MiNK Therapeutics, Inc. (NASDAQ:INKT) Q4 2023 Earnings Call Transcript

MiNK Therapeutics, Inc. (NASDAQ:INKT) Q4 2023 Earnings Call Transcript March 21, 2024

MiNK Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-0.16 EPS, expectations were $-0.15. INKT isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good day everyone, and welcome to the MiNK Therapeutics’ Fourth Quarter 2023 Financial Results. Today’s call is being recorded. All lines have been placed on mute to prevent any background noise and after the speakers’ remarks, there will be a question and answer session. [Operator Instructions] I would now like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.

Zack Armen: Thank you, Lisa, 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 Doctor Jennifer Buell, President and Chief Executive Officer; Christine Klaskin, Principal Financial and Accounting Officer and Doctor Marc Van Dijk, Chief Scientific Officer. Doctor Joy Zhou, Head of CMC is also here for any questions. Now, I’d like to turn the call over to Doctor Buell to highlight our progress in 2023 and to speak to our outlook for 2024.

Jennifer Buell: Thank you very much, Zack. It’s a pleasure to have you all with us this morning to hear about our accomplishments throughout the course of last year and what we plan to do in 2024. Throughout 2023 and into the beginning of this year already, we’ve achieved some significant milestones that I’m going to go through today. And these are all related to advancing our allogenic iNKT or Invariant Natural Killer T cell programs. Notably, we initiated phase – a phase 2 trial in gastroesophageal cancer, a development I’ll delve into very shortly. This pivotal program built upon crucial data presented at four major medical conferences throughout the course of 2023, along with the publication of our findings in esteemed journals, such as Nature Communications and Oncogene.

Our comprehensive dataset nearly 100 patients treated to-date showcases the efficacy and activity of iNKTs in addressing solid tumor cancers and in other immune-related diseases such as acute respiratory distress syndrome with promising outcomes observed. These achievements underscore our pivotal role in advancing state-of-the-art cell therapies on what we believe to be an optimal cell platforms positioning iNKT Therapeutics as a key contributor to the progress of living medicines. Today MiNK stands as one of the most clinically advanced companies pioneering this novel cell type iNKT is and is a reminder, iNKTs are what we believe to be the most potent and highly conserved cell types in immunity. Through the progression of our clinical programs and robust R&D initiatives, we’ve made significant contributions to an expanding repository of clinical and preclinical data showcasing the distinct advantages of iNKTs in immune therapy for immune-related diseases.

This year, our efforts have culminated in presentations at four major medical meetings and the publications of the two manuscripts that I just mentioned a moment ago. We’ve showcased our observations of activity in patients with cancer, as well as patients with severe respiratory distress, both of which I’m going to go into in just a moment. But before going into our priorities for this year, let me just reiterate our fully integrated capabilities. These are unique to MiNK in this space and these capabilities really underscore our efficiency and the progress we’ve been able to make to-date. With our state-of-the-art discovery platforms, which Marc has shared with you and will go into you some more detail today, our AI capabilities, our high throughput genomic analyses and engineering capabilities, we possess the agility to swiftly identify targets and develop therapeutic approaches whether through CAR iNKTS, T cell engagers, TCRS or native allogenic iNKTs. These programs advanced seamlessly through our fully internal GMP manufacturing capabilities, which have been optimized, further scaled and received FDA clearance to produce material in-house for our clinical programs.

We’re advancing on multiple fronts with the focus on really revolutionizing treatment and access to these effective cell therapies in cancer, pulmonary diseases and other immune-related disorders. Our flagship program is a native, naturally engineered allogenic, donor-derived iNKT cell product. This is called agenT-797. It’s now advancing the Phase 2 trial in second-line gastric cancer. And in addition, our collaboration with Immunoscape, which we announced last year, spearheaded by Marc and powers us to leverage the potential of our T cell receptive platform and programs, as well as our novel and proprietary targets. Furthermore, our T cell engager platform bodes unique development capabilities and also holds the promise that’s really quite unique to MiNK of delivering engager T cells in combination with native iNKTs. This is innovative, it’s strategic and it’s unique to what we can bring to a clinical development.

I’m going to speak a bit about our programs in oncology, as we look ahead to 2024 focus really remains squarely on advancing our lead program agenT-797. Our objectives are very clear. We must continue expanding our clinical data set and exploring therapeutic areas with potential rapid development pathways. Our focus on 797 serves as the cornerstone of our vision driving us forward to redefine treatment standards, positively impacting patients’ lives with the accessible, living medicines designed to deliver benefit without the disabling side-effects of standard chemotherapeutic approaches and this is particularly evident in patients with gastric cancer. In February, we announced a significant milestone with the launch of our Phase 2 study of 797.

This trial focuses on combining 797 with botensilimab, which many of you are quite familiar with. Botensilimab is an Fc-engineered molecule. It’s a multi modal T cell activator, which also binds the CTLA-4. This agent combines with balstilimab and anti-PD-1 therapy, both of those antibodies are through our collaboration with Agenus. And this combination is also added on top of standard of care chemotherapy in second line gastroesophageal cancers. This is a therapeutic area where there are currently no therapeutic or curative options for patients and it’s a critical need in oncology. The initiation of the trial follows a compelling clinical data set presented at AACR in SITC last year and most recently the publication of a manuscript outlining 797’s clinical activity in patients that are refractory to immune checkpoint inhibitors and prior chemotherapies, specifically in gastric cancers.

This collective evidence showcases that 797’s potential to overcome resistance to immune checkpoint inhibitors demonstrating durable disease stabilization and activity in refractory solid tumor cancers, including a confirmed response in chemotherapy and anti-PD 1 refractory gastric cancers. As a reminder, the patient who has published in Oncogene was the patient who failed prior chemotherapy full facts as well as nivolumab and pembrolizumab. So this patient then was treated with cells in combination with Nivo and had a partial response that was durable and remained so throughout the trial period. The trial is led by Dr. Yelena Janjigian. Yelena is the Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center. The trial is supported by Stand Up to Cancer and this phase 2 study holds promise in really changing the treatment landscape for patients with this cancer.

We launched the trial in February and have already accrued our initial cohort of patients and have had the pleasure of seeing some very initial preliminary positive signals which we’re quite excited about. These findings form the foundation of continued discussions with regulators to expand the benefits for patients with gastric cancer and a trial that we plan to provide an update for you before the end of this year. Now beyond oncology, this is a growing area of therapeutic opportunity for cell therapies and we are particularly well-positioned in this space given our scalability and our efficiency and being able to generate an allogenic, donor-derived iNKTs at scale that can be cryopreserved and retained their functional characteristics.

This allows us to have the cells at the sites when the patients need them and able to be delivered at the point of administration without any delays from needle-to-needle time. So, we’ve been working outside of oncology and we made some important advancements with 797 outside of this of oncology. A published data highlights the important role that iNKTs could play in immunity more broadly and these include infections, inflammatory diseases, as well as autoimmunity and you’re going to hear some data in an upcoming conference in the first half of this year about some important signals that in the treatment paradigm with patients who have both autoimmunity and infections, which I think will make you as excited as it has made me. Last year, we presented data at the American Thoracic Society and it showed a survival benefit of 75% in patients treated with agenT-797 and these data stand in stark contrast to 10% survival in the in-hospital case controls enrolled at the same time period of our trial.

We’ll present these data at a conference in the first half of this year and will follow with an announcement about the next steps for this important program. And I think importantly at the ATS conference, we also showed that patients on the most severe forms of life supports with ARDS, these patients are treated with ECMO, VV ECMO and those patients treated with VV ECMO actually had a survival rate of over 80%, which is also really quite unexpected in this patient population. And again, you’ll hear more data in an upcoming conference in the first half of this year. Now these clinical trials have demonstrated promising results regarding the activity of iNKT cells in patients facing severe respiratory distress. Now, this is a condition affecting over 600,000 individuals annually in the US alone.

Compared to conventional therapies like corticosteroids, our trials have demonstrated these activities in critical endpoints such as respiratory function, oxygenation levels, as well as overall survival rates. And they present an important foundation for the development of 797 in patients with ARDS, potentially reshaping treatment paradigms for intensive and acute pulmonary care settings. In summary, our approach to rapidly advanced iNKT cells in patients with respiratory distress underscores our commitment to addressing unmet medical needs and improving patient outcomes in oncology and beyond. And we’re excited about the potential of these cells to make a meaningful difference in the lives of patients and we look forward to providing an update in the month ahead.

In order to support our growing 797 clinical programs, of course we’ve maintained a steadfast focus on delivering our in-house manufacturing of allogenic iNKT cells. These cells, this is a critical capability led by Dr Joy Zhou, and this removes any reliance that we currently have or had previously had on third-party CDMOs. And it ensures our control end-to-end control over an efficient and reliable play of our products. We are currently providing in-house manufacturing products for our ongoing clinical studies and plan to do so for our in-house programs, as well as our collaborative programs that are under active discussion. Our CMC team has achieved a major milestone in developing and implementing an FDA cleared end-to-end automatic, closed and industrialized iNKT manufacturing process, which is fully in-house demonstrating MiNK’s internal manufacturing capacity in compliance with rigorous regulatory standards and its readiness for clinical production to support our trials.

This process represents a top-notch industrialized allogenics of therapy manufacturing process and leverages our cutting-edge closed technology to streamline production from start to finish and minimize any manual intervention. This minimizes of course and in our hands has eliminated contamination as far as we can tell at this point and maintains product integrity throughout the manufacturing process. I’m now going to turn the call over to Dr. Marc Van Dijk to go over MiNK’s technology platforms and another important component of our next-generation pipeline, Marc?

Marc Van Dijk : Thank you, Jen. I’m going to talk a bit about our CAR iNKT program MiNK 215 and then about TCRs recent activity there and cell engagers. So, one thing to refine, given the potent tumor infiltrating and in gene modulating activity of MiNK 215 that we’ve observed in pre-clinical studies including lung cancer, we anticipated actually may elicit clinical responses in difficult-to-treat solid tumors. For patients with microsatellite-stable or mismatch repair-proficient colorectal cancer frequently had liver metastases. This is associated with very poor response to current pharmacological treatments including immune checkpoint blockade. For the tumor microenvironment of colorectal cancer liver metastases is characterized by a highly immunosuppressive phenotype, which prevents the patient’s T cells from infiltrating attacking these metastases even when these are reactivated and reinvigorated using anti-PDL1 or anti-PDL1 antibodies.

This underscores the urgent need for innovative therapeutic approaches targeted specifically to patients with liver metastases. So to better model immune checkpoint blockade refractory human colorectal cancer liver metastases, we, together with our colleagues from Agenus, developed an ex vivo human organoid model the recapitulates the histological and immunological features of human disease. And our findings underscore that in treatment-refractory liver metastatic organoid models, mean to one five can potentially overcome the limitations of immune checkpoint therapy effectively homes decisive [Ph] disease reprograms the tumor microenvironments, recruits tumor reactive T cells and enhances tumor killing. This data will actually be presented at an upcoming American Association for Cancer Research Annual Meeting in April.

So, our additional unique research capabilities of making cleans a proprietary library of phosphoryl peptide neoantigens derived from a wide range of solid tumors and hematological malignancies. We’ve assembled this target library over the last couple of years through internal efforts expanding on the original acquisition of [Indiscernible] 2015. So we believe that these phosphoryl peptides represent broadly presented neoantigen tumor targets that can be utilized to discover potent T cell receptors that can then be used to attack solid tumors. So the further our discovery and developments of new candidate T cell receptors, we entered into a research collaboration agreement with Immunoscape. This collaboration is designed to accelerate the development of TCR-based therapies against novel targets in T cells invariant to iNKT cells and other modalities.

In this collaborative effort, Immunoscape will leverage its capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevance of TCRs targeting the library of phosphoryl peptide antigens. MiNK Therapeutics will further characterize these tumor-specific T cell receptors levering its proprietary platform and capabilities to analyze and select TCR candidates for optimal tumor targeting when expressed in iNKTcells or as bispecific cell engagers. We believe that invariant iNKT cells are perfect allogenic whole cells for expressing tumor-targeting T cell receptors and developing off-the-shelf TCR-based cell therapies. We look forward to working with Immunoscape with the Immunoscape’s team to deliver new therapeutics that can potentially eliminate tumor cells and alleviating immune suppression for durable anti-cancer immunity, especially for solid tumors.

Now, another development that we’re actually very enthusiastic about is combining our off-the-shelf invariant iNKT cells with cell engagers both with existing third-party T cell engagers as well as with our own invariant iNKT cell engagers. We’ve seen our off-the-shelf invariants iNKT cells strongly enhance tumor killing and immune activation when combined with cell engages in our model systems and we believe that co-administration of invariants iNKT cells and T-cell engagers has to potential to extremely increase clinical efficacy especially in solid tumors where cell engagers have not yet shown great results. Invariant iNKT cells have shown they can infiltrate solid tumors where conventional T cells struggle. So we administer our iNKT cell products without link for the patient, which is crucial for maintaining the full immune potential of the patient.

Co-administering invariant iNKT cells with engagers could ensure that a wave of these very positive immune cells enter the tumor first. This not only helps ensure a focused attack, a focused direct attack on the tumor. But at least as important to combat local immune suppression and brings in the patient’s own immune cells. We’re actively exploring these combinations and we look forward to updating you on our progress in the near future. I’ll now turn the call back over Jen. Jen?

Jennifer Buell: Marc, thank you very much. Excellent. Excellent. So as we reflect of course on our advancements last year and throughout this year, I just wanted to touch upon our financial prudence that has supported our progress. We’ve remained really diligent leveraging our in-house manufacturing process, which is incredibly efficient to significantly reduce their external dependencies, as well as costs. And our phase 2 trial in second-line gastric cancer is led by the world’s experts in this tumor type and it’s a world-leading institution and externally funded by Stand Up to Cancer, which enables us to essentially access insights into a development pathway in an incredibly efficient way. So we’re excited about our ability to do that.

Partnering remains core to our strategy and as Marc has mentioned, the capability that we possess to be able to deliver ourselves at such efficiency does allow us not only to develop the product independently, but also to combine it well with therapeutics that may not be delivering the kind of clinical outcomes that are that are necessary for approval and that includes expanding the benefit of T cell engagers. And this is an active data set that we’ve generated in our own hands, as well as in the hands of potential partners. So, we are quite excited about what the future holds and we’ll continue to be very prudent in the selection of our clinical programs to high impact trials and high impact results as we continue to pursue ways of improving our financial health, as well in parallel.

I’m going to turn the call over to Christine to go over our financials.

Christine Klaskin : Thank you, Jen. We ended the year with a cash balance of $3.4 million. Since year end, we received $5 million under our convertible node agreement that we executed last month with Agenus. Cash used in operations for the three and 12 months ended December 31, 2023 was $3 million and $15.8 million respectively. This compares to $4.4 million and $18.9 million for the same periods in 2022. Our net loss for the year ended December 31, 2023 was $22.5 million or $0.65 per share, which compares to net loss for the same period in 2022 of $28 million or E0.83 per share. I will now turn the call back over to our operator for questions.

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Q&A Session

Operator: [Operator Instructions] Thank you. [Operator Instructions] We’ll take our first question from Emily Bodnar with H.C. Wainwright.

Emily Bodnar: Hi, good morning. Thanks for taking the questions. A few from me. On your clinical trial.gov listing for the phase 2 gastric study, it looks like they’re also combining with ramucirumab. So, can you go through what patients might be getting by in their treatment plan? And given that you’re combining agenT-797 with several agents, how do you kind of think about the efficacy of components based on what we might expect with standard of care?

Jennifer Buell : Emily, this is an excellent question. So, and something that we’ve we thought quite a bit about and I’ll share with you that we are developing the data set to interrogate patients with iNKTs alone with a bot/bal and plus with and without ramucirumab in paclitaxel. Now, ram/tax those are the standard of care agents used in second-line gastric cancer. They have very limited activity and as you know, probably just a little over 20%, 25%, which gives us a big opportunity to really make a significant difference in the treatment landscape here. We will generate the data set that that will include how patients perform on the cells alone. How they perform with the cells on top of standard of care, as well as the cells in the multiple combination with bot/bal and the standard of care chemo.

And we already have some preliminary signals of each of these settings that we will be sharing with you as we continue to develop the data set in the second half of the year. It’s really quite exciting and it does give us an opportunity to present to the agency what we believe to be the most impactful would be and the speediest to develop would be dropping the therapies on top of standard of care ram/tax. That is, that allows us not to salvage patients post ram/tax. It allows us to take advantage of some of the neoantigen released from the tumor killing that does come along with the chemotherapy. And we know that the cells can be dosed tolerably in that disease setting. We also know that they can they can combine tolerably with checkpoint modulating antibodies such as PD-1 and now with bot/bal.

So, I’m hoping that I answered your question. The data set includes and will be – cells alone, cells in combination with ram/tax to get us on top of standard of care and then the cells in the multi combination that includes bot/bal. And I should say we did not include a ram/tax arm alone, because we have thousands of patients that have been treated with that combination and a robust data set – from real world evidence to actually drive what the expectations are from the chemo alone. So we did not want to add that arm in the trial at this time. We would do so provided they are positive signals. It would probably be a requirement to do so in a registrational study that would follow this sometime mid-year

Emily Bodnar: Okay. That makes awesome. Just I guess, a confirmation question, are you only evaluating patients who have failed one prior line or is it like a minimum of one prior line?

Jennifer Buell : Right now, we have it essentially as a minimum of one prior line, but really the focus is one prior line. And these patients who have failed full tox nivo really have nothing to go to barring their HER2 status. So they would essentially be treated with ram/tax. So, there’s there isn’t very much more for those patients to go on.

Emily Bodnar: Okay. Excellent. And then, last question. I know you talked about the $5 million convertible note from Agenus, but maybe just discuss like strategies for bringing additional capital into the company. Thank you.

Jennifer Buell : Thank you, very much, Emily. Absolutely. So, first. I should say that as you look at the year – prior year 2023, you’ll see that the financial consumption of about $15.8 million drove the execution and completion really of three clinical trials and our manufacturing optimization. So, that that really does speak to the efficiency that our team has been able to operate with. This year, of course, we’re being even more financially prudent with the externalization of the financing for our clinical programs at this time. The cells are in high demand for trials such as the one that we’re conducting with Dr. Janjigian. But we would like to of course conclude some financial transactions that would allow us to independently sponsor our own programs and accelerate the development.

Now, this is going to come in three different ways as far as we can tell right now. The first is of course through a strategic collaboration. And as I have discussed previously, these are some very active discussions with individuals who first need to better understand iNKTs. We are the most advanced company bringing these forward. So the science is lesser known and that does require in groups to get up to speed on what the science depicts our clinical data is very much helping that. But it has required us to enable material transfer, so that partners can work with the cells in their own hands and much of that work has been done and now discussions are starting to advance. Now a collaboration would not only help us to expand on the work that we’re doing.

It would also allow us to expand our discovery pipeline and could give us infrastructure outside of the US where we currently do not have bandwidth or infrastructure. The other is of course a regional partner, which I also mentioned is something that we are continued to be in active discussions for an R&D partnership, as well as access to the cells alone just essentially just supply arrangement for combinations in a pipeline. And of course, the third would be expanding our interactions with project-based financing and investors and these again are active discussions that are underway.

Emily Bodnar: Great. Thanks for taking the questions.

Jennifer Buell : Of course.

Operator: Our next question comes from Jack Allen with Baird.

Jack Allen: Hey. Thanks for being the questions and congratulations on the progress made over the quarter. I guess the first one on gastric. Could you provide some color on the cadence of enrollment? Are there any staggers early in the study with these multiple arms between the different patients?