MiNK Therapeutics, Inc.

Good day and welcome to the Mink Therapeutics second quarter 2022 earnings conference call. Please note today's conference call is being recorded. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star followed by the number one again. Thank you. At this time, I would like to turn the conference over to Kimberly Haw, Head of Investor Relations.

Thank you, Operator, and thank you all for joining us today. Today's call is being webcasted 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 Beal, President and Chief Executive Officer, Dr. Joy Zhou, Vice President of Manufacturing, Christine Klaskin, Principal Financial and Accounting Officer, and Melissa Orlel, Director of Global Financial Operations. Now, I'd like to turn the call over to Dr. Buhl to highlight our progress and speak to our outlook for the remainder of the year.

Thank you very much, Kimberly, and thank you all for joining us for our first quarterly earnings call. Mink Therapeutics was launched as an IPO just about 10 months ago, and today, We stand as the most advanced company pioneering allogeneic or off-the-shelf invariant natural killer T cells, or INKT cells, in three active clinical programs. We have shown that we can isolate these cells from healthy donors. We can produce them at scale in our in-house GMP manufacturing suite. And we've also demonstrated that our product retains full potency and tumor-killing efficiency. potential after freezing. Thus, for all of our clinical trials, our cells are at the site when the patient needs them. Our focus is on isolating the most highly conserved cells in immunity and delivering them to patients who need them most, patients whose immune system has failed to eliminate cancer or prevent serious complications from infection. Currently, we have three active clinical programs, and we expect to share data from these programs at a conference this year. As a pioneer in the field, we appreciate that MINK must not only advance science at record-breaking paces, but also contribute to the growth of information in the application of INKTs and immune-related diseases. By way of background, our immune system has two distinct arms to immunity, innate and our natural immunity, that which we are born with and responds immediately when faced with a threat, and adaptive immunity, that which we acquire over time to adapt to new external threats, like COVID-19. At MINK, we are pursuing INK T-cells because of their unique properties to modulate both arms of immunity and leverage the strengths of both T-cells and NK-cells. This makes them critical in every line of the body's natural defense. So what happens without IMKT cells or when these cells are in limited quantity in vivo? What we've shown in preclinical models and in humans, when IMKT cells are not functional or are deficient, we observe the development of autoimmune diseases such as diabetes, heart disease, asthma, and cancer. A remarkable feature of these cells is their invariant T-cell receptor, or TCR. This receptor is common in everyone, and this allows us to isolate cells from one individual, a healthy donor, and deliver them to another individual, or a severely ill patient. Without engineering the cells, and without rejection from the recipient, there is no graft versus host disease. with these cells. In fact, we actually have evidence to suggest that INKT cells could actually prevent rejection. They may help patients accept transplants and prevent graft versus host disease subsequently. This is why we're pursuing our INKT cell therapies for cancer and other immune-related or immune-mediated diseases. We expect these cells to have a major impact with a significant effect specifically in solid tumor cancers. That's our focus. And Minx developed the platform to achieve this. For cell therapies to deliver transformative benefits across the majority of tumors, and I'm talking about solid tumor cancers, they need to be affordable, effective, and able to be manufactured at scale. And our recent progress, including the full internalization of our discovery platforms, our engineering capabilities, And now our internal GMP manufacturing, we're set up in the best position to deliver for these patients. Our newly appointed chief scientific officer is Dr. Mark Van Dyke, an industry veteran who has built the platforms and technology that have given rise to dozens of clinical and commercial stage novel antibodies, bispecifics, and TCRs, including those at Bristol-Myers Squibb, GenMav, and Agenis. Additionally, we recently appointed Dr. Joy Zhao as head of manufacturing. Joy brings decades of cell therapy, cell and gene therapy manufacturing expertise from J&J, from Takeda, and more recently from Rubeus. And now she's applying those internally here at Mink. Our manufacturing platform and proprietary reagents are set up to deliver more than 10,000 doses annually. These programs and platforms are scalable to deliver nearly a billion doses with our own in-house capacity. Our proprietary reagents and process enable a product that is more than 99% pure INKT cells from healthy donors. And these cells retain their tumor killing potential after lengthy cryopreservation. Thus, they can be stored. and delivered internationally. Our manufacturing team has delivered a process and infrastructure to facilitate a scalable and reproducible manufacturing process for aloe INKTs that are available to the patient the moment they need them. They're currently distributed to our site for clinical trials internationally. We recently recognized our in-house GMP readiness with the completion of our GMP manufacturing runs internally at scale. This is a remarkable achievement and the first known industrialization of native INKT cell manufacturing in the field. Importantly, this progress was completed with an already outfitted manufacturing facility and an experienced team. This was also completed without the capital-intensive requirements commonly necessary for cell therapy production. Today, our lead program, Agent 797, an allo-cell therapy of native IMKT cells, is in three active clinical programs. Our Phase 1-2 study of IMKTs alone, and in combination with Keytruda or Opdivo in patients with solid tumor cancers launched in May of this year, Data readouts are expected at a major conference within the next few months. Our encouraging signals, including the reduction of metastatic liver disease in a patient with refractory rectal cancer, builds on data presentations from the Society of Immune Therapy for Cancer, otherwise known as CIDC, last year. Our leading scientist, Dr. Borju Yist, presented and showed that INKT cells traffic to the liver, lungs, and bone marrow. They lyse tumors, and they persist. We believe that these features will contribute to these cells' ability to bring durable protective benefit to patients with cancer. These data also support the potential benefit of INKT cells over other cell types, like gamma-delta cells and natural killer cells. INKTs are unique in that they can take advantage of their invariant TCR that recognizes the lipid ligand CD1D, which enables the initiation of T cell responses. So importantly, if you think about INKTs with their invariant TCR, they're naturally engineered effectively to home to where they need to go. INKTs also express activating NK cell receptors making them able to initiate a potent NK cell-like cytotoxic response. And importantly, they don't express the inhibitory NK cell receptors, so they can retain and advance that response. Lastly, INK T-cells can modulate the tumor microenvironment and transactivate T-cells and NK cells. We're also evaluating HN797, native LO-INKTs, and relapsed refractory multiple myeloma. While progress has been made with BCMA CAR-T therapies in myeloma, the treatments require cytotoxic lymphodepletion, and the durability is still somewhat underwhelming. Importantly, two-thirds of patients who progress following BCMA CAR-T therapy still exhibit the BCMA antigen. The other feature of multiple myeloma is that it's rich in CD1B ligands, meaning that INKTs will naturally hone to this lipid antigen that's highly expressed in this cancer type. The cells will recruit T cells and NK cells and secrete tumor-killing cytokines without engineering. And importantly, we believe that Agent 797 can be administered without lymphodepletion And we expect that these cells will also improve the durability of response in this tumor type. In our earliest patients treated, we reported lengthy disease stabilization beyond 10 months and suppression of tumor biomarkers in our first treated patient. A 50-year-old male was treated with 100 million cells per dose and experienced a rapid reduction in M-spike protein, a greater than 50% reduction in tumor cells in the bone marrow, and disease stabilization exceeding 10 months. Enrollment's ongoing, and we plan to present more data later this year. These cells are also very active in controlling infection. INKT cells are one of our earliest lines of defense and are particularly active in protecting lung epithelial tissue. This is critical in severe cases of acute respiratory distress, secondary to COVID or influenza, pneumonia, or other related diseases. As such, we've brought our therapy in to help during the heart of the pandemic. Our preclinical data had shown that these cells can extend survival in influenza, mitigate harmful consequences of pneumonia, and treat effectively SARS-CoV-1 and MERS in preclinical models. In our phase one trial of agent 797 and viral acute respiratory distress syndrome, secondary to COVID-19, We previously reported a survival benefit exceeding 77% in our first release of 13 patients. These patients were predominantly elderly, all were on mechanical ventilation, and all had failed available therapies. We completed our phase one cohort evaluation, and we plan to present data before the end of this year, which will include expanded data of survival, as well as other important secondary benefits, of Agent 797. These data have led to our INKT cells identified as selectable for funding by the Defense Advanced Research Projects Agency, or DARPA, to investigate the cells against immune dysregulation in viral infections, including ARDS and influenza. Our next step with DARPA is to evaluate what our collaboration will look like, including and we're thrilled with the possibility of supporting DARPA in mitigating current and future pandemic threats with Agent 797, a potential variant agnostic approach to disease mitigation. We expect to provide more details of our potential collaboration later in this year. In addition to the signals of clinical activity, we've also demonstrated that 797 can be administered in patients with a host of immune diseases with a favorable safety profile at doses now up to a billion cells per dose. We've observed no neurotoxicity or cytokine release syndrome, and we've also been able to deliver these cells without lymphodepletion. MENX-HOLION pipeline spans our next-generation engineered INKT programs, including CARs, PCRs, and bispecific INKT cell engagers. Our BCMA CAR-INKT and stromal-targeting CAR-INKT are both an IND-enabling activities, and we plan to present data on these programs in an upcoming meeting this year. This includes the target selection and first data presentation on our stromal-targeting CAR-INKT for solid tumors. Through our relationship with the genus, we are uniquely positioned to launch novel combinations with our IMKT cells and potential best-in-class immune-activating agents, like a Genesis Boconcilumab. Our priority is to advance Agent 797 in its native form alone and in combination with checkpoint-modulating antibodies with approaches that can lead to rapid registration, such as in combination with standard-of-care agents in cancers, including cancers of the liver, bladder, and lung. At Mink, we remain focused on delivering our allogeneic off-the-shelf therapy to eliminate diseases of the immune system. I appreciate your time, and I will now turn the call over to Christine Klaskin to go over our financials. Christine?