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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 announced that Phil Gomez, CEO since 2016, intends to retire in 2023. The Board of Directors is actively searching for a new CEO, with Gomez remaining in his role until a successor is appointed to ensure a smooth transition. Dr. Gomez's leadership has focused on strengthening operations and addressing global health crises, such as the monkeypox outbreak. His vision includes positioning SIGA for new opportunities moving forward. SIGA, a pharmaceutical company specializing in health security, is known for its antiviral drug TPOXX, approved for treating smallpox by both the FDA and EMA.
SIGA Technologies reported financial results for Q3 2022, noting approximately $72.2 million in total revenues, compared to $42.9 million in Q3 2021. The net income for Q3 2022 was $33.0 million, or $0.45 per share, a significant improvement from a loss in the previous year. The company secured $61 million in international orders, expanding its customer base to 13 clients. Clinical trials for TPOXX to treat monkeypox are ongoing, backed by funding from NIAID and international governments. A conference call will provide further updates today.
SIGA Technologies, Inc. (SIGA) will host a webcast and conference call on November 3, 2022, at 4:30 P.M. ET to provide a business update. Presenters include CEO Dr. Phil Gomez and CFO Daniel Luckshire. The call can be accessed via phone or through a live webcast on SIGA's website. SIGA specializes in health security, focusing on biodefense and antiviral therapies, notably TPOXX®, an approved treatment for smallpox. The company has seen regulatory approvals for its products but faces various risks related to contract performance and market conditions.
SIGA Technologies, Inc. (SIGA) is advancing its clinical trials for TPOXX, targeting monkeypox treatment across the U.S., U.K., and Democratic Republic of Congo. These randomized, placebo-controlled trials aim to confirm the safety and efficacy of TPOXX, with over 500 participants in the U.S. and additional trials in the U.K. and DRC. Pending positive results, SIGA plans to seek regulatory approval for TPOXX's broader use. The drug is already approved for smallpox and has received significant international orders totaling approximately $76 million.
SIGA Technologies announced on September 29, 2022, that the U.S. Department of Defense awarded them a contract to procure up to $10.7 million of oral TPOXX (Contract number: W911SR22C0051), with $5.1 million targeted for delivery in 2022. This follows a previous contract for $7.4 million (W911SR22C0032). SIGA continues to collaborate with the DoD on the development of Post Exposure Prophylaxis (PEP) for TPOXX, supported by a $26 million contract. TPOXX is approved for treating smallpox and has received further approvals in Canada, Europe, and the UK for treatments related to monkeypox.
SIGA Technologies, Inc. (SIGA) announced approximately $16 million in international procurement orders for oral TPOXX® (tecovirimat) in August and early September 2022. This includes a $10 million order from the European Commission for emergency stockpiling related to the monkeypox outbreak, funded by HERA. Additionally, two orders totaling $6 million were received from the Asia Pacific region. SIGA expects to deliver at least $65 million of orders in 2022, contributing to addressing the ongoing monkeypox crisis.
SIGA Technologies, Inc. (SIGA) announced the exercise of procurement options with the U.S. Department of Health and Human Services for intravenous (IV) TPOXX treatment courses valued at approximately $26 million. This marks the first procurement exercise under the 19C contract. Product deliveries are targeted for 2023. CEO Phil Gomez emphasized the importance of IV TPOXX for those unable to swallow and the ongoing cooperation with the U.S. government for further procurements. The procurement also includes manufacturing bulk drug substance for IV TPOXX.
SIGA Technologies reported a strong second quarter with approximately $9 million in product sales, including the first sale of oral TPOXX to the U.S. Department of Defense and around $5 million in international sales. Year-to-date, SIGA has secured $60 million in international orders from ten jurisdictions, highlighting a growing demand for its products due to health security concerns. The company also paid a special dividend of $0.45 per share and repurchased shares worth $3.6 million. The reported revenues for Q2 2022 were $16.7 million, significantly up from $8.7 million in Q2 2021.
SIGA Technologies, Inc. (SIGA) has announced a business update conference call scheduled for August 4, 2022, at 4:30 P.M. ET. The call will feature key management including CEO Dr. Phil Gomez and CFO Daniel Luckshire. Participants can join via phone or access a live webcast on SIGA's website. SIGA focuses on health security, with its lead product TPOXX® approved for smallpox treatment and recently endorsed by the European Medicines Agency for additional uses. The company is under contract with BARDA for further development of TPOXX.
SIGA Technologies, Inc. (SIGA) announced a collaboration with KaliVir Immunotherapeutics to provide TPOXX® for their oncolytic vaccinia immunotherapy program. TPOXX, approved by the FDA for smallpox treatment, will support KaliVir's innovative virus platform designed for cancer therapy. Dr. Phil Gomez, SIGA's CEO, expressed enthusiasm for the partnership, emphasizing TPOXX's potential to enhance immunotherapeutic outcomes. KaliVir aims to pair oncolytic therapies with antiviral agents to improve treatment efficacy. This collaboration marks a significant step in advancing cancer immunotherapies.