NNVC 10-K & 10-Q changes, risk factors and insider trading
Nanoviricides, Inc. · NYSE · Pharmaceutical Preparations · CIK 1379006 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Largest changes
“Our Ebola drug candidate at present does not have any known competition, but at least two drugs are currently in a clinical trial.”see in full comparison
We have estimated a total cash expenditure budget of approximatelysee in full comparison$11$12.3 million for the fifteen month period of July20252026 through October20262027 of which approximately$7.0$8.2 million is expected to be spent on research anddevelopmentdevelopment,forthatour drug candidates, including completion and reporting of the Phase I clinical trial. $1 million has been budgeted toward execution ofincludes the Phase II clinical trial ofour lead drug candidateNV-387 for the treatment ofMPox,Mpox and Ebola, and approximately$3$4.1 million is budgeted for general and administrative expenses. Our existing cash resources are not sufficient for these 15-month budgeted expenses, and we will require additional financings from non-dilutive and dilutive sources.
Management believes that the Company’s cash and cash equivalents balance of approximatelysee in full comparison$1.6$2.8 million, additional capital raised subsequent to June 30, 2026, of approximately$1.25$3.4million,million net of the placement agent’s fees and offering expenses payable byATMthesalesCompany in a Registered Direct Offerings (“RDO”) ofourcommonstock from July 1, 2025 through September 24, 2025,stock, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result, substantial doubt exists about the Company’s ability to continue as a going concern. Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
“We believe we have sufficient funds on hand to complete the remaining tasks of the Phase I clinical trial and obtain a completed clinical study report, and to develop and file a Phase II clinical trial application to evaluate use of NV-387 for the treatment of RSV infection.”see in full comparison
Full comparison: every changed paragraph (21)
Page 62 of 107
Page 69 of 119
Page 63 of 107
Management believes that the Company’s cash and cash equivalents balance of approximately $1.6$2.8 million, additional capital raised subsequent to June 30, 2026, of approximately $1.25$3.4 million,million net of the placement agent’s fees and offering expenses payable by ATMthe salesCompany in a Registered Direct Offerings (“RDO”) of our common stock from July 1, 2025 through September 24, 2025,stock, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result, substantial doubt exists about the Company’s ability to continue as a going concern. Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to its plan. There is no assurance that we will be successful in obtaining sufficient financing on terms acceptable to us to fund continuing operations.
Page 70 of 119
Page 64 of 107
Page 71 of 119
Page 65 of 107
Page 72 of 119
We have no products on the market and except for NV-CoV-2 (NV-387) which is in Phase Ia/Ib clinical trials, all of our other product candidates are in preclinical development. In particular, none of our product candidates, other than NV-CoV-2 (NV-387), have ever been tested in a human subject. Our ability to achieve and sustain profitability depends on obtaining regulatory approvals for and, if approved, successfully commercializing our product candidates, either alone or with third parties. Before obtaining regulatory approval for the commercial distribution of our product candidates, we or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety, purity and potency of our product candidates.
Page 67 of 107
Page 74 of 119
We believe we have sufficient funds on hand to complete the remaining tasks of the Phase I clinical trial and obtain a completed clinical study report, and to develop and file a Phase II clinical trial application to evaluate use of NV-387 for the treatment of RSV infection.
We have estimated a total cash expenditure budget of approximately $11$12.3 million for the fifteen month period of July 20252026 through October 20262027 of which approximately $7.0$8.2 million is expected to be spent on research and developmentdevelopment, forthat our drug candidates, including completion and reporting of the Phase I clinical trial. $1 million has been budgeted toward execution ofincludes the Phase II clinical trial of our lead drug candidate NV-387 for the treatment of MPox,Mpox and Ebola, and approximately $3$4.1 million is budgeted for general and administrative expenses. Our existing cash resources are not sufficient for these 15-month budgeted expenses, and we will require additional financings from non-dilutive and dilutive sources.
Page 69 of 107
Page 76 of 119
Our Ebola drug candidate at present does not have any known competition, but at least two drugs are currently in a clinical trial.
We hope that our drug candidates under development and in clinical trials will address major markets within the anti-viral sector. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities. Additionally, the timing of the market introduction of some of our potential drugs or of competitors’ products may be an important competitive factor. Accordingly, the relative speed with which we can develop drugs, complete pre-clinical testing, clinical trials, approval processes and supply commercial quantities to market are important competitive factors. We expect that competition Page 85 of 119 among drugs approved for sale will be based on various factors, including product efficacy, safety, reliability, availability, price and patent protection.
Page 78 of 107
The Company’s continued viability depends on its ability to raise capital. Changes in economic, regulatory or competitive conditions may lead to cost increases. Management may also determine that it is in the best interest of the Company to develop new services or products. In any such case additional financing is required for the Company to meet its operational requirements. The sale or the proposed Page 88 of 119 sale of substantial amounts of our common stock in the public markets may adversely affect the market price of our common stock and our stock price may decline substantially.
Page 81 of 107
Management's Discussion & Analysis (MD&A)
New heading “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures”
New heading “Improvements to Income Tax Disclosures”
Removed heading “Segment and Geographic Information”
Largest changes
“Management believes that the Company’s cash and cash equivalents balance of approximately $2.8 million at June 30, 2026, capital raised subsequent to the yearend of approximately $3.4 million net of placement agent’s fees and offering expenses, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As a result, substantial doubt exists about the Company’s ability to continue as a going concern. …”see in full comparison
“Management believes that the Company’s cash and cash equivalents balance of approximately $1.6 million at June 30, 2025, and additional capital raised of approximately $1.25 million by ATM sales of our common stock from July 1, 2025 through September 24, 2025 and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. …”see in full comparison
“Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures”see in full comparison
On Aprilsee in full comparison5,15, 2024, the Company entered intoa newan ATM sales agreementwith.with E.F. Hutton Securities (nowD. BoralD.Boral Capital), thesalesSalesagent, replacing the prior August 1, 2023 sales agreement,Agent, pursuant to which the Company may offer and sell, from time to time, through or to the SalesAgents,Agent, shares of common stock having an aggregate offering price of up to $50millionmillion.(eachFromsuchJulyoffering1,an2025“At-the-Market” or ATM Offering). As ofthrough June 30,2024,2026 the Company sold1,308,6511,264,988 shares of common stock at an average price of approximately$2.47$1.56 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No.333-271706),333-271706, which became effective on May 22,2023.2023). The net proceeds to the Company from the offering was approximately$3,120,000$1,909,000 after placement agent fees and other estimated offering expenses. On June 5, 2026 we filed a registration statement on Form S-3 (File No. 333-296550) with the Securities and Exchange Commission (the Page 98 of 119 “SEC”), which registration statement was declared effective by the SEC on June 15, 2026. Under this shelf registration process, we may, from time to time, sell shares of common stock, shares of preferred stock, debt securities, warrants and units.
Full comparison: every changed paragraph (32)
Research and Development Expenses - Research and development expenses for the year ended June 30, 20252026 increaseddecreased approximately $112,000,$841,000, to approximately $5,549,000$4,708,000 from approximately $5,437,000$5,549,000 for the year ended June 30, 2024.2025. This year-to-year increasedecrease is generally attributable to ana increasedecrease in outside lab fees relatedincurred toin preparation of the Company’s Phase II clinical trial applications.applications in the prior year.
General and Administration Expenses - General and administrative expenses increaseddecreased approximately $964,000$444,000 to approximately $3,599,000 for the year ended June 30, 2026 from approximately $4,043,000 for the year ended June 30, 2025 from approximately $3,079,000 for the year ended June 30, 2024.2025. The increasedecrease in general and administrative expenses is generally attributable to ana increasedecrease in professional services including, legal, accounting, and investor outreach expenditures.
Interest Expense- The Company has incurred interest expense of approximately $149 and $50,000 for the years ended June 30, 2025 and June 30, 2024 respectively. The decrease in interest expense for the year ended June 30, 2025 is a result of the milestone payment interest expense charged pursuant to the milestone payment note with TheraCour for the year ended June 30, 2024.
Net Loss - For the year ended June 30, 2025,2026, the Company had a net loss of approximately $8,219,000, or a basic and fully diluted loss per share of $0.41 compared to a net loss of approximately $9,467,000, or a basic and fully diluted loss per share of $0.63 compared to a net loss of approximately $8,294,000, or a basic and fully diluted loss per share of $0.70 for the year ended June 30, 2024.2025. The increasedecrease in the Company’s net loss for the year ended June 30, 20252026 from the year ended June 30, 20242025 of $1,173,000$1,248,000 is generally attributable to the items discussed above.
Table : R&D Costs Allocation
As many of our programs share a substantial amount of materials as well as laboratory work, we do not maintain project-based accounting of costs at present. The table above represents estimated cost allocations for specific activities in the different programs, with the bulk of common activities reported under the “NV-387 Manufacture, Clinical Trials, R&D” heading.programs.
Page 87 of 107
On May 5, 2023, we filed a registration statement on Form S-3 (File No. 333-271706) with the Securities and Exchange Commission (the “SEC”), as amended on May 8, 2023, which registration statement was declared effective by the SEC on May 22, 2023. Under this shelf registration process, we may, from time to time, sell up to $150 million in the aggregate of shares of common stock, shares of preferred stock, debt securities, warrants and units. Approximately $140 million remains available for sale as of the date of this filing.
On or about August 1, 2023, the ATM Sales Agreement that we previously had with EF Hutton, division of Benchmark Investments, LLC and B. Riley Securities, Inc., taken together as the Sales Agent, was amended to name EF Hutton as the only sales agent (the “Agent”) and to remove B. Riley as a sales agent. On August 4, 2023, we filed a prospectus supplement relating to the issuance and sale of our common stock, par value $0.00001 per share, having an aggregate offering price of up to $5,713,022, from time to time through or to our sole sales agent, EF Hutton. These sales, if any, would have been made pursuant to the terms of the August 1, 2023 ATM Sales Agreement.
On April 5,15, 2024, the Company entered into a newan ATM sales agreement with.with E.F. Hutton Securities (now D. BoralD.Boral Capital), the salesSales agent, replacing the prior August 1, 2023 sales agreement,Agent, pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agents,Agent, shares of common stock having an aggregate offering price of up to $50 millionmillion. (eachFrom suchJuly offering1, an2025 “At-the-Market” or ATM Offering). As ofthrough June 30, 2024,2026 the Company sold 1,308,6511,264,988 shares of common stock at an average price of approximately $2.47$1.56 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706),333-271706, which became effective on May 22, 2023.2023). The net proceeds to the Company from the offering was approximately $3,120,000$1,909,000 after placement agent fees and other estimated offering expenses. On June 5, 2026 we filed a registration statement on Form S-3 (File No. 333-296550) with the Securities and Exchange Commission (the Page 98 of 119 “SEC”), which registration statement was declared effective by the SEC on June 15, 2026. Under this shelf registration process, we may, from time to time, sell shares of common stock, shares of preferred stock, debt securities, warrants and units.
On November 10, 2025, the Company entered into a securities purchase agreement (the “November 2025 Securities Purchase Agreement”) pursuant to which the Company agreed to sell and issue to a single investor in a registered direct offering (the “Registered Direct Offering”): (i) 1,970,000 shares of common stock, par value $0.00001 per share (the “Common Stock”), at an offering price of $1.68 per share, and (ii) pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 1,601,429 shares of Common Stock, at an offering price of $1.67999 per Pre-Funded Warrant. Each Pre-Funded Warrant is exercisable for one share of Common Stock. The Pre-Funded Warrants have an exercise price of $0.00001 per share, are immediately exercisable, and may be exercised at any time until exercised in full. The net proceeds from the offering was approximately $5,404,000. The aggregate gross proceeds from the offering was approximately $6,000,000 million before deducting the placement agent’s fees and offering expenses payable by the Company. Also pursuant to the Securities Purchase Agreement, in a concurrent private placement offering (the “PIPE Offering,” and collectively with the Registered Direct Offering, the “Offering”), the Company agreed to sell and issue to the Investor detachable Series A common stock Purchase Warrants (the “Series A Warrants”) to purchase up to 3,571,429 shares of common stock and detachable Series B common stock Purchase Warrants (the “Series B Warrants,” and collectively with the Series A Warrants (the “Common Warrants”) to purchase up to 3,571,429 shares of common stock. The Series A Warrants will be exercisable beginning six months from the date of issuance at an exercise price of $1.75 per share, and will expire two years from the date of issuance. The Series B Warrants will be exercisable beginning six months from the date of issuance at an exercise price of $2.00 per share, and will expire five and one-half years from the date of issuance. The warrants meet the criteria for equity classification.
On May 15, 2026, the Company entered into a securities purchase agreement (the “May 2026 Securities Purchase Agreement”) pursuant to which the Company agreed to sell and issue to a single investor in a registered direct offering (the “Registered Direct Offering”): (i) 1,133,334 shares of common stock par value $0.00001per share, (ii) Pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 200,000 shares of Common Stock, at an offering price of $1.49999 per Pre-Funded Warrant, and (iii) accompanying common warrants to purchase up to 1,333,334 shares of common stock (“Common Warrants”). Each Pre-Funded Warrant is exercisable for one share of Common Stock. The Pre-Funded Warrants have an exercise price of $0.00001 per share, are immediately exercisable, and may be exercised at any time until exercised in full. The Common Warrants will be exercisable beginning six months from the date of issuance at an exercise price of $1.75 per share, and will expire three years from the date of issuance. The warrants meet the criteria for equity classification.
On July 24, 2026, the Company and a certain purchaser (the “Investor”) entered into a securities purchase agreement (the “July 2026 Securities Purchase Agreement”) pursuant to which the Company agreed to sell and issue to the Investor in a registered direct offering: (i) 2,416,339 shares of common stock, par value $0.00001 per share (the “Common Stock”), at an offering price of $1.53 per share, (ii) pre-funded warrants to purchase up to 100,000 shares of Common Stock, at an offering price of $1.52999 per pre-funded warrant (the “Pre-Funded Warrants”), and (iii) accompanying common warrants to purchase up to 2,516,339 shares of Common Stock (the “Common Warrants”). Each Pre-Funded Warrant will be exercisable for one share of Common Stock at an exercise price of $0.00001 per share, will be immediately exercisable upon issuance, and may be exercised at any time until exercised in full. Each Common Warrant will be exercisable for one share of Common Stock at an exercise price of $1.75 per share, will be exercisable six months from the date of issuance, may be exercised at any time until exercised in full, and will expire five and one-half years from the date of issuance.
From July 1, 2024 through June 30, 2025, the Company sold 3,351,096 shares of common stock at an average price of approximately $1.65 per share. The shares were issued pursuant to a prospectus supplement dated May 5, 2023 and filed with the Securities and Exchange Commission on May 5, 2023 in connection with the Company’s shelf registration statement on Form S-3, as amended (File No. 333-271706), which became effective on May 22, 2023. The net proceeds to the Company from the offering was approximately $5,296,000 after placement agent fees and other estimated offering expenses.
From July 1, 2025 through September 24, 2025 subsequent to the Company’s fiscal year end, the Company sold 824,535 shares of common stock at an average price of approximately $1.57 per share. The net proceeds to the Company from the offering was approximately $1.25 million after placement agent fees and other estimated offering expenses.
Management believes that the Company’s cash and cash equivalents balance of approximately $1.6 million at June 30, 2025, and additional capital raised of approximately $1.25 million by ATM sales of our common stock from July 1, 2025 through September 24, 2025 and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As 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.
Management believes that the Company’s cash and cash equivalents balance of approximately $2.8 million at June 30, 2026, capital raised subsequent to the yearend of approximately $3.4 million net of placement agent’s fees and offering expenses, and the Company’s existing resources, including availability under its $3 million line of credit will not be sufficient to fund the Company’s planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-K. As 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. The ability of the Company to continue as a going concern is dependent upon controlling its overall expenses and identifying and securing additional financing.
The Company believes that it has have several important milestones, including data from and final reports from the Phase Ia/Ib human clinical trial for our broad-spectrum drug NV-387 that is now in progress. Additional milestones include filing of clinical trial application for Phase II clinical trialtrials of NV-387 for MPox indication,and anticipatedEbola approval of the application, initiation of the Phase II Clinical Trial,indications, Interim Datasets regarding the Safety and Effectiveness of NV-387 for the treatment of MPox, Interim Datasets regarding the safety and effectiveness of NV-387 for the treatment of Ebola, Completion of the Phase II Clinical Trial for MPox, Completion of the Phase II Clinical Trial for Ebola, as well as filing of clinical trial application for Phase II clinical trial of NV-387 for Viral-ARI/SARI indication, anticipated approval of the application, initiation of the Phase II Clinical Trial, interim datasets regarding the safety and effectiveness of NV-387 for the treatment of a multitude of respiratory viral infections, completion of the Phase II Clinical Trial and data analysis with data regarding efficacy of NV-387 in the treatment of Influenza, RSV, Coronavirus, and possibly other respiratory viruses. Additional milestones include filing of clinical trial application for Phase II clinical trial of NV-387 for Measles indication, anticipated approval of the application, initiation of the corresponding Phase II Clinical Trial, interim datasets regarding the safety and effectiveness of NV-387 for the treatment of a multitude of respiratory viral infections, completion of the Phase II Clinical Trials, among others milestones.
Additional milestones we look forward to include: Pursuing of orphan drug designation filingfilings to the US FDA for NV-387 for the treatment of MPox, smallpoxSmallpox and Measles, Pre-IND Application filing to the US FDA for Smallpox/MPox/Orthopoxviruses, as well as for Ebola and for Measles; and an IND filing to the US FDA, possibly for NV-387 for the treatment of smallpoxor underfor the FDAtreatment “Animalof Rule”.Measles.
Management believes that it has on-going access to the capital marketsmarkets. includingOn July 17, 2026, the “At-The-Market”Company (ATM)entered agreementinto an At The Market Issuance Sales Agreement with D. Boral Capital,Capital LLC (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through or to the Sales Agent, thatshares becameof activethe aroundCompany’s Aprilcommon 5, 2024.stock, However, we cannot provide assurance that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates.
As of June 30, 20252026 we havehad a cash balance of approximately $1.6$2.8 million and raised an approximate additional $1.25$3.4 million through September 24, 2025 through ATM salesnet of ourplacement commonagent’s stock.fees and offering expenses on July 27, 2026.
Page 101 of 119
Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
On November 4, 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public business entities (PBEs) to disclose, in interim and annual reporting periods, additional information about certain expenses in the notes to financial statements. The requirements of ASU 2024-03 apply to all public business entities. The ASU requires disaggregated disclosure of income statement expenses for public business entities (PBEs). The ASU does not change the expense captions an entity presents on the face of the income statement; rather, it requires disaggregation of certain expense captions into specified categories in disclosures within the footnotes to the financial statements. ASU 2024-03 is effective for all PBEs for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning Page 90 of 107 after December 15, 2027. EarlyThe adoptionCompany adopted this ASU, as of July 1, 2026, for the fiscal year ending June 30, 2027. There is permitted. While the Company is currently evaluating the adoptionno impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements andat theJune Company’s30, disclosures.2026.
ASU 2023-09 Income Taxes (Topic 740) Improvements to Income Tax Disclosures. The amendments in this Update require that public business entities on an annual basis (1) disclose specific categories in the rate reconciliation and (2) provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5 percent of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). Additionally, the ASU requires all entities to disclose the amount of income taxes paid disaggregated by federal, state, and foreign taxes, as well as individual jurisdictions where income taxes paid are equal to or greater than 5 percent of total income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 31, 2025. Early adoption is permitted and this ASU should be applied on a prospective basis. While the Company is currently evaluating the adoption impact of this ASU on its financial statements, the preliminary assessment is that the adoption of this standard is not expected to have a material effect on the Company’s financial statements and the Company’s disclosures.
Improvements to Income Tax Disclosures
In December 2023, the FASB issued ASU 2023-09, “Improvements to Tax Disclosures” (Topic 740). The new guidance is intended to enhance the transparency and decision usefulness of income tax disclosures through changes to the rate reconciliation and the income taxes paid information disclosed. The ASU is effective retrospectively for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company adopted this ASU as of July 1, 2025 and the impact on the financial statements is not material, beyond certain expanded disclosure.
Segment and Geographic Information
The Company adopted Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024. This ASU requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), an amount for other segment items by a reportable segment and a description of its composition, and disclosure of the title and position of the CODM.
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the CODM, or decision making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment: life science. The life science segment consists of the development of clinical and preclinical product candidates for the development of the Company’s proprietary anti-viral therapies. The Company’s CODM is the President and Executive Chairman of the Board of Directors.
Segment revenue, profit or loss, significant segment expenses and other segment items - The accounting policies of the Company’s single operating and reportable segment are the same as those described in this Summary of Significant Accounting Policies. The Company’s method for measuring segment profitability includes net income (loss), which the CODM uses to assess performance and make decisions for resource allocation, consistent with the measurement principals for net income (loss) as reported on the Company’s statement of operations. The significant expenses regularly reviewed by the CODM are consistent with those reported on the Company’s statement of operations, and expenses are not regularly reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how to allocate resources.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.
What changed in the latest 10-Q
Risk Factors
We are a smaller reporting company as defined by 17 C.F.R. and are not required to provide information under this item.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
“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.”see in full comparison
“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. …”see in full comparison
“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. …”see in full comparison
“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. …”see in full comparison
Interest Income – Interest income for the three months endedsee in full comparisonDecemberMarch 31,20252026decreasedincreased$19,254$8,512 to$12,455$40,885 from$31,709$32,373 for the three months endedDecemberMarch 31,2024.2025. Interest income for thesixnine months endedDecemberMarch 31,20252026 decreased$48,650$40,139 to$24,082$64,967 from$72,732$105,106 for thesixnine months endedDecemberMarch 31,2024.2025. 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 thethreenineandmonthsix monthsperiod endedDecemberMarch 31,20252026 compared to the prior period is due to alowerhigher interest bearing balanceduring the periodandlowerhigher interest rates during thecurrent three and six month period compared to theprior period.
“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. …”see in full comparison
Full comparison: every changed paragraph (62)
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.
AsViruses 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,escaping vaccines, antibodiesantibodies, and small chemical drugs arehas readilybeen escapeda bymajor virusesproblem in conquering viral infections. This is because the viruses continuously change in the field, rendering these medical countermeasures ineffective. This was repeatedly observed during the COVID pandemic.
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.
Nanoviricides Drugs Are Designed So that They Can be Used in Potentially All Segments of Patient Population 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.toxicity.
The host-mimicry nanoviricide platform has enabled development of extremely broad-spectrum antiviral drugs such as NV-387, as well as virus-type-specificvirus- family-specific drugs such as NV-HHV-1 (Herpesviridae) and NV-HIV-1 (HIV-1, 2; all mutants).
NV-387 for the Treatment of Viral Acute Respiratory Infections (V-ARI) We believe that as a single drug that can potentially treat almost any acute respiratory viral infection, NV-387 could be as revolutionary an antiviral drug as penicillin was as the anti-bacterial drug, if and when approved after clinical trials. If a patient presents with a suspected bacterial respiratory infection, the physician can immediately prescribe a broad-spectrum antibacterial treatment such as amoxicillin without waiting for test results. In contrast, at present if a patient presents with a suspected viral respiratory infection, there is no treatment available except for influenza and now COVID. Even in the case of influenza, the available drugs have limited effectiveness and need to be given within 48 hours of initial symptoms for best efficacy, as per prescribing information and literature. The COVID drug paxlovid has not shown efficacy in healthy adults, and has other limitations regarding eligibility of a patient as per prescribing information and literature.
NV-387 for the Treatment of Monkeypox and Smallpox
NV-387 for the Treatment of Measles
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 ).
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.
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.
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.
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.
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 thea potentialpotentially 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.
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.
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 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 CDC3. Effectively, the US no longer has Measles elimination status4, 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 literature5.
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.
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 beenwere 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.
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).
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.
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.
The design of NV-387 suggests that it is likely to be active against most, if not all respiratory viral infections (see below).
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).
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.
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.
Our objective is to bring the data from the clinical trials externalabroad 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:
Assuming an ODD is granted, weWe plan on following up with further US FDA engagementsengagements, after future ODD grants, by filing pre-IND applications:applications.
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.
Recently threea seventh new case of MPox Clade I cases in unconnected persons werewas 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/storywww.newsmirror.net/news/healthcdph-closely-monitoring-mpox-activity/2025/10/17/california-mpox-strain-cases/86748970007/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.
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%.
These poor vaccine effectiveness data clearly make the case that an effective therapeutic (treatment) for MPox is sorely needed.
Thus, although the current threat level is low, MPox Clade I could result in becoming an endemic virus in the USA.
3 The Measles vaccine, a live attenuated strain developed circa 1968, continues to be in use,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.
We believe our unique and successful mimicking of S-PG is responsible for the observed broad-spectrum activity of NV-387. NV-387 is an example of NanoViricides Platform Modality #1 implementation discussed in our Annual report filed with the SEC on September 29, 2025.
Virus Escaping a Nanoviricide Drug is Unlikely
We believe our unique and successful mimicking of S-PG is responsible for the observed broad-spectrum activity of NV-387. NV-387 is an example of NanoViricides Platform Modality #1 implementation discussed in our Annual report filed with the SEC on September 27, 2024 Virus Escaping a Nanoviricide Drug is Unlikely The NanoViricides Platform Technology has an important advantage in that no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug, because the nanoviricide drug is designed to mimic the very features that the virus uses to bind to and enter cells. These specific molecular signature features on the cellular side do not change even as the virus mutates, and nanoviricides are designed to mimic these host-side features. In contrast viruses readily escape antibodies as drugs, as well as vaccine-induced immunity as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.
Our nanoviricides™ platform technology is based on biomimetic engineering that copies the features of the human cellular receptor of the virus. No matter how much the virus mutates, all virus variants bind to the same receptor in the same fashion. ThusThus, our platform technology is inherently designed to combat the issue of viruses escaping drugs by generation of variants.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
As of DecemberMarch 31, 2025,2026, we had cash and cash equivalents of $5,150,580,$3,213,256, prepaid expenses of $145,985$164,656 and net property and equipment of $6,656,439.$6,528,873. Accounts payable and accrued expenses were $1,195,925,$1,065,407, inclusive of accounts payables to related parties of $929,232.$904,690. Stockholders’ equity was $11,071,715$9,153,597 at DecemberMarch 31, 2025.2026. 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.
During the sixnine month period ended DecemberMarch 31, 2025,2026, we used approximately $3.6$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.
During the six month period ended December 31, 2024, we used approximately $4.8 million in cash toward operating activities.
Revenues The Company is a biopharmaceutical company and did not have any revenue for the three and sixnine month periods ended DecemberMarch 31, 20252026 and 2024.2025.
Research and Development Expenses – Research and development expenses for the three months ended DecemberMarch 31, 20252026 decreasedincreased $37,702$3,691 to $1,118,649$1,285,942 from $1,156,351$1,282,251 for the three months ended DecemberMarch 31, 2024.2025. Research and development expenses for the sixnine months ended DecemberMarch 31, 20252026 decreased $977,727$974,036 to $2,111,715$3,397,657 from $3,089,442$4,371,693 for the sixnine months ended DecemberMarch 31, 2024.2025. The decreaseincrease in research and development expenses for the three months ended DecemberMarch 31, 20252026 is due to aan decreaseincrease in outsidePhase lab fees andII clinical trial costs. The decrease in research and development expenses for the sixnine months ended DecemberMarch 31, 20252026 is due to a decrease in outside lab fees that were required for a Phase II Clinical Trial Application in 2024,2025, and not required in 2025.2026, and an increase in Phase II clinical trial costs.
General and Administration Expenses – General and administrative expenses for the three months ended DecemberMarch 31, 20252026 increaseddecreased $211,825$222,629 to $1,114,525$744,276 from $902,700$966,905 for the three months ended DecemberMarch 31, 2024.2025. General and administrative expenses for the sixnine months ended DecemberMarch 31, 20252026 decreased $219,299$411,929 to $1,918,144$2,662,420 from $2,137,443$3,104,349 for the sixnine months ended DecemberMarch 31, 2024.2025. The increasedecrease 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 sixnine months ended DecemberMarch 31, 20252026 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.
Interest Income – Interest income for the three months ended DecemberMarch 31, 20252026 decreasedincreased $19,254$8,512 to $12,455$40,885 from $31,709$32,373 for the three months ended DecemberMarch 31, 2024.2025. Interest income for the sixnine months ended DecemberMarch 31, 20252026 decreased $48,650$40,139 to $24,082$64,967 from $72,732$105,106 for the sixnine months ended DecemberMarch 31, 2024.2025. 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 threenine andmonth six monthsperiod ended DecemberMarch 31, 20252026 compared to the prior period is due to a lowerhigher interest bearing balance during the period and lowerhigher interest rates during the current three and six month period compared to the prior period.
Interest Expense – Interest expense decreased by $149 to $0 for the threenine months ended DecemberMarch 31, 20252026 from $149 for the threenine months ended DecemberMarch 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, 2024.2025.
Net Loss – For the three months ended DecemberMarch 31, 2025,2026, the Company had a net loss of $(2,220,7191,989,333) or $(0.110.09) per share compared to a net loss of $(2,027,4912,216,783) or $(0.14) per share for the three months ended DecemberMarch 31, 2024.2025. For the sixnine months ended DecemberMarch 31, 2025,2026, the Company had a net loss of $(4,005,7775,995,110) or $(0.220.31) per share compared to a net loss of $(5,154,3027,371,085) or $(0.360.50) per share for the sixnine months ended DecemberMarch 31, 2024.2025. The increasedecrease in the net loss for the three months ended December 31, 2025, and decrease in the net loss for the sixnine months ended DecemberMarch 31, 20252026 is generally attributable to the factors discussed above.
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 DecemberMarch 31, 20252026 of approximately $152.8$154.8 million and a net loss of approximately $4.0$6.0 million and net cash used in operating activities of approximately $3.6$5.6 million for the sixnine 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 DecemberMarch 31, 2025,2026, the Company had available cash and cash equivalents of approximately $5.2$3.2 million. The Company’s liabilities at DecemberMarch 31, 20252026 were approximately $1.2$1.1 million. TheDuring the nine month period ended March 31, 2026, the Company raised capital of approximately $664,000,$1,909,000, net of offering expenses, from ATM sales of our common stock during the current period from October 1, 2025 through December 31, 2025.stock. Additionally, theon CompanyNovember successfully11, 2025, we raised capital worthof approximately $5.4 million net of expenses in a Registered Direct Offering of common stockstock, 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.
Additional milestones include filingexecution of Clinical Trial Application (CTA) forthe 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.
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.
Additionally, government funding for advanced regulatory development of NV-387 will be likely, especially for a new smallpox therapeutics.
NNVC insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
No Form 4 stock transactions in this period.
Well-known investors holding NNVC (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Renaissance Technologies | 2026-06-30 | 128,600 | $177.5K | 0.0% | Reduced 5% |