Q4 2024 MiNK Therapeutics Inc Earnings Call
Thank you.
Speaker Change: Hello, everyone, and welcome to MNK Therapeutic's fourth quarter, 2024 Financial Results Call. Please note that this call is being recorded. After the speaker is prepared remarks, there will be a question and answer session. If you'd like to ask a question during that time, please press star, followed by one on your telephone keypad. Thank you.
Speaker Change: I now like to hand a call over to Zack Armen, investor relations, you may now begin.
Speaker Change: 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 a replay.
Speaker Change: I'd like to remind you that this call will include forward-looking statements, including those related to our clinical development, regulatory, and commercial plans, timelines for data release, and partnership opportunity.
These statements are subject to risk and uncertain.
Speaker Change: Please refer to our SEC filings available on our website for a detailed description of these risks.
Speaker Change: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, and Christine Klaskin, Principal Financial and Accounting Officer.
Speaker Change: Now I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter.
Speaker Change: Thank you very much, Zack, and thank you all for joining us today. 2024 was a defining year for MAKE Therapeutic. A year in which we executed on our strategic vision, strengthened our leadership, advanced our clinical programs, and expanded partnerships that positioned us for significant impact in the year ahead.
Speaker Change: Our focus remains unwavering, to bring the most scalable, durable, and effective, of allergenic INKT self therapies to patients with solid tumors and immune-driven diseases.
Speaker Change: In the fourth quarter, we announced an important addition to our leadership team and we welcome Dr. Robert Cadlet to our board of directors.
Speaker Change: This is a substantial addition for our company. Dr. Kalik is a renowned leader in bio-defense and pandemic preparedness. He's the former head of Asgard at the Department of Health and Human Services, and he was instrumental in Operation Work Speed Initiative.
Speaker Change: His expertise in public health strategy and medical countermeasures adds tremendous strategic depth as we explore the applications of our IAMKT platform and biodefense, pandemic preparedness and infectious diseases.
Speaker Change: At the same time, we also announced the departure of our General Council, Robert or Bob Foster.
Speaker Change: Bob has transitioned to a leading role in the Department of Health and Human Services as a chief counsel for food, research, and drugs in our new administration.
Speaker Change: We are deeply grateful for Bob's commitment, contributions, and integrity throughout his tenure of Mink, and we wish him continued success and his service to our country.
Speaker Change: On the big side, we've made strong progress on multiple fronts. In addition to strengthening our leadership, we expanded our innovation toolkits, and the fourth quarter-badred into a collaboration with Autonomous Therapeutics to combine their encrypted RNA technology with our I&KT self-derabies.
Speaker Change: This collaboration is highly strategic by integrating autonomous precision and coded RNA platforms with our cell therapy candidates like 797 and our FAPCAR INKT. We aim to create next-generation treatments for metastatic cancer.
Speaker Change: The idea is to target and eliminate metastatic tumor cells with greater precision.
Speaker Change: In pre-clinical models and in the clinic, we've already demonstrated that INKT cells have shown us that they can affectively attack tumors, and for instance, in very difficult to treat metastatic colorectal cancer models.
Speaker Change: and in second line gastric cancer. By arming these cells with encoded RNA-T loads that activate only in the tumor environment, we hope to spare healthy cells with a liver and potent tumor and signal.
Speaker Change: This partnership exemplifies how we are leveraging external innovations to amplify the power of our INKT platform and can open entirely new avenues for treating solid tumor cancers.
Speaker Change: In 2024, we executed across our clinical programs, expanding data of INKT South therapy and all the tumors, respiratory distress, and immune-driven diseases.
Speaker Change: at major conferences throughout the course of this year, including the inaugural AACRIO.
Speaker Change: ASCO GI and CITC. We present a data demonstrating that 797 enhances immune activation.
Speaker Change: expands the benefit of checkpoint inhibitors and vice-acific engages, and overcomes resistance in some of the most challenging cancers, including gastro-cancer.
Speaker Change: At the AACR IO conference, just this past February , we presented new translational data from our ongoing phase two study.
Speaker Change: which is first of its kind in delivering an allergenic IMKT cell therapy in refractory
Our data demonstrated powerful synergy between our L.O.I.K.T. cells.
Speaker Change: Importance, first of time checkpoint inhibitors, including buttons to the left, and valve to the left, and standard chemotherapy.
Speaker Change: This combination led to robust immune reactivation and otherwise unresponsive tumors, essentially taking an immune desert and turning that immune desert hot, and we demonstrated that pathologically and immunologically in the data we presented A-C-R-I-L.
Speaker Change: We also reported that the addition of 797 leads you higher in deferring gamma levels, increased T-cell infiltration, and strong antigen presenting cell engagement.
Speaker Change: These critical biomarkers are known to correlate with better, more durable clinical responses, further validating the role of INKT cells in driving immune reactivation.
Importantly
Speaker Change: These seminal observations revealed the importance of optimal sequencing, and in fact, the strongest responses were observed when we took our cell therapy, 7 and 7, and we combined it with checkpoint inhibitors before applying standard care immunosuppressive chemotherapy.
Speaker Change: This sequencing led to the most significant immune expansion and powerful peripheral memory
Speaker Change: Highlighting the value of early alloy and KT induction as a key driver of therapeutic benefits.
Speaker Change: These findings underscore the unique ability of IOT cells to intensify immune activity, reinvigorate memory T cells, and reshape the tumor-micro-environment, offering a scalable, electronic solution with global patient access. We'll be looking forward to sharing additional clinical updates later this year with the clinical outputs from this program.
Speaker Change: In addition, we're advancing our novel pipeline, including our Frame TCR program and our next
Speaker Change: We've demonstrated with our Prame TCR IMKT's that targeting intracellular tumor antigens previously unreachable by conventional therapies can actually demonstrate very high specificity and potent tumor killing.
Speaker Change: At the 60-2024 conference in November , we showed that 7-9-7 worked synergistically with checkpoint inhibitors and by specific engages, basically. When used together, the anti-tour activity was significantly enhanced.
Speaker Change: Beyond what either of those therapies, checkpoints or by specific engages, can achieve alone. This builds on my earlier statement, demonstrating the clinical observations of 797 in combination with checkpoint inhibitor of the gastrocancer.
Speaker Change: This is important because it suggests that alloying KTs could be added to existing cancer treatments to overcome resistance and boost efficacy, potentially turning non-dresponders
Speaker Change: At the same conference at CCC, we reported on our Prame-Targeted TCR INKT program, which is one of our next generation engineered product.
Speaker Change: that the praying tumor antigen commonly expressed in prevalent tumors like lung, ovarian, melanoma,
Speaker Change: has been challenging to treat and as evaded traditional T-cell therapies. Our prefrontal results show
Speaker Change: This suggests a promising solution for treating a range of solid tumors that express pain, or encouraged by these data, and in a showcase how adaptable and potent our platform can be.
Speaker Change: Now, there's something that's really quite important that these cells can deliver. We've shared some of this data with you previously. Beyond oncology, we continue to advance Agent 797 in immunology and inflammatory condition.
Speaker Change: The most advanced program is our clinical program in patients with severe acute respiratory distress.
Speaker Change: This remains a field with significant unmet need and no approved therapies.
Speaker Change: Results from our phase one study, published in Nature Communications, and more recently presented at the American Therapeutic Society annual meeting, showed that 797 achieved an 80% survival rate in patients who were on the most severe form of life support, UDX-MO.
Speaker Change: and that compares to just 10% of in-hospital controls. These findings, again, underscored the potential of INKT's and addressing high impact health challenges. And very importantly, we also notice that these cells prevented secondary infection.
Speaker Change: Fungemia, Backteremia, that often caused mortality in the ICU setting, that's a really critical part of the story.
As we begin to continue our expansion in I&I,
Speaker Change: We are looking to announce our externally supported program in acute graft-versus host disease or GBHD. We planned our phase one trial of 7-9-7-a-patients undergoing allergenic bone marrow transplant.
Speaker Change: The trial is particularly valuable as it will be conducted predominantly with external support to offset our development costs.
We have been awarded probable funding.
Speaker Change: by the National Institute of Allergy and Infectious Diseases, or N-A-I-A-D, to explore the activity in Subma-7 and a QGVHD. Now, I see probable funding and that was...
Speaker Change: and specific language that was leveraged by the government agencies and we will await the evolution of the administration and look forward to announcing more formally the funding granted by this agency.
Speaker Change: A PUTU VHD is severe and potentially life-retting, complication of transplant, and current options are limited.
Speaker Change: Our goal is to use immune-modulating IKT cells to prevent and treat DBHD by dialing down the harmful donor-derived T-cell responses that cause it without compromising the graph's cancer-fighting benefits.
The phase one study will primarily assess safety.
Speaker Change: Determine an optimal dose of 797 and explore the clinical benefits in these patients. Given 797's favorable safety profile in early trials, we're optimistic, but it will be well-tollivated in the transplant setting as well.
Speaker Change: The trial being submitted to local and national regulators and we expect to dose this year.
Speaker Change: Before I hand the call over to Christine, I want to emphasize how these pieces come together for MiNK.
Christine Klaskin: The leadership update, the partnership with Autonomists, the clinical progress both in oncology
Speaker Change: and I&I, or inflammatory immunologic diseases like respiratory distress and GBHD are all part of our strategy to execute efficiently while expanding the impact of our I&KT platform.
Speaker Change: We're entering 2025 with strong momentum, a different shade of technology, provocative clinical data, and a growing network of experts and partners in a clear plan to reach our next value reflection point. We remain committed to our mission of delivering the self-derived patients and we're doing so with an IAM Smart Research Management and Strategic Growth Opportunities.
I'll now turn the call over to Christine.
Thank you, Jen.
Speaker Change: We ended the year with a cash balance of $4.6 million.
Speaker Change: Cancer used in operations for the three and 12 months ended December 31, 2024 was $1.7 million and $9.6 million respectively.
Speaker Change: This compares to $3 million and $15.8 million for the same periods in 2023, reflecting our efforts to contain our spend while still advancing our programs.
Speaker Change: Our net loss for the year ended 2024 was $10.8 million or $2.86 per share.
Speaker Change: This compares to a net loss for the prior year of $22.5 million or $6.54 per share.
Jen: I'll now tune the call back to Jen for closing remarks.
Thank you, Christine.
Jen: To wrap up, I'd really like to reiterate how proud I am with the MiNK team on our achievements in 2024. We built a strong foundation scientifically, clinically, and operationally. And this foundation positions us for an important year ahead.
Jen: In 2025, we expect to deliver on multiple milestones. Additional clinical data from our gastrocancer trial, advancing our 2VHD study into patient dosing and expanding our pipeline through strategic innovation.
Jen: We also plan to continue foraging alliances and enhancer platforms and broaden the applications of INCT self therapy and to new indications and areas of high-end met need.
Jen: Our commitment to execution is really unwavering. We have the right people, now including Dr. Cadillac's expertise on our board, the right partners, and a differentiated therapeutic approach that can create significant impact for patients.
Jen: And at the same time, we remain deeply focused on operational efficiency and excellence in fiscal responsibility and sharing that we utilize our resources very wisely as we move forward. This balance of innovation and prudence is central as we continue to advance our company.
Jen: We look forward to keeping you updated throughout the course of the next year and thank you again for your support. Operator, we're ready to take questions.
Thank you for watching. Bye.
Speaker Change: We are now opening the floor for question-and-answer session. If you'd like to ask a question, please press start, followed by one on your telephone keypad.
Speaker Change: Can we limit your questions to one question and one follow-up? Your first question comes from the line of Emily Bodnar from HC Wainwright, Your Line is now open.
Thank you for watching. Bye.
Speaker Change: Provide a bit more on the status of the Phase II study, kind of where you are in terms of involvement. And then I know you said you plans to have data this year, but if there's any kind of more granular timelines, you can provide and how much data we should be expecting to see at that update.
Speaker Change: Emily, thank you very much for your question. I'm going to start with the last. So for 7-9-7 this year, we absolutely plan to advance 7-9-7 in gastric cancer as well as in GVHC.
Those are very important and as well as…
Speaker Change: They build upon the data that we generated so far. And before I go to our next generation pipeline, which is also a key catalyst for 2025, I just want to remind you that we'll be presented data at the AACRIO conference. We really focused on some of the translational biomarkers of our observation because those...
Speaker Change: have been, that's been a major gap, INKT cell therapies are what we believe to be the most potent cells in immunology.
Speaker Change: in which they're durable and persist beyond six months, which gives us a big therapeutic window to evaluate benefits.
Speaker Change: They also have demonstrated to be tolerable and most importantly, you can administer them without HLA matching and without lipid adepletion and you don't compromise that durability and persistence which is a key differentiator and we use the ASIO conference to demonstrate
Speaker Change: Really those key biomarkers and the kind of bioactivity and immunologic activity of those.
Speaker Change: Setting up the foundation for the clinical data that we plan to present at the end of the year.
Speaker Change: or I'll say in the second half of the year at a major conference.
Speaker Change: Importantly, because of the biomarker data that we demonstrated, how 797 can show this broad immune activation.
Speaker Change: A hallmark of the durable responses, a very high interferon gamma.
Speaker Change: Signature, which is, by the way, these cells are the most productive interferon gamma to the credo.
Speaker Change: and those findings that we have been the first to describe in such depth and detail in the clinic at the AACRIO conference.
set us up now.
Speaker Change: Just start to leverage those findings to show how they translate into the clinic. We have the majority of patients enrolled in our clinical trial.
Speaker Change: and as you know, we serve in a woman in February of 2023, which gives us a very nice, lengthy runway of demonstrating responses, durability of response, and survival, which is an important outcome, particularly in this disease setting.
Speaker Change: So that trial continues to enroll. The majority of patients are in and we will be presenting data at the in the second half of the year.
Speaker Change: The other catalyst for 2025 will be our most exciting step-car INKT. As you might recall, this is an IL-15 armored, FAP targeting car INKT.
Speaker Change: that we've presented now in a few different occasions demonstrating the pre-clinical differentiation of this very valuable asset. We're advancing through INA enabling studies and we still plan to get that into the clinic in 2025.
Great. Thanks for all the colors.
Certainly.
Speaker Change: Your next question comes from the line of Mayant Mamtani, from B. Riley Securities. Your line is now open.
Mayank Mumtani: Hi, good morning, team. Thanks for taking our questions and a place to see the progress reported here. On the ASER IO presentation, are you able to share with us any...
Speaker Change: KRL, Investigative Feedback, and obviously specifically interested in how you see this agent in kind of having the path following the study and view.
Speaker Change: and participate, you know, a prospect of an accurate approval based on the data you are generating. And then the second question, the follow-up here was around the frame TCR.
Speaker Change: disclosure which seems very interesting, I would love to hear how you think, you know, the INKP approach here differentiates versus maybe the alternative therapy approaches and also obviously data ratio for bi specifics we have ahead of us.
Bye, everyone. Bye.
Speaker Change: Thank you very much, and I especially appreciate your very provocative question about approval based on our randomized phase 2 data that's being conducted.
Speaker Change: We had come to that in just a moment, so for KOL Speed Bad,
Speaker Change: This is the true opportunity for us to have, actually, the lead investigator, Dr. Yelena J. G. Geons speak independently about this. I believe she will be the presenter of data for an upcoming conference, particularly the clinical data she's been deeply involved.
Speaker Change: with our interrogation of the results, of course the accumulation of patients as she's leading the trial, but also the interpretation of our observation.
Speaker Change: She's quite intrigued and very motivated to continue this trial. We have not yet expanded enrollment into the trial. We're still accumulating the patients onto the currently estimated 40 patients into the program.
Speaker Change: She is very bullish, I'll say, and I'll have her speak for herself, she'll be willing to do so as well as her investigator, Dr. Sam Satarian, who is also an investigator when we're from Kettering, this is enrolling at nine centers.
at this time.
Speaker Change: So she expanded the program to enable greater access to patients.
Speaker Change: That essentially underscores the sentiment that she has for this program. We also have the continued support and we're grateful for the continued support funding wise from stand-up to cancer.
Speaker Change: and so they remain really steadfast in their commitment to advancing this innovative approach for patients.
and you know, is-
Speaker Change: With respect to will this program be registrational, we're going to continue to accumulate as much data as possible and demonstrate the clinical benefit for all patients and then of course we'll be advancing this into regulatory discussions. We are all seeking
Speaker Change: The most aggressive and efficient task to get global access to patients, particularly with the second-line gastric where there is nothing available.
Speaker Change: We're really quite intrigued because these patients who are having, these are patients who have not responded, the full thoughts are PD1 which, again, underscores the reactivation of what these cells can do for patients.
Speaker Change: For Frank TCRs, now I am Kate Tease as I just mentioned in my last response to Emily is how valuable they are with respect to their delivery and their tolerability and no-actually matching no-limb of depletion. They are durable.
Speaker Change: and they're really quite selectors and potent. And, as you might recall, because of their invariant PCR, which is common in all of us, I can take one donor CCR and give them to another and they bind to an important lipid ligand, CD-1D.
Speaker Change: Once they do that, they recruit T-cells, conventional T-cells and N-K-cells. So in addition to their endemic response locally, their conversion, suppression of myeloids drives pressure cells that we've demonstrated now immunologically.
Speaker Change: They also recruit T-cells, conventional T-cells and N-K-cells that's highly different than what's currently available to patients from any other preem targeting approach and we've demonstrated that the data are available on our website and perhaps we'll push it out again, maybe
Speaker Change: so that you'll have rapid access to some of the data that we previously presented.
Mayank Mumtani: I should say my answer is that one last part that I did not mention, MAK is of course the holder of a proprietary platform of over 4,000
Mayank Mumtani: plus four related neoantigens, and we've created very important medicines targeting a couple of these antigens.
Mayank Mumtani: This is an approach that is growing in insurance. Of course, we've known talent for and these intercellular target approaches are ours. We presented data on our MLL targeting TCR and on our claims targeting TCR.
Mayank Mumtani: Now, of course, we're being incredibly, visibly responsible right now, and I shall say that these...
Mayank Mumtani: programs are of active interest both to our own in our own hands, but also in the hands of some others given that the growing interest in the neo-antitune space in the personalized individualized UCR approach.
Mayank Mumtani: MiNK has been able to demonstrate that we can deliver on this approach really quite efficiently and it's something you'll be hearing more about in 2025.
Speaker Change: Thank you. If I could squeeze one more end on the fifth clean through the inside, since you are being, you know, across different programs, there in IMD filing timeline, you're putting on any of the next generation IMD programs, including two one five. Thanks again for this information.
Speaker Change: 215 IND filing is planned for 2025, so we remain on target for that IND filing and we'll continue to update you on the planned IND filing for the KCR programs. These will be announced to mention it with other announcements related to those programs.
Got it. Thank you again.
Speaker Change: If you'd like to ask a question, please press star, followed by one on your telephone keypad. Your next question comes from the line of Jack Allen from Beard, Your Line is now open.
Jack Allen: Hi, thank you for taking the questions and congratulations on the progress made over the recent months.
Jack Allen: I want to start off by asking a little bit more about the Grafers of Toast Disease study.
You mentioned you do have this proverbial funding from NAAID.
Jack Allen: I just wanted to ask, I guess, what is the timing? I know it's very glued as it relates to the funding with the federal government, but what do you, what are yourself from the timing around?
when that, that funding could be more solidified.
Speaker Change: First of all, Jack, you are at the top of your game and congratulations on your new baby. I'm so glad to have you back on the talk with respect. Thank you. Thank you.
You're welcome.
Speaker Change: So with respect to wrappers and so forth timing, we'll just ask that you stay tuned. It is certainly a fluid time right now. We have the great luxury of having a scientific advisory board member named Dr. Jenny Guffers.
Speaker Change: The mechanism as to how, in very natural killer T-cells, our particular formulation.
Speaker Change: is quite active in graft-versus, so it's a cute and chronic actually in her pre-monetal models and her most recent publications.
Speaker Change: She is our collaborator on both the pre-clinical work and the clinical work that is advancing and we're thrilled to have the opportunity to have her given her experience and gravitas in the space.
We're optimistic.
Speaker Change: that this very important program will advance, I believe, that our government despite some of the most recent efficiencies.
Speaker Change: Does see the importance of this patients undergoing as you know?
Speaker Change: Hematophilitis, stem cell, transplant, the majority of whom succumb to graft-versus-hoeshears and ultimately graft failure, and that is an enormous...
Speaker Change: Burton on our healthcare system, and it's taking young people at the workforce, and I just based on our conversations with the government, they can appreciate the importance of finding approaches.
Speaker Change: that are not only very tolerable, but that can augment a successful engraftment and then also mitigate some of the subsequent complications of engraftment.
and have a drive following a transplant.
Speaker Change: I'm optimistic, but I don't want to give any predictions at this point, so we'll keep you tuned.
Speaker Change: and we will certainly announce at the moment that we hear about the funding clearing and the launch of the program.
Speaker Change: The program will be a multi-center trial, and it will be lead.
Speaker Change: by Dr. Jenny Goufers, as well as some of her colleagues in the clinic at University of Wisconsin. So, it's designed, it's been submitted to the regulatory boards both locally, at the IRBs, as well as...
and now Shirley at the FDA.
Speaker Change: So, once that funding clears, we should be ready to go. As far as backup strategies, this is also a great interest to partners as well as to investors.
Speaker Change: And this is an opportunity for us to secure some very specific financing to advance the trial as a backup or even as a complement to the non-delutive financing from the government.
Speaker Change: Got it great. Thank you so much. Thanks for congratulations on the color there. I guess just because we're going to rate also, if you could provide any comments on existing financial position of the making that you thought some of the cash from my moving forward.
Speaker Change: So we right now based on our financial projections and some additional efficiencies that we have internally, we have cashed through the end of 2025.
Speaker Change: Thank you so much, Sharon. It's great to connect and congratulations again on the progress.
Thank you very much and again, congratulations to you, Jack.
Speaker Change: That concludes our Q&A session. I'd now like to hand back over to Dr. Jennifer Buell for closing remarks.
Thank you for watching!
Speaker Change: Thank you very much operator and thank you all for joining us and for your continued support. We look forward to touching base with you in the next couple of weeks.
Thank you for attending today's call. You may now disconnect.