Alaunos Therapeutics, Inc.

Good day and thank you for standing by. Welcome to the Alano Therapeutics 4th Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Danielle Dungeon with Stern IR. Please go ahead.

Danielle Dungeon Good morning and welcome to the ALONOS Therapeutics fourth quarter and full year 2022 financial results conference call and audio webcast. Earlier this morning, ALONOS issued a press release announcing financial results for the three months and full year ended December 31, 2022. We encourage everyone to read today's press release, as well as the Alanos annual report on Form 10-K for the year ended December 31st, 2022, which was filed with the SEC this morning. The company's press release and annual report will also be available on the Alanos website at alanos.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, March 7, 2023. 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 filing 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 me today are Kevin Boyle Sr., Chief Executive Officer, Drew Deniger, Vice President of Research and Development, Abhi Srivastava, Vice President of Technical Operations, and Mike Long, Vice President of Finance. With that said, I would like to turn the call over to Kevin.

Thank you, Danielle. Good morning, and thank you for joining us today for an update on the exciting progress we are making here at Alanos. 2022 was a transformational year for Alanos Therapeutics as we achieved several meaningful corporate milestones, including advancing our library TCR T-cell program into the clinic and subsequently achieving our first objective clinical response. We are a highly focused company, committed to leading the scientific development of T-cell receptor therapies to revolutionize solid cancer treatment and improve patient outcomes. I'm extremely proud of our team's work in realizing the promise of our novel technologies and R&D efforts with clinical execution. We believe TCRT, targeting high frequency driver mutations, is potentially the most promising advanced immunotherapy to kill solid tumors. We are proud to be on the leading edge of cell therapy. We are the first company to demonstrate an objective clinical response in a patient with a solid tumor using a non-viral TCRT cell therapy. We are encouraged and motivated by the significant interest these results have since generated among physicians, patients, investors, potential partners, and other key stakeholders. Every day, multiple patients are reaching out to inquire into our clinical study from across the country. This growing momentum provides a tremendous foundation for the year ahead. We have been hard at work to ensure that we can meet our TCRT Library Phase 1-2 program milestones in 2023. In the fourth quarter, we filed an IND amendment for the trial. As part of this amendment, we made several critical enhancements to our enrollment and manufacturing processes. First, We combined our treatment and screening protocols, streamlining enrollment, making it easier for both patients and physicians. Second, we are no longer required to retest the patient's tumor mutation if more than six months has passed between screening and treatment, which will allow for faster accrual. We are confident that these driver mutations will be retained as they are at the core of the cancer. Lastly, we added cryopreservation to our manufacturing process. Cryo reduces the manufacturing process time from 30 days to 26 days, while simultaneously increasing flexibility for patient scheduling and treatment. As we look ahead, cryopreservation also allows us to open additional trial sites outside of Texas. And yes, contrary to the common belief of many Texans, There is a big world outside of this great state. In this expansive IMD amendment, we again added to our industry-leading TCR library for use against solid cancers with two new TCRs targeting frequent mutations and HLAs. This addition effectively doubles our eligible patient pool for the study. with now more than 10% of all patients screened for our trial at MD Anderson matching a library TCR. Taken together, we are confident that these changes will enable us to increase the pace of enrollment in our trial, allowing us to become Phase II ready by the end of the year. I'd like to talk about our TCRT Library Phase I-II trial and what this year will look like. as we move towards phase two readiness. As you will recall, this is a basket trial targeting driver mutations across six solid tumor indications, non-small cell lung, colon, endometrium, pancreas, ovary, and bile duct cancers. We are actively enrolling patients at MD Anderson with any one of these six cancers based on matching both a specific mutation and HLA combination to a TCR that is available in our library. As a result of the most recent IND amendment, our TCR library now consists of 12 TCRs, 5 KRAS, 6 TP53, and 1 EGFR. In December, we successfully dosed the third patient in the trial. This patient was diagnosed with pancreatic cancer with a tumor expressing HLA-A11 and KRAS-G12V mutation, matching one of the TCRs within our TCR library. The patient was treated at the second dose level with 58 billion TCR T-cells. As with the first two patients, patient three had a manageable safety profile with no DLTs or ICANS observed. The flexibility of our platform is astonishing with the first three patients on the study representing three distinct indications being treated with three different TCRs. As we treat additional patients, we believe that presenting safety and efficacy data on multiple patients at the same time is the most credible, clinically meaningful, and industry standard practice. and we look forward to sharing additional Patient 3 data with other patient results later this year. We will remain flexible on what venues we use to provide patient updates, when we provide updates, and how many patients will be included in each update based on what is in the best interest of the company. In total, we anticipate treating between 12 and 15 patients in the Phase 1 portion of the trial. With three patients having been dosed in 2022, we are confident that our growing patient pipeline and manufacturing capacity will support treating the remaining balance of patients this year. Our resolve and commitment to developing the best-in-class TCRT cell therapies has been strengthened by the growing momentum we are seeing in the patient and physician interest in our trial. Now before I hand the call over to Drew, I'll briefly speak to our financial position. In December, we completed a follow-on offering where we raised approximately $15 million in gross proceeds despite the most challenging market conditions facing the biotech industry over the past five years. As responsible stewards of the company, the Board carefully evaluated all available financing options and firmly believes that this was the right decision to allow the company to continue to advance our pioneering science. For perspective, in 2022, only 58 follow-on financings were completed compared to over 200 in the years prior. As one of the few companies to close a financing at market terms without issuing warrants, the promise of our science and technology was recognized by investors. The additional cash has allowed us to extend our runway into the fourth quarter and should enable us to accelerate the enrollment of patients and the manufacturing of clinical products to generate additional, meaningful clinical data this year. Now let me hand the call over to Drew to highlight our ongoing R&D efforts and discuss where we see opportunities to explore next-generation TCR T-cell therapies to further deepen clinical responses. Drew?