MiNK Therapeutics, Inc.

Good morning and welcome to Mink Therapeutics' first quarter 2024 conference call and webcast. All participants will be in a listen-only mode until the question and answer session. Please note this event is being recorded. If anyone has any objections, you may disconnect at this time. I would now like to turn the conference over to Zach Arman from Mink's Investor Relations. Zach, please go ahead.

Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities, among other updates. These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, Dr. Mark Van Dyke, Chief Scientific Officer, and Christine Klaskin, Principal Financial and Accounting Officer. Now, I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter.

Thank you, Zach. It's a privilege to connect with all of you this morning to discuss our achievements in the first quarter and the milestones that advance our long-term strategic goals. Today, I will highlight our latest clinical advancements, notably in our leading programs, Agent 797 and Mink 215. I will also discuss our strength in financial foundation and outline our plans for sustained innovation and growth. Let's start by our progress in streamlining operations and our financials. This quarter, we focus on advancing our pipeline, improving our operational efficiency, and fortifying our financial health. Since this time last year, we have successfully reduced our operating expenses by over 45% through improved manufacturing efficiency, strategic infrastructure alignment, and most critically, the external non-dilutive financing to support our ongoing phase two trial and second line gastric cancer. This financial prudence has enabled us to allocate resources more effectively towards accelerating our key clinical programs. Importantly, yesterday we announced an investment of $5.8 million at a 25% premium from a new investor committed to our vision. This funding will be dedicated to support the rapid advancement of MINK215, our innovative CAR-INKT cell therapy targeting fibroblast activation proteins. or FAP in solid tumors. MINK215 is our lead program from our discovery pipeline that we are particularly excited about. And this investment underscores the unique potential of the program. We've previously presented data at the American Society of Cell and Gene Therapy showing exciting preclinical activity of MINK215 and FAP expressing non-small cell lung cancer tumors. More recently, as a matter of fact, just this past month at the American Association of Cancer Research, or AACR, annual meeting, our scientists presented compelling data demonstrating 215's ability to eradicate tumors in human organoid models of colorectal cancer with liver mets. These recent advancements build on our prior findings and position 215 as an important component in addressing the urgent need for effective treatments in colorectal cancer. This is now the leading cause of death in men under 50 and the second in women in that same age category. Our findings show that administration of MINK215 not only improves immune-mediated tumor destruction, but also targets and depletes immune-suppressive FAP-expressing stellate cells, thereby enabling increased immune infiltration or CD8 T-cell infiltration into the tumor. More simply, this mechanism enhances the body's ability to mount a robust T-cell response against liver mets, which can be further amplified by the combination with immune checkpoint inhibitors. While Mark is going to go through this in more detail, our scientists demonstrated this benefit with a combination of MINK215 and a Genesis late-stage antibody, botanfilumab, a multifunctional T-cell activator. and Balsilumab, a PD-1 antagonist, which are advancing in late-stage clinical trials. These were the data that were presented at AACR, and Mark will highlight these in just a few moments. Now, I will turn to our lead program, 797, and as a reminder, this is our allogeneic, unmodified IMKT cell therapy advancing in Phase II clinical trials. In February, we achieved a significant milestone for this program with the launch of the Phase II investigator-sponsored study, an externally funded program in second-line gastric cancer. This pivotal trial is evaluating a combination of 797 with botanosilumab and valosilumab. And this combination is on top of standard of care chemotherapy. The study is led by Dr. Yelena Genjigian. She's the chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center. And the program is supported and funded by Stand Up to Cancer, an organization dedicated to funding and developing the most innovative and promising cancer research. Enrollment in the trial is actively underway. We eagerly anticipate initial data from the trial, which we expect later this year. Beyond cancer, we've also continued to advance 797 and pulmonary diseases, specifically in severe respiratory distress. This is a condition affecting over 600,000 individuals annually in the US alone. Most recently, the full data set from our Phase 1 clinical trial was published in Nature's Communications just a couple of months ago. These data highlighted the clinical activity and important role that INKT cells play in this disease. There are currently no effective or active or approved therapies for patients with severe respiratory distress. We are excited to share additional updates from 797 at the upcoming American Thoracic Society 2024 Annual Meeting, or the APS meeting in San Diego, California on May 21st. Dr. Therese Hammond, a critical care and pulmonology expert, will present the data from the continued dosing of patients with severe respiratory distress through our compassionate and expanded access mechanisms. Her latest case is a patient following renal transplant who was diagnosed with severe acute respiratory distress and treated with 797 under emergency use. While the data have not yet been disclosed and will be disclosed at the conference, this presentation further supports our previously published data and underscores a significant unmet need and severe respiratory distress. We're excited about the potential of INKT cells to make a meaningful difference in the lives of these patients, and we expect further updates on this program in the months ahead. Overall, the progress we've made this quarter positioned us to accelerate the development of our INKP cell platform and programs, and these include programs that are actively advancing in the clinic as well as our lead discovery programs. We'll also expand and continue our in-house manufacturing of INKP cells, setting the stage for an exciting year in 2024 with 797 and pulmonary respiratory distress, and the advancement of our Phase II trial in gastric cancer. We continue to be unwavering in our commitment to improving patient outcomes, and we deeply appreciate your continued support. I'm now going to turn the call over to Dr. Mark Van Dyke to provide deeper insights into the MINK 215 program. Mark?