ZIOPHARM Oncology Inc

Greetings. Welcome to the ZioPharm Oncology, Inc. Second Quarter 2021 Corporate Update. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone. Please note this conference is being recorded. I will now turn the conference over to your host, Adam Levy, Executive Vice President of Corporate Development and Investor Relations. Thank you. You may begin.

Thank you, operator. Good afternoon and welcome to the ZioPharm Oncology conference call and webcast to review our updates for the second quarter ended June 30th, 2021. This afternoon, we issued our press release, which is available in the investors section of our website, ziopharm.com. Additionally, we posted a PowerPoint presentation to accompany today's commentary, which can also be found in the investors section of our website. Let me remind everyone that during the 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 most recent 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. She will be joined by Dr. Rafael Abafa, Chief Medical Officer, who will present an update on our clinical programs. In addition, we are joined by Ellie DeGroote, our EVP and GM of Cell Therapy, and James Wong, our Executive Chairman, who will be available during the Q&A portion after our prepared remarks. And to get things started, I'll turn the call over to Heidi Hagen. Heidi, please go ahead.

Thank you, Adam, and welcome, everyone. Let me start by saying that I'm excited by the progress we have made across multiple fronts since our last call in May. Indeed, since the beginning of the year, we have truly transformed the company, and you can see the progress reflected on slide four of the deck we posted. This is a different company. Turning now to the details of our progress, which are summarized on slide six of the materials, since our last quarterly update, we have achieved several key milestones for our TCRT program. We successfully completed the commissioning of the CGMP Clinical Production Unit and completed aseptic process validation for the facility in Houston. These critical steps enable the facility to be used for our Phase I-II TCRT library trial. In addition, the team is completing process qualifications with healthy donor cells, which will support the use of the facility to manufacture TCRT cells for the clinical trial. We remain on track to dose patients in our Phase 1-2 TCRT library trial in the second half of 2021, and we are anticipating doing so in the fourth quarter. We have been emphasizing our strategy on our TCR program, and all of the company's efforts are being directed towards this program. We've never been more enthusiastic or optimistic. Raffaele will share more on this in a few moments. Moving now to the balance sheet. We ended the first half of 2021 with approximately $76.7 million, and today we announce that we have successfully executed a venture debt facility with Silicon Valley Bank for $50 million. with an immediate drawdown of initial $25 million tranche, which is not included in our end of second quarter cash balance. The $25 million initial tranche extends the company's cash runway into the fourth quarter of 2022, well beyond the time required to generate and assess the initial clinical data from our phase one to TCRT library trial. I want to make it clear that the company had and continues to have a multitude of options for financing and balance sheet fortification. The board and management team were deliberative on the best path forward and took into account both where the science is and where our cash runway brought us. The guiding principle, of course, was shareholder impact. We've done this in a smart way with minimal dilution. As we said previously, we have no intention of selling shares at the current stock price. which we believe significantly undervalues the company. And regarding our current market valuation, we understand the concern shareholders have expressed. We believe continuing to execute is the right way to demonstrate to the market that we are a leading oncology-focused TCR company. We firmly believe we are on the right track. The company is now operating from a position of strength with meaningful progress in our groundbreaking TCRT library trial enabling activity and in our efforts to strengthen the balance sheet. We are doing exactly what we said we would do earlier this year and we have growing momentum that is exciting to see. We are now in a position where the company will succeed or fail based on the science and the clinical data rather than operational considerations and challenges. Before I turn the call over to Raffaele, let me say a word on the search for a permanent CEO. As we mentioned in our press release, the board is very close to a decision, and we would expect an announcement in the very near future. A number of well-qualified candidates were considered, and we are looking forward to making an announcement. Let me turn the call over. Raffaele?