Tecovirimat

December 10, 2024 -- The antiviral drug tecovirimat 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, according to an interim data analysis from the international clinical trial called the Study of Tecovirimat for Mpox (STOMP). There were no safety concerns associated with tecovirimat. Considering these definitive findings, the study’s Data Safety and Monitoring Board (DSMB) recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. As the study sponsor, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) accepted the DSMB’s recommendation. Given the lack of an efficacy signal, NIAID also closed enrollment into an open-label study arm for participants with or at elevated risk of severe disease that was not designed to estimate the drug’s efficacy. “The initial STOMP findings provide valuable insight to inform clade II mpox medical countermeasures and underscore the critical importance of conducting well-designed randomized clinical trials during infectious disease outbreaks,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “Before 2022, no treatment candidate had been studied in people with mpox, and this trial is a critical step in our systematic evaluation of existing antivirals like tecovirimat while pursuing novel antivirals and antibody-based mpox therapeutics.” Mpox is caused by a virus that spreads mainly through close contact. Two types of the virus have been identified, referred to as clades I and II, historically present in Central and West Africa, respectively. A clade II subtype virus caused a global mpox outbreak in 2022 and the virus continues to circulate at low levels. In 2024, a clade I outbreak in Central and East African countries was declared a public health emergency of international concern by the World Health Organization. Travel-related cases of clade I mpox have been reported internationally and the first reported case in the United States was diagnosed on November 15. In the United States, the risk of clade I mpox to the public remains low. People with significantly compromised immune systems or certain preexisting skin conditions, children, and individuals who are pregnant have an elevated risk of developing severe mpox. Tecovirimat, also known as TPOXX, was initially approved by the Food and Drug Administration (FDA) to treat smallpox—a virus closely related to, but far more serious than, the virus that causes mpox—but the drug’s safety and efficacy as an mpox treatment have not been established prior to this year. The STOMP study began in September 2022 as part of the U.S. whole-of-government response to the clade II mpox outbreak. The randomized international efficacy study enrolled participants who had been ill with mpox for less than 14 days in Argentina, Brazil, Japan, Mexico, Peru, Thailand and the United States, including Puerto Rico. Participants were randomized at a two-to-one ratio to receive tecovirimat or a placebo. Randomized participants and investigators were blinded, meaning they did not know who received tecovirimat or placebo. Children, pregnant people, and other participants with severe disease, certain skin conditions, or substantially suppressed immune systems were assigned to an open-label study arm, meaning they all received tecovirimat instead of being randomized. The STOMP study assessed all participants’ safety and, in randomized arms, evaluated whether a 14-day course of tecovirimat reduced the time to clinical resolution of visible mpox lesions and improved other outcome measures like pain, compared to a placebo. A planned interim analysis at 75% of the study’s target enrollment showed there was no difference in the time to lesion resolution between participants treated with tecovirimat compared with those who received a placebo. Pain decreased similarly between participants treated with tecovirimat and those who received a placebo. At the DSMB’s request, an additional assessment was performed and showed that there was a less than 1% chance that the study would show tecovirimat to be effective if it were to complete enrollment and follow-up, based on the study design and available data. At the time of analysis, reported adverse events were low and comparable between tecovirimat and placebo. By design, the open-label study arm did not assign participants to receive a placebo, so STOMP will not draw conclusions about the efficacy of tecovirimat in participants with, or at elevated risk for, severe clade II mpox. Further analyses of the study data are ongoing. Study participants are being notified of the findings and study clinicians will make individual clinical care plans with participants based on their disease severity and symptoms. The Centers for Disease Control and Prevention (CDC) holds an expanded access investigational new drug (EA-IND) protocol for mpox treatment outside of research settings. Eligible persons include those with severe immunocompromise, including people with advanced HIV, for whom the role of tecovirimat treatment has not been fully established through a clinical trial. Information on the tecovirimat EA-IND is on the CDC Web site. “STOMP was a banner study for its speed of startup, inclusiveness, and collaboration across governments and public health authorities” said study chair Timothy Wilkin, M.D., M.P.H., chief of the Division of Infectious Diseases and Global Public Health at the University of California, San Diego. “This study may serve as a model for outbreak response, delivering essential scientific evidence while also enabling equitable treatment access.” The STOMP findings are consistent with results reported earlier this year from a NIAID-cosponsored randomized controlled trial of tecovirimat among children and adults with clade I mpox in the Democratic Republic of the Congo. The NIAID-sponsored study was implemented by the NIH-funded ACTG, a global clinical trials network focused on HIV and other infectious diseases. SIGA Technologies, Inc., based in New York, provided tecovirimat for the study. Throughout the study, NIAID and STOMP investigators collaborated closely with the CDC, FDA, other study country health authorities, teams conducting other studies of tecovirimat, and additional key partners in the mpox response. These consultations allowed research partners to arrive at efficient answers to scientific questions, balance evidence needs with compassionate use considerations, and to avail up-to-date information for clinicians treating clade II mpox globally. An additional study, UNITY, sponsored by ANRS Emerging Infectious Disease, is evaluating tecovirimat with a similar study design to STOMP in Argentina, Brazil and Switzerland. More information about the UNITY study can also be found on ClinicalTrials.gov using the identifier NCT05597735. NIAID is supporting research to address evidence gaps on medical countermeasures for mpox and other health threats. These efforts include the Research and Development of Vaccines and Monoclonal Antibodies for Pandemic Preparedness Network, the Antiviral Program for Pandemics, and the Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern, which collectively conduct discovery, basic and translational research to develop safe and effective vaccines, monoclonal antibodies, and antiviral medicines against virus families of pandemic potential. For more information about STOMP, please visit ClinicalTrials.gov using the identifier NCT05534984. NIH is grateful to the research sites and volunteers who participate in studies to improve the mpox response. Learn more about the NIAID mpox research agenda. NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov. Source: NIH Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Product Revenues for the Three and Nine months Ended September 30, 2024 were $9 million and $53 million, respectivelyReceived $122 Million of Procurement Orders from the U.S. Government in the Third QuarterCorporate Update Conference Call Today at 4:30 PM ET NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three and nine months ended September 30, 2024. “Building on strong momentum, SIGA received $122 million in orders during the third quarter, including a significant $112.5 million order for oral TPOXX under the 19C BARDA contract and a $9 million order for oral TPOXX from the U.S. Department of Defense,” said Diem Nguyen, Chief Executive Officer. “As of September 30, 2024, the Company had approximately $146 million of outstanding procurement orders, positioning the Company for substantial revenue in the fourth quarter and 2025. Deliveries related to the $112.5 million order began in late September and continued into October. We remain committed to diversifying and expanding our revenue base, enhancing shareholder value, advancing our development programs, and continuing our public health mission, while preparing to negotiate the next contract with the U.S. Government.”Summary Financial Results ($ in millions, exceptper share amounts)Three MonthsEnded September 30 Nine MonthsEnded September 30 2024 2023 2024 2023 Product sales(1)$8.9 $8.0 $53.5 $14.9 Total revenues$10.0 $9.2 $57.3 $23.4 Operating income (loss)(2)$0.5 ($1.3) $12.9 ($8.1)Income (loss) before income taxes(2)$1.9 ($0.4) $17.5 ($5.1)Net income (loss)$1.3 ($0.4) $13.5 ($4.2)Diluted income (loss) per share$0.02 ($0.01) $0.19 ($0.06) (1) Includes supportive services related to product sales. (2) Operating income (loss) excludes, and income (loss) before income taxes includes other income. Both line items exclude the impact of income taxes. Recent Developments: In October 2024, the Company announced that it obtained an exclusive license to a portfolio of preclinical fully human monoclonal antibodies (mAbs) from Vanderbilt University that have the potential to treatment a broad range of orthopoxviruses, including smallpox and mpox. Under the agreement, SIGA has exclusive rights to develop, manufacture, and commercialize these mAbs globally. The U.S. Department of Defense is currently funding the development of these mAbs as potential orthopoxvirus treatments through Phase 1 clinical trials under a contract awarded to a contract manufacturing organization with proven biologics development and manufacturing expertise.In October 2024, the Company announced its first sale of TPOXX (tecovirimat) in Africa, made in response to a request from the Ministry of Health in Morocco. This milestone sale occurred during the third quarter.In August 2024, the Company received a procurement contract and related order from the U.S. Department of Defense for approximately $9 million of oral TPOXX, as well as a small amount of IV TPOXX.In August 2024, the Company reported that the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from a preliminary analysis of the PALM 007 (Tecovirimat for Treatment of Monkeypox Virus) clinical trial (NCT05559099). NIAID reported that the study did not meet its primary endpoint of a statistically significant improvement in time to lesion resolution within 28 days post-randomization for patients in the Democratic Republic of the Congo with mpox who were administered tecovirimat versus placebo. Improvement was observed, however, in patients receiving tecovirimat whose symptoms began seven days or fewer before randomization and in those with severe or grave disease, defined by the World Health Organization as having 100 or more skin lesions. The Company believes these data are consistent to tecovirimat’s mechanism of action and support further trials to assess its potential benefit in post exposure prophylactic settings, or in patients who present for medical care soon after symptoms, and in those with the most severe disease. In July 2024, the Company received a procurement order for $112.5 million of oral TPOXX from the U.S. Government under the 19C BARDA contract, for delivery to the U.S. Strategic National Stockpile (SNS). Capital Management Activity: On April 11, 2024, a special cash dividend of $0.60 per share was paid, an increase of $0.15 per share from last year’s special cash dividend. This dividend was declared on March 12, 2024. Conference Call and Webcast SIGA will host a conference call and webcast to provide a business update today, Thursday, November 7, 2024, 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 www.siga.com 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: 1146096. 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 and the UK 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 including with respect to securing new contracts and the timing of delivery of ordered oral TPOXX courses. 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, (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, and (xvii) risks associated with responding to an mpox outbreak, 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, 2023 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. Contacts:Suzanne Harnettsharnett@siga.com and InvestorsMediaJennifer Drew-Bear, Edison GroupJdrew-bear@edisongroup.comHolly Stevens, Berry & Companyhstevens@berrypr.com SIGA TECHNOLOGIES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)As of September 30, 2024 December 31, 2023 ASSETS Current assets Cash and cash equivalents $99,269,756 $150,145,844 Accounts receivable 12,089,010 21,130,951 Inventory 62,024,473 64,218,337 Prepaid expenses and other current assets 7,302,979 3,496,028 Total current assets 180,686,218 238,991,160 Property, plant and equipment, net 1,411,315 1,331,708 Deferred tax asset, net 12,104,765 11,048,118 Goodwill 898,334 898,334 Other assets 253,605 2,083,535 Total assets $195,354,237 $254,352,855 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $1,260,762 $1,456,316 Accrued expenses and other current liabilities 7,184,514 10,181,810 Deferred IV TPOXX® revenue 13,729,440 20,788,720 Income tax payable 127,815 21,690,899 Total current liabilities 22,302,531 54,117,745 Other liabilities 3,609,572 3,376,203 Total liabilities 25,912,103 57,493,948 Commitments and contingencies Stockholders’ equity Common stock ($.0001 par value, 600,000,000 shares authorized, 71,369,274 and 71,091,616, issued and outstanding at September 30, 2024 and December 31, 2023, respectively) 7,137 7,109 Additional paid-in capital 238,033,324 235,795,420 Accumulated deficit (68,598,327) (38,943,622)Total stockholders’ equity 169,442,134 196,858,907 Total liabilities and stockholders’ equity $195,354,237 $254,352,855 SIGA TECHNOLOGIES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME/(LOSS) (UNAUDITED) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Revenues Product sales and supportive services $8,942,875 $7,958,289 $53,496,869 $14,924,058 Research and development 1,066,906 1,276,882 3,753,658 8,512,303 Total revenues 10,009,781 9,235,171 57,250,527 23,436,361 Operating expenses Cost of sales and supportive services 1,620,510 896,537 17,157,508 3,021,145 Selling, general and administrative 4,822,591 5,999,761 18,228,786 14,660,828 Research and development 3,024,593 3,648,117 8,966,905 13,810,307 Total operating expenses 9,467,694 10,544,415 44,353,199 31,492,280 Operating income/(loss) 542,087 (1,309,244) 12,897,328 (8,055,919)Other income, net 1,330,505 883,148 4,590,935 2,964,482 Income/(Loss) before income taxes 1,872,592 (426,096) 17,488,263 (5,091,437)(Provision)/Benefit for income taxes (528,647) 33,030 (4,034,362) 904,638 Net and comprehensive income/(loss) $1,343,945 $(393,066) $13,453,901 $(4,186,799)Basic income/(loss) per share $0.02 $(0.01) $0.19 $(0.06)Diluted income/(loss) per share $0.02 $(0.01) $0.19 $(0.06)Weighted average shares outstanding: basic 71,368,585 71,084,735 71,191,019 71,453,397 Weighted average shares outstanding: diluted 71,766,503 71,084,735 71,853,341 71,453,397