SIGA Technologies Inc.

Welcome to the SIGA business update call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call. For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K for the year ended December 31, 2024, and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Zem Win, Chief Executive Officer of SIGA, ZEM.

Good afternoon, everyone, and thank you for joining today's call and a review of our business results for the second quarter of 2025. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update on our company. After the update, we'll be happy to answer your questions. At the midpoint of 2025, I'm pleased to share that Seca continues to make steady progress as we advance our strategic initiatives. The evolving global landscape calls for agility and focus, and our team remains deeply committed to strengthening our role in the global health security and delivering enduring value to our shareholders. In the second quarter of this year, we achieved two important positive results, significant product revenues and a significant increase to the development funding under the BARDA 19C contract. In the quarter, product revenues totaled approximately 79 million, comprising of 53 million of oral TPOCs and 26 million of IV TPOCs delivered to the U.S. Strategic National Stockpile, or SNS. These deliveries fulfilled the 70 million of orders outstanding at year end 2024. At the end of the second quarter, there were approximately 26 million of remaining outstanding orders from the U.S. government. This outstanding balance relates to the March 2025 U.S. government exercise of an option under the 19 contract to procure an additional 26 million of IV TPOCs. We note this option exercise during our last investor call and expect to deliver this order in 2026. Also during this quarter, we received commitments from the U.S. government to provide 27 million of incremental development funding. This increase in development funding occurred in two buckets. In April, the government modified the 19C contract by adding $14 million in funding to support manufacturing activities, which we expect to occur over the next two to three years. Most recently in June, the government committed to an additional $13 million of development funding to further support the pediatric program. We believe these recent actions surrounding IV TPOCs, in procurement and additional manufacturing support, and with a respect to the pediatric program, reflect the continued importance of maintaining a full complement of TPOX formulations in the stockpile as treatment options for smallpox. Maintaining both oral and IV formulations ensures the flexibility in response strategies as the IV formulation is an important alternative for those who are unable to swallow capsules. Given the severity of smallpox, We view these investments as a strong signal of the United States government's continued commitment to the national health preparedness and recognition of the critical role antivirals play. We're proud to support these efforts. Looking ahead beyond our current 19C contract, we continue to engage constructively with the U.S. government. Our goal remains clear to establish a new comprehensive long-term agreement that reflects the value of TPOCs. Such a framework will not only strengthen the nation's bioterrorism preparedness, but also advance our collective commitment to global health security and public health resilience. As I've highlighted during prior calls, antivirals play a critical role alongside vaccines, treating individuals who are unvaccinated or who may not benefit from vaccination. With rising threats from emerging infectious diseases and bioterrorism, this dual approach is increasingly essential. In a comprehensive preparedness plan, strategic stockpiling of medical countermeasures is critical to ensuring a rapid response in crisis. Importantly, given our longstanding partnership with the U.S. government and our government's demonstrated commitment to proactive biodefense, we remain prepared to respond to an RFP when issued and to complete a procurement agreement in an efficient manner. Internationally, we have been engaging with stakeholders on critical role by defense in shaping resilient health security frameworks. Strategic stockpiling supported by multi-year funding dedicated to crisis preparedness is essential given evolving security considerations. Our aim is to help ensure that various regions of the world are not caught unprepared if smallpox outbreak becomes an unfortunate reality. Regarding international markets, I'd like to discuss a regulatory development in Europe. At the end of July, the EMA's Committee of Medicinal Products for Human Use, or CHMP, commenced a referral procedure for ticovirumab. The CHMP raised questions about the product's efficacy in treating MPOX following a review of the data from the recent MPOX clinical trials, including POM007 and STOMP. As part of the referral procedure, the CHMP has provided a detailed set of questions largely focused on the MPOCS trials and will evaluate all non-clinical and clinical data to determine if the product maintains a positive benefit-risk ratio for its approved indications. Our priority right now is to provide thorough science-based responses to the agency's questions and fully support the referral procedure. As a reminder, Ticovirumab was developed as a smallpox treatment with a goal of reducing mortality and is backed by a robust and comprehensive data package. It has been studied extensively and has demonstrated a strong safety profile in humans. In preclinical trials, Ticovirumab significantly reduced mortality and viral load across four pivotal studies in non-human primates and two in rabbits, each of which it is important to note was designed to replicate smallpox in humans. It remains the only antiviral approved in the EU for smallpox treatment, and it stands out for its strong safety profile. Safety has been demonstrated in about 10,000 tigivirumab recipients across more than 20 clinical trials, including normal healthy volunteers and patients with mpox in open-label or double-blinded placebo-controlled studies. Should there ever be a smallpox outbreak, we believe ticavirumab would serve as a critical countermeasure for mass distribution given its strong safety profile. Turning to our late-stage pipeline, we continue to advance TPoC's post-exposure prophylaxis program for smallpox, or PEP. Collaboration with the CDC and consultation with the FDA remains active as the CDC continues to move towards completing the required analysis of the samples collected to support the study's immunogenicity objective. The FDA has remained closely engaged with us on this program, offering real-time guidance that we believe has strengthened our regulatory plan. The CDC continues to expect to complete their work during the fourth quarter. As such, we're targeting an FDA submission for the PEP indication in 2026. Also in our pipeline, our pediatric program continues to move forward in partnership with the Biomedical Advanced Research and Development Authority, or BARDA, within the U.S. Department of Health and Human Services under the Administration of Strategic Preparedness and Response, or ASPR. This initiative is designed to address an important and met need, providing a treatment option for children too small for the current oral formulation of TPOX. Clinical trial material has been manufactured, and we remain on track to submit an IND in the second half of this year, with a trial targeted to begin thereafter. As we look toward the second half of the year, our focus remains clear, sustaining a strong financial foundation and executing our strategic priorities with discipline. We continue to concentrate on the core areas that we have consistently delivered results and positioned us for durable success. First, continuing our partnership with the U.S. government, Second, advancing regulatory approvals of TPOCs and new indications. Third, cultivating strategic partnerships to expand global access to TPOCs. And fourth, leveraging our capabilities to move into complementary therapeutic areas. In closing, we believe CEGA remains well equipped to continue its progress over time, building on its long history of public and private successes with a focused strategy, financial discipline, differentiate a TPOCs franchise, and a proven track record. We're moving forward with purpose, staying true to our role in supporting global preparedness and driving meaningful shareholder returns. With that, I'll turn it over to Dan to review the financial results in more detail. Dan?

Thanks, Em. As noted earlier in the call, FIGA's product sales for the three months ended June 30th, 2025 are $79 million. Product sales for the quarter comprised $53 million of oral TPOC sales and $26 million of IV TPOC sales to the U.S. government under the 19C BARDA contract. For the six months ended June 30, 2025, product sales are $85 million. In addition to product sales, the company has research and development revenues of approximately $2 million and $3 million for the three and six months ended June 30th, 2025, respectively. As a supplemental note, there are $26 million of remaining outstanding orders as of June 30th. This amount reflects the $26 million IV TPOX order received in the first quarter of this year under the 19C contract, which is targeted for delivery in 2026. Pre-tax operating income for the quarter which excludes interest income and taxes, is approximately $46 million. For the six months ended June 30th, 2025, pre-tax operating income is approximately $43 million. Net income for the quarter, as well as the six months ended June 30th, 2025, is approximately $35 million. In turn, fully diluted income per share for the three and six months ended June 30th, is $0.49 per share. The company continues to maintain a strong balance sheet. At June 30, 2025, the company had a cash balance of approximately $182 million and no debt. This concludes the financial update. At this point, I will turn the call back to Zen.