MiNK Therapeutics, Inc. (NASDAQ:INKT) Q3 2022 Earnings Call Transcript November 6, 2022

Operator: Good morning, and welcome to MiNK Therapeutics' Third Quarter 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. 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 time lines 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 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 and speak to our outlook for the remainder of the year.

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Jennifer Buell : Thank you very much. Good morning, and thanks for joining our third quarter earnings call. Today, I'm going to keep my corporate update short and invite you to join us for two very exciting events next week. The first, MiNK was selected to present five abstracts for presentation at the Society of Immunotherapy for Cancer Conference or otherwise known as SITC conference. The conference will be held in our home city of Boston next week. And following our presentations, we will host our inaugural R&D Day event, which will include presentations from leaders of immune therapies for diseases of the immune system, including cancer, infections and autoimmunity. The event will be invite only for in-person participation, but we will also be publicly webcasting the conference as well.

These activities are a combination of significant progress at MiNK. We've continued to advance our invariant natural killer T cell, or iNKT cell platform through multiple clinical trials with our lead product candidate, Agent-797. 797 is an allogeneic or off-the-shelf product in clinical trials designed to administer the product alone or in combination with KEYTRUDA or OPDIVO in solid tumor cancers. We also have advanced our clinical trials in multiple myeloma and severe viral acute respiratory distress syndrome. We've brought these trials to important milestones, which include enrollment completion and data readouts, both of which you'll be hearing more about at the upcoming conference. Our next-generation pipeline is advancing very rapidly.

We recently announced 2 exciting CAR-iNKT programs. These include a novel stromal targeting FAP CAR-iNKT for solid tumor cancers and a soon-to-be disclosed armored BCMA CAR-T program, the latter of which is designed as a next-generation scalable approach to deliver durable benefit without lymphodepletion in patients with multiple myeloma. These CAR-iNKT programs are advancing in IND-enabling studies and we announced that our FAP CAR-iNKT will be filed to an IND in 2023 next year. Both programs are advancing into IND studies at this time. Our engineered CAR-iNKT programs are built from our proprietary CARDIS platform. This is designed for the selection of therapeutic candidates that have an optimal safety program profile and key biologic advantages over available products.

We'll tell you more about our CARDIS platform at the upcoming R&D Day. Our presentations at SITC will include updates on three clinical programs of Agent-797 in heavily pretreated solid tumor cancers in combination with backbone IO therapy as well as data from our trials in viral acute respiratory distressed syndrome and multiple myeloma. Additionally, our team will present data on our novel CAR-iNKT pipeline candidates demonstrating potential first-in-class features with an allogeneic CAR-iNKT approach. Finally, we will be reporting on novel mechanisms that have not yet been observed on iNKT biology as we advance the science of these cells and continue to believe that these features support the optimal therapeutic platform for delivering a scalable cell therapy product.

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Before we head into the conference, I want to take a moment just to provide a refresher on iNKTs. These cells are a subset of T cells. They modulate both innate and adaptive immunity. And in cancer, iNKTs can directly kill tumor cells. They also modulate myeloid biology specifically suppressing myeloid-derived suppressor cells. They also recruit additional immune support by driving T cells and natural killer or NK cells to the location of need. These mechanisms support earlier independent data showing that autologous iNKT cells are clinically beneficial in solid tumor cancers, an area in which other cell therapy approaches have not yet shown benefit. We'll discuss these mechanisms at a much deeper level at the upcoming SITC conference. Beyond cancer, our team has explored the application of these cells as a variant agnostic approach for severe infections.

Viral ARDS takes the lives of approximately 40% of patients in the intensive care unit, and there are no approved products to address this indication. We previously reported an over 75% survival rate in severely sick patients suffering from ARDS, a marked improvement over the expected 22% survival. New findings from our Phase I clinical trial will be presented at the SITC conference by Dr. Terese Hammond. Terese is the Medical Director of the Cardiac Care unit and ICU at St. John's Health Center, and she's a pulmonary critical care expert specializing in critical care medicine, acute respiratory failure and ECMO and has pioneered the COVID-19 efforts. As a matter of fact, Dr. Hammond was courageously on the front lines at the start of the pandemic and one of the first to take patient samples and help identify the SARS-CoV-2 virus.

Our work in iNKTs and severe infections has been selected as fundable by DARPA, and contract negotiations are underway to fund the advancement of Agent-797 in diseases of immune dysregulation. We look forward to additional announcements on this program. Finally, our presentations at SITC will also outline our key pipeline programs, namely MiNK-215, an allogeneic FAP CAR-iNKT, which we believe has the potential to be a differentiated therapeutic agent for solid tumor cancers. We'll also disclose details regarding MiNK-413, an armored BCMA CAR-iNKT, which is an off-the-shelf product designed as a next-generation scalable approach to deliver benefit without lymphodepletion in patients with multiple myeloma. This is a program that we continue to consider to advance through strategic collaborations.

Again, these programs are the culmination of our strong advancements at MiNK, spanning key pillars across research, clinical data and manufacturing. Earlier this year, we announced our internalization of our GMP manufacturer to enable independence in delivering these cells at scale. You'll be hearing more about our manufacturing capabilities from Dr. Joy Zhou, our Head of Manufacturing, at our upcoming R&D Day. I'm going to stop there and invite you to learn more at our upcoming R&D Day on November 10 from 4 to 6 p.m. Featured speakers will include members of our management team, our leading scientists and pioneering leaders in cancer immunology and biology, including Dr. Manuel Hidalgo, Chief Hematology and Oncology at Wild Cornell Medical Center in New York; Dr. Lydia Lynch, Head of the Lynch lab at Harvard and Brigham; Dr. Terese Hammond, the Program Director of the CCU and ICU at Providence St. John's Hospital in California and the lead investigator on our ARDS program; Dr. David Einstein, a leading medical oncologist and specialist in GU oncology at the Harvard Beth Israel Deaconess Medical Center and lead investigator on our solid tumor cancer program.

The R&D Day will be webcast live and institutional investors, analysts and others are invited to attend in person through special invitation. We look forward to providing further updates on our progress and upcoming data releases at SITC and our R&D Day. I will now turn the call over to Christine to go over our financials.

Christine Klaskin : Thank you, Jen. We ended the third quarter 2022 with a cash balance of $24.2 million as compared to $38.9 million at December 31, 2021. Cash used in operations for the 9 months and third quarter ended September 30, 2022, was $14.4 million and $5.6 million, respectively. This compares to $11.1 million and $3.5 million for the same period in 2021. This expanded funding was primarily related to the internalization of our manufacturing of Agent- 797 that Jen just mentioned. Net loss for the quarter ended September 30, 2022 at $6.3 million or $0.19 per share compared to a net loss for the same period of 2021 of $14.3 million or $0.59 per share. Net loss for the 9 months ended September 30, 2022, was $20.2 million or $0.60 per share compared to $24.4 million or $1.01 per share for the nine months ended September 30, 2021. I will now turn the call over to our operator.

Operator: Emily Bodnar with H.C. Wainwright. Your line is open.

Emily Bodnar : Hi, good morning and thanks for taking the questions. I just have two on Agent-797. First, when do you think you'll evaluate other combination agents like the CTLA-4 inhibitors? And do you have plans to maybe evaluate other combinations, beside checkpoint inhibitors? And then on the Phase I study in your combination arm, I believe you're evaluating patients who are checkpoint inhibitor experienced. So do you think you would evaluate patients who are checkpoint naive at any point? Do you have any plans to do that?

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