ZIOPHARM Oncology Inc

Thank you for standing by. This is the conference operator. Welcome to the ZioPharm Oncology, Inc. first quarter 2021 earnings conference call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. To join the question queue, you may press star then one on your telephone keypad. Should you need assistance during the conference call, you may signal an operator by pressing star and zero. I would now like to turn the conference over to Adam Levy, Executive Vice President, Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good afternoon and welcome to the Ziopharm Oncology conference call and webcast to review results for the first quarter ended March 31, 2021. This afternoon, we filed our 10-Q and issued our financial news release both of which are available in the investors section of our website, xiofarm.com. For informational purposes, we have also posted a set of PowerPoint slides to accompany today's commentary. These slides can also be found on our website in the investors section. During this call, the company will make a number of forward-looking statements, including statements regarding the potential therapeutic candidates in our development pipeline, regulatory status, financial information, and business trends. Forward-looking statements are subject to numerous risks and uncertainties as described in our 10-K and 10-Q filings and within other filings that we may make with the SEC from time to time. On our call today, we have Heidi Hagen, Interim Chief Executive Officer, who will present a brief corporate summary and financial overview, and Dr. Raffaele Baffa, Chief Medical Officer, who will present an update on our clinical programs. In addition, we are joined by Jill Buck, our EVP of Operations and Strategy and GM of Gene Therapy, Ellie DeGroot, our EVP and GM of Cell Therapy, and James Wong, our Executive Chairman, all of whom will be part of the Q&A which we will open up after the formal remarks by Heidi and Raffaele. And to get started, I'll turn the call over to Heidi Hagen. Heidi, please go ahead.

Thank you, Adam, and welcome, everyone. I am pleased to provide an update on our progress this quarter. The first quarter was one of focus and execution as we emphasized building shareholder value over the long term. I would like to give an overview of several achievements and moves we've made reflecting this focus as we prioritize our portfolio strategically guided by capital allocation. During the first quarter, the first patient was infused in the CD19 RPM CAR-T Phase I trial being conducted by our joint venture partner, Eden BioCell. We look forward to providing updates on this important trial in the second half of the year. We made meaningful progress expanding our infrastructure during the quarter. We completed construction of our cell therapy GMP facility and will be qualifying and validating the facility over the summer. This will be followed by qualifying the process in the facility and adding the facility to the TCR IND to supplement our CMO's partner's capabilities with our own GMP manufacturing for the TCR Phase I trial at MD Anderson. This will allow the company to control our own destiny and expand patient capacity as we continue to progress our TCRT work. We have made the difficult decision announced today to accelerate and complete the wind down of our existing IL-12 clinical trials. We have not taken this decision lightly, but the management team and board agree that capital and resources can be better deployed elsewhere. we remain open to partnerships and continue to believe in the potential benefits of this experimental therapy. In addition, as we explore next-gen technologies, we have begun evaluating synergies between our IL-12 program and cell therapy program. We anticipate a small number of layoffs through the end of 2021 associated with the closure of the existing IL-12 program. These reductions represent approximately 15% of our total HUD count. We will be reallocating capital and human resources to support our growing TCR clinical program over the remainder of the year. Also, we anticipate the closure of the CD19 RPM CAR-T allogeneic phase one trial. Our focus and our investor focus should be on our CAR-T program in Taiwan being conducted by our joint venture partner, Eden BioCell. We ended quarter one with cash of $100.1 million, giving us a runway into late quarter two of 2022. And management believes this could be further extended. Management and the board are working diligently and smartly to define the best approach for future capital needs. As we have discussed previously, we are committed to shareholder value as we consider and implement our capital raising approach. We will have more to say on this in the near term. Other details on our financial performance during the first quarter can be found in our press release and 10Q, both of which were issued earlier today. Regarding our search for a permanent chief executive officer, the board seeks an individual who can continue to drive execution and deliver success for all our stakeholders. I am pleased to report that the board has made good progress on identifying a strong initial set of candidates. We will continue to update you on this as it progresses. Before I turn the call over to Raffaele, I want to remind investors that we will hold our annual shareholder meeting on May 19th. This will be a virtual meeting, and we look forward to shareholder participation as we continue to execute on our strategy. With that, I will now turn the call over to our Chief Medical Officer, Dr. Raffaele Bafa. Raffaele?