Cidofovir

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American: NNVC ) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD). If approved, orphan drug designation will qualify NanoViricides for incentives including: Tax credits for qualified clinical trials; Exemption from certain user fees; Potential seven years of market exclusivity after approval; according to the US FDA ( ). "NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat." WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus. MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern. There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections 1 . Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study" 2 . In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial 3 . The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results. The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles 4 . MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived 5 . The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX. NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox. In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases 6 . Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation. NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors. NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles. Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective. Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system. These factors make NV-387 unique in the field of antiviral drugs and vaccines. ABOUT NANOVIRICIDES NanoViricides, Inc. (the "Company") ( ) is a publicly traded (NYSE-American, stock symbol NNVC) 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 1 The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439. 2 Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network . 3 . 4 Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir. 5 Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • • Vol. 31, No. 2, February 2025. DOI: . 6 . SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire

Pritelivir met its primary endpoint of superior lesion healing, achieving a 62.7% lesion healing rate compared to 34.0% with standard-of-care therapies (investigator’s choice), resulting in an adjusted treatment difference of 28.4% (p = 0.0047) Pritelivir demonstrated a favorable safety and tolerability profile, with fewer treatment-emergent adverse events and drug-related discontinuations compared to investigator’s choice Aicuris is on track to submit a New Drug Application (NDA) to the U.S. FDA in Q1 of 2026 The 2026 Tandem Meetings cover the latest research and breakthroughs in the evolving field of hematopoietic cell transplantation (HCT), cellular therapy and gene therapy Wuppertal, Germany, February 5, 2026 - Aicuris Anti-infective Cures AG (“Aicuris”) today announced positive results from its pivotal Phase 3 trial (PRIOH-1, NCT03073967 ), evaluating pritelivir in immunocompromised patients with refractory herpes simplex virus (HSV) infections, with or without resistance (R±R). Pritelivir, a novel small molecule antiviral targeting the helicase-primase complex of HSV, demonstrated superior efficacy and a favorable safety and tolerability pro to investigator’s choice therapy (ICT). The results will be presented by study investigator Genovefa Papanicolaou, MD, in an Oral Late Breaker presentation at the 2026 Tandem Meetings on February 7, 2026, in Salt Lake City, USA. As announced in October 2025, the trial met its primary efficacy endpoint and demonstrated favorable safety and tolerability results. Pritelivir achieved a clinically meaningful and statistically significant superiority in lesion healing of 62.7% compared to 34.0% for ICT, with an adjusted treatment difference of 28.4% (p = 0.0047). Pritelivir was associated with fewer drug-related treatment-emergent adverse events (TEAEs), including renal, electrolyte and drug-related TEAEs, leading to discontinuations compared with ICT (2.0% vs. 20% respectively). The most common TEAEs were headache, diarrhea, nausea, decreased appetite, vomiting and dizziness with a ≥5% incidence. “Current therapeutic options for hematopoietic cell transplant patients with refractory or resistant herpes simplex viral infection are limited by poor response rates, significant toxicities, and the burden of daily intravenous infusions in a healthcare setting,” said Genovefa Papanicolaou, MD, Clinical Director of Infectious Disease Service at Memorial Sloan Kettering Cancer Center and Professor at Weill Cornell College of Medicine . Pritelivir addresses a critical unmet medical need for an oral agent offering statistically superior and clinically meaningful lesion healing with fewer side effects. It has the potential to significantly improve both clinical outcomes and quality of life for these vulnerable patients.” “For more than two decades, there has been no innovation in antiviral medicines for HSV, leaving clinicians with limited treatment options for patients who do not respond to existing antivirals. By targeting an essential step in the virus’s replication process, pritelivir offers a novel approach that can overcome current antiviral resistance,” Cynthia Wat, MD, CMO of Aicuris , added. “Together, these results mark a pivotal moment for patients with refractory HSV infections, supporting pritelivir’s potential to redefine the standard of care for patients at high risk of morbidity and mortality. We look forward to bringing it swiftly to those with few effective and well tolerated alternatives.” The global, controlled, open-label comparative trial ( NCT03073967 / Eudra-CT 2023-510088-37-00 ) randomized and treated a total of 101 immunocompromised patients with R±R HSV infection, including transplant recipients (hematopoietic stem-cell and solid organ), patients with malignancies, autoimmune or inflammatory disorders, and patients with an HIV infection. An additional 56 patients were treated in the non-randomized part of the trial. Participants received either oral pritelivir (100 mg daily, 400 mg loading dose on the first day of therapy) or ICT (IV foscarnet, IV/topical cidofovir or topical imiquimod) for up to 28 days, with the option to extend treatment to 42 days, if lesion improvement was observed. About Herpes Simplex Virus Herpes Simplex Virus (HSV) includes two types, HSV-1 and HSV-2, both of which cause lifelong infections. HSV-1 most commonly causes labial herpes, typically presenting as cold sores, while HSV-2 is the primary cause of genital herpes. HSV infections are characterized by recurrent, painful lesions and sores and, in severe cases, can lead to complications such as encephalitis, meningitis, disseminated disease, keratitis and neonatal herpes. HSV infections represent a substantial global public health burden. According to the World Health Organization, an estimated 3.8 billion people under the age of 50, or 64% of the global population, were infected with HSV-1 in 2020. 520 million people aged 15 to 49 were living with HSV-2. The disease burden is particularly high in immunocompromised patients, who are at increased risk of more severe, more frequent and treatment-refractory HSV infections. About Pritelivir Pritelivir, a novel helicase-primase inhibitor developed by Aicuris, targets both HSV-1 and HSV-2. These viruses are responsible for genital, oral, or disseminated infections with increasing severity and limited treatment options, particularly in immunocompromised patients where being treatment refractory or resistant to existing antivirals is a significant clinical challenge. Unlike traditional antivirals, pritelivir blocks viral DNA synthesis by inhibiting the helicase-primase complex, a mechanism distinct from marketed nucleoside analogues. Because of this distinct mode of action, pritelivir is active against strains resistant to nucleoside analog-and foscarnet based therapies. 1 Earlier clinical trials in immunocompetent and immunocompromised individuals showed a favorable safety pro early signals of clinical efficacy compared to standard of care treatments like valacyclovir and foscarnet. Based on these results, pritelivir was granted FDA Breakthrough Therapy designation. In October 2025, Aicuris announced that pritelivir met its primary endpoint in the pivotal Phase 3 trial. The company expects to marketing authorization with the U.S. FDA in Q1 of 2026. About Aicuris Aicuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS ® , marketed by our partner MSD, prevents CMV in a defined group of transplant recipients. Our pivotal Phase 3 candidate, pritelivir, aims to address refractory HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people, an otherwise manageable infection can mean life or death. Aicuris, with its expertise and growing pipeline, is committed to providing therapeutic solutions for them now and in the future. Contact: Aicuris Anti-infective Cures AG info@aicuris.com Trophic Communications Dr. Stephanie May and Anja Heuer Phone: +49 171 1855 682 Email: aicuris@trophic.eu 1 Sallée, L. and Boutolleau, D. (2024), Management of Refractory/Resistant Herpes Simplex Virus Infections in Haematopoietic Stem Cell Transplantation Recipients: A Literature Review. Rev Med Virol, 34: e2574. Attachment Tandem Data PR