SIGA Technologies Inc.

Welcome to the SEGA Business Update call. Before we turn the call over to SEGA management, please note that any forward-looking statements made during this call are based on management's current expectation and observations and are subject to risk and uncertainties that could cause actual results to differ from the forward-looking statements. SEGA 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, 2022, and its subsequent report on Form 10-Q and Form 8-K.

Thank you for taking the time to join today's call. Today, I'm joined by Dr. Dennis Ruby, our Chief Scientific Officer, and Dan Luxshire, our CFO. We are pleased to have this opportunity to provide a business, R&D, and financial update to our shareholders. We'll then be happy to take questions. On our last call, we noted that we expect the company's streak of positive financial performance to continue in 2023, with deliveries of oral teapots to the Strategic National Stockpile being a key driver. With this expectation, we have been proactively building inventory in anticipation of a substantial replenishment order of oral teapots for the Strategic National Stockpile. Based on a series of considerations, we are currently targeting for 2023 approximately $113 million of oral TPOS deliveries to the Strategic National Stockpile. These deliveries would occur under the current 19 contract. Additionally, we are targeting approximately $11 million of oral TPOS deliveries to the U.S. Department of Defense for 2023. Furthermore, in addition to pursuing U.S. government sales of oral teapots, we will also continue to work toward generating revenues in 2023 from deliveries of IV teapots to the strategic national stockpile, as well as generating international sales of oral teapots. With respect to the international sales effort, as of March 31, 2023, there were firm commitment orders from two European countries for the delivery in 2023 of approximately $8 million of oral teapots. Additionally, we are currently engaged in active negotiation to add to this amount. In sum, we will continue to work hard to build on the 2023 international base as the year progresses. With an eye towards growth, we continue to make progress on two key initiatives. One, the monkeypox observational clinical trials, and two, the PEP program for oral TPOX. At this point, I will turn the call over to Dennis to discuss these two important initiatives. Thanks, Phil.

With respect... With respect to MPOX, TPOX has been an essential component of the public health response to the global outbreak. TPOX has been used to compassionately treat more than 6,900 MPOX cases in the U.S., as well as many cases internationally. Nine clinical trials have been launched to study the use of TPOX for MPOX, five of which are randomized placebo-controlled trials that are sponsored by government agencies or NGOs. To date, more than 175 MPOX patients have been enrolled in these trials. While the number of MPOX cases have ebbed over the last series of months in the U.S., the clinical trials continue to enroll a global cross-section of patients as they become available. It's worth noting that there has been an uptick in MPOX cases in some locations, a development we will continue to monitor in consultation with government officials. Overall, I would like to reiterate what we said on prior investor calls in connection with the timing, the ultimate number of participants of the trials. These factors will depend on the path of the MPOCS outbreak and the general speed of enrollment. Hence, the timing and likely ultimate enrollment levels of the trials, especially the randomized placebo-controlled trials, continues to be currently unknown. For example, it remains to be seen whether there will be Any type of MPOX case count increase over the coming summer months in the northern hemisphere to roughly mirror the spike in MPOX case counts last year, as the CDC has predicted. As such, given the currently unknown factors, the timing and composition of an FDA submission for an MPOX label for TPOX remains to be determined. That said, it's encouraging to note that the various RCTs are contemplating an aggregation of their data as it is unblinded. with the idea of potentially reaching sufficient subject numbers for regulatory evaluation. While the short-term path of the MPOCS outbreak is uncertain, what we have seen and learned to date indicates there's a high probability that the United States and other countries across the world will have to deal with MPOCS cases in future years. It's just unknown as to the ultimate magnitude of cases, the scope of the cases across different communities, and whether case levels become consistent or whether case levels come and go periodically. We believe that in most scenarios, there will be a need for TPOX. Shifting gears, I would like to provide an update on the PEP label expansion program for oral TPOX. I'm happy to report that the company has recently met enrollment targets for both the Imogenicity Trial and the Expanded Safety Trial. As a quick reminder, the Genios plus TPOX Imogenicity Trial test subjects as to whether oral TPOX interferes with JYNNEOS vaccination, while the expanded safety trial tests the safety of oral TPOX over a 28-day PEP regimen. In contrast, the treatment indication for oral TPOX is 14 days. Samples are currently being analyzed for both trials. We expect unblinded results and data lock for both trials to occur within the next 60 days, if everything goes according to schedule. With respect to the PEP program, I'd like to note a few things. Based on previous animal challenge experiments and clinical trials, we expect both trials will be successful and supportive for the use of TPOX for PEP. 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. Provided unblinded results from the trials are supportive of a regulatory submission. The next step after sample analysis would be to commence preparation activities for an NDA supplemental submission. For such a submission, we're targeting early 2024. At this point, I would like to turn the call over to Dan for a financial update.