NANOVIRICIDES, INC.
For the period ended Mar 31, 2026. Filed May 15, 2026.
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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, 2026 · Filed May 15, 2026
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 2025-12-31; filed 2026-02-17.
0001104659-26-016476
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-15.
0001104659-26-061499
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 363 previous paragraphs and 378 current paragraphs.
328 unchanged; 29 reworded; 17 added; 4 removed; 2 previous and 4 current paragraphs rearranged.
Tables are not compared: 19 previous and 13 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 (17)
Current report
Nanoviricides technology solves this problem of virus escape by mimicking the essential, conserved, host-side features of the receptors that a particular virus uses. A virus is highly unlikely to escape the nanoviricide drug that we create against it by generating mutants and variants in the field, because all of its variants still require the same signature host features that our drugs mimic.
Current report
NV-387 for the Treatment of Monkeypox and Smallpox
Current report
In contrast to Europe, UK, Mexico, and Canada, the USA has seen smaller but sustained outbreaks of Measles that have persisted since about December 2024 to date affecting over with 1,803 confirmed cases in 2026 and 2,263 in 2025, associated with outbreaks excluding travel (https://www.cdc.gov/measles/data-research/index.html ). Although there is an effective vaccine for Measles, to treat a patient requires a medicine, not a vaccine. Additionally, a drug given as a prophylactic could substantially eliminate the societal and economic impact associated with isolation of contacts, especially that from the virtual closures and remoting of classrooms. This is because, even if vaccines are given to contacts, the effect of vaccine in generating protecting antibodies would be apparent only 2-3 weeks after vaccination, and the measles vaccine requires 2 doses separated in time.
Current report
On April 27, 2026, the US FDA awarded an Orphan Drug Designation (ODD) for NV-387 as a treatment of Measles, in a rapid turnaround, pursuant to our ODD application in February. This is an important milestone for the Company, and would help us to move the Measles treatment program relatively rapidly with significant FDA assistance in meetings and specific guidance.
Current report
In March, 2026, we also filed for a Rare Pediatric Disease Drug (“RPDD”), application for NV-387 as a treatment of Measles, and we are awaiting the response. The Company employed the consultants OnlyOrphansCote, LLC for this filing. The Priority Review Voucher program (PRV) for Rare Pediatric Disease Drugs was re-authorized by the US Congress and signed into Law by the President on February 6, 2026. Under the PRV program, a sponsor that obtains approval of a new drug or biologic to treat a rare pediatric disease can obtain a transferable voucher for priority review of a subsequent application.
Current report
We are on course to begin the Phase II clinical trial of NV-387 as a Treatment of Monkeypox in DRC very soon. Our CRO has already made site visits and the clinical trial site preparation is in progress. With the declining Mpox cases in the urban areas of Kinshasa, we opted for a remote hospital site where we can potentially run the clinical trial relatively rapidly because of the number of weekly cases. The site preparation activities increased substantially because of this change, leading to some delays.
Current report
We plan to propose a novel and unique clinical trial wherein NV-387 would be given as treatment at enrollment based on clinical indication of acute respiratory infection at presentation. Testing for viral and bacterial infections on the pre-treatment samples will be performed to determine the infectious agent. This information will be used in the interpretation of clinical outcomes. A separate arm of Standard-of-Care (SOC) treatment will be followed for comparison to gauge the effect of NV-387 treatment.
Current report
As stated earlier, we have begun our US FDA engagement for NV-387 in the rare diseases of Measles, Monkeypox, and Smallpox, with appropriate drug designation applications (ODD and RPDD).
Current report
Now that Measles ODD is approved, we plan to follow up with preliminary FDA meetings for guidance, as appropriate. These include certain exploratory meetings and pre-IND meetings.
Current report
A PRV enabled by a RPDD designation for NV-387 for the Treatment of Measles will provide substantial economic benefits to the Company for developing this indication. A PRV currently has commercial economic value of about $150~$200 million. We will accelerate the Measles program if this RPDD is granted by the FDA.
Current report
These poor vaccine effectiveness data clearly make the case that an effective therapeutic (treatment) for MPox is sorely needed.
Current report
During the three months ended March 31, 2026, we have focused primarily on the Phase II clinical trial of NV-387 for the Treatment of MPox in DRC. We have been involved in clinical trial site selection, and now in the site setup activities. As noted earlier, the change of site to a remote hospital location from the original Kinshasa site, as necessitated by the change in prevalence of cases, has increased our workload for site setup, and has caused some additional delays. Nevertheless, we believe that the site should be ready fairly soon, and thereafter, we will have a short training period before first dosing. We eagerly look forward to the start of this clinical trial.
Current report
On February 3, 2026, we applied to the US FDA for three Orphan Drug Designations, namely: NV-387 for the Treatment of MPox, NV-387 for the Treatment of Smallpox, and NV-387 for the Treatment of Measles. On April 27, 2026, the US FDA awarded an ODD for NV-387 as a treatment of Measles, and we await the results on the other applications.
Current report
In March, 2026, we also filed for a Rare Pediatric Disease Drug (“RPDD”) designation application for NV-387 as a Treatment of Measles, and we are awaiting the response.
Current report
We are also developing strategies for further regulatory progress of NV-387 for the treatment of Measles, particularly in light of the continuing epidemic in the USA and the recent large epidemic in Bangladesh.
Current report
We have continued our investor awareness efforts. Dr. Diwan, our President and Executive Chairman, participated in the DealFlow Discovery Conference, January 28 and 29, 2026, in Atlantic City, where he presented a talk and met with several investors. Dr. Diwan was interviewed on the Mission Matters Podcast by Mr. Adam Torres in February. The interview video is available at https://youtu.be/nU_2dgd-u1g. Dr. Diwan presented the Company and met with several investors at the National Investment Brokers Association’s (NIBA’s) 152nd Investment Conference in Fort Lauderdale, Florida, on March 11 and 12, 2026.
Current report
Additional milestones are expected to result from NV-387 regulatory development under the US FDA. We anticipate filing for and obtaining a preliminary meeting with the US FDA for guidance on developing NV-387 as a treatment for Measles. Thereafter, we anticipate filing appropriate paperwork with the FDA to enable use of NV-387 in Measles patients during the current epidemic in the USA, and filing a pre-IND application to the US FDA for Measles.
Removed paragraphs (4)
Previous report
At present there is no economic model or business case for development of a drug for Measles. We plan on engaging Measles drug development in full force if it is supported by non-dilutive grants and contracts funding. Measles may be eligible for a traditional tradeable Priority Review Voucher (PRV) issuance from the FDA. If so, the potential trade value of a PRV, currently at or above $150 Million, would provide enticement for us to develop NV-387 for Measles.
Previous report
During the three months ended December 31, 2025, we have focused on preparing regulatory documentation in accordance with the requirements for the Phase II MPox clinical trial of NV-387 in DRC under the regulatory agency ACOREP as requested by them. We have now submitted almost all of the documents constituting a clinical trial application, in a “rolling review”-like process to the DRC regulatory agency, ACOREP.
Previous report
We completed manufacture of a pilot batch of the NV-387 oral gummies drug product (new formulation) and we have conducted required stability studies on the same.
Previous report
Additionally, government funding for advanced regulatory development of NV-387 will be likely, especially for a new smallpox therapeutics.
Reworded paragraphs (29)
Previous wording
As used in this report “Safety”, “Efficacy”, “Effectiveness” and related terms refer to the results of the Company’s research studies and these statements have not been evaluated by regulatory bodies including the Food and Drug Administration (“US FDA”) that have the authority for the purpose of commercial use of the drugs.
Current wording
As used in this report “Safety”, “Efficacy”, “Effectiveness” and related terms refer to the results of the Company’s research studies and these statements have not been evaluated by regulatory bodies including the FDA that have the authority for the purpose of commercial use of the drugs.
Previous wording
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 wording
Viruses escaping vaccines, antibodies, and small chemical drugs has been a major problem in conquering viral infections. This is because viruses continuously change in the field, rendering these medical countermeasures ineffective. This was repeatedly observed during the COVID pandemic.
Previous wording
As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Additionally, a nanoviricide is designed and constructed so that its components are biocompatible and metabolizable without toxicitiy.
Current wording
As a direct-acting antiviral, a nanoviricide drug is not expected to interfere with human bodily systems or enzymes, which is expected to result in significant levels of safety, unlike most of the antiviral drugs. Additionally, a nanoviricide is designed and constructed so that its components are biocompatible and metabolizable without toxicity.
Previous wording
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 wording
The host-mimicry nanoviricide platform has enabled development of extremely broad-spectrum antiviral drugs such as NV-387, as well as virus- family-specific drugs such as NV-HHV-1 (Herpesviridae) and NV-HIV-1 (HIV-1, 2; all mutants).
Previous wording
Further, the same drug NV-387 was found to be highly active against (vi) Measles virus in a humanized mouse model of lethal Measles virus infection.
Current wording
Further, the same drug NV-387 was found to be highly active against (vi) Measles virus in a humanized mouse model of lethal Measles virus infection. Measles is re-emerging globally with significant and large outbreaks in the Western world. In Bangladesh, recently over 100 child deaths from Measles have been reported (https://apnews.com/article/bangladesh-measles-vaccination-unicef-who-5b3b376246e7c00373028cf8eb800eb3 ).
Previous wording
On February 3, 2026, the Company s filed and the FDA Office of Orphan Drugs received, applications for Orphan Drug Designation (ODD) of three drugs, namely (i) NV-387 for the treatment of Measles, (ii) NV-387 for the treatment of MPox, and (iii) NV-387 for the treatment of Smallpox. The Company has retained OnlyOrphansCote, LLC, (“OOC”), led by Dr. Timothy Cote, under a Master Services Agreement as of November 25, 2025, for the orphan drug related activities. Dr. Cote previously served as the Director of FDA Office of Orphan Drugs. OOC prepared and filed the ODD applications on behalf of the Company. FDA can take 90 to 120 days to respond to the ODD applications.
Current wording
On February 3, 2026, the Company filed and the FDA Office of Orphan Drugs received, applications for Orphan Drug Designation (ODD) of three drugs, namely (i) NV-387 for the treatment of Measles, (ii) NV-387 for the treatment of MPox, and (iii) NV-387 for the treatment of Smallpox. The Company has retained OnlyOrphansCote, LLC, (“OOC”), led by Dr. Timothy Cote, under a Master Services Agreement as of November 25, 2025, for the orphan drug related activities. Dr. Cote previously served as the Director of FDA Office of Orphan Drugs. OOC prepared and filed the ODD applications on behalf of the Company.
Previous wording
We believe that the potential relatively rapid regulatory path for NV-387 would be enabled by any of its indications that are eligible for “Orphan Drug” status in the USA. Generally speaking, an Orphan Drug is a drug for a disease that has less than 200,000 incidence rate annually, or for a specific bio-terrorism agent such as smallpox. Based on our animal model studies to date, we have identified three different treatment indications that are orphan drug indications for NV-387, namely: (i) NV-387 for the treatment of Measles, (ii) NV-387 for the treatment of MPox, and (iii) NV-387 for the treatment of smallpox. Orphan Drug Designation for these cases would enable several benefits.
Current wording
A PRV recently sold for $180 million. Thus, a PRV, subsequent to approval of NV-387 for the treatment of Measles, could provide an important and immediate income source for the Company. We believe that a potentially relatively rapid regulatory path for NV-387 would be enabled by any of its indications that are eligible for “Orphan Drug” status in the USA. Generally speaking, an Orphan Drug is a drug for a disease that has less than 200,000 incidence rate annually, or for a specific bio-terrorism agent such as smallpox. Based on our animal model studies to date, we have identified three different treatment indications that are orphan drug indications for NV-387, namely: (i) NV-387 for the treatment of Measles, (ii) NV-387 for the treatment of MPox, and (iii) NV-387 for the treatment of smallpox. Orphan Drug Designation for these cases would enable several benefits.
Previous wording
Additionally, success of this MPox Phase II clinical trial is likely to enable US Government funding from an agency such as Biomedical Advanced Research and Development Agency (BARDA) or the National Institutes of Health (NIH) for further development of the drug NV-387 as a treatment for the bioterrorism agent smallpox which is a closely related virus. Current FDA guidance for Smallpox drug development is based on the “Animal Rule” and does not require human clinical trials (which would be unethical and impossible to conduct), a licensure route that we believe NV-387 would be successful in, based on relevant animal model studies already conducted.
Current wording
Additionally, we anticipate success of this MPox Phase II clinical trial is likely to enable US Government funding from an agency such as Biomedical Advanced Research and Development Agency (BARDA) or the National Institutes of Health (NIH) for further development of the drug NV-387 as a treatment for the bioterrorism agent smallpox which is a closely related virus. Current FDA guidance for Smallpox drug development is based on the “Animal Rule” and does not require human clinical trials (which would be unethical and impossible to conduct), a licensure route that we believe NV-387 would be successful in, based on relevant animal model studies already conducted.
Previous wording
Measles has become an important emerging disease in the USA. While measles was declared eliminated in the USA in 2000, its resurgence has led to sustained transmission over the entire 2025 year with 2,230 cases, resulting in 11% hospitalizations, and 3 deaths, and it has continued unabated in the USA, with over 733 cases as of February 5, 2026, per CDC 3. Effectively, US no longer has Measles elimination status 4, and it has become an endemic disease in the USA. Measles vaccination rates have fallen in various geographic areas well below the 95% vaccination rate required for maintaining “herd immunity” or population immunity, keeping the virus from spreading. Vaccination rates with the Measles vaccine (usually given to children in 2 doses as a component of the triple MMR vaccine) are likely to continue to fall. Additionally, the Measles virus strain now in circulation is substantially different from the vaccine strain(s) that were derived from the 1968 era. While this old vaccine continues to be effective, its effectiveness may have started decreasing with breakthrough infection rates increasing, based on scientific literature 5.
Current wording
Measles has become an important emerging disease in the USA. While measles was declared eliminated in the USA in 2000, its resurgence has led to sustained transmission over the entire year 2025 with 2,230 cases, resulting in 11% hospitalizations, and 3 deaths, and it has continued unabated in the USA, with over 733 cases as of February 5, 2026, per CDC 3. Effectively, the US no longer has Measles elimination status 4, and it has become an endemic disease in the USA. Measles vaccination rates have fallen in various geographic areas well below the 95% vaccination rate required for maintaining “herd immunity” or population immunity, keeping the virus from spreading. Vaccination rates with the Measles vaccine (usually given to children in 2 doses as a component of the triple MMR vaccine) are likely to continue to fall. Additionally, the Measles virus strain now in circulation is substantially different from the vaccine strain(s) that were derived from the 1968 era. While this old vaccine continues to be effective, its effectiveness may have started decreasing with breakthrough infection rates increasing, based on scientific literature 5.
Previous wording
We began working with the local regulatory agency in DRC, namely ACOREP, circa February 2025. After initial due diligence from them, the Ethics Committee of ACOREP agreed that NV-387 was worth evaluating as a treatment for MPox and gave us a go-ahead with a preliminary approval for a potential Phase II clinical trial in April, 2025. Since then we have been providing technical documents to ACOREP as parts of the clinical trial application, in what would be considered an informal “rolling review” of sorts. After all of the questions having been resolved, we received a final approval for starting a Phase II clinical trial from ACOREP at the end of October, 2025. This approval requires us to fulfill certain conditions and provide certain final documentation. We are currently working on completing these last set of requests (see below).
Current wording
We began working with the local regulatory agency in DRC, namely ACOREP, circa February 2025. After initial due diligence from them, the Ethics Committee of ACOREP agreed that NV-387 was worth evaluating as a treatment for MPox and gave us a go-ahead with a preliminary approval for a potential Phase II clinical trial in April, 2025. Since then we have been providing technical documents to ACOREP as parts of the clinical trial application, in what would be considered an informal “rolling review” of sorts. After all of the questions were resolved, we received a final approval for starting a Phase II clinical trial from ACOREP at the end of October, 2025. This approval requires us to fulfill certain conditions and provide certain final documentation. We are currently working on completing these last set of requests (see below), while simultaneously working on site preparation tasks.
Previous wording
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). The design of NV-387 suggests that it is likely to be active against most if not all respiratory viral infections (see below).
Current wording
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 have prepared a preliminary protocol design of a Phase II adaptive clinical trial with these inputs.
Previous wording
Our objective is to bring the data from the clinical trials external to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA. As discussed earlier, NV-387 has certain orphan disease as well as bioterrorism related indications. We believe some of these applications qualify for orphan drug designations. Therefore, we first plan to file the appropriate Orphan Drug Designations (ODD) for the following three treatments:
Current wording
Our objective is to bring the data from the clinical trials abroad to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA.
Previous wording
Assuming an ODD is granted, we plan on following up with further US FDA engagements by filing pre-IND applications:
Current wording
We plan on following up with further US FDA engagements, after future ODD grants, by filing pre-IND applications.
Previous wording
Recently three new MPox Clade I cases in unconnected persons were found in California that were not associated with travel to Africa, and community spread of MPox Clade I is suspected to be occurring in California, bringing the USA even closer to a potential epidemic from this MPox variant (https://www.usatoday.com/story/news/health/2025/10/17/california-mpox-strain-cases/86748970007/).
Current wording
Recently a seventh new case of MPox Clade I in unconnected persons was found in California that were not associated with travel to Africa, and community spread of MPox Clade I is suspected to be occurring in California, bringing the USA even closer to a potential epidemic from this MPox variant (https://www.newsmirror.net/news/cdph-closely-monitoring-mpox-activity/article_8a3b9f8f-968f-4d9c-9214-9eb82fb81af3.html ). Additionally, MPox Clade II cases, which is a less pathogenic variant of the virus, are on the rise in the USA.
Previous wording
Thus, although the current threat level is low, MPox Clade I could result in becoming an endemic virus in the USA.
Current wording
Thus, although the current threat level is low, MPox Clade I could result in becoming an endemic virus in the USA. There is a 2-dose vaccine, JYNNEOS, developed for smallpox, that is approved for MPox. However, its effectiveness against disease progression (not infection prevention) after 2-doses is only 66.6% in HIV negative subjects and 44.8% in HIV positive subjects, for MPox Clade II, based on US surveillance data (Lancet Infect Dis 2025; 25: 1106–15; https://doi.org/10.1016/ S1473-3099(25)00180-X). The same paper cites post-exposure (i.e. after MPox infection) use of JYNNEOS vaccine had effectiveness against progression of only 15.9%.
Previous wording
3 The Measles vaccine, a live attenuated strain developed circa 1968, continues to be in use, even as the Measles virus itself has changed significantly. The vaccine was originally found to be 95% protective, which means 5% of the fully vaccinated persons could still get measles, called a “vaccine breakthrough” infection. At least 95% of the population needs to be vaccinated to confer “population immunity” or “herd immunity” which can be roughly defined as blocking person-to-person spread of the virus. This high percentage required is a result of the extremely contagious and persistent nature of the Measles virus. However, immune-compromised subjects do not benefit well from any vaccines. The percentage of such subjects that do not benefit fully from vaccination has been estimated at about 7-10% of the US population, and is rising due to chronic diseases, auto-immunity, inflammation, diabetes, obesity, as well as environmental factors that have led to increase in cancer rates in younger population in the USA. Analysis of post-elimination Measles cases in the USA have led to vaccine breakthrough rates estimated at 11-13% rather than the historically used value of 5% (J. Leung et al. Measles Cases in the US, 2001–2022 • CID 2025;80(3):663–72. https://doi.org/10.1093/cid/ciae470). There is also personal reluctance for the risk that one’s own child may be affected by a major side effect even as documented rates of side effects are small. There are also communities with religious prohibition for using vaccines. Therefore, reaching 95% vaccination rate is becoming an ever distant goal. Thus, there is an urgent need for a Measles drug to treat persons that get sick.
Current wording
3 The Measles vaccine, a live attenuated strain developed circa 1968, continues to be in use and remains effective, even as the Measles virus itself has changed significantly. The vaccine was originally found to be 95% protective, which means 5% of the fully vaccinated persons could still get measles, called a “vaccine breakthrough” infection. At least 95% of the population needs to be vaccinated to confer “population immunity” or “herd immunity” which can be roughly defined as blocking person-to-person spread of the virus. This high percentage required is a result of the extremely contagious and persistent nature of the Measles virus. However, immune-compromised subjects do not benefit well from any vaccines. The percentage of such subjects that do not benefit fully from vaccination has been estimated at about 7-10% of the US population, and is rising due to chronic diseases, auto-immunity, inflammation, diabetes, obesity, as well as environmental factors that have led to increase in cancer rates in younger population in the USA. Analysis of post-elimination Measles cases in the USA have led to vaccine breakthrough rates estimated at 11-13% rather than the historically used value of 5% (J. Leung et al. Measles Cases in the US, 2001–2022 • CID 2025;80(3):663–72. https://doi.org/10.1093/cid/ciae470). There is also personal reluctance for the risk that one’s own child may be affected by a major side effect even as documented rates of side effects are small. There are also communities with religious prohibition for using vaccines. Therefore, reaching 95% vaccination rate is becoming an ever distant goal. Thus, there is an urgent need for a Measles drug to treat persons that get sick.
Previous wording
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 wording
We note that the Trump administration and the Secretary of Health and Human Services (“Secretary”) 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.
Previous 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.
Current wording
In January 2025 we engaged a CRO for the Phase II clinical trial for the evaluation of NV-387 for the treatment of MPox in the Central African region. This collaboration has continued and we are now on the verge of starting a Phase II clinical trial in DRC for this purpose.
Previous wording
As of December 31, 2025, we had cash and cash equivalents of $5,150,580, prepaid expenses of $145,985 and net property and equipment of $6,656,439. Accounts payable and accrued expenses were $1,195,925, inclusive of accounts payables to related parties of $929,232. Stockholders’ equity was $11,071,715 at December 31, 2025. In comparison, as of June 30, 2025, we had $1,558,564 in cash and cash equivalents, prepaid expenses of $112,146 and $6,833,891 of net property and equipment. Our liabilities at June 30, 2025 were $1,306,519 including accounts payable of $459,094 payable to third parties and accounts payable to related parties of $821,456.
Current wording
As of March 31, 2026, we had cash and cash equivalents of $3,213,256, prepaid expenses of $164,656 and net property and equipment of $6,528,873. Accounts payable and accrued expenses were $1,065,407, inclusive of accounts payables to related parties of $904,690. Stockholders’ equity was $9,153,597 at March 31, 2026. In comparison, as of June 30, 2025, we had $1,558,564 in cash and cash equivalents, prepaid expenses of $112,146 and $6,833,891 of net property and equipment. Our liabilities at June 30, 2025 were $1,306,519 including accounts payable of $459,094 payable to third parties and accounts payable to related parties of $821,456.
Previous wording
During the six month period ended December 31, 2025, we used approximately $3.6 million in cash toward operating activities. This was substantially less than the prior one year ago period primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II in the prior one year ago period.
Current wording
During the nine month period ended March 31, 2026, we used approximately $5.6 million in cash toward operating activities. This was substantially less than the prior one year ago period primarily due to certain one-time costs related to investor outreach activities and certain required additional non-clinical studies to advance NV-387 into Phase II in the prior one year ago period.
Previous wording
Revenues The Company is a biopharmaceutical company and did not have any revenue for the three and six month periods ended December 31, 2025 and 2024.
Current wording
Revenues The Company is a biopharmaceutical company and did not have any revenue for the three and nine month periods ended March 31, 2026 and 2025.
Previous wording
Research and Development Expenses* –*Research and development expenses for the three months ended December 31, 2025 decreased $37,702 to $1,118,649 from $1,156,351 for the three months ended December 31, 2024. Research and development expenses for the six months ended December 31, 2025 decreased $977,727 to $2,111,715 from $3,089,442 for the six months ended December 31, 2024. The decrease in research and development expenses for the three months ended December 31, 2025 is due to a decrease in outside lab fees and clinical trial costs. The decrease in research and development expenses for the six months ended December 31, 2025 is due to a decrease in outside lab fees that were required for a Phase II Clinical Trial Application in 2024, and not required in 2025.
Current wording
Research and Development Expenses* –*Research and development expenses for the three months ended March 31, 2026 increased $3,691 to $1,285,942 from $1,282,251 for the three months ended March 31, 2025. Research and development expenses for the nine months ended March 31, 2026 decreased $974,036 to $3,397,657 from $4,371,693 for the nine months ended March 31, 2025. The increase in research and development expenses for the three months ended March 31, 2026 is due to an increase in Phase II clinical trial costs. The decrease in research and development expenses for the nine months ended March 31, 2026 is due to a decrease in outside lab fees that were required for a Phase II Clinical Trial Application in 2025, and not required in 2026, and an increase in Phase II clinical trial costs.
Previous wording
General and Administration Expenses* –*General and administrative expenses for the three months ended December 31, 2025 increased $211,825 to $1,114,525 from $902,700 for the three months ended December 31, 2024. General and administrative expenses for the six months ended December 31, 2025 decreased $219,299 to $1,918,144 from $2,137,443 for the six months ended December 31, 2024. The increase in general and administrative expenses for the three months ended December 31, 2025 is due to an increase in professional fees associated with investor outreach expense. The decrease in general and administrative expenses for the six months ended December 31, 2025 is due to a decrease in professional fees associated with investor outreach expense. From time to time the Company investor outreach strategies change, with occasional changes in expenditures.
Current wording
General and Administration Expenses* –*General and administrative expenses for the three months ended March 31, 2026 decreased $222,629 to $744,276 from $966,905 for the three months ended March 31, 2025. General and administrative expenses for the nine months ended March 31, 2026 decreased $411,929 to $2,662,420 from $3,104,349 for the nine months ended March 31, 2025. The decrease in general and administrative expenses for the three months and nine months ended March 31, 2026 is due to a decrease in professional fees associated with investor outreach expense. From time to time the Company investor outreach strategies change, with occasional changes in expenditures.
Previous wording
Interest Income* –*Interest income for the three months ended December 31, 2025 decreased $19,254 to $12,455 from $31,709 for the three months ended December 31, 2024. Interest income for the six months ended December 31, 2025 decreased $48,650 to $24,082 from $72,732 for the six months ended December 31, 2024. The decrease in interest income for the three and six months ended December 31, 2025 is due to a lower interest bearing balance during the period and lower interest rates during the current three and six month period compared to the prior period.
Current wording
Interest Income* –*Interest income for the three months ended March 31, 2026 increased $8,512 to $40,885 from $32,373 for the three months ended March 31, 2025. Interest income for the nine months ended March 31, 2026 decreased $40,139 to $64,967 from $105,106 for the nine months ended March 31, 2025. The increase in interest income for the three months ended March 31, 2026 is due to a higher interest bearing balance during the period arising from a capital raise. The decrease in interest income for the nine month period ended March 31, 2026 compared to the prior period is due to a higher interest bearing balance and higher interest rates during the prior period.
Previous wording
Interest Expense* –*Interest expense decreased by $149 to $0 for the three months ended December 31, 2025 from $149 for the three months ended December 31, 2024. Interest expense decreased by $149 to $0 for the six months ended December 31, 2025 from $149 for the six months ended December 31, 2024.
Current wording
Interest Expense* –*Interest expense decreased by $149 to $0 for the nine months ended March 31, 2026 from $149 for the nine months ended March 31, 2025.
Previous wording
Net Loss* –*For the three months ended December 31, 2025, the Company had a net loss of $(2,220,719) or $(0.11) per share compared to a net loss of $(2,027,491) or $(0.14) per share for the three months ended December 31, 2024. For the six months ended December 31, 2025, the Company had a net loss of $(4,005,777) or $(0.22) per share compared to a net loss of $(5,154,302) or $(0.36) per share for the six months ended December 31, 2024. The increase in the net loss for the three months ended December 31, 2025, and decrease in the net loss for the six months ended December 31, 2025 is generally attributable to the factors discussed above.
Current wording
Net Loss* –*For the three months ended March 31, 2026, the Company had a net loss of $(1,989,333) or $(0.09) per share compared to a net loss of $(2,216,783) or $(0.14) per share for the three months ended March 31, 2025. For the nine months ended March 31, 2026, the Company had a net loss of $(5,995,110) or $(0.31) per share compared to a net loss of $(7,371,085) or $(0.50) per share for the nine months ended March 31, 2025. The decrease in the net loss for the three and nine months ended March 31, 2026 is generally attributable to the factors discussed above.
Previous wording
The Company’s condensed financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the condensed financial statements, the Company has an accumulated deficit at December 31, 2025 of approximately $152.8 million and a net loss of approximately $4.0 million and net cash used in operating activities of approximately $3.6 million for the six months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of December 31, 2025, the Company had available cash and cash equivalents of approximately $5.2 million. The Company’s liabilities at December 31, 2025 were approximately $1.2 million. The Company raised approximately $664,000, net of offering expenses, from ATM sales of our common stock during the current period from October 1, 2025 through December 31, 2025. Additionally, the Company successfully raised capital worth approximately $5.4 million net of expenses in a Registered Direct Offering of common stock and a Private Placement of Series A 2-year and Series B 5.5 year common stock warrants, exercisable into common stock at $1.75 and $2.00, respectively, from a single investor. The Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Current wording
The Company’s condensed financial statements have been prepared assuming that it will continue as a going concern, which contemplates continuity of operations, realization of assets and liquidation of liabilities in the normal course of business. As reflected in the condensed financial statements, the Company has an accumulated deficit at March 31, 2026 of approximately $154.8 million and a net loss of approximately $6.0 million and net cash used in operating activities of approximately $5.6 million for the nine months then ended. In addition, the Company has not generated any revenues and no revenues are anticipated in the foreseeable future. Since May 2005, the Company has been engaged exclusively in research and development activities focused on developing targeted antiviral drugs. The Company has not yet commenced any product commercialization. Such losses are expected to continue for the foreseeable future and until such time, if ever, as the Company is able to attain sales levels sufficient to support its operations. There can be no assurance that the Company will achieve or maintain profitability in the future. As of March 31, 2026, the Company had available cash and cash equivalents of approximately $3.2 million. The Company’s liabilities at March 31, 2026 were approximately $1.1 million. During the nine month period ended March 31, 2026, the Company raised capital of approximately $1,909,000, net of offering expenses, from ATM sales of our common stock. Additionally, on November 11, 2025, we raised capital of approximately $5.4 million net of expenses in a Registered Direct Offering of common stock, and a Private Placement of Series A 2-year and Series B 5.5 year common stock warrants, exercisable into common stock at $1.75 and $2.00, respectively, from a single investor. The Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Previous wording
Additional milestones include filing of Clinical Trial Application (CTA) for Phase II clinical trial of NV-387 as treatment for MPox, execution of the Phase II clinical trial and attendant top-line readout, and the anticipated successful completion of the clinical trial. The Company anticipates that its Phase II clinical trial will be successful in demonstrating that NV-387 is effective and safe in the treatment of MPox infection, based on the known safety of NV-387 in both animal studies and the observations in Phase I human clinical trial, and the activity of NV-387 against lethal orthopoxvirus infection in animal models that simulate the dermal transfer of infection as well as direct lung infection.
Current wording
Additional milestones include execution of the Phase II clinical trial of NV-387 as treatment for MPox, and attendant top-line readout, and the anticipated successful completion of the clinical trial. The Company anticipates that its Phase II clinical trial will be successful in demonstrating that NV-387 is effective and safe in the treatment of MPox infection, based on the known safety of NV-387 in both animal studies and the observations in Phase I human clinical trial, and the activity of NV-387 against lethal orthopoxvirus infection in animal models that simulate the dermal transfer of infection as well as direct lung infection.
Previous wording
The Company has planned a novel Phase II clinical trial for evaluating NV-387 as a first line, empiric therapy for any respiratory viral infection, in an adaptive, basket-style clinical trial design. We are in discussions to execute this clinical trial in India. In a single and relatively low cost clinical trial, we will be able generate substantial, statistically declarative information, regarding NV-387 as a treatment for (1) Influenza, (2) COVID, (3) RSV, (4) human MetaPneumovirus (hMPV), along with valuable information on effectiveness of NV-387 against many other respiratory infections including Adenoviruses, Enteroviruses, and others, depending upon the rates of incidence in the incoming patients. NV-387 can then progress towards licensure individually against RSV, Influenza, COVID, and other respiratory viruses under the US FDA and internationally.
Current wording
The Company has planned a novel Phase II clinical trial for evaluating NV-387 as a first line, empiric therapy for any respiratory viral infection, in an adaptive, basket-style clinical trial design. We are in discussions to execute this clinical trial in India. In a single and relatively low cost clinical trial, we will be able generate substantial, statistically declarative information, regarding NV-387 as a treatment for (1) Influenza, (2) COVID, (3) RSV, (4) human MetaPneumovirus (hMPV), along with valuable information on effectiveness of NV-387 against many other respiratory infections including Adenoviruses, Enteroviruses, and others, depending upon
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
NV-387 for the Treatment of Viral Acute Respiratory Infections (V-ARI)
Current report — wording carried from elsewhere
NV-387 for the Treatment of Measles
Current report — wording carried from elsewhere
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
the rates of incidence in the incoming patients. NV-387 can then progress towards licensure individually against RSV, Influenza, COVID, and other respiratory viruses under the US FDA and internationally.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
During the six month period ended December 31, 2024, we used approximately $4.8 million in cash toward operating activities.
Previous report — wording carried elsewhere
Further, the regulatory timelines for these three orphan diseases are likely to be substantially shorter than, say RSV, COVID, or Influenza drug development. This is because in the case of rare and orphan diseases, there are inherent limitations on the clinical trial recruitment due to the small number of available subjects, and the clinical protocols are designed to take this into account. Smaller number of subjects usually makes a clinical trial go faster, except in cases where the incidence rate of the disease cannot support the required recruitment level.