Q1 2024 MiNK Therapeutics Inc Earnings Call

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Operator: Good morning, and welcome to MiNK Therapeutics' first quarter 2024 conference call-in 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, they may disconnect at this time. I would now like to turn the conference over to Zack Armen from MiNK's Investor Relations. Zack, please go ahead.

make therapeutics: Good morning, and welcome to make therapeutics first quarter 'twenty 'twenty four conference call and webcast.

Speaker Change: All participants will be in a listen only mode until the question and answer session.

Speaker Change: Please note this event is being recorded.

Speaker Change: Anyone has meant any objections you may disconnect at this time.

Speaker Change: I would now like to turn the conference over does that Carmen <unk> Investor Relations.

Zack: Zack Please go ahead.

Zack Armen: 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 replay. I'd like to remind you that this call includes 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.

Zack: Thank you operator, and thank you all for joining US today today's call is being webcast and will be available on website for replay.

Zack: I'd like to remind you that this call forward looking statements, including statements regarding clinical development regulatory and commercial plans and timelines as well as timelines for data release and partnership opportunities.

Speaker Change: 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.

Zack Armen: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, Dr. Mark Van Dyke, Chief Scientific 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 on this course.

Speaker Change: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer.

Dr. Fuel: Mark Van <unk>, Chief Scientific Officer, and Christine <unk> principal financial and accounting officer, now I'd like to turn the call over to Dr. Fuel to highlight our progress from this quarter.

Jennifer S. Buell: Thank you, Zack. It's a privilege to connect with all of you this morning to discuss our achievements in the first quarter and the milestones that advance our long-term strategic goals. Today, I will highlight our latest clinical advancements, notably in our leading programs, AGENT 797 and MiNK 215. I will also discuss our strength in the financial foundation and outline our plans for sustained innovation and growth. Let's start by discussing our progress in streamlining operations and our financials. This quarter, we focus on advancing our pipeline, improving our operational efficiency, and fortifying our financial health. Since this time last year, we have successfully reduced our operating expenses by over 45 percent through Improved Manufacturing Efficiency.

Dr. Fuel: Thank you Zach it's a privilege to connect with all of you. This morning to discuss our achievements in the first quarter and the milestones that advance our long term strategic goals.

Dr. Fuel: I will highlight our latest clinical advancements, notably in our leading programs agent 797, and make 215 I will also discuss our strengthened financial foundation and outline our plans for sustained innovation and growth.

Zach: Let's start by our progress in streamlining operations and our financials.

Zach: This quarter, we focus on advancing our pipeline improving our operational efficiency and fortifying our financial health.

Zach: Since this time last year, we have successfully reduced our operating expenses by over 45%.

Zach: Through improved manufacturing efficiency.

Jennifer S. Buell: Strategic Infrastructure Alignment, and most critically, external, non-dilutive financing to support our ongoing Phase II trial and second-line gastric cancer. This financial prudence has enabled us to allocate resources more effectively towards accelerating our key clinical programs. Importantly, yesterday, we announced an investment of $5.8 million at a 25% premium from a new investor committed to our vision.

Speaker Change: Strategic infrastructure alignment and most critically the external non dilutive financing to support our ongoing phase two trial in second line gastric cancer. This financial Prudence has enabled us to allocate resources more effectively towards accelerating our key clinical programs.

Speaker Change: Importantly, yesterday, we announced an investment of $5 $8 million at a 25% premium from a new investor committed to our vision.

Jennifer S. Buell: This funding will be dedicated to support the rapid advancement of MiNK 215, our innovative CAR-INKT cell therapy targeting fibroblast activation protein, or FAP, in solid tumors. MiNK 215 is our lead program from our Discovery Pipeline that we are particularly excited about, and this investment underscores the unique potential of the program.

unknown: This funding will be dedicated to support the rapid advancement of <unk> to one five our innovative car <unk> K T cell therapy targeting fibroblast activation protein or fab in solid tumors.

Speaker Change: Meet your one five as our lead program from our discovery pipeline that we are particularly excited about.

Speaker Change: And this investment underscores the unique potential of the program. We previously presented data at the American Society of cell and gene therapy, showing exciting preclinical activity of <unk> <unk>, five and <unk> expressing non small cell lung cancer tumors.

Jennifer S. Buell: We've previously presented data at the American Society of Cell and Gene Therapy showing exciting preclinical activity of MiNK215 and SAP expressing non-small cell lung cancer tumors. More recently, as a matter of fact, just this past month at the American Association of Cancer Research, or AACR, annual meeting, our scientists presented compelling data demonstrating MiNK215's ability to eradicate tumors in human organoid models of colorectal cancer These recent advancements build on our prior findings and position 215 as an important component in addressing the urgent need for effective treatments for colorectal cancer, which is now the leading cause of death in men under 50 and the second in women in that same age category.

Scientists: More recently as a matter of fact, just this past month at the American Association of cancer research or ACR annual meeting our scientists presented compelling data.

Scientists: Demonstrating <unk> ability to eradicate tumors and human Organoid models of colorectal cancer with liver Mets.

Scientists: These recent advancements builds on our prior findings and positioned to one five is an important component in addressing the urgent need for effective treatments in colorectal cancer.

Speaker Change: This is now the leading cause of death in men under 50 in the second and women in that Sandwich category.

Jennifer S. Buell: Our findings show that administration of MiNK215 not only improves immune-mediated tumor destruction but also targets and depletes immune suppressive FAP expressing stellate cells, thereby enabling increased immune infiltration or CD8 T cell infiltration into the tumor. More simply, this mechanism enhances the body's ability to mount a robust T-cell response against liver mets, which can be further amplified by the combination with immune checkpoint inhibitors While Marcus is going to go through this in more detail, our scientists demonstrated this benefit with a combination of MiNK-215 and a Genesis late-stage antibody, Fotensilumab, a multifunctional T-cell activator, and Valisilumab, a PD-1 antagonist, which are advancing in late-stage clinical trials. These are the data that were presented at AACR, and Mark will highlight these in just a few moments.

Speaker Change: Our findings showed that administration of <unk> 215, not only improves the immune mediated tumor destruction.

Speaker Change: But also targets and depletes immune suppressive staffed expressing stellate cells, thereby enabling increased immune infiltration, our CD eight T cell infiltration into the tumor.

Speaker Change: More simply this mechanism enhances the body's ability to Mount a robust T cell response against liver Mets, which can be further amplified by the combination with immune checkpoint inhibitors.

Mark: While Mark is going to go through this in more detail. Our scientists demonstrated this benefit with the combination of May 215, and a genesis late stage antibodies.

Mark Smith: <unk>, a multi functional T cell activator and <unk>, a PD, one antagonist, which are advancing in late stage clinical trials.

Mark: The data that were presented at ACR and Mark will highlight these in just a few moments.

Jennifer S. Buell: Now I will turn to our lead program, 797. As a reminder, this is our allogeneic, unmodified INKT cell therapy advancing in phase 2 clinical trials. In February, we achieved a significant milestone for this program with the launch of the Phase II Investigator-Sponsored Study, an externally funded study in second-line gastric cancer. This pivotal trial is evaluating the combination of 797 with botansilamab and thalasilamab, and this combination is on top of standard of care chemotherapy.

Mark Smith: Now I will turn to our lead program 787, and as a reminder, this is our allogeneic unmodified <unk> K T cell therapy advancing in phase two clinical trials.

Mark Smith: In February we achieved a significant milestone for this program with the launch of the Phase II investigator sponsored study and externally funded program in second line gastric cancer.

Speaker Change: This pivotal trial is evaluating the combination of 787 with both <unk> and <unk>.

Speaker Change: And these are this combination is on top of standard of care chemotherapy.

Jennifer S. Buell: The study is led by Dr. Yelena Janjigian, Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center. And the program is supported and funded by Stand Up to Cancer, an organization dedicated to funding and developing the most innovative and promising cancer research. Enrollment in the trial is actively underway.

Speaker Change: This study is led by Dr. Jelena change again, she is the chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center.

Speaker Change: And the program is supported and funded by stand up to cancer, an organization dedicated to finding and developing the most innovative and promising cancer research.

Speaker Change: Enrollment in the trial is actively underway, we eagerly anticipate initial data from the trial, which we expect later this year.

Jennifer S. Buell: We eagerly anticipate initial data from the trial, which we expect later this year. Beyond cancer, we've also continued to advance 797 and pulmonary diseases, specifically in severe respiratory distress. This is a condition affecting over 600,000 individuals annually in the U.S. alone. Most recently, the full data set from our Phase I clinical trial was published in Nature's Communications just a couple of months ago. These data highlight the clinical activity and an important role that INKT cells play in this disease. There are currently no effective or active or approved therapies for patients with severe respiratory distress.

Speaker Change: Beyond cancer. We have also continued to advance 787 and pulmonary diseases, specifically in severe respiratory distress.

Speaker Change: This is a condition affecting over 600000 individuals annually in the U S alone.

Nature Communications: Most recently the full data set from our phase one clinical trial was published in nature Communications, just just a couple of months ago. These.

Nature Communications: These data highlighted.

Speaker Change: The clinical activity and important role that <unk> T cells play in this disease.

Speaker Change: There are currently no effective we're active we're approved therapies for patients with severe respiratory distress.

Jennifer S. Buell: We are excited to share additional updates from 797 at the upcoming American Thoracic Society 2024 Annual Meeting or the APS meeting in San Diego, California, on May 21st. Dr. Therese Hammond, a critical care and pulmonology expert, will present data from the continued dosing of patients with severe respiratory distress through our compassionate and expanded access mechanisms. Her latest case was a patient following a renal transplant who was diagnosed with severe acute respiratory distress and treated with 797 under emergency use.

Speaker Change: We are excited to share additional updates from 787 at the upcoming American Forest Thoracic Society 2024 annual meeting or the Ats meeting in San Diego, California on May 20 <unk>.

Speaker Change: Dr. Terry Tillman of critical care in Pulmonology expert will present, the data from the continued dosing of patients with severe respiratory distress, who our compassionate and expanded access mechanism.

Speaker Change: Her latest case as a patient.

Speaker Change: Following renal transplant, who was diagnosed with severe acute respiratory distress and treated with 787 under emergency use.

Jennifer S. Buell: While the data have not yet been disclosed and will be disclosed at the conference, this presentation further supports our previously published data and underscores a significant unmet need and severe respiratory distress. We're excited about the potential of INKT cells to make a meaningful difference in the lives of these patients, and we expect further updates on this program in the months ahead. Overall, the progress we've made this quarter positions us to accelerate the development of our INKT cell platform and programs, which include programs that are actively advancing in the clinic, as well as our lead discovery program. We will also expand and continue our in-house manufacturing of INKT cells.

Speaker Change: Well the data have not yet been disclosed and will be disclosed at the conference. This presentation. Further supports our previously published data and underscores the significant unmet need in severe respiratory distress.

Speaker Change: We're excited about the potential buying J T cells to make a meaningful difference in the lives of these patients and we expect further updates on this program in the months ahead.

Speaker Change: Okay.

Speaker Change: Overall, the progress we've made this quarter position us to accelerate the development of our <unk> T cell platform and.

Speaker Change: And programs and these include programs that are actively advancing in the clinic as well as our lead discovery program.

Speaker Change: Also expand and continue our in house manufacturing of buying J T cells.

Jennifer S. Buell: Setting the stage for an exciting year in 2024 with 797 and respiratory distress, and the advancement of our Phase 2 trial in gastric cancer. We continue to be unwavering in our commitment to improving patient outcomes, and we deeply appreciate your continued support. I'm now going to turn the call over to Dr. Mark Van Dijk to provide deeper insights into the MiNK 215 program. Mark? Thank you, Jen.

unknown: Setting the stage for an exciting year in 2024 was 787 in pulmonary respiratory distress.

Speaker Change: And the advancement of our phase II trial in gastric cancer.

Speaker Change: We continue to be unwavering in our commitment to improving patient outcomes and we deeply appreciate your continued support and now going to turn the call over to Dr. Mark <unk> to provide deeper insights into the main 215 program.

Speaker Change: <unk>.

Mark <unk>: Thank you Jim Good morning, everyone I am Mark <unk> will.

Mark Van Dyke: Thank you, Jen. Good morning, everyone. I'm Mark van Dijk, and I will provide some further insight into the unique properties and promising potential of RNKT cell-based cancer therapies, which are uniquely designed to maximize the efficacy of solid tumors through two key differentiators. Actually, three.

Mark <unk>: He will provide some further insights into the unique properties and promising potential of oranges T cell based cancer therapies, which are uniquely designed to maximize efficacy muscle matures two key differentiators.

Mark Van Dyke: Targeted tissue homing, relief of immune suppression, and the avoidance of lymphodepletion, which is very, very important for the overall outcome of cancer treatment, in our opinion. Our clinical data covering 80 patients across cancer and severe pulmonary disease indicate that our lead RNKT cell therapy, Agent 797, rapidly translocates from the bloodstream to essential tissues, such as the liver and the lungs. Importantly, these cells remain active and detectable for up to six months post-infusion.

Mark <unk>: Three targeted tissue homey relief of immune suppression.

Speaker Change: So the implementation and the lessor is very very important for the overall outcome.

Mark <unk>: Cancer treatments.

Mark <unk>: Thank you.

Speaker Change: Our clinical data covering 80 patients across cancer and severe pulmonary disease indicates that our lease T cell therapy patients 707.

Speaker Change: Rapidly transportation from the bloodstream to essential tissues, such as the liver envelopes importantly.

Mark <unk>: Cells remain undetectable for up to six months post infusion.

Mark Van Dyke: This prolonged presence is essential, as it significantly amplifies the body's own immune response, enhancing the potential for durable therapeutic effects in cancer and other immune-related diseases. Turning to our latest advancements, I'd like to focus on MINK215, the subject of our news this week, and differentiate it.

Speaker Change: This prolonged presence is elements as it significantly younger for us the body's own immune response and also the potential for durable therapeutic effects in cancer and other immune related diseases.

Company Representative: Turning to our latest evolves I'd like to focus on mix one five subjects of our news this week and differentiate it first class armored car T therapy targeting fibroblast activating protein or <unk> for short this.

Mark Van Dyke: First class armored CAR-IKT therapy targeting fibroblast-activating protein, or FAP for short. This therapy is specifically engineered to counteract the challenging immunosuppressive environment found in epithelial-derived tumors, including colorectal and non-small cell lung cancer. In preclinical models, we've previously reported that MiNK 215 showed robust efficacy in small cell lung cancer models, resulting in substantial tumor elimination in the lung and improved survival compared to T-cells alone. These findings were commensurate with restoring the killing capacity of partially-exhausted T-cells and increasing T-cell infiltration, which is consistent with the natural properties of native RNK T-cells.

Speaker Change: This therapy is specifically engineered to counteract the challenging immune suppressive environment phones material origin tumors, including colorectal and non small cell lung cancer.

preclinical models: In preclinical models, we've previously reported at least one five showed robust efficacy in small cell lung cancer models.

unknown: <unk> substantial tumor elimination in the loan and improved survival compared to T cells alone.

Speaker Change: These findings were commensurate with distorting the killing capacity of course vehicles to T cells, and increasing T cell infiltration, which is consistent with initial properties of major target T cells.

Mark Van Dyke: We further reported that MINK-215 specifically targeted and eliminated fat-expressing cancer-associated fibroblasts, thereby disrupting the tumor-promoting stromal network and reducing immune suppression in the local tumor microenvironment. We've recently expanded upon this data at the recent AACR meeting, as Jan already alluded to, in April of this year, where we showcased NINC215's effectiveness in an advanced preclinical organoi Liver metastases are notorious for limiting the success of traditional immunotherapies in patients with microsatellite-stable colorectal cancer.

We: We further reported that means one five specifically targeted and eliminated expressing cancer associated fibroblasts, thereby disrupting the tumor promoting stromal networks as inducing immune suppression in the local tumor microenvironment.

Speaker Change: We've recently expanded enrollments data at the recent ACR meeting in January.

Speaker Change: In April of this year, when we showcased <unk> effectiveness.

Speaker Change: Preclinical organoid model for colorectal cancer liver metastases.

Speaker Change: A little metastases are notorious for limiting the successful traditional immunotherapy in patients with microsatellite stable colorectal cancer.

Mark Van Dyke: These tumor metastases typically create an immune-excluded environment, characterized by a lack of T-cells and an abundance of immune-suppressive cells, which conventional treatments struggle to overcome. Mink215, an IL-15-armored CAR-INKT cell therapy targeted fab, is designed to overcome these challenges. It not only remolds the tumor stroma to facilitate deeper T-cell infiltration but also enhances the immune system's ability overall to fight cancer more effectively. Our preclinical results have shown that MINK215 can trigger significant tumor reduction and even eradication in this treatment-resistant model of liver metastases.

Speaker Change: Jim.

S&P: S&P has typically creates an immune excluded environment characterized by a lack of T cells in an abundance of immune suppressive cells, which conventional treatment struggled to overcome.

S&P: So on slide.

S&P: <unk> armored car T cell therapy targeting fab is designed to overcome these challenges.

S&P: Only removes the tumor stroma to facilitate deeper T cell infiltration.

Speaker Change: Also enhances the immune system.

S&P: Overall.

S&P: Cash and more effectively.

Speaker Change: Our preclinical results have shown that makes one five can trigger significant tumor reduction and even eradication.

Speaker Change: And in this treatment resistant model update and metastasis.

Mark Van Dyke: And, as Jen already alluded, it showed that it can deplete FAP-expressing stellate cells, which is a key immunosuppressive component of these liver metastases. And this provides new hope for patients who currently have very limited options. Our team is committed to advancing this innovative therapy to the clinical stage, and with the recently announced financial backing and the relentless efforts of our research and development teams, we're on track to accelerate R&D funding to early 2025 and aim to produce clinical-grade material as early as this year.

Jim Good: As Jim already alluded it shows that it can deplete cash sort of FAP expression stellate cells, which is repeat administer precious components obese.

Speaker Change: Your question please.

Jim: And this provides new hope for patients who currently have very limited options.

Our team: Our team is committed to advancing this innovative therapy preclinical stage and with our recently announced financial backing and relentless efforts of our research and development teams. We're on track to accelerate R&D fund early 'twenty 'twenty four is an ancient produce clinical grade material as early as this year.

Mark Van Dyke: This underscores our commitment to not just advance science but also to bring potentially life-saving treatments to patients as quickly as possible. I will now turn the call over to Christine to go over our financials.

Speaker Change: This underscores our commitment to not just involved in size, but also to bring potentially life saving treatments to patients as quickly as possible.

Christine: I will now turn the call over to Christine to go over our financials.

Speaker Change: Christi.

Christine M. Klaskin: a cash balance of $5.8 million. This is prior to the receipt of the funds Jen mentioned earlier. Cash used in operations for the three months ended March 31, 2024 was $2.5 million, compared to $4 million for the same period in 2023. The net loss for the first quarter of 2024 was $3.8 million, or $0.11 per share, compared to a net loss of $5.7 million, or $0.17 per share, for the first quarter of 2023. I will now turn the call back over to the operator for questions.

Christine: Cash balance of $5 $8 million. This is prior to the receipt of the funds Jen mentioned earlier.

Christine: Cash used in operations for the three months ended March 31, 2000, $24 million to $5 million compared to four <unk>.

Christine: For the same period in 2023.

Christine: Net loss for the first quarter of 2024 was $3 $8 million or <unk> 11 per share compared to a net loss of $5 7 million or <unk> 17 per share for the first quarter of 2023.

Operator: I will now turn the call back over to the operator for questions.

Operator: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you'd like to withdraw your question, simply press star 1 again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. Again, press star 1 to join the queue. And your first question comes from the line by Emily Bodnar with H.C. Wainwright. Please go ahead.

Operator: Thank you we will now begin the question and answer session. If you have dialed in and we'd like to ask a question. Please press star one on your telephone keypad to raise your hand and joined the queue. If you would like to withdraw your question simply press Star one again.

Operator: If you are called upon to ask your question and they're listening they're loud speaker in your device.

Speaker Change: <unk> pick up your handset and ensure that your phone is not on mute when asking a question.

Speaker Change: Again press star one to join the queue.

Speaker Change: And your first question comes from the line of Emily Wagner with H C. Wainwright. Please go ahead.

Emily Claudia Bodnar: Hi, good morning. Thanks for taking the questions. A few for me, I guess. First one, if you could maybe comment on how the enrollment in the FACE-Q Vastu study has been going so far since you enrolled the first patient in February, and then could you maybe clarify how many patients are expected to be treated with each of the three treatment arms in that study? And then last question is... A bit of a financial question, but given your operating expenses have decreased quite a bit this quarter, could you maybe just comment on what your current priorities are pipeline-wise and which indications you're kind of focusing on and which ones are kind of taking more of a backburner at the moment? Thank you.

Emily Claudia Bodnar: Hi, good morning, Thanks for taking the questions.

Emily Claudia Bodnar: A few for me I guess, so first one if you can maybe comment on how the enrollment in the phase <unk> study has been going so far since you enrolled the first patient in February.

Emily Claudia Bodnar: Could you maybe clarify how many patients are expected to be triggered with each of the three treatment arms in that study.

Emily Claudia Bodnar: And then last question is a.

Speaker Change: A bit of a financial question, but.

Speaker Change: Given your operating expenses have decreased.

Emily Claudia Bodnar: Quite a bit.

Speaker Change: Or could you maybe just comment on <unk>.

Speaker Change: What your current priorities, our pipeline wise, and which indications you're kind of focusing on and which ones are kind of taking more of a back burner at the moment. Thank you.

Jennifer S. Buell: Emily, thank you very much for your question. We'll start with your first question, which is about enrollment in the phase 2 gastric cancer trial. So maybe just as a reminder, this trial did not require us to do, wait, and do essentially a 28-day wait between patients. So we were able to enroll patients very quickly into the trial and continue to do so, and that allows us to get exposure to patients that will receive the cells alone. The Cells Plus BotBowl, The Cells Plus BotBowl, and RAM-CAC, Standard of Care and Second Line Gastric Cancer

Company Representative: Alright. Thank you very much for your question I will start with your first question, which is that enrollment into the phase two gastric cancer trials. So maybe just as a reminder, this this trial did not require us to do.

Company Representative: To wait to do with essentially a 28 day wait between patient. So we were able to enroll patients very quickly into the trial and continue to do so and that allows us to get exposure to.

Speaker Change: Patients that will get the cells alone.

Company Representative: The cells plus bought bell the cells, plus barbell and Ram cap standard of care in second line gastric cancer, we have been able to dose we have not specified on publicly yet the number of patients in each cohort, but suffice it to say, we will have a requisite number of patients that will not only allow us.

Jennifer S. Buell: We have been able to dose, we have not specified publicly yet the number of patients in each cohort, but suffice it to say we will have a requisite number of patients that will not only allow us to demonstrate the safety of each of these products alone and in combination, but also activity so that we can decouple where we see the most pronounced benefit for patients. And essentially, in about a 40-patient study, we will be able to tease out the contribution of components to some extent as we start to expand the cohorts and deepen signals in the areas where we see the most profound benefit.

Speaker Change: To demonstrate safety of each of these products alone and in combination, but also activity. So that we can decouple, where we see the most pronounced benefit for patients.

Speaker Change: And.

Speaker Change: Essentially in about a 40 patient study, we will be able to tease out contribution of components to some extent as we start to expand the cohorts and deepen signals in the areas that we see the most profound benefit.

Jennifer S. Buell: We do believe, mechanistically, that the combination of Botval I and KTs with standard of care may be not only beneficial to patients but also quite tolerable, and we've been able to demonstrate that so far in the first patients who have been enrolled. We do have patients that have been exposed to all five agents, and those patients are tolerating the combinations quite well, and we're pretty excited to share an update on those, which we expect will be in the second half of this year. Given the pace of enrollment in the first quarter of this year, we started enrolling in February.

Speaker Change: We do believe that Mechanistically.

Speaker Change: That the combination of popped out I N K t's with standard of care.

Not specified: Not only be quite beneficial to patients, but also quite tolerable and we've been able to demonstrate that so far in the first patients who have been enrolled we do have patients that have been exposed to all five agents and those patients are tolerating the combinations quite well.

Speaker Change: We're pretty excited to share an update on those which we expect will be the second half of this year given the pace of enrollment in the first quarter of this year. We started enrolling in February we've been able to bring in patients as I mentioned is really quite quickly. So we'll have the mature data to pre.

Jennifer S. Buell: We've been able to bring in patients, as I mentioned, really quite quickly, so we'll have some mature data to present at a late-year conference, I'll say the second half of this year, and additional information will be elucidated during those presentations. So I think that addressed your enrollment in phase two and the number of patients, while we haven't been discreet about the total number of patients in each one of the arms, we will have exposure of a proportion of patients on each of the arms with the largest proportion of patients on the multi-combo, which is INK T-cells agent 797 plus botansilamab and valstilamab. So that's the multifunctional immune activator that also binds to CTLA-4 from Agenis. Bell Stilamab is a Genesis PD-1 antibody.

Speaker Change: <unk> it.

Speaker Change: The late late year Conference I'll say second half of this year and additional information will be elucidated during those presentations.

Speaker Change: So I think that addressed your enrollment in the phase two and the number of patients while we haven't been discrete about the total number of patients in each one of the arms. We will have exposure of a proportion of patients on each of the arms with the largest proportion of patients on the multi combo, which is I N K T cell they've been 797.

Speaker Change: Plus boat and fill them up and they'll still a mab to that's the multi functional.

Speaker Change: Immune activator that also binds to <unk> four from a genus fell.

Speaker Change: While still a map of the Genesis PD one.

Speaker Change: And then of course standard of care arm taxed in this in this patient population.

Jennifer S. Buell: And then, of course, the standard of care RAM tax in this patient population. Financially, I'm going to conclude your questions with your financial question, which would be the allocation of funds. So, our operational efficiency really was, in large part, the reduction that we saw this year, in particular, at least in the first quarter, largely driven by the external funding of the phase two gastric cancer trial. So, MiNK has been executing on a number of trials, sponsor-driven trials, a phase one trial in ARDS, also our phase one trial in solid tumor cancers, and we have Agent 797 in the multiple myeloma study.

Speaker Change: Financially I'm going to conclude your questions with the your financial question, which would be allocation of funds.

Link: Our operational efficiency really was in large part so the reduction that we saw this year in particular at least in the first quarter is largely driven by the external funding of the phase two gastric cancer trial. So link has been had been executing on a number of trials of sponsor driven trials.

Link: Phase one trial in a R. D. S. Also our phase one trial in solid tumor cancers, and we can had.

Link: I had also agents have an 87 in the multiple myeloma study what we have been able to now continue to pursue is expand on the cohorts that we're really most excited about the phase two trial in gastric cancer is funded.

Jennifer S. Buell: What we have been able to now continue to pursue is expand on the cohorts that we're really most excited about, and the Tori Coast Foundation, which is essentially the designated foundation that is focused on accelerating effective therapies for patients with gastric cancer. Dr. Jelena Jantjigian, chief at Memorial Sloan-Kettering, is the leader of that dream team, it's called.

Speaker Change: The room stand up to cancer as torry.

Speaker Change: Tori Coast Foundation, which is essentially the designated founder.

Speaker Change: <unk> Foundation that is.

Speaker Change: <unk>, an accelerating effective therapies for patients with gastric cancer Doctor Galena Genting in the Chiefs at Memorial Sloan Kettering is the leader of that Dream team. It's called and this is the trial, where she's been then focusing her efforts to expand chip therapeutic.

Jennifer S. Buell: And this is the trial where she's been focusing her efforts to expand therapeutic options for patients with second-line gastric cancer. That has resulted in the most significant reduction in our operating expenses to expand that trial and to have it off the cost offset through non-dilutive external parties. Additionally, our ARDS programs are an area of great interest to us, as I mentioned earlier, and we have not only concluded and published our phase one study, but we're continuing to treat patients under compassionate access while we are preparing to launch a randomized phase two trial, which we will be conducting with non-dilutive financing support, as well as some support from our own team. So, it will be a joint program, largely externally And that will also allow us to continue to control our operating expenses.

Speaker Change: Options for patients with second line gastric cancer that has resulted in the most significant reduction in our operating expenses to expand that trial and to have it off the cost offset through non dilutive external parties.

Speaker Change: Additionally, our <unk> programs are an area of great interest to us as I mentioned earlier and we have not only concluded and published our phase. One study we are continuing to treat patients under a compassionate access while we are preparing to launch <unk>.

Speaker Change: <unk> phase II trial, which we will be.

Speaker Change: Ducting with non dilutive financing support as well as some support from our our own team. So it will be a joint program largely externally finance and it will be conducted through a large platform trial.

Speaker Change: And that will allow us to also continue to control our operating expenses. So our focus will be on really delivering the phase two gastric cancer study.

Emily Claudia Bodnar: So, our focus will be on really delivering the phase two gastric cancer study, ascertaining the data this year, and developing a pathway to advance that program as quickly as possible. We also, in parallel, will be expanding our signal in acute respiratory distress severe, and a large randomized clinical trial that will be largely externally financed and a high priority for the company. The signals that we observed that we published in major communication showed the true pronounced benefit that we believe these cells can bring to patients who showed rapid extubation, clearance of virus, prevention of secondary infections, and we saw survival rates that exceeded 75% in a population of patients that historically saw a mortality rate that exceeded about 65%.

Speaker Change: Retaining the data this year and developing a pathway to advance that program as quickly as possible.

Speaker Change: We also in parallel we'll be expanding our our signal and acute respiratory distress severe and a large randomized clinical trial that will be largely externally finance high priority for the company. The signals that we observed that we published in nature Communications showed.

Speaker Change: The true pronounced benefit that we believe these cells can bring to patients that showed rapid ex the patient clearance of virus prevention of secondary infections and.

Emily Claudia Bodnar: And we saw survival rates that exceeded 75% and a population of patients that historically saw a mortality rate that exceeded about 65%. So this is a dramatic improvement over what's been available to patients which is currently corticosteroids.

Emily Claudia Bodnar: So, this is a dramatic improvement over what's currently available to patients, which is currently corticosteroids. And that's where we're focusing our effort at this point in the clinic. Additionally, as I mentioned earlier, our discovery programs and our pipeline continue to mature. And during our last call, which was our 2023 annual summary, Mark Van Dijk presented how we're advancing our TCR portfolio through a partnership with Immunoscape. We will be, as I just announced today and yesterday morning, advancing our MiNK 215 program through our new investment, which will allow us to accelerate the development of this very promising armored STAP car INKT, and we're looking to generate clinical-grade material as early as this year and get it into the clinic as quickly as possible with the imperative to try to do so by early 2025. I hope that answers your question.

Emily Claudia Bodnar: And that's where we're focusing our effort at this point in the clinic. Additionally, as I mentioned earlier, our discovery programs in our pipeline continue to mature and during our last call.

Operator: Yes, very helpful. Thank you.

Jack Kilgannon Allen: Your next question comes from the line of Jack Allen with Baird. Please go ahead.

Jack Kilgannon Allen: Great. Thank you so much.

Speaker Change: Our 2023 annual summary.

Speaker Change: Mark Van Dijk presented how we're advancing our TCR portfolio through a partnership with the munis Gabe.

Speaker Change: We will be as I, just announced this today and and yesterday morning, we will be advancing our link to one five program through our new investment, which will allow us to accelerate the development of this very promising armored stop car NK T and we're looking to generate clinical grade material.

Jack Kilgannon Allen: It is early as this year and get it into the clinic as quickly as possible with the imperative to try to do so by early 2025.

Jack Kilgannon Allen: I hope that answers your question.

Jack Kilgannon Allen: Yes, that's very helpful. Thank you.

Jack Kilgannon Allen: Your next question comes from the line of Jack Allen with Baird. Please go ahead.

Jennifer S. Buell: I guess the first question I had was on the 215 program. As you look to advance that, ask that into the clinic, what sorts of solid tumors do you expect to study that in? How do you think about the clinical development there? And then I have a few follow-ups on both the ARDS program and then also a question about where things sit in graft-versus-host disease as well.

Jack Kilgannon Allen: Alright. Thank you so much I guess the first question I had was on the 215 program.

Speaker Change: It looks at advance that asset.

Jennifer S. Buell: Correct.

Speaker Change: Solid tumors do you expect the study got it and how do you think about the clinical development. There and then I have a few follow ups on both the <unk> program and then also a question about where things sit in graft versus host disease as well.

Jennifer S. Buell: Excellent. Well, Jack, we'll start with the first, which is 215.

Jack: Excellent well Jack will start with the first which is 215 now.

Jack: As we approach the clinic, we've been able to interrogate a lot of preclinical functionality of the molecule and determine where we believe this could be best fit and most impactful in the clinic, obviously SAP expressing tumors would be our area of great interest, we will explore the asset more broadly, but with an emphasis.

Jennifer S. Buell: Now, as we approach the clinic, we've been able to interrogate a lot of preclinical functionality of the molecule and determine where we believe this could be best fit and most impactful in the clinic. Obviously, FAP-expressing tumors would be our area of great interest. We will explore the asset more broadly, but with an emphasis on FAP-expressing colorectal cancers, because this is an area of high unmet need.

Speaker Change: <unk> and FAP expressed in colorectal cancers. This is an area of high unmet need we know that this the disease is really growing in prevalence and incidence in the younger population and there's an urgent need to move therapies forward as quickly as possible on the preclinical data we presented at ACR really demonstrates the potential of this molecule and topics.

Jennifer S. Buell: We know that the disease is really growing in prevalence and incidence in a younger population, and there's an urgent need to move therapies forward as quickly as possible. And the preclinical data we presented at AACR really demonstrates the potential of this molecule in FAP-expressing colorectal cancer. Similarly, we shared some very exciting data in FAP-expressing non-small cell lung cancer preclinical models. Those are some very obvious unmet areas of need where we believe there's not only a development opportunity, but we have a molecule that can actually biologically address the gap that we're currently observing in patients with FAP-expressing tumors in the lungs as well as in colorectal.

Jennifer S. Buell: Rest in colorectal cancer. Similarly, we shared some very exciting.

Jennifer S. Buell: Data and our SAP expressing non small cell lung cancer.

Speaker Change: Clinical models those are some very obvious unmet areas of need where we believe there's not only a development opportunity, but we have a molecule that can actually biologically addressed the gap.

Jennifer S. Buell: We're currently observing in patients with FAP expressing tumor and lung as well as in colorectal. So that's where we're starting of course, we willing to interrogate.

Jennifer S. Buell: So, that's where we're starting. Of course, we will interrogate the molecule and a couple of other disease indications. Expressing FAP sarcoma represents another one, but this is an opportunity for us to pursue and even optimize and accelerate development through the identification of patients with THAP-expressing tumors with a large emphasis on non-small cell lung cancer and colorectal cancer.

Speaker Change: The molecule and a couple of other disease indications expressing fab sarcoma represents another one but this is an opportunity for us to pursue an even.

Speaker Change: Optimize and accelerate development by the identification of patients with <unk> expressing tumors.

Speaker Change: With a large emphasis and non small cell lung cancer and colorectal cancer.

unknown: Got it got it that's great color and then as it relates to <unk>, Yes, where do you think that's not really.

Jack Kilgannon Allen: Got it. That's a great color.

Speaker Change: Securing that external funding what are the.

Jennifer S. Buell: And then as it relates to ARDS, where do things sit as it relates to securing that external funding? What are the potential aspects that need to be buttoned up there before you have that funding? And then on graft versus host disease, I believe there was also a previous discussion of an external program there. I'd love to hear any updates as it relates to that getting off the ground as well.

unknown: All aspects that need to be buttoned up there before you had that funding and then on graft versus host disease. I believe there was also a previous discussion another nice thermal program there I'd love to hear any updates as it relates to that.

Jennifer S. Buell: I'll figure out as well.

Jennifer S. Buell: Absolutely. So, with external funding, we have the platform trial identified, and the team that is essentially responsible for the operational execution of that platform trial has already designed the protocol and started activating centers. We have agreed to the terms of the contract, and we're just making some final modifications with respect to the budget allocation over time, which we expect we should wrap up sometime even as early as by the end of this week. That's our goal to do so, and then we would be announcing it shortly thereafter.

Speaker Change: Absolutely so on on the external funding we have the platform trial identified and the team that essentially is responsible for the operational execution of that platform trial is has already designed the protocol and started activating centers. We have agreed to the terms of the.

Speaker Change: A contract and we're just making some final modifications with respect to the budget allocation over time, which we expect we should wrap up sometime even as early as by the end of this week that is our goal to do so and then we would be announcing it shortly thereafter.

Jennifer S. Buell: On graft-versus-host disease, we are pursuing an investigator-sponsored trial. This is an area, of course, of unmet need, and, Jack, you did a brilliant job of summarizing not only the potential of the cells in the syndication, but we've also deepened our own scientific insights into how these molecules and these cells may actually have a profound effect on not only mitigating but then preventing graft-versus-host disease in patients who are undergoing hematopoietic stem cell transplantation

Jennifer S. Buell: And graft versus host disease, we are pursuing an investigator sponsored trial. This is an area of courses of unmet need in and Jack you did a brilliant job in summarizing not only the potential of the cells in the syndication. We've also deepened our own scientific insights into how these molecules in these cells.

Jennifer S. Buell: May actually.

Jack: Have a profound effect and not only mitigating but then.

Jack: Preventing graft versus host disease in patients who are undergoing hematopoietic stem cell transplantation, we have not yet announced the launch of that program. So we have designed the program, but we have not yet accumulated the financing that would be necessary to launch. It. So during this time, we are being really quite prudent about her.

Jennifer S. Buell: We have not yet announced the launch of that program, so we have designed the program, but we have not yet accumulated the financing that would be necessary to launch it. So, during this time, we are being really quite prudent about our focused efforts in the clinical programs that we're advancing, but we will continue to find ways to get graft-versus-host disease moving, and this is a priority for us to be able to do so, but it's not an area that, at this very moment, we can allocate capital to doing at this time.

Speaker Change: Our focused efforts in the clinical programs that we're advancing but we will continue to find ways to get graft versus host.

Jennifer S. Buell: Advancing and this is a this is a priority for us to be able to do so but it's not an area that at this very moment, we can allocate capital to doing it at this time.

Jack Kilgannon Allen: Got it. That makes a lot of sense.

Jennifer S. Buell: Got it that makes all the sense congratulations again on the progress and thanks for taking the question.

Jack Kilgannon Allen: Congratulations again on the progress and thanks for doing the questions. Thanks so much, y'all.

Jack Kilgannon Allen: Thanks, so much Jack.

Operator: Your next question comes from the line of Matt Phipps with William Blair. Please go ahead.

Jack Kilgannon Allen: Your next question comes from the line of Matt Phipps with William Blair. Please go ahead.

Operator: Yeah.

Matthew Christopher Phipps: On FAPCAR, I know in a lot of the preclinical work you've done, you've combined it with other therapies, including other kinds of PCR-directed T-cells. And just curious how you think of a mild therapy activity of this, or if it is something that has to be combined. But if the IL-15 addition is something that can drive enough activity, or again, really should think about this being combined with other

Operator:

Operator: On the Fab car I know in a lot of the preclinical work Youll Don used combined with others.

Matthew Christopher Phipps: Although therapies, including.

Speaker Change: Including other accountable to fewer directed T cells.

Matthew Christopher Phipps: Just curious how you think of a monotherapy activity of this or if it is something that has to be combined with the IL 15 edition is something that can drive enough activity you'll again.

Matthew Christopher Phipps: It really should think about this being combined with everything.

Matthew Christopher Phipps: Matt, this is an excellent question, and we have invited a couple of special guests onto the call today who are leading up this effort that includes the investigation of 215 as a monotherapy and the kind of efficacy that we're observing with the molecule in that capacity, which would be a really important milestone for us to demonstrate monotherapy activity. And in the case that we may need to expand that and address other tumor escape mechanisms, we are, in parallel, exploring where those optimal combinations may take us. So there are three people on the line, and you'll be familiar with them.

Matthew Christopher Phipps: Matt. This is an excellent question and we have invited a couple of special guests onto the call today, who are leading up this effort that includes the interrogation of 215 as a monotherapy in the kind of efficacy that we're observing with the molecule and that capacity which would be.

Speaker Change: A really important milestone for us to demonstrate monotherapy activity and in the case that we may need to expand that and address other tumor escape mechanisms. We are in parallel exploring where those optimal combination may or may not take so there are three people on the line and you'll be familiar with with them and this is Dr. Dan Chan.

Jennifer S. Buell: And this is Dr. Dan Chan. He's the head of discovery at Agenis, one of the inventors of botansilamab, and leading our discovery and combination efforts at Agenis. Dr. Nils Rupquist, who you may not have met before. Nils is an accomplished scientist who joined us from MD Anderson Cancer Center. He was an associate professor there, and prior to that, he was at Weill Cornell working in the radiation oncology department. And his emphasis is really on optimizing immune biology and determinants of how to modulate the tumor microenvironment and enhance efficacy.

Speaker Change: He is the head of discovery at Genesee one of the inventors on boat and sell them up and leading up our discovery combination efforts out of genus Doctor Nils request with who you may not have met before Nils is an accomplished scientist who joined US from MD Anderson cancer Center. He was an associate professor.

Jennifer S. Buell: Sure.

Nils Rupquist: And prior to that he was at Weill Cornell working in the radiation oncology Department and his his and his emphasis is really on optimizing immune biology, and determinant of how to modulate the tumor microenvironment and enhanced efficacy.

Jennifer S. Buell: Eleni is also our head of discovery at our Cambridge, UK, site for mink therapeutics, and this team together has been working to address exactly this question. I'm gonna turn it over to Dan just to lead in and give you a quick review of how we're thinking about this. And from my perspective, our goal will be to launch interrogating monotherapy activity, particularly in SAP-expressing tumors, which would give us the most rapid development path forward and identify areas where we wanna expand efficacy with combinations. And I'll turn it over to Dan to give you some deeper insights, and he can work with Eleni and Nils and give you some more, a deeper response to your question.

Speaker Change: <unk> is also our head of discovery in our Cambridge U K site for make therapeutics in this team together.

Jennifer S. Buell: <unk> been working to address exactly this question I'm going to turn it to Dan just to lead in and give you a.

Jennifer S. Buell: A quick review of how we're thinking about this and from my perspective, our goal would be to launch interrogate monotherapy activity, particularly in SAP expressing tumors, which would give us the most rapid development path forward and and identify areas, where we want to expand efficacy with combinations and I'll turn.

Jennifer S. Buell: It over to Dan to give you some deeper insights and he could work with <unk> and Nelson can give you some more.

Dan: A deeper response to your question.

Dan Chan: Thank you for the question. To the first part, we do expect monotherapy activity with MiNK-215, and for several reasons based on preclinical data. First, in preclinical models, we observed direct tumor killing of FAPA-expressing cells, including FAPA-expressing cancer cell fibroblasts and tumor cells. In turn, we've observed that post- There was a massive infiltration of T-cells within the tumor microenvironment, which is particularly evident in cold tumors, like liver metastases or other tumor models that we've tested.

Speaker Change: Thank you for the question so.

Dan: So the first part we do expect monotherapy activity with me too far even for several reasons based on the preclinical data first in preclinical models, we observed direct.

Dan Chan: Tumor, killing at Fox expressing cells, including SAP expressing cancers fibroblast on tumor cells and <unk>.

Speaker Change: We've observed that post.

Dan Chan: Okay.

Speaker Change: There was a massive infiltration of T cells within the tumor microenvironment is particularly evident in cold tumors.

Speaker Change: Liver metastases.

Speaker Change: Two malls that we've tested.

Dan Chan: So we do expect monotherapy activity, given the ability to promote T-cell infiltration and remodel the tumor microenvironment to enhance T-cell responsiveness. We expect this to be an ideal combination partner with BotBow, particularly in areas where we have seen non-responsiveness to PD-1 and CTLA-4. The data, which includes both the liver metastases model as well as pancreatic models, suggest that in situations where the tumors are refractory to developed, adding INKTs, including MINK215, can open up a response to checkpoint therapy and indeed promote monotherapy activities.

Dan Chan: So we do expect monotherapy activity given the ability to promote T cell infiltration and remodel the tumor microenvironment to enhance T cell responsiveness. We expect this to be an ideal combination partner with bought boat.

Dan Chan: Particularly in areas where.

Dan Chan: We have seen non.

MINK215: Non responsiveness to PD, one CTO before.

Dan Chan: Okay, Andrew which includes both the liver metastases models pancreatic.

Dan Chan: Yeah.

MINK215: In situations, where the tumors are refractory to <unk>.

Dan Chan: Q2's, including 215.

MINK215: <unk> opened up our response to checkpoint therapy.

Speaker Change: Third your activity as well.

Dan Chan: Yeah.

Dan Chan: Thank you Dan.

Dan Chan: Oh.

Dan Chan: Okay.

Matthew Christopher Phipps: Matt, did you have any other questions? That's it for me. Thank you.

Matt: Matt did you have any other questions.

Speaker Change: That's it for me thank you.

Matt: Thank you.

Matthew Christopher Phipps: Okay.

Operator: And with that, that concludes our Q&A session. I will now turn the conference back over to Jennifer Buell for closing remarks.

Speaker Change: And with that that concludes our Q&A session I will now turn the conference back over to Jennifer Buell for closing remarks.

Jennifer S. Buell: Thank you very much, and thank you all for joining us today. We look forward to continuing to keep you updated on our progress and advancements with a real focus on advancing our clinical stage programs, continuing to strengthen our financial foundation, and delivering innovative medicines to patients with cancer and other immune-mediated diseases. I appreciate your time today.

Operator: Yeah.

Jennifer S. Buell: Thank you very much and thank you all for joining US today, we look forward to continuing to keep you updated on our progress in advancements with a real focus on advancing our clinical stage programs continuing to strengthen our financial foundation.

Speaker Change: And deliver innovative <unk>.

Jennifer S. Buell: <unk> to patients with cancer and other immune mediated diseases I appreciate your time today.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining us. You may now disconnect.

Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.

Operator: Yeah.

Operator: [music].