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 statement to reflect events or change circumstances after this call. For discussion of factors that could cause results to differ, precede 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, 2022, and its subsequent reports on Form 10-Q and Form 8-K. I would now like to turn the conference over to Phil Comas, Chief Executive Officer, thank you. Please go ahead.

Thank you for taking the time to join today's call. Today I'm joined by Dennis Ruby, our Chief Scientific Officer, Jay Varma, our Chief Medical Officer, and Dan Luckshire, our CFO. We are pleased to have this opportunity to provide an update to our shareholders. We'll then be happy to take questions. I'd like to start this call by highlighting key financial targets for 2023. We expect orders for oral and IV TPOCs to be approximately $164 million in 2023, with a substantial percentage of those orders to be delivered in 2023. As such, as previously disclosed, we are targeting 2023 pre-tax operating income of between $90 million and $100 million based on the timing of deliveries that are currently being coordinated among the company, our supply chain, and our government customers. Target pre-tax operating income for 2023 is based on the following target revenues. Approximately $113 million of revenues from fourth quarter deliveries of oral teapots to the U.S. Strategic National Stockpile. Approximately $5 million of revenue from fourth quarter deliveries of oral teapots to the U.S. Department of Defense. $15 to $18 million of revenue from fourth quarter international deliveries of oral teapots to the two European countries in connection with the recently announced Hira joint procurement framework contract, and up to $15 million of revenue from fourth quarter deliveries of IV teapots to the U.S. strategic national stockpile. To the degree that any target deliveries and related target revenues of pre-tax operating income do not occur in the fourth quarter of this year due to any timing constraints in connection with our customers or our packaging vendor, we expect that such deliveries and revenue would occur in January of 2024. In particular, one thing that could impact the timing of deliveries between fourth quarter 2023 and January 2024 is the packaging of final drug products. This step of the process has been taking longer this year than in prior years, and longer than expected so far this year. Needless to say, we've been in daily contact with our packaging vendor, and we continue to work together on getting packaging done as soon as possible and with an eye toward making the remaining target deliveries in 2023. Beyond 2023, we will continue to execute on our strategic plan to maximize growth opportunities. I will now ask Dennis to provide an update on the PEP and MPOS programs for Oral PFOX.

Dennis? Thanks, Phil. I'd like to provide a summary of the strategy for PEP as we received some questions on this topic after the last investor call. Based on the studies and trials that have been conducted, we believe TPOX will work for PEP. The FDA has not asked for any additional studies to prove the efficacy of TPOX for PEP. They have asked for extended safety data in humans for treatment for 28 days, which we've completed. In a smallpox outbreak, TPOX would likely be used in combination with a smallpox vaccine, so the JYNNEOS plus TPOX study we will discuss is designed to solely evaluate if TPOX interferes with the generation of an immune response to the vaccine. Let me now provide a quick recap of what was noted in the last investor call. Earlier this year, the company met enrollment targets for both the immunogenicity trial and the expanded safety trial. For the expanded safety trial, as expected, the clinical trial result did not show any drug-related serious adverse events. For the JYNNEOS plus TPOX immunogenicity trial, as a quick reminder, the goal of this trial was to show that TPOX did not reduce the immune response to the vaccine. This is supplemental and separate to our current approval for the treatment of smallpox. In the preliminary analysis of the trial data performed by our CRO, the results did not show a meaningful difference between the immunogenicity of those that received JYNNEOS vaccine while on placebo compared with those that received JYNNEOS vaccine while on TBOX, which is consistent with what we expected. However, as noted on the last investor call, the CRO results indicated that a number of volunteers that had measurable immune response to the JYNNEOS vaccine in both placebo and TBOX groups was lower than expected. Given that this result, one, would prevent non-inferior statistical determination from being the primary endpoint as originally planned, two, is unexpected, and three, is scientifically odd, we've been investigating the CRO results over the past series of months. Since the last investor call, in addition to conducting many other investigations, we sent a subset of the JYNNEOS plus TPOXX samples to our colleagues at CDC. who performed their validated tRNT analyses on them. These samples showed the expected immune responses. As such, we're now working on getting the entire set of samples reanalyzed and in parallel working toward a supplemental NDA submission in 2024. We are grateful to our colleagues at CDC for this collaboration and are pleased to have identified a path forward. In terms of getting the maximum and most timely benefit from the immunogenicity trial, in the context of stockpile expansion conversations with the government. We believe the steps taken over the past series of months is worth the extra time and effort to ensure the highest quality data. To be clear, we're working on finalizing the immune response levels of volunteers in the vaccine. The analyses are not about the efficacy or safety of TPOX, nor are they about TPOX's impact on those individuals who are showing an immune response. To reiterate contextual comments made on the prior investor call, we believe that in regard to the PEP program, the totality of the studies and trials that have been conducted, including the immunogenicity trial, as well as previous animal challenge experiments and clinical trials, are supportive of the use of TPOX for PEP, pending discussions and review with the FDA. In the case of an orthopoxvirus epidemic, be it Mpox or smallpox, Use of TPOX for PEP will be important to reduce the morbidity and mortality in the population. Shifting gears, let me also provide an update on the current MPOX trials involving TPOX, which include five randomized controlled trials, as well as multiple observational studies. As a general comment, these studies continue to enroll patients and collect data. To provide a couple specific data points, in Africa, as of October 19th, The NIAID PALM trial being conducted in the DRC had enrolled 314 patients, a big jump from the 188 patients noted in the last investor call. In the NIAID STOMP trial, as of October 31st, there were 169 patients. The increase in patient numbers in the aforementioned trials highlights that case counts continue to accumulate, especially in Africa. Importantly, it also provides a glimpse to the overall global health risk posed by orthopoxviruses. Jay will provide further comments on mpox and orthopoxviruses. Before I turn the call over to Jay, I'd like to provide a quick update on our pediatric program for TPOX. Having completed a clinical trial that demonstrates equivalence of drug exposure in volunteers given the TPOX oral capsules or the powder for reconstitution liquid formulation, we are commencing advanced development. We've chosen a scale-up manufacturer to prepare clinical supplies, and we're in the process of designing a clinical development program which would support licensure. We consider this program to be an exciting path for potentially providing protection to the pediatric population. At this point, I'll turn the call over to Jay. Thanks, Dennis.