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SIGA Technologies Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company that targets the health security market. SIGA specializes in the development of antiviral therapeutics aimed at treating some of the world's most lethal pathogens including smallpox, Ebola, dengue, and Lassa fever. The company's flagship product, TPOXX® (also known as tecovirimat and ST-246®), is an oral and intravenous formulation antiviral drug approved for the treatment of human smallpox disease caused by the variola virus.
TPOXX has received approval from multiple regulatory bodies. In 2018, the U.S. Food and Drug Administration (FDA) approved the oral formulation of TPOXX, followed by approval for the intravenous formulation in 2022. The European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom also approved oral TPOXX in 2022 for treating smallpox, monkeypox, cowpox, and complications arising from vaccinia virus infections post smallpox vaccination.
In recent developments, SIGA has expanded its reach in Europe through a joint procurement mechanism, allowing multiple EU countries to access oral TPOXX. Orders under this mechanism are anticipated to generate around $164 million in 2023, with a substantial portion of deliveries expected within the year. As such, the company projects a pre-tax operating income between $90 million and $100 million for 2023. Additionally, SIGA has recently amended its international promotion agreement with Meridian Medical Technologies, Inc., granting SIGA primary responsibility for promoting oral TPOXX in various territories, including the European Union, thereby enhancing its global reach.
SIGA also maintains a strong relationship with the Biomedical Advanced Research and Development Authority (BARDA) for the procurement and development of both oral and intravenous formulations of TPOXX under Project BioShield. This partnership underscores SIGA's commitment to enhancing global health security through its innovative antiviral treatments.
With a clear focus on health security, SIGA aims to address high-priority biological threats, providing solutions that are crucial in preparing for and mitigating the impact of infectious diseases and potential bioterrorist threats.
SIGA Technologies announced that TEPOXX (tecovirimat) has received regulatory approval in Japan for treating orthopoxviruses, including smallpox, mpox, and cowpox, as well as complications from smallpox vaccination in adults and pediatric patients weighing at least 13 kg. This marks the first approval of an antiviral for orthopoxviruses in Japan.
SIGA has partnered with Japan Biotechno Pharma as its exclusive distributor and has already delivered TEPOXX to Japan's strategic national stockpile. The approval is based on data from 15 clinical trials involving over 800 healthy volunteers, including a pivotal study in Japan with 20 participants. The trials demonstrated no drug-related serious adverse events.
TEPOXX works by inhibiting the VP37 protein found on orthopoxviruses, preventing virus spread from infected cells. The drug is already approved in the U.S. and Canada for smallpox treatment, and in the EU and UK for smallpox, mpox, cowpox, and vaccination complications.
SIGA Technologies announced interim results from the STOMP clinical trial of tecovirimat (TPOXX) for mpox treatment. The study revealed that tecovirimat did not improve time to lesion resolution compared to placebo in adults with mild to moderate clade II mpox. Based on these findings, the study's Data Safety Monitoring Board recommended stopping patient enrollment.
Key points include: approximately 75% of patients received treatment more than five days after symptom onset; tecovirimat maintained its strong safety profile with results comparable to placebo; and the drug's efficacy in severe cases was not assessed in this study. The results align with previous findings suggesting that antivirals are most effective when administered early in infection and show greatest benefit in severe cases.
SIGA Technologies reported financial results for Q3 2024, highlighting $122 million in new orders, including a $112.5 million order for oral TPOXX from BARDA and a $9 million order from the U.S. Department of Defense. Product revenues reached $8.9 million for Q3 and $53.5 million for the first nine months of 2024. The company reported net income of $1.3 million for Q3 and $13.5 million for the nine-month period. With $146 million in outstanding procurement orders, SIGA is positioned for substantial revenue in Q4 2024 and 2025. The company also secured an exclusive license for monoclonal antibodies from Vanderbilt University and made its first TPOXX sale in Africa.
SIGA Technologies (NASDAQ: SIGA) announced it will host a webcast and conference call to provide a business update on November 7, 2024, at 4:30 P.M. ET. CEO Diem Nguyen and CFO Daniel Luckshire will participate in the call. The webcast will be available on the company's website, with dial-in options for domestic (1-800-717-1738) and international callers (1-646-307-1865). A two-week replay will be available via phone and the company website.
SIGA Technologies (NASDAQ: SIGA) has entered into an exclusive license agreement with Vanderbilt University for a portfolio of preclinical fully human monoclonal antibodies (mAbs). These mAbs have potential as treatments for a broad range of orthopoxviruses, including smallpox and mpox. The agreement grants SIGA exclusive rights to develop, manufacture, and commercialize these mAbs globally.
The mAbs, developed by Dr. James Crowe at Vanderbilt University Medical Center, have shown promise in preclinical models and could be used as standalone treatments or in combination with SIGA's TPOXX® franchise. The U.S. Department of Defense is currently funding the development of these mAbs through Phase 1 clinical trials. SIGA aims to leverage its expertise in orthopoxvirus and partnerships with U.S. Government agencies to maximize the impact of these potential new therapies.
SIGA Technologies, Inc. (NASDAQ: SIGA) has announced an agreement to supply TPOXX® (tecovirimat) in Morocco. This marks SIGA's first commercial sale of TPOXX in Africa. The contract was executed in response to a request from Morocco's Ministry of Health to prepare and protect citizens against potential mpox outbreaks.
Tecovirimat is already approved in the U.S., Canada, and the EU, and has been available in Africa through clinical trials and WHO's emergency use access protocol. SIGA's Vice President of International Markets, Victor Gomes, expressed pride in providing access to this antiviral therapy in Morocco and thanked the Ministry of Health for their collaboration in ensuring quick delivery.
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 announced topline results from the PALM 007 clinical trial of tecovirimat for mpox treatment. The study did not meet its primary endpoint of statistically significant improvement in lesion resolution time. However, meaningful improvements were observed in patients treated early (within 7 days of symptom onset) and those with severe disease (100+ skin lesions). Tecovirimat demonstrated a safety profile comparable to placebo. Despite missing the primary endpoint, SIGA remains encouraged by the potential benefits for specific patient groups. The company plans to analyze the data further and continue additional clinical trials to evaluate tecovirimat's efficacy in real-world settings.
SIGA Technologies (NASDAQ: SIGA) reported financial results for Q2 and H1 2024. Key highlights include:
- Q2 product sales of $20.7 million, including $18 million of IV TPOXX sales to the U.S. Government
- H1 product revenues of $44.6 million from diverse TPOXX deliveries
- Q2 net income of $1.8 million ($0.03 per diluted share)
- H1 net income of $12.1 million ($0.17 per diluted share)
- Received a $113 million procurement order for oral TPOXX from the U.S. Government in July
- Expanded international presence with new customers in ASEAN and Asia Pacific regions
- Special cash dividend of $0.60 per share paid in April
SIGA Technologies, Inc. (NASDAQ: SIGA), a commercial-stage pharmaceutical company, has announced a webcast and conference call scheduled for August 1, 2024, at 4:30 P.M. ET. The purpose of this event is to provide a business update following the release of the company's second-quarter 2024 financial results. CEO Diem Nguyen and CFO Daniel Luckshire will be participating in the call.
Investors and interested parties can access the live webcast on SIGA's website or dial in using the provided numbers. A replay of the call will be available for two weeks, and the archived webcast will be accessible in the Investor Relations section of the company's website.
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