Alaunos Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Alana's Therapeutics third 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'll need to press star 1 1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Alex Lobo, with Stern Investor Relations. Please go ahead.

Thank you. Good morning, and welcome to the Alanos Therapeutics third quarter 2022 financial results conference call and audio webcast. Please note that today's webcast contains slides, which are available through the audio webcasting platform. A copy of the presentation will be available on our website after today's call. Earlier this morning, Alanos issued a press release announcing financial results for the three months ended September 30th, 2022. We encourage everyone to read today's press release, as well as the Alanos quarterly report on Form 10-Q for the quarter ended September 30th, 2022, which was filed this morning with the SEC. The company's press release and quarterly 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 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, November 14th, 2022. Actual results could differ materially from those stated or implied by forward-looking statements made on today's call 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 it may be required by applicable securities law. With me today are Kevin Boyle Sr., Chief Executive Officer, Abhi Srivastava, Vice President of Technical Operations, Drew Denneker, Vice President of Research and Development, and Mike Wong, Vice President of Finance. With that said, I would like to turn the call over to Kevin Boyle. Kevin, you may begin.

Thank you, Alex. And as we finish this Veterans Day weekend, I just want to thank you to all those folks that have served our country. Good morning to everybody today. We appreciate you joining us for an update on the remarkable progress we have made over the past year. As you can see on slide four, our team has worked diligently to transform our promising technology and research and development efforts into meaningful clinical progress. We are very pleased to report that we achieved the first in human confirmed partial response in our clinical trial for a patient treated with sleep and beauty TCRT cells. It is even more impressive that this response happened at the first dose level. We've been gaining momentum in our TCRT library phase 1-2 trial as we are working closely with our investigators to identify patients at MD Anderson who have a match to one of our TCRs in our library. I am pleased to say that we anticipate treating our next patient before the end of this year. In our manufacturing suite, we have updated our standard operating procedures and hired additional personnel so we can manufacture multiple products at the same time, increasing potential throughput in our state-of-the-art C-GMP suite. We have consistently produced high-quality TCR T-cells at clinical scale and have successfully manufactured our product at the second dose level. We continue to advance our Hunter program, identifying new TCRs to add to our library, thereby increasing the addressable market for our TCRT cell therapy. We remain committed to being strategic and prudent with our cash spent. I believe we have demonstrated our good stewardship of shareholder capital as our highly engaged team of employees continues to advance our programs while spending less than half compared to last year. On slide five, we remind you of our pipeline. The company's success is not based on a single product. Alanos is a promising solid tumor platform. We are differentiated from other TCR-T companies in that we target hotspot mutations with T-cells that have been transposed with TCRs using our proprietary non-viral sleeping beauty technology. Our lead program is the TCR-T Library Phase 1-2 trials. It is a basket trial targeting hotspot mutations across six solid tumor indications, lung, colorectal, endometrium, pancreas, ovary, and bile duct cancers. We are actively enrolling patients at MD Anderson Cancer Center with one of these six cancers based on matching mutation and HLA pairings that are available in our TCR library, which currently consists of 10 TCRs, four KRAS, five TP53, and one AGFR. Three of these 10 TCRs have been associated with confirmed partial responses in a clinical setting, giving us great confidence in the power of TCRs to treat solid tumors. We'll speak in a moment about the confirmed partial response we saw in our trial at the first dose level in a patient treated with a KRAS TCR, as well as provide an update on this patient at the six-month mark. A second TCR we have in our library was the subject of a case study in the New England Journal of Medicine involving a pancreatic cancer patient with a partial response to one of our KRAS TCRs. The third TCR yielding a clinical response was reported by the NCI and was a breast cancer patient treated with the same TP53 TCR as our second patient. We will now provide an update on our clinical program. Recently, we had the honor of being invited to showcase early data from our Phase 1-2 trial in a proper talk at the CRI ENCI AACR 6th International Cancer Immunotherapy Conference, or SCICON 22 for short. As we turn to slide 7, we will share our great enthusiasm and excitement over the early clinical data from this trial. The findings presented at SCICON 2022, to our knowledge, represent the very first time that an objective clinical response was observed using a non-viral TCRT cell therapy in a solid tumor. The team is very excited to be among the leaders in the field, and the team's working hard to achieve even greater accomplishments. We are pleased to disclose data from our first two patients who were treated at dose levels one and two, respectively. Moving from dose level 1 to dose level 2 in the first two patients highlights the strength of our adaptive clinical trial design and robustness of our manufacturing platform. We observed a manageable safety profile in both patients with no dose-limiting toxicities. We were also able to detect TCR T-cell persistence out to six months. Most excitingly, our product is efficacious. achieving a confirmed partial response in the first patient at the lowest dose level. This early clinical validation has reinforced our belief that we are taking the right approach targeting tumor-specific hotspot mutations using our commercially scalable, non-viral Sleeping Beauty technology. We've produced evidence that our technology is safe, the cells persist, and our product is efficacious. Now I used to live in horse country in Louisville, Kentucky, and we would call this a winning trifecta. We are very excited about the promising results and the buzz created by this early data, generating increased interest from patients and clinicians alike. We are actively working with our investigators at MD Anderson to screen and enroll additional patients into the trial, and we anticipate the next patient being treated in the fourth quarter. I'd like to provide an in-depth review of the results that we presented at SCICON, in addition to highlighting six-month follow-up data from patient number one. On slide nine, you can see that the first patient dose was diagnosed with non-small cell lung cancer, had previously progressed on multiple prior lines of treatment, and was refractory to checkpoint inhibitors. The patient had HLA-A11 and a KRAS G12D mutation, matching one of the 10 TCRs within our library. This patient received standard CyFlu lymphodepletion prior to an infusion at the first dose level of 9 billion TCR T-cells, which were produced by our employees using Sleeping Beauty at our in-house CGMP manufacturing facility. The potential power of our TCR T-cells is supported by these scans, with the patient experiencing complete resolution, of a non-small cell lung cancer target lesion in their right lower lobe, shown in red circles through week 24. There was also significant and durable reduction of non-measurable disease in the right lung, as noted in the orange circles. Moving to slide 10, you can see that the patient also experienced a sustained reduction in their right upper lobe lesion