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 materially 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 actual results to differ, PC the company's filings with 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 now turn the call over to Zem Nguyen, Chief Executive Officer of SICA.

Zem, please go ahead.

Good afternoon, everyone, and thank you for joining today's call and review of our business results for the fourth quarter and full year of 2024. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update to our company. After the update, we'll be happy to answer your questions. I am pleased to share that 2024 was a year of impactful execution and strong financial performance for SIGA. In 2024, we also made considerable progress on several initiatives to drive shareholder value, including, one, continuing our partnership with the U.S. government, two, advancing regulatory approvals for TPOCs, and three, cultivating strategic partnerships to expand global access to TPOCs. With product sales of 133 million, up approximately 2% from 2023, we deliver the second consecutive year of product sales growth, reinforcing the critical role that TPOCs and a comprehensive smallpox preparedness program play in strengthening national security. Additionally, our results highlight the strength of our financial position. Of the $133 million in product sales, about $80 million was generated in the fourth quarter from a diverse mix of revenue sources, led by deliveries of oral and IV TPOCs to the U.S. Strategic National Stockpile. This was followed by deliveries of both oral and IV TPOCs to the U.S. Department of Defense and deliveries of oral TPOCs in international markets. The latter included a notable sale in East Asia for 11 million of oral teapots, which is more than double the size of the largest prior individual teapot sale in the region. This latest international milestone follows the first sale of teapots in Africa in the third quarter in response to a request from the Ministry of Health in Morocco. Beyond the 2024 top-line financial results, we have taken important steps to advance our key initiatives and strengthen our company, which we believe will produce shareholder value over time. I would like to highlight some of these steps. We continue to make progress on our international markets. Two examples stand out. First, midway through 2024, our company assumed responsibility for promoting TPOCs outside the U.S. from Meridian Medical Technologies. This action has brought us much closer to our current and potential future customers, thereby enabling us to better understand and meet their needs. We've started to build an international sales and marketing infrastructure in 2024 and plan to continue to invest in that infrastructure to achieve our full potential in the international market. We believe our conversations and actions will yield positive results over time. Second, As announced earlier this year, we achieved another international regulatory approval when Japan's Pharmaceuticals and Medical Devices Agency, in collaboration with the Japan Ministry of Health, Labor, and Welfare, approved TPOX for the treatment of a broad range of orthopoxviruses. This approval marked another important milestone in our efforts to expand access to TPOX. Additionally, it, coupled with the growing sales of teapots in East Asia, reinforces the value of antiviral stockpiling to ensure supply resilience during immediate crisis response to safeguard communities and individuals against smallpox. To obtain this approval, and in collaboration with our local partner, Japan Biotechnopharma, we submitted a robust data package, which included studies involving healthy human volunteers, non-human primates, and rabbits. No other drug approved to treat smallpox or any other orthopoxvirus is supported by such a comprehensive and extensive data package. Shifting gears on cultivating strategic partnerships, in October, we announced an exclusive license to a portfolio of preclinical, fully human monoclonal antibodies from the Vanderbilt University that have the potential to create a broad range of orthopoxviruses, including smallpox and mpox. Leveraging our existing capabilities to create new opportunities over the long term, we believe this portfolio has the potential to complement our TPOX franchise and provide patients with additional therapies in this space. While monoclonal antibodies represent an early stage component of our pipeline, our TPOX post-exposure prophylaxis program for smallpox, or PEP, is far more advanced. We continue to collaborate with the CDC in consultation with the FDA to complete the analysis of the samples collected to support the study's immunogenicity objective. As a reminder, the safety objective has already been successfully achieved. The CDC's work is underway, and we believe they will complete their analysis around the middle of this year. Based upon their projected timeline, we are now targeting an FDA submission for the PEP indication in early 2026. In addition to our successes, we've also faced some challenges this year given the POM007 and STOMP clinical trial results in MPOCS. While the results of these trials were not a surprise given the mechanization of TPOCs and the design of the trials, they have led to some important discussions about TPOCs that I'd like to address today. By the way of background, TPOX was developed as a treatment for smallpox with the primary goal of reducing mortality and saving lives in an event of an outbreak. Approval under the FDA's rigorous animal rule, TPOX is supported by extensive studies demonstrating its safety and efficacy in reducing mortality from smallpox. Since smallpox vaccination programs were discontinued several decades ago, herd immunity has diminished. leaving populations vulnerable to its potential reintroduction. For example, in the US, approximately 190 million people were born after the end of the routine vaccination, leaving these Americans vulnerable. Additionally, the robustness of the immune response in those vaccinated more than 50 years ago cannot be determined. As such, the potential for its intentional reintroduction remains a serious concern. For POM007 and STOMP, TIGA donated the product to trial sponsors to help advance MPOX research and support response to the 2022 global MPOX outbreak. Because MPOX is a far milder and largely self-resolving disease with a much lower mortality rate than smallpox, these trials were designed to measure the time for all lesions to heal between patients receiving TPOX and those receiving placebo. While these studies did not show statistical significance difference between ticavirumab and placebo at this primary endpoint, the POM007 results did signal potential benefits for patients treated early or with severe disease. Generally speaking, viruses replicate faster in the initial stages of infection. Administrating antivirals early helps curb virus replication before reaching its peak load, thereby reducing the severity of the disease. This principle was exemplified during the COVID-19 pandemic, where timely administration of antivirals proved critical in proving patient outcomes. The same principle applies to TPOX. Ticovirumab works to reduce viral release from infected cells. Based upon Ticovirumab's mechanism of action, we believe treatment would be optimized when administered early in symptoms, or ideally post-exposure prophylactics. The early phase of disease includes viral implication and dissemination throughout the body. As the disease progresses, the immune system works to clear the virus already released from the cell after replication. In POM007, we saw the potential benefits for patients treated early or with severe disease. We're currently assessing viral load impact in MPOCS patients over time, as we expect reduction in virus load with tic of aromat administration early consistent with our non-human primate models. Both POM007 and STOMP enrolled patients at later stages of disease, a medium about 5.9 and 8 days, respectively, after self-reported symptom onset. We believe these trials are not necessarily reflective of how or when the drug should be used based on its mechanism of action and potential value in smallpox outbreak. We believe CPOX remains a vital countermeasure for reducing mortality from smallpox. In a comprehensive preparedness plan, antivirals provide a critical line of defense. Complementing vaccines, antivirals can be used to treat an infection in patients who have not been vaccinated or do not benefit from vaccination. Certain antivirals have the potential to prevent onset of viral illness after exposure to the virus. The relationship between vaccines and antivirals is particularly important as we face the growing challenge of emerging infectious diseases and the threats of bioterrorism. Strategic stockpiling of antivirals helps ensure a swift, coordinated response when disasters strike. Looking forward, we believe securing a new contract for the continuing supply of TPOCs to the Strategic National Stockpile, or SNS, represents an opportunity to enhance our company's long-term potential and help advance our national security through bioterrorism preparedness. Since the new U.S. administration took office, we have seen many bold initiatives launch and executive orders enacted, with more changes expected as new leaders are nominated, confirmed, and put in place. With any change of administration, this takes time. While change can create uncertainty, it can also create long-term opportunities as priorities are clarified and new policies are enacted to enhance national security. We will continue to monitor these developments and assess the potential impact, if any, on our company. Whatever transpires, we believe we are well-positioned to engage with the new ASPR as well as other senior officials on the nature and timing of an RFP for a new contract for TPOCs. As a reminder, ASPR is within the USHHS and houses the center of the Biomedical Advanced Research and Development Authority, or BARDA, and the SNS. For reference, SEGA has been providing TPOCS to the ASPR for more than a decade, and national security is an issue that transcends political considerations. We believe the new administration is committed to maintaining a robust preparedness strategy, which includes a supply of antibiotherapies to treat smallpox. Furthermore, our current 19C contract was awarded under President Trump's leadership in 2018. With this in mind, we stand ready to negotiate with the new ASPR with the objective of completing a new contract in 2025. In summary, this is a dynamic time for CIGA. We are strong, resilient, and profitable. Our strategy is yielding results. Our disciplined approach to capital management gives us optionality. Our TPox franchise meets a critical need for smallpox preparedness, and our team has the expertise to drive results over the long term in the best interest of our customers and shareholders. In short, with a strong foundation, we believe we are well positioned for the future and the opportunities ahead. With that, I'll turn it over to Dan to review the financial results in more detail.