ZIOPHARM Oncology Inc

Greetings. Welcome to the ZioPharm Oncology third quarter 2021 earnings conference call. 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 keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Alex Lobo, Stern Investor Relations. Thank you. You may begin.

Thank you. Good afternoon and welcome to ZioPharm Oncology's third quarter 2021 financial results conference call and audio webcast. With me today are Kevin Boyles, senior, ZioPharm's chief executive officer, and Rafael Abafa, ZioPharm's chief medical officer and executive vice president of research and development. Earlier this afternoon, ZioPharm issued a press release announcing financial results for the three months ended September 30th, 2021. We encourage everyone to read today's press release, as well as Zyre Farm's quarterly report on Form 10-Q for the third quarter of 2021, which has been filed with the SEC. The company's press release and quarterly report will also be available on Zyre Farm's website at zyrefarm.com. In addition, this conference call is being webcast through the investor relations section of the company's website and will be archived there for future reference. Please note, That certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time-sensitive information that are accurate only as of the date of this live broadcast, November 8, 2021. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable securities law. With that said, I would like to now turn the call over to Kevin Boyle. Kevin, you may begin.

Thank you, Alex. and welcome everyone to Zyafarm's third quarter 2021 earnings call. When I joined Zyafarm just over two months ago, I promised to be transparent with shareholders and share my observations and perspectives at the next opportunity. Today, I'd like to do that and highlight some of our recent accomplishments and lay out my vision for the next year. A month ago, we made the decision to strategically restructure the organization and focus our efforts on advancing our differentiated TCR T-cell platform. As a result, we took immediate action to right-size the organization with a focus on generating clinical data while maintaining a robust R&D discovery engine. I'm impressed by the quality, dedication, and resiliency of our team at XioPharm and am confident we possess the internal capabilities to advance our innovative scientific research into the clinic. We appreciate the importance of generating clinical data to validate our TCRT platform and are making excellent progress in that regard. We realized the fastest way to the clinic was not to rely on an external contract manufacturer, but to operationalize our in-house CGMP clinical production unit, or CPU. I am very proud to announce that we completed the necessary engineering and process qualification runs in October at our CPU. The Xifarm team did an excellent job working together in a cross-disciplinary manner to accomplish this important step. We remain committed to begin treating patients in the first half of 2022. Our TCRT platform is predicated on a robust research and development lab and team based in Houston. The R&D team is working on several different programs. First, we continue to support the lead program, our TCRT library trial, and are working to incorporate additional TCRs into this IND. Second, we are advancing the development of our membrane-bound IL-15 program and expect to have further updates on future calls. Third, we have devoted significant resources to generating our own TCR discovery platform. These activities will allow us to generate our own intellectual property and have exclusive use of the TCRs we identify. I'm impressed by the breadth and depth of our R&D team and TCRT platform, which holds the potential to meaningfully improve the lives of cancer patients. I will let Raffaele take a deeper dive into our upcoming TCRT library study but I want to elaborate briefly on our rationale for this program. Our TCRT library platform is enabled by our versatile non-viral Sleeping Beauty technology combined with our extensive library of TCRs. This gives us an advantage as we can target multiple solid tumor indications within this single trial. This enables a timely and cost-effective approach to potentially identifying several indications that could benefit from our TCRT platform and give us multiple paths forward once we have generated this initial data set. This is critical to our go-forward strategy, and we are focused on dosing our first patient in this study. I would now like to turn the call over to Raffaele, our Chief Medical Officer, to provide an update across our manufacturing, clinical, and R&D efforts. that will support our future growth and bring value to our stakeholders. Raffaele?