5/7/2026

speaker
Operator
Conference Operator

Thank you. . . . . . . ¶¶

speaker
Operator
Conference Operator

Welcome to the CEGA Business Update Call. Before we turn the call over to CEGA 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. CEGA does not undertake any obligation to update publicly. any forward-looking statement to reflect events or changes, 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, 2025, and its subsequent reports on Form 10-Q and Form 8-K. With that, I will turn the call over to Zem Nguyen, Chief Executive Officer of SIGA. Zem?

speaker
Zem Nguyen
Chief Executive Officer

Good afternoon, everyone, and thank you for joining today's call and review of our business results. I'm joined by Dan Luxhire, 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. SIGA's focus remains unchanged. partnering with governments around the globe to build and strengthen long-term preparedness strategies against potential biological threats, specifically smallpox. We are proud to supply our smallpox antiviral treatment to many countries and NGOs, and we remain committed to ensuring that TPOX is positioned for rapid, large-scale deployment whenever it is needed to help save lives. The case for preparedness has never been stronger. Smallpox and other high-consequence threats whether the result of an accident, a deliberate act, or a natural occurrence, represent a real and serious threat that can be managed only with proactive sustained investment. Stockpiling medical countermeasures is a cornerstone of preparedness strategies. And in today's environment of rising geopolitical tension, accelerating technological risks, including those enabled by AI tools, and growing biological threats, The urgency to make that investment is clear. We believe TPOCs is uniquely suited to meet the smallpox threat with a well-established safety profile and targeted mechanism action that supports broad use in emergency situations. The first quarter of 2026 reflected a variable rhythm inherent to our business. Activity levels vary quarter to quarter. The first quarter had minimal product deliveries, whereas in the second quarter, we expect to deliver approximately 13 million of oral TPOCs to an international customer, as well as make additional IV TPOCs deliveries to SNS. As a reminder, given this quarter-to-quarter variability, we recommend that our results be viewed in the context of our longer-term performance rather than in isolation. We believe our long-term outlook continues to offer substantial opportunities. This belief is grounded in the fundamentals of our business and the enduring need for governments to protect against biological threats. We continue to maintain engagement with the U.S. government, particularly key stakeholders at HHS. Although the pace of progress toward a new contract with the U.S. government has been slower than prior contract processes, we believe the 27 million in funding secured in 2025 to support pediatric formulation development and IV TVOX technology transfer efforts, as well as the 2025 IV TPOX order, are strong signals highlighting the continued role of TPOX is expected to play in the U.S. bio-threat preparedness. It's worth reiterating that the CEGAS operating model is closely aligned with the U.S. government priorities. Specifically, the U.S. government receives our lowest price of oral teapots and our active pharmaceutical ingredient in all finished drug products is manufactured domestically. Turning to our international business, we continue to engage with governments and other key stakeholders around the world who continue to review their preparedness strategies and funding. Strategic stockpiling remains central to those conversations. Government procurement is a deliberate process. That said, discussions continue and we see potential for additional international sales over time. As noted last quarter and earlier on this call, we received a $13 million order from a country in the Asia Pacific region, which we expect to deliver in the second quarter of this year. We also took important steps towards potential sales in a region where CEGA has historically been underrepresented. We recently entered into an exclusive license and distribution agreement with HICMA MENA SZE that gives HICMA the right to register and commercialize teapots across the Middle East, North Africa, or MENA. Under the agreement, Siegel will serve as an exclusive manufacturer and supplier of finished products for HICMA. This agreement represents a key step in our strategy to broaden global access to teapots, and HICMA is the right partner for it. Their unparalleled regional presence and deep expertise in bringing innovative medicines to market make HICMA well-positioned to bring TPOCs to these markets. Turning to our pipeline, we continue to advance our post-exposure prophylaxis, or PEP, in pediatric programs. On the pediatric program, we filed our IND and initiated a Phase I study. Results are expected in the second half of this year, which will inform next steps. On the PEP program, the CDC continues its work on the analysis of immunogenicity samples. We are targeting an FDA submission for PEP indication in the next 12 months. Looking forward, we remain focused on what has always driven this business, financial and operational discipline, and building on the partnership that positioned CIGA for long-term success. As we move further into 2026, we do so with a clear sense of purpose. The global need for biological preparedness is real and growing, and SEGA is prepared to meet it. We have a product approved by regulators around the world, strong government relationships, and a team that executes. We look forward to continued progress and to updating you along the way. With that, I'll turn it over to Dan to review the financial results in more detail. Dan?

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