Preliminary analysis shows the study did not reach statistical significance on its primary endpoint of tecovirimat being superior to placebo in lesion resolution for all patients Results suggest tecovirimat provides clinical benefit vs. placebo in two important patient populations: those treated early and those with severe disease Results affirm tecovirimat's strong safety profile Multiple additional clinical trials evaluating tecovirimat for mpox continue NEW YORK, Aug. 15, 2024 (GLOBE NEWSWIRE) -- The Nat ...

TPOXX® Deliveries and Contracts - The company has delivered approximately 35,700 courses of oral TPOXX® to the Strategic Stockpile, receiving $11.1 million in payments[77] - The 19C BARDA Contract includes potential payments up to approximately $602.5 million, with $519.6 million in exercised options and $31.2 million in unexercised options as of July 18, 2024[76][79] - The company has cumulatively delivered $337.7 million worth of oral TPOXX® to the Strategic Stockpile as of June 30, 2024[78] - The company fulfilled a $5.1 million firm commitment under DoD Contract 2 in March 2023 and delivered an additional $5.5 million of oral TPOXX® in Q4 2023[84] TPOXX® Sales and Revenue - International sales of oral TPOXX® totaled $3.0 million and $11.0 million for the three and six months ended June 30, 2024, respectively, across 11 countries[85] - Revenues from product sales and supportive services for the three months ended June 30, 2024 were $20.7 million, including $17.6 million from IV TPOXX® sales to the U.S. Government and $3.1 million from oral TPOXX® international sales[93] - Revenues from product sales and supportive services for the six months ended June 30, 2024 were $44.6 million, including $17.6 million from IV TPOXX® and $14.7 million from oral TPOXX® sales to the U.S. Government, and $11.0 million from international sales[98] TPOXX® Research and Development - The company is targeting a Supplemental NDA filing for smallpox post-exposure prophylaxis (PEP) indication for oral TPOXX® within the next twelve months[73] - Four randomized, placebo-controlled clinical trials for TPOXX® as an mpox treatment are active as of June 30, 2024, with one trial completed and three still enrolling patients[74] - The company’s partner in Japan, Japan Biotechno Pharma, filed a new drug application for oral TPOXX® for smallpox, mpox, cowpox, and vaccinia complications on April 11, 2024[75] Financial Performance and Expenses - Revenues from research and development activities for the three months ended June 30, 2024 decreased by $3.5 million to $1.1 million, primarily due to the completion of billable activities under the PEP Label Expansion R&D Contract[94] - Cost of sales and supportive services for the three months ended June 30, 2024 were $12.3 million, associated with the manufacture and delivery of IV and oral TPOXX® to the U.S. Government and international countries[95] - Selling, general and administrative expenses for the three months ended June 30, 2024 increased by $1.1 million to $5.5 million, reflecting higher promotion fees and compensation expenses[96] - Research and development expenses for the three months ended June 30, 2024 decreased by $2.2 million to $2.9 million, primarily due to lower vendor-related expenses under the PEP Label Expansion R&D Contract[96] - Revenues from research and development activities for the six months ended June 30, 2024 decreased by $4.5 million to $2.7 million, primarily due to the completion of billable activities under the PEP Label Expansion R&D Contract[99] - Cost of sales and supportive services for the six months ended June 30, 2024 were $15.5 million, associated with the manufacture and delivery of IV and oral TPOXX® to the U.S. Government and international countries[100] - Selling, general and administrative expenses for the six months ended June 30, 2024 increased by $4.7 million to $13.4 million, reflecting higher international promotion fees and compensation expenses[101] Financial Position and Controls - As of June 30, 2024, the company had $106.9 million in cash and cash equivalents, compared to $150.1 million at December 31, 2023[105] - SIGA's disclosure controls and procedures were deemed effective as of June 30, 2024[113] - No material changes in SIGA's internal control over financial reporting occurred during the quarter ended June 30, 2024[114] Risks and Legal Matters - SIGA's forward-looking statements include risks related to the BARDA Contract, potential delays in product delivery, and uncertainties in the international biodefense market[111] - SIGA may face legal proceedings, but believes current matters will not have a material adverse effect on its business[116] Investment Strategy - SIGA's investment portfolio is conservative, focusing on capital preservation and avoiding derivative financial instruments[112] International Agreements - The International Promotion Agreement with Meridian provides a high single-digit percentage fee to Meridian for sales in specified territories, effective until May 31, 2026[86] Gross Margins - The company estimates gross margins for IV TPOXX® sales under the 19C BARDA Contract to be less than 40% if remaining IV FDP options are exercised[81]

Group 1 - SIGA Technologies, Inc. will host a webcast and conference call for a business update on August 1, 2024, at 4:30 P.M. ET, featuring CEO Diem Nguyen and CFO Daniel Luckshire [1] - The call will be accessible via the company's website and through specific dial-in numbers for domestic and international participants [2] - A replay of the call will be available for two weeks, along with an archived webcast on the company's website [3] Group 2 - SIGA is a commercial-stage pharmaceutical company focused on developing innovative medicines for infectious diseases, particularly orthopoxviruses [4] - The company's flagship product, TPOXX® (tecovirimat), is approved in the U.S. and Canada for smallpox treatment and authorized in Europe and the UK for smallpox, mpox, cowpox, and vaccinia complications [4]

The most recent trading session ended with Siga Technologies Inc. (SIGA) standing at $9.72, reflecting a +0.83% shift from the previouse trading day's closing. The stock exceeded the S&P 500, which registered a loss of 2.32% for the day. Elsewhere, the Dow lost 1.25%, while the tech-heavy Nasdaq lost 3.64%. The investment community will be closely monitoring the performance of Siga Technologies Inc. in its forthcoming earnings report. Investors should also take note of any recent adjustments to analyst esti ...

Core Points - SIGA Technologies, Inc. announced a procurement option exercised by the U.S. Department of Health and Human Services for approximately $113 million of oral TPOXX® treatment courses [1][5] - This order is part of ongoing efforts to enhance orthopoxvirus preparedness and ensure public health against various threats [5] Company Overview - SIGA is a commercial-stage pharmaceutical company focused on developing innovative medicines for infectious diseases, particularly orthopoxviruses [6] - The company's flagship product, TPOXX® (tecovirimat), is approved in the U.S. and Canada for smallpox treatment and authorized in Europe and the UK for smallpox, mpox, cowpox, and vaccinia complications [6]

The most recent trading session ended with Siga Technologies Inc. (SIGA) standing at $9.06, reflecting a +0.55% shift from the previouse trading day's closing. The stock's performance was ahead of the S&P 500's daily loss of 0.78%. Meanwhile, the Dow lost 1.29%, and the Nasdaq, a tech-heavy index, lost 0.7%. Prior to today's trading, shares of the company had gained 42.56% over the past month. This has outpaced the Medical sector's gain of 2.23% and the S&P 500's gain of 2.14% in that time. The investment c ...

The most recent trading session ended with Siga Technologies Inc. (SIGA) standing at $8.69, reflecting a +1.88% shift from the previouse trading day's closing. The stock exceeded the S&P 500, which registered a loss of 0.88% for the day. On the other hand, the Dow registered a gain of 0.08%, and the technology-centric Nasdaq decreased by 1.95%. Investors will be eagerly watching for the performance of Siga Technologies Inc. in its upcoming earnings disclosure. It is also important to note the recent changes ...

Prior to today's trading, shares of the company had gained 0.78% over the past month. This has outpaced the Medical sector's loss of 0.44% and lagged the S&P 500's gain of 4.08% in that time. Regarding the entire year, the Zacks Consensus Estimates forecast earnings of $1.18 per share and revenue of $177.56 million, indicating changes of +24.21% and +26.9%, respectively, compared to the previous year. Based on our research, we believe these estimate revisions are directly related to near-team stock moves. T ...

A spokesperson from the Ministry of Health, Brunei Darussalam said, "We are pleased to support the ASEANwide effort to prepare for and respond to public health events. Ensuring adequate supply and access to countermeasures is a vital part of preparedness and this initiative by the region strengthens our collective health security against the Mpox threat." ASEAN, established in August 1967, is comprised of Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand, a ...

Company Overview - SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on health security, including countermeasures for biological threats and therapies for infectious diseases [4] - The company's lead product is TPOXX (tecovirimat), an antiviral drug for treating smallpox [4] Recent Developments - SIGA announced an agreement to expand access to TPOXX for ASEAN member states, coordinated with Meridian Medical Technologies [1][2] - The agreement reflects the use of ASEAN funds to support public health preparedness against potential health events, particularly the Mpox threat [2] Strategic Importance - The ASEAN region, with a population exceeding 600 million and a GDP of $3.6 trillion, represents a significant market for SIGA [2] - This contract establishes a footprint in a densely populated area and lays the groundwork for future activities in Asia [2] Product Information - TPOXX is a novel small-molecule drug approved by the FDA for smallpox treatment in 2018, with an intravenous formulation approved in 2022 [5] - The drug has also received approvals from the European Medicines Agency and the UK's Medicines and Healthcare Products Regulatory Agency for multiple indications, including Mpox and cowpox [5] Market Context - Orthopoxviruses, including smallpox and Mpox, pose a risk to global health security, necessitating effective antiviral solutions [6][7] - Recent Mpox outbreaks in various regions highlight the importance of preparedness and response strategies [6]