Alaunos Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Alano's Therapeutics fourth quarter and full year 2021 financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. If you require operator assistance during the program, please press star zero. I will now turn the call over to your host, Alex Lobo, Stern Investor Relations. You may begin.

Good morning and welcome to Alano's Therapeutics fourth quarter and full year 2021 financial results conference call and audio webcast. With me today are Kevin Boyle Sr., ALANA's Therapeutics Chief Executive Officer, Drew Dennegar, Vice President of Research and Development, and Mike Wong, our Vice President of Finance. Earlier this morning, ALANA's issued a press release announcing financial results for the three months and full year ended December 31st, 2021. We encourage everyone to read today's press release as well as the ALANA's annual report on Form 10-K for the year ended December 31st, 2021. which was filed this morning with the SEC. The company's press release and annual 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 provision 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 30, 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 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?

Thank you, Alex, and welcome, everyone, to the Alanos Therapeutics fourth quarter and full year 2021 earnings call. It has been just over six months since I joined the company, And in that time, we have made great strides advancing our novel TCRT program for the treatment of solid tumors. Our vision for the year is all about execution and delivering clinical results. I'm very proud of the team as we have made meaningful progress across both our clinical and preclinical pipeline, all the while being good stewards of capital and significantly reducing spend. I want to begin by reiterating the confidence that we have in weaponizing our TCRTs to attack solid tumors. Our team is motivated to treat patients and translate our expertise and unique scientific approach into clinical progress. We appreciate the importance of generating clinical data to validate our TCRT platform and create shareholder value. Our TCRT library study is a basket trial targeting hotspot mutations across six solid tumor indications, non-small cell lung cancer, colon, rectum, endometrium, pancreas, ovary, and bile duct cancers. This study is an open-label dose escalation study being conducted at MD Anderson Cancer Center and will enroll patients with one of these six cancers based on matching neoantigen and HLA pairings that are available in our TCRT library. In December, we further amended the study's IND application to include evaluation of an additional four TCRs. Our library now has a total of 10 TCRs, four KRAS, five TP53, and one EGFR. The addition to the library further increases the addressable market and pool of patients eligible for the trial. Once enrolled, patients will be infused at one of three dose levels with autologous T-cells that have been engineered to express TCRs using our Sleepy Beauty transposon technology that are reactive against such mutated neoantigens. We believe that this adaptive trial design is an optimal approach to advancing our TCRT library as it should allow us to rapidly identify the recommended dose and then cost-effectively advance multiple indications in the clinic. We are one step closer towards value creation as we have consented the first patient in our study and anticipating treating our first patient in the second quarter. The manufacturing for this trial will be performed at our own state-of-the-art CGMP manufacturing facility, which we built in 2021. This facility has been fully qualified and is staffed entirely by Alano's personnel for the manufacture and release of clinical product. The current anticipated capacity in the CGMP suite this year allows for the manufacture of approximately one product per month. Before I turn the call over to Drew Deniger, our Vice President of Research and Development, for an update on our pre-clinical programs, I would like to thank Raffaele Baffa for his service to the company. As per our 10-K filed earlier today, Raffaele will depart his role as Chief Medical Officer effective tomorrow. His contributions over the last year to update the clinical trial design for our Phase 1-2 TCRT library study and successfully amend the IND application, have helped position Elanos for success. Raffaele remains a shareholder and firm supporter of the Elanos TCRT platform. We wish him all the best on his future endeavors. We have engaged a consultant with over 30 years of experience in clinical and drug development, and we will also leverage the expertise of our board member, Dr. Chris Bowden. I'd like to turn the call over now to Drew to highlight our research and development efforts.