Tecovirimat

NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (Nasdaq: SIGA), a commercial-stage pharmaceutical company, announced today the appointment of Retired United States Army General John “Jack” Keane to its Board of Directors, effective immediately. General Keane, a retired four-star general, completed 37 years of public service in December 2003, culminating with his appointment as acting Chief of Staff and Vice Chief of Staff of the U.S. Army from 1999 to 2003. He is a foreign policy and national security expert who serves as an advisor to presidents, cabinet officials, members of congress, international leaders, CEOs, and business leaders. He also provides nationwide analysis and commentary in speeches, articles, congressional testimony, and through television and radio interviews. General Keane has served as the Chairman of the Institute for the Study of War since 2007 and as President of GSI, LLC, a consulting firm, since 2004. General Keane holds a bachelor’s degree in accounting from Fordham University and a master’s degree in philosophy from Western Kentucky University. He is a graduate of the Army War College and the Army Command and General Staff College. Among his numerous awards, General Keane was the first military leader to be honored with the Ronald Reagan Peace Through Strength Award at the Reagan Library and is a recipient of the Presidential Medal of Freedom. "We are honored to welcome General Keane to our Board of Directors,” said Diem Nguyen, Chief Executive Officer of SIGA Technologies. “His extensive experience, spanning a distinguished military career, as well as a deep understanding of U.S. national security and foreign policy, will add a critical dimension to our team. General Keane’s insights into global security challenges will be invaluable as we strive to expand the reach of our life-saving antiviral, collaborating with the Administration and key government stakeholders to bolster our national biodefense capabilities." "I am delighted to join this dynamic board and contribute to SIGA’s important national security mission,” said General Keane. “Throughout my life in the Army and my work in national security, I’ve seen firsthand how critical preparedness is in protecting our country from evolving threats. SIGA’s commitment to supplying its FDA-approved antiviral TPOXX to the U.S. strategic national stockpile, as well as to international governments, aligns with my strong belief in proactive, strategic readiness. I look forward to helping our partners enhance our biodefense efforts to safeguard our people and our nation." 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 www.siga.com. 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 BARDA elects, in its sole discretion as permitted under the 75A50118C00019 BARDA Contract (the “BARDA Contract”), not to exercise the remaining unexercised option under the BARDA Contract, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) 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, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) 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, (vi) 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, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) 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, (x) 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, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) 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, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (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, 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 http://www.sec.gov. 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.

LOS ANGELES, March 12, 2025 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, recently presented data demonstrating that tecovirimat did not improve mpox resolution. The results from STOMP (Study of Tecovirimat for Mpox, also known as A5418) were shared as the oral abstracts, “Tecovirimat is Safe but not Efficacious in People with Clade II Mpox” and “Host and Disease Factors Were Not Associated with the Resolution of Mpox in Participants Receiving Tecovirimat” at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, California. STOMP stopped enrolling participants in December 2024 after an interim analysis showed that the treatment did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease. “The results from STOMP reinforce the value of randomized clinical trials during outbreaks of infectious diseases, like mpox,” said Past ACTG Chair Judith Currier M.D., M.Sc. “There was considerable hope that tecovirimat would be an effective mpox treatment and it was only through this rigorously designed trial that we were able to conclusively demonstrate that tecovirimat alone did not speed time to resolution of mpox.” STOMP was a phase 3, randomized, placebo-controlled, double-blind trial evaluating the safety and efficacy of tecovirimat for the treatment of mpox. Tecovirimat (SIGA Technologies, Inc.) is approved by the U.S. Food and Drug Administration (FDA) to treat smallpox, but prior to STOMP it was not yet known if it could effectively or safely treat mpox. STOMP was initiated in September 2022 in response to a global outbreak of mpox that was characterized by increased person-to-person transmission. Mpox continues to circulate in the United States and around the world and there are no therapies that have been shown to be effective. STOMP enrolled participants who had had symptoms of mpox for less than 14 days and randomized them to receive either tecovirimat (600 mg) or a placebo twice daily for 14 days. Participants with or at risk for severe disease, pregnant women, and children were enrolled in an open-label arm in which everyone received tecovirimat. Tecovirimat is Safe but Not Efficacious in People with Clade II MpoxToday’s presentation, which was highlighted in a CROI press conference, found that tecovirimat did not reduce the time to clinical resolution of mpox lesions or improve pain control among adults with clade II mpox. There were no safety concerns and no deaths in either arm. STOMP randomized 412 eligible participants to tecovirimat (275) and placebo (137) at 50 sites in seven countries. Among those participants, 24 percent were enrolled remotely, 98 percent were male, 53 percent were White, 11 percent were Black, and 45 percent were Hispanic. 33 percent were living with HIV and 22 percent had received at least one dose of an mpox vaccine. “Importantly, STOMP showed that we can quickly design and execute international clinical trials in the face of an ongoing pandemic,” said Protocol Chair Timothy Wilkin, M.D., M.P.H., University of California San Diego. “It will be necessary, based on today’s results, to pursue alternative treatments for mpox and other orthopoxviruses.” Host and Disease Factors Were Not Associated with the Resolution of Mpox in Participants Receiving Tecovirimat This presentation analyzed a number of host and disease-related factors, including age, HIV status, vaccination status, and duration of symptoms, that might be associated with clinical mpox resolution and when mpox DNA was no longer detectable in skin lesions among the study participants who were enrolled in the open-label arm of STOMP. This analysis did not identify predictors of clinical mpox resolution and researchers suggested further investigation of this topic. While there were trends between younger age and lower levels of mpox DNA with faster clinical resolution, researchers found no significant associations in multivariate modeling (a statistical technique that determines the contributions of a number of factors to a singular outcome) with either clinical resolution or clearance of mpox DNA. “In the setting of public health emergencies, clinical trials like STOMP play an important role in not only evaluating treatments for safety and efficacy, but also potentially identifying key risk factors associated with worse outcomes,” said STOMP Vice Chair and Lead Author William Fischer, M.D., University of North Carolina. “The data presented here represent an important step forward in the evaluation of tecovirimat and in our understanding of mpox.” STOMP was led by Dr. Wilkin, Dr. Fischer, Jason Zucker, M.D., Columbia University (Vice Chair), and Dr. Currier. ACTG is led by Joseph J. Eron, M.D., UNC (ACTG Chair) and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice Chair). It is sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID, which also funds ACTG) under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu