NANOVIRICIDES INC
For the period ended Dec 31, 2024. Filed Feb 14, 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.
Dec 31, 2024 · Filed Feb 14, 2025
NNVC$1.32+2.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-14.
0001410578-24-001991
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 206 previous paragraphs and 241 current paragraphs.
140 unchanged; 52 reworded; 40 added; 12 removed; 2 previous and 9 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
NV-387 Has Successfully Completed Phase I Clinical Trial in Healthy Human Subjects
Current report
NV-387 in two different oral formulations has successfully completed a Phase Ia/Ib 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”). All subjects were discharged and follow-up visits have been completed as of approximately the end of December 2023. 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 of that NV-387 was well tolerated by the healthy subjects in this clinical trial. We are awaiting the final clinical trial study report from this clinical trial.
Current report
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, wherein an extremely high level of safety of NV-387 was observed, as indicated by the NOAEL value of 1,200 mg/kg, and the MTD value of 1,500 mg/kg, when administered as a slow injection, in a standard rat model study (NOAEL = No Observed Adverse Event Level. MTD = Maximum Tolerable Dose).
Current report
NV-387 Phase II Clinical Trials Preparation and Plans
Current report
NV-387 Phase II Clinical Trial for MPox Epidemic; Strong Potential Markets and Non-Dilutive Funding Possibilities
Current report
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 report
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 report
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 report
There is no drug currently available for the treatment of MPox. A drug, tecovirimat (TPOXX®, SIGA) was approved by US FDA under the “Animal Rule” for the treatment of Smallpox (and MPox). However, it failed in a large clinical trial as a treatment of the MPox Clade 1/1b infections, with no statistical improvement observed in comparison to the standard of care (NIH/NIAID Press Release, 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 report
Notably, these procurements reflect replenishments and not initial stocking. The initial stocking orders would be substantially larger. This clearly illustrates the strong market size and demand for a Smallpox/Mpox drug.
Current report
Thus, an effective MPox/Smallpox drug can be estimated to have global public health governmental markets reaching into billions of dollars because of the recognition of Smallpox as a bioterrorism threat agent, and the continuing spread of its cousin MPox that threatens a global pandemic that could be fueled by likely potential additional mutations in the virus as it simmers in Africa.
Current report
NV-387 has been found to possess strong activity against orthopoxvirus infection in animal model studies, making it a viable candidate for clinical trial as a treatment for MPox infection.
Current report
NV-387 Potential Phase II Clinical Trial Positioning the Drug as an “Emperic Antiviral Therapy” that Could be Revolutionary
Current report
We are in discussions with experts regarding a Phase II clinical trial for the evaluation of the effectiveness of NV-387 in the treatment of ARI and SARI of Viral origin (ARI = Acute Respiratory Infection and SARI = Severe Acute Respiratory Infection.) We believe that for the very first time in the world, such clinical trial has become possible because the design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections.
Current report
About half of ARI and SARI cases are caused by viruses and most of the remaining are caused by bacteria. For a suspected bacterial infection, the physician can prescribe an antibiotic immediately upon presentation (called “Emperic Therapy”), and thereafter monitor, diagnose the causative bacterium, and modify therapy as necessary. Unfortunately, until now, there is no emperic therapy available for viral infections.
Current report
NV-387, if successful in the treatment of ARI and SARI, would presumably become the first ever antiviral that can be given as an empiric therapy by the physician immediately upon the patient presenting to the doctor. We believe this could be as revolutionary for the treatment of viral infections as the discovery of penicillin was for the treatment of bacterial infections.
Current report
The market size for a successful ARI/SARI clinical trial and potential subsequent emergency use and full registration of NV-387 upon completing the regulatory approval processes could open up tens of billions of dollars for NV-387 worldwide. Whenever a new effective therapy enters the market for a virus with no previous treatment or unsatisfactory prevalent treatments, the market size expands substantially, as has been historically witnessed for HIV/AIDS, Hepatitis C, HPV vaccine, and others.
Current report
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 report
Thus, this Phase II Clinical Trial Design for the evaluation of safety and effectiveness of NV-387 in viral ARI and SARI would be expected to provide important information for effectiveness of NV-387 against RSV, Influenza, hMPV, as well as Coronaviruses.
Current report
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 report
H5N1 and NV-387 - A Drug that the Virus Would Not Escape - is Already Available to Respond to Potential Pandemic
Current 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.
Current report
In this scenario, NV-387 stands apart in the field of antiviral countermeasures in that escape of virus even as it evolves is highly unlikely. This is because (i) NV-387 mimics the essential host-side feature that the virus requires for causing infection, and (ii) the activity spectrum of NV-387 is so broad, encompassing not just a single type of virus, but across many different types of viruses, that any small changes in a virus would be unlikely to enable the virus to escape NV-387.
Current report
The first fatality from H5N1 Bird Flu in the USA was announced on January 6, 2025 - an elderly Louisiana person with existing medical issues who died after fighting the virus for at least 20 days in the hospital. Just before this, a Canadian teenager girl survived a severe H5N1 infection suffering for almost 30 days with over 20 days in the hospital. In both cases, the virus was Influenza A H5N1 genotype D1.1 which is globally distributed in wild birds, and in open range bird flocks. Both cases were thought to have acquired infection from birds in the field.
Current report
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 report
This high propensity towards mutations in H5 can be expected to render vaccines and antibodies ineffective, as was experienced during the COVID pandemic.
Current report
Widespread H5N1 infection in dairy cows led California to declare a bird flu emergency in December, 2024. This virus was different from the one that caused the fatality, and is classified as Influenza A H5N1 genotype B3.13. The dairy cow H5N1 has infected over 60 persons, but has caused milder disease than the genotype D1.1.
Current report
Of increased concern, the more pathogenic D1.1 H5N1 virus has also been found in milk tests of certain dairy cow herds in Nevada in the USA in January/February 2025, raising the level of alert regarding the potential of its spread into humans.
Current report
In addition, another HPAI virus, H5N9, has been found to be circulating in ducks in California. It differs in the N protein from the H5N1 virus. At present none of these H5Nx viruses are known to transmit from human to human. However, continuous changes in the viral genome are thought to eventually lead to a virus that can effectively transmit from human to human, which could lead to a pandemic.
Current report
We plan to seek non-dilutive funding to advance NV-387 drug for the H5N1 indication, as well as for NV-387 as a treatment for COVID indication.
Current report
NV-387 Regulatory Development for the Treatment of Pediatric RSV Infection
Current report
Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection, namely, Arexvy® from GSK, and Abrysvo® from Pfizer. Both vaccines were demonstrated to only reduce the severity of RSV infection in vaccinated persons. Abrysvo was recently approved for use in pregnant women for protection of infants, despite significant side effects, indicative of the urgency for developing pediatric medical countermeasures against RSV infection.
Current report
NV-HHV-1, Nanoviricide for the Treatment of Herpesvirus Infections (VZV – Chickenpox and Shingles, HSV-1, HSV-2)
Current report
NanoViricides Further Technology Developments Curing Virus Infections and Business Strategy
Current report
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 report
Our Current Priorities – MPox, H5N1, and RSV
Current report
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 report
We are also working on being prepared to respond to a H5N1 Bird Flu pandemic in humans, should it occur, with NV-387 for the treatment of bird flu.
Current report
We will continue to seek non-dilutive funding for further development of NV-387 as a treatment for COVID and Long COVID.
Current report
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.
Removed paragraphs (12)
Previous report
There is no drug for the treatment of MPox infection in this public health emergency. Tecovirimat (TPOXX®, SIGA), a drug approved for smallpox under the US FDA “Animal Rule” protocol, was found to be safe and well tolerated but not superior to standard of care in a clinical trial assessing its effectiveness to treat MPox viral infection caused by Clade 1/1b that was co-sponsored by NIAID/NIH (https://www.nih.gov/news-events/news-releases/antiviral-tecovirimat-safe-did-not-improve-clade-i-MPox-resolution-democratic-republic-congo).
Previous report
We believe that NV-387 would be eligible for a Phase II clinical trial to assess its effectiveness against MPox infection under the MEURI protocol of WHO (MEURI = “Monitored Emergency Use of Unregistered and Investigational Interventions”, https://en.wikipedia.org/wiki/Monitored_Emergency_Use_of_Unregistered_and_Investigational_Interventions”, especially given the failure of tecovirimat in the clinical trial. We believe that if successful in a Phase II clinical trial, NV-387 would also be approvable for the treatment of smallpox.
Previous report
Clinical Development Program: NV-387 Phase I Clinical Trial
Previous report
In the Phase I human clinical trial, even at the highest dose level, dosed multiple times, NV-387 was found to be well tolerated, and there were no reported adverse events of the drug that was given orally.
Previous report
This clinical trial finding is consistent with the findings that the evaluation of safety of NV-387 in pre-clinical studies demonstrated a No-Observed-Adverse-Effects-Level (NOAEL) at 1,200 mg/Kg, and the Maximum Tolerable Dose level (MTD) at 1,500 mg/Kg in rats, which are very high numbers (high is good).
Previous report
We intend to initiate a Phase II clinical trial in India shortly after the Phase I final report becomes available. We are in discussions with subject matter experts in India regarding the best indication to go with in Phase II; RSV and Influenza being some of the choices.
Previous report
In light of the WHO public health emergency declaration regarding the MPox epidemic in Central Africa, we have begun efforts to progress NV-387 for Phase II evaluation of efficacy in the treatment of MPox virus infection. This is an unmet medical need since there is no drug available for the treatment of MPox infection given the failure of tecovirimat in clinical trial.
Previous report
Additionally, we anticipate that NV-387 would be expected to be eligible for the development of Poxvirus therapeutics under the FDA “Animal Rule”. The Animal Rule program requires well-controlled GLP studies in specific animal poxvirus infection models as replacement of the Phase II/III human clinical trials, and expanded Phase I human clinical trials to elucidate safety of the drug in human use. We plan to seek non-dilutive government funding for this indication.
Previous report
Two vaccines have recently been approved for RSV prophylaxis. Arexvy (GSK), and Abrysvo (Pfizer) were approved in May, 2023 for use in adults over 60 years of age and both reduced severity of RSV infection. There are no vaccines currently approved for infants and children.
Previous report
KMPL has successfully obtained required regulatory permissions to conduct clinical evaluation of NV-CoV-2 that contains the active ingredient NV-387, as a COVID treatment in India, on or about January 30, 2023. Previously, on September 15, 2021, we signed a Master Services Agreement with KMPL in which KMPL declared its intent to license NV-COV-2 and NV-CoV-2-R (both of which contain the active ingredient NV-387; NV-CoV-2-R being remdesivir encapsulated within NV-387) for commercialization in India, and undertook the responsibility to obtain necessary licenses and regulatory approvals as would be needed for the clinical evaluation and commercialization of the drugs in India. No binding licensing activity took place under that earlier agreement. Subsequently KMPL proceeded to develop and file the required regulatory documents including a clinical trials application with the regulatory authority in India. KMPL has retained a local clinical research organization (CRO) for the purpose of developing such documents and planning and executing the clinical trials. We helped KMPL with assembling the necessary datasets and information. Around June, 2023, began the Phase 1a/1b clinical trial of NV-CoV-2. The healthy subjects part of the single ascending dose (“SAD”) and the multiple ascending dose(“MAD”) clinical trial cohorts were completed at the end of December, 2023. KMPL and we spent the next several months in an attempt to initiate the COVID-patient part of the proposed Phase 1a/1b. However, by the time we were able to obtain the required approvals for engaging a different clinical site where COVID patients existed when we initiated our efforts, the COVID wave was gone and it did not become possible to recruit COVID patients. The clinical trial was therefore completed as safety and tolerability study of NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies in healthy subjects only.
Previous report
Interest Expense* –*Interest expense for the three months ended September 30, 2024 decreased $36,493 to $0.00 from $36,493 for the three months ended September 30, 2023. The decrease in interest expense for the three months ended September 30, 2024 is a result of the interest accrued on the $1,500,000 convertible promissory note issued in lieu of a cash milestone payment. On October 27, 2023, TheraCour cancelled all of the accrued interest on the Note and converted the principal of the Note to Series A preferred shares.
Previous report
Income Taxes – There is no provision for income taxes due to ongoing operating losses.
Reworded paragraphs (52)
Previous wording
We are a clinical stage 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 as mutations occur, 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. 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.
Previous wording
These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine design. After decades of development, this novel nanoviricide technology has now successfully reached clinical stage.
Current wording
These distinctive features that set nanoviricides apart from the entire world of current antiviral approaches are made possible by our novel nanoviricide chemical nanomachine technology platform. After decades of development, this novel nanoviricide technology is now advancing through clinical stages towards regulatory approvals.
Previous wording
Further Clinical Development of NV-387 Towards Drug Approvals: Multiple Indications for NV-387 Against Different Viral Infections Enable Maximizing Return on Investments While Fulfilling Unmet Medical Needs
Current wording
Broad-Spectrum Antiviral Drug NV-387 Advancing in Clinical Trials - Further Clinical Development of NV-387 Towards Drug Approvals: Multiple Indications for NV-387 Against Different Viral Infections Enable Maximizing Return on Investments While Fulfilling Unmet Medical Needs
Previous wording
We developed NV-387 to mimic the host-side features of sulfated proteoglycans (“S-PG”) such as heparan sulfate proteoglycan (HSPG). Over 90% of human pathoneic viruses are known to use HSPG as the first attachment site to cause infection into human cells. Thus, NV-387 is designed to have an extremely broad range of viruses against which it could be potentially clinically active.
Current wording
NV-387 was designed to be active against many viruses that affect humans. This is because NV-387 mimics a host-side feature of sulfated proteoglycans (“S-PG”). S-PG are a class of biochemicals that are used by most of the viruses as “Attachment Receptor(s)” before the viruses can infect cells and cause disease. S-PG class includes Heparan Sulfate Proteoglycans (HSPG), Chondroitin Sulfate, Dermatan Sulfate, and others. Over 90% of human pathogenic viruses are known to use HSPG as the first attachment site to cause infection into human cells. Thus, NV-387 is designed to have an extremely broad range of viruses against which it could be potentially clinically active.
Previous wording
Indeed, NV-387 has been found to have strong activity in lethal animal models of several viral diseases. Its activity was evident from NV-387-treated animals demonstrating significant increase in survival lifetime, as well as protection of lungs and reduction of clinical pathologies caused by the different viruses we have tested to date.
Current wording
NV-387 has been found to have strong activity in lethal animal models of several viral diseases. Its activity was evident from NV-387-treated animals demonstrating significant increase in survival lifetime, as well as protection of lungs and reduction of clinical pathologies caused by the different viruses we have tested to date.
Previous wording
This extremely broad antiviral spectrum of NV-387 is reminiscent of the broad antibacterial spectrum of antibiotics such as penicillin and we believe NV-387 could revolutionize the treatment of viral infections the same way that penicillin revolutionized the treatment of bacterial infections.
Current wording
This broad antiviral spectrum of NV-387 is reminiscent of the broad antibacterial spectrum of antibiotics such as penicillin and we believe NV-387 could revolutionize the treatment of viral infections the same way that penicillin revolutionized the treatment of bacterial infections.
Previous wording
Multiple indications of NV-387 enable us to maximize return on investments. The Phase I safety and tolerability clinical trial would be generally applicable across all indications. All of IND-enabling non-clinical studies would also be reused, with the addition of animal model antiviral activity studies for the specific indication. The Chemistry, Manufacture, and Controls for the drug substance would remain substantially the same and potentially the drug product sections also could be reused.
Current wording
Multiple indications of NV-387 enable us to maximize return on investments. The Phase I safety and tolerability clinical trial would be generally applicable across all indications. All of IND-enabling non-clinical studies would also be reused, with the addition of animal model antiviral activity studies for the specific indication. The Chemistry, Manufacture, and Controls for the drug substance would remain substantially the same and potentially the drug product sections also could be reused. All of this enables significant savings in time, material, labor, and costs shared across the multiple programs, resulting in a significant improvement in return on investments (ROI) as compared to a drug developed for a single indication.
Previous wording
We therefore anticipate that NV-387 can be given to patients across all patient population, in age from infants to seniors, including immunocompromised persons, patients with co-morbidities, and others, when approved. This is in contrast to available antiviral therapeutics that, limited by their toxicity and metabolic effects, cannot be given to many pools of patients.
Current wording
Further, NV-387 was found to be non-mutagenic, non-immunogenic, non-allergenic, and non-genotoxic in IND-enabling studies. We therefore anticipate that NV-387 can be given to patients across all patient population, in age from infants to seniors, including immunocompromised persons, patients with co-morbidities, and others, when approved. This is in contrast to available antiviral therapeutics that, limited by their toxicity and metabolic effects, cannot be given to many pools of patients.
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, and possibly other respiratory viral infections, thus covering all of the “tripledemic” viruses and more with this single drug.
Current 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.
Previous wording
We believe NV-387 can meet the challenge of becoming an effective treatment for MPox infection that is currently ravaging in multiple nations in Central Africa. WHO declared a Public Health Emergency of International Concern for MPox on August 14, 2024. The current strain of the virus, MPXV Clade 1 and 1b, is thought to be more severe than the Clade 2 strain that resulted in a global PHEIC in July 2022, which was declared over in May, 2023. 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 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).
Previous wording
SIGA Technologies, Inc. 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). Smallpox is an important disease from biodefense perspective, and the US BARDA (Biomedical Advanced Research and Development Authority) has new drug development for smallpox as an important objective.
Current wording
Smallpox is an important disease from biodefense perspective, and the US BARDA (Biomedical Advanced Research and Development Authority) has new drug development for smallpox as an important objective.
Previous wording
In addition, we plan on pursuing NV-387 as a treatment for Influenza virus infections. NV-387 was found to be superior in activity against Influenza A/H3N2 lethal lung infection in comparison to the three approved drugs oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, BioCryst), and baloxavir (Xofluza®, Shionogi/Roche) in an animal model.
Current wording
We plan on pursuing NV-387 as a treatment for Influenza virus infections. NV-387 was found to be superior in activity against Influenza A/H3N2 lethal lung infection in comparison to the three approved drugs oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, BioCryst), and baloxavir (Xofluza®, Shionogi/Roche) in an animal model.
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.
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 “usual” Influenza viruses.
Previous wording
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.
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
Previous wording
We also plan on initiating a Phase IIa clinical trial of NV-387 for the treatment of RSV infection under the US FDA (see further below). We are in the process of developing a Pre-IND application to the US FDA for this purpose. Our overall objective of the program is to evaluate NV-387 for commercialization as a treatment of infants to young children. We believe that our Phase IIa clinical trial design will enable us to proceed to a Phase II/III registration clinical trials in infants and young children with RSV infection. This is an unmet medical need.
Current wording
We are in the process of developing a Pre-IND application regarding NV-387 as a treatment for pediatric RSV infections to the US FDA. Treatment of pediatric RSV infections is an unmet medical need.
Previous wording
RSV causes severe infections primarily in infants and young children, persons over age of 60 and immune-compromised persons. Each year in the United States, an estimated 58,000–80,000 children younger than 5 years old are hospitalized due to RSV infection. Globally, RSV is a common cause of childhood acute lower respiratory infection (ALRI, which includes pneumonia) and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3.2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
Current wording
Globally, RSV is a common cause of childhood acute lower respiratory infection (ALRI, which includes pneumonia) and a major cause of hospital admissions in young children. Globally in 2015, 33 million episodes of RSV-ALRI, resulted in about 3.2 million hospital admissions, and 59,600 in-hospital deaths in children younger than 5 years. About 45% of hospital admissions and in-hospital deaths due to RSV-ALRI occur in children younger than 6 months.
Previous wording
However, there are no safe and effective therapeutics for RSV to date. Ribavirin, a highly toxic drug, is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure. Synagis (palivizumab), and recently approved Beyfortus (nirsevimab) are antibodies approved only for prophylactic use in children and infants at high risk of severe RSV infection, but neither is approved for treatment of RSV infection, which remains an unmet medical need.
Current wording
There is no safe and effective therapeutic approved for the treatment of RSV infection to date, which remains an unmet medical need. Ribavirin, a highly toxic drug, is conditionally approved only for patients with high risk of progressively severe RSV disease, due to significant side effects including hemolytic anemia and kidney failure.
Previous wording
In addition to NV-387, we have developed NV-HHV-1, a drug for the treatment of HSV-1 (“cold sores”), HSV-2 (“genital ulcers”), and VZV (“Shingles”, “chickenpox”) that mimics the host-side feature of the HVEM host protein that is required by all of these viruses for cell entry and infection. NV-HHV-1 formulated as skin cream has substantially completed IND-enabling studies for the treatment of Shingles rash. We plan to pursue clinical trials and regulatory approval of NV-HHV-1 after NV-387 undergoes a Phase II clinical trial.
Current wording
In addition to NV-387, we have developed NV-HHV-1, a drug for the treatment of HSV-1 (“cold sores”), HSV-2 (“genital ulcers”), and VZV (“Shingles”, “chickenpox”) that mimics the host-side feature of the HVEM host protein that is required by all of these viruses for cell entry and infection. HVEM is the “HerpesVirus Entry Mediator” receptor on the cell surface. NV-HHV-1 formulated as skin cream has substantially completed IND-enabling studies for the treatment of Shingles rash. We plan to pursue clinical trials and regulatory approval of NV-HHV-1 after NV-387 undergoes a Phase II clinical trial.
Previous wording
In addition, with the goal of curing virus infections, we have developed novel platform technologies. Under these technologies, we have developed several other drug candidates that are at different preclinical drug development stages in our pipeline.
Current wording
In addition, with the goal of curing virus infections, we have developed novel platform technologies. Under these technologies, we have developed several additional drug candidates that are at different preclinical drug development stages in our pipeline.
Previous wording
**2.**RSV: Oral dosing with NV-387 led to full survival of mice lethally infected with RSV/A2 to cause severe lung disease, whereas the only available drug against RSV, namely ribavirin, showed a limited increase in lifespan. The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all time points during the study, whereas animals in the ribavirin-treated group showed progressive pathology, eventually leading to death. Ribavirin is a highly toxic drug and is given only as a last resort. Two vaccines have recently been approved for protection of persons 60+ years old from RSV infection (Arexvy®, GSK, and Abrysvo®, Pfizer). Abrysvo was recently approved for use in pregnant women for protection of infants. A new antibody, nirsevimab (Beyfortus®) was approved for protection of newborn children at risk of RSV disease, but not for treatment. There is no approved drug for the treatment of RSV infection, other than the last resort drug, ribavirin that has limited effectiveness.
Current wording
**2.**RSV: Oral dosing with NV-387 led to full survival of mice lethally infected with RSV/A2 to cause severe lung disease, whereas the only available drug against RSV, namely ribavirin, showed a limited increase in lifespan. The lethally RSV-infected animals in the NV-387-treated group showed no lung damage in lung histo-pathology study at all time points during the study, whereas animals in the ribavirin-treated group showed progressive pathology. There is no approved drug for the treatment of RSV infection, other than the last resort drug, ribavirin that has limited effectiveness.
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 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.
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
Previous wording
Further, NV-387 also acts as a unique and novel drug delivery vehicle, similar in action to exosomes. Thus, encapsulation of remdesivir in NV-387 enabled oral delivery of NV-387 and the activity of the resulting drug, NV-387-g-Rp, given orally in lethally infected animals, was found to be superior to that of each of NV-387 and remedesivir (Veklury®, Gilead).
Current wording
Further, NV-387 also acts as a unique and novel drug delivery vehicle, similar in action to exosomes. Thus, encapsulation of remdesivir in NV-387 enabled oral delivery of NV-387 and the activity of the resulting drug, NV-387-g-Rp, given orally in lethally infected animals, was found to be superior to that of each of NV-387 and remdesivir (Veklury®, Gilead).
Previous wording
Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Chickengunya Virus, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, and Poxviruses, among others (Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472). Thus, a large number of virus families use these S-PG family attachment receptors to concentrate next to cells and thereby efficiently infect cells, with different virus families having preferences to one or more of such attachment factors.
Current wording
Over 90% of known pathogenic viruses bind to one or more of these S-PG class attachment receptors. These viruses include Coronaviruses, Paramyxoviruses (RSV - Respiratory Syncytial Virus, and HMPV- human Metapneumovirus), Dengue Viruses, Chikungunya Virus, Herpesviruses, Human Papillomavirus (HPV), HIV, Hendra and Nipah Viruses, Ebola and Marburg Viruses, and Poxviruses, among others (Cagno V, Tseligka ED, Jones ST, Tapparel C. Heparan Sulfate Proteoglycans and Viral Attachment: True Receptors or Adaptation Bias? Viruses. 2019 Jul 1;11(7):596. doi: 10.3390/v11070596. PMID: 31266258; PMCID: PMC6669472). Thus, a large number of virus families use these S-PG family attachment receptors to concentrate next to cells and thereby efficiently infect cells, with different virus families having preferences to one or more of such attachment factors.
Previous wording
We are now a clinical stage innovative drug development company, advancing from the research and development (“R&D”) stage into regulatory development of our drug candidates towards commercialization. We have been executing rapidly and efficiently, as well as in a cost-effective and productive manner, resulting in successful completion of the Phase I Safety and Tolerability clinical trial of our drug candidate, NV-CoV-2 (API NV-387). We believe that this successful completion with no reported adverse events, which is the most desirable outcome from Phase I clinical trial to establish safety and tolerability of the drug candidate NV-387 is a very important milestone enabling NV-387 to advance for multiple antiviral indications into Phase II efficacy clinical trials. Additionally, this Phase I bodes well for our entire platform technology as being capable of producing drug candidates that are capable of successfully completing Phase I safety and tolerability studies.
Current wording
We are a clinical stage innovative drug development company, advancing from the research and development (“R&D”) stage into regulatory development of our drug candidates towards commercialization. We have been executing rapidly and efficiently, as well as in a cost-effective and productive manner, resulting in successful completion of the Phase I Safety and Tolerability clinical trial of our lead drug candidate, NV-387. We believe that this successful completion with no reported adverse events, which is the most desirable outcome from Phase I clinical trial to establish safety and tolerability of the drug candidate NV-387 is a very important milestone enabling NV-387 to advance for multiple antiviral indications into Phase II efficacy clinical trials. Additionally, this Phase I bodes well for our entire platform technology as being capable of producing drug candidates that are capable of successfully completing Phase I safety and tolerability studies.
Previous 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.
Current 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.
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 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.)
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
Previous wording
During the three months ended September 30, 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 designing a Phase II clinical trial protocol for the treatment of MPox infection with NV-387 under the MEURI guidelines. We have also started working on a Phase II clinical trial protocol for the treatment of RSV infection.
Current 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
Previous wording
In addition, we have continued to further scale-up the manufacture of NV-387 in our cGMP-compliant facility, effectively doubling the prior batch size, in preparation for supplying the drug products for the Phase II clinical trials. We believe this scale will be sufficient for a Phase II clinical trial for MPox or for a Phase II clinical trial for RSV. We will commission additional batches as we engage into additional clinical trials.
Current wording
Further, we have continued to increase the scale of manufacture of NV-387 in our cGMP-compliant facility, effectively doubling the prior batch size, in preparation for supplying the drug products for the Phase II clinical trials. We believe this scale will be sufficient for a Phase II clinical trial for MPox or for a Phase II clinical trial for RSV. We will commission additional batches as we engage into additional clinical trials.
Previous wording
We have initiated the production program for Phase II clinical supply of NV-387 drug products.
Current 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).
Previous wording
Thus NV-387 can now be advanced into Phase II human clinical trials against the different antiviral indications within its antiviral activity spectrum.
Current wording
Thus NV-387 is ready to be advanced into Phase II human clinical trials against the different antiviral indications within its antiviral activity spectrum.
Previous wording
Therefore, while we fully believe that (i) NV-387 has demonstrated strong pan-coronavirus antiviral activity in pre-clinical studies and therefore (ii) NV-387 is a viable clinical drug candidate for COVID treatment; (iii) NV-387 could be substantially superior to available drugs such as remdesivir and Paxlovid®; and (iv) NV-387 would be available to the entire patient population while the available drugs have severe limitations, regrettably, we have determined that we cannot take NV-387 forward for COVID indication with our limited resources.
Current wording
Therefore, while we fully believe that (i) NV-387 has demonstrated strong pan-coronavirus antiviral activity in pre-clinical studies and therefore (ii) NV-387 is a viable clinical drug candidate for COVID treatment; (iii) NV-387 could be substantially superior to available drugs such as remdesivir and Paxlovid®; and (iv) NV-387 would be available to the entire patient population while the available drugs have severe limitations, regrettably, we have determined that we cannot take NV-387 forward for COVID indication with our limited resources. We will continue to seek non-dilutive resources such as government grants and contracts for the development of NV-387 for the treatment of COVID and potentially long COVID. We are also seeking to advance NV-387 for COVID and Long COVID indications via partnerships.
Previous wording
We are currently focused on the development of NV-387 with the goal of the treatment of pediatric RSV infection with urgency. 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
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.
Previous 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.
Current 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.
Previous wording
We plan to take NV-387 into Phase II/III clinical trials for treatment of RSV infections. We plan on obtaining non-dilutive funding for the poxvirus drug development program. We plan on seeking partnerships for our COVID program as well as our RSV, Poxvirus, and other 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 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.
Previous wording
We have previously substantially completed IND-enabling studies for a drug candidate for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). We plan on taking the shingles drug candidate into human clinical trials after phase II clinical trials of our NV-387 drug candidate for RSV.
Current wording
We have previously substantially completed IND-enabling studies for a drug candidate for the treatment of shingles rash caused by reactivation of the chickenpox virus (aka varicella-zoster virus, VZV). We plan on undertaking further development of our HerpeCide program into clinical trials after sufficient funding becomes available for re-engaging these programs.
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 RSV and/or MPox infection. If our studies are not successful, we will have to 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 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.
Previous wording
We have not engaged any other new collaborators during the reported quarter.
Current 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.
Previous wording
As of September 30, 2024, we had cash and cash equivalents of $3,866,289, prepaid expenses of $175,133 and net property and equipment of $7,365,681. Accounts payable and accrued expenses were $1,632,706, inclusive of accounts payables to a related party of $636,550. Stockholders’ equity was $10,107,791 at September 30, 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 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.
Previous wording
During the three month period ended September 30, 2024, we used approximately $2.6 million in cash toward operating activities. This was substantial 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 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.
Previous wording
During the three month period ended September 30, 2023, we used approximately $1.2 million in cash toward operating activities.
Current wording
During the six month period ended December 31, 2023, we used approximately $2.9 million in cash toward operating activities.
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Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
We believe NV-387 can meet the challenge of becoming an effective treatment for MPox infection that is currently ravaging in multiple nations in Central Africa.
Current report — wording carried from 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.
Current report — wording carried from elsewhere
RSV causes severe infections primarily in infants and young children, persons over age of 60 and immune-compromised persons.
Current report — wording carried from elsewhere
Synagis (palivizumab), and the recently approved Beyfortus (nirsevimab) are antibodies approved only for prophylactic use in children and infants at high risk of severe RSV infection, but neither is approved for treatment of RSV infection.
Current report — wording carried from 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.
Current report — wording carried from 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
Current report — wording carried from 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.)
Current report — wording carried from elsewhere
We continue to work on further development of NV-387 with the goal of the treatment of pediatric RSV infections.
Current report — wording carried from elsewhere
The process scale-up area is operational at kilogram to multi-kg scales for different chemical synthesis and processing steps. It comprises
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
Further, NV-387 was found to be non-mutagenic, non-immunogenic, non-allergenic, and non-genotoxic in IND-enabling studies.
Previous report — wording carried elsewhere
We are seeking to advance NV-387 for COVID and Long COVID indications via partnerships.