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Liquidity and Going Concern | 3 Months Ended
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Sep. 30, 2025
Liquidity and Going Concern |
Liquidity and Going Concern | Note 2 – Liquidity and Going Concern 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 September 30, 2025 of approximately $150.6 million and a net loss of approximately $1.8 million and net cash used in operating activities of approximately $1.6 million for the three 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 September 30, 2025, the end of the reporting period, the Company had approximately $1.1 million in cash and cash equivalents. The Company’s liabilities at September 30, 2025 were approximately $1.2 million, including accounts payable of approximately $255 thousand payable to third parties, accounts payable to related parties of approximately $901 thousand, and accrued expenses of approximately $26 thousand. Management believes that the Company’s cash and cash equivalents balance of approximately $1.1 million at September 30, 2025 along with additional capital raised of approximately $6 million through a combination of At the Market (ATM) sales and a separate registered direct offering, as described in Note 11, between October 1, 2025 through November 12, 2025, and the Company’s 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 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 several important milestones, building on the successful Phase Ia/Ib human clinical trial for the Company’s broad-spectrum, antiviral drug NV-387 as described elsewhere, with further progress of NV-387 into Phase II clinical trials. The Company has received a draft of the Phase Ia/Ib clinical study report (“CSR”). We believe the report should be finalized soon. The Company plans on submitting the final CSR to the regulatory authorities in India, which would be a significant milestone in the regulatory progress of NV-387. Additional milestones include filing of a Clinical Trial Application (CTA) for a 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 include applying for, and potentially receiving, “Orphan Drug Designations” from the US FDA for the three specific uses of NV-387, namely (1) NV-387 for Treatment of MPox, (2) NV-387 for Treatment of Smallpox, and (3) NV-387 for Treatment of Measles. An ODD carries with it several benefits, that include rapid FDA meetings, R&D tax breaks, and a Seven year exclusivity for the drug upon licensure. The Company then plans to take advantage of the increased FDA interactions for filing appropriate Pre-IND applications and IND applications with the US FDA. We believe that the MPox Phase II if successful, will likely enable a Phase II/III licensure clinical trial under the US FDA auspices upon completion, which may provide the shortest possible timeline for NV-387 licensure. Additionally, government funding for advanced regulatory development of NV-387 will be likely, especially for a new smallpox therapeutics. 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. 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. The Company executes its plans in a manner consistent with available resources, which can lead to reshuffling of priorities in its programs. Nevertheless, the Company has in the past and will continue to progress towards its goal of revolutionizing antiviral therapeutics. Management believes that as these various milestones are achieved, the Company would likely experience improvement in the liquidity of the Company’s stock, and such improvement, if any, would enhance the Company’s ability to raise funds on the public markets at terms that may be favorable to the terms offered at present. Management is actively exploring additional required funding through non-dilutive grants and contracts, partnering, as well as 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. Management believes that it has on-going access to the capital markets including the “At-The-Market” (ATM) agreement with D. Boral Capital (Formerly EF Hutton LLC), the Sales Agent. There can be no 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. The Company will need to raise additional capital to fund its long-term operations and research and development plans including human clinical trials for its various drug candidates until it generates revenue that reaches a level sufficient to provide self-sustaining cash flows. There can be no assurance that the Company will be able to raise the necessary capital or that it will be on acceptable terms. The accompanying financial statements do not include any adjustments that may result from the outcome of such unidentified uncertainties.

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