MiNK Therapeutics, Inc.

Good morning, and welcome to Mink Therapeutics' fourth quarter and full year 2022 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 will now turn the call over to Zach Arman, Head of Investor Relations at Mink.

Thank you, 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 contain forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. Joining me today on the call are Dr. Jennifer Buell, President and Chief Executive 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 in 2022 and plans for the year ahead.

Thank you so much, Zach. Good morning, everyone. Thanks for joining our fourth quarter and full year 2022 earnings call. It's a great pleasure to be with you today and to share an update on the progress of our company. And I'm really excited and proud to share that our dedication to advance the field of cell therapy has yielded quite exciting and differentiated results in 2022 and set us up for a very active 2023. We've made important strides in advancing INKT cells, our platform, in generating critical data in research as well as in the clinic, some of which we've already presented publicly and more of which will be coming your way this year. Recall that Agent 797, our lead product advancing in the clinic, is an allogeneic, unmodified, or naked INKT cell. These cells have shown promise as a monotherapy as well as in combination with approved anti-PD1s, Keytruda or Opdivo, in clinical trials. And these are trials in patients that are heavily pretreated with solid tumor cancers. We're excited to present an update on this progress at the upcoming AACR meetings next month, and we'll also be announcing our plans for developing INKPs in solid tumor cancers such as non-small cell lung cancer and relapsed refractory gastric cancer in collaboration with world leaders in these diseases. These data build upon our earlier presentation at the Society of Immune Therapy for Cancer, or CITC, conference in Boston last November. We also detailed our findings in our inaugural R&D day last November, where we reported on our lead program, and we showed that it can be demonstrated tolerably alone and in combination with commercially approved anti-PD1s. We demonstrated that we could dose patients tolerably up to a billion cells per dose without lymphodepletion and with no observations of cytokine release syndrome, CRS, or neurotoxicity. These data enable the development flexibility to deliver the benefit of these cells without toxicity observed with first-generation cell therapies. Furthermore, we concluded our Phase I study of 797, our allo-INKTs, in patients with viral ARDS. We reported 70% survival, which compares favorably to in-hospital control and CDC data of survival rates of 10% to 22%. Even more compelling were the observations of a reduction in secondary infections that are oftentimes fatal in patients in the ICU. We've submitted these data to a top-tier journal and expect a publication this year. Now, these results in patients with viral ARDS have generated great interest from government and public financing and private financing opportunities. We're currently in discussions to externally finance the development of INKT cells in acute infections and associated fatal consequences like respiratory distress, an indication for which there are no approved therapies. We'll be providing more updates on the advancement of these discussions this year. The development of allo-INKTs and indications outside of oncology is only made possible through the manufacturing productivity that our team has made. MINK has addressed the limitations of the use of cell therapy products beyond oncology and in infections in many ways. First, we focused on the development of INKT cells, which have shown promise in treating viral infections and respiratory illnesses by using INKT cells We can avoid some of the limitations associated with traditional cell therapies, such as the need for matching donors and recipients, the use of lymphodepletion, and the limitations of cost and scalability. We've addressed this. We've invested in high-throughput manufacturing technology, which allows for the rapid production of large quantities of INKT cells. generating billions of cells from a single donor and thousands of doses per donor. Our process is now FDA cleared for implementation into our clinical trials without external dependency. Our manufacturing approach is designed to make INKT cell therapy more accessible to patients and to improve the scalability of cell therapies overall. As we continue to make progress in our clinical programs, we're also making important advancements in deepening our understanding of the novel mechanisms of action of INKT cells and their unique advantages over available cell therapies. At the end of last year, we presented data elucidating the long hypothesized mechanism of INKT cells that underscore their potential as a highly effective living medicine for patients with cancer. Specifically, Our scientists demonstrated that INKTs have the killing power of NK cells and the memory of T cells. They activate dendritic cells. These are signalers that help the immune system recognize tumors. We've shown that INKTs also kill M2 macrophages. M2 macrophages are immunosuppressive cells that constrain the body's ability to fight tumors. And we also reported that INKTs can restore the tumor killing capacity of exhausted T cells. This is a very important mechanism in which CD8 T cells become exhausted and lose their tumor fighting capability. And as we reported at CITSE last year, INKTs can overcome this mechanism and reinvigorate exhausted CD8 T cells, restoring their killing capacity. These mechanisms help to explain some of the early signals of benefit that we've observed in solid tumor cancers. Additionally, our research team has made important progress on our pipeline, including the development and advancement of MINK215. MINK215 is an armored IL-15 FAP CAR INKT designed to target the tumor stroma and modulate the tumor microenvironment to increase tumor killing capability. Targeting FAP, which is fibroblast activation protein, with CAR INKTs, these are chimeric antigen receptor invariant natural killer T cells, can benefit patients in several ways. FAP is a protein that's found in high levels in the stroma of many evasive solid tumor cancers, but it's absent in most normal tissues. By targeting FAP CAR INKT, we could specifically seek out and destroy cancer cells that express FAP while leaving healthy cells intact. Moreover, FAP is known to play a key role in promoting tumor growth and metastatic disease, and FAP inhibits the body's immune response against cancer. So by targeting FAP with CAR-INKT, it's possible to overcome these barriers of resistance and activate a potent immune response against cancer. So in summary, targeting FAP with CAR-INKTs can provide a highly specific and effective approach to fighting cancer while minimizing damage to any healthy tissues and boosting the body's natural immune defense. The molecule is an IND-enabling studies for an IND submission planned in 2024. Now, we are in dynamic markets and a unique time where fiscal responsibility and prudence will be critical to delivering the value of our science and the potential of our technology for patients with cancer. Partnering remains core to our strategy to fully leverage the potential of our platforms and products quickly, and these include public and private collaborations. At Mink, we'll focus our internal efforts on deepening our datasets and select solid tumor cancer indications where INKTs can complement available and approved standard of care and we believe expand the benefit of available therapies to patients with specific tumor types and will further elucidate our development plans with the data release at the upcoming AACR conference. We will continue to leverage our research productivity and exciting findings outside of oncology through strategic collaboration. I will now turn the call over to Christine to go over our financials. Thank you, Jen.