Q4 2023 Mink Therapeutics Inc Earnings Call

Participants

Zack Armen; Head of IR; MiNK Therapeutics, Inc.

Jennifer Buell; President & CEO; MiNK Therapeutics, Inc.

Marc Van Dijk; Chief Scientific Officer; MiNK Therapeutics, Inc.

Christine Klaskinand; Principal Financial and Accounting Officer; MiNK Therapeutics, Inc.

Emily Bodnar; Analyst; H.C. Wainwright & Co.

Jack Allen; Analyst; Robert W. Baird & Co. Incorporated

Mayank Mamtani; Analyst; B. Riley Financial, Inc.

Presentation

Operator

Everyone, and welcome to the mink Therapeutics Fourth Quarter 2023 financial results. Today's call is being recorded. at time, simply press star one on your telephone keypad. If you would like to withdraw your question. (Operator Instructions)
I would now like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.

Zack Armen

Thank you, Lisa, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities. Among other updates, these statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks.
Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer; Christine Klaskinand, Principal Financial and Accounting Officer, and Dr. Marc van Dijk, Chief Scientific Officer. Dr. Joy Zhou, 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.

Jennifer Buell

Thank you very much. Zack it's a pleasure to have you all with us this morning to hear about our accomplishments throughout the course of last year and what we plan to do in 2024. So out 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 INKT. or invariant natural killer T cell programs. Notably, we initiated Phase I Phase two 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 STM journals such as nature, communications and oncogene.
Our comprehensive data set in nearly 100 patients treated to date showcases the efficacy and activity of INKT.s in addressing solid tumor cancers and in other immune-related diseases such as acute respiratory distress syndrome with promising outcomes observed. These achievements underscore our pivotal role in advancing state-of-the-art cell therapies and what we believe to be an optimal cell platform. Positioning of therapeutics is a key contributor to the progress of living medicines today make stand as one of the most clinically advanced companies pioneering this novel cell type INKT.s.
And as a reminder, INKT.s are what we believe to be the most potent and highly conserved cell type in immunity through the progression of our clinical programs and robust R&D initiatives. We've made significant contributions to an expanding rapid repository of clinical and preclinical data, showcasing the distinct advantages of INKT.s in immune therapy for immune-related diseases this year. Our efforts have culminated in presentations at four major medical meetings and the publications of the two manuscripts that I just mentioned a moment ago.
We've showcased our observations of activity in patients with cancer as well as patients with severe respiratory distress, both of which I'm going to go into in just a moment. But before going into our priorities for this year.
Let me just reiterate, our fully integrated capabilities is a unique to make in this space. And these capabilities really underscore our efficiency and the progress we've been able to make to date with our state-of-the-art discovery platforms with Marcus 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 and the agility to swiftly identify targets and develop therapeutic approaches, whether through CAR INKT.s T cell engagers, TCRs for native allogeneic INKP.s. These programs advanced seamlessly through our fully internal GMP manufacturing capabilities, which have been optimized further scaled and received FDA clearance to produce material in-house for our clinical programs. We're advancing on multiple fronts with 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 INK. T cell product.
This is called agent seven nine seven. It's now advancing in a Phase two trial in second-line gastric cancer. And in addition, our collaboration with immuno scape, which we announced last year, spearheaded by Marc empowers us to leverage that potential of our T cell receptor platform and programs as well as our novel and proprietary targets. Furthermore, our T cell engager platform boasts unique development capabilities and also holds a promise that's really quite unique to make of delivering engager T cells in combination with native INKT.s.
This is innovative. It's strategic and it's unique to what we can bring it to two clinical development. I'm going to speak a bit about our programs in oncology. As we look ahead to 2024, focus really remains squarely on advancing our lead program agents seven nine seven.
Our objectives are very clear we must continue expanding our clinical dataset and exploring therapeutic areas with potential rapid development pathways. Our focus on seven nine seven 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 benefit without the disabling side effects of standard chemotherapeutic approaches. And this is particularly evident in patients with gastric cancer. In February, we announced a significant milestone with the launch of our Phase two study of seven nine seven. This trial focuses on combining seven nine seven with both in selling that, which many of you are quite familiar with.
But in selling that as an Fc-engineered molecule, it's a multi modal T-cell activator, which also binds to CTLA-4 this agent combined with balstilimab and anti-PD-1 therapy. Both of those antibodies are through our collaboration with the Genesis. And this combination is also added on top of standard of care chemotherapy in second-line gastroesophageal cancers. This is a therapeutic area where there are currently no therapeutic or curative options for patients, and it's a critical need in oncology.
The initiation of the trial follows a compelling clinical data set presented at ACR in 50 last year and most recently, the publication of a manuscript outlining seven nine seven clinical activity in patients that are refractory to immune checkpoint inhibitors and prior chemotherapy, specifically in gastric cancer. This collective evidence showcases its evidence of its potential to overcome resistance to immune checkpoint inhibitors.
They are demonstrating durable disease stabilization and activity in refractory solid tumor cancers, including a confirmed response in chemotherapy and anti-PD-1 refractory gastric cancer. As a reminder, the patient who's published an oncogene was a patient who failed prior chemotherapy for Fox as well as nivolumab and pembrolizumab. So this patient then was treated with cells in combination with nivo and had a partial response that was durable and remains so on throughout the trial period. The trials led by Dr. Elena Jinji Angeline as the Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center. T
he trial supported by Stand Up to Cancer in this Phase two study holds promise and really changing the treatment landscape for patients with this cancer. We launched the trial in February and have already accrued our initial cohort of patients and have had the pleasure of seeing some very initial preliminary positive signals, which we're quite excited about. These findings form the foundation of continued discussions with regulators to expand the benefit for patients with gastric and gastric cancer and a trial that we plan to provide an update for you before the end of this year.
Now beyond oncology, this is a growing area of therapeutic opportunity for cell therapies. And we are particularly well positioned in this space, given our scalability and our efficiency and being able to generate an allogeneic donor-derived INKT.s at scale that can be cryopreserved and retain their functional characteristics.
This allows us to have the cells at the sites when the patients need them and able to be delivered at the point 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 seven and seven. Outside of this of oncology, our published data highlights the important role that INKT.s could play in immunity more broadly, and these include infections, inflammatory diseases as well as autoimmunity.
And you're going to hear some data at an upcoming conference in the first half of this year about some important signals that and in the treatment paradigm with patients who have both autoimmunity and infections, which I think will make you as excited as it has made me last year, we presented data at the American Thoracic Society and it showed a survival benefit of 75% in patients treated with agents seven, nine seven.
And these data stand in stark contrast to 10% survival in the in-hospital case controls enrolled at the same time period of our trials. We'll present these data at a conference in the first half of this year and will follow with an announcement about the next steps for this important program. And I think importantly, at the ATS conference, we also showed that patients on the most severe form of late support with ARDS.
These patients are treated with MOVVX. amount. And those patients treated with ECMO actually had a survival rate of over 80%, which is also really quite an Factive in this patient population. 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 INK. T 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 these active 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 seven nine seven in patients with ARDS., potentially reshaping treatment paradigms for intensive and acute pulmonary care settings.
In summary, our approach to rapidly advance INK. T cells in patients with respiratory distress underscore their 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 and seven clinical programs. Of course, we've maintained a steadfast focus on delivering our in-house manufacturing of allogenic INK. T cells.
These cells is a critical capability led by Dr. Joyce Zhou, and this removes any reliance that we currently have or had previously had on third party CDMOs. And it ensures our control end to end control over an efficient and reliable supply of our products. We are currently providing 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 has achieved a major milestone in developing and implementing an FDA cleared and to end automatic closed an industrialized INKT. manufacturing process, which is fully in house, demonstrating mixed internal manufacturing capacity in compliance with the 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 and integrity throughout the manufacturing process.
And now I will turn the call over to Dr. Mark Van Dyke to go over main technology platforms and another important component of our next-generation pipeline. Mark?

Marc Van Dijk

Thank you, Jen. I'm going to talk a bit about our current KT. programming 25, and then about TCRs recent activity there and selling ages. And so owning 25, given the potent tumor infiltrating and immune modulating activity, opening 25 that we've observed in preclinical studies, including lung cancer, we anticipated actually may elicit clinical responses in difficult-to-treat solid tumors.
So patients with microsatellite stable or mismatched repair proficient colorectal cancer, frequently have liver metastases, which is associated with very poor response to correct pharmacological treatments, including immune checkpoint blockade for the tumor microenvironment of colorectal cancer. Liver metastases is characterized by a highly immunosuppressive phenotype, which prevents the patient's T cells from infiltrating attacking these metastases. Even when these are reactivated and reinvigorated by immune checkpoint blockade using anti-PD-1 or anti-PD-L1 antibodies, this underscores the urgent need for innovative therapeutic approaches, targeted specifically to patients with liver mets, liver metastases, so to better model immune checkpoint blockade, refractory human colorectal cancer, liver metastases.
We together with our colleagues from agendas 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 being 2.5 can potentially overcome the limitations of immune checkpoint therapy, effectively homes to sites of disease, reprogram the tumor microenvironment recruits, tumor reactive T-cells and enhances tumor killing. And this data will actually be presented at the upcoming American Association for Cancer Research Annual Meeting in April.
So our additional unique research capabilities that link include a proprietary library of phospho peptide neoantigens derives from a wide range of solid tumors and hematological malignancies. We've assembled this target library over the last couple of years to internal efforts expanding on the original acquisition of fossil unit 2015.
So we believe that these four peptides represent broadly presented neoantigen tumor targets that can be utilized to discover potent T cell receptors. It can then be used to attack solid tumors to further our discovery and developments of new candidate T cell receptors, we entered into a research collaboration agreement with Immunomedics.
This collaboration is designed to accelerate the development of TCR based therapies against novel targets in T-cells, invariant and K. T cells and other modalities. In this collaborative efforts, immune escape will leverage its capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevant TCRs targeting the library of phosphor peptide antigens. And the 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 IK. T cells or as bispecific cell engagers. We believe that in variant and a piece of our perfect allogeneic host cells for expressing tumor, targeting T-cell receptors and developing off-the-shelf TCR based cell therapies. We look forward to working with immune escape with immune escape team to deliver new therapeutics that can potentially eliminate tumor cells and alleviate immune suppression for durable anticancer immunity, especially for solid tumors.
Now a lot of development that we're actually very enthusiastic about is combining our off-the-shelf invariant and K. T cells with cell engagers, both with existing third party T-cell engagers as well as at our own invariant and K. T cell engagers. We've seen our off-the-shelf invariant and K. T cells truly enhance tumor-killing immune activation when combined with cell engagers in our model systems. And we believe that co-administration of in variance and K. T cells and T cell engagers as the potential to strongly increase clinical efficacy, especially in solid tumors where cell engagers have not yet shown great results. Invariant and K. T cells have shown, they can infiltrate solid tumors where conventional T cells struggle. So we administer our INK. T cell products without lymphodepletion, which is crucial for maintaining the full immune potential of the patients co administering in Varian and K. T cells with engagers could ensure that a wave of these very potent immune cells enter the tumor first, This not only helps ensure a focused attacked focused direct attack on the tumor, but at least as important combats local immune suppression and brings in the patient's own immune cells. We're actively exploring these combinations and we look forward to updating you on our progress in the near future. I'll now to turn the call back over to Jen.

Jennifer Buell

Yes Mark, thank you very much for excellent Excellent.
So as we reflect, of course, on our advancements last year and throughout this year, I just wanted to touch upon our financial prudence that has supported our progress. We've remained really diligent leveraging our in-house manufacturing process, which is incredibly efficient to significantly reduce our external dependencies as well as costs. And our Phase 2 trial in second-line gastric cancer is led by the world's experts in this tumor type and at a world leading institution and externally funded by Stand Up to Cancer, which enables us to essentially access and insights into a development pathway in an incredibly efficient way. So we're excited about our ability to do that.
And 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. It does allow us not only to develop the product independently, but also to combine it well with therapeutics that may not be delivering the kind of clinical outcomes that are that are necessary for approval. And that includes expanding the benefits of our T cell engagers. And this is an active dataset that we've generated in our own hands as well is in the hands of potential partners. So we are quite excited about what the future holds, and we'll continue to be very prudent in the selection of our clinical programs to 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.

Christine Klaskinand

Thank you, Jen. We ended the year with a cash balance of $3.4 million since year end we received $5 million under our convertible note agreement that we executed last month with a Genesis 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 periods in 2022. Our net loss for the year ended December 31, 2023 was $22.5 million, or $0.65 per share, which compares to net loss for the same period in 2022 of $28 million or $0.83 per share.
I will now turn the call back over to our operator for questions in queue.

Question and Answer Session

Operator

(Operator Instructions) Emily Bodner, HC. Wainwright.

Emily Bodnar

Hi good morning thanks for taking the question for me on your clinicaltrial.gov listing for the Phase two gastric study, looks like you're also combining with RMS for I-Mab. So can you discuss about what patients might be getting back in the in their treatment plan? And then given that you're combining agents seven, nine seven with several agents. How do you kind of think about the efficacy of components based on what we might have?
It was standard of care.

Jennifer Buell

Emily this is an excellent question 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 INKT.s alone with a bot bound and I'm at a place with and without ramucirumab and paclitaxel now ramped up. Those are the standard of care agents used in second-line gastric cancer. They have very limited activity and as you as you know, probably just a little over 20%, 25%, which gives us a big opportunity to really make a significant difference in the treatment landscape here, we will generate the dataset that that will include how patients perform on the cells alone, how they perform with the cells on top of standard of care as well as ourselves and the multiple combination with both now and the standard of care chemo.
And we already have some preliminary signals 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, and it's really quite exciting. And it does give us an opportunity to present to the agency what we believe to be the motion, it would be in the SPTS to develop. We'd be dropping the therapies on top of standard of care around tax.
That is that allows us not to salvage patients post RAM tax. It allows us to take advantage, have some of the neoantigens released from the tumor killing that does come along with the chemotherapy. And we know that the cells can be dose tolerability in that disease setting. We also know that they can they can combine tolerant bleak with and with upwards checkpoint modulating antibodies such as PD-1 and now with with blood down.
So I'm hoping that I heard your question, the dataset in Korea and will be the cells alone cells in combination with RAM tax to get us on top of standard of care and then the sales in the multi combination.
That includes about Dow, I should say we did not include around tax arm alone because we have thousands of patients that have been treated with that combination and a robust data set for real from real-world evidence to actually drive what the expectations are from the chemo alone.
So we did not want to at 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 midyear.

Emily Bodnar

Okay.
That makes sense. And just I guess a confirmation question. Are you only evaluating patients who have failed one prior line or is it like a minimum of one prior line?

Jennifer Buell

Right now we have it essentially as a minimum of one prior line. But really the focus is one prior line and these patients who have failed four or five nivo really have nothing to go to barring their HER2 status. So they would essentially be treated with RAM tax down. There isn't very much more for those patients to go on.

Emily Bodnar

And I think since then last question, I know you talked about the $5 million convertible note from John as, but maybe just discuss like strategies for bringing additional capital into the company thinking?
Thanks.

Jennifer Buell

Thank you very much, Emily. Absolutely. So first, I should say that as you look at the year prior year, 2023, you'll see that the and the financial consumption of about $15.8 million drove the execution and completion really of three clinical trials and our manufacturing optimization so that that really does speak to the efficiency that our 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. Jim Reagan. But we would like to, of course, conclude some financial transactions that would allow us to independently sponsor our own programs and accelerate the development.
Now this is going to come in three different ways as far as we can tell right now, the first, he's 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 INKT.s.
We are the most advanced company bringing these forward.
So the science is lesser 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 and much of that work has been done and now discussions are starting to advance.
Now a collaboration would not only help us to expand on the work that we're doing. It would also allow us to expand our discovery pipeline and could give us infrastructure outside of the US where we currently do not have on bandwidth or infrastructure of the other is, of course, a regional partner, which I also mentioned is something that we are continue 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 the pipeline. And of course, the third would be expanding our interactions with them with project financing and investors. And these again are active discussions that are underway.

Emily Bodnar

Thanks for taking the question.

Jennifer Buell

Thanks.

Operator

(Operator Instructions) Jack Allen, Baird.

Jack Allen

Thanks for taking the questions. And congratulations on the progress made over the quarter. I guess the first one on gastric on, could you provide some color on the cadence of enrollment? Are there any staggers early in the study with these multiple arms and between the different patients.

Jennifer 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. And that given the on the experience and the visibility of Dr. Elena Jinji And 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 I'm enormously helpful. In part, it speaks to the unmet need. It also speaks to and heard a convincing argument about the unmet need and the urgency of delivering therapies for these patients.
John Patrick, maybe given the cadence of enrollment, I should say it's moving really, really quite quickly.

Jack Allen

It could you speak to maybe on the patient implants that they have us working with the new centers at Memorial Sloan Kettering and what the potential demand could be for this 40 person study?

Jennifer Buell

Well, I will just share with you without disclosing too much.
I'll just share with you what Dr. G&G and just presented to our team and Board this week, she said I have patients lined up for this trial. The demand is very high and I know I hesitate to give any more for further guidance, but I will say we will I believe that we'll be on track to have concluded enrollment in the first half of this year.

Jack Allen

Okay, great.
And then just one more on the gastric study. What is the dialogue between make and investigator in the study? I guess how frequently you're getting updates as it relates to data and how should we think about that dynamic?

Jennifer Buell

We have Deca G&G and has quite a bit of experience with and with a Genesis about that combination as well as now the cells, we have really quite frequent interactions with ours. So we have a good sense and both the activity of the product as well as the safety profile of the product in real time, I should say, though, and given her gravitas, it will benefit all of us too. And to ensure that the data enter interpretations of the data will come really from from Dr. Jinji and Inter-Team, and we expect that to be at a major conference. And so so it would be coming from Dr. Genge again, Steve.

Jack Allen

Got it.
Great. 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? And where do things sit as it relates to those other opportunities beyond ARDS. and oncology?

Jennifer Buell

So I suggested you 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 dosed comparably and quite impactfully. And there are a few different settings that we have continue to pursue.
We are working aggressively.
We have the trial designed and we're working aggressively to find the support to and the financial support to execute on this trial. It would be a very rapid trial 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.
And but as I've mentioned, we're being really rigorous about our financial prudence and garnering the kind of finances that we need to to advance the program. This is something that with a small cohort of patients, we believe we can generate the data that would be and necessary to support what a pivotal program could look like in this indication. And this would be really quite a liquid a large indication for us, and it's something that we're committed to moving forward very, very quickly.
Our ARDSO. should not be underestimated, and I can tell you. I'm really our observations of the demand as increasing in the post pandemic era. We are seeing a much higher frequency. I've a couple of different pulmonary disorders that are presenting including vulnerability and increased incidence of ICU and 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, the 600,000 patients annually was based on and 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 from TME 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 the secondary components are really important and what we have observed in our clinical trials and published in Nature Communications. It's in patients who are on mechanical ventilation and on VVMO. at the administration of these cells do appear to be lifesaving in a number of patients and so we're continuing to expand that trial and we have the opportunity and to do so in incredibly efficient way through a Phase 2 trial large national platform program 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 patients with respiratory distress and the urgent need to be able to do so.

Jack Allen

Thank you, also color drivers and regenerative products.

Jennifer Buell

Thank you, Jack.

Operator

(Operator Instructions) Mayank Mamtani, B. Riley Securities.

Mayank Mamtani

Good morning. Thanks for taking the questions and appreciate the comprehensive update at Jan, could you talk to the status of your engineered INK. T cell efforts, including in autoimmune diseases if there is any and also was curious on the next steps on the ARDS program for seven nine selling, what are you what sort of registration or native development do you have that understanding you may need a partner that and then I have a follow up for the gastric cancer study.

Jennifer Buell

Okay.
So Mayank, thank you very much for the questions. I will say on the last part, and this is specific to the platform trial I just mentioned, there's an infrastructure and the capability in existence, and we've been invited and two and we actually are in active contract negotiations to act 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. This is a trial that will be the stage. 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 seven nine seven. So I will provide very much more detail on this in the moment that we conclude the contract execution.
And with respect to autoimmunity, I'd note just a moment ago asked about our trial advancement in GVHD, 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 external funding. We have a few options that are coming to fruition now that will allow us to execute on the trial that's 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 ARDS.
Now is, these cells we have at last after city in 2022, we presented an R&D day and we had a world leader and metabolic diseases and disorders and an expert in INK. T cell biology and the potential of these cells too, it leverage their features. And I can have Mark speak a bit to this and 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 entertaining some discussions and with partners on the development of the cells in this area, I'm going to have Mark to say two or three words about the potential in this I'm in this particular space.
And finally, I also should mention that I have previously we can we are engaged and have been engaged with the government given for financing some of the programs that we have going going forward because as you know, respiratory distress, it is debilitating and it is debilitating not only for individuals, but also for our economy and it presents and 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 to protect our National Securities.
Marc, maybe just a moment on the metabolic opportunity?

Marc Van Dijk

Also more broadly, I see the autoimmune opportunity, and we've been looking at this.
Now, again, this is an antibody company may 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 has intrinsically many more response mechanisms to its to 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 can do many things, a combination of antibodies, but cells have an infinitely more complex response mechanism and ability to influence it invariant and K. T cells are actually tissue resident immune orchestrate this.
They actually are 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 disease balance that you are aiming to restore with INK. T cells. And these cells are able to do that. We've seen this in COVID patients and in some of our emergency use patients has a dramatic effect in restocking sort of a new normal function. And we also think that in metabolic disorders, we can actually achieve this. We've seen IK. T cells get into places where conventional T cells don't really like to be. And IT. T cells can go there and do change the environment much more to a much more stable and rebalanced situation. That's what we're looking for. And there are many new disorders where we feel this will be a benefit. I think I'll leave it at that high level then.

Mayank Mamtani

Yeah, look forward to learning more on that.
Thank you. And then on the Phase two gastric cancer study or just early findings. I understand there. Could you talk specifically to your plan of understanding contribution between our Board and the cells, be it through clinical or translational data. I'm not sure if you've seen our data of blood value data in this particular deal with a cold tumor. So if you could help us understand how you're thinking about that, and thanks again for taking the question.

Jennifer Buell

Mayank, thank you very much. So on I had mentioned to Emily just a bit ago about the way that we will interrogate the activity of these cells for standard of care, thousands of patients worth of data. We did not add it in standard of care arm into the randomized Phase two and we didn't we don't need to at this at this point. So the we will study the cells on top of standard of care. This sells on top of that now with and without standard of care.
Now our ability to interrogate the addition of the additional benefit or the contribution of the cells to Bob Bell is going to take shape in a few ways. It will take shape in this study, but it also will take shape in a study that we will be announcing as well. And that will be externally funded in colorectal cancer in patients with metastatic disease to the liver.
So as you know, and Brent Miller, for those of you who don't know about that has generated really remarkable activity in cold tumors and more than 900 patients studied nine different tumor types that are companies that have been previously unresponsive to immune therapies are actually responding to that down, and it opens up an enormous opportunity for patients with these diseases that have previously gone unable to be treated effectively 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 and it will represent the largest killer of men under 50 and shortly. And this has been widely published and available in both the scientific literature as well as in the literature and what we have observed with and with the activity and nearly 400 patients treated with MSS CRC is it popped out standard of care therapies bring anywhere from a 2% to 3% a tumor shrinkage. And 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 in the randomized Phase 2 study, we have observed a more than doubling and beyond two years of survival, which is really as far as we can tell unprecedented in this indication, the one area where where we believe we can improve upon the activity of thought that we do see that barbell is active in generating a survival benefit in patients with metastatic disease to the liver, but not it's not as active in shrinking tumors within the liver and now what we know, but INKT.s as they actually home to the liver disease.
And we have observed in our own hands at INET.s can modulate disease in the liver. So we believe that in addition to the survival benefit that bottle can bring to patients with MSS CRC with liver mets. We think that the addition of INKT.s may actually contribute to the reduction of disease burden in the liver and may actually expand survival benefit even further beyond what that 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 be happening in the first half of this year.

Mayank Mamtani

Thank you Jen and looking forward to those updates.

Jennifer Buell

Thank you very much Mayank.

Operator

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.

Jennifer Buell

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.

Operator

Thank you, everyone.
That does conclude today's presentation. Thank you for your participation today. You may now disconnect.