The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.
The main questions it aims to answer are:
* Is tecovirimat effective in treating mpox infection.
* Is tecovirimat safe to treat patients with mpox infection.
Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.

Start Date09 Aug 2024

Sponsor / Collaborator

University Medical Center of Utrecht

[+4]

NCT06721585

/ CompletedNot ApplicableIIT

A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease - Extension Amendment

The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.

Start Date10 Jul 2024

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT05534165

/ SuspendedPhase 3IIT

Placebo-controlled Randomized Trial of Tecovirimat in Non-hospitalized Patients With Monkeypox: Canadian Feasibility Study (PLATINUM-CAN)

PLATINUM-CAN is a parallel collaborative trial linked with the sister trial PLATINUM led by Oxford University. PLATINUM-CAN is a multi-centre, randomized, placebo-controlled trial of Tecovirimat in non-hospitalized patients with presumptive or PCR confirmed monkeypox infection. The study will provide evidence on the efficacy and safety of Tecovirimat for laboratory-confirmed monkeypox in outpatients with monkeypox infection and determine the feasibility of conducting interventional monkeypox trials in Canada.

Start Date14 Aug 2023

Sponsor / Collaborator

Centre universitaire de santé McGill

[+5]

100 Clinical Results associated with Tecovirimat

100 Translational Medicine associated with Tecovirimat

100 Patents (Medical) associated with Tecovirimat

389

Literatures (Medical) associated with Tecovirimat

01 Feb 2027·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Computational screening of bacterial and fungal natural compounds targeting monkeypox virus DNA polymerase (F8) holoenzyme

Article

Author: Hossain, Tanvir ; Tabrez, Shams ; Islam, Md Shoket ; Ayman, Umme ; Siddiquee, Noimul Hasan ; Khan, Mohd Shahnawaz ; Alvee, Nabil Jonayeth ; Sayed, Abu

The Orthopoxvirus known as the monkeypox virus (MPXV) has resurfaced as a global public health concern and is becoming increasingly difficult to control due to growing resistance to tecovirimat and the limitations of current antiviral treatments. This study focused on natural product-based inhibitors targeting the viral DNA polymerase holoenzyme (PDB ID: 8HG1), an essential replication complex mechanistically distinct from conventional therapies. A comprehensive computer-aided drug design workflow was used to screen 36,395 natural compounds through molecular docking, followed by pharmacokinetic and toxicity evaluation. This initial phase identified CIDs: 14378518, 135779135, and 101904856 as lead candidates with high binding free energies of -10.221, -10.055, and -10.054 kcal/mol, along with favourable pharmacokinetic and safety profiles. Further validation using MM-GBSA, QM calculations, and SAR analysis supported their binding potential and antiviral relevance. To thoroughly evaluate the stability and binding integrity of these complexes, 100 ns molecular dynamics (MD) simulations were conducted, analysing metrics including RMSD, RMSF, Rg, SASA, hydrogen bond, protein-ligand contact analyses, PCA, and DCCM. Overall, CIDs: 14378518 (Juglomycin C) from Streptomyces sp. strain 815 and 135779135 (Lamellicolic anhydride) from Coniothyrium cereale demonstrated optimal stability, compactness, and sustained protein-ligand interactions during simulation. Juglomycin C showed the most favourable binding energy profile observed in both post-docking (-5.44 kcal/mol) and post-simulation analyses (-26.30 to -27.24 kcal/mol), whereas Lamellicolic anhydride exhibited the best overall simulation stability, outperforming all evaluated compounds across the majority of dynamic parameters. Thus, these findings emphasize their potential as promising natural product-derived candidates for future experimental validation in MPXV antiviral research.

31 Dec 2026·Emerging Microbes & Infections

Assessment of three antiviral compounds against Borealpox virus infection in a mouse model

Article

Author: Safronetz, David ; Tailor, Nikesh ; Sloan, Angela ; Prévost, Jérémie ; Soule, Geoff ; Fulton, Kathleen ; Audet, Jonathan ; Medina, Sarah J.

Borealpox virus (BRPV) is a zoonotic orthopoxvirus which was first documented in Alaska in 2015. Although most human infections are mild, a recent fatal case in an immunocompromised individual highlights the importance of studying this emerging pathogen. To date, less than 10 human cases of BRPV infection have been confirmed which limit the availability of clinical data on the effectiveness of antiviral therapy. Here, we examined the effectiveness of cidofovir, brincidofovir, and tecovirimat in cell culture and found all three were potent inhibitors of BRPV. In order to further study these modalities in vivo, we assessed immunocompetent and immunodeficient mice as disease models for BRPV. CAST/EiJ mice proved to be a suitable immunocompetent model for BRPV infection with high viral titres in several organs and route-dependent lethality. BRPV infection in immunodeficient mice, including STAT1^-/-, scid, and NSG strains, was uniformly lethal and characterized by high viral titres as well as profuse fluid retention in the peritoneal cavity. Using CAST/EiJ mice, we then evaluated cidofovir, brincidofovir, and tecovirimat therapies. Post-exposure treatment resulted in significant reductions in viral titres and an improved clinical course of infection. Our results demonstrate the utility of mouse models to study the pathogenicity of BRPV and support the use of these antivirals to treat human infections.

31 Dec 2026·Emerging Microbes & Infections

Differential pathogenesis and antiviral treatment outcomes of MPXV clade Ib and clade IIb in a BALB/c mouse model

Article

Author: Peng, Bo ; Shen, Chenguang ; Wang, Fuxiang ; Li, Baisheng ; Chang, Fangfang ; Jia, Penghui ; Chen, Shiman ; Zhang, Shengjie ; Yang, Wei ; Liu, Yingxia ; Zhang, Mingxia ; Lin, Yuanlong ; Feng, Yong ; Yang, Yang ; Liang, Xiaowen ; Peng, Yun

The global emergence of monkeypox virus (MPXV) clade IIb since 2022, together with the recent spread of clade Ib, underscores the continuing public health threat posed by MPXV. Clinical and epidemiological observations suggest that clade Ib infection may differ from clade IIb infection, but the biological basis of these differences remains insufficiently defined. In this study, we established an intranasal BALB/c mouse model of MPXV clade Ib infection and compared its pathogenicity with that of clade IIb. Clade Ib caused lethal disease at an inoculation dose approximately ten-fold lower than that required for clade IIb. Compared with clade IIb, clade Ib infection showed faster disease progression, higher pulmonary viral burden at later stages of infection, and more severe lung pathology. Single-cell transcriptome and cytokine response analyses further uncovered clade-specific differences in pulmonary immune cell landscapes, the distribution of MPXV-positive cells, and the expression patterns of key inflammatory mediators at specific time points. Antiviral evaluation showed that tecovirimat and cidofovir were active against both clades, although a higher dose of cidofovir was required to achieve protection in the clade Ib infection model. Together, these findings establish a susceptible BALB/c mouse model for MPXV clade Ib and provide experimental evidence for clade-dependent differences in MPXV pathogenicity and antiviral treatment outcomes.

141

News (Medical) associated with Tecovirimat

29 Sep 2026

·www.biospace.com

NanoViricides, Inc. Has Filed its Annual Report: Broad-spectrum Antiviral NV-387 Is In Phase II Clinical Trials

SHELTON, CT / ACCESS Newswire / September 29, 2026 / NanoViricides, Inc. (NYSE American: NNVC ) (the "Company"), reports that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 with the Securities and Exchange Commission (SEC) on Monday, September 28, 2026. The report can be accessed at the SEC website ( ). Accomplishments in Reported Fiscal Year ending June 30, 2026 In the fiscal year 2026, we have achieved a substantial level of accomplishments. We have focused on regulatory advancement of our broad spectrum antiviral drug NV- 387. We received approval for Phase II clinical trial to evaluate the safety and efficacy of NV-387 Oral Gummies for the treatment of Mpox in September, 2025, from the regulatory agency ACOREP in the Democratic Republic of Congo (DRC). Unfortunately, the MPox Clade I epidemic that led WHO to declare a Public Health Emergency of International Concern (PHEIC) in August, 2024, had substantially abated in the Kinshasa region. We therefore chose a remote site where Mpox cases were still prevalent. We had to upgrade the facilities at this site including patient isolation facilities as well as laboratory facilities significantly to enable conducting the clinical trial there. This Phase II clinical trial began enrollment at the end of September, 2026. Meanwhile, in May 2026, WHO declared a PHEIC for the Ebola Bundibugyo virus disease outbreak that had just begun in the Ituri province. There is no approved treatment nor an approved vaccine for this virus. Moreover, this Bundibugyo virus (BDBV) differs significantly from previous Bundibugyo viruses that caused outbreaks, as well as from other Ebola viruses. Subsequent to the reporting period, in July, 2026, we applied for regulatory approval to conduct a Phase II clinical trial to evaluate he safety and efficacy of NV-387 Oral Gummies for the treatment of Ebola virus disease (any Ebola virus). In August, 2026, we received the approval for this Phase II clinical trial of NV-387 from ACOREP in DRC. This Phase II clinical trial also began enrollment at the end of September, 2026 at an Ebola Treatment Center in Ituri province. The current Ebola outbreak in DRC is rapidly growing. As of September 23, 2026, there have been 7,890 confirmed cases, 3,799 confirmed deaths, and 1,966 confirmed recoveries in DRC, according to the WHO daily report i . In comparison, as of August 14, 2026, there were reported 4,945 confirmed cases and 2,325 confirmed deaths due to this virus. The crude fatality rate (crude CFR) is about 48%, but the probability of an infected person dying is estimated at 67% ii . In addition, we also began our efforts towards US FDA regulatory approvals for NV-387. We applied for an Orphan Drug Designation (ODD) of NV-387 as a Treatment for Measles in February, 2026. Subsequently, we also applied for a Rare Pediatric Disease Drug (RPDD) designation for NV-387 as a pediatric Measles treatment. The US FDA approved the ODD and the RPDD designation for NV-387 as a treatment of Measles in May and June, 2026, respectively. In addition, we have continued process development work for the manufacture of NV-387. We have also worked on improved formulations of the NV-387 oral gummies. Thus, we have made significant achievements towards regulatory approvals for NV-387 in the reported year. NV-387 Would become an Important Medical Countermeasure for Combatting Several Difficult Viral Infections with Outbreak, Epidemic, and Pandemic Occurrences, if Approved MPox Clade I and Clade II There is no approved drug for the treatment of MPox, Clade I or Clade II. Tecovirimat, a drug approved by the US FDA under the "Animal Rule", and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, failed in clinical trials. Another drug, brincidofovir, also approved by the US FDA under the "Animal Rule", and stockpiled by the US Government in pandemic preparedness program for Smallpox bioterrorism, is currently in clinical trial for MPox. First fifty randomized MPox patients (our assumption is possibly 25 in the brincidofovir arm and 25 in a control arm) were evaluated for safety and tolerability. No new safety signals (i.e. toxicities) were found according to a press release in January, 2026 iii . The brincidofovir prescribing information carries a black box warning and lists gastrointestinal toxicities and elevation of liver enzymes as major toxicities of the drug iv . MPox Clade II has become endemic in the Western world after the global epidemic that began in Africa in 2022. It has remained primarily in the cohorts of men-having-sex-with-men (MSM) and their sexual contacts. MPox Clade II virus is difficult to transmit and is transmitted via contact with eroded MPox skin lesions and open bruises. There were 999 cases of MPox (Clade I and Clade II together) in 2026, as of September 2, 2026, according to CDC. Cases of MPox Clade I are increasing in the USA, and those cases not related travel have begun to show up in the since August, 2026. If sustained transmission of MPox Clade I occurs, it could lead to an outbreak in the USA, however, the probability is considered small. MPox Clade I is highly pathogenic, and also transmits more easily compared to Clade II. The case fatality rate of MPox Clade I is between 0.5% to 3%, whereas that for Clade II is less than 0.1% (above information compiled from CDC website v ). CDC recommends two doses of JYNNEOS vaccine to protect from MPox. JYNNEOS was developed as a Smallpox vaccine. The effectiveness of this vaccine in MPox Clade II is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II vi . The vaccine effectiveness is likely to be much less against the more severe MPox Clade I. However, without a drug to treat a viral infection, vaccines alone are not sufficient, even if highly effective. Thus a drug to treat MPox is an unmet medical need. NV-387 for treatment of MPox, if successful, has a strong financial potential. Ebola and Marburg Viruses Family (Filoviruses) There is no approved drug for the treatment of all Ebola and Marburg viruses. Two monoclonal antibodies are approved, and two vaccines are approved, but only for the EBOV Zaire version that caused the 2022 West Africa outbreak. A clinical trial called "PARTNERS" is evaluating Infusion of MBP134, a monoclonal antibody cocktail, Infusion of Remdesivir, and Infusion of both, as a treatment for Ebola BDBV infection against standard treatment control group, in DRC. Infusions are very difficult to administer in the BSL4-like isolation setting required for Ebola. Also, infusion even if approved, would not be scalable for administration to large number of patients in a large outbreak as is occurring in DRC at present. NV-387 Oral Gummies, as an oral drug, has the ideal target product pro fighting this Ebola outbreak. Measles There is no approved drug for Measles. NV-387 is the only drug candidate that has shown effectiveness against Measles virus in a lethal infection study in a humanized (hSLAM+knockin,IfnAR-/-) mouse model for the disease, to the best of our knowledge. Measles cases and outbreaks are rising globally. In the USA, in 2026, as of September 24, 2026, there were 3,659 confirmed measles cases, one confirmed Measles infection death and additional three possibly Measles-related deaths were reported, according to the CDC and news reports vii . Our Strategy of NV-387 for Orphan Diseases of Pandemic Potential has Strong Financial Incentives and Potential for Early Revenues Smallpox and MPox are important for the US Government from the perspective of pandemic preparedness and bioterrorism potential. Likewise, Ebola and Marburg family of viruses is important for pandemic preparedness, and these are considered priority pathogens. A drug that can work against all of them would be sought after for acquisition at least by the US Government and potentially by several other governments. If NV-387 is successful against either MPox or Ebola or both, there would be a strong case that USG agencies may provide non-dilutive funding for its regulatory approval, and upon approval, may acquire the drug for the Strategic National Stockpile (SNS) for preparedness. SNS acquisition contracts have been in the range of high hundreds of millions per year. NV-387 for Measles would be eligible, upon approval, for receiving a Priority Review Voucher (PRV) from the US FDA as a benefit of the RPDD designation. A PRV can be sold and recent trades have fetched as much as $200 million viii . The sale of PRV can fetch such revenues even before commercially meaningful revenues from sale of the drug can be developed, offering a strong incentive for our NV-387 for Measles drug development. We believe that NV-387 is on its way to become a revolutionary antiviral therapy that could be prescribed for practically any respiratory viral infection without first testing for the causative virus, just as broad-spectrum antibiotics can be prescribed even before testing for the causative bacteria. This "empiric therapy" approach would enable immediate treatment and thus improve effectiveness; it is well known that antiviral treatments are most effective when given early. NV-387 would play in a market size of well over $20 Billion as a dominant player, if approved for such empiric therapy of viral ARI/SARI. To this end, we have proposed a novel adaptive, Phase II clinical trial for the evaluation of NV-387 as a treatment for Viral Acute/Severe Acute Respiratory Infections (V-ARI, V-SARI) towards this goal. A preliminary clinical protocol for this complex trial has been developed. We plan on leveraging the MPox studies towards approval of NV-387 as a treatment of Smallpox under the US FDA "Animal Rule". The US agency BARDA has programs to support such development if NV-387 qualifies. Financials We reported that, as of June 30, 2026, we had cash and cash equivalent current assets balance of approximately $2.79 Million. In addition, we reported approximately $6.40 Million in Net Property and Equipment (P&E) assets (after depreciation). The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT, where we manufacture our clinical trial drug substance and drug products, thus producing substantial savings as compared to working with an external manufacturer (CDMO). The total current liabilities were approximately $1.19 Million. In comparison, as of June 30, 2025, we had cash and cash equivalent balance of approximately $1.67 Million, P&E assets of approximately $6.83 Million (after depreciation), and total current liabilities of approximately $1.31 Million. The net cash utilized in the reported period for operating activities was approximately $7.70 million, which includes continuing expenditures for completion of the Phase Ia/Ib clinical trial of NV-387 in India, Clinical Trial Application for Phase II Clinical Trial of NV-387 as a Treatment for MPox in DRC, and R&D and preparatory work including cGMP manufacture of the drug substance for the Phase II clinical trial of NV-387 for treatment of MPox. We raised approximately $7.10 million in sale of equity and warrants in registered direct offerings, and $1.91 million from sale of common stock in ATM equity offering, for a total financing of approximately $9.01 million during the reported period. Subsequent to the reporting period, in July 2026, we raised approximately $3.8 million in gross proceeds from a registered direct offering comprising common stock and warrants to a single investor. Further, our founder, Dr. Anil Diwan has provided a line of credit (LOC) of $3 million to the Company. We have not yet drawn on the LOC. As such, we reported that we do not have sufficient funding in hand as of now to continue operations through September 30, 2027, for our planned objectives. As a result substantial doubt exists about the Company's ability to continue as a going concern, as evaluated based on applicable guidelines. We are actively exploring additional required funding through non-dilutive grants and contracts, partnering, debt or equity financing pursuant to our plan. We believe that the Company has on-going access to the capital markets including the "At-The-Market" (ATM) agreement that became active around July 17, 2026. We have previously adjusted our objectives and development plans on the basis of available resources and we will continue to do so. We Have Several Important Milestones in the Ensuing Year The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for MPox: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of MPox cases. The Phase II Clinical Trial for the evaluation of NV-387 Oral Gummies as a Treatment for Ebola: Commissioning of Enrollment and Dosing, Initial Results from Phase IIA (primarily safety and tolerability), Initial Results from Phase IIB (primarily efficacy), Reports Preparation and Submission. A Phase III Application will be undertaken if there continue to be sufficient number of Ebola cases. Pursuing Orphan Drug Designations for NV-387-for-MPox, NV-387-for-Smallpox, and NV-387-for-Ebola. Filing of a pre-IND with the US FDA towards NV-387 for Smallpox treatment under the "Animal Rule". Filing of an IND with the US FDA towards evaluation of NV-387 as a Smallpox treatment leading to registration. Filing of the Phase II Clinical Trial Application for the evaluation of NV-387 as a treatment for Viral Acute Respiratory Infections (Viral-ARI) in India, its Approval by the regulator, and Commissioning of the clinical trial, and Interim Results. This Phase II clinical trial is expected to yield data on the safety and efficacy of NV-387 for the treatment of Influenza, RSV, Coronaviruses, and hMPV, which are the most important seasonal epidemic/pandemic viruses, in a single clinical trial. 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. More About Our Drug Pipeline We believe the Company has a bright future. Our Phase II clinical stage drug NV-387 has completed Phase I clinical trial with the successful results that there were no drop-outs, and there were no reported adverse events, both of which clearly indicate excellent safety and tolerability in humans. NV-387, as mentioned above, is likely to become a revolutionary broad-spectrum antiviral therapeutic, that could change how we treat viral infections forever. In addition, the Company has developed a pan-Herpesvirus drug, NV-HHV-1. Its skin cream formulation for the treatment of Shingles rash, Chickenpox, HSV-1 Cold Sores, and HSV-2 Genital Ulcers, has completed certain IND-enabling non-clinical studies. NV-HHV-1 has demonstrated effectiveness in a human skin model of VZV infection (Varicella-Zoster-Virus, which causes Chickenpox and Shingles). A systemic form of the herpesvirus drug is in development. The Company has also developed an anti-HIV drug, NV-HHV-1, which the HIV viruses would not be able to escape despite rapid virus evolution. NV-HHV-1 has demonstrated strong effectiveness superior to triple-drug combination HAART therapy in a humanized animal model of HIV infection. The Nanoviricides™ Technology and Non-Clinical Animal Studies Results in Brief The Company's technology is based on mimicking the host-side binding sites that the virus uses which remain the same despite several and extensive changes in the virus. We design and make chemical mimics of these sites to create virus-binding ligands that we attach to a base polymer. This makes the drug look like a cell membrane to the virus. The nanoviricide drug is thus designed to fool the virus into entering the nanoviricide drug micelle and uncoating itself by using the virus's own smarts against it. We believe viruses would not be able to escape nanoviricide drugs because of this design. In contrast, viruses readily escape vaccines, antibodies, and most of the small chemical drugs. Oral NV-387 was found to be superior to the three known drugs oseltamivir (Tamiflu ® , Roche), peramivir (injection, Rapivab ® , BioCryst), as well as baloxavir (Xofluza ® , Shionogi/Roche) in a lethal lung infection animal model of Influenza. Oral NV-387 was found to cure lethal lung RSV infection in an animal model. There is no current approved drug for treating RSV infection. Previously, NV-387 given both orally and as I.V. injections was found to be substantially superior to remdesivir (injection, Gilead) in a lethal lung infection animal model for COVID-19. Oral NV-387 was found to be equivalent to or superior than tecovirimat (TPOXX ® , SIGA) in two different lethal animal models of orthopoxvirus diseases. One of these models simulated skin infection which is the primary route of MPox Clade II infections. Another animal model simulated direct lung infection which is the likely route of Smallpox infection in case of bioterrorism. Oral NV-387 was found to be highly effective as a treatment of lethal Measles virus lung infection in humanized (hSLAM+knockin, IfnAR-/-) mice. There is no approved treatment for Measles. About NanoViricides NanoViricides, Inc. (the "Company") ( ) 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. NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. 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 i , retrieved on Monday September 28, 2026 at 00:58 EDT. See also, . ii The Crude CFR is calculated simply by dividing the confirmed deaths by the confirmed number of cases on the same reporting date. It ignores the fact that the deaths are actually occurring in patients that were confirmed infected several days earlier; i.e. the time lag of sickness is not accounted for in the crude CFR. If it is accounted for, the actual fatality rate per confirmed infection (Infected Fatality Rate or IFR) would be much higher than the crude CFR. For example, if one assumes an average time lag of 21 days (Aug 14 to Sept 5), then the IFR on September 5 would be (3,175/4,945 = ) 64%. Not all infections are reported or confirmed by lab tests; however, it is likely that most deaths are counted. This produces a large uncertainty in such CFR and IFR estimates. Another way to estimate IFR would be to simply take a ratio of confirmed deaths to that of confirmed deaths plus confirmed recoveries. This metric, probability of death, is more robust and insensitive to the lag times, except it ignores patients that are still in hospital. The p(death) based on this metric is (using Sept. 10 numbers,(3,398)/(3,398 +1,671) = 67%. That said, a number of cases as well as deaths remain unconfirmed or unreported because of the regional issues. iii iv brincidofovir TEMBEXA prescribing information, from US FDA website, . v . vi From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43. vii see also . viii SOURCE: NanoViricides, Inc. View the original press release on ACCESS Newswire

Phase 2Orphan DrugDrug ApprovalVaccineClinical Result

23 Sep 2026

·www.biospace.com

Phase II Clinical Trial of NV-387 as a Treatment for Monkeypox (MPox) Has Begun in DRC, Announces NanoViricides

SHELTON, CT / ACCESS Newswire / September 23, 2026 / NanoViricides, Inc. (NYSE American: NNVC ) (the "Company") today announced that the Phase II Clinical Trial of the Company's Novel Broad-Spectrum Antiviral Drug NV-387 as a Treatment for Monkeypox Virus Infection has begun with enrollment of first patients in the Democratic Republic of Congo (DRC). This clinical trial was registered in the Pan African Clinical Trials Registry database ( pactr.samrc.ac.za ). The unique identification number for this clinical trial is PACTR202609506749917. The clinical trial is entitled: "An adaptive international, multi-center, randomized, open-label, interventional, parallel group, phase II (IIa and IIb) clinical trial to evaluate the efficacy and safety of a new chemical entity NV-387 formulated as oral gummies in comparison to standard of care, administered in patients with clinical signs of mpox disease and laboratory confirmed or presumptive hmpxv infection." The Principal Investigator for this clinical trial is Prof. Vivi Maketa Tevuzula, MD, MSc, PhD, Professor in the Department of Tropical Medicine at the University of Kinshasa and Principal Investigator at the Institut Multisectoriel pour l'Amélioration du Bien-être (IMABE), Kinshasa, DRC. Her work focuses on infectious diseases, including clinical trials demonstrating the safety and efficacy of novel drugs, and safety, immunogenicity, and efficacy of vaccines, as well as health systems research in resource-limited settings. She has served as principal investigator on multiple international studies on malaria, Mpox, and vaccine-preventable diseases, and leads interdisciplinary research on genomic surveillance and One Health approaches. Bayer Foundation awarded Dr. Vivi Maketa with the prestigious Early Excellence in Science Award 2023 in Medical Science, recognizing her exceptional contributions to the design and implementation of research projects on infectious and neglected tropical diseases i . "We are pleased to have Professor Maketa lead this clinical trial," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, adding, "This is the very first Phase II clinical trial of the broad-spectrum antiviral drug NV-387 and aims to explore its safety and effectiveness in Mpox." There is no approved drug for Mpox. Clinical trials of a drug called tecovirimat (TPOXX, SIGA) have previously failed to demonstrate efficacy against both Mpox Clade II and Mpox Clade I. Tecovirimat was approved by US FDA for Smallpox under the Animal Rule provision. A pan-African clinical trial called "MOSA" of a drug called brincidofovir, which is approved by US FDA for Smallpox under the Animal Rule provision, that started in January, 2025, is currently ongoing. As of January 2026, according to a press release, this study's Data Safety and Monitoring Board (DSMB) did not identify any new safety concern after the first 50 patients were randomized, and the trial plans to enrol a further 50 patients in the first half of 2026, to perform interim efficacy analysis of brincidofovir ii . Brincidofovir requires constant physician care due to dose-limiting liver and gastro-intestinal toxicity concerns iii . NV-387 could become the "go to" pandemic response drug if it is successful in this Phase II MPox clinical trial, and becomes a FDA-licensed (approved) drug. US Government SNS stockpiling contracts for existing smallpox drugs TPOXX and TEMBEXA have been in several hundreds of millions of dollars, representing an equivalent potential opportunity for NV-387. The Phase II clinical trial for NV-387 as a treatment of mpox is being conducted at Lodja in Sankuru province in DRC. As of now, this province is not an ebola-affected region. Professor Maketa's team is already on site in DRC. In addition, The team of our CRO from India, Om Sai Clinical Research Pvt. Ltd., is also on site in DRC to start the clinical trial. Lodja is a remote location and mpox cases are continuing to occur in that area. This is a resource-poor region. Setting up the clinical sites required several months of effort because of the resource limitations at the hospital. MPox Clade I is endemic in DRC and all cases in the clinical trial are expected to be of the Clade I virus. The other prominent MPox virus, MPox Clade II is substantially less severe an infection than MPox Clade I. MPox Clade II has become endemic in the USA, circulating at low levels. It primarily affects a limited population of Men-having-Sex-with-Men (MSM), because of transmission during sexual activity. MPox is an "Orphan Disease" in the USA. NanoViricides has applied to the US FDA for Orphan Drug Designation (ODD) of NV-387 for the treatment of MPox. This ODD, assuming it is granted, would enable several benefits including frequent meetings with FDA, waiver of certain FDA fees, certain R&D credits, as well as extension in exclusivity in marketing once approved. These ODD benefits can have a positive economic impact for NanoViricides estimated in the range of tens of millions of dollars. MPox Clade I cases in the USA have been slowly increasing. As of August 27, 2026, since November 2024, there have been more than 50 confirmed cases of Mpox Clade I in the USA, all of which were either travelers to Mpox-manifesting countries or regions, or contacts of such travelers, according to the CDC iv . Community spread of the MPXV Clade I is likely occurring, with 3 cases of MPox Clade I with no travel to Africa, in California in unconnected persons, according to the CDC v . However, the potential for a widespread outbreak remains low. From 2023-2025, about 1,700-2,800 cases of Mpox Clade II were confirmed in the USA, mostly occurring in men-having-sex-with men and associated sexual partners, according to the CDC (ibid #4). Clade II is transmitted via skin abrasions. Thus MPox is becoming important in the USA from the perspective of pandemic preparedness and response. Although there is a vaccine originally developed for smallpox, namely, Jynneos, that is in use to prevent MPox (primarily in clade II contacts), its immune protection was found to wane rapidly in a clinical study vi . The effectiveness of this vaccine is limited, at 36% for one dose and 66% for 2 doses against the less pathogenic MPox Clade II vii . The vaccine effectiveness is likely to be much less against the more severe MPox Clade I. Vaccines do not protect in the first few weeks, limiting their usefulness during pandemic. We believe that there will be a strong opportunity for NV-387 for pandemic preparedness and response for the threats of Mpox and Smallpox in the USA if this Phase II clinical trial of NV-387 for the treatment of Mpox is successful. The two drugs in the USA Strategic National Stockpile (SNS), TPOXX and TEMBEXA, would be unsuitable for pandemic response if MPox Clade I spreads. Although both of these drugs are approved for Smallpox, a bioterrorism agent, under the FDA animal rule, the clinical trial failure of tecovirimat against Mpox which is a much less severe and far less lethal disease compared to Smallpox raises questions about its possible utility in a Smallpox bioterrorism event. In addition, the known toxicity pro warnings for brincidofovir make it unsuitable for wide-scale deployment in a large outbreak scenario. "NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria." NV-387 was found to possess strong antiviral activity against an orthopoxvirus in an animal model that is considered an important model to establish potential effectiveness against MPox and Smallpox viruses, as all of these viruses belong to the same family of orthopoxviruses. In fact, NV-387 effectiveness matched the effectiveness of the small chemical drug tecovirimat in two different models of infection, one was direct skin infection, and the other was a direct lung infection, by the virus. Escape of virus from tecovirimat is known to occur by a single point mutation in a viral protein called VP-37. Vaccines, antibodies, and small chemical drugs such as tecovirimat for MPox/Smallpox, or oseltamivir (Tamiflu ® ), baloxavir (Xofluza ® ) for Influenza are readily escaped by viruses simply by introduction of small changes that viruses undergo when they are faced with these challenges in the field. In contrast, escape of virus from NV-387 is highly unlikely because no matter how much the virus changes in the field, it continues to use sulfated proteoglycans such as HSPG as "attachment receptor" in order to cause cell infection. NV-387 mimics the sulfated proteoglycan signature feature that the viruses require. NV-387 is a host-mimetic drug that "looks like a cell" to the virus, displaying numerous ligands that mimic the sulfated proteoglycan, enticing the virus to bind to and become engulfed by the NV-387 dynamic shape-shifting polymeric micelle. Therefore development of NV-387, a broad-spectrum host-mimetic, direct-acting antiviral drug that the viruses cannot escape even as they change constantly, will be revolutionary once the drug undergoes regulatory development for approval for use in humans. New viruses and existing viruses acquiring greater pathology and infectivity are bound to keep appearing in time. To combat such threats, we need to develop broad-spectrum drug arsenal that the viruses cannot escape. Vaccines and antibodies simply will not do, and their limitations have become clearly evident during the COVID-19 pandemic. About NanoViricides NanoViricides, Inc. (the "Company") ( ) 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. NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. 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. Where stated with an ® , the name is a registered trademark, which belongs to the owner of the trademark name. 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 i ii iii According to the drug label (prescribing information), brincidofovir ("TEMBEXA") carries a black box warning, and has warnings for elevations in hepatic transaminases and bilirubin (liver toxicity) and diarrhea and other gastrointestinal adverse events. Brincidofovir administration must be performed under physician care with continuous evaluation of liver toxicity. iv v vi vii From the Mpox Emergency Response Team, CDC (2023-05) "Vaccine Effectiveness of JYNNEOS against Mpox Disease in the United States," N Engl J Med 2023;388:2434-43. SOURCE : NanoViricides View the original press release on ACCESS Newswire

Phase 2Drug ApprovalLicense out/inOrphan DrugVaccine

07 Aug 2026

·www.biospace.com

SIGA Reports Financial Results for Three and Six Months Ended June 30, 2026

$37 Million of TPOXX Sales Generated in the Second Quarter Corporate Update Conference Call Today at 4:30 PM ET NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three and six months ended June 30, 2026. “In the second quarter, we delivered approximately $37 million of TPOXX to three customers: $24 million of IV TPOXX to the U.S. strategic national stockpile and $13 million of oral TPOXX to two international customers,” stated Diem Nguyen, Chief Executive Officer. “With product deliveries across the U.S., Europe, and the Asia- Pacific region, spanning multiple formulations, SIGA continues to execute its long-term plan of selling TPOXX across a diverse range of regions and customers.” Summary Financial Results ($ in millions, except per share amounts) Three Months Ended June 30 Six Months Ended June 30 2026 2025 2026 2025 Product sales (1) $ 37.9 $ 79.1 $ 41.4 $ 84.9 Total revenues (2) $ 41.0 $ 81.1 $ 47.2 $ 88.2 Operating income (3) (4) $ 13.9 $ 45.7 $ 8.6 $ 43.4 Income before income taxes (3) $ 14.9 $ 47.3 $ 10.8 $ 46.7 Net income $ 12.5 $ 35.5 $ 9.0 $ 35.1 Diluted income per share $ 0.17 $ 0.49 $ 0.13 $ 0.49 (1) Includes supportive services related to product sales. (2) Includes research and development revenues. (3) Operating income excludes, and income before income taxes includes, other income. Both line items exclude the impact of income taxes. (4) Differences in operating income margin between periods reflect different product mixes in those periods. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Key Business and Operational Activity In the second quarter of 2026, the Company delivered approximately $13 million of oral TPOXX to two international customers. In the second quarter of 2026, the Company delivered approximately $24 million of IV TPOXX to the U.S. strategic national stockpile under the 19C contract. These deliveries completed the last procurement order under the 19C contract. Capital Management Activity On March 26, 2026, a special cash dividend of $0.60 per share was declared, and was paid on April 23, 2026, to shareholders of record at the close of business on April 7, 2026. Conference Call and Webcast SIGA will host a conference call and webcast to provide a business update today, Thursday, August 6, 2026, at 4:30 P.M. ET. Participants may access the call by dialing 1-800-717-1738 for domestic callers or 1-646-307-1865 for international callers. A live webcast of the call will also be available on the Company's website at in the Investor Relations section of the website. Please log in approximately 5-10 minutes prior to the scheduled start time. A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference ID: 11157253. The archived webcast will be available in the Investor Relations section of the Company’s website . ABOUT SIGA SIGA is a commercial-stage pharmaceutical company and leader in global health focused on the development of innovative medicines to treat and prevent infectious diseases. With a primary focus on smallpox, we are dedicated to protecting humanity against the world’s most severe infectious diseases, including those that occur naturally, accidentally, or intentionally. Through partnerships with governments and public health agencies, we work to build a healthier and safer world by providing essential countermeasures against these global health threats. For more information about SIGA, visit . FORWARD-LOOKING STATEMENTS This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA’s future business development and plans. Forward-looking statements include statements regarding our future financial position, business strategy, budgets, projected costs, plans and objectives of management for future operations, and delivering products to domestic and international customers under procurement contracts. The words “may,” “continue,” “estimate,” “intend,” “plan,” “will,” “believe,” “project,” “expect,” “seek,” “anticipate,” “could,” “should,” “target,” “goal,” “potential” and similar expressions may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that SIGA is not able to secure in a timely manner new contracts with the U.S. Government to substantially maintain or expand the U.S. Government stockpile of TPOXX®, (ii) the risk that SIGA may not complete performance under the 19C BARDA Contract (the "BARDA Contract"), with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") on schedule or in accordance with contractual terms, (iii) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX® internationally, (iv) the risk that potential products, including potential alternative uses or formulations of TPOXX® that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (v) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vi) the risk that SIGA or its collaborators will not obtain or maintain appropriate or necessary governmental approvals to market these or other potential products or uses, (vii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (viii) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (ix) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking, obtaining or maintaining needed approvals to market these products, (x) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xi) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiii) the impacts of significant recent shifts in trade policies, including the imposition of tariffs, retaliatory tariff measures, and subsequent modifications or suspensions thereof, and market reactions to such policies and resulting trade disputes, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, or the changes in the U.S. administration, and (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2025 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Investor and Media Contact Suzanne Harnett sharnett@siga.com SIGA TECHNOLOGIES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) As of June 30, 2026 December 31, 2025 ASSETS Current assets Cash and cash equivalents $ 117,584,444 $ 154,966,414 Accounts receivable 7,170,229 3,263,736 Inventory 41,110,808 49,054,873 Prepaid expenses and other current assets 4,512,301 5,571,841 Total current assets 170,377,782 212,856,864 Property, plant and equipment, net 1,530,954 1,090,824 Deferred tax asset, net 2,789,666 4,428,519 Goodwill 898,334 898,334 Other assets 140,050 192,893 Total assets $ 175,736,786 $ 219,467,434 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 909,834 $ 824,522 Accrued expenses and other current liabilities 6,907,137 6,520,057 Deferred IV TPOXX® revenue — 10,240,000 Income tax payable 28,335 408,000 Total current liabilities 7,845,306 17,992,579 Other liabilities 2,600,845 2,653,283 Total liabilities 10,446,151 20,645,862 Commitments and contingencies Stockholders’ equity Common stock ($.0001 par value, 600,000,000 shares authorized, 71,844,042 and 71,611,302, issued and outstanding at June 30, 2026 and December 31, 2025, respectively) 7,184 7,161 Additional paid-in capital 243,262,409 241,885,214 Accumulated deficit (77,978,958 ) (43,070,803 ) Total stockholders’ equity 165,290,635 198,821,572 Total liabilities and stockholders’ equity $ 175,736,786 $ 219,467,434 SIGA TECHNOLOGIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (UNAUDITED) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 Revenues Product sales and supportive services $ 37,870,335 $ 79,124,860 $ 41,408,212 $ 84,946,107 Research and development 3,131,918 1,995,144 5,836,622 3,214,711 Total revenues 41,002,253 81,120,004 47,244,834 88,160,818 Operating expenses Cost of sales and supportive services 17,561,185 25,554,462 20,502,069 25,712,200 Selling, general and administrative 5,148,992 5,487,576 9,822,005 11,163,238 Research and development 4,386,498 4,398,097 8,336,344 7,860,910 Total operating expenses 27,096,675 35,440,135 38,660,418 44,736,348 Operating income 13,905,578 45,679,869 8,584,416 43,424,470 Other income, net 946,898 1,592,304 2,224,378 3,277,288 Income before income taxes 14,852,476 47,272,173 10,808,794 46,701,758 Provision for income taxes (2,389,042 ) (11,789,070 ) (1,799,610 ) (11,626,878 ) Net and comprehensive income $ 12,463,434 $ 35,483,103 $ 9,009,184 $ 35,074,880 Basic income per share $ 0.17 $ 0.50 $ 0.13 $ 0.49 Diluted income per share $ 0.17 $ 0.49 $ 0.13 $ 0.49 Weighted average shares outstanding: basic 71,752,539 71,465,521 71,701,531 71,446,629 Weighted average shares outstanding: diluted 71,883,798 71,748,888 71,998,573 71,678,838

Financial Statement

100 Deals associated with Tecovirimat

External Link

KEGG	Wiki	ATC	Drug Bank
D09390	Tecovirimat	J05AX24	DB12020

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Vaccinia	United Kingdom	SIGA Technologies, Inc.	08 Jul 2022
Cowpox	European Union	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Iceland	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Liechtenstein	SIGA Technologies, Inc.	06 Jan 2022
Cowpox	Norway	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	European Union	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Iceland	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Liechtenstein	SIGA Technologies, Inc.	06 Jan 2022
Monkeypox	Norway	SIGA Technologies, Inc.	06 Jan 2022
Smallpox	United States	SIGA Technologies, Inc.	13 Jul 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Morgellons Disease	Phase 2	United States	SIGA Technologies, Inc.	01 Jun 2009
Orthopoxvirus infection	Preclinical	United States	SIGA Technologies, Inc.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05534984 (STOMP/A5418, Pubmed \| N Engl J Med)	Phase 3	Monkeypox	336	Tecovirimat	mecorglexf(qcvzcghgaz): HR = 0.98 (95.0% CI, 0.74 - 1.31) View more	Negative	26 Feb 2026
				Placebo
NCT05534984 (STOMP/A5418 \| STOMP, CTgov)	Phase 3	Monkeypox	719	Tecovirimat Oral Capsule (Tecovirimat (Arm A))	ygwmoqnhpf = lmlnxfqzei vidasrrtiq (phhdafgorx, ayxofvqata - hjsrvcrwjc) View more	-	10 Feb 2026
				Placebo (Placebo (Arm B))	ygwmoqnhpf = sfzwfbnxpu vidasrrtiq (phhdafgorx, tfhtfrkpzm - ylyoxgsvil) View more
NCT05559099 (PALM007 \| PALM 007, CTgov)	Phase 2	Monkeypox	597	Tecovirimat Oral Capsule (Tecovirimat)	vwbzzawfkr(ibnjabvkat) = safbgnkmwc sscbstfpid (kqnzezwhan, jftaizkkrh - teaiwdrklt) View more	-	09 Oct 2025
				Placebo (Placebo)	vwbzzawfkr(ibnjabvkat) = cjyxmemgwo sscbstfpid (kqnzezwhan, tamwayxjhj - qtfladplpg) View more
NCT05559099 (PALM007, Pubmed \| N Engl J Med)	Phase 2	Monkeypox clade I MPXV	597	Tecovirimat	nozssqjgen(gmbmkfjrxc) = sohnbgiueq fxeeqkihlu (ybygmlfjzf ) View more	Negative	17 Apr 2025
				Placebo	nozssqjgen(gmbmkfjrxc) = ghrqaupufg fxeeqkihlu (ybygmlfjzf ) View more
NCT05534984 (STOMP, GlobeNewswire) Manual	Phase 3	Monkeypox	-	tecovirimat	mdsrzuzdkv(wbwmebhowc) = NIAID reported that SIGA’s tecovirimat, a highly targeted antiviral treatment, did not demonstrate efficacy in time to skin and mucosal lesion resolution compared to placebo in patients with mild to moderate clade II mpox. jfgecrutzx (trqcnfoddp )	Negative	10 Dec 2024
				placebo
NCT04971109 (CTgov)	Phase 3	Smallpox	467	TPOXX (TPOXX)	thzcfdvauw = lvkwfnpack ntiirvlzhg (rmsaxefpdc, fdatpjohsg - bfusicojkh) View more	-	23 Oct 2024
				TPOXX Placebo (TPOXX Placebo)	thzcfdvauw = rqgvlbarys ntiirvlzhg (rmsaxefpdc, mgsgmdwmfc - wubhhaegot) View more
NCT04485039 (CTgov)	Phase 4	Smallpox	44	Tecovirimat (TPOXX: Oral Antiviral)	ggtytstfwr(pgnghujlfs) = ycpcrhphjt lwbpepobmu (bvjxsdnbjq, 39.6) View more	-	09 Oct 2024
				Tecovirimat+sevelamer carbonate oral tablet (TPOXX: Oral Antiviral and Sevelamer Carbonate)	wfuyohbevw(qefjqxihad) = jvznichrux etfkrsvswj (nxhhqbxvdj, lwlachyhsi - uqjfhsjjsv) View more
NCT04392739 (CTgov)	Phase 4	Smallpox	34	Tpoxx	mwsiimegex(mesbcyurrd) = opvgdrqrts ilwdcfslln (kelqbcshgb, 26.0) View more	-	19 Sep 2024
NCT05559099 (PALM 007, GlobeNewswire) Manual	Phase 2	Monkeypox	-	Tecovirimat + SOC	cwhszhgmif(wqsbjmecng) = not superior to placebo in lesion resolution for all patients rxquvkkexs (sxqzptlqbm ) Not Met View more	Negative	15 Aug 2024
				Placebo + SOC
IAS2023	Not Applicable	Monkeypox	19	Tecovirimat 600mg	pvzugttdar(dbtdqnbxdn) = 1 participant reported blurry vision nuozujqjek (ipwgwnooel ) View more	Positive	23 Jul 2023

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