MiNK Therapeutics (ticker: MNK) announced their fourth quarter 2023 financial results, detailing their progress in clinical trials, strategic partnerships, and financial standing. The company highlighted the advancement of their flagship allogenic iNKT cell program, agenT-797, into a Phase 2 trial for gastroesophageal cancer and their efforts in developing therapies beyond oncology.
A significant achievement includes the FDA-cleared end-to-end automatic iNKT cell manufacturing process. Financially, MiNK Therapeutics ended the year with a cash balance of $3.4 million and secured $5 million through a convertible note agreement.
Key Takeaways
- MiNK Therapeutics has initiated a Phase 2 trial in gastroesophageal cancer with their agenT-797 program.
- They have developed an FDA-cleared manufacturing process for iNKT therapy, focusing on in-house production.
- The company is exploring therapeutic opportunities in severe respiratory distress and other non-oncology areas.
- Financially, the company has a cash balance of $3.4 million and has received $5 million under a convertible note.
- MiNK Therapeutics is actively pursuing strategic collaborations and project-based financing to support their clinical programs.
Company Outlook
- MiNK Therapeutics is expanding their pipeline through strategic collaborations, regional partnerships, and project-based financing.
- They plan to independently sponsor their own programs to accelerate development.
- The company is engaged with the government for financing programs related to respiratory distress.
Bearish Highlights
- The company reported a financial consumption of $15.8 million in the previous year, primarily for clinical trials and manufacturing optimization.
Bullish Highlights
- Enrollment for the gastroesophageal cancer study is progressing quickly with high demand indicated by Dr. Janjigian's ready lineup of patients.
- The company's non-oncology programs are gaining traction, with plans for a trial in acute graft versus host disease and treatment for respiratory distress.
- MiNK Therapeutics' engineered iNKT cells show promise in autoimmune diseases and metabolic disorders due to their immune-modulating capabilities.
Misses
- There were no specific financial misses discussed in the earnings call.
Q&A Highlights
- The company is discussing the potential of iNKT cells in metabolic-related disorders and the production of material for large populations.
- An externally funded trial for metastatic colorectal cancer is set to be announced in the first half of the year, focusing on reducing disease burden in the liver and improving survival.
In summary, MiNK Therapeutics is making strides in their clinical trials and manufacturing capabilities while actively seeking financial partnerships to support their growth. The company's focus on iNKT cell therapies holds potential for significant advancements in both oncology and non-oncology fields.
InvestingPro Insights
MiNK Therapeutics (ticker: MNK) has been navigating a challenging financial landscape, as evidenced by the InvestingPro Data. Their Market Cap stands at a modest $30.93 million, reflecting the size and current market sentiment towards the company.
The lack of a P/E Ratio indicates that MiNK Therapeutics has not reported positive earnings, which is consistent with a company focused on clinical trials and development. The adjusted P/E Ratio for the last twelve months as of Q3 2023 is -1.24, further underscoring the company's current lack of profitability.
InvestingPro Tips reveal a mixed picture. On the positive side, management's aggressive share buybacks could indicate confidence in the company's future, and the fact that MiNK holds more cash than debt on its balance sheet provides some financial stability.
Still, concerns arise with the company's quick cash burn and weak gross profit margins. Moreover, short-term obligations exceeding liquid assets and the anticipation by analysts that the company will not be profitable this year are significant considerations for investors.
MiNK Therapeutics' strategic focus on advancing their clinical trials and securing financing is crucial as they work towards profitability. The company's progress in iNKT cell therapies suggests potential, but the InvestingPro Tips highlight the financial hurdles they face. Investors interested in deeper analysis can find additional tips on InvestingPro, with a total of 9 tips available for MiNK Therapeutics that could provide further insight into the company's prospects. For those looking to explore these insights, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at https://www.investing.com/pro/MNK.
Full transcript - Mink Therapeutics Inc (INKT) Q4 2023:
Operator: Good day everyone, and welcome to the MiNK Therapeutics' Fourth Quarter 2023 Financial Results. Today’s call is being recorded. All lines have been placed on mute to prevent any background noise and after the speakers’ remarks, there will be a question and answer session. [Operator Instructions] I would now like to turn the conference over to Zack Armen, Head of Investor Relations. Please go ahead.
Zack Armen: Thank you, Lisa, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans, and timelines, as well as timelines for data release and partnership opportunities among other updates. These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Doctor Jennifer Buell, President and Chief Executive Officer; Christine Klaskin, Principal Financial (NASDAQ:PFG) and Accounting Officer and Doctor Marc Van Dijk, Chief Scientific Officer. Doctor Joy Zhou, Head of CMC is also here for any questions. Now, I'd like to turn the call over to Doctor Buell to highlight our progress in 2023 and to speak to our outlook for 2024.
Jennifer Buell: Thank you very much, Zack. It's a pleasure to have you all with us this morning to hear about our accomplishments throughout the course of last year and what we plan to do in 2024. Throughout 2023 and into the beginning of this year already, we've achieved some significant milestones that I'm going to go through today. And these are all related to advancing our allogenic iNKT or Invariant Natural Killer T cell programs. Notably, we initiated phase – a phase 2 trial in gastroesophageal cancer, a development I’ll delve into very shortly. This pivotal program built upon crucial data presented at four major medical conferences throughout the course of 2023, along with the publication of our findings in esteemed journals, such as Nature Communications and Oncogene. Our comprehensive dataset nearly 100 patients treated to-date showcases the efficacy and activity of iNKTs in addressing solid tumor cancers and in other immune-related diseases such as acute respiratory distress syndrome with promising outcomes observed. These achievements underscore our pivotal role in advancing state-of-the-art cell therapies on what we believe to be an optimal cell platforms positioning iNKT Therapeutics as a key contributor to the progress of living medicines. Today MiNK stands as one of the most clinically advanced companies pioneering this novel cell type iNKT is and is a reminder, iNKTs are what we believe to be the most potent and highly conserved cell types in immunity. Through the progression of our clinical programs and robust R&D initiatives, we've made significant contributions to an expanding repository of clinical and preclinical data showcasing the distinct advantages of iNKTs in immune therapy for immune-related diseases. This year, our efforts have culminated in presentations at four major medical meetings and the publications of the two manuscripts that I just mentioned a moment ago. We've showcased our observations of activity in patients with cancer, as well as patients with severe respiratory distress, both of which I'm going to go into in just a moment. But before going into our priorities for this year, let me just reiterate our fully integrated capabilities. These are unique to MiNK in this space and these capabilities really underscore our efficiency and the progress we’ve been able to make to-date. With our state-of-the-art discovery platforms, which Marc has shared with you and will go into you some more detail today, our AI capabilities, our high throughput genomic analyses and engineering capabilities, we possess the agility to swiftly identify targets and develop therapeutic approaches whether through CAR iNKTS, T cell engagers, TCRS or native allogenic iNKTs. These programs advanced seamlessly through our fully internal GMP manufacturing capabilities, which have been optimized, further scaled and received FDA clearance to produce material in-house for our clinical programs. We're advancing on multiple fronts with the focus on really revolutionizing treatment and access to these effective cell therapies in cancer, pulmonary diseases and other immune-related disorders. Our flagship program is a native, naturally engineered allogenic, donor-derived iNKT cell product. This is called agenT-797. It's now advancing the Phase 2 trial in second-line gastric cancer. And in addition, our collaboration with Immunoscape, which we announced last year, spearheaded by Marc and powers us to leverage the potential of our T cell receptive platform and programs, as well as our novel and proprietary targets. Furthermore, our T cell engager platform bodes unique development capabilities and also holds the promise that’s really quite unique to MiNK of delivering engager T cells in combination with native iNKTs. This is innovative, it's strategic and it's unique to what we can bring to a clinical development. I'm going to speak a bit about our programs in oncology, as we look ahead to 2024 focus really remains squarely on advancing our lead program agenT-797. Our objectives are very clear. We must continue expanding our clinical data set and exploring therapeutic areas with potential rapid development pathways. Our focus on 797 serves as the cornerstone of our vision driving us forward to redefine treatment standards, positively impacting patients’ lives with the accessible, living medicines designed to deliver benefit without the disabling side-effects of standard chemotherapeutic approaches and this is particularly evident in patients with gastric cancer. In February, we announced a significant milestone with the launch of our Phase 2 study of 797. This trial focuses on combining 797 with botensilimab, which many of you are quite familiar with. Botensilimab is an Fc-engineered molecule. It's a multi modal T cell activator, which also binds the CTLA-4. This agent combines with balstilimab and anti-PD-1 therapy, both of those antibodies are through our collaboration with Agenus (NASDAQ:AGEN). And this combination is also added on top of standard of care chemotherapy in second line gastroesophageal cancers. This is a therapeutic area where there are currently no therapeutic or curative options for patients and it's a critical need in oncology. The initiation of the trial follows a compelling clinical data set presented at AACR in SITC last year and most recently the publication of a manuscript outlining 797’s clinical activity in patients that are refractory to immune checkpoint inhibitors and prior chemotherapies, specifically in gastric cancers. This collective evidence showcases that 797’s potential to overcome resistance to immune checkpoint inhibitors demonstrating durable disease stabilization and activity in refractory solid tumor cancers, including a confirmed response in chemotherapy and anti-PD 1 refractory gastric cancers. As a reminder, the patient who has published in Oncogene was the patient who failed prior chemotherapy full facts as well as nivolumab and pembrolizumab. So this patient then was treated with cells in combination with Nivo and had a partial response that was durable and remained so throughout the trial period. The trial is led by Dr. Yelena Janjigian. Yelena is the Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center. The trial is supported by Stand Up to Cancer and this phase 2 study holds promise in really changing the treatment landscape for patients with this cancer. We launched the trial in February and have already accrued our initial cohort of patients and have had the pleasure of seeing some very initial preliminary positive signals which we’re quite excited about. These findings form the foundation of continued discussions with regulators to expand the benefits for patients with gastric cancer and a trial that we plan to provide an update for you before the end of this year. Now beyond oncology, this is a growing area of therapeutic opportunity for cell therapies and we are particularly well-positioned in this space given our scalability and our efficiency and being able to generate an allogenic, donor-derived iNKTs at scale that can be cryopreserved and retained their functional characteristics. This allows us to have the cells at the sites when the patients need them and able to be delivered at the point of administration without any delays from needle-to-needle time. So, we've been working outside of oncology and we made some important advancements with 797 outside of this of oncology. A published data highlights the important role that iNKTs could play in immunity more broadly and these include infections, inflammatory diseases, as well as autoimmunity and you're going to hear some data in an upcoming conference in the first half of this year about some important signals that in the treatment paradigm with patients who have both autoimmunity and infections, which I think will make you as excited as it has made me. Last year, we presented data at the American Thoracic Society and it showed a survival benefit of 75% in patients treated with agenT-797 and these data stand in stark contrast to 10% survival in the in-hospital case controls enrolled at the same time period of our trial. We’ll present these data at a conference in the first half of this year and will follow with an announcement about the next steps for this important program. And I think importantly at the ATS conference, we also showed that patients on the most severe forms of life supports with ARDS, these patients are treated with ECMO, VV ECMO and those patients treated with VV ECMO actually had a survival rate of over 80%, which is also really quite unexpected in this patient population. And again, you'll hear more data in an upcoming conference in the first half of this year. Now these clinical trials have demonstrated promising results regarding the activity of iNKT cells in patients facing severe respiratory distress. Now, this is a condition affecting over 600,000 individuals annually in the US alone. Compared to conventional therapies like corticosteroids, our trials have demonstrated these activities in critical endpoints such as respiratory function, oxygenation levels, as well as overall survival rates. And they present an important foundation for the development of 797 in patients with ARDS, potentially reshaping treatment paradigms for intensive and acute pulmonary care settings. In summary, our approach to rapidly advanced iNKT cells in patients with respiratory distress underscores our commitment to addressing unmet medical needs and improving patient outcomes in oncology and beyond. And we're excited about the potential of these cells to make a meaningful difference in the lives of patients and we look forward to providing an update in the month ahead. In order to support our growing 797 clinical programs, of course we've maintained a steadfast focus on delivering our in-house manufacturing of allogenic iNKT cells. These cells, this is a critical capability led by Dr Joy Zhou, and this removes any reliance that we currently have or had previously had on third-party CDMOs. And it ensures our control end-to-end control over an efficient and reliable play of our products. We are currently providing in-house manufacturing products for our ongoing clinical studies and plan to do so for our in-house programs, as well as our collaborative programs that are under active discussion. Our CMC team has achieved a major milestone in developing and implementing an FDA cleared end-to-end automatic, closed and industrialized iNKT manufacturing process, which is fully in-house demonstrating MiNK’s internal manufacturing capacity in compliance with rigorous regulatory standards and its readiness for clinical production to support our trials. This process represents a top-notch industrialized allogenics of therapy manufacturing process and leverages our cutting-edge closed technology to streamline production from start to finish and minimize any manual intervention. This minimizes of course and in our hands has eliminated contamination as far as we can tell at this point and maintains product integrity throughout the manufacturing process. I'm now going to turn the call over to Dr. Marc Van Dijk to go over MiNK’s technology platforms and another important component of our next-generation pipeline, Marc?
Marc Van Dijk: Thank you, Jen. I'm going to talk a bit about our CAR iNKT program MiNK 215 and then about TCRs recent activity there and cell engagers. So, one thing to refine, given the potent tumor infiltrating and in gene modulating activity of MiNK 215 that we've observed in pre-clinical studies including lung cancer, we anticipated actually may elicit clinical responses in difficult-to-treat solid tumors. For patients with microsatellite-stable or mismatch repair-proficient colorectal cancer frequently had liver metastases. This is associated with very poor response to current pharmacological treatments including immune checkpoint blockade. For the tumor microenvironment of colorectal cancer liver metastases is characterized by a highly immunosuppressive phenotype, which prevents the patient's T cells from infiltrating attacking these metastases even when these are reactivated and reinvigorated using anti-PDL1 or anti-PDL1 antibodies. This underscores the urgent need for innovative therapeutic approaches targeted specifically to patients with liver metastases. So to better model immune checkpoint blockade refractory human colorectal cancer liver metastases, we, together with our colleagues from Agenus, developed an ex vivo human organoid model the recapitulates the histological and immunological features of human disease. And our findings underscore that in treatment-refractory liver metastatic organoid models, mean to one five can potentially overcome the limitations of immune checkpoint therapy effectively homes decisive [Ph] disease reprograms the tumor microenvironments, recruits tumor reactive T cells and enhances tumor killing. This data will actually be presented at an upcoming American Association for Cancer Research Annual Meeting in April. So, our additional unique research capabilities of making cleans a proprietary library of phosphoryl peptide neoantigens derived from a wide range of solid tumors and hematological malignancies. We’ve assembled this target library over the last couple of years through internal efforts expanding on the original acquisition of [Indiscernible] 2015. So we believe that these phosphoryl peptides represent broadly presented neoantigen tumor targets that can be utilized to discover potent T cell receptors that can then be used to attack solid tumors. So the further our discovery and developments of new candidate T cell receptors, we entered into a research collaboration agreement with Immunoscape. This collaboration is designed to accelerate the development of TCR-based therapies against novel targets in T cells invariant to iNKT cells and other modalities. In this collaborative effort, Immunoscape will leverage its capabilities in multiplex antigen screening and in-depth T cell profiling to identify relevance of TCRs targeting the library of phosphoryl peptide antigens. MiNK Therapeutics will further characterize these tumor-specific T cell receptors levering its proprietary platform and capabilities to analyze and select TCR candidates for optimal tumor targeting when expressed in iNKTcells or as bispecific cell engagers. We believe that invariant iNKT cells are perfect allogenic whole cells for expressing tumor-targeting T cell receptors and developing off-the-shelf TCR-based cell therapies. We look forward to working with Immunoscape with the Immunoscape’s team to deliver new therapeutics that can potentially eliminate tumor cells and alleviating immune suppression for durable anti-cancer immunity, especially for solid tumors. Now, another development that we're actually very enthusiastic about is combining our off-the-shelf invariant iNKT cells with cell engagers both with existing third-party T cell engagers as well as with our own invariant iNKT cell engagers. We've seen our off-the-shelf invariants iNKT cells strongly enhance tumor killing and immune activation when combined with cell engages in our model systems and we believe that co-administration of invariants iNKT cells and T-cell engagers has to potential to extremely increase clinical efficacy especially in solid tumors where cell engagers have not yet shown great results. Invariant iNKT cells have shown they can infiltrate solid tumors where conventional T cells struggle. So we administer our iNKT cell products without link for the patient, which is crucial for maintaining the full immune potential of the patient. Co-administering invariant iNKT cells with engagers could ensure that a wave of these very positive immune cells enter the tumor first. This not only helps ensure a focused attack, a focused direct attack on the tumor. But at least as important to combat local immune suppression and brings in the patient's own immune cells. We're actively exploring these combinations and we look forward to updating you on our progress in the near future. I'll now turn the call back over Jen. Jen?
Jennifer Buell: Marc, thank you very much. Excellent. Excellent. So as we reflect of course on our advancements last year and throughout this year, I just wanted to touch upon our financial prudence that has supported our progress. We’ve remained really diligent leveraging our in-house manufacturing process, which is incredibly efficient to significantly reduce their external dependencies, as well as costs. And our phase 2 trial in second-line gastric cancer is led by the world's experts in this tumor type and it’s a world-leading institution and externally funded by Stand Up to Cancer, which enables us to essentially access insights into a development pathway in an incredibly efficient way. So we're excited about our ability to do that. Partnering remains core to our strategy and as Marc has mentioned, the capability that we possess to be able to deliver ourselves at such efficiency does allow us not only to develop the product independently, but also to combine it well with therapeutics that may not be delivering the kind of clinical outcomes that are that are necessary for approval and that includes expanding the benefit of T cell engagers. And this is an active data set that we've generated in our own hands, as well as in the hands of potential partners. So, we are quite excited about what the future holds and we'll continue to be very prudent in the selection of our clinical programs to high impact trials and high impact results as we continue to pursue ways of improving our financial health, as well in parallel. I'm going to turn the call over to Christine to go over our financials.
Christine Klaskin: Thank you, Jen. We ended the year with a cash balance of $3.4 million. Since year end, we received $5 million under our convertible node agreement that we executed last month with Agenus. Cash used in operations for the three and 12 months ended December 31, 2023 was $3 million and $15.8 million respectively. This compares to $4.4 million and $18.9 million for the same periods in 2022. Our net loss for the year ended December 31, 2023 was $22.5 million or $0.65 per share, which compares to net loss for the same period in 2022 of $28 million or E0.83 per share. I will now turn the call back over to our operator for questions.
Operator: [Operator Instructions] Thank you. [Operator Instructions] We'll take our first question from Emily Bodnar with H.C. Wainwright.
Emily Bodnar: Hi, good morning. Thanks for taking the questions. A few from me. On your clinical trial.gov listing for the phase 2 gastric study, it looks like they're also combining with ramucirumab. So, can you go through what patients might be getting by in their treatment plan? And given that you're combining agenT-797 with several agents, how do you kind of think about the efficacy of components based on what we might expect with standard of care?
Jennifer Buell: Emily, this is an excellent question. So, and something that we've we thought quite a bit about and I'll share with you that we are developing the data set to interrogate patients with iNKTs alone with a bot/bal and plus with and without ramucirumab in paclitaxel. Now, ram/tax those are the standard of care agents used in second-line gastric cancer. They have very limited activity and as you know, probably just a little over 20%, 25%, which gives us a big opportunity to really make a significant difference in the treatment landscape here. We will generate the data set that that will include how patients perform on the cells alone. How they perform with the cells on top of standard of care, as well as the cells in the multiple combination with bot/bal and the standard of care chemo. And we already have some preliminary signals of each of these settings that we will be sharing with you as we continue to develop the data set in the second half of the year. It's really quite exciting and it does give us an opportunity to present to the agency what we believe to be the most impactful would be and the speediest to develop would be dropping the therapies on top of standard of care ram/tax. That is, that allows us not to salvage patients post ram/tax. It allows us to take advantage of some of the neoantigen released from the tumor killing that does come along with the chemotherapy. And we know that the cells can be dosed tolerably in that disease setting. We also know that they can they can combine tolerably with checkpoint modulating antibodies such as PD-1 and now with bot/bal. So, I'm hoping that I answered your question. The data set includes and will be - cells alone, cells in combination with ram/tax to get us on top of standard of care and then the cells in the multi combination that includes bot/bal. And I should say we did not include a ram/tax arm alone, because we have thousands of patients that have been treated with that combination and a robust data set - from real world evidence to actually drive what the expectations are from the chemo alone. So we did not want to add that arm in the trial at this time. We would do so provided they are positive signals. It would probably be a requirement to do so in a registrational study that would follow this sometime mid-year
Emily Bodnar: Okay. That makes awesome. Just I guess, a confirmation question, are you only evaluating patients who have failed one prior line or is it like a minimum of one prior line?
Jennifer Buell: Right now, we have it essentially as a minimum of one prior line, but really the focus is one prior line. And these patients who have failed full tox nivo really have nothing to go to barring their HER2 status. So they would essentially be treated with ram/tax. So, there's there isn't very much more for those patients to go on.
Emily Bodnar: Okay. Excellent. And then, last question. I know you talked about the $5 million convertible note from Agenus, but maybe just discuss like strategies for bringing additional capital into the company. Thank you.
Jennifer Buell: Thank you, very much, Emily. Absolutely. So, first. I should say that as you look at the year - prior year 2023, you'll see that the financial consumption of about $15.8 million drove the execution and completion really of three clinical trials and our manufacturing optimization. So, that that really does speak to the efficiency that our team has been able to operate with. This year, of course, we're being even more financially prudent with the externalization of the financing for our clinical programs at this time. The cells are in high demand for trials such as the one that we're conducting with Dr. Janjigian. But we would like to of course conclude some financial transactions that would allow us to independently sponsor our own programs and accelerate the development. Now, this is going to come in three different ways as far as we can tell right now. The first is of course through a strategic collaboration. And as I have discussed previously, these are some very active discussions with individuals who first need to better understand iNKTs. We are the most advanced company bringing these forward. So the science is lesser known and that does require in groups to get up to speed on what the science depicts our clinical data is very much helping that. But it has required us to enable material transfer, so that partners can work with the cells in their own hands and much of that work has been done and now discussions are starting to advance. Now a collaboration would not only help us to expand on the work that we're doing. It would also allow us to expand our discovery pipeline and could give us infrastructure outside of the US where we currently do not have bandwidth or infrastructure. The other is of course a regional partner, which I also mentioned is something that we are continued to be in active discussions for an R&D partnership, as well as access to the cells alone just essentially just supply arrangement for combinations in a pipeline. And of course, the third would be expanding our interactions with project-based financing and investors and these again are active discussions that are underway.
Emily Bodnar: Great. Thanks for taking the questions.
Jennifer Buell: Of course.
Operator: Our next question comes from Jack Allen with Baird.
Jack Allen: Hey. Thanks for being the questions and congratulations on the progress made over the quarter. I guess the first one on gastric. Could you provide some color on the cadence of enrollment? Are there any staggers early in the study with these multiple arms between the different patients?
Jennifer Buell: So, I should I should share with you, Jack, that's a great question and it is something that we - in the industry has typically been plagued with waiting 28 days per patient. I will say that given the experience and the visibility of Dr. Yelena 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 the unmet need. It also speaks to her convincing argument about the unmet need and the urgency of delivering therapies for these patients.
Jack Allen: Got it. Okay.
Jennifer Buell: The rate of enrolment I should say it's moving really, really quite quickly.
Jack Allen: Got it. Could you speak to maybe the patient and thoughts that they have at this – 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. 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. And I had to take to give anymore further guidance, but I will say, we will - I believe that we will be on track to have concluded enrollment in the first half of this year.
Jack Allen: Got it. Great. And then, just one more on the gastric study. What is the dialog between MiNK and the investigator in the study? I guess, how frequently you're getting updates as a relates to data? And how should we think about that dynamic?
Jennifer Buell: We have Dr. Janjigian has quite a bit of experience with a genesis of bot/bal 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 the 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 would be coming from Dr. Janjigian’s team.
Jack Allen: Got it. 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 spoke that potentially testing the cells and graph with cells disease where do you think sit as it relates those other opportunities beyond ARDS and oncology?
Jennifer Buell: So, Jack, I'm 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 tolerably and quite impactfully. 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 to - 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 move forward 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. 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. The 600,000 patients annually it was 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 from [Indiscernible] 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 of those secondary components are really important. And what we have observed in our clinical trials and published in Nature Communications is in-patients on mechanical ventilation and on VV ECMO, 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 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 and 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: Got it. Thank you so much for the color. Congratulations again on the progress.
Jennifer Buell: Thank you, Jack.
Operator: We will take our next question from Mayank Mamtani with B. Reilly Securities.
Mayank Mamtani: Good morning. Thanks for taking the questions and appreciate the comprehensive update. Jen, could you talk to the status of your engineered iNKT cell efforts including in autoimmune diseases if there is any? And also I was curious on the next steps on the ARDS programs for 797. What - are you - what sort of illustration based development do you have planned understanding you may need a partner there? 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 in the capability in existence and we've been invited to - and we actually are an 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 these 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 and the moment that we conclude the contract execution. With respect to autoimmunity, now Jack 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, as you know, these cells we have - last after in SITC 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 could have Marc speak a bit to 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 entertaining some discussions with partners on the development of these cells in this area. I'm going to have Marc to say two or three words about the potential in this particular space. And finally, I also should mention and 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 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 to protect our national security. Marc, maybe just a moment on the metabolic opportunity?
Marc Van Dijk: Yeah. And also more broadly the autoimmune opportunity and we've been looking at this and Agenus 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 has intrinsically many more response mechanisms 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 and combination of antibodies but cells have an infinitely more complex response mechanism and ability to influence. And being variant iNKT cells are actually tissue residents immune orchestrators. They actually are 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 release soon as in COVID patients and in some of our emergency use patients, it has a dramatic effect in restoring sort of immune normal functions. And we also think that in metabolic disorders, we can actually achieve this. We've seen iNKT cells are getting into places where conventional T cells don't really like to be. And iNKT cells can go there and do change the environments much more to a much more stable and rebalance 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.
Mayank Mamtani: Yeah, look forward to learning more on that. Thank you. And then on the phase 2 gastric campus study, just early findings - I understand there - could you talk specifically to your plan of understanding contribution between bot/bal and the cells being through clinical or translation data? I'm not sure if you've seen a ton of bot/bal data in this particular cold tumors. So if you could help us understand how you're thinking about that, Jen? Thanks again for taking my questions.
Jennifer Buell: 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 in a standard of care arm into the randomized Phase 2. We didn't - we don't need to at this point. So, we will study the cells on top of standard of care. The cells on top of bot/bal with and without standard of care. Now, our ability to interrogate the addition of the additional benefit of the contribution of the cells to bot/bal 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 deliver. So as you know, or for those of you who don't know, bot/bal has generated really remarkable activity in cold tumors and more than 900 patients studied nine different tumor types that are that have been previously unresponsive to immune therapies are actually responding to bot/bal 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, MSS CRC 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 the late literature. What we have observed with the activity in nearly 400 patients treated with MSS CRC is, bot/bal standard of care therapies bring anywhere from 2% to 3% tumor shrinkage. And we're seeing more than a tenfold improvement of tumor shrinkage in that indication when patients are treated with bot/bal. And while we have not yet achieved a median survival in this study in the in the randomized phase 2 study, We have observed a 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 bot/bal, we do see that bot/bal is active in generating a survival benefit in patients with metastatic disease to deliver. But not as - it's not as active in shrinking tumors within the liver. Now what we know about iNKTs is they actually home to the 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 bot/bal can bring to patients with MSS CRC with liver match, we think that the addition of iNKTs may actually contribute to the reduction of disease burden in the liver and may actually expand survival benefit even further beyond what bot/bal could 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. 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. 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.
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