NanoViricides, Inc. Has Filed its Quarterly Report
NanoViricides (NYSE:NNVC) has filed its Q4 2024 quarterly report, highlighting its progress with NV-387, a broad-spectrum antiviral drug. The company reported $3.96M in cash and equivalents, with $7.17M in net property and equipment assets. Total current liabilities were $1.18M.
The company is preparing for Phase II clinical trials of NV-387 to treat MPox infection in Central Africa, where clinical trial sites have been identified. NV-387 successfully completed Phase Ia/Ib trials with no adverse events. The drug has shown promising results against various viruses, including Bird Flu H5N1, RSV, Influenza, and MPox.
However, NNVC reported insufficient funding to continue operations through February 14, 2026, for planned objectives. The company raised approximately $4M through an ATM offering and has access to a $3M credit line from its founder.
NanoViricides (NYSE:NNVC) ha presentato il rapporto trimestrale del Q4 2024, evidenziando i progressi con NV-387, un farmaco antivirale ad ampio spettro. L'azienda ha riportato $3,96M in contante e equivalenti, con $7,17M in beni netti di proprietà e attrezzature. Le passività correnti totali ammontavano a $1,18M.
L'azienda si sta preparando per la fase II degli studi clinici di NV-387 per trattare l'infezione da MPox in Africa Centrale, dove sono stati identificati i siti per gli studi clinici. NV-387 ha completato con successo gli studi clinici di fase Ia/Ib senza eventi avversi. Il farmaco ha mostrato risultati promettenti contro vari virus, inclusi l'Influenza Aviaria H5N1, RSV, Influenza e MPox.
Tuttavia, NNVC ha segnalato un finanziamento insufficiente per continuare le operazioni fino al 14 febbraio 2026, per gli obiettivi pianificati. L'azienda ha raccolto circa $4M attraverso un'offerta ATM e ha accesso a una linea di credito di $3M dal suo fondatore.
NanoViricides (NYSE:NNVC) ha presentado su informe trimestral del Q4 2024, destacando su progreso con NV-387, un medicamento antiviral de amplio espectro. La compañía reportó $3.96M en efectivo y equivalentes, con $7.17M en activos netos de propiedad y equipos. Las obligaciones corrientes totales fueron de $1.18M.
La empresa se está preparando para los ensayos clínicos de fase II de NV-387 para tratar la infección por MPox en África Central, donde se han identificado los sitios de ensayo clínico. NV-387 completó con éxito los ensayos de fase Ia/Ib sin eventos adversos. El medicamento ha mostrado resultados prometedores contra varios virus, incluyendo la Influenza Aviar H5N1, RSV, Influenza y MPox.
Sin embargo, NNVC reportó financiación insuficiente para continuar las operaciones hasta el 14 de febrero de 2026, para los objetivos planificados. La compañía recaudó aproximadamente $4M a través de una oferta ATM y tiene acceso a una línea de crédito de $3M de su fundador.
나노바이러스 (NYSE:NNVC)는 2024년 4분기 분기 보고서를 제출하며 NV-387, 광범위 항바이러스 약물의 진행 상황을 강조했습니다. 회사는 현금 및 현금성 자산으로 $3.96M을 보고했으며, 순 자산 및 장비는 $7.17M입니다. 총 유동 부채는 $1.18M이었습니다.
회사는 MPox 감염 치료를 위한 NV-387의 2상 임상 시험을 준비하고 있으며, 중앙 아프리카에서 임상 시험 사이트가 확인되었습니다. NV-387은 부작용 없이 1a/1b 단계 시험을 성공적으로 완료했습니다. 이 약물은 조류 인플루엔자 H5N1, RSV, 인플루엔자 및 MPox를 포함한 다양한 바이러스에 대해 유망한 결과를 보여주었습니다.
그러나 NNVC는 계획된 목표를 위해 2026년 2월 14일까지 운영을 지속할 자금이 부족하다고 보고했습니다. 회사는 ATM 제공을 통해 약 $4M을 모금했으며, 창립자로부터 $3M의 신용 한도에 접근할 수 있습니다.
NanoViricides (NYSE:NNVC) a déposé son rapport trimestriel du Q4 2024, mettant en avant ses progrès avec NV-387, un médicament antiviral à large spectre. La société a déclaré avoir $3,96M en espèces et équivalents, avec $7,17M en actifs nets de biens et équipements. Les passifs courants totaux s'élevaient à $1,18M.
La société se prépare pour les essais cliniques de phase II de NV-387 pour traiter l'infection par MPox en Afrique centrale, où des sites d'essai clinique ont été identifiés. NV-387 a réussi à compléter les essais de phase Ia/Ib sans événements indésirables. Le médicament a montré des résultats prometteurs contre divers virus, y compris la grippe aviaire H5N1, le VRS, la grippe et le MPox.
Cependant, NNVC a signalé un financement insuffisant pour poursuivre ses opérations jusqu'au 14 février 2026, pour les objectifs prévus. La société a levé environ $4M grâce à une offre ATM et a accès à une ligne de crédit de $3M de son fondateur.
NanoViricides (NYSE:NNVC) hat seinen vierteljährlichen Bericht für das 4. Quartal 2024 eingereicht und dabei die Fortschritte mit NV-387, einem breit angelegten antiviralen Medikament, hervorgehoben. Das Unternehmen meldete $3,96M in Bargeld und Äquivalenten sowie $7,17M an Nettovermögenswerten und Ausrüstungen. Die gesamten kurzfristigen Verbindlichkeiten beliefen sich auf $1,18M.
Das Unternehmen bereitet sich auf die klinischen Phase-II-Studien von NV-387 zur Behandlung von MPox-Infektionen in Zentralafrika vor, wo die Standorte für klinische Studien identifiziert wurden. NV-387 hat die Phase Ia/Ib-Studien erfolgreich ohne unerwünschte Ereignisse abgeschlossen. Das Medikament hat vielversprechende Ergebnisse gegen verschiedene Viren gezeigt, darunter die Vogelgrippe H5N1, RSV, Influenza und MPox.
NNVC berichtete jedoch über unzureichende Mittel, um die Operationen bis zum 14. Februar 2026 für die geplanten Ziele fortzusetzen. Das Unternehmen hat durch ein ATM-Angebot etwa $4M gesammelt und hat Zugang zu einer Kreditlinie von $3M von seinem Gründer.
- Successful completion of Phase Ia/Ib trials for NV-387 with no adverse events
- NV-387 demonstrated superior activity compared to existing drugs in animal trials
- Strong property and equipment assets of $7.17M
- Access to $3M credit line from founder
- Insufficient funding to continue operations through February 2026
- Net cash utilization of $4.79M in six months ending December 2024
- Ongoing need for additional financing through ATM offerings causing dilution
Insights
The Q4 2024 financial report reveals both promising developments and significant challenges for NanoViricides. The company's cash position of
The successful completion of NV-387's Phase I trial with no adverse events is particularly noteworthy. The drug's broad-spectrum antiviral properties, targeting host-cell features that viruses need for infection, presents a novel approach that could potentially revolutionize antiviral treatment. This mechanism differs fundamentally from traditional antivirals, which typically target specific viral proteins and are vulnerable to viral mutations.
Three critical market opportunities stand out:
- The MPox/Smallpox market, estimated at
$1 billion globally, represents an immediate opportunity with competition - The pediatric RSV market, where NV-387 has shown promising results, could be a multi-billion dollar opportunity in the US alone
- The emerging H5N1 bird flu threat creates potential for emergency use authorization and government contracts
However, investors should note several risk factors:
- The current cash position is insufficient to fund operations through February 2026
- The company relies heavily on ATM offerings for funding, which could lead to dilution
- Clinical trial execution across multiple indications will require significant capital
The company's strategy to pursue non-dilutive funding through partnerships and grants could help mitigate financing risks, but concrete agreements have yet to materialize. The broad-spectrum approach of NV-387 could attract pharmaceutical partners looking to expand their antiviral portfolios, particularly given the growing concern about viral pandemics and the limitations of existing treatments.
Broad-Spectrum Antiviral NV-387 Phase II Clinical Trial Responding to MPox Pandemic in Africa, Readying to Tackle Bird Flu
SHELTON, CT / ACCESS Newswire / February 19, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the quarter ending December 31, 2024 with the Securities and Exchange Commission (SEC) on Friday, February 14, 2025. The report can be accessed at the SEC website (https://www.sec.gov/Archives/edgar/data/1379006/000141057825000140/nnvc-20241231x10q.htm) .
Company Financials
We reported that, as of December 31, 2024, we had cash and cash equivalent current assets balance of approximately
The net cash utilized during the six months ended December 31, 2024 was approximately
We have approximately
NV-387 - Phase II Clinical Trial to Treat MPox Infection - Unmet Medical Need
We have retained a Clinical Research Organization (CRO) to help with organizing and executing a Phase II clinical trial of NV-387 for the treatment of MPox infection in Central Africa. Clinical trial sites in two different countries have been identified and are being engaged. We are now preparing the clinical trial applications to be filed to the regional regulatory agencies.
There is no drug available for the treatment of MPox infection. The MPox Clade 1/1b has a substantially greater fatality rate than COVID, at 3
The MPox Clade 1/1b infection has been declared a Public Health Emergency of International Concern (PHEIC) by the WHO. Spillover cases have occurred in several Eastern and Western countries already, raising the probability that the epidemic may spread more widely, although the current MPox virus is not as communicable as coronaviruses.
MPox/Smallpox drug represents a billion dollar market globally, should an effective drug be developed.
NV-387 - Phase I Clinical Trial Completed Successfully with No Reported Adverse Events
NV-387 has successfully completed a Phase Ia/Ib clinical trial in healthy subjects with all subjects discharged as of end of December, 2023. There were no adverse events reported. We are now awaiting a final report of this Phase I clinical trial.
NV-387 Preparing to Respond to Bird Flu
Bird Flu H5N1 in two different genotypes is now widely distributed in the USA and Canada in wild birds, backyard birds, poultry farms, as well as dairy herds. Infections in pets are being reported increasingly. At least 68 human cases have been confirmed, primarily in dairy workers and also veterinarians. Two sever cases, one fatal and one recovery after lengthy hospitalization, have occurred, both due to the more severe H5N1 D1.1 genotype. While the virus has not acquired ability to easily transmit from human to human, this ability is now known to be only a few mutations away.
The rapid mutation rate of the virus (faster than coronaviruses) suggests that vaccines will be far behind the virus and therefore would not provide a sufficiently effective countermeasure.
While Tamiflu (oseltamivir) is currently supposed to be active against the virus, its effectiveness is limited as found in the two severe cases, and a virus resistant to all currently available drugs could rapidly arise if the virus mutates and acquires rapid human to human transmission traits.
NV-387, unlike vaccines, antibodies and existing small chemical drugs, is a broad-spectrum antiviral that the H5N1 virus is unlikely to escape despite genetic changes in the virus. This is because NV-387 mimics a host-side feature that the virus needs in order to cause effective infection, no matter how much it changes.
NV-387 was found to be substantially superior in its activity against a lethal Influenza A H3N2 viral infection in animal models in comparison to the known anti-influenza drugs, oseltamivir (Tamiflu®), peramivir (Rapivab®), and baloxavir (Xofluza®).
Thus NV-387 offers the best countermeasure against H5N1 pandemic threat.
With the confirmation of Health and Human Services Secretary Robert F. Kennedy Jr., we anticipate in a greater emphasis on developing broad-spectrum antivirals that the virus cannot escape in oder to combat potential pandemics. The COVID experience has also generated wide-spread and well-deserved skepticism in the general population regarding vaccines against rapidly changing infectious viruses such as H5N1.
NanoViricides will be ready for the challenge of H5N1 should this virus turn into a human epidemic or pandemic.
NV-387 A Potentially Revolutionary Antiviral Drug that the Viruses are Unlikely to Escape
Our host-mimetic, direct-acting, broad-spectrum, antiviral agent. NV-387 was found to have activity that surpassed the activity of known agents in lethal virus infection animal model trials for COVID, RSV, Influenza, and Mpox/Smallpox.
In fact, we found that NV-387 treatment possibly completely cured the lethal RSV infection in mice, based on indefinite survival of the animals with no lung pathology. There is currently no treatment for RSV infection. In particular, pediatric RSV infection treatment is an unmet medical need that we believe is of critical importance. Pediatric RSV treatment itself is expected to be a multi-billion-dollar market in the USA alone.
NV-387 treatment was found to be substantially superior to three approved anti-influenza drugs, namely, oseltamivir (Tamiflu®, Roche), peramivir (Rapivab®, Biocryst), and baloxavir (Xofluza®, Shionogi/Roche).
Additionally, NV-387 also demonstrated activity against lethal poxvirus infection animal models that was on par with or superior to the approved drug tecovirimat (TPOXX®, SIGA).
NV-387 acts by a mechanism that is significantly different compared to the tested existing antiviral agents for COVID, Influenza and Poxviruses.
This demonstrated broad-spectrum activity of NV-387 against widely varying viruses is because NV-387 is designed to attack the virus particle by mimicking sulfated proteoglycan (S-PG) feature, and all of these viruses are known to utilize heparan sulfate proteoglycans for gaining cell entry.
Further, for all of these tested viruses, even as the virus genome changes in the field, NV-387 is expected to continue to be effective, and the virus would be highly unlikely to escape NV-387. This is because despite all of the genomic changes, the virus continues to use HSPG, as is well known. Thus NV-387 solves the greatest problem in antiviral countermeasures; the problem of virus escape. Viruses are known to escape all of the current antiviral tools that include vaccines, antibodies, and small chemical drugs.
Thus we anticipate that NV-387 would revolutionize the treatment of viral infections reminiscent of how penicillin revolutionized the treatment of bacterial infections.
NV-387 Regulatory Strategy
In the ensuing year, we plan on advancing NV-387 into Phase II clinical trials. In addition to the Phase II clinical trial to assess effectiveness of NV-387 in treating MPox infections, we are also planning to advance NV-387 into a Phase II clinical trial for treatment of Viral Acute Respiratory Infections (V-ARI), and Viral Severe Acute Respiratory Infections (V-SARI). This clinical trial is expected to provide information on NV-387 effectiveness in treating Influenza viruses, Coronaviruses (including SARS-CoV-2/COVID) as well as RSV.
Thereafter we are planning a regulatory program for advancing NV-387 as the treatment of pediatric RSV infection.
We plan on advancing the regulatory processes for NV-387 registration for other indications including Influenza and COVID via partnerships and non-dilutive funding.
As we meet the milestones, we believe we will be able to raise financing for further regulatory activities for NV-387 registration via non-dilutive grant funding, partnership revenues, as well as equity-based funding.
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.
The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.
The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.
The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.
FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.
Contact:
NanoViricides, Inc.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
SOURCE: NanoViricides, Inc.
View the original press release on ACCESS Newswire
FAQ
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