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SIGA Technologies Inc. reports developments as a commercial-stage pharmaceutical company focused on infectious-disease countermeasures, with a primary focus on orthopoxviruses. Its recurring updates center on TPOXX (tecovirimat), including oral and IV product sales, deliveries to large institutional customers and international governments, Strategic National Stockpile activity, and procurement contracts.
Company news also covers quarterly and annual results, research and development revenue, BARDA 19C development funding for pediatric and manufacturing activities, regulatory developments for tecovirimat indications, business update calls, and capital actions such as special cash dividends on common stock.
SIGA Technologies has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for oral tecovirimat, previously approved as TPOXX by the FDA. This filing seeks a broader indication to treat smallpox, monkeypox, cowpox, and Vaccinia complications, targeting approval in the second half of 2021. SIGA aims to enhance access to this essential antiviral across Europe, following its collaborative development with the U.S. Government. The U.S. maintains a stockpile of 1.7 million doses of TPOXX to mitigate bioterror threats.
SIGA Technologies (NASDAQ: SIGA) announced the delivery of oral TPOXX® (tecovirimat) to the U.S. Department of Health and Human Services (HHS), valued at approximately $32 million. This delivery marks the initial phase of a contract option worth $101.3 million under the 2018 BARDA Contract. The contract has up to $414 million remaining for future procurement. Dr. Phil Gomez emphasized the importance of preparing for potential biological threats during the ongoing COVID-19 pandemic.
SIGA Technologies, Inc. (SIGA) has received an increase in funding of approximately $23 million from the United States Department of Defense (DoD) to support research for expanding the FDA label of its antiviral drug TPOXX (tecovirimat) for Post-Exposure Prophylaxis (PEP) against smallpox. This potential label expansion is crucial in the event of a smallpox outbreak, as vaccines alone have limitations in effectiveness. TPOXX may be administered over 28 days for PEP, contrasting with the 14-day treatment for active infections. The company aims to enhance early treatment options for individuals at risk.
On June 1, 2020, SIGA Technologies, Inc. (SIGA) announced that its 2020 Annual Meeting of Stockholders will be held virtually on June 16, 2020, at 10:30 a.m. Eastern Time, due to COVID-19 safety concerns. Stockholders as of April 24, 2020, can attend the meeting via a live audio webcast. They must submit their votes in advance, as voting during the meeting will not be permitted. SIGA focuses on health security and is known for TPOXX, a treatment for smallpox. A notice regarding the virtual format has been filed with the SEC.
SIGA Technologies announced the delivery of 2,500 courses of TPOXX® (tecovirimat) to the Canadian Department of National Defence as part of an agreement for up to 15,325 courses valued at $14.3 million. Deliveries are expected to continue pending regulatory approval by Health Canada. Additionally, SIGA plans to deliver $101.3 million of TPOXX to the U.S. Government related to a BARDA contract. The contract could yield up to $414 million in future purchases, underscoring SIGA's role in biodefense and health security.
SIGA Technologies, Inc. (SIGA) reported a Q1 2020 revenue of approximately $2.6 million, resulting in an operating loss of about $4.0 million and a loss per diluted share of $0.11. The company exercised contract options totaling $101.3 million from BARDA for oral TPOXX® deliveries expected by April 2021. SIGA also maintains a strong cash position of $77.4 million. Despite concerns over the COVID-19 pandemic, the company does not anticipate a material adverse effect on its financial condition or annual results.
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