCour was represented by DuaneMorris LLP. In consideration for the CoV Agreement the Company issued 100,000 shares of the Company’s Series A preferred shares upon execution of the agreement in 2021.
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.
Since the cellular binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that the virus would be highly unlikely to escape our drug candidates even as a virus changes rapidly as it evolves.
Since the host-side or cell-side binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that the virus would be highly unlikely to escape our drug candidates even as a virus changes rapidly as it evolves.
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.
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.
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.
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.
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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThis 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. ​ The amount of capital we may need will depend on many factors, including the: ● progress, timing and scope of our research and development programs; ​ ● progress, timing and scope of our preclinical studies and clinical trials; ​ ● time and cost necessary to obtain regulatory approvals; ​ ● time and cost necessary to establish our own marketing capabilities or to seek marketing partners; ​ ● time and cost necessary to respond to technological and market developments; ​ ● changes made or new developments in our existing collaborative, licensing and other commercial relationships; and ​ ● new collaborative, licensing and other commercial relationships that we may establish. ​ Our fixed expenses, such as real estate taxes and facility and equipment maintenance, rent, and other contractual commitments, may increase in the future, as we may: ● enter into leases for new facilities and capital equipment; ​ ● enter into additional licenses and collaborative agreements; and ​ ● incur additional expenses associated with being a public company. ​ We have limited experience in drug development, and may not be able to successfully develop any drugs.
Biggest changeThe amount of capital we may need will depend on many factors, including the: ● progress, timing and scope of our research and development programs; ● progress, timing and scope of our preclinical studies and clinical trials; ● time and cost necessary to obtain regulatory approvals; ● time and cost necessary to establish our own marketing capabilities or to seek marketing partners; ● time and cost necessary to respond to technological and market developments; ● changes made or new developments in our existing collaborative, licensing and other commercial relationships; and ● new collaborative, licensing and other commercial relationships that we may establish.
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 59 of 95 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; ● 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.
Recently, a new drug, Xofluza (Baloxavir marboxil), developed by Shionogi, Inc., has been approved in Japan, USA, and most of the world by Genetech/Roche. It is an influenza viral endonuclease PA inhibitor. Other drugs in this class are in clinical trials. So are drugs targeting the m7G cap-snatching activity (PB2) of influenza virus such as VX787, and antibodies.
Recently, a new drug, Xofluza (Baloxavir marboxil), developed by Shionogi, Inc., and licensed by Roche, has been approved in Japan, USA, and most of the world. It is an influenza viral endonuclease PA inhibitor. Other drugs in this class are in clinical trials. So are drugs targeting the m7G cap-snatching activity (PB2) of influenza virus such as VX787, and antibodies.
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. ​ ● 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. ​ Page 57 of 95 Table of Contents ● We will be subject to continual regulatory review and periodic inspection and approval of manufacturing modifications, including compliance with current GMP regulations.
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. ● 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.
If we are unable to generate successful results from preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed. We have no products on the market and except NV-CoV-2 (NV-387) which is in Phase 1a/1b clinical trials, all of our other product candidates are in preclinical development.
If we are unable to generate successful results from preclinical and clinical studies of our product candidates, or experience significant delays in doing so, our business may be materially harmed. We have no products on the market and except NV-CoV-2 (NV-387) which is in Phase Ia/Ib clinical trials, all of our other product candidates are in preclinical development.
Approximately 862,576 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 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.
Page 69 of 95 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 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 60 of 95 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.
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.
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. 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 70 of 106 Table of Contents We have limited manufacturing experience.
In contracting with government agencies, we will be subject to various federal contract requirements. Future sales to U.S. government agencies will depend, in part, on our ability to meet these requirements, certain of which we may not be able to satisfy.
We anticipate entering into contracts with various U.S. government agencies. In contracting with government agencies, we will be subject to various federal contract requirements. Future sales to U.S. government agencies will depend, in part, on our ability to meet these requirements, certain of which we may not be able to satisfy.
Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or a IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues; ​ ● manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and ​ ● the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized. ​ Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful.
Among other things, such delays may be caused by slow enrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis or a IND and later NDA, preparation, discussions with the FDA, an FDA request for additional pre-clinical or clinical data or unexpected safety or manufacturing issues; ● manufacturing costs, pricing or reimbursement issues, or other factors that make the product not economical; and ● the proprietary rights of others and their competing products and technologies that may prevent the product from being commercialized.
Even if our rights are not directly challenged, disputes among third parties could lead to the weakening or invalidation of those intellectual property rights. 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 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.
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 71 of 95 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. ​ There is a risk of market fraud.
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.
Page 68 of 95 Table of Contents Our RSV drug does not have any direct competition at present but there are two protective antibodies as well as two vaccines for RSV, although there are no approved treatments other than the highly toxic last-resort drug, ribavirin.
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.
The manufacturer could refuse to allow us to use their technology or could demand terms to use their technology that are not acceptable. Page 56 of 95 Table of Contents We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our drug candidates.
The manufacturer could refuse to allow us to use their technology or could demand terms to use their technology that are not acceptable. We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our drug candidates.
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.
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.
The failure of the government and third-party payers to provide adequate coverage and reimbursement rates for our drug candidates could adversely affect the market acceptance of our drug candidates, our competitive position and our financial performance Page 61 of 95 Table of Contents We will rely upon licensed patents to protect our technology.
The failure of the government and third-party payers to provide adequate coverage and reimbursement rates for our drug candidates could adversely affect the market acceptance of our drug candidates, our competitive position and our financial performance We will rely upon licensed patents to protect our technology.
Shareholders should be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse.
There is a risk of market fraud. Shareholders should be aware that, according to SEC Release No. 34-29093, the market for penny stocks has suffered in recent years from patterns of fraud and abuse.
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.
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.
In addition, our manufacturing operations are subject to routine inspections by regulatory agencies. Page 64 of 95 Table of Contents Our collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.
In addition, our manufacturing operations are subject to routine inspections by regulatory agencies. Our collaborative relationships with third parties could cause us to expend significant resources and incur substantial business risk with no assurance of financial return.
Page 63 of 95 Table of Contents We may be unable to attract, retain, and motivate skilled personnel which will delay our product development programs and our research and development efforts. Our success depends on our continued ability to attract, retain, and motivate highly qualified scientific personnel who must undergo extensive training to assist in our research programs.
We may be unable to attract, retain, and motivate skilled personnel which will delay our product development programs and our research and development efforts. Our success depends on our continued ability to attract, retain, and motivate highly qualified scientific personnel who must undergo extensive training to assist in our research programs.
Page 58 of 95 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.
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.
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.
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.
We control the research and work TheraCour performs on our behalf and no costs may be incurred without our prior authorization or approval. 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 71 of 106 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; Page 53 of 95 Table of Contents ​ ● the successful commercialization of our product candidates; and ​ ● market acceptance of our products. ​ All of our existing product candidates are in early stages of development.
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.
We are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes. We may incur significant costs complying with environmental laws and regulations adopted in the future.
We are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes. We may incur significant costs complying with environmental laws and regulations adopted in the future. We cannot eliminate the risk of contamination or injury from these materials.
These additional costs will reduce or might eliminate our profitability. Our Company is required to file periodic reports with the Commission pursuant to the Exchange Act and the rules and regulations promulgated thereunder. To comply with these requirements, our independent registered auditors will have to review our quarterly financial statements and audit our annual financial statements.
Our Company is required to file periodic reports with the Commission pursuant to the Exchange Act and the rules and regulations promulgated thereunder. To comply with these requirements, our independent registered auditors will have to review our quarterly financial statements and audit our annual financial statements.
At June 30, 2023, shareholders of the Company held 1,492,542 shares of restricted common stock, or approximately 12.8% 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, 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.
Page 54 of 95 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.
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.
These risks include the ability of the U.S. government to unilaterally: ● suspend or prevent us for a set period of time from receiving new contracts or extending existing contracts based on violations or suspected violations of laws or regulations; ​ ● terminate our existing contracts; ​ ● reduce the scope and value of our existing contracts; ​ ● audit and object to our contract-related costs and fees, including allocated indirect costs; ​ ● control and potentially prohibit the export of our drug candidates; and ​ ● change certain terms and conditions in our contracts. ​ The U.S. government may terminate any of its contracts with us either for its convenience or if we default by failing to perform in accordance with the contract schedule and terms.
These risks include the ability of the U.S. government to unilaterally: ● suspend or prevent us for a set period of time from receiving new contracts or extending existing contracts based on violations or suspected violations of laws or regulations; ● terminate our existing contracts; ● reduce the scope and value of our existing contracts; ● audit and object to our contract-related costs and fees, including allocated indirect costs; ● control and potentially prohibit the export of our drug candidates; and ● change certain terms and conditions in our contracts.
Anil Diwan owns approximately 90% of the capital stock of TheraCour, which as of June 30, 2023, owned 4.0% of our common stock, and 350,000 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, 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.
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 70 of 95 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). ​ Our Company is subject to the periodic reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which will require us to incur audit fees and legal fees in connection with the preparation of such reports.
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).
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. ​ Even if we successfully develop and market our drug candidates, we may not generate sufficient or sustainable revenue to achieve or sustain profitability.
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 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. ​ Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our company.
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.
Moreover, the award of one government contract would not necessarily secure the award of future contracts covering the same drug. If the U.S. government makes significant future contract awards for the supply of its emergency stockpile to our competitors, our business will be harmed and it is unlikely that we will be able to ultimately commercialize our competitive drug candidate.
If the U.S. government makes significant future contract awards for the supply of its emergency stockpile to our competitors, our business will be harmed and it is unlikely that we will be able to ultimately commercialize our competitive drug candidate.
Further, as a U.S. government contractor, we may become subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities to which purely private sector companies are not.
Further, as a U.S. government contractor, we may become subject to an increased risk of investigations, criminal prosecution, civil fraud, whistleblower lawsuits and other legal actions and liabilities to which purely private sector companies are not. We may fail to obtain contracts to supply the U.S. government, and we may be unable to commercialize our drug candidates.
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”. ● 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.
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.
Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available for several years.
Further development and extensive testing will be required to determine their technical feasibility and commercial viability. Our success will depend on our ability to achieve scientific and technological advances and to translate such advances into reliable, commercially competitive drugs on a timely basis. Drugs that we may develop are not likely to be commercially available for several years.
It will be several years, if ever, until we have a commercial drug product available for resale. If we do not successfully develop and commercialize these products, we will not achieve revenues or profitability in the foreseeable future, if at all. If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations.
All of our existing product candidates are in early stages of development. It will be several years, if ever, until we have a commercial drug product available for resale. If we do not successfully develop and commercialize these products, we will not achieve revenues or profitability in the foreseeable future, if at all.
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.
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.
We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts.
We may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
Our common stock is listed on the NYSE MKT (now known as “NYSE American”), a national securities exchange, which imposes continued listing requirements with respect to listed shares.
Our common stock is listed on the NYSE American, a national securities exchange, which imposes continued listing requirements with respect to listed shares.
As of June 30, 2023, 1,492,542 of 11,698,497 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, 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.
We may fail to successfully develop and commercialize our drug candidates if they: ● are found to be unsafe or ineffective or fail to meet the appropriate endpoints in clinical trials; ​ ● do not receive necessary approval from the FDA or foreign regulatory agencies; ​ ● fail to conform to a changing standard of care for the diseases they seek to treat; or ​ ● are less effective or more expensive than current or alternative treatment methods. ​ Drug development failure can occur at any stage of clinical trials and as a result of many factors and there can be no assurance that we or our collaborators will reach our anticipated clinical targets.
We may fail to successfully develop and commercialize our drug candidates if they: ● are found to be unsafe or ineffective or fail to meet the appropriate endpoints in clinical trials; ● do not receive necessary approval from the FDA or foreign regulatory agencies; ● fail to conform to a changing standard of care for the diseases they seek to treat; or ● are less effective or more expensive than current or alternative treatment methods.
We have estimated a total cash expenditure budget of approximately $7.1 million for the period of July 2023 through October 2024 of which approximately $4.1 million is expected to be spent on research and development for our drug candidates, including the human clinical trials of our lead drug candidate NV-CoV-2 for treatment of coronavirus diseases, 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 $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.
The process of obtaining FDA approval has historically been costly and time consuming.
Page 63 of 106 Table of Contents The process of obtaining FDA approval has historically been costly and time consuming.
As part of any such audit or review, the U.S. government may review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, compensation and/or management information systems.
Based on the results of these audits, the U.S. government may adjust our contract-related costs and fees, including allocated indirect costs. As part of any such audit or review, the U.S. government may review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing, property, compensation and/or management information systems.
Our ability to achieve revenues and profitability in our business will depend, among other things, on our ability to: ● develop products internally or obtain rights to them from others on favorable terms; ​ Page 55 of 95 Table of Contents ● complete laboratory testing and human studies; ​ ● obtain and maintain necessary intellectual property rights to our products; ​ ● successfully complete regulatory review to obtain requisite governmental agency approvals; ​ ● enter into arrangements with third parties to manufacture our products on our behalf; and ​ ● enter into arrangements with third parties to provide sales and marketing functions. ​ Development of pharmaceutical products is a time-consuming process, subject to a number of factors, many of which are outside of our control.
Our ability to achieve revenues and profitability in our business will depend, among other things, on our ability to: ● develop products internally or obtain rights to them from others on favorable terms; ● complete laboratory testing and human studies; ● obtain and maintain necessary intellectual property rights to our products; ● successfully complete regulatory review to obtain requisite governmental agency approvals; ● enter into arrangements with third parties to manufacture our products on our behalf; and ● enter into arrangements with third parties to provide sales and marketing functions.
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. ​ If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully complete the development or commercialization of our product candidates, which would materially harm our business.
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.
We are a clinical drug development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.
If we are unable to generate revenues or achieve profitability, we may be unable to continue our operations. We are a clinical drug development stage company with a limited operating history, making it difficult for you to evaluate our business and your investment.
Page 62 of 95 Table of Contents We are dependent upon TheraCour for the rights to develop the products we intend to sell and our license agreements with TheraCour require that TheraCour is the sole developer and supplier of our licensed products.
We are dependent upon TheraCour for the rights to develop the products we intend to sell and our license agreements with TheraCour require that TheraCour is the sole developer and supplier of our licensed products. Our ability to develop, manufacture and sell the products the Company plans to develop is derived from our licensing agreements with TheraCour.
As appropriate, we safely store these materials and wastes resulting from their use at our laboratory facility pending their ultimate use or disposal. We contract with a third party to properly dispose of these materials and wastes.
We use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment. As appropriate, we safely store these materials and wastes resulting from their use at our laboratory facility pending their ultimate use or disposal. We contract with a third party to properly dispose of these materials and wastes.
In addition the 547,674 shares of Series A preferred stock are restricted and convertible into 1,916,859 shares of common stock only upon of a change of control of the Company.
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.
We have implemented a remediation plan to remediate this material weakness. Risks Related to the Biotechnology/Biopharmaceutical Industry The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with enterprises equipped with more substantial resources than us.
We may be unable to compete with enterprises equipped with more substantial resources than us. The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors.
In particular: ● Our executive officers or directors or their affiliates may have an economic interest in, or other business relationship with, partner companies that invest in us. ​ ● Our executive officers or directors or their affiliates have interests in entities that provide products or services to us. ​ Page 66 of 95 Table of Contents In any of these cases: ​ ● Our executive officers or directors may have a conflict between our current interests and their personal financial and other interests in another business venture. ​ ● Our executive officers or directors may have conflicting fiduciary duties to us and the other entity. ​ ● The terms of transactions with the other entity may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations. ​ We anticipate entering into contracts with various U.S. government agencies.
In any of these cases: ● Our executive officers or directors may have a conflict between our current interests and their personal financial and other interests in another business venture. ● Our executive officers or directors may have conflicting fiduciary duties to us and the other entity. ● The terms of transactions with the other entity may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations.
Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages. Our R&D and manufacturing activities will involve the use of biological and hazardous materials.
If we use biological and hazardous materials in a manner that causes injury, we may be liable for damages. Our R&D and manufacturing activities will involve the use of biological and hazardous materials.
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. Other than this safeguard, the Company currently does not have any policy in place, should such a conflict arise.
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.
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. However, we cannot provide assurance that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
We cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
Page 67 of 95 Table of Contents We may fail to obtain contracts to supply the U.S. government, and we may be unable to commercialize our drug candidates. The U.S. government has undertaken commitments to help secure improved countermeasures against bio-terrorism. The process of obtaining government contracts is lengthy and uncertain, and we would compete for each contract.
The U.S. government has undertaken commitments to help secure improved countermeasures against bio-terrorism. The process of obtaining government contracts is lengthy and uncertain, and we would compete for each contract. Moreover, the award of one government contract would not necessarily secure the award of future contracts covering the same drug.
Management of our relationships with our collaborators will require: ● significant time and effort from our management team; ​ ● coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and ​ ● effective allocation of our resources to multiple projects. ​ 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.
Management of our relationships with our collaborators will require: ● significant time and effort from our management team; ● coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and ● effective allocation of our resources to multiple projects.
We have incurred significant operating losses and may not ever be profitable. As of June 30, 2023, we had a cash and cash equivalent balance of $8,149,808. Also, we have incurred significant operating losses since its inception, resulting in an accumulated deficit of $131,080,749 at June 30, 2023. 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 $139,374,895 at June 30, 2024. Such losses are expected to continue for the foreseeable future.
If we are unable to complete clinical trials and have our products approved due to our failure to comply with regulatory requirements, we will be unable to commence revenue-generating operations. 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 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.
Compliance with these laws and regulations may result in significant costs, which could materially reduce our ability to become profitable. We use hazardous materials, including chemicals and biological agents and compounds that could be dangerous to human health and safety or the environment.
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.
Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. 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. Risks Related to the Securities Markets and Investments in Our Common Stock General securities market uncertainties resulting from international turmoil.
Similarly, if we develop a drug candidate that is approved by the FDA, but the U.S. government does not place sufficient orders for this drug, our future business may be harmed. Failure to remediate a material weakness in internal accounting controls could result in material misstatements in our financial statements.
Similarly, if we develop a drug candidate that is approved by the FDA, but the U.S. government does not place sufficient orders for this drug, our future business may be harmed. Risks Related to the Biotechnology/Biopharmaceutical Industry The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition.
Page 65 of 95 Table of Contents We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources.
In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.
Termination for convenience provisions generally enable us to recover only our costs incurred or committed, and settlement expenses and profit on the work completed prior to termination. 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.
The U.S. government may terminate any of its contracts with us either for its convenience or if we default by failing to perform in accordance with the contract schedule and terms. Termination for convenience provisions generally enable us to recover only our costs incurred or committed, and settlement expenses and profit on the work completed prior to termination.
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. Further development and extensive testing will be required to determine their technical feasibility and commercial viability.
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.
The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition based primarily on scientific and technological factors. 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.
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.
As of June 30, 2023, we had 11,698,497 shares of common stock outstanding, 8,004 warrants convertible to 8,004 shares of common stock, and 547,674 shares of Series A preferred stock convertible into 1,916,859 shares of common stock only in the event of a change in control.
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.
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Page 52 of 95 Table of Contents ● 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.
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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.
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While we believe we have sufficient cash to be able to take our NV-CoV-2 drug candidates, into initial human clinical trials, we currently do not have sufficient resources to complete the development, clinical trials, and commercialization of any of our proposed products.
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Because we are subject to these risks, you may have a difficult time evaluating our business and your investment in our company.
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We believe we have sufficient funds on hand to take one drug candidate into initial human clinical trials.
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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.
Removed
Our ability to develop, manufacture and sell the products the Company plans to develop is derived from our licensing agreements with TheraCour.
Added
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.
Removed
As a U.S. government contractor, we may become subject to periodic audits and reviews. Based on the results of these audits, the U.S. government may adjust our contract-related costs and fees, including allocated indirect costs.
Added
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.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeITEM 2: PROPERTIES Description of Property The Company’s principal executive offices are located at 1 Controls Drive, Shelton, CT, and include approximately 18,000 square feet of office, laboratory, and cGMP-capable drug manufacturing space. These facilities are fully owned by the Company. We subcontract the laboratory research and development work to TheraCour under the License Agreement with TheraCour.
Biggest changeITEM 2: PROPERTIES Description of Property The Company’s principal executive offices are located at 1 Controls Drive, Shelton, CT, and include approximately 18,000 square feet of office, laboratory, and cGMP-capable drug manufacturing space. These facilities are fully owned by the Company with no outstanding debt or mortgage.
Removed
Management believes that the space is sufficient for the Company to monitor the developmental progress at its subcontractors. Page 73 of 95 Table of Contents

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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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.
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
Removed
Not applicable. ​ Page 74 of 95 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+1 added−0 removed0 unchanged
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, 10,205,955 shares are unrestricted, of which 0 shares are held by affiliates, 862,576 shares are restricted securities held by non-affiliates, and the remaining 629,966 shares are restricted securities held by affiliates.
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.
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, 2023, a total of 11,698,497 shares of the Company’s common stock are outstanding and held by 152 shareholders of record.
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.
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.
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
Added
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

31 edited+31 added−35 removed33 unchanged
Biggest changeThe Company has an accumulated deficit at June 30, 2023 of approximately $131,081,000 and a net loss of approximately $8,589,000 and net cash used in operating activities of approximately $5,670,000 for the fiscal year then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future.
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.
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, 2023.
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.
Results of Operations The Company is a biopharmaceutical company and does not have any revenue for the years ended June 30, 2023 and June 30, 2022. Comparison of the Year End June 30, 2023 to the Year Ended June 30, 2022 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, 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.
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 1a/1b 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, and we have advanced our first drug candidate for treatment of COVID into Phase Ia/Ib clinical studies.
On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022, from time to time through or to our sole sales agent, EF Hutton, a division of Benchmark Investments, LLC (the “Agent”).
On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022, from time to time through or to our sole sales agent, EF Hutton.
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. The entire amount of $150 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 $145 million remains available for sale as of the date of this filing.
Page 76 of 95 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 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.
Net Loss - For the year ended June 30, 2023, the Company had a net loss of approximately $8,589,000, or a basic and fully diluted loss per share of $0.74 compared to a net loss of approximately $8,107,000, or a basic and fully diluted loss per share of $0.70 for the year ended June 30, 2022.
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.
Page 81 of 95 Table of Contents 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.
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.
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 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.
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. ​
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.
The Company estimates that it will need additional funding to continue further development of its drug candidates through later stages of human clinical trials if it does not form a collaborative licensing or partnership agreement with a party that would provide such funding such as Big Pharma.
We believe we will need additional funding to continue further development of our drug candidates through later stages of human clinical trials into regulatory approvals if we do not form a collaborative licensing or partnership agreement with a party that would provide such funding such as Big Pharma.
The increase in the Company’s net loss for the year ended June 30, 2023 from the year ended June 30, 2022 of $482,000 is generally attributable to increased license milestone expenses incurred in the year ended June 30, 2023. Research and Development Costs The Company does not maintain separate accounting line items for each project in development.
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.
Page 79 of 95 Table of Contents On or about August 1 st , 2023, the ATM Sales Agreement was amended to name EF Hutton, division of Benchmark Investments, LLC as the only sales agent (the “Agent”) and to remove B. Riley Securities, Inc. as a sales agent.
On or about August 1, 2023, the ATM Sales Agreement that we previously had with EF Hutton, division of Benchmark Investments, LLC and B. Riley Securities, Inc., taken together as the Sales Agent, was amended to name EF Hutton as the only sales agent (the “Agent”) and to remove B. Riley as a sales agent.
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 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.
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’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.
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.
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.
General and administrative expenses increased approximately $222,000 to approximately $2,551,000 for the year ended June 30, 2023 from approximately $2,329,000 for the year ended June 30, 2022. The increase in general and administrative expenses is generally attributable to an increase in legal and professional expenses and investor relations expenses.
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.
Operating Expenses - Research and development expenses for the year ended June 30, 2023 increased approximately $608,000, to approximately $6,392,000 from approximately $5,785,000 for the year ended June 30, 2022. This year-to-year increase is generally attributable to the increase in license fees.
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.
Income Taxes - There is no provision for income taxes due to ongoing operating losses. As of June 30, 2023, we had estimated cumulative tax benefits and development tax credits and other deferred tax credits resulting in a deferred tax asset of approximately $37,391,000. This amount has been offset by a full valuation allowance.
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.
However, the Company cannot provide assurance that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The accompanying audited financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.
However, we cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
Staffing costs for the scientific staff and consulting firms to assist with FDA compliance, material characterization, pharmaco-kinetic, pharmaco-dynamic and toxicology studies, and other items related to FDA compliance, as required for development of necessary data for filing an IND with the FDA for Phase II clinical trials based on the data of the Phase 1a/1b clinical trials, which we believe we can do for the RSV indication. ​ 4.
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.
R&D Cost Allocations ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ Program ​ June 30, 2023 ​ June 30, 2022 1 Pan-Coronavirus Drug Program (Including COVID) $ 6,092,414 $ 5,684,862 2 RSV ​ 200,000 ​ 0 3 HerpeCide™ Program.
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.
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.
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.
Interest Income - Interest income was approximately $356,000 and approximately $12,000 for the years ended June 30, 2023 and 2022, respectively. Interest income increased due to higher interest rates for the majority of the year ended June 30, 2023 offset by lower cash balances.
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.
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.
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.
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.
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.
These estimates assume that our drug candidates are highly effective and therefore would require relatively few patients in each arm of each trial in order to establish statistically significant results. 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.
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 therefore rely on third party collaborations for the testing of our drug candidates. We continue to engage with our previous collaborators. Our animal efficacy studies as well as safety/toxicology studies are performed by third parties.
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.
These anticipated expenses for the subsequent period commencing on July 1, 2023 can be summarized as follows: 1.
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.
Page 77 of 95 Table of Contents Interest Expense - The Company has incurred interest expense of approximately $900 and $5,000 for the years ended June 30, 2023 and June 30, 2022 respectively. The decrease results from the repayment of an insurance loan in October 2022.
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.
Removed
Herpes Simplex virus infections (HSV-1, HSV-2) and VZV Indications: Cold Sores, Genital Ulcers, Shingles and ARN ​ ​ 100,000 ​ ​ 100,000 ​ Total $ 6,392,414 $ 5,784,862 ​ Our Shingles Skin Cream, has completed IND-enabling studies, and we intend to file an IND for this drug after the pan-coronavirus program and RSV program drugs are into clinical trials.
Added
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.
Removed
We have completed scale-up as well as c-GMP-compliant manufacture of NV-387, the drug substance (API) in NV-CoV-2, and the drug products NV-CoV-2 Orals Syrup and NV-CoV-2 Oral Gummies clinical batches.
Added
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.
Removed
As these drug candidates are advancing into the clinic, we believe that our additional drug candidates, including two or more drug candidates in the HerpeCide program will also enter into IND-enabling studies. We intend to further re-engage our FluCide and HIVCide drug development programs once we have established our platform technology with the Coronavirus and HerpeCide program drug candidates.
Added
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.
Removed
Page 78 of 95 Table of Contents On or about August 1st, 2023, the ATM Sales Agreement was amended to name EF Hutton, division of Benchmark Investments, LLC as the only sales agent (the “Agent”) and to remove B. Riley Securities, Inc. as a sales agent.
Added
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.
Removed
These sales, if any, will be made pursuant to the terms of an At Market Issuance Sales Agreement, or the sales agreement, between us and the Agent. ​ Liquidity and Capital Reserves As of June 30, 2023, the end of the reporting period, we had approximately $8,150,000 in cash and cash equivalents, prepaid expenses of approximately $295,000 and approximately $8,107,000 of property and equipment, net of accumulated depreciation.
Added
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).
Removed
Our liabilities at June 30, 2023 are approximately $2,034,000, including accounts payable of approximately $157,000 payable to third parties, accounts payable to TheraCour of approximately $233,000, accrued expenses approximately $144,000, and a non-current liability of $1,500,000 payable to TheraCour. Stockholders’ equity was approximately $14,866,000 at June 30, 2023.
Added
As of June 30, 2024, the Company sold 1,308,651 shares of common stock at an average price of approximately $2.47 per share.
Removed
In comparison, as of June 30, 2022, we had approximately $14,066,000 in cash and cash equivalents, prepaid expenses of approximately $350,000 and property and equipment of approximately $8,694,000, net of accumulated depreciation.
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 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.
Removed
Our liabilities at June 30, 2022 were approximately $413,000, including accounts payable of approximately $58,000 payable to third parties, accounts payable to TheraCour of approximately $214,000, a loan payable of approximately $95,000, and accrued expenses of approximately $46,000. Stockholders’ equity was approximately $23,082,000 at June 30, 2022.
Added
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.
Removed
The Company believes that it has several important milestones that it will be achieving in the ensuing year. Management believes that as it achieves these milestones, the Company’s ability to raise additional funds in the public markets would be enhanced.
Added
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.
Removed
There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. Management believes that the Company’s cash and cash equivalents balance of approximately $8,150,000 will be sufficient to fund the Company’s planned operations and expenditures through October 2024.
Added
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.
Removed
Our Shingles Skin Cream, has completed IND-enabling studies, and we intend to file an IND for this drug after the pan-coronavirus program and RSV program drugs are into clinical trials. We have completed scale-up as well as c-GMP-compliant manufacture of NV-387, the drug substance (API) in NV-CoV-2, and the drug products NV-CoV-2 Orals Syrup and NV-CoV-2 Oral Gummies clinical batches.
Added
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.
Removed
As these drug candidates are advancing into the clinic, we believe that our additional drug candidates, including two or more drug candidates in the HerpeCide program will also enter into IND-enabling studies. We intend to further re-engage our FluCide and HIVCide drug development programs once we have established our platform technology with the Coronavirus and HerpeCide program drug candidates.
Added
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.
Removed
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. The entire amount of $150 million remains available for sale.
Added
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.
Removed
On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022, from time to time through or to our sole sales agent, EF Hutton, a division of Benchmark Investments, LLC (the “Agent”).
Added
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.
Removed
These sales, if any, will be made pursuant to the terms of an At Market Issuance Sales Agreement, or the sales agreement, between us and the Agent. Requirement for Additional Capital We have ended the year with sufficient cash on hand by controlling costs and expenditures.
Added
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.
Removed
We project that our current capital resources are sufficient for accomplishing the goal of completing the Phase 1a/1b human clinical trials of our lead drug candidate, NV-CoV-2, and for filing an IND for the same drug for the RSV indication. We will need additional financing to complete human clinical trials of our drug candidates into drug approval.
Added
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.).
Removed
Planned costs for the Phase 1a/1b human clinical trials of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies (expected recruitment of 36 healthy volunteers in Phase 1a, 36 healthy volunteers in the healthy part of Phase 1b, and 36 COVID patients in the COVID part of Phase 1b). ​ 2.
Added
We plan on initiating the Phase II study for MPOX as soon as feasible if we get the appropriate regulatory clearances.
Removed
Planned costs for the Bioanalytical studies and reports for the Phase 1a/1b clinical trials. 3.
Added
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.
Removed
Additional R&D Expenditures for RSV Project. 5. Drug Substance and Drug Product Manufacturing costs, and 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.
Added
To this end, we are also evaluating the possibility of a Phase IIa clinical trial of a RSV Infection Challenge in Humans.
Removed
As a rule of thumb, we estimate that, for each drug candidate that goes into clinical trials, we estimate approximately $1.5 million for Phase I clinical trials in the United States, approximately $5 million for Phase II and approximately $10 million for Phase III, assuming each of the prior phase studies are successful.
Added
As these milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present.
Removed
After completing these clinical trials we would be able to file a New Drug Application (NDA) with the FDA for obtaining marketing approval. These estimates are based on rough quotes from potential investigators, and assumptions relative to additional costs.
Added
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.
Removed
We believe that our coronavirus program is maturing rapidly through human clinical trials.
Added
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.
Removed
We believe that assuming that we can take the same drug (NV-387) forward successfully as a treatment for RSV indication, we may be able to get a “Fast Track” designation with the FDA for this unmet medical need; we would be able to go directly into a Phase II/III efficacy evaluation study; and may be able to get accelerated approval treatment and early access to revenues.
Added
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.
Removed
Page 80 of 95 Table of Contents We believe we have sufficient funding to take our Coronavirus drug candidate through Phase 1a/1b clinical trials, and for filing an IND towards Phase II clinical trials for the treatment of RSV infection.
Added
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.
Removed
We will need to raise additional funds to take NV-HHV-1 and additional topical HerpeCide drug candidate indications into IND filing and clinical trials. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund these programs.

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