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SIGA Announces New Contract Awarded by U.S. Department of Defense for the Procurement of $9 Million of TPOXX®

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SIGA Technologies (NASDAQ: SIGA) has secured a new $9 million contract with the U.S. Department of Defense for the procurement of TPOXX®, an antiviral medication. This marks the third DOD contract in three years for SIGA. The order primarily consists of oral TPOXX®, with a small amount of intravenous formulation included.

SIGA is also collaborating with the DOD's JPEO-CBRND on developing a Post-exposure Prophylaxis (PEP) indication for oral TPOXX®, supported by a $27 million development contract. With this new award, SIGA now has approximately $154 million in outstanding TPOXX® orders, with over 85% generated in the past three months.

SIGA Technologies (NASDAQ: SIGA) ha ottenuto un nuovo contratto di $9 milioni con il Dipartimento della Difesa degli Stati Uniti per l'acquisto di TPOXX®, un farmaco antivirale. Questo rappresenta il terzo contratto DOD in tre anni per SIGA. L'ordine consiste principalmente in TPOXX® orale, con una piccola quantità di formulazione endovenosa inclusa.

SIGA sta anche collaborando con il JPEO-CBRND del DOD per sviluppare un'indicazione di Profilassi Post-esposizione (PEP) per TPOXX® orale, supportata da un contratto di sviluppo di $27 milioni. Con questo nuovo contratto, SIGA ha ora circa $154 milioni in ordini di TPOXX® in sospeso, di cui oltre l'85% generati negli ultimi tre mesi.

SIGA Technologies (NASDAQ: SIGA) ha obtenido un nuevo contrato de $9 millones con el Departamento de Defensa de EE. UU. para la adquisición de TPOXX®, un medicamento antiviral. Esto marca el tercer contrato del DOD en tres años para SIGA. El pedido consiste principalmente en TPOXX® oral, con una pequeña cantidad de formulación intravenosa incluida.

SIGA también está colaborando con el JPEO-CBRND del DOD en el desarrollo de una indicación de Profilaxis Post-exposición (PEP) para TPOXX® oral, respaldada por un contrato de desarrollo de $27 millones. Con este nuevo contrato, SIGA ahora tiene aproximadamente $154 millones en pedidos pendientes de TPOXX®, con más del 85% generado en los últimos tres meses.

SIGA Technologies (NASDAQ: SIGA)는 미국 국방부와 항바이러스 약물 TPOXX® 구매를 위한 900만 달러 계약을 체결했습니다. 이는 SIGA에게 있어 3년 동안 세 번째 DOD 계약을 의미합니다. 이 주문은 주로 경구 복용 형태의 TPOXX®로 구성되어 있으며, 소량의 정맥 주사 형태도 포함되어 있습니다.

SIGA는 또한 경구 TPOXX®에 대한 노출 후 예방(PEP) 적응증 개발을 위해 DOD의 JPEO-CBRND와 협력하고 있으며, 이는 2700만 달러 개발 계약에 의해 지원됩니다. 이 새로운 계약으로 SIGA는 현재 약 1억 5400만 달러의 TPOXX® 미결 주문을 보유하고 있으며, 이 중 85% 이상이 지난 3개월 동안 발생했습니다.

SIGA Technologies (NASDAQ: SIGA) a obtenu un nouveau contrat de 9 millions de dollars avec le département de la Défense des États-Unis pour l'acquisition de TPOXX®, un médicament antiviral. Cela marque le troisième contrat DOD en trois ans pour SIGA. La commande consiste principalement en TPOXX® oral, avec une petite quantité de formulation intraveineuse incluse.

SIGA collabore également avec le JPEO-CBRND du DOD pour développer une indication de prophylaxie post-exposition (PEP) pour TPOXX® oral, soutenue par un contrat de développement de 27 millions de dollars. Avec cette nouvelle attribution, SIGA dispose désormais d'environ 154 millions de dollars de commandes TPOXX® en attente, dont plus de 85 % ont été générées au cours des trois derniers mois.

SIGA Technologies (NASDAQ: SIGA) hat einen neuen Vertrag über 9 Millionen US-Dollar mit dem US-Verteidigungsministerium zur Beschaffung von TPOXX®, einem antiviralen Medikament, gesichert. Dies ist der dritte DOD-Vertrag innerhalb von drei Jahren für SIGA. Der Auftrag besteht hauptsächlich aus oralem TPOXX®, mit einer kleinen Menge einer intravenösen Formulierung.

SIGA arbeitet auch mit dem JPEO-CBRND des DOD zusammen, um eine Postexpositionsprophylaxe (PEP) für oral TPOXX® zu entwickeln, unterstützt durch einen Entwicklungsvertrag über 27 Millionen US-Dollar. Mit diesem neuen Auftrag hat SIGA nun etwa 154 Millionen US-Dollar an ausstehenden TPOXX®-Bestellungen, von denen über 85% in den letzten drei Monaten generiert wurden.

Positive
  • Secured a new $9 million contract with the U.S. Department of Defense for TPOXX®
  • Third DOD contract awarded in the past three years, indicating consistent demand
  • Ongoing collaboration with DOD for developing Post-exposure Prophylaxis indication
  • Current outstanding TPOXX® orders total approximately $154 million
  • Over 85% of outstanding orders generated within the past three months, showing strong recent demand
Negative
  • None.

Insights

The $9 million contract with the U.S. Department of Defense for TPOXX® procurement is a positive development for SIGA Technologies. This marks the third DOD contract in three years, indicating a consistent demand for their product. The company's total outstanding orders now stand at $154 million, with over 85% generated in the past three months, suggesting strong recent momentum.

The ongoing collaboration with DOD for developing Post-exposure Prophylaxis indication, supported by a $27 million contract, demonstrates potential for future growth. However, investors should note that government contracts can be subject to political and budgetary fluctuations. The diversification of TPOXX® formulations (oral and IV) could provide additional revenue streams and market opportunities.

SIGA's continued success in securing government contracts for TPOXX® underscores the strategic importance of their product in national biodefense. The development of both oral and IV formulations demonstrates SIGA's commitment to meeting diverse medical needs. The pursuit of a Post-exposure Prophylaxis (PEP) indication is particularly noteworthy, as it could significantly expand TPOXX®'s market potential beyond treatment to prevention.

However, investors should be aware that SIGA's heavy reliance on government contracts for a single product line presents both opportunities and risks. While it provides stable revenue, it also exposes the company to potential shifts in government priorities or budget allocations. Diversification of the product pipeline or expansion into international markets could mitigate these risks and drive future growth.

NEW YORK, Aug. 21, 2024 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company and leader in infectious diseases, today announced a new contract with the U.S. Department of Defense (DOD) for the procurement of approximately $9 million of TPOXX® (Contract number: W911SR24C0030). This award is comprised primarily of oral TPOXX®, with a small amount of intravenous (IV) TPOXX®, and represents the third procurement contract award from the DOD over the past three years.

SIGA has been collaborating with the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop the Post-exposure Prophylaxis (PEP) indication for oral TPOXX®, and this work has been supported by a development contract with a value of approximately $27 million (Contract number: MCDC1901-001-2019-400) as well as a Cooperative Research and Development Agreement.

“We are pleased to announce this new contract, continuing our long-term partnership with the Department of Defense. Providing TPOXX® plays a critical role in protecting and supporting our military personnel against orthopoxvirus risks, such as smallpox. This underscores our commitment to ensuring the safety of our troops while also developing innovative treatments that benefit people worldwide as we advance the PEP indication,” said Diem Nguyen, Chief Executive Officer.

Inclusive of this award, SIGA currently has approximately $154 million of outstanding oral and IV TPOXX® orders, of which more than 85% of this amount was generated within the past three months.

Reference to the DOD, JPEO-CBRND, or other agency of the United States does not constitute or imply an endorsement or recommendation by the U.S. government or any agency thereof.

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 filling outstanding orders. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “will”, “project” and similar words and phrases are intended to identify such forward-looking statements.   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 TPOXX for smallpox or additional 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.

Investor and Media Contact:
Suzanne Harnett
sharnett@siga.com


FAQ

What is the value of SIGA's new contract with the U.S. Department of Defense for TPOXX®?

SIGA Technologies has been awarded a new contract worth approximately $9 million by the U.S. Department of Defense for the procurement of TPOXX®.

How many DOD contracts has SIGA (NASDAQ: SIGA) received for TPOXX® in recent years?

This is the third procurement contract award SIGA has received from the U.S. Department of Defense over the past three years for TPOXX®.

What is the total value of SIGA's outstanding TPOXX® orders as of August 2024?

As of August 2024, SIGA Technologies has approximately $154 million of outstanding oral and IV TPOXX® orders.

What percentage of SIGA's current TPOXX® orders were generated recently?

Over 85% of SIGA's current $154 million in outstanding TPOXX® orders were generated within the past three months.

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