Alaunos Therapeutics, Inc.

Thank you for standing by. Welcome to the Alanis Therapeutics First Quarter 2022 Financial Results Conference Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during that session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded, and if you require any assistance during the call, please press star 0. I would now like to hand the conference over to your speaker today, Mr. Alex Lobo, Investor Relations. Mr. Lobo, the floor is yours.

Good morning, and welcome to the Alanos Therapeutics First Quarter 2022 Financial Results Conference Call and Audio Webcast. With me today is Kevin Boyle, Sr., Chief Executive Officer, Drew Deniger, Vice President of Research and Development, and Mike Wong, Vice President of Finance. Earlier this morning, Elanos issued a press release announcing financial results for the three months ended March 31st, 2022. We encourage everyone to read today's press release, as well as the Elanos quarterly report on Form 10Q for the quarter ended March 31st, 2022, which was filed this morning with the SEC. The company's press release and quarterly report will also be available on the Elanos website at elanos.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 is accurate only as of the date of this live broadcast, May 16, 2022. Actual results could differ materially from those stated or implied by forward-looking statements made today 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 live webcast, except as may be required by applicable securities law. With that said, I would like to turn the call over to Kevin Boyle. Kevin?

Thank you, Alex, and welcome, everyone, to the Alanos Therapeutics First Quarter 2022 Earnings Call. Our team has been working diligently to advance our strategy of generating meaningful clinical progress and delivering shareholder value. I am proud of our team and the significant progress made since we last spoke. we recently announced the successful dosing of the first patient in our Phase I-II TCRT library trial. We expect to continue to enroll and treat patients in this trial in accordance with our manufacturing capabilities. We also have two posters that have been accepted at upcoming scientific conferences, namely ASGCT later today and ASCO in early June. Drew will provide additional details on both posters in just a couple of minutes. I would like to focus today's call on our TCRT library trial. As you may recall, this Phase I-II study is a basket trial, targeting hotspot mutations across six solid tumor indications, non-small cell lung, colorectal, endometrium, pancreas, ovary, and bile duct cancers. We are enrolling patients at MD Anderson Cancer Center with one of these six cancers based on matching neoantigen HLA pairings that are available in our TCRT library. Our library consists of 10 TCRs, 4 KRAS, 5 TP53, and 1 EGFR. Two weeks ago, we reported that we dosed the first patient in the trial. The patient has non-small cell lung cancer, and has now cleared the 28-day safety window. The patient was treated with TCRT cells targeting a KRAS G12D mutation. The trial design calls for the first imaging at six weeks post-infusion. With the Bayesian trial design, it is possible that the second patient in the study will be dosed at the second dose level. That decision will be made at a later point in consultation with the investigators. As excited as we are to have treated the first patient, we are actively working to consent and enroll additional patients in this trial. In collaboration with MD Anderson, we have screened approximately 500 lung or colorectal patients for both tumor mutation and HLA. We have found greater than 5% of the patients match one of the TCRs in our library. We expect to report initial data from the TCRT library trial at a medical meeting in the second half of this year, potentially ESMO or the sixth annual CRI-ENCI-AACR International Cancer Immunotherapy Conference. We do not intend to provide a patient-by-patient update or provide readouts before the chosen conference. With regards to manufacturing, the dose received by the first patient represents the first clinical product that has been fully manufactured using our in-house CGMP suite. This is a great accomplishment and a testament to our team's dedication over the last year in building out our in-house capabilities. As we noted on our previous quarterly call, our current anticipated capacity in the CGMP suite allows for the manufacture of approximately one product per month. We believe this will be sufficient to support our clinical efforts throughout the rest of this year. However, we recognize that as we expand the program, we will require additional capacity. To do this, we are implementing a three-pronged strategy to expand our manufacturing capabilities, of which we are already working on the first two. First, we are working to implement SOPs that will allow for simultaneous production of multiple products. This includes further optimizing our manufacturing process by introducing cryopreserved cell product. Second, we are working to hire additional staff to support multiple shifts. And third, as we raise additional capital, we will investigate physically expanding our CGMP footprint. I would like to turn the call over to Drew now to highlight our upcoming scientific presentations. Drew?