Q4 2023 MiNK Therapeutics Inc Earnings Call

March 21, 2024

Jennifer S. Buell: 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 oncology. Our published data highlights the important role that INKTs could play in immunity more broadly, which includes infections, inflammatory diseases, as well as autoimmunity.

Speaker Change: [music].

Jennifer S. Buell: And you're going to hear some data at an upcoming conference in the first half of this year about some important signals in the treatment paradigm for 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 AGEN 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 we'll 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 form of life support 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.

Cool.

Okay.

Operator: Good day, everyone, and welcome to 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.

Speaker Change: Good day, everyone and welcome to the main 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 I would like to ask a question during that time simply press star one on your telephone keypad. If you would like to withdraw your question. It is star one.

Operator: And after the speaker's remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press star one on your telephone keypad. If you would like to withdraw your question, it is star one again. I would now like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.

Speaker Change: Got it.

Speaker Change: I would now like to turn the conference over to Zac Harman 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 Dr. Jennifer Buell, President and Chief Executive Officer, Christine Klaskin, Principal Financial and Accounting Officer, and Dr. Mark Van Dyke, Chief Scientific Officer. Dr. Joy Zhu, head of CMC, is also here for any questions. Now I'd like to turn the call over to Dr. Buell to highlight our progress in 2023 and to speak to our outlook for 2024. Thank you very much, Zack.

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 web site for replay.

Zack Armen: 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.

Zack Armen: 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.

Jennifer S. Buell: And again, you'll hear more data at 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 U.S. alone. Compared to conventional therapies like corticosteroids, our trials have demonstrated activity 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 inpatients with ARDS, potentially reshaping treatment paradigms for intensive and acute pulmonary care settings.

Speaker Change: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, Christine Classic and principal financial and accounting Officer and Dr. Mark Van Dyke, Chief Scientific Officer, Dr. Joey Xu head of CMC is also here for any questions now I would like to turn the call over to Dr. Buell to highlight our progress in 2023.

Speaker Change: And to speak to our outlook for 2024.

Speaker Change: 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 'twenty 'twenty four.

Jennifer S. Buell: It's a pleasure to have you all here 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 gonna go through today. And these are all related to advancing our allogeneic INKT or invariant natural killer T cell program. Notably, we initiated a Phase 2 trial in gastroesophageal cancer, a development I'll delve into very shortly. This pivotal program builds 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 data set and nearly 100 patients treated to date showcase the efficacy and activity of INKTs in addressing solid tumor cancers and other immune-related diseases, such as acute respiratory distress syndrome, with promising outcomes observed.

Speaker Change: Our 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 allogeneic I N K T or invariant natural killer T cell programs.

Speaker Change: Notably we initiated phase a phase two trial and gastroesophageal cancer development I'll delve into very shortly this pivotal program builds upon crucial data presented at four major medical conferences throughout the course of 2023.

Jennifer S. Buell: In summary, our approach to rapidly advance 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 months 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 allogeneic INKT cells. These cells, this is a critical capability led by Dr. Joy Zhao, 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 supply of our product.

Along with the publication of our findings and esteemed journals, such as nature Communications and uncle gene or.

Speaker Change: Our comprehensive dataset nearly 100 patients treated to date.

Speaker Change: Okay says the efficacy in activity of ion K, T's, and addressing solid tumor cancers, and other immune related diseases, such as acute respiratory distress syndrome.

Speaker Change: 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 thank therapeutic with a key contributor to the progress of living medicines.

Jennifer S. Buell: These achievements underscore our pivotal role in advancing state-of-the-art cell therapies on what we believe to be an optimal cell platform, positioning MiNK Therapeutics as a key contributor to the progress of living medicine. Today, MiNK stands as one of the most clinically advanced companies pioneering this novel cell type, INKTs. And as a reminder, INKTs are what we believe to be the most potent and highly conserved cell type in immunity.

Speaker Change: Today makes stands as one of the most clinically advanced companies pioneering this novel cell type I N K T's and as a reminder, I N T teaser of what we believe to be the most potent and highly conserved cell type and immunity through the progression of our clinical programs and robust R&D initiatives, we've made significant contributions to an expanding.

Jennifer S. Buell: 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 publication of the two manuscripts that I just mentioned a moment ago. We 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.

Speaker Change: Repository of clinical and preclinical data showcasing the distinct advantages of I N K t's and immune therapy for immune related diseases.

Jennifer S. Buell: We are currently providing our in-house manufacturing product 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 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. This demonstrates 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 allogeneic cell 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. Mark van Dijk to go over MiNK's technology platforms and another important component of our next-generation pipeline. Mark?

Speaker Change: This year our efforts have culminated in presentations at four major medical meetings and publications of the two manuscripts that I just mentioned a moment ago, we've showcased their 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.

Speaker Change: Going into our priorities for this year, let me just reiterate our fully integrated capabilities that are unique to link in this space and these capabilities really underscore our efficiency and the progress we've been able to make to date.

Jennifer S. Buell: 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 Mark has shared with you and we'll go into 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 Allogeneic INKTs.

Speaker Change: With our state of the art discovery platforms with Mark has shared with you and we'll go into some more detailed today, our AI capabilities, our high throughput genomic analyses and engineering capabilities, we possess the agility the agility to swiftly identify targets and develop therapeutic approaches.

Speaker Change: Whether through car I N K t's.

Speaker Change: T cell engages TCE ours or native allogeneic I N. K T's. These programs had been seamlessly through our fully internal GMP manufacturing capabilities, which have been optimized further scaled and received FDA clearance to produce material in house for a clinical program.

Jennifer S. Buell: These programs advance 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 a focus on really revolutionizing treatment and access to these effective cell therapies for cancer, pulmonary diseases, and other immune-related disorders. Our flagship program is a native, naturally engineered, allogeneic, donor-derived INKT cell product. It is called Agent 797.

Speaker Change: Yes.

Speaker Change: We're advancing on multiple fronts with a 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 allogeneic donor derived I N K T cell.

Speaker Change: Product, which is called agents 797.

Jennifer S. Buell: It's now advancing in a phase two trial in second line gastric cancer. And in addition, our collaboration with Immunoscape, which we announced last year and is spearheaded by Mark, empowers us to leverage the potential of our T cell receptor platform and programs, as well as our novel and proprietary target. Furthermore, our T-cell Engager platform boasts 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.

Speaker Change: It is now advancing in a phase two trial in second line gastric cancer.

Speaker Change: And in addition, our collaboration with immune escape, which we announced last year spearheaded by Mark empowers us to leverage the potential of our T cell receptor platform and programs as well as our novel and proprietary targets.

Marcus Antonius van Dijk: Thank you, Jen. I'm going to talk a bit about our CAR-NKT program, MINK215, and then about TCRs, recent activities there, and selling ages. So on MINK215, given the potent tumor infiltrating and immune-modulating activity of MINK215 that we've observed in preclinical studies, including lung cancer, we anticipate it may actually elicit clinical responses in difficult-to-treat solid tumors. For example, patients with microsatellite-stable or mismatch-repair-proficient colorectal cancer frequently have liver metastases, So the tumor microenvironment of colorectal cancer liver metastases is characterized by a highly immunosuppressive phenotype, which prevents the patient's T cells from infiltrating and attacking these metastases, even when these are reactivated and reinvigorated by immune checkpoint blockade using NTPD1 or NTPDL1 antibody.

Speaker Change: Furthermore, our T cell engaging platform both unique development capabilities and also holds a promise that's really quite unique to mink of delivering engage your T cells in combination with native I N. K T's. This is an innovative it's strategic and it's unique to what we can bring to our clinical development.

Jennifer S. Buell: This is innovative, it's strategic, and it's unique to what we can bring to clinical development. I'm going to speak a bit about our programs and oncology. As we look ahead to 2024, our focus really remains squarely on advancing our lead program, Agent 797. Our objectives are very clear.

Let met.

Speaker Change: I'm going to speak a bit about our programs and oncology as we look ahead to 2024 focus really remains squarely on advancing our lead program H M. Seven nine and seven our objectives are very clear, we must continue expanding our clinical dataset and exploring therapeutic air.

Jennifer S. Buell: 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 accessible living medicines designed to deliver benefits without the disabling side effects of standard chemotherapeutic approaches. This is particularly evident in patients with gastric cancer.

He is with potential rapid development pathways are focus on 787 series is a cornerstone of our vision driving us forward to redefine treatment standards.

Tivoli impacting patients' lives with 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.

Jennifer S. Buell: In February, we announced a significant milestone with the launch of our Phase 2 study of 797. This trial focuses on combining 797 with botansilamab, which many of you are quite familiar with. Botansilamab is an FC-engineered molecule.

Speaker Change: In February we announced a significant milestone with the launch of our phase II study of 787.

Speaker Change: This trial focuses on combining 797.

Speaker Change: With boat and sell them at which many of you are quite familiar with built in selenide, There's an FC engineered molecule. It's a multi modal T cell activator, which also binds to see T. L. A four.

Jennifer S. Buell: It's a multimodal T-cell activator that also binds to CTLA-4. This agent works well with balacelamab and anti-PD-1 therapy. Both of those antibodies are through our collaboration with Agenis, and this combination is also added on top of standard of care chemotherapy and 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 SITI 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 chemotherapy, specifically in gastric cancer. This collective evidence showcases the 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 cancer.

Speaker Change: This agent combined with Bell still amount of an anti PD one therapy both of those antibodies are our through our collaboration with the genus.

Marcus Antonius van Dijk: This underscores the urgent need for innovative therapeutic approaches targeted specifically to patients with liver metastases. To better model immune checkpoint blockade refractory human colorectal cancer liver metastases, we, together with our colleagues from Agenis, developed an ex vivo human organoid model that recapitulates the histological and immunological features of human disease. And our findings underscore that in treatment-refractory liver metastatic organoid models, MINK215 can potentially overcome the limitations of immune checkpoint therapy, effectively target sites of disease, reprograms the tumor microenvironment, recruits tumor-reactive T cells, and enhances tumor care.

Speaker Change: And this combination is also added on top of standard of care chemotherapy.

Speaker Change: 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.

Speaker Change: Initiation of the trial follows a compelling clinical dataset presented at ACR and <unk> 50 last year and most recently the publication of a manuscript outlining 797th clinical activity in patients that are refractory to immune checkpoint inhibitors in prior chemotherapy, specifically in gastric cancer.

Speaker Change: This collective evidence showcases at 790 seven's potential to overcome resistance to immune checkpoint inhibitors.

Speaker Change: Demonstrating durable disease stabilization and activity in refractory solid tumor cancers, including a confirmed response in chemotherapy and anti PD, one refractory gastric cancer.

Jennifer S. Buell: As a reminder, the patient who was published in Oncogene was a patient who failed prior chemotherapy, full FOX, as well as nivolumab and pembrolizumab. So this patient then was treated with cells in combination with NEVO and had a partial response that was durable and remained so throughout the trial period. The trial is led by Dr. Yelena Jenjikian.

Speaker Change: As a reminder, the patient who has published an uncle Jean was a patient who failed prior chemotherapy full box as well as in a bowl of map and Pemba lithium hub. So this patient then was treated with cells in combination with Geneva and had a partial response it was terrible and remains so throughout the trial period. The trials led by Dr. Lena.

Marcus Antonius van Dijk: This data will actually be presented at the upcoming American Association for Cancer Research Annual Meeting in April. Thus, our additional unique research capabilities at MiNK include a proprietary library of phosphopeptide neoantigens derived from a wide range of solar tumors and hematological malignancies. We've assembled this target library over the last couple of years through internal efforts expounding on the original acquisition of fossing unit 2015. Thus, we believe that these phosphopeptides represent broadly presented new antigen tumor targets that can be utilized to discover potent T-cells that can then be used to attack solar tumors.

Jennifer S. Buell: 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 two study holds promise of 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 early preliminary positive signals, which we're quite excited about. These findings form the foundation of continued discussions with regulators to expand the benefit 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 in being able to generate allogeneic donor-derived INKTs at scale that can be cryopreserved and retain their functional characteristics.

Speaker Change: Angie can you lean as the chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center. The trials supported by stand up to cancer and this phase III 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.

Speaker Change: The pleasure of seeing some very initial preliminary positive signals, which we're quite excited about.

Speaker Change: These findings form the foundation of continued discussions with regulators to expand the benefit for patients with gastric <unk> gastric cancer and Ah trial that we plan to provide an update for you before the end of this year.

Speaker Change: Now beyond oncology. This is a growing area of the 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 allogeneic donor derived I N K T.

Marcus Antonius van Dijk: So, to further our discovery and development of new candidate T cell receptors, we entered into a research collaboration agreement with Immunostructure. This collaboration is designed to accelerate the development of TCR-based therapies against novel targets in T cells, variant NKT cells, and other modalities. In this collaborative effort, ImmuneScape will leverage capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevant TCRs targeting the library of phosphopethyl enzymes. 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 INK T-cells or as bispecific cell engages. We believe that invariant NKT cells are perfect allogeneic host cells for expressing tumor-targeting T cell responses and developing Off-the-Shelf PCR-Based Cell Therapy.

Speaker Change: He's at scale that can be cryo preserved and retain their functional characteristics. This allows us to have the cells at the site when the patients who need them and able to be delivered at the point at the point of administration without any delays from needle to needle time.

Speaker Change: We've been working outside of oncology and we made some important advancements with seven nine and seven outside of this of oncology our published data highlights the important role that I N K T's could play in immunity more broadly and these include infections inflammatory diseases as well as.

Speaker Change: Auto immunity and you're going to hear some data at an upcoming conference in the first half of this year about some important signals that Ah Ah Ah <unk> in the treatment paradigm with patients who have both auto immunity and infections, which I think will make he was excited as it has made me.

Speaker Change: Last year, we presented data at the American Thoracic Society and it showed.

Speaker Change: Survival benefit of 75% in patients treated with agents 797, and these state data stand in Stark contrast to 10% survival in the in hospital case controls enrolled at the same time period of our trial will present. These data at a conference in the first half of this year and will follow.

Marcus Antonius van Dijk: We look forward to working with the Immunoscape team to deliver new therapeutics that can potentially eliminate tumor cells and alleviate immune suppression for durable anti-cancer immunity, especially for solar tumors. Now, another development that we're actually very enthusiastic about is combining our off-the-shelf invariant NKT cells with cell engagement, both with existing third-party T cell engagements, as well as with our own invariant NKT cells. We've seen our off-the-shelf invariant NKT cells strongly enhance tumor killing and immune activation when combined with cell engages in our model set. And we believe that co-administration of invariant NKT cells and T-cell engages has the potential to strongly increase clinical efficacy, especially in solid tumors where cell engages have not yet shown great results. Invariant NKT cells have shown they can infiltrate tumors where conventional T cells struggle.

Speaker Change: 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 form of life support a with a R. D. S. These patients are treated with Ecmo Vv ecmo and those patients treated with VB ecmo actually had a survival rate of over.

Speaker Change: 80%.

Speaker Change: Which is also really quite unexpected in this type of patient population and again, you'll hear more data at an upcoming conference in the first half of this year.

Speaker Change: Now these clinical trials have demonstrated promising results regarding the activity of I N K T cells in patients facing severe respiratory distress. Now this is a condition affecting over 600000 individuals' annually in the U S alone.

Jennifer S. Buell: 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 inpatients with ARDS, potentially reshaping treatment paradigms for intensive and acute pulmonary care settings. In summary, our approach to rapidly advance 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 months 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 allogeneic INKT cells.

Speaker Change: Compared to conventional therapies like corticosteroids are trials have demonstrated these active activities in critical end points, such as respiratory function oxygenation levels as well as overall survival rates and they presented an important foundation for the development of 797 in patients with a R. D S protect.

Kelly reshaping treatment paradigms for intensive and acute pulmonary care settings.

Marcus Antonius van Dijk: So we administer our INK T-cell products without lymphodepletion, which is crucial for maintaining the full immune potential of the patient; co-administering invariant NKT cells with engages could ensure that a wave of these very potent immune cells enters the tumor first. This not only helps ensure a focused attack, a focused direct attack on the tumor, but at least as important, combats local immune suppression and brings in the patient' We're actively exploring these combinations, and we look forward to updating you on our progress in the near future. And I'll turn the call back over to Jen. Jen?

Speaker Change: In summary, our approach to rapidly advance I N K T 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 months ahead.

In order to support our growing seven nine and seven clinical programs of course, we've maintained a steadfast focus on delivering our in house manufacturing of Allogeneic NK T cells.

Jennifer S. Buell: These cells, this is a critical capability led by Dr. Joy Zhao, 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 supply of our product. We are currently providing our in-house manufacturing product 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 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. This demonstrates 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 allogeneic cell 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. Mark van Dijk to go over MiNK's technology platforms and another important component of our next-generation pipeline. Mark?

Speaker Change: These so this is a critical capability led by Dr. George Zhao and this removes any reliance that we currently have or had previously had on third party C. D M O's and it ensures our control end to end control over an efficient and reliable supply of our product. We are currently providing our in house manufacturing.

Jennifer S. Buell: Mark, thank you very much. It's excellent. Excellent. As we reflect, of course, on our progress 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 our external dependencies as well as costs.

Speaker Change: For our ongoing clinical studies and plan to do so far 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 and to end automatic closed an industrialized I N K T manufacturing process.

Speaker Change: Which is fully in house, demonstrating makes internal manufacturing capacity and compliance with rigorous regulatory standards and its readiness for clinical production to support our trials.

Christine M. Klaskin: And our Phase II trial and second line gastric cancer is led by the world's expert in this tumor type and at 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 Mark has mentioned, the capability that we possess 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 necessary for approval. And that includes expanding the benefit of T cell engagers.

Speaker Change: This process represents a top notch industrialized allogeneic cell therapy manufacturing process and Leverages, our cutting edge closed technology to streamline production from start to finish and minimize any manual intervention.

Speaker Change: This minimize of course and in our hands has eliminated contamination as far as we can tell at this point and make it means product with integrity throughout the manufacturing process.

Speaker Change: I'm now going to turn the call over to Dr. Mark Van Dijk to go over them makes technology platforms and another important component of our next generation pipeline Mark.

Thank you, Jim I'm going to talk a bit about our car and keep programming to them and about Ccr's recent activities here in Chile.

Speaker Change: Hum.

Speaker Change: Opening two of heart given the potent tumor infiltrating immune modulating activity of mix one five what we've observed in preclinical studies, including lung cancer.

Speaker Change: We anticipated actually may elicit clinical responses in difficult to treat solid tumors.

Speaker Change: Patients with microsatellite stable or mismatch repair proficient colorectal cancer frequently have liver metastases, which is associated with very poor response to correct pharmacological treatments, including immune checkpoint blockade.

Christine M. Klaskin: 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 will continue to be very prudent in the selection of our clinical programs to have 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. Thank you, Jim. We ended the year with a cash balance of $3.4 million. Since year-end, we have received $5 million under our convertible note agreement that we executed last month with Agena. 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 period in 2022. Our net loss for the year ended December 31, 2023, was $22.5 million, or $0.65 per share, which compares to a net loss for the same period in 2022 of $28 million, or $0.83 per share.

Speaker Change: Because the tumor microenvironment of colorectal cancer literal Mckesson fees is correct, Josh why a highly immunosuppressive phenotype.

Speaker Change: Prevents the patient's T cells for mutual trading there that can be true.

Speaker Change: Even when these are reactivated and reinvigorated by immune checkpoint blockade using anti PD, one or anti PDL, one and people.

Speaker Change: This underscores the urgent need for innovative therapeutic approaches targeted specifically for patients with liver metastases.

Speaker Change: So to better model immune checkpoint blockade refractory human colorectal cancer liver metastases, we together with our colleagues from agenda has developed an ex vivo human Organoid model.

Marcus Antonius van Dijk: This underscores the urgent need for innovative therapeutic approaches targeted specifically to patients with liver metastases. Therefore, to better model immune checkpoint blockade refractory human colorectal cancer liver metastases, we, together with our colleagues from Agenis, developed an ex vivo human organoid model that recapitulates the histological and immunological features of human disease. And our findings underscore that in treatment-refractory liver metastatic organoid models, MINK215 can potentially overcome the limitations of immune checkpoint therapy, effectively target sites of disease, reprograms the tumor microenvironment, recruits tumor-reactive T cells, and enhances tumor control.

Speaker Change: Capitulation astrological immunological features of human disease.

Speaker Change: Findings underscore that treatment refractory liver Mets, a stuffy organoid models.

Speaker Change: One five can potentially overcome the limitations of immune checkpoint therapy.

Speaker Change: If you have homes to start to disease.

Speaker Change: Programs the tumor marker environment.

Speaker Change: Crudes tumor reactive T cells in an office to Mercury.

Speaker Change: This data will actually be presented at the upcoming American Association for cancer Research annual meeting in April.

Speaker Change: So all additional unique research capabilities with new conclude a proprietary library fulfilled peptide neo antigens derives from a wide range of solid tumors and chemo.

Speaker Change: It's a logical malignancies.

So we've assembled this target libraries here over the last couple of years to internal efforts expanding on the original acquisition of caution you in 2015.

Marcus Antonius van Dijk: This data will actually be presented at the upcoming American Association for Cancer Research Annual Meeting in April. Thus, our additional unique research capabilities at MiNK include a proprietary library of phosphopeptide neoantigens derived from a wide range of solar 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 Fosinune in 2015. We believe that these phosphopeptides represent broadly presented new antigen tumor targets that can be utilized to discover potent T-cells that can then be used to attack solar tumors.

Speaker Change: So we believe that these fulfill pick large represent broadly presented do you want to do tumor targets, which can be utilized to discovered potent T cell receptors that can then be used to attack solid tumors.

Speaker Change: So the fruit of our discovery and development of new kinds of the T cell receptors, we entered into a research collaboration agreement with immune escape.

Speaker Change: This collaboration is designed to accelerate the development of TCR based therapies against mobile targets and peaceful and variance in Q T cells and auto Modelo Peach.

Operator: I will now turn the call back over to our operator for questions. Thank you. If you would like to ask a question on the phone lines today, it is star one on your telephone keypad. We'll pause for a moment. We'll take our first question from Emily Bodnar with HC Wingright. Hi, good morning. Thanks for taking the questions. A few for me.

Speaker Change: And this collaborative effort immune escape will leverage capabilities and multiplex screening and in depth T cell profiling to identify relevant piece yours.

Speaker Change: We're getting the larger your forceful peptide antigens.

Speaker Change: Thanks Therapeutics will further correct yac's tumor specific T cell receptors levering its proprietary platform of capabilities to analyze and select TCR candidates for optimal tumor targeting went expression or NK T cells or as bar specific cell engages.

Marcus Antonius van Dijk: To further our discovery and development of new candidate T cell receptors, we entered into a research collaboration agreement with Immunostructure. This collaboration is designed to accelerate the development of TCR-based therapies against novel targets in T cells, in variant NKT cells, and other modalities. In this collaborative effort, ImmuneScape will leverage capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevant TCRs. Targeting the Library of Phosphopeth, that entity

Emily Claudia Bodnar: On your clinicaltrials.gov listing for the Phase 2 gastric study, it looks like you're also combining with Ramadurumab. So, can you discuss what patients might be getting 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? Emily, this is an excellent question.

Speaker Change: He believes in very under in Q T cells are perfect. I went generic wholesales were expressing tumor targeting T cell receptors and developing off the shelf TCR based cell therapies.

Speaker Change: We look forward to working with him in his script with you mean escaped team to deliver new therapeutics that can potentially eliminate tumor cells and alleviate immune suppression for durable anti cancer immunity, especially for solid tumors.

Speaker Change: No not a development that we're actually very enthusiastic about is combining our off the shelf and variance in Q T cells with cell engages.

Marcus Antonius van Dijk: 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 INK T cells or as bispecific cell engages. We believe that invariant NKT cells are perfect allogeneic host cells for expressing tumor-targeting T cell responses and developing Off-the-Shelf PCR-Based Cell Therapy. We look forward to working with the ImmuneScape team to deliver new therapeutics that can potentially eliminate tumor cells and alleviate immune suppression for durable anti-cancer immunity, especially for solar tumors. Now, another development that we're actually very enthusiastic about is combining our off-the-shelf invariant NKT cells with cell engagement, both with existing third-party T cell engagements, as well as with our own invariant NKT cells.

Speaker Change: Both with existing third party diesel engages just wanted to put our own and very peaceful engages.

Speaker Change: We've seen our off the shelf and variants peaceful truly in homes tumor, killing immune activation when combined with show engages in intermodal systems and we believe the co administration of invariance country T cells and T cell engagement has the potential to strongly increase clinical efficacy, especially in solid tumors, we're still engaged.

Jennifer S. Buell: So this is something that we've 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 Bat Bal, and plus with and without Ramicerumab and Paclitaxel. Now, Ramatax, those are the standard of care agents used in second-line gastric cancer. They have very limited activity, as you know, probably just a little over 20 percent, which gives us a big opportunity to really make a significant difference in the treatment landscape here. We will generate a data set 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 combination with Bat Bal and standard of care chemo. And we already have some preliminary signals for each of these settings that we'll be sharing with you as we continue to develop the data set in the second half of the year.

Speaker Change: Just have you have shown great results.

Speaker Change: And very the NK T cells have shown they can infiltrate solid tumors, where conventional T cells struggle. So.

Speaker Change: So we administer our T cell product without lymphoid accretion, which is crucial for maintaining the full potential of the patient.

Administering and variant in Q T cells with engages couldn't shoot at a wave of these very potent immune cells into the tumor.

Speaker Change: This will only helps ensure a focus detect folks direct attack on the tumor.

Marcus Antonius van Dijk: We've seen our off-the-shelf invariant NKT cells strongly enhance tumor killing and immune activation when combined with cell engages in our models, and we believe that co-administration of invariant NKT cells and T-cell engages has the potential to strongly increase clinical efficacy, especially in solid tumors where cell engages have not yet shown great results. In variant NKT cells, they have shown they can infiltrate tumors where conventional T cells struggle.

Speaker Change: At least as important congrats local immune suppression and brings in the patient's own immune cells.

Speaker Change: We are actively exploring these combinations and we look forward to updating you on our progress in the near future.

Speaker Change: I'll now turn the call back over to Jim Jim.

Jim: Mark. 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 at two <unk>.

Jennifer S. Buell: 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 fastest to develop, would be dropping the therapies on top of standard of care Ramtax. That allows us not to salvage patients post-Ramtax. It allows us to take advantage of some of the neoantigen release from the tumor killing that does come along with chemotherapy.

Jim: Difficult reduce our external dependencies as well as costs and our phase two trial in second line gastric cancer is led by the world's experts in this tumor type and at a world leading institution and externally funded by stand up to cancer, which enables us to essentially access.

Jennifer S. Buell: So we administer our INK T-cell products without lymphodepletion, which is crucial for maintaining the full immune potential of the patient. Co-administering invariant NKT cells with engages could ensure that a wave of these very potent immune cells enters the tumor first. This not only helps ensure a focused attack, a focused direct attack on the tumor, but, at least as important, combats local immune suppression and brings in the patient's own immune system. We're actively exploring these combinations, and we look forward to updating you on our progress in the near future. And I'll turn the call back over to Jen. Jen?

Jim: Insights into a development pathway in an incredibly efficient way. So we're excited about our ability to do that.

Speaker Change: Partnering remains core to our strategy and as Mark 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.

Jennifer S. Buell: And we know that the cells can be dosed tolerably in that disease setting. And we also know that they can be combined tolerably with checkpoint modulating antibodies, such as PD-1, and now with Bat Bal. So, I'm hoping that I have answered your question.

Speaker Change: For approval and that includes expanding the benefit of a T cell engages and this is an active dataset that we've generated in our own hands as well is in the hands of potential partners. So.

Jennifer S. Buell: The data set in conclusion will be cells alone, cells in combination with RAM-TACS to get us on top of standard of care, and then cells in the multi-combination that includes BotBowl. And I should say, we did not include a RAM-TACS 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 to the trial at this time.

Speaker Change: We are quite excited about what the future holds and we'll continue to be very prudent in our selection of our clinical programs to have heightened 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.

Christine M. Klaskin: In our phase two trial and second line, gastric cancer, is led by the world's expert in this tumor type and at 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 Mark has mentioned, the capability that we possess 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 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.

Christine M. Klaskin: And Jos.

Christine M. Klaskin: Yeah.

Christine M. Klaskin: Thank you Jim.

Christine M. Klaskin: We ended the year with a cash balance of $3 $4 million.

Jennifer S. Buell: We would do so provided there are positive signals. It would probably be a requirement to do so in a registrational study that would follow this sometime mid-year. Okay, that makes a lot of sense. Just, I guess, a confirmation question.

Christine M. Klaskin: Since year end, we received $5 million under our convertible note agreement that we executed last month with a genus.

Christine M. Klaskin: Cash used in operations for the three and 12 months ended December 31, 2023 was $3 million and $15 $8 million respectively.

Jennifer S. Buell: Are you only evaluating patients who have failed one prior line, or is it like a minimum of one prior line? Right now, we have it essentially as a minimum of one prior line, but really, the focus is on one prior line. These patients who have failed full Fox Nivo really have nothing to go to, barring their HER2 status. So, they would essentially be treated with Ramtax. So, there isn't very much more for those patients to go on. Okay, that makes sense. And then last question, I know you talked about the 5 million convertible note from Agendas, but maybe we could just discuss strategies for bringing additional capital into the company. Thank you. Thank you very much, Emily. Absolutely.

Christine M. Klaskin: This compares to $4 $4 million and $18 $9 million for the same periods in 2022.

Christine M. Klaskin: Our net loss for the year ended December 31, 2023, with $22 $5 million or <unk> 65 per share, which compares to net loss for the same period in 2022 of $28 million or <unk> 83 per share.

Christine M. Klaskin: So, we are quite excited about what the future holds and will continue to be very prudent in the selection of our clinical programs to have 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. Thank you, Jim. We ended the year with a cash balance of $3.4 million. Since year-end, we received $5 million under our convertible note agreement that we executed last month with Agena. Cash used in operations for the 3 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 period in 2022. Our net loss for the year ended December 31, 2023, was $22.5 million, or $0.65 per share, which compares to a net loss for the same period in 2022 of $28 million, or $0.83 per share.

Speaker Change: I will now turn the call back over to our operator for questions.

Speaker Change: Thank you if you would like to ask a question on the phone lines today. It is star one on your telephone keypad.

Speaker Change: We'll pause for a moment.

Speaker Change: We'll take our first question from Emily Wagner with H C Wainwright.

Hi, good morning, Thanks for taking the questions a few for me I'm on your clinical trial dog, what's the timing for the phase two gastric study.

Jennifer S. Buell: So, first, I should say that as you look at the prior year, 2023, you'll see that the financial consumption of about $15.8 million drove the execution and completion of three clinical trials and our manufacturing optimization. So, 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. Genchigian, but we would like, of course, to 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.

Emily Claudia Bodnar: It looks like they're also combining with around a third or so.

Emily Claudia Bodnar: Can you discuss what what patients might be getting that in the.

Emily Claudia Bodnar: And their treatment plan and.

Emily Claudia Bodnar: Given that you are combining agents southern 97 with several agents how do you kind of think about the efficacy of components.

Emily Claudia Bodnar: On what we might expect with center of care.

Speaker Change: And while this is an excellent question, so and something that we've got quite a bit about and I'll share with you that we are developing the dataset to interrogate patients with I N K T's alone.

Speaker Change: But bell and.

Speaker Change: Plus with and without Red Mr amount and Paclitaxel now Ram tax those are the standard of care agents used in second line gastric cancer, they have very limited activity and.

Speaker Change: As you as you know probably just a little over 20, 25%.

Jennifer S. Buell: The first is, of course, through 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 less known, and that does require, you know, groups to get up to speed on what the science depicts.

Speaker Change: Which gives us a big opportunity to really make a significant difference in the treatment landscape here, we will generate the dataset that that will include how patients perform on the cells alone.

Jennifer S. Buell: On your clinicaltrials.gov listing for the phase 2 gastric study, it looks like you're also combining with Ramadurumab. So, can you discuss what patients might be getting that 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? Emily, this is an excellent question, so this is something that we've 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 Bott Bell, and plus with and without Ramice Now, Ram-Taq, those are the standard of care agents used in second-line gastric cancer.

Speaker Change: They perform with the shelves on top of standard of care as well as yourselves and the multiple combination with Bob al and the standard of care chemo.

Jennifer S. Buell: 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. 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, but it would also allow us to expand our discovery pipeline and could give us infrastructure outside of the U.S. 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 continue to be in active discussions for in an R&D partnership as well as access to the cells alone, just essentially just And, of course, the third would be expanding our interactions with project-based financing and investors.

Speaker Change: We already have some preliminary signals of of each of these settings that we'll be sharing with you as we continue to develop the dataset in the second half of the year.

Speaker Change: 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 a that allows us not to salvage patients post ramp tax it allows us to take.

Speaker Change: The advantage of some of the Neo antigen are released from the tumor killing that does come along with a chemotherapy.

Jennifer S. Buell: They have very limited activity, 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 a data set 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 combination with Bott Bell and standard of care chemo. And we already have some preliminary signals for each of these settings that we'll be sharing with you as we continue to develop the data set in the second half of the year.

Speaker Change: And we know that the cells can be dose tolerably in that disease setting. We also know that they can they can combine tolerably with them with <unk> with checkpoint modulating antibodies, such as PD, one and now with with bought down.

Speaker Change: So I'm, hoping that I heard your question the dataset and.

We'll see.

Speaker Change: <unk> alone sells in combination with Ram tax to get us on top of standard of care and then the cells in them will be combination that includes Bob al 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.

Jennifer S. Buell: 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 fastest to develop, would be dropping the therapies on top of standard of care Ram-Taqs. That allows us not to salvage patients post-Ram-Taqs. It allows us to take advantage of some of the neoantigen release from the tumor killing that does come along with chemotherapy.

Jennifer S. Buell: And these, again, are active discussions that are underway. Great, thanks for taking the question. Thank you. Our next question comes from Jack Allen with Baird.

Speaker Change: Set for rent 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.

Jennifer S. Buell: And we know that the cells can be dosed tolerably in that disease setting. And we also know that they can be combined tolerably with checkpoint modulating antibodies, such as PD-1, and now with Bott Bell. So, I'm hoping that I answered your question.

Jack Kilgannon Allen: Great, thanks for doing 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? So I should share with you, Jack, that's a great question.

Speaker Change: Perfect.

Speaker Change: Awesome.

Speaker Change: I guess copper.

Speaker Change: Confirmation question are you only evaluating patients who have failed one prior line or is it like a minimum of one airline.

Jennifer S. Buell: The data set in conclusion will be cells alone, cells in combination with Ram-Tacs to get us on top of standard of care, and then cells in the multi-combination that includes BotBowl. And I should say, we did not include a Ram-Tacs 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 to the trial at this time.

Speaker Change: 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 Fox Knievel really have nothing to go two barring a they're her two status. So they would essentially be treated with <unk>. So.

Jennifer S. Buell: And it is something that we in the industry have typically been plagued with, waiting 28 days per patient. I will say that given the experience and the visibility of Dr. Yelena Jenjigian, she was able to navigate and negotiate this very aggressively with our regulatory partners, and we do not have any gaps. So there's no staggering in the trial, which is enormously helpful. In part, it speaks to the unmet need.

Speaker Change: There isn't very much more for those patients to go on.

Speaker Change: Uh-huh excellence.

Speaker Change: And of course, then I know you talked about the 5 million convertible note from John as well, maybe just discuss like strategies for bringing in additional capital into the company.

Speaker Change: Yes.

Speaker Change: Thank thank you very much Emily absolutely. So first I should say that as you look at the the year prior year 2023, you'll see that the the financial consumption of about $15 $8 million drove the execution and completion really of three clinical trials.

Jennifer S. Buell: Are you only evaluating patients who have failed one prior line, or is it like a minimum of one prior line? Right now, we have it essentially as a minimum of one prior line, but really, the focus is on one prior line. These patients who have failed full Fox Nivo really have nothing to go to, barring their HER2 status. So, they would essentially be treated with Ramtax. So, there isn't very much more for those patients to go on. Okay, that makes sense. And then last question, I know you talked about the $5 million convertible note from Agenez, but maybe just discuss strategies for bringing additional capital into the company. Thank you very much, Emily. Absolutely not.

Speaker Change: And our manufacturing optimization, so that that really does speak to the efficiency that our our team has been able to operate with this year of course, we're being even more financially prudent with the external amortization of the financing for our clinical programs at this time the cells are in high demand.

Jennifer S. Buell: It also speaks to her convincing argument about the unmet need and the urgency of delivering therapies for these patients. So the pace of enrollment, I should say, is moving really, really quite quickly. Doctor, could you speak to maybe the, you know, patient, about the plots that they have at this, within these centers at Memorial Sloan-Kettering and what the potential demand could be for this 40-person study. Well, I will just share with you, without disclosing too much, I'll just share with you what Dr. Janjigian just presented to our team and board this week. She said, "I have patients lined up for this trial. The demand is very high." I hesitate to give any more further guidance, but I will say I believe that we'll be on track to have concluded enrollment in the first half of this year. Great.

Speaker Change: It's about four trials such as the one that we're conducting with Dr. Ginger again, 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 in three different ways as far as we can tell right now the first.

Jennifer S. Buell: So first, I should say that as you look at the prior year, 2023, you'll see that the financial consumption of about $15.8 million drove the execution and completion of three clinical trials and our manufacturing optimization. So 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, of course, to 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.

Speaker Change: <unk> 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 I N. K T's. We are the most advanced company, bringing these forward. So the science is lesser known and that does require you know groups to get up to speed.

Speaker Change: And what the science depicts our clinical data is very much helping that.

Speaker Change: 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 our 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.

Jennifer S. Buell: And then just one more on the gastric study. What is the dialogue between MiNK and the investigator in the study? I guess, how frequently are you getting updates as it relates to data? And how should we think about that then?

Speaker Change: Give us infrastructure outside of the U S, where we currently do not have a bandwidth or infrastructure.

Jennifer S. Buell: The first is, of course, 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 less known, and that does require 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. Much of that work has been done, and now discussions are starting to advance. A collaboration would not only help us to expand on the work that we're doing, but it would also allow us to expand our discovery pipeline and could give us infrastructure outside of the U.S. where we currently do not have bandwidth or infrastructure.

Jennifer S. Buell: We have – Dr. Janjigian has quite a bit of experience with the Genesis-BotBowl combination as well as now the cells. We have really quite frequent interactions with her, so we have a good sense of both the activity of the product as well as its safety profile of the product in real time. I should say, though, given her gravitas, it will benefit all of us to ensure that the data and her interpretations of the data will come really from Dr. Janjigian and her team, and we expect that to be at a major conference, so it will come from Dr. Janjigian's team. Got it. I got it.

Speaker Change: 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 a supply arrangement for combinations in our pipeline.

Speaker Change: And and of course, the third would be expanding our interactions with them with project based financing and investors and these again are active discussions that are underway.

Speaker Change: Great. Thanks for taking the questions.

Speaker Change: Of course.

Speaker Change: Our next question comes from Jack Allen with Baird.

Jack Kilgannon Allen: Hi, Thanks for taking the questions and congratulations on the progress made over the quarter.

Jack Kilgannon Allen: So first of all on gastric could you provide some color on the cadence of enrollment or are there any staggers early in the study with multiple arms.

Jack Kilgannon Allen: Between the different patients.

Jennifer S. Buell: The other is, of course, a regional partner, which I also mentioned is something that we continue to be in active discussions for in an R&D partnership as well as access to the cells alone, just essentially just a 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. Great, thanks for taking the question. [inaudible] Our next question comes from Jack Allen with Baird.

Speaker Change: So I should I should share with you Jack that's a great question and it is something that we and the industry has typically been plagued with waiting 28 days per patient I will say.

Jennifer S. Buell: And then, shifting gears, I was hoping you could provide an update on some of the other non-oncology programs. I know in the past, you've looked at potentially testing the cells in graft-versus-host disease. Where do things sit as it relates to those other opportunities beyond ARDS?

Speaker Change: And that given the the experience and the visibility of Dr. You're laying out a ginger again, she was able to navigate and negotiate this very aggressively with our regulatory partners.

And we do not have any gaps so theres no staggering in the trial, which is an enormously helpful. In part it speaks to the unmet need it also speaks to him.

Jennifer S. Buell: Great, thanks for doing 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?

Jennifer S. Buell: So, Jack, I am so grateful for your thinking on GVHD because, as we all know, the cells actually can naturally prevent GVHD, and we know that they can be dosed tolerably and quite effectively. And there are a few different settings that we have continued to pursue. We're working aggressively. We have the trial designed, and we're working aggressively to find the support and the financial support to execute on this trial. It would be a very rapid trial in acute graft-versus-host disease and something that we could move forward with very, very quickly. We do expect to announce this trial in 2024. Now, we had hoped to do so a little earlier this year, but, as I have mentioned, we're being really rigorous about our financial prudence and garnering the kind of finances that we need to advance the program.

Speaker Change: Her her a convincing argument about the unmet need and the urgency of delivering therapies for these patients.

Jennifer S. Buell: So I should share with you, Jack, that's a great question, and it is something that we in the industry have typically been plagued with, waiting 28 days per patient. I will say that given the experience and the visibility of Dr. Jelena Janjigian, she was able to navigate and negotiate this very aggressively with our regulatory partners, and we do not have any gaps, so there's no staggering in the trial, which is enormously helpful. In part, it speaks to an unmet need.

Speaker Change: Okay.

Speaker Change: The cadence of enrollment I should just say, it's moving really really quite quickly.

Speaker Change: Could you speak to maybe the.

Speaker Change: <unk>.

Speaker Change: Patient.

Speaker Change: And plus what they have.

Speaker Change: With many centers at Memorial Sloan Kettering, and what the potential demand could be for this 40 person study.

Speaker Change: Well I will just share with you without disclosing too much I'll just share with you what Dr. Ginger, Ian just presented to our team and board. This week. She said I have patients lined up for this trial the demand is very high.

Speaker Change: And I, you know I I I hesitate to give any more for further guidance, but I will say, we will I believe that will be on track to have concluded enrollment in the first half of this year.

Jennifer S. Buell: It also speaks to her convincing argument about the unmet need and the urgency of delivering therapies for these patients. So the pace of enrollment, I should just say, is moving really, really quite quickly. Doctor, could you speak to maybe the, you know, patient about the input that they have with the new centers at Memorial Sloan-Kettering and what the potential demand could be for this 40-person study. Well, I will just share with you, without disclosing too much, I'll just share with you what Dr. Janjigian just presented to our team and board this week. She said, "I have patients lined up for this trial. The demand is very high."

Speaker Change: Sure.

Speaker Change: And then just one more on the.

Speaker Change: Gastric study.

Speaker Change: What is the dialogue between bank investor.

Jennifer S. Buell: This is something that, with a small cohort of patients, we believe we can generate the data that would be necessary to support what a pivotal program could look like in this indication. And this would be really quite a big indication for us, and it's something that we're committed to moving forward very, very quickly. ARDS, though, should not be underestimated, and I can tell you, really, our observations of demand are increasing in the post-pandemic era. We are seeing a much higher frequency of a couple of different pulmonary disorders that are presenting, including vulnerability and increased incidence of ICU in patients with bilateral pneumonia and patients with RSV, as well as secondary to influenza A. And this year will really profoundly contribute to the numbers that I mentioned earlier.

Speaker Change: Investigator in the study I guess, how frequently are you getting updates as it relates to data.

Speaker Change: And how should we think about that dynamic.

Speaker Change: We have Dr. Ginger again has quite a bit of experience with them with a genesis bopped Io combination as well as now the cells, we have really quite frequent interactions with her so we have a good sense of them both the activity of the product as well as the safety profile.

Jennifer S. Buell: I hesitate to give any more further guidance, but I will say I believe that we'll be on track to have concluded enrollment in the first half of this year. Great. And then just one more on the gastric study: what is the dialogue between MiNK and the investigator in the study? I guess, how frequently are you getting updates as it relates to data? And how should we think about that?

Speaker Change: All of the product and in real time.

Speaker Change: I should say, though given her gravitas it will benefit all of us to.

Speaker Change: To ensure that the data enter interpretations of the data will come really from from Dr. <unk> and her team and we expect that to be at a major conference. So so it would be coming from Dr. <unk> team.

Jennifer S. Buell: We have Dr. Janjigian has quite a bit of experience with the Genesis-BotBowl combination as well as now the cells. We have really quite frequent interactions with her, so we have a good sense of both the activity of the product as well as its safety profile of the product in real time. I should say, though, given her gravitas, it will benefit all of us to ensure that the data and her interpretations of the data will come really from Dr. Janjigian and her team, and we expect that to be at a major conference, so it will come from Dr. Janjigian's team. Got it. I got it.

Speaker Change: Got it got it great.

Speaker Change: And then shifting gears I was I was hoping you could provide an update on some of the other non oncology programs I know in the past you've looked at it.

Speaker Change: It's asking yourselves in graft versus host disease.

Jennifer S. Buell: The 600,000 patients annually is based on numbers that have been generated since prior to 2022, and we expect those numbers to increase dramatically based on the observations today. Additionally, these cells can prevent secondary infections, fungemia, and bacteremia, based on the observations that we've seen and published. And that is a major contributor to ICU mortality in patients, even when they recover from respiratory distress. So those secondary components are really important.

Speaker Change: Where do you think as soon as it relates to those other opportunities beyond.

Speaker Change: Yes.

Speaker Change: Oncology.

Speaker Change: So check that.

I am so grateful for your for your thinking on Gvhd, because as we all know the cells actually can naturally prevent gvhd and we know that they can be dose tolerably and quite impactful Lee and there are a few different settings that we have continued to pursue we're working aggressively we have the trial designed and we're working aggressively to find.

Jennifer S. Buell: And then, shifting gears, I was hoping you could provide an update on some of the other non-oncology programs. I know in the past you've looked at potentially testing the cells in graft-versus-host disease. Where do things sit as it relates to those other opportunities beyond ARDS?

Speaker Change: And the support to the financial support to execute on this trial it would be a very rapid trial.

Speaker Change: And acute graft versus host disease, and something that we could we could move forward very very quickly and we do expect to announce this trial in 2024 now we had hoped to do so a little earlier this year.

Jennifer S. Buell: So, Jack, I am so grateful for your thinking on GVHD because, as we all know, the cells actually can naturally prevent GVHD, and we know that they can be dosed tolerably and quite effectively. And there are a few different settings that we have continued to pursue. We're working aggressively. We have the trial designed, and we're working aggressively to find the support and the financial support to execute on this trial. It would be a very rapid trial in acute graft-versus-host disease and something that we could move forward with very, very quickly. We do expect to announce this trial in 2024. Now, we had hoped to do so a little earlier this year, but as I've mentioned, we're being really rigorous about our financial prudence and garnering the kind of finances that we need to advance the program.

Jennifer S. Buell: And what we have observed in our clinical trials and published in Nature Communications is that in patients on mechanical ventilation and on VV ECMO, the administration of these cells does appear to be life-saving in a number of patients. And so we're continuing to expand that trial, and we have the opportunity to do so in an incredibly efficient way through a phase two trial, a large national platform program that would allow us to compare the cells to standard of care corticosteroids, which we believe is going to, we have a lot of confidence in what the cells can do compared to standard of care based on what our observations have been to date. So I don't want to underestimate the importance of what we can deliver for patients with respiratory distress and the urgent need to be able to do so. Thank you so much, Tyler Keller. Congratulations again on your progress. Thank you, Jeff. We'll take our next question from Mayank Mamtani with B. Reilly Security. Good morning.

Speaker Change: But as I've mentioned, we're being really rigorous about our financial prudence and garnering the kind of finances that we need to advance. The program. This is something that with a small cohort of patients. We believe we can generate the data that would be.

Necessary to support what a pivotal program could look like in this indication and this would be really quite a quite a large indication for us and it's something that we're committed to moving forward very very quickly.

Speaker Change: Our D S, though should not be underestimated and I can tell you I'm really.

Speaker Change: Really our observations of the demand.

Speaker Change: Is increasing in the post pandemic era, we are seeing a much higher frequency of a couple of different pulmonary disorders that are presenting including vulnerability and increased incidents of ICU.

Jennifer Buell: This is something that, with a small cohort of patients, we believe we can generate the data that would be necessary to support what a pivotal program could look like in this indication. And this would be really quite a large indication for us, and it's something that we're committed to moving forward very, very quickly. ARDS, though, should not be underestimated, and I can tell you, really, our observations of the demand is increasing in the post-pandemic era. We are seeing a much higher frequency of a couple of different pulmonary disorders that are presenting, including vulnerability and increased incidence of ICU in patients with bilateral pneumonia and patients with RSV, as well as secondary to influenza A. And this year really will profoundly contribute to the numbers that I mentioned earlier.

Speaker Change: In patients with bilateral pneumonia.

Speaker Change: And patients with RSV as well as secondary to influenza a and this year really will profoundly contribute to the numbers that I mentioned earlier. The 600000 patients annually was based on our numbers that have been generated since prior to 2022, and we expect those numbers to increase dramatically based.

Speaker Change: On the observations today.

Speaker Change: Additionally, these cells can prevent secondary infections from <unk> back to <unk> based on the observations that we've seen and published them and that is a major contributor to ICU mortality in patients even when they recover from respiratory distress of the secondary components are really important and what we have.

Speaker Change: Observed in our clinical trials and published in nature Communications is in patients on mechanical ventilation and on Vv Ecmo.

Mayank Mamtani: Thanks for taking our questions and appreciating the comprehensive update. Jen, could you talk about the status of your engineered INKT cell efforts, including in autoimmune diseases, if there are any, and also was curious about the next steps on the ARDS program for 797. What are you, what sort of registration or basic development do you have planned, understanding, you know, you may need a partner there.

The administration of these cells do appear to be life saving in a number of patients and so we're continuing to expand that trial and we have the opportunity to do so in an incredibly efficient way through a phase two trial large national platform program.

Speaker Change: That would allow us to interrogate the cells compared to standard of care corticosteroids, which we believe is going to we have a lot of confidence in what the cells can do compared to standard of care based on what our observations have been to date. So I don't want to underestimate the importance of what we can deliver for.

Speaker Change: With respiratory distress and the urgent need to be able to do so.

Speaker Change: Got it. Thank you so much the color and congratulations again on the progress.

Jennifer S. Buell: And then I have a follow-up for the gastric cancer study. Okay, so Mayank, thank you very much for the questions. I will say, and this is specific to the platform trial I just mentioned, there's an infrastructure and a capability in existence, and we've been invited to, and we are actually in active contract negotiations to join a program that would be quite large, and we're going to be able to provide a very detailed update upon contract execution. Now, this is a trial that will be, the operational costs will be covered. The platform and sites and centers are in existence, and the leadership of this platform are world experts and very high-profile individuals. So, we were not only thrilled to have the opportunity to be invited to this platform program but also to the potential that it does offer to independently generate the data that may be supportive of a registrational program with 797. So, I will provide very much more detail on this at the moment when we conclude the contract execution.

Speaker Change: Thank you Jack.

Speaker Change: We will take our next question from Miami to me with B Riley Securities.

Speaker Change: Hi, good morning, Thanks for taking my questions I appreciate the comprehensive update.

Miami: Jim could you talk to the status of your Internet.

Speaker Change: So that's one.

Speaker Change: Including into auto immune diseases.

Speaker Change: Does any and.

Speaker Change: Also was curious on the next steps.

Speaker Change: The Ibs program or 797.

Speaker Change: Are you what sort of penetration based on development.

Speaker Change: And understanding.

Speaker Change: We need a partner there and then I have a follow up for the gastric cancer study.

Speaker Change: Okay. So is it Mike. Thank you very much for the questions I will say on that the last part and this is specific to the platform trial I. Just mentioned there is an infrastructure and the capability in existence and we have been invited.

Speaker Change: Two and we actually are in active contract negotiations to etch to join our program that would be quite large and we're gonna be able to provide a very detailed update upon contract execution. Now. This is a trial that will be.

Speaker Change: These operational costs will be covered the platform and sites and centers are in existence and the leadership of this platform our world experts.

Speaker Change: And very high profile individuals. So we were not only thrilled to have the opportunity to be invited to this platform program, but also to the potential that it does offer to independently generate the data that may be supportive of a registrational program with 787, So I will provide.

Speaker Change: Ride very much more detail on this in a moment that we conclude the contract execution.

Jennifer S. Buell: With respect to autoimmunity, Jack a moment ago asked about our trial advancement in GVHC, an area that we've been very interested in advancing, and we're continuing to do so. Now, this would be something that we are pursuing aggressively with external funding. We have a few options that are coming to fruition now that will allow us to execute on a trial that's already been designed, including with investigators identified and willing to contribute to the trial design and willing to execute.

Speaker Change: With respect to auto immunity.

Speaker Change: Just a moment ago asked about our trial advancement in Gvhd, an area that we've been very interested in advancing.

Speaker Change: And where we're continuing to do so now this would be something that we are pursuing aggressively external funding we have a few options.

Speaker Change: That are coming to fruition now that will allow us to execute on a child thats already been designed including with investigators identified and willing and contributing to the trial design and willing to execute so that's one component of other immune related diseases. In addition to the E. R. D. S. Now.

Jennifer S. Buell: So that's one component of other immune-related diseases in addition to ARDS. Now, as you know, these cells, we have last, after CITSE in 2022, we presented an R&D day, and we had a world leader in metabolic diseases and disorders and an expert in INKT cell biology. And the potential of these cells to leverage their features, and I can have Mark speak a bit about this, in modulating immunity and addressing metabolic-related disorders is immense. It's something that we have the capability to produce material for large populations of patients, and we also have been having some discussions with partners on the development of these cells in this area. I'm going to have Mark say two or three words about the potential of this particular space.

Speaker Change: As you know these cells we have.

Speaker Change: Last after sits see in 2022 we presented an R&D day, and we had a world leader and metabolic diseases and disorders and an expert in I N K T cell biology.

Speaker Change: And the potential of these cells to leverage their features and I could have Marc speak a bit to this and modulating immunity and addressing them metabolic related disorders is immense and it's something that we have the capability to produce material for large populations.

Speaker Change: Patients and we also have been entertaining some discussions with partners on the development of the cells in this area I'm going to have Mark just say two or three words about the the potential in this in this particular space and finally I also should mention and I have previously we can.

Jennifer S. Buell: And finally, I also should mention, and I have previously mentioned this, we are engaged and have been engaged with the government for financing some of the programs that we have going forward. Because, as you know, respiratory distress is debilitating, and it is debilitating not only for individuals but also for our economy, and it presents, it falls into a category that's considered a national threat.

Speaker Change: We are engaged and have been engaged with the government.

Speaker Change: Given for financing some of the programs that we have going and going forward because as you know respiratory distress.

Speaker Change: Is debilitating and it is debilitating not only for individuals but also for our economy and it presents it falls into a category. That's considered a national threat. So this is an area that we will continue to work with our government collaborators to support initiatives that are necessary.

Jennifer S. Buell: So, this is an area that we will continue to work with our government collaborators to support initiatives that are necessary to protect our national security. Mark, maybe just a moment on the metabolic opportunity. Yeah, and also more broadly, the autoimmune opportunity. And we've been looking at this, and you know, Genesys is an antibody company; MiNK came out of an antibody company because there is an unmet need. You can only address so many parameters with an antibody, and a cell intrinsically has many more response mechanisms to its, you know, its delivery arsenal. And this is quite important in diseases such as cancer and autoimmunity and metabolic disorders, because these are multifactorial. An antibody can do one thing, or it can do many things, a combination of antibodies, but cells have an infinitely more complex response mechanism and ability to influence.

Speaker Change: To protect our national security.

Speaker Change: Mark maybe just a moment on them on the metabolic opportunity.

Mark: Yeah or.

Mark: So more broadly so I'll go through the autoimmune or opportunity and we've been looking at this.

Mark: This isn't antibody company mean came out of an antibody companies because there is an unmet need.

Mark: You can only address so many parameters with an antibody and if so has intrinsically menu more schools mechanisms to its two as delivery personal and this is quite important in diseases, such as cancer and old community and metabolic disorders. Because these are multi factorial and everybody can do one thing can do many things in combination of antibodies, but still.

Mark: Have an infinitely more complex response mechanism and ability to influence in these various T cells are likely tissue residents immune orchestrator stay actually are there to modulate and rebalanced the immune system in a lot of these indications that we've now been pursuing.

Marcus Antonius van Dijk: And these invariant NKT cells are actually tissue residents, immune orchestrators. They are actually there to modulate and rebalance the immune system. And a lot of these indications that we've now been pursuing, ARDS, as well as graft-versus-host disease, they have an intrinsic immune disbalance that you are aiming to restore with INKT cells. And these cells are able to do that. We've seen this in COVID patients and in some of our, you know, emergency use patients, has a dramatic effect on restoring sort of normal immune function. And we also think that in metabolic disorders, we can actually achieve this. We've seen INKT cells get into places where conventional T cells don't really like to be, and they can go there and change the environment much more to a much more stable and rebalanced situation. That's what we're looking for, and there are many immune disorders where we feel this will be of benefit. I think I'll leave it at that.

Mark: Yes as wireless.

Graft versus host disease, they have an intrinsic even just balance that you're aiming to restore with only three T cells and b cells are able to do that we've seen this in COVID-19 patients and in some of our.

Mark: Emergency use patients that's a dramatic effects in restoring sort of new normal function and we also think that in metabolic disorders.

Mark: We can actually achieve this we've seen <unk>.

Mark: T cells are getting to places where conventional T cells don't really like to be.

Mark: T T cells can go there and do change the environments much more to a much more stable and rebalanced situations. That's what we're looking for and there are many disorders, where we feel this will be a benefit.

Speaker Change: I think I'll leave it at that time.

Jennifer S. Buell: Yeah, I look forward to learning more about that. Thank you. And then on the phase two gastric cancer study, just early findings I understand there. Could you talk specifically about your plan for understanding the contribution between BODBAL and the cells, you know, be it through clinical or translation data? I'm not sure if you've seen a ton of BODBAL data on this particular cold tumor. So if you could, you know, help us understand how you're thinking about that, Jen.

Speaker Change: Yes.

Speaker Change: Good day learning more on that thank you and then on the phase III guests have gone who study just early findings I understand could you talk specifically to your plan of understanding contribution between.

Speaker Change: So be it.

Speaker Change: Through clinical translation data I'm not sure if you've seen.

Speaker Change: Our data <unk> data in this particular deal with cold tumor. So if you could.

Speaker Change: Good.

Speaker Change: I guess I understand how you're thinking about that Jen thanks again for taking English.

Jennifer S. Buell: Thanks again for taking the time. Mayank, thank you very much. So I had mentioned to Emily just a bit ago about the way that we will interrogate the activity of these cells. So for standard of care, thousands of patients' worth of data, we did not add a standard of care arm into the randomized phase two. We don't need to at this point.

Jen: Thank you very much so I had mentioned to Emily just a bit ago about the way that we will interrogate the activity of these cells. So for standard of care thousands of patients worth of data, we did not add in a standard of care arm into the randomized phase two.

Jen: We didn't we don't need to at this at this point.

Jennifer S. Buell: So we will study the cells on top of standard of care, the cells on top of BotBowl with and without standard of care. Now our ability to interrogate the addition of the additional benefit or the contribution of the cells to BotBowl is going to take shape in a few ways. It'll take shape in this study, but it also will take shape in a study that we will be announcing as well that will be externally funded in colorectal cancer in patients with metastatic disease to the liver. So as you know, or for those of you who don't know, BotBowl has generated really remarkable activity in cold tumors, and in more than 900 patients studied, nine different tumor types that have been previously unresponsive to In metastatic colorectal cancer, MSSCRC, now this is the largest population of colorectal cancers. It represents about 95% of the population of patients with colorectal cancer, and it's growing. It will represent the largest killer of men under 50 shortly, and this has been widely published and available in both the scientific literature as well as in lay literature.

Jen: The we will study the cells on top of standard of care.

Jen: The cells on top of BOP Bell with them without standard of care now our ability to interrogate. The addition of the additional benefit of the contribution of the cells to BOP out it's gonna take shape in a few ways it'll take shape in this study, but it also will take shape in a study that we will be announcing as well.

Speaker Change: We'll be externally funded in colorectal cancer and patients with metastatic disease of the liver so as you know.

Speaker Change: Or for those of you who don't know about Val has generated really remarkable activity in cold tumors and more than 900 patient studied nine different tumor types that are that have been previously unresponsive to immune therapies are actually responding to BOP valve and it opens up an enormous opportunity for patients with <unk>.

Speaker Change: These diseases that have previously gone.

Speaker Change: Unable to be treated effectively.

Speaker Change: Metastatic colorectal cancer M. S. S. CRC now this is the largest population of colorectal cancers. It represents about 95% of the population of patients with colorectal cancer and its growing.

It will represent the largest killer of men under 50.

Speaker Change: Shortly and this has been widely published and available in both the scientific literature as well as in the literature.

Jennifer S. Buell: What we have observed with the activity in nearly 400 patients treated with MSS CRC is that BOT-BAL standard of care therapies bring anywhere from 2 to 3% tumor shrinkage, and we're seeing more than a tenfold improvement in tumor shrinkage in that indication when patients are treated with BOT-BAL. And while we have not yet achieved median survival in the randomized phase 2 study, we have observed more than doubling beyond two years of survival, which is really, as far as we can tell, unprecedented in this indication. The one area where we believe we can improve upon the activity of BotBowl is that BotBowl is active in generating a survival benefit in patients with metastatic disease to the liver, but it's not as active in shrinking tumors within the liver.

Speaker Change: What we have observed with them with the activity and nearly 400 patients treated with MSS CRC is it popped out standard of care therapies spring anywhere from 2% to 3% tumor shrinkage.

Speaker Change: We're seeing more than a tenfold improvement of tumor shrinkage in that indication when patients are treated with pop out and while we have not yet achieved a median survival in the study and the randomized phase II study, we have observed a more than doubling.

Speaker Change: Beyond two years of survival, which is really as far as we can tell unprecedented in this indication.

Speaker Change: The one area, where we believe we can improve upon the activity of BOP out we do see that barbell is active in generating a survival benefit in patients with metastatic disease to deliver.

Speaker Change: But not as it's not as active in shrinking tumors within the liver and now what we know about IMTT is because they actually home to the liver disease and we have observed in our own hands that imtt's can modulate disease in the liver.

Jennifer S. Buell: Now, what we know about INKTs is they're actually home to liver disease, and we have observed in our own hands that INKTs can modulate disease in the liver. So we believe that in addition to the survival benefit that BotBowl can bring to patients with MSF-CRC with liver mats, we think that the addition of INKTs may actually contribute to the reduction of disease burden in the liver and may actually expand the survival benefit even further beyond what BotBowl can do alone. We will be testing that in an externally funded trial with a KOL that we will announce very shortly as soon as we launch that program, which is going to happen in the first half of this year.

Speaker Change: We believe that in addition to the survival benefit that barbell can bring to patients with MSS CRC with liver match. We think that the addition of Imtt's may actually contribute to the reduction of disease burden in the liver and may actually expand survival benefit even further beyond what <unk> can do alone we will be testing that in.

Speaker Change: And externally funded trial.

Speaker Change: With a K O L that we will announce very shortly as soon as we launched that program, which is going to be happening in the first half of this year.

Speaker Change: Thank you Jan looking forward to the Olympics.

Jan: Thank you very much my uncle.

Speaker Change: Thank you and that does conclude the question and answer session I would like to turn the call back over to Dr. <unk> for closing remarks.

Jennifer S. Buell: Thank you again, and I'm looking forward to those updates. Thank you very much, Mayank. Thank you, and that does conclude the question and answer session. I would like to turn the call back over to Dr. Jen Buell for closing remarks.

Speaker Change: Thank you very much operator, and thank you all for your questions and your participation today, we really appreciate your continued support and look forward to speaking with you again soon thank you.

Speaker Change: Thank you everyone that does conclude todays presentation. Thank you for your participation today you may now disconnect.

Speaker Change: Okay.

Speaker Change: [music].

Jennifer S. Buell: Thank you very much, operator. Thank you all for your questions and your participation today. We really appreciate your continued support and look forward to speaking with you again soon. Thank you. Thank you, everyone. That does conclude today's presentation. Thank you for your participation today.

Speaker Change: Okay.

Speaker Change: [music].

Speaker Change: Yeah.

Speaker Change: [music].

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