SIGA Technologies Inc.

FIGA does not undertake any obligation to update publicly any forward-looking statement 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 13th, 2021. Excuse me, 2021. and its subsequent reports on Form 10Q and Form 8K. With that said, I'd like to turn the call over to Mr. Phil Gomez, your host.

Thank you for taking the time to join today's call. Today I'm joined by Dan Luckshire, our CFO, and Dr. Dennis Ruby, our CSO. 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. With the global monkeypox outbreak, we've been very busy over the last approximately 75 days responding to inquiries from a broad multitude of people and entities across the public health ecosystem, as well as building on existing governmental and public health relationships. One initial result of this activity has been a significant increase in the international procurement orders this year versus 2021, with approximately $60 million of oral TPOCs orders from 10 international jurisdictions this year through July 31st, in comparison to approximately $13 million of international orders last year. Of the 10 international jurisdictions who have ordered oral TPOCs in 2022, nine of the jurisdictions are first-time customers in 2022. We believe that the increasing number of international governments that are procuring oral TPOCs in addition to the large number of continuing inquiries regarding TPOX usage for monkeypox in its potential procurement, highlight two key elements. Firstly, that is essential that governments across the world adopt a more proactive approach to addressing the health risks posed by families of viruses, such as the orthopoxvirus family. And secondly, that TPOX is a significant component to any robust public health program designated to protect against orthopoxvirus risks and threats. With respect to the monkeypox outbreak, the sheer magnitude of inquiries and usage requests and the oftentimes frenetic manner of such inquiries highlight the seriousness of the outbreak, both currently and for what the outbreak could become. The recent WHO designation of the monkeypox outbreak as a public health emergency of international concern reinforces the serious nature of the outbreak and its potential. Right now, it is early innings, to use a baseball analogy. the number of global cases of monkeypox has quickly grown to more than 25,000 cases. And there are anecdotal reports that the breadth of transmission appears to be expanding. At this early stage, we are in the same spot as the public health community in that we have much more to learn in order to get a better sense of what to expect with regard to the ultimate scale and scope of the monkeypox cases to come. Based on what we've learned so far, we believe the following is clear. First, monkeypox is a severe disease. As case reports and patient stories have made clear, an infection can have significant consequences. Patients are experiencing severe pain, scarring, and hospitalization to manage the complications of the disease when antiviral therapy is not available. Second, quarantines that require three weeks or more have significant impact on patients who cannot work or interact with family members. Third, although currently focused in the social networks of the men having sex with men or MSM community, Most experts do not anticipate the outbreak will be limited to this population. In other words, it is likely the virus will spread to a variety of segments and real life examples of this are growing. Fourth, vaccines alone cannot mitigate this outbreak. Supply challenges, vaccine hesitancy and ongoing cases require both vaccination and treatment to address the impact. Fifth, The outbreak has highlighted the importance of stockpiling of teapots to mitigate the impact of orthopoxvirus outbreak. Procurement by governments after an outbreak takes too long for governments to be able to access the drug. And six, the population needs better access to teapots. In sum, we believe the monkeypox outbreak is a clarion call to governments to increase the pace of building stockpiles for smallpox and monkeypox where none exist, and of resizing and expanding stockpiles that do exist. As such, we will continue to pursue, in coordination with international promotion partner Meridian Medical Technologies, tangible procurement activity in regions and countries in which monkeypox continues to grow and or become endemic. In addition to being a catalyst for international procurement orders, the monkeypox outbreak has also been a catalyst for opportunities to enroll patients in trials being planned for oral TPOC. This is important because collecting data from trials and from usage in the population is a key focus point for us as we pursue monkeypox approval with the FDA, which is one way to get better access to TPOX for monkeypox patients. As background, the FDA has indicated that it wants efficacy data in the treatment of monkeypox for full approval of TPOX in the U.S. for the monkeypox indication. Dennis will discuss the trial opportunities in a few minutes. Before I hand over the call to Dennis, I would like to touch on a few achievements over the past series of months. On the regulatory front, the IV formulation of TPOX was approved by the FDA in May, and oral TPOX was approved in July by the Medicines and Healthcare Products Regulatory Agency, MHRA, in the United Kingdom. With these approvals, we have now achieved four regulatory approvals for TPOX in the approximate span of little more than half a year. The other regulatory approvals being the oral TPOX approval by the European Medicines Agency, EMA, in January, and Health Canada approval in December 2021. I will note that the EMA and MHRA approvals include broad labeling for oral TPOCs, indicating its use for the treatment of monkeypox, smallpox, cowpox, and vaccinia complications following vaccination against smallpox. All of these regulatory approvals were based on animal efficacy data, with human clinical trials conducted to demonstrate safety and pharmacokinetics consistent with the levels that protected non-human primates. Those studies published by Dennis in the New England Journal of Medicine in 2018 showed over 90% protection from death in a lethal challenge model. During an outbreak, whether smallpox or monkeypox, we always anticipated collecting confirmatory efficacy data in humans. Dennis will provide an update on the clinical trials being planned or ongoing to collect the data. These clinical trials are important as they are focused on broader use of TPOX in outpatient settings. The data in non-human primates showed that treatment with TPOX stopped progression of the disease and reduced viral shedding. We believe these studies will provide a basis for approval in the U.S. for monkeypox and support for wider use of TPOX to treat a broader set of patients presenting with the infection. On the procurement front, we signed our first procurement contract with the U.S. Department of Defense in May. The procurement contract is for approximately $7.5 million of oral teapots, of which approximately half was delivered in the second quarter, and we expect the option for the other half to be likely exercised in 2022. Additionally, we believe there will be opportunities to add to this procurement. One way this procurement is important is that it continues to expand our revenue base. As a reminder, our revenue base expanded in the first quarter when we made our first deliveries of intravenous teapots to the U.S. government. At this point, I'd like to hand the call over to Dennis Ruby, who will provide a regulatory and R&D update, including details on the PEP clinical program. Dennis?

Thank you, Phil. I will start my comments with an update on post-exposure prophylaxis, or PEP, clinical trials, and then I will comment on the monkeypox outbreak and the oral TPOX trials in connection with the treatment of monkeypox. With respect to PEP, as a reminder, we're working with our DOD colleagues on executing two clinical trials needed to support regulatory approval of TPOX for post-exposure prophylaxis. For the expanded safety study, we have set up nine clinical sites around the US, and these sites began dosing mid-quarter. I would characterize enrollment as being also a substantial and strong start. As of the end of July, approximately half the study had been enrolled, with most enrollees having completed the 28-day dosing period. For the TPOXX plus JYNNEOS immunogenicities trial, we have two sites recruiting and screening volunteers. This trial started in early 2022, and enrollment got off to a slow start. This was due in part to post-COVID vaccine hesitancy in the U.S., among other factors. In coordination with the DoD, we've made protocol adjustments and other adjustments so as to normalize the speed of enrollment. Over the past series of weeks, even before the monkeypox outbreak gained a substantial foothold in the U.S., enrollment has begun to improve. With the monkeypox outbreak, we're continuing to work to further enhance enrollment in this trial. For both studies, the goal is to have all the volunteers complete the active phase by late in the third quarter of 2022 or early in the fourth quarter. If the studies show the expected results, we would commence assembly activities for a package requesting regulatory approval of TPOX for PEP. Shifting gears, I'd like to now discuss clinical activity in connection with oral TPOX and monkeypox. We are currently supporting and assisting with launching up to 10 clinical trials in Africa, Europe, and North America to formally assess the effectiveness of TPOX to treat and or prevent monkeypox in human patients. These include both multinational observational studies as well as placebo-controlled research clinical trials. The first of these is launching as I speak, and we hope to quickly accrue data to support potential approval of a monkeypox indication here in the U.S. to facilitate getting drug to those who need it. Before I turn the call over to Dan, I'd like to highlight something that's been mentioned previously in investor calls and earlier today by Phil, which is that we think of TPOX through the lens of being a treatment for the orthopox family of viruses. And we believe the monkeypox outbreak shows the wisdom of this approach. As such, we will continue to look for opportunities and work with our governor partners in pursuit of broad label indications for TPOX whenever possible. With that update, I'll turn the call over to Dan.