SIGA Technologies Inc.

Greetings. Welcome to CIGA Business Update Call. Before we turn the call over to CIGA 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 risk and uncertainties that could cause actual results to differ from the forward-looking statements. CIGA does not undertake any obligations 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 end December 31, 2020, and its subsequent reports on Form 10-Q and Form 8-Q. I would now like to turn the conference over to your host today, Mr. Phil Gomez, Chief Executive Officer. Thank you. You may begin.

Thank you for taking the time to join today's call. Today, I'm joined by Dan Luxhire, our CFO, and Dr. Dennis Ruby, our CSO. We're 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. We had a significant third quarter with the exercise of 113 million procurement option under the 19th ABARDA contract. In connection with this option exercise, We are targeting multiple deliveries of oral teapots to the U.S. government in the fourth quarter, which would have a cumulative value of $113 million. In October, we delivered approximately $33 million of oral teapots toward this goal. To complete all targeted deliveries by year end, we will need to complete manufacturing, secure transportation, and have available delivery slots at the U.S. government locations where teapots are stockpiled. As we have all read in the news, supply chain disruptions continue to be a challenge and our SIGA team is working extremely hard to ensure we do not have delays or barriers to completing the delivery. On a related note, we are proactively coordinating manufacturer of active pharmaceutical ingredient or API to ensure we are well positioned in the future for domestic and international procurement orders given the ongoing supply chain risks. Looking beyond 2021, The 19C contract has approximately $300 million of procurement options available for future exercise by the U.S. government. This amount includes two remaining procurement options of approximately $113 million each for oral TPOCs and a series of intravenous or IV procurement options that have a total value of $77 million. If these options are exercised when product in the U.S. government stockpile expires, then we would expect these options to be exercised in the next three years. At some point during the next three years, the current 19C contract could be replaced with a longer-term 10-year contract, which could provide a more consistent and transparent product delivery timeline. Such a contract format is being used for other contracts that cover products delivered to the Strategic National Stockpile. In turn, if the TPOX contract is transitioned, it would be natural for the smallpox stockpile size, and by extension, the TPOX contract size, to reflect consideration of our post-exposure prophylaxis indication under development. Please note that with respect to COVID-19, even with the highly effective vaccines, the U.S. government is contracted to purchase nearly 5.7 million courses of COVID therapeutics for over $4 billion. We believe the stockpile of 1.7 million courses of TPOX in a smallpox outbreak would not be sufficient to treat all those who would need care, and that is an active part of our ongoing conversations with the U.S. government. Shifting gears slightly, I'd like to talk about another U.S. stockpile, the antibiotic stockpile. As described on previous calls, we have a collaboration with CIPLA. The goal of that collaboration is to respond to an anticipated BARDA RFP for antibiotics to be developed for bio-threats and stockpiles. The request for information or RFI was posted last fall, but the RFP has not yet issued. We now anticipate the RFP will issue early next year, and we will continue to track it closely with our colleagues at CIPLA. Given the COVID-19 related work that BARDA is doing, it's not entirely surprising that this initiative has been delayed. However, we believe the antimicrobial resistant initiative at BARDA, AMR, is a continuing focal point, and we look forward to responding when the RFP is issued. On the international sales front, it's been a quarter with progress in many areas, but continued delay on a target contract issuance. On the progress side of the ledger, we delivered $2.3 million of oral TPOCs to the Canadian military during the third quarter, which is ahead of schedule as we anticipated they would not exercise this option until after Health Canada approval. And beyond Canada, we have seen a pickup in opportunities for travel and meetings with customers. As such, SIGA presented at conferences in Germany and Italy this quarter with our colleagues at Meridian Medical Technologies. With respect to the aforementioned delay, we continue to work with Meridian in a new foreign jurisdiction toward finalizing an order that would be similar in size to the initial orders received from Canada in 2020 and early 2021. The timing of the completion of the order has been and may continue to be impacted by the COVID-19 pandemic. As background, it is becoming clear that as countries order TPOCs for the first time, there are extensive logistics questions that arise as to how the country will import the product, what waivers may be necessary given that the product will be stockpiled and not immediately used by patients, regulatory requirements, and detailed terms and conditions. We remain optimistic about future sales potential as we gain EMA approval and advance discussion with customers in Europe, the Middle East, and Asia. I'll now pass the call over to Dennis, who will provide an R&D update. Dennis?

Thank you, Phil. The SIGA R&D team has had a very busy quarter advancing regulatory filings and directing earlier stage development activities. First, an update on regulatory filings in progress. The IV TPOX NDA application is under active review by the FDA. We are responding to questions and providing information as requested. Barring any unforeseen delays, we are targeting approval to be received during the first quarter of 2022. Our Health Canada application is also under active review, and approval could come as soon as late fourth quarter of 2021. Of note, Health Canada is following FDA guidance on approval of products under the animal rule guidance, and as such, will restrict the label to treatment of smallpox. Finally, our EMA MAA application is being actively advanced as well. We've responded to the 180-day questions and are awaiting the EMA response. The MAA approval is targeted for the first quarter 2022. Thus far, the EMA has not objected to our request for a broader indication that includes all human orthopoxvirus pathogens, vaccinia, cowpox, smallpox, and monkeypox. An approval for monkeypox would greatly facilitate the use of TPOX against this growing disease threat in Africa as well as exported cases elsewhere. In support of this effort, CIGA has provided TPOX for use in a clinical trial managed by Oxford University in collaboration with Institute Pasteur to study the use of TPOX in monkeypox patients in the Central African Republic. All the necessary paperwork is in place, drug is on site, and they are preparing to treat their first patients. CIGA is also in the process of setting up additional clinical trials with other international partners in additional African countries. We are hopeful that acquisition of safety and efficacy data for the use of TPOX in monkeypox patients will afford us the opportunity to revisit with the FDA, broadening the TPOX indication to include monkeypox and potentially other orthopox pathogens for which there's strong animal data. Dental development activities are underway for oral TPOX. First, we've completed a post-marketing commitment to conduct a PK study in volunteers weighing more than 120 kilograms, which is approximately 13% of the US population. Based on the results and after discussions with the FDA, the TPOX label will be modified to suggest 600 milligrams three times a day in these patients. Of note, in case of an outbreak, this adjustment will effectively reduce the size of the stockpile to treat the overall population. Second, we continue to advance our Powder for Reconstitution pediatric formulation, and as such, our two leading formulations have been transitioned to our CRO partner to begin adaptive PK clinical trials. Last and most importantly, in terms of TPoC's development activities, our collaboration with the Department of Defense to obtain approval for post-exposure prophylaxis use of TPOX continues to progress. After iterative discussions with the FDA, we have agreement on clinical trial design. The TPOX plus JYNNEOS immunogenicity clinical trial will start patient recruitment during the fourth quarter of 2021. The larger TPOX 28-day safety trial should commence patient recruitment in the first quarter of 2022. If the results are as expected upon completion of these studies, we will file for regulatory approval. The immunogenicity data from the TPOX plus JYNNEOS study will be the most important data to support the use of TPOX in PEP, and we anticipate that data will be available in the second half of 2022. With respect to earlier stage programs, we continue to advance our ST357 smallpox antiviral. Current efforts are aimed at developing co-crystals of ST357 and its protein target, and conducting computer modeling to predict analogs with improved drug characteristics. Additionally, we are actively developing the experimental plan for conducting animal experiments to support the development of plazomycin against plague and tularemia. This work is being done as part of a broader preparation for an antimicrobial resistance RFP that we expect to launch in the coming months, to which we will reply in coordination with CIPLA as part of our collaboration. With that update, I'll hand you over to Dan to provide a financial update.