NANOVIRICIDES, INC.
For the period ended Mar 31, 2025. Filed May 15, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
NNVC$1.32+2.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-12-31; filed 2025-02-14.
0001410578-25-000140
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001410578-25-001336
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 241 previous paragraphs and 283 current paragraphs.
189 unchanged; 44 reworded; 40 added; 2 removed; 6 previous and 10 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (40)
Current report
The host-mimicry nanoviricide platform has enabled development of extremely broad-spectrum antiviral drugs such as NV-387, as well as virus-type-specific drugs such as NV-HHV-1 (Herpesviridae) and NV-HIV-1 (HIV-1, 2 all mutants).
Current report
As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Phase I human clinical trial of NV-387 was completed with no adverse events meeting or exceeding safety and tolerability objectives of the trial. In non-clinical IND-enabling studies NV-387 as well as NV-HHV-1 have been found to be extremely good in terms of their effects on animal physiology, clinical and blood chemistry, as well as no organ-specific negative findings. These clinical and non-clinical findings validate our nanoviricide platform as being capable of clinically relevant drug development.
Current report
The Company’s lead drug candidate, NV-387, is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model trials for the treatment of Coronaviruses, RSV, Influenza viruses as well as Smallpox and MPox, and the Company has predicted it to be active against all influenza viruses including bird flu H5N1 and H7N9, as well as against the Measles virus. All of these distinctly different viruses utilize HSPG (heparan sulfate proteoglycans) for cell infection; so do H5N1, H7N9, the highly pathogenic influenza viruses, and even the Measles virus.
Current report
The Company has initiated work towards evaluating the effectiveness of NV-387 in a humanized animal model of Measles virus infection.
Current report
NV-387 is expected to be active against most if not all Highly Pathogenic Influenza viruses (HPAI) including H5N1 “Bird Flu” (or Avian Flu), and the Company plans to obtain non-dilutive funding to advance this drug for the H5N1 indication such as grants or contracts from government agencies.
Current report
In addition, the Company is planning clinical trials towards the approval of NV-387 for the treatment of RSV infection in pediatric patients in the US.
Current report
In addition to NV-387, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans to progress NV-HHV-1 into human clinical trials, and further develop the HerpeCide TM program after the Phase II clinical trial of NV-387 for RSV, MPox, ARI/SARI, and possibly for multiple other indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.
Current report
The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), a related party substantially owned by Dr. Anil Diwan, to which the Company has broad, exclusive licenses. The licenses are to entire fields and not limited to specific compounds. In all, the Company has exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated), Varicella Zoster Virus (“VZV”) infections (i.e. Shingles and Chickenpox), and SARS-CoV-2 infections. Additionally, the Company has signed a Memorandum of Understanding (“MoU”) on September 23, 2024 to codify the process for all antivirals drug development with TheraCour. Despite the name (“MoU”), this is a legal agreement between the Parties that has formally assigned a right of first refusal (ROFR) for all antiviral drug developments from TheraCour to the Company.
Current report
This MoU expands the Company’s abilities to opportunistically and rapidly develop novel drugs to treat viral infections of public health importance, even for those viruses that do not exist today and cannot be predicted. The MoU has also formalized the process of development of drugs for unlicensed viral indications leading later to appropriate license agreements. There was no compensation paid to or due to TheraCour as a result of this MoU. The Parties have also agreed in this MoU that any cash milestone payments related to development activities, that are awardable, will become payable only upon the Company having sufficient revenue, thus extending the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements.
Current report
In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, and the process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour. Milestone payments were made or are specified in certain of the license agreements, details of which have been disclosed at the time the agreements were entered into. The Company negotiates and licenses specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested.
Current report
The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored the NV-CoV-2 (NV-387) into Phase Ia/Ib human clinical trial, to study the safety and tolerability of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies formulations of the API NV-387 in healthy human subjects, described earlier. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive from KMPL a royalty of 70% calculated as the percentage of final invoiced sales less the cost of sales and goods sold to unaffiliated third parties.
Current report
NV-387 Phase II Clinical Trials Plans for Respiratory Viruses – A Single Drug to Combat “Tripledemics”
Current report
We are working on starting Phase II clinical trials to evaluate safety and effectiveness of NV-387 treatment in MPox patients, in light of the continuing MPox Clade Ia/Ib pandemic in Central African region with increasing spill over cases into the rest of the world reported since April, 2025.
Current report
Measles Virus and NV-387 - A Drug to Respond to Current Measles Outbreak – Highly Likely to be Effective
Current report
Measles virus cases have been increasing in the USA year over year and in 2025 there have been over 935 confirmed cases and 3 deaths as of May 1, 2025 (https://www.cdc.gov/measles/data-research/index.html). The CDC has updated the Measles treatment overview fact sheet for health care providers to include recommendations for the use of vitamin A, antibiotics, and inhaled steroids, under the supervision of clinician, to treat measles.
Current report
There is no antiviral approved for the treatment of Measles virus, an urgent and unmet medical need. CDC fact sheet says that ribavirin is not approved for Measles, although it has been used in some patients, and that clinical data is lacking regarding its effectiveness. Ribavirin may be used only under an emergency use IND filing with the US FDA.
Current report
CDC notes that “MMR vaccination is the best way to prevent measles and its complications,” and that “those who cannot or prefer not to get vaccinated, risk of measles infection and severe illness.”
Current report
Vaccination rates for MMR vaccines in particular have fallen across the world, primarily because of loss of public faith in the communications regarding vaccines, compulsion during the COVID pandemic, as well supported belief that the side effects of vaccines have not been systematically captured and reported, and that, instead, there has been a strong bias in the health community to avoid associating side effects with the use of vaccines. The US Secretary of Health has begun revising the policies in order to perform more thorough evaluations of vaccines especially since vaccines are to be used in the entire population, unlike treatments that are used only in affected patients.
Current report
In particular, Measles is the most communicable disease known to man, and “herd immunity” that is required for elimination of Measles from the population, requires 95% of the population to be vaccinated. An increasing portion of the population is becoming incapable of generating full immunity upon vaccination because of immune system compromise, auto-immune diseases, severe allergies, chronic health issues such as diabetes and obesity, and advanced age. There is also personal reluctance for the risk that one’s own child may be affected by a major side effect even as documented rates of side effects are small. There are also communities with religious prohibition for using vaccines. Therefore, reaching 95% vaccination rate is becoming an ever distant goal.
Current report
New genotypes of the Measles virus are arising whereas Measles vaccine is based on an old genotype A.
Current report
Measles incidence rates are increasing worldwide. The need for an effective therapeutic cannot be over-emphasized.
Current report
NV-387 is anticipated to be effective against Measles virus. This is because of its broad-spectrum activity against viruses that use HSPG to infect cells. Measles virus belongs to the same class as RSV (paramyxoviruses), and uses HSPG for causing infection.
Current report
We believe that NV-387 has sufficient non-clinical and clinical data that it can be used in severe Measles cases under specific US FDA provisions related to investigator-initiated clinical trial in one or few patients that can provide preliminary information.
Current report
We note that the Trump administration and the Secretary of Health are in the process of revising the overall HHS goals, budgets and staffing with a focus on health maintenance, chronic diseases, nutrition, and antiviral treatments, with reduced focus on vaccines.
Current report
We believe that the emphasis of the Secretary on antiviral drug treatments would be beneficial to our drug development programs.
Current report
Phase II Clinical Trial for the Treatment of MPox with NV-387
Current report
Our CRO has already engaged one clinical trial site as of this reporting, and we are working on an additional site.
Current report
Importantly, we have recently received an approval to proceed to a Phase II clinical trial for MPox from the Regional Ethics Committee in the Democratic Republic of Congo (DRC), based on the non-clinical data on safety and efficacy, as well as the safety and tolerability data from a draft report of the Phase I clinical trial of NV-387.
Current report
This clears the path for us to submit a Phase II Clinical Trial Application (CTA) for the use of NV-387 for the treatment of MPox disease (caused by MPXV infection) to the DRC regulatory agency.
Current report
We are now completely focused on preparing the Phase II MPox CTA for NV-387.
Current report
Treatment of Measles Virus Infection Using NV-387
Current report
During the reported quarter, we have initiated a program for the development of NV-387 as an antiviral treatment for Measles virus infection. We have acquired a Measles virus in our BSL2 Virology lab and we have grown it in cell cultures in a small quantity sufficient for initial animal studies.
Current report
We have completed designing an experiment for the evaluation of NV-387 as a treatment for Measles virus infection in an animal model. Measles virus is host restricted and requires the use of humanized hCD150 (h-SLAP) mice for this work. These mice are grown only on order and take several weeks for delivery. We have already commissioned this animal model study.
Current report
If the animal model study is successful, we plan on opening an IND with the US FDA for a Phase II clinical trial for the evaluation of NV-387 as a treatment of measles virus. We plan on seeking non-dilutive grant support for development of NV-387 as a treatment for Measles virus.
Current report
We already have the supporting data required for such an IND as summarized below.
Current report
We have initiated work on evaluating NV-387 as a treatment for Measles virus infection in a relevant animal model. If successful, we believe this will enable us to apply for Phase II human clinical trials with the US FDA and seek non-dilutive grant funding for the same.
Current report
COVID and Long COVID
Current report
We believe we have sufficient funds for undertaking the Phase II clinical trial for evaluation of NV-387 for the treatment of MPox in DRC. We plan on seeking additional funding for all of our drug programs from non-dilutive sources as well as raising equity-based financing as appropriate.
Current report
**: The PCT application PCT/US22/35210 was filed with request for priority of PCT/US21/39050.
Current report
Excluding those sold under the ATM, all of the securities referred to above were issued without registration under the Securities Act of 1933, as amended (the “Securities Act”) in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as provided in Rule 506(b) of Regulation D promulgated thereunder. None of the foregoing securities as well as common stock issuable upon conversion or exercise of such securities, have been registered under the Securities Act or any other applicable laws and are deemed restricted securities, and unless so registered may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act.
Removed paragraphs (2)
Previous report
Importantly, the H5N1 bird flu virus from wild birds is rapidly evolving as it is contracted by humans; this is now established. Mutations were found in H5 gene that clearly indicate that the virus can readily escape vaccines and antibody drugs. Other mutations indicate the virus could acquire resistance to existing drugs rapidly, although in the Canadian girl’s case, no evidence of reduced antiviral susceptibility was found.
Previous report
We are also performing additional pre-clinical experiments to further understand the spectrum of antiviral activity of NV-387 towards obtaining information for regulatory advancement against different antiviral indications.
Reworded paragraphs (44)
Previous wording
We are a clinical stage nano-biopharmaceutical company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling the virus without assistance from the human immune system. As a host-mimetic, viruses cannot escape a nanoviricide drug by generating mutants and variants in the field, because all variants still require the same signature host features that our drugs mimic. In contrast, vaccines, antibodies and small chemical drugs are readily escaped by viruses because the viruses continuously change in the field, rendering these medical countermeasures ineffective. This was repeatedly observed in the recent COVID pandemic. As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response.
Current wording
We are a clinical stage nano-biopharmaceutical company developing (a) host-mimetic, and (b) direct-acting, nanomachines capable of dismantling the virus without assistance from the human immune system.
Previous wording
Antibiotics such as penicillin directly attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to directly attack the viral surface and destroy the virus particle. Similar to antibiotics that possess a broad-spectrum to treat bacterial infections, NV-387 could be a much needed, ultra-broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections.
Current wording
NV-387 could be a much needed, ultra-broad-spectrum, direct acting, antiviral agent to treat multiple different viral infections reminiscent of antibiotics that possess a broad-spectrum to treat bacterial infections. Antibiotics such as penicillin directly attack the bacterial surface and thereby kill the bacteria. Similarly, NV-387 is designed to directly attack the viral surface and destroy the virus particle.
Previous wording
We are now preparing for Phase II human clinical trials to assess effectiveness of NV-387 treatment in a number of different viral diseases in humans. We plan to further develop NV-387, as an ultra-broad-spectrum antiviral medication to treat a number of viral infections including Coronaviruses (SARS-CoV-2, MERS-CoV, Seasonal Coronaviruses, hCoV-NL63), Respiratory Syncytial Virus (RSV), Influenza Viruses including Bird Flu H5N1 (all variants), and possibly other respiratory viral infections, thus covering all of the “tripledemic” viruses and more with this single drug.
Current wording
We plan to further develop NV-387, as an ultra-broad-spectrum antiviral medication to treat a number of viral infections including Respiratory Syncytial Virus (RSV), Influenza Viruses including Bird Flu H5N1 (all variants), Coronaviruses (SARS-CoV-2, MERS-CoV, Seasonal Coronaviruses, hCoV-NL63), as well as possibly other respiratory viral infections, thus covering all of the “tripledemic” viruses and more with this single drug.
Previous wording
NV-387 Phase II Clinical Trial for MPox Epidemic; Strong Potential Markets and Non-Dilutive Funding Possibilities
Current wording
NV-387 Phase II Clinical Trial for MPox Epidemic
Previous wording
We have initiated work to begin Phase II clinical trials to evaluate safety and effectiveness of NV-387 treatment in MPox patients, due to the recent MPox epidemic in the Central African region. To this effect, the Company has engaged a CRO in January 2025 to help with conducting the MPox clinical trial of NV-387 in countries in the Central African region. Trial sites have also been previously identified. The Company is now preparing a clinical trial application for the Phase II clinical trial for submission to the appropriate regulatory agency. We believe that if successful in a Phase II clinical trial against MPox, NV-387 would also be approvable for the treatment of Smallpox.
Current wording
To this effect, the Company has engaged a Contract Research Organization (CRO) to help with conducting the MPox clinical trial of NV-387 in countries in the central African region. Trial sites have also been identified already. The Company is preparing a clinical trial application for the MPox Phase II clinical trial for submission to the appropriate regulatory agencies in DRC (Democratic Republic of Congo) and in Uganda. Recently, the Company has received approval from the regional ethics committee in the DRC for conducting a Phase II clinical trial to evaluate the effectiveness of NV-387 as a treatment for MPox infections.
Previous wording
MPox caused by Clade 1 and 1b variants is currently a pandemic emergency in the Central African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. This led to the declaration of a Public Health Emergency of International Concern (PHEIC) on August 14, 2024 by the WHO. Clade 1b is more transmissible than Clade 1 and Clade 2, and is also causing more pediatric infections. (https://www.who.int/news/item/14-08-2024-who-director-general-declares-MPox-outbreak-a-public-health-emergency-of-international-concern).
Current wording
MPox caused by Clade Ia and Ib variants is continuing as a pandemic emergency in the Central African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. WHO declared MPox outbreak in 2024 a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, and maintains that the outbreak status still meets the PHEIC definition (https://www.who.int/news/item/17-03-2025-third-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-upsurge-of-mpox-2024). Clade Ib is more transmissible than Clade I and Clade II, and is also causing more pediatric infections (https://www.who.int/news/item/14-08-2024-who-director-general-declares-MPox-outbreak-a-public-health-emergency-of-international-concern).
Previous wording
A less pathogenic variant, MPox Clade 2, has spread across the globe. The Clade 2 MPox virus caused a widespread epidemic in May 2022 in the Western world, and has now become endemic. It continues to cause cases in the USA every year.
Current wording
A less pathogenic variant, MPox Clade II, particularly Clade IIb, has spread across the globe. The Clade II MPox virus caused a widespread epidemic in May 2022 in the Western world, and has now become endemic. It continues to cause cases in the USA every year as per May 2025 report of WHO on MPox outbreak global trends (https://worldhealthorg.shinyapps.io/mpx_global/).
Previous wording
Smallpox has always been considered a bioterrorism threat agent of highest priority, with MPox joining its ranks. The market size for a Smallpox/MPox drug can be estimated to be in the range of billions of dollars worldwide. Since the outbreak of MPox Clade 1b, which is both more transmissible and more pathogenic than the prior versions of this virus, globally public health protection agencies and governments have been concerned for pandemic preparation.
Current wording
Smallpox has always been considered a bioterrorism threat agent of highest priority, with MPox joining its ranks. The market size for a Smallpox/MPox drug can be estimated to be in the range of billions of dollars worldwide. Since the outbreak of MPox Clade Ib, which is both more transmissible and more pathogenic than the prior versions of this virus, globally public health protection agencies and governments have been concerned for pandemic preparation.
Previous wording
There is no drug currently available for the treatment of MPox. A drug, tecovirimat (TPOXX®, SIGA) was approved by US FDA under the “Animal Rule” for the treatment of Smallpox (and MPox). However, it failed in a large clinical trial as a treatment of the MPox Clade 1/1b infections, with no statistical improvement observed in comparison to the standard of care (NIH/NIAID Press Release, August 15, 2024, at https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo). Even so, SIGA Technologies, Inc. had, for TPOXX, approximately $146 million of outstanding procurement orders, out of which there was $122 million of procurement orders from the U.S. Government alone in the third quarter ended September 2024, according to its financial report (SIGA press release dated November 7, 2024). Overall, SIGA has received procurement orders for tecovirimat from US Government alone for over $250 million in 2023-2024, illustrative of the market size of an effective drug against poxviruses (www.siga.com, various press releases).
Current wording
August 15, 2024, at https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo). Even so, SIGA Technologies, Inc. had, for TPOXX, approximately $146 million of outstanding procurement orders, out of which there was $122 million of procurement orders from the U.S. Government alone in the third quarter ended September 2024, according to its financial report (SIGA press release dated November 7, 2024). Overall, SIGA has received procurement orders for tecovirimat from US Government alone for over $250 million in 2023-2024, illustrative of the market size of an effective drug against poxviruses (www.siga.com, various press releases).
Previous wording
Viral ARI and SARI are primarily caused by a number of different viruses that include all Coronaviruses (SARS-CoV-2 that led to COVID-19, SRAS-CoV-1, hCoV-NL63, hCoV-OC43 and others), Influenza viruses including the H5N1 Bird Flu viruses, RSV, human Metapneumoviruses (hMPV), and Para-Influenza Viruses (PIV).
Current wording
Viral ARI and SARI are primarily caused by a number of different viruses that include all Coronaviruses (SARS-CoV-2 that led to COVID-19, SRAS-CoV-1, hCoV-NL63, hCoV-OC43 and others), all Influenza viruses including the H5N1, H7N9 and other Bird Flu viruses, RSV, human Metapneumoviruses (hMPV), and Para-Influenza Viruses (PIV).
Previous wording
Notably, NV-387 was found to be active against all tested respiratory viral infections (lethal lung infections) in animal model studies, which included RSV, Influenza viruses, Coronaviruses, as well as MPox/Smallpox. Further hMPV is similar to RSV in terms of its infection process, suggesting that NV-387 could be effective against it. Additionally, NV-387 is expected to be active against many other viruses because of its design that mimics the human host-side sulfated proteoglycans that all of these viruses use for causing effective cell infection.
Current wording
Notably, NV-387 was found to be active against all tested respiratory viral infections (lethal lung infections) in animal model studies, which included RSV, Influenza viruses, Coronaviruses, as well as MPox/Smallpox. hMPV is similar to RSV in terms of its infection process, suggesting that NV-387 could be effective against it.
Previous wording
H5N1 and NV-387 - A Drug that the Virus Would Not Escape - is Already Available to Respond to Potential Pandemic
Current wording
H5N1 and NV-387 - A Drug that the Virus Would Not Escape to Respond to Potential Pandemic
Previous wording
We believe NV-387 would be effective against H5N1 bird flu as well. Also we believe NV-387 would be effective against influenza viruses resistant to available drugs. NV-387 is expected to be active against substantially all of the Highly Pathogenic Influenza viruses (HPAI) including H5N1 “Bird Flu” (or Avian Flu) because the HPAI viruses including H5N1 viruses possess in the HA protein a “polybasic” site that has high affinity to HSPG, which NV-387 mimics. The polybasic site is thought to be partly responsible for the high pathogenicity of these viruses. Thus these HPAI/H5N1/H5N9 viruses can be expected to be attacked by NV-387 perhaps even more strongly than the “usual” Influenza viruses.
Current wording
We believe NV-387 would be effective against H5N1 bird flu as well. Also we believe NV-387 would be effective against influenza viruses resistant to available drugs. NV-387 is expected to be active against substantially all of the Highly Pathogenic Influenza viruses (HPAI) including H5N1 “Bird Flu” (or Avian Flu) because the HPAI viruses including H5N1 viruses possess in the HA protein a “polybasic” site that has high affinity to HSPG, which NV-387 mimics. The polybasic site is thought to be partly responsible for the high pathogenicity of these viruses. Thus these HPAI/H5N1/H5N9 viruses can be expected to be attacked by NV-387 perhaps even more strongly than the other Influenza viruses.
Previous wording
In both cases, mutations in the H5 protein of the virus were found that increased the virus’ ability to target the human receptor (E186D, Q222H, A134V, and N182K). Additional mutations were also found in other important genes that can lead to greater pathology and resistance to current small chemical drugs.
Current wording
In both cases, mutations in the H5 protein of the virus were found that increased the virus’ ability to target the human receptor (E186D, Q222H, A134V, and N182K). Mutations were found in the H5 gene that clearly indicate that the virus can readily escape vaccines and antibody drugs. Additional mutations were also found in other important genes indicating that the virus could acquire resistance to existing drugs rapidly.
Previous wording
In addition, we plan on Phase II clinical trial of NV-387 for the treatment of RSV infection, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV. RSV is an important disease particularly for infants and children under 6 years of age, as well as for older persons and immunocompromised patients. The market size for RSV is estimated at
Current wording
In addition, we plan on Phase II clinical trial of NV-387 for the treatment of RSV infection, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV. RSV is an important disease particularly for infants and children under 6 years of age, as well as for older persons and immunocompromised patients. The market size for RSV is estimated at $2.6 billion in 2024, growing to $4.3 billion in three years, at a rate of 18.9% as reported by GrowthPlusReports (https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519). There are two protective antibodies and two protective vaccines, approved in the U.S. but no drug for the treatment of RSV infection, other than the last resort toxic drug ribavirin.
Previous wording
RSV causes severe infections primarily in infants and young children, persons over age of 60 and immune-compromised persons.
Current wording
RSV causes severe infections primarily in infants and young children, persons over age 60 and immune-compromised persons.
Previous wording
We plan on seeking non-dilutive grant and contracts funding for our drug candidates that are responsive to bio-defense and pandemic-preparedness objectives.
Current wording
We plan to seek non-dilutive grant and contracts funding for our drug candidates that are responsive to bio-defense and pandemic-preparedness objectives, as well as objectives of importance to the health agencies such as RSV and Measles.
Previous wording
**3.**Smallpox/MPox: Oral dosing with NV-387 led to an increase in lifespan of mice lethally infected with ectromelia virus (a cousin and model stand-in for smallpox/MPox viruses) into lungs that was comparable to treatment with tecovirimat (TPOXX®, SIGA). In addition, we also found that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment. This model is relevant to the skin-abrasion mode of MPox transmission that was
Current wording
**3.**Smallpox/MPox: Oral dosing with NV-387 led to an increase in lifespan of mice lethally infected with ectromelia virus (a cousin and model stand-in for smallpox/MPox viruses) into lungs that was comparable to treatment with tecovirimat (TPOXX®, SIGA). In addition, we also found that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment. This model is relevant to the skin-abrasion mode of MPox transmission that was found to be dominant in the recent MPox pandemic, and is also found to be operative in the current Congo MPox epidemic. Tecovirimat, approved for Smallpox treatment under the FDA “Animal Rule”, is currently stockpiled under the US Strategic National Stockpile.
Previous wording
chemically synthesize the optimal ligands, and separately attach them to the polymeric micelle scaffold to generate a number of initial “nanoviricide” drug candidates to screen against the virus. Thus the nanoviricide is designed to “look like” the cell membrane with copious amounts of sites for the virus to bind to. When initial interaction of a few ligands with the virus particle takes place, the “metstable” nanoviricide micelle is anticipated to shift its shape, inverting itself onto the virus particle promoted by the “lipid-lipid mixing effect” driven by the lipid chains normally on the interior of a nanoviricide micelle and the lipid membrane that is on the virus surface. Such an attack on the virus particle is expected to de-stabilize the virus particle and uproot the surface glycoproteins it uses for fusing with a cell. Thus the virus would no longer be capable of infecting a cell. This process would result in complete blockage of the “Re-Infection Cycle” of the virus if successful. We call this mechanism “Re-Infection Inhibition”. This mechanism goes beyond the simple neutralization of the virus by antibodies, which requires the human immune system to further take care of the resulting virus-antibody complex. This mechanism also goes beyond the simple blocking of virus entry by small chemical entry inhibitors, which would require extremely high concentrations of the inhibitor to effect complete blockage of each virus particle based on mass-action considerations.
Current wording
We mimic the feature on the cellular protein at which the virus binds, and, using molecular modeling, design small molecules that act as “ligands” to bind to the virus surface glycoproteins as though the virus was binding to that cellular protein itself. This host-side chemical signature that the virus uses for infecting cells does not change even as the virus mutates, evolves and generates variants. We chemically synthesize the optimal ligands, and separately attach them to the polymeric micelle scaffold to generate a number of initial “nanoviricide” drug candidates to screen against the virus. Thus the nanoviricide is designed to “look like” the cell membrane with copious amounts of sites for the virus to bind to. When initial interaction of a few ligands with the virus particle takes place, the “metstable” nanoviricide micelle is anticipated to shift its shape, inverting itself onto the virus particle promoted by the “lipid-lipid mixing effect” driven by the lipid chains normally on the interior of a nanoviricide micelle and the lipid membrane that is on the virus surface. Such an attack on the virus particle is expected to de-stabilize the virus particle and uproot the surface glycoproteins it uses for fusing with a cell. Thus the virus would no longer be capable of infecting a cell. This process would result in complete blockage of the “Re-Infection Cycle” of the virus if successful. We call this mechanism “Re-Infection Inhibition”. This mechanism goes beyond the simple neutralization of the virus by antibodies, which requires the human immune system to further take care of the resulting virus-antibody complex. This mechanism also goes beyond the simple blocking of virus entry by small chemical entry inhibitors, which would require extremely high concentrations of the inhibitor to effect complete blockage of each virus particle based on mass-action considerations.
Previous wording
This total attack on the complete lifecycle of the virus is expected to result in the most effective drug candidates. It is now well accepted that multiple antivirals together produce better effectiveness than single ones individually. Our strategy goes beyond simply a mix of multiple antivirals. Our unique, shape-shifting nanomedicine technology leads to substantial improvement in the pharmacokinetic properties of the guest antiviral drug. We have demonstrated this capability in the case of NV-387-g-R, as discussed above, wherein encapsulation of Remdesivir within the polymeric micelles of NV-387 protects the former drug from bodily metabolism in animal studies. This allows higher concentrations of the guest drug to be reached and simultaneously extends the effectiveness time period in
Current wording
This total attack on the complete lifecycle of the virus is expected to result in the most effective drug candidates. It is now well accepted that multiple antivirals together produce better effectiveness than single ones individually. Our strategy goes beyond simply a mix of multiple antivirals. Our unique, shape-shifting nanomedicine technology leads to substantial improvement in the pharmacokinetic properties of the guest antiviral drug. We have demonstrated this capability in the case of NV-387-g-R, as discussed above, wherein encapsulation of remdesivir within the polymeric micelles of NV-387 protects the former drug from bodily metabolism in animal studies. This allows higher concentrations of the guest drug to be reached and simultaneously extends the effectiveness time period in comparison to the standard Veklury® (Gilead) formulation. The resulting drug, NV-387-g-R has not only significantly improved characteristics for its remdesivir component, but additionally provides the novel re-infection blocking mechanism of NV-387; together enabling complete block of the viral lifecycle, which would potentially result in a cure. (Chakraborty A, Diwan A, Chiniga V, Arora V, Holkar P, Thakur Y, et al. (2022) Dual effects of NV-CoV-2 biomimetic polymer: An antiviral regimen against COVID-19. PLoS One 17(12): e0278963. https://doi.org/10.1371/journal. pone.0278963.)
Previous wording
During the three months ended December 31, 2024, we have focused on preparing regulatory documentation that will be necessary for primarily (i) a Phase II MPox clinical trial of NV-387, and (ii) a Phase II RSV clinical trial of NV-387. We are in the process of developing a Phase II clinical trial application for submission to a regulatory agency in the Central African region, for the treatment of
Current wording
During the three months ended March 31, 2025, we have focused on preparing regulatory documentation that will be necessary for primarily (i) a Phase II MPox clinical trial of NV-387, and (ii) a Phase II RSV clinical trial of NV-387.
Previous wording
MPox infection with NV-387. To this end we have retained a CRO to help us with the execution of the clinical trial. Sites for clinical trial have also been identified. In addition, we have started working on a Phase II clinical trial protocol for the treatment of RSV infection.
Current wording
We are in the process of developing a Phase II clinical trial application for submission to a regulatory agency in the Central African region, for the treatment of MPox infection with NV-387. To this end we have retained a CRO to help us with the execution of the clinical trial.
Previous wording
We have initiated the production program for Phase II clinical supply of NV-387 drug products. We have improved the NV-387 drug product formulations with organoleptic considerations (i.e. taste, flavor, feel and smell).
Current wording
We are currently executing the production program for Phase II clinical supply of NV-387 drug products. We have improved the NV-387 drug product formulations with organoleptic considerations (i.e. taste, flavor, feel and smell). We have ordered additional custom equipment, made in the USA, for the gummies blister-pack filling and sealing operation that is expected to be delivered soon.
Previous wording
A Phase I clinical trial of (i) NV-387 Oral Syrup and (ii) NV-387 Oral Gummies formulations to evaluate Safety and Tolerability in healthy human subjects was completed with the discharge and final visit of the last subject at the end of December, 2023. There were no reported adverse events, and there were no drop-outs in this clinical trial of 72 subjects. Thus, the drug NV-387, in both of the oral formulations studied, namely oral syrup and oral gummies (a soft solid form that dissolves in the mouth), is deemed to be safe and well tolerated and can be further advanced into Phase II clinical trials, as per communications with the Data Safety and Monitoring Board (DSMB) for this clinical trial. We are awaiting a final report of the clinical trial. This statement regarding safety and tolerability will be evaluated, after we submit the final Phase I report, by the regulatory agency.
Current wording
A Phase I clinical trial of (i) NV-387 Oral Syrup and (ii) NV-387 Oral Gummies formulations to evaluate Safety and Tolerability in healthy human subjects was completed with the discharge and final visit of the last subject at the end of December, 2023. There were no reported adverse events, and there were no drop-outs in this clinical trial of 72 subjects. Thus, the drug NV-387, in both of the oral formulations studied, namely oral syrup and oral gummies (a soft solid form that dissolves in the mouth), is deemed to be safe and well tolerated and can be further advanced into Phase II clinical trials, as per communications with the Data Safety and Monitoring Board (DSMB) an independent expert review committee commissioned for this clinical trial. We are awaiting a final report of the clinical trial. This statement regarding safety and tolerability will be evaluated, after we submit the final Phase I report, by the regulatory agency.
Previous wording
Our Current Priorities – MPox, H5N1, and RSV
Current wording
Our Current Priorities – Measles, MPox, H5N1, and RSV
Previous wording
We are presently working on the Phase II clinical regulatory development of NV-387 as a treatment for MPox infection. If successful, this program is expected to enable us to tap into governmental programs for development and stockpiling of MPox and Smallpox treatments as preparedness against potenatial MPox pandemic and Smallpox bioterrorism events.
Current wording
We are presently working on the Phase II clinical regulatory development of NV-387 as a treatment for MPox infection. If successful, this program is expected to enable us to tap into governmental programs for development and stockpiling of MPox and Smallpox treatments as preparedness against potential MPox pandemic and Smallpox bioterrorism events.
Previous wording
Further, we continue to perform pre-clinical investigations to expand the usage of NV-387 as an antiviral drug against other viruses to improve return on investment, ROI. Additionally, we are also performing topical drug development against several indications related to infections by herpes family viruses.
Current wording
We plan on continuing to perform pre-clinical investigations to expand the usage of NV-387 as an antiviral drug against other viruses to improve return on investment, ROI.
Previous wording
reactors and process vessels on chassis or skids, ranging from 250mL to 100L capacities, as needed. Many of the reactors and vessels have been designed by us for specific tasks related to our unique manufacturing processes.
Current wording
The process scale-up area is operational at kilogram to multi-kg scales for different chemical synthesis and processing steps. It comprises reactors and process vessels on chassis or skids, ranging from 250mL to 100L capacities, as needed. Many of the reactors and vessels have been designed by us for specific tasks related to our unique manufacturing processes.
Previous wording
We have established several different types of assays for screening of drug candidates against Coronaviruses, SARS-CoV-2 Pseudovirions, VZV, HSV-1, HSV-2, Influenza viruses, RSV, Ectromelia virus (a stand-in for MPox and Smallpox viruses), among others in this lab. Our BSL-2 Virological capability has been instrumental in our rapid development of potential drug candidates for further investigation towards human clinical trials. We believe that having developed the internal capabilities for cell culture testing of our ligands and nanoviricides against a variety of viruses has substantially strengthened and accelerated our drug development programs.
Current wording
We have established several different types of assays for screening of drug candidates against Coronaviruses, SARS-CoV-2 Pseudovirions, VZV, HSV-1, HSV-2, Influenza viruses, RSV, Ectromelia virus (a stand-in for MPox and Smallpox viruses), among others in this lab. We are working on developing an H5N1 Bird Flu pseudovirion assay. We have begun working on the Measles virus during the reported quarter. Our BSL-2 Virological capability has been instrumental in our rapid development of potential drug candidates for further investigation towards human clinical trials. We believe that having developed the internal capabilities for cell culture testing of our ligands and nanoviricides against a variety of viruses has substantially strengthened and accelerated our drug development programs.
Previous wording
As we develop NV-387 further into Phase II clinical trials, we plan on seeking non-dilutive funding for the Smallpox/Mpox, COVID and Long COVID, Bird Flu, as well as RSV drug development programs as the opportunities arise. We plan on seeking partnerships for all of our drug development programs, as these programs mature further.
Current wording
As we develop NV-387 further into Phase II clinical trials, we plan on seeking non-dilutive funding for the Measles, RSV, Smallpox/Mpox, COVID and Long COVID, as well as Influenza and Bird Flu drug development programs as the opportunities arise. We plan on seeking partnerships for all of our drug development programs, as these programs mature further.
Previous wording
As a risk factor, we recognize that the FDA may require additional studies to be done before approving the IND for any of our programs. Assuming that the FDA allows us to conduct human clinical studies as we intend to propose, we believe that this coming year’s work plan will lead us to obtain certain information about the safety and efficacy NV-387 in human clinical studies for the treatment of of MPox infection. If our studies are not successful, we will have to perform additional clinical trials for NV-387 for other appropriate indications, and/or develop additional drug candidates and perform further studies. If our studies are successful, then we expect to be able to undertake further additional studies as necessary towards drug approval or licensure from regulatory agencies.
Current wording
As a risk factor, we recognize that the FDA may require additional studies to be done before approving the IND for any of our programs. Assuming that the FDA and other International regulatory agencies allow us to conduct human clinical studies as we intend to propose, we believe that the coming year’s work plan will lead us to obtain certain information about the safety and efficacy NV-387 in human clinical studies for the treatment of MPox infection and possibly Measles infection. If our studies are not successful, we will have to perform additional clinical trials for NV-387 for other appropriate indications, and/or develop additional drug candidates and perform further studies. If our studies are successful, then we expect to be able to undertake further additional studies as necessary towards drug approval or licensure from regulatory agencies.
Previous wording
We have not engaged any other new collaborators during the reported quarter. In January 2025 we engaged a CRO to help us execute a Phase II clinical trial for the evaluation of NV-387 for the treatment of MPox in Central African region.
Current wording
In January 2025 we engaged a CRO to help us execute a Phase II clinical trial for the evaluation of NV-387 for the treatment of MPox in the Central African region.
Previous wording
As of December 31, 2024, we had cash and cash equivalents of $3,958,052, prepaid expenses of $113,807 and net property and equipment of $7,171,865. Accounts payable and accrued expenses were $1,184,064, inclusive of accounts payables to related parties of $866,783. Stockholders’ equity was $10,386,579 at December 31, 2024. In comparison, as of June 30, 2024, we had $4,797,778 in cash and cash equivalents, prepaid expenses of $172,742 and $7,512,463 of net property and equipment. Our liabilities at June 30, 2024 were $1,358,776 including accounts payable of $376,270 payable to third parties and accounts payable to TheraCour of $720,039, and accrued expenses of $262,467.
Current wording
As of March 31, 2025, we had cash and cash equivalents of $2,542,590, prepaid expenses of $184,716 and net property and equipment of $6,982,750. Accounts payable and accrued expenses were $1,198,911, inclusive of accounts payables to related parties of $813,477 and accrued expenses of $32,616. Stockholders’ equity was $8,833,049 at March 31, 2025. In comparison, as of June 30, 2024, we had $4,797,778 in cash and cash equivalents, prepaid expenses of $172,742 and $7,512,463 of net property and equipment. Our liabilities at June 30, 2024 were $1,358,776 including accounts payable of $376,270 payable to third parties and accounts payable to related parties of $720,039, and accrued expenses of $262,467, of which $227,435 was due to a related party.
Previous wording
During the six month period ended December 31, 2024, we used approximately $4.8 million in cash toward operating activities. This was substantially greater than the prior one year ago period primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II.
Current wording
During the nine month period ended March 31, 2025, we used approximately $6.8 million in cash toward operating activities. This was substantially greater than for the nine months ended March 31, 2024 primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II.
Previous wording
Revenues The Company is a biopharmaceutical company and did not have any revenue for the six month period ended December 31, 2024.
Current wording
Revenues The Company is a biopharmaceutical company and did not have any revenue for the nine month period ended March 31, 2025.
Previous wording
Research and Development Expenses* –* Research and development expenses for the three months ended December 31, 2024 decreased $417,528 to $1,156,351 from $1,573,879 for the three months ended December 31, 2023. Research and development expenses for the six months ended December 31, 2024 increased $48,898 to $3,089,442 from $3,040,544 for the six months ended December 31, 2023. The decrease in research and development expenses for the three months ended December 31, 2024 is due to a decrease in outside lab fees and clinical trial costs. The increase in research and development expenses for the six months ended December 31, 2024 is due to an increase in outside lab fees.
Current wording
Research and Development Expenses* –* Research and development expenses for the three months ended March 31, 2025 increased $67,590 to $1,282,251 from $1,214,661 for the three months ended March 31, 2024. Research and development expenses for the nine months ended March 31, 2025 increased $116,488 to $4,371,693 from $4,255,205 for the nine months ended March 31, 2024. The increase in research and development expenses for the three and nine months ended March 31, 2025 is due to an increase in outside lab fees and clinical trial costs.
Previous wording
General and Administration Expenses* –* General and administrative expenses for the three months ended December 31, 2024 increased $291,823 to $902,700 from $610,877 for the three months ended December 31, 2023. General and administrative expenses for the six months ended December 31, 2024 increased $961,640 to $2,137,443 from $1,175,803 for the six months ended December 31, 2023. The increase in general and administrative expenses for the three and six months ended December 31, 2024 is due to an increase in professional fees associated with investor outreach.
Current wording
General and Administration Expenses* –* General and administrative expenses for the three months ended March 31, 2025 increased $273,163 to $966,905 from $693,742 for the three months ended March 31, 2024. General and administrative expenses for the nine months ended March 31, 2025 increased $1,234,804 to $3,104,349 from $1,869,545 for the nine months ended March 31, 2024. The increase in general and administrative expenses for the three and nine months ended March 31, 2025 is due to an increase in professional fees associated with investor outreach.
Previous wording
Interest Income* –* Interest income for the three months ended December 31, 2024 decreased $51,425 to $31,709 from $83,134 for the three months ended December 31, 2023. Interest income for the six months ended December 31, 2024 decreased $109,740 to $72,732 from $182,472 for the six months ended December 31, 2023. The decrease in interest income for the three and six months ended December 31, 2024 is due to a lower interest bearing balance during the period and lower interest rates during the current three and six month period compared to the prior period.
Current wording
Interest Income* –* Interest income for the three months ended March 31, 2025 decreased $21,554 to $32,373 from $53,927 for the three months ended March 31, 2024. Interest income for the nine months ended March 31, 2025 decreased $131,293 to $105,106 from $236,399 for the nine months ended March 31, 2024. The decrease in interest income for the three and nine months ended March 31, 2025 is due to a lower interest bearing balance during the period and lower interest rates during the current three and nine month period compared to the prior periods.
Previous wording
Interest Expense* –* Interest expense decreased $13,166 to $149 for the three months ended December 31, 2024 from $13,315 for the three months ended December 31, 2023. Interest expense decreased $49,659 to $149 for the six months ended December 31, 2024 from $49,808 for the six months ended December 31, 2023. The decrease in interest expense for the three and six months ended December 31, 2024 is a result of interest expense charged pursuant to the milestone payment note with TheraCour during the six month period ended December 31, 2023. The interest charged pursuant to the milestone payment note was cancelled by TheraCour on October 27, 2023. The cancellation of the note interest reduced accrued expense and increased additional paid in capital by $49,808.
Current wording
Interest Expense* –* There was no interest expense incurred during the three months ended March 31, 2025 and March 31 2024. Interest expense decreased $49,659 to $149 for the nine months ended March 31, 2025 from $49,808 for the nine months ended March 31, 2024. The decrease in interest expense for the nine months ended March 31, 2025 is a result of cancellation of the milestone payment note with TheraCour during the nine month period ended March 31, 2024. The interest charged pursuant to the milestone payment note was cancelled by TheraCour on October 27, 2023. The cancellation of the note interest reduced accrued expense and increased additional paid in capital by $49,808.
Previous wording
Net Loss* –*For the three months ended December 31, 2024, the Company had a net loss of $(2,027,491) or $(0.14) per share compared to a net loss of $(2,114,937) or $(0.18) per share for the three months ended December 31, 2023. For the six months ended December 31, 2024, the Company had a net loss of $(5,154,302) or $(0.36) per share compared to a net loss of $(4,083,683) or $(0.35) per share for the six months ended December 31, 2023. The decrease in the net loss for the three months ended December 31, 2024, and increase in the net loss for the six months ended December 31, 2024 is generally attributable to the factors discussed above.
Current wording
Net Loss* –*For the three months ended March 31, 2025, the Company had a net loss of $(2,216,783) or $(0.14) per share compared to a net loss of $(1,854,476) or $(0.16) per share for the three months ended March 31, 2024. For the nine months ended March 31, 2025, the Company had a net loss of $(7,371,085) or $(0.50) per share compared to a net loss of $(5,938,159) or $(0.51) per share for the nine months ended March 31, 2024. The increase in the net loss for the three and nine months ended March 31, 2025 is generally attributable to the factors discussed above.
Showing the first 40 of 44 pairs. Open the source sections for the rest.
Rearranged current paragraphs (10)
Current report — wording carried from elsewhere
As a host-mimetic, viruses cannot escape a nanoviricide drug by generating mutants and variants in the field, because all variants still require the same signature host features that our drugs mimic. In contrast, vaccines, antibodies and small chemical drugs are readily escaped by viruses because the viruses continuously change in the field, rendering these medical countermeasures ineffective. This was repeatedly observed during the COVID pandemic.
Current report — wording carried from elsewhere
Any viral infection that causes significant pathology does so by virtue of host immune system disrepair, either pre-existing, or caused by the virus itself. Therefore, nanoviricides can be expected to be superior to approaches such as vaccines and antibodies that require a good functional host immune system for antiviral response.
Current report — wording carried from elsewhere
The Company has initiated work to begin Phase II clinical trials to evaluate safety and effectiveness of NV-387 treatment in MPox patients (see below).
Current report — wording carried from elsewhere
MPox caused by Clade 1 and 1b variants is currently a pandemic emergency in the African region covering multiple nations including Democratic Republic of Congo (DRC), Uganda, and nearby countries. A less pathogenic variant, MPox Clade 2, has spread across the globe and caused a widespread epidemic in May 2022 in the Western world that has now become endemic.
Current report — wording carried from elsewhere
The Company is also in discussions with experts regarding a Phase II clinical trial for the evaluation of the effectiveness of NV-387 in the treatment of ARI and SARI of Viral origin (ARI = Acute Respiratory Infection and SARI = Severe Acute Respiratory Infection). The design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections (see below).
Current report — wording carried from elsewhere
NV-387 has completed a Phase I human clinical trial for safety and tolerability in healthy subjects that was sponsored by our licensee and collaborator in India, Karveer Meditech Private Limited (“KMPL”). As topline results of this clinical trial, there were no reported adverse events at all doses studied, and there were no drop-outs either, observations that are indicative that NV-387 was well tolerated by the healthy subjects in this clinical trial. These results of the Phase I clinical trial are consistent with the results of safety/tolerability studies in animals conducted in support of the clinical trial application. We are awaiting the final clinical trial study report from this clinical trial.
Current report — wording carried from elsewhere
We are planning to advance NV-387 into Phase II human clinical trials to assess effectiveness of NV-387 treatment in a number of different viral diseases in humans as resources allow.
Current report — wording carried from elsewhere
There is no drug currently available for the treatment of MPox. A drug, tecovirimat (TPOXX®, SIGA) was approved by US FDA under the “Animal Rule” for the treatment of Smallpox (and MPox). However, it failed in a large clinical trial as a treatment of the MPox Clade 1/1b infections, with no statistical improvement observed in comparison to the standard of care (NIH/NIAID Press Release,
Current report — wording carried from elsewhere
Additionally, NV-387 is expected to be active against many other viruses because of its design that mimics the human host-side sulfated proteoglycans that all of these viruses use for causing effective cell infection.
Current report — wording carried from elsewhere
funds by mortgaging its existing fully owned campus and cGMP manufacturing facilities in Shelton, CT, in order to free up a portion of the fixed capital for use as liquid working capital. These facilities were recently valued at $12 to $15 million by industry experts. However, there is no guarantee that we will be able to raise funds on reasonable terms acceptable to us, or at all.
Rearranged previous paragraphs (6)
Previous report — wording carried elsewhere
$2.6 billion in 2024, growing to $4.3 billion in three years, at a rate of 18.9% as reported by GrowthPlusReports (https://www.growthplusreports.com/report/respiratory-syncytial-virus-rsv-therapeutics-market/8519). There are two protective antibodies and two protective vaccines, approved in the U.S. but no drug for the treatment of RSV infection, other than the last resort toxic drug ribavirin.
Previous report — wording carried elsewhere
found to be dominant in the recent MPox pandemic, and is also found to be operative in the current Congo MPox epidemic. Tecovirimat, approved for Smallpox treatment under the FDA “Animal Rule”, is currently stockpiled under the US Strategic National Stockpile.
Previous report — wording carried elsewhere
We mimic the feature on the cellular protein at which the virus binds, and, using molecular modeling, design small molecules that act as “ligands” to bind to the virus surface glycoproteins as though the virus was binding to that cellular protein itself. This host-side chemical signature that the virus uses for infecting cells does not change even as the virus mutates, evolves and generates variants. We
Previous report — wording carried elsewhere
comparison to the standard Veklury® (Gilead) formulation. The resulting drug, NV-387-g-R has not only significantly improved characteristics for its Remdesivir component, but additionally provides the novel re-infection blocking mechanism of NV-387; together enabling complete block of the viral lifecycle, which would potentially result in a cure. (Chakraborty A, Diwan A, Chiniga V, Arora V, Holkar P, Thakur Y, et al. (2022) Dual effects of NV-CoV-2 biomimetic polymer: An antiviral regimen against COVID-19. PLoS One 17(12): e0278963. https://doi.org/10.1371/journal. pone.0278963.)
Previous report — wording carried elsewhere
The process scale-up area is operational at kilogram to multi-kg scales for different chemical synthesis and processing steps. It comprises
Previous report — wording carried elsewhere
During the six month period ended December 31, 2023, we used approximately $2.9 million in cash toward operating activities.