Latest news with #TPOXX
Miami Herald
14-05-2025
- Business
- Miami Herald
Measles Cases Are Increasing Globally; MPox Continues to Be a Threat - Broad-Spectrum Antiviral Drug Could Be the Solution
NanoViricides Explains Its Drug Strategy for Combating Viral Infections and Pandemics SHELTON, CT / ACCESS Newswire / May 14, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: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, explains its drug development strategy to combat important global viral threats. Measles outbreaks have continued to expand in the US, and the dramatic ten-fold increase in annual Measles cases in Europe last year indicates that Measles will be here to stay. Measles vaccine failure cases have also been increasing according to the European data, which is an important cause for concern. Vaccination rates are falling in developed countries. In this global scenario, NV-387, the clinical stage broad-spectrum, host-mimetic antiviral nanomedicine drug could perhaps be the only currently available drug candidate to combat the Measles virus and disease. There is no approved drug for Measles virus infection. The Company has already initiated the process for conducting an animal efficacy study that would provide an answer to how effective NV-387 would be against Measles virus. The Company will make NV-387 available to any licensed physicians intending to treat Measles cases under the Individual Patient Expanded Access protocol of the US FDA. The Company has its own cGMP manufacturing facility. The Company is pleased to state that it is moving forward with the Phase II Clinical Trial Application (CTA) for the evaluation of NV-387 as treatment of MPox in the Domestic Republic of Congo (DRC). The National Ethics Committee of DRC has recently cleared NV-387 as a potential drug candidate that should advance into the clinical trial, enabling the CTA. MPox is endemic in DRC, and has continued to cause large numbers of cases in the WHO African Region. In April, 2025, the WHO has restated that MPox continues to be a Public Health Emergency of International Concern (PHEIC), a designation it first declared for the MPox epidemic in August, 2024. This PHEIC is driven by MPox Clade 1a and 1b viruses that are highly pathogenic and highly transmissible. A milder version, MPox Clade 2, caused an epidemic in 2022, and since then became endemic, in certain subsets of populations in the Western World. It is thought that MPox Clade 1a/1b viruses could possibly lead to a wider epidemic including the rest of the world beyond Africa. There is currently no approved drug for the treatment of MPox infection. A drug, tecovirimat, (TPOXX®, SIGA) failed in clinical trials for the treatment of MPox. TPOXX has been approved for Smallpox in the USA under the FDA "Animal Rule" and continues to be stockpiled by the US Strategic National Stockpile. A broad-spectrum antiviral effective against all orthopoxviruses including MPox and Smallpox is needed. "NV-387 is a revolutionary antiviral drug that can combat many viral infections," said Anil R. Diwan, PhD, President and Executive Chairman of the Company, "We are advancing it rapidly towards establishing human clinical effectiveness data and regulatory approvals. We believe our MPox and Measles work will enable rapid advancement of the drug, and make a great global impact in large markets fulfilling unmet medical needs." The Company is also developing NV-387 as an "emperic" treatment of respiratory viral infections. We are developing a clinical protocol for a "basket-type" clinical trial, i.e. evaluating a single drug, namely, NV-387, against many viruses within a single clinical trial. The focus of this proposed clinical trial will be on All Influenzas, All Coronaviruses, and RSV. If successful, this study would enable NV-387 to be prescribed immediately when a patient presents to the physician with a respiratory infection suspected to be viral, without waiting for test results to determine which viral infection it is. Additionally, the Company is developing a pan-herpesvirus drug, NV-HHV-1. Herpesvirus infections from HSV-1, HSV-2, VZV, EBV, as well as HHV-6 have been linked to neurological damage that can eventually lead to Alzheimer's disease. An effective drug that can eradicate herpesviruses is an unmet medical need. Such a drug can make a major impact on chronic diseases such as Alzheimer's. To date, only effective drugs have brought or maintained endemic or circulating viruses under control. There are no vaccines for herpes viruses, HIV or hepatitis C virus. Yet, successful drugs have helped patients to be cured (HCV), or recover from episodes (HSV), or at least maintain healthy lifespan (HIV) without any vaccines. Market sizes for effective antiviral drugs run into several billions of dollars for each indication. Also, market sizes expand rapidly once an effective drug is introduced. "NanoViricides is poised to revolutionize how we treat viral infections, just as antibiotics revolutionized treatment of bacterial infections," said Dr. Diwan, adding, "We continue to march forward and strive hard to make this bright future a reality and to make a meaningful impact on public health, chronic diseases, and individual patients." Measles confirmed cases in the US have surpassed 1,000 already as of May 8th, 2025, across 31 jurisdictions, according to CDC report ( . Measles cases in Europe were over 35,000 in 2024, an almost ten-fold increase from 2023, according to the annual report of European Center for Disease Prevention and Control (ECDC). Only approximately 87% of cases were in unvaccinated persons, and 13% of the cases were of vaccine failure, out of the cases with known vaccination status. The significant Measles vaccine failure rate observed in Europe is alarming, considering that the two-dose vaccine is supposed to be 97% effective. Overall, childhood vaccination was about 94% and declining. This rate is below the 95% considered the threshold for achieving "herd" or community immunity. Given the various causes of vaccine failure, and of vaccine hesitancy, attaining 95% vaccine coverage cannot be considered a very probable solution to combating the Measles epidemic. An effective drug is needed to combat the epidemic. 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, Public Relations Contact:ir@ SOURCE: NanoViricides, Inc.
Yahoo
08-05-2025
- Business
- Yahoo
SIGA Reports Financial Results for Three Months Ended March 31, 2025
Received $26 Million IV TPOXX Procurement Order from the U.S. Government in March $94 million in TPOXX Orders (to be Delivered to U.S. Strategic National Stockpile) outstanding as of March 31, 2025 Corporate Update Conference Call Today at 4:30 PM ET NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three months ended March 31, 2025. 'SIGA has carried its momentum from 2024 into 2025, achieving steady progress on its key initiatives,' stated Diem Nguyen, Chief Executive Officer. 'In the first quarter, an international sale of approximately $6 million marks what we expect to be the beginning of substantial sales over the next series of months. With outstanding Strategic National Stockpile orders of $94 million as of March 31, 2025, we expect to deliver the $70 million of orders outstanding as of December 31, 2024 by the end of the third quarter of 2025, with the remainder expected to be delivered in 2026. We view these anticipated sales as a strong base upon which to build.' ($ in millions, except per share amounts) Three Months Ended March 31 2025 2024 Product sales (1) $5.8 $23.9 Total revenues (2) $7.0 $25.4 Operating (loss) / income(3) $(2.3) $11.3 (Loss) / Income before income taxes $(0.6) $13.2 Net (loss) / income $(0.4) $10.3 Diluted (loss) / income per share $(0.01) $ 0.14 (1) Includes supportive services related to product sales.(2) Includes research and development revenues.(3) Operating (loss)/income excludes, and (loss)/income before income taxes includes other income. Both line items exclude the impact of income April 2025, the Company delivered approximately $53 million of oral TPOXX and approximately $9 million of IV TPOXX to the SNS. In April 2025, the Company's 19C contract with the U.S. Government was modified to add $14 million of funding for activities to support manufacturing. In March 2025, the Company received a procurement order for $26 million of IV TPOXX from the U.S. Government under the 19C BARDA contract. In March 2025, the Company delivered approximately $6 million to an international customer, representing a sale to this country in five out of the last six years. In January 2025, the Company announced that TPOXX received regulatory approval in Japan (as TEPOXX) for the treatment of smallpox, mpox, cowpox, as well as complications following smallpox vaccination in adults and pediatric patients weighing at least 13 kg. TEPOXX is the first antiviral therapy approved by the Pharmaceuticals and Medical Devices Agency (PDMA), in collaboration with the Japan Ministry of Health, Labour and Welfare, for the treatment of April 8, 2025, a special cash dividend of $0.60 per share was declared, to be paid on May 15, 2025 to shareholders of record at the close of business on April 29, will host a conference call and webcast to provide a business update today, Thursday, May 8, 2025, 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, or by clicking here. 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: 1160299. 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 orthopoxviruses, 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. Our flagship product, TPOXX® (tecovirimat), is an antiviral medicine approved in the U.S. and Canada for the treatment of smallpox and authorized in Europe, the UK, and Japan for the treatment of smallpox, mpox (monkeypox), cowpox, and vaccinia complications. 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. 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 may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (ii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into new contracts to supply TPOXX® to, the U.S. Government, (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 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 or obtaining 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, 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, 2024 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. The information contained on any website referenced in this Form 10-Q is not incorporated by reference into this filing. Contacts:Suzanne Harnettsharnett@ and Investors Media Jennifer Drew-Bear, Edison GroupJdrew-bear@ Holly Stevens, CG Lifehstevens@ TECHNOLOGIES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) As of March 31, 2025 December 31, 2024 ASSETS Current assets Cash and cash equivalents $ 162,271,052 $ 155,400,262 Accounts receivable 7,185,485 21,166,129 Inventory 59,060,679 49,563,880 Prepaid expenses and other current assets 5,104,614 4,914,613 Total current assets 233,621,830 231,044,884 Property, plant and equipment, net 1,188,008 1,298,423 Deferred tax asset, net 11,132,552 10,854,702 Goodwill 898,334 898,334 Other assets 226,485 240,683 Total assets $ 247,067,209 $ 244,337,026 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 1,230,039 $ 1,340,337 Accrued expenses and other current liabilities 16,226,824 5,640,110 Deferred IV TPOXX® revenue 10,330,800 10,330,800 Income tax payable 12,687 8,020,366 Total current liabilities 27,800,350 25,331,613 Other liabilities 3,134,232 3,200,650 Total liabilities 30,934,582 28,532,263 Commitments and contingencies Stockholders' equity Common stock ($.0001 par value, 600,000,000 shares authorized, 71,441,083 and 71,404,669, issued and outstanding at March 31, 2025 and December 31, 2024, respectively) 7,144 7,140 Additional paid-in capital 239,371,718 238,635,635 Accumulated deficit (23,246,235 ) (22,838,012 ) Total stockholders' equity 216,132,627 215,804,763 Total liabilities and stockholders' equity $ 247,067,209 $ 244,337,026 SIGA TECHNOLOGIES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME/(LOSS) (UNAUDITED) Three Months Ended March 31, 2025 2024 Revenues Product sales and supportive services $ 5,821,247 $ 23,878,677 Research and development 1,219,568 1,551,178 Total revenues 7,040,815 25,429,855 Operating expenses Cost of sales and supportive services 157,738 3,225,314 Selling, general and administrative 5,675,662 7,875,773 Research and development 3,462,813 3,053,369 Total operating expenses 9,296,213 14,154,456 Operating (loss)/income (2,255,398 ) 11,275,399 Other income, net 1,684,983 1,942,437 (Loss)/Income before income taxes (570,415 ) 13,217,836 Benefit/(Provision) for income taxes 162,192 (2,940,496 ) Net and comprehensive (loss)/income $ (408,223 ) $ 10,277,340 Basic (loss)/income per share $ (0.01 ) $ 0.14 Diluted (loss)/income per share $ (0.01 ) $ 0.14 Weighted average shares outstanding: basic 71,427,527 71,093,653 Weighted average shares outstanding: diluted 71,427,527 71,562,996 Sign in to access your portfolio
