Q2 2024 MiNK Therapeutics Inc Earnings Call

Speaker Change: Only 25 people lost their lives in the strike and the demonization The strike denounced and evicted civil society from all major government bodies Without any security from the government or the people The asylum-seeking terrorist cooperated with special police The strike denounced and evicted civil society from all major government bodies The strike denounced and evicted civil society from all major government bodies

Operator: [inaudible] able to do this. She's the first one to be able to do this. She's the first one to be able to do this. Good morning, and welcome to MiNK Therapeutics' second quarter 2024 conference call and webcast. All participants will be in listen-only mode until the question and answer session.

Speaker Change: [inaudible]

Speaker Change: Good morning and welcome to Mink Therapeutics' second quarter 2024 conference call and webcast. All participants will be in listen-only mode until question and answer session.

Operator: Please note this event is being recorded. If anyone has any objection, you may now disconnect at this time. I would now like to turn the conference over to Zack Armen from MiNK's Investor Relations. Zack, please go ahead.

Zack Armen: Thank you, operator, and thank you all for doing this. 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 others. 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.

Speaker Change: Joining me today are Dr. Jenn, Buell, President and Chief Executive Officer, Dr. Barbara Finck, Chief Scientific Officer.

Zack Armen: Joining me today are Dr. Jen Buell, President and Chief Executive Officer, Dr. Mark Van Dyke, Chief Scientific Officer, Dr. Joy Zhao, Head of CMC, and Christine Klaskin, Principal Financial and Account Officer. Now I'd like to turn the call over to Dr. Buell to highlight our progress on the sport. Thank you, Zack.

Speaker Change: Joey.

Speaker Change: And Christine Classic principal financial and accounting officer.

Speaker Change: Sure.

Speaker Change: Now I'd like to turn the call over to Dr. Buell to highlight our progress on this quarter.

Dr. Buell: Thank you Zack good morning, and thanks for joining us today.

Jennifer Buell: Good morning, and thanks for joining us today. I'm excited to share the strides we've made in the first half of 2024 as we continue to align our achievements with our long-term strategic goals. And for those of you new to the story, at MiNK... Our mission is focused on delivering the immune potent potential of invariant natural killer T cells to tackle diseases of the immune system and cancer. Today, I'll be highlighting our latest clinical developments, particularly in our lead programs, Agent 797, these are native, unmodified INKT cells, and MiNK 215, our armored FAP car INKT. Additionally, I'll discuss how we fortified our financial foundation, setting the stage for sustained innovation and growth. We've made substantial progress in streamlining our operations to optimize our financials in this market.

Dr. Buell: I'm excited to share the strides we've made in the first half of 'twenty 'twenty four as we continue to align our achievements with our long term strategic goal and for those of you new to the story it Nate.

Speaker Change: Our mission is focused on delivering the immune co in potentially a big.

Speaker Change: Various natural killer T cell to tackle diseases of the immune system in cancer.

Speaker Change: Today I'll be highlighting our latest clinical developments, particularly in our lead programs H F. 797. These are native.

Speaker Change: Modified our U K T cells and May choose one five hour armored car I N T.

Speaker Change: Additionally, I'm just guess that we fortified our financial foundation setting the stage for sustained innovation and growth.

Speaker Change: We've made substantial progress in streamlining our operations to optimize our financials in this market and this quarter. We continued to generate critical data from our ongoing clinical programs. We continue to advance our R&D effort.

Jennifer Buell: In this quarter, we continue to generate critical data from our ongoing clinical programs. We continue to advance our R&D efforts, and in short, efficient in-house manufacturing, all the while appreciating further reductions to our operating burn, now reduced more than 50% from this time last year, mainly from the internalization of key activities.

Speaker Change: And in short efficient in house manufacturing all the while appreciating further reductions to our operating burn now reduced more than 50% from this time last year, mainly from the internalization of key activities. These reductions had been a result of the internalization of our efforts and continued external.

Jennifer Buell: These reductions have been the result of the internalization of our efforts and continued external financial support to advance our exciting program. I'll walk you through these developments and illustrate how we're paving the way for MACE success. We'll begin with our operational and financial progress. Our lead program 797 is an allogeneic, unmodified INKT cell therapy currently advancing in a phase 2 trial for second-line gastric cancer and acute respiratory disease syndrome, or ARDS.

Speaker Change: Financial support to advance our exciting program.

Speaker Change: I'll walk you through these developments that illustrate how we're taking away from base success.

Speaker Change: I will begin with our operation operational and financial progress.

Speaker Change: Our lead program 790, Sevens, and allogeneic unmodified I N K T cell therapy currently advancing in a phase two trial for second line gastric cancer and acute respiratory disease syndrome or a rvs.

Jennifer Buell: On gastric cancer, second-line gastric cancer is a challenging condition with a poor prognosis and a high mortality rate. Patients undergoing second-line therapy for advanced gastric or gastroesophageal junction cancer typically have a median overall survival of only four to ten months, although depending on factors such as performance status.

Speaker Change: Gastric cancer second line gastric, it's a challenging condition with a poor prognosis and a high mortality rate.

Speaker Change: Patients undergoing second line therapy for advanced gastric or gastroesophageal junction cancer typically have a median overall survival of only four to 10 months depend.

Speaker Change: Depending on factors such as performance status.

Jennifer Buell: A Treatment Regimen [inaudible] In parallel, 797 is also being evaluated for ARDS. This is a rapidly progressive and light-sensitive condition that affects the right and main condition, with a mortality rate of approximately 40%. Our commitment to addressing these critical unmet medical needs underscores the potential of 797 to provide meaningful therapeutic benefits in both oncology and respiratory care. Let me begin with our program in ARDS. This is a rapidly progressive form of respiratory failure with alarmingly high mortality rates.

Speaker Change: <unk> regimen.

Speaker Change: In parallel 797 is also being evaluated for a rvs such as a rapidly progressive life threatening condition.

Speaker Change: With a mortality rate of approximately 40%.

Speaker Change: Our commitment to addressing these critical unmet medical needs underscores the potential of seven nine starting to provide a meaningful therapeutic benefit in both oncology and respiratory care.

Speaker Change: Let me begin with our program in <unk>. This is a rapidly progressing form of respiratory failure with alarmingly high mortality rates the prevalence of a hard yes, it's been growing particularly in younger populations and this is likely exacerbated by the aftermath of the COVID-19 pandemic.

Jennifer Buell: The prevalence of ARDS has been growing, particularly in younger populations, and this is likely exacerbated by the aftermath of the COVID-19 pandemic. This condition represents a significant burden on health care systems globally, given its high incidence and severe outcomes. The urgency to address ARDS has been underscored by the most recent announcement from the Biomedical Advanced Research and Development Authority, or BARDA, which has committed almost $120 million to a randomized phase 2 program focused on critical outcomes such as survival and ventilator-free days.

Speaker Change: This condition represents a significant burden on health care systems globally, given its high incidence and severe outcomes.

Speaker Change: The urgency to address a hard yes, it's been underscored by the most recent announcements from the biomedical advanced research and development authority or BARDA.

Jennifer Buell: This substantial investment highlights the critical need for innovative and effective treatment in this challenging disease setting. The BARDA program is expected to evaluate three therapeutic options, two of which are monoclonal antibodies and have already been disclosed, with the third agent not yet announced. Our published data from the Phase I-II trial of 797 demonstrates a 75% survival rate and significant improvement in ventilator-free days for patients with ARVS, suggesting that IMKT cells could play a pivotal role in ARVS management. These promising results indicate that 797 can be seamlessly incorporated into standard treatment protocols and provide potential for substantial clinical benefits at the recent American Thoracic Society or ATS annual meeting. We presented additional compelling data.

Speaker Change: Just committed almost a $120 million to a randomized phase two program focused on critical outcomes such as survival in ventilator free days. This substantial investment highlights the critical need for innovative and effective treatments in this challenging disease setting.

Speaker Change: BARDA program is expected to evaluate three therapeutic options two of which are monoclonal antibodies and have already been disclosed with a third agent not yet announced.

Speaker Change: Published data from the Phase one two trial of 797 demonstrates a 75% survival rate and significant improvement in ventilator free days for patients with AARP as suggesting that IMTT T cells could play a pivotal role in a RBS management.

Speaker Change: These promising results indicate the 787 can be seamlessly incorporated into standard treatment protocols and provide potential for substantial clinical benefit.

Speaker Change: At the recent American thoracic society or Ats annual meeting we presented additional compelling data. This is from our expanded access program building on our findings from our phase <unk> clinical trial.

Jennifer Buell: This is from our expanded access program building on our findings from our phase one and two clinical trials, showing the clinical efficacy of 797 in a critically ill, immune-compromised transplant patient with severe COVID-19-induced respiratory distress. Following a single administration of 797, similar to the dosing and clinical trial, this patient experienced a rapid reduction in planetary cytokines leading to a successful excavation and rapid discharge from the hospital. With nearly 600,000 individuals in the United States alone affected by acute respiratory distress, and about 30 to 40% of those patients with severe acute respiratory conditions annually, the burden on our healthcare system is immense.

Speaker Change: So in the clinical efficacy of 797 in a critically ill immune compromised transplant patient with <unk>.

Speaker Change: Severe COVID-19 induced respiratory distress.

Speaker Change: Following a single administration of <unk> 97, seven similar to the dosing in our clinical trial. This patient experienced a rapid reduction in inflammatory cytokines, leading to successful explanation.

This rapid discharge from the hospital.

Speaker Change: With nearly 600000 individuals in the United States alone affected by acute respiratory distress about 30% to 40% of those patients with severe acute respiratory conditions.

Speaker Change: I believe the burden on our health care system is a mess.

Jennifer Buell: The Promising Results of 7A and 7A scores potential is an important therapy to contribute to eliminating or mitigating ARBS, and that has broader regulatory and healthcare implications. MiNK Therapeutics is among a select group of a few companies advancing therapies in this challenging disease setting, and our early data suggests that 797 could be one of the most promising candidates in the field. Now I'm going to be transitioning to another disease setting that we feel is a significant priority for us and for patients, building on the promising findings in immune optimization with our therapy.

Speaker Change: The promising results of 787 underscores the potential as an important therapy to contribute to eliminating or mitigating RBS and this has brought in regulatory and health care.

Speaker Change: Implications.

<unk> therapeutics as a brand a select group of a few companies advancing therapies in this challenging disease setting and our early data suggests that 797 could be one of the most promising candidates in the field.

Speaker Change: Now I'm going to be transitioning to another disease setting that we feel is a significant priority for us and for patients and building on the promising findings and immune optimization with our therapy, we're excited to announce the upcoming launch.

Jennifer Buell: We're excited to announce the upcoming launch of a Phase I trial in steroid-regulatory acute graft-versus-host disease and improved outcomes in allogeneic hematopoietic stem cell transplantation. Our investigator-sponsored trial will include two leading hematology centers, one in the U.S. and one in Europe, and represents a critical step in broadening the therapeutic applications of our INKT cell platform in GVHD is a serious and potentially life-threatening complication of bone marrow transplants, where donor immune cells attack the recipient's body.

Speaker Change: Just one child in steroid refractory acute graft versus host disease, and improved outcomes and allogeneic hematopoietic stem cell transplantation.

Speaker Change: Our investigator sponsored trials are included two leading hematology centers one in the U S and one in Europe and represents a critical step in broadening the therapeutic applications of our island <unk> T cell platform in regions, where patients have limited effective treatment options.

Speaker Change: Gvhd is a serious and potentially life threatening complication of bone marrow transplants, where donor immune cells attack. The recipients funny Orion J T cell therapy is designed to modulate the immune response aiming to reduce the incidence and severity of gvhd, while preserving the graft versus.

Jennifer Buell: Our INKT cell therapy is designed to modulate this immune response, aiming to reduce the incidence and severity of GVHD while preserving the graft-versus-tumor, or disease, effect. The trial will also explore other important endpoints, such as disease recurrence, infections, and improved engraftment, which INKT cells may positively influence. We're currently collaborating with our partnering institutions and investigators to finalize the study design of plans to activate the science to readiness this year with first hosting by late this year or very early 2025.

Speaker Change: Its tumor or disease affect.

Speaker Change: The trial will also explore other important endpoints such as disease recurrent infections and improve and grassman with giant take T cells may positively influence.

Speaker Change: We are currently collaborating with our partnering institutions and investigators to finalize the study design with plans to activate the science to readiness. This year with first dosing by late here, we're very early in 2025.

Speaker Change: Now another important initiatives, we have ongoing in oncology is our program.

Jennifer Buell: Now, another important initiative we have ongoing in oncology is our program of 797 advancing in a phase two trial in second-line gastric cancer. This trial is currently underway at Memorial Sloan Kettering Cancer Hospital under the leadership of Dr. Yelena Dengidian, who is the chief of gastrointestinal oncology and an internationally recognized expert in gastric cancer.

Dr. <unk>: And of 797 advancing in a phase two trial in second line gastric cancer. This trial is currently underway at Memorial Sloan Kettering Cancer Hospital under the leadership of Dr. <unk>, you laid out in Tianjin and she said she gastrointestinal oncology an internationally recognized expert in gastric cancer.

Speaker Change: Sir.

Speaker Change: Our studies evaluating the potential of 787 in combination with the Genesis next generation checkpoint inhibitors.

Jennifer Buell: Our study is evaluating the potential of 797 in combination with the Genesys Next Generation Checkpoint Inhibitors Botanfilamab and Valfilamab, which have shown very promising anti-tumor responses in a number of disease settings. Our collaboration represents a critical opportunity to explore the synergistic benefit of INKT cell therapy with advanced checkpoint inhibitors, potentially offering a powerful new treatment modality for patients with advanced gastric cancer This is a condition with historically limited therapeutic options, and as I mentioned earlier, survival rates are between four and ten months in these camps.

Speaker Change: Matt.

Speaker Change: And also on that which is showing very promising anti tumor responses in a number of disease.

Speaker Change: Our collaboration represents a critical opportunity to explore the synergistic benefit of ion K T cell therapy with advance checkpoint inhibitor potentially offering powerful new treatment modality for patients with advanced gastric cancer. This is a condition with historically limited therapeutic options and as I mentioned there.

Speaker Change: Survival between four and 10 months in these patients.

Jennifer Buell: Enrollment is actively underway, and the first cohort of patients are now exceeding three to six months of follow-up in the trial and showing very exciting signals of clinical activity where the majority of patients have already demonstrated some semblance of benefit in this population. We're very optimistic about the balance of clinical activity and tolerability of these combinations. We expect to see data presentation at a major oncology conference this year or very early in 2025. Now I will turn the call over to Dr. Mark van Dijk, our Chief Scientific Officer, and he'll review our earlier stage programs that are advancing. Mark.

Speaker Change: Enrollment is actively underway and the first cohort of patients are now exceeding three to six months of follow up in the trial and showing very exciting signals of clinical activity with the majority of patients have already demonstrated some semblance of benefit in this population, we're very optimistic about the balance of peripheral.

Speaker Change: Activity and Tolerability of this combination we expect to see data presentation at a major oncology conference this year or very early in 2025.

Mark Vendetti: Now I will turn the call over to Dr. Mark Vendetti, our Chief Scientific Officer, and he'll review our earlier stage programs that are advancing mark.

Mark Vendetti: Thank you Jim.

Marcus Dijk: Thank you, Jen. Turning to our preclinical pipeline, we are rapidly advancing MiNK 2.0 and 5.0 and Interleukin-15-armored FAP-targeting CAR-invariant natural killer T-cell therapy. That's a mouthful, but it targets tumor stroma. This therapy has demonstrated very promising pre-tender fatiguity against solid tumors, including microsatellite-stable colorectal cancer liver metastasis, and NullSmell, Don't Smell So Lonely. The strategic focus on targeting FAP-expressing tumors stems from the overexpression of FAP in tumor myocardial infarction, which plays a key role in supporting tumor growth and suppressing immune response.

Mark Vendetti: Turning to our preclinical pipeline, we are rapidly advancing <unk> five.

Mark Vendetti: Luke in 15 armoured car targeting <unk> targeting car T cell therapy, that's a mouthful, but it's targeting tumor stroma. This therapy has demonstrated very promising preclinical activity against solid tumors, including microsatellite stable colorectal cancer liver metastases and north mill, both small cell lung cancer.

Mark Vendetti: The strategic focus on targeting <unk> expressing tumors.

Speaker Change: From the overexpression of SAP in the tumor microenvironment, which plays a key role in supporting tumor growth in suppressing immune responses.

Marcus Dijk: By disrupting this environment, Minto V is designed to enhance immune-mediated tumor destruction, offering a novel approach to combating these resistant cancers. Our team is dedicated to bringing this innovative therapy into the clinical arena, with plans to file an ID in 2025. We're developing a robust pre-clinical package that will allow us to identify and enrich a biomarker-based patient population facilitating more rapid signals such as six signal detection and development. The potential for MINK215 to disrupt the treatment landscape in solid tumors is significant, particularly as we continue to see breakthroughs in CAR-T therapy.

Mark Vendetti: Disrupting this environment mutual five is designed to enhance immune mediated tumor destruction offering a novel approach to combating these resistant cancers.

Mark Vendetti: Our team is dedicated to bringing this innovative therapy into the clinical arena, which.

Speaker Change: Plans to final 90 in 2025.

Speaker Change: We're developing a robust preclinical package that will allow us to identify and then rich biomarker based patient population.

Speaker Change: Taking more rapid signals are mixed signal detection and development.

Speaker Change: The potential for mutual employers to disrupt the treatment landscape in solid tumors is significant particularly as we continue to see breakthroughs in car T therapies.

Georgia: Our manufacturing is led by Georgia.

Marcus Dijk: Our manufacturing is led by Joy Zhao, who is driving our efforts to fully develop MiNK-215 manufacturing in-house. By leveraging our state-of-the-art facilities, we aim to maximize scale and performance, ensuring the efficient production of high-quality allogeneic cells. Our partnership with a leading lentiviral vector producer utilizing their novel technology ensures a seamless and efficient production process for our lentiviral vector, critical for the development of MiG-215. The recent approval of allogeneic cell therapy in solid cancer marks a significant milestone in the field and serves as a relevant benchmark for MiNK.

Georgia: Driving our efforts to fully develop mix one five manufacturing in house.

Georgia: By leveraging our state of the art facilities, we aim to maximize scanning performance, ensuring the efficient production of high quality LNG makes cell therapies, our partnership with a leading lithium all electric producer utilizing mobile technology ensures a seamless and efficient production process for all anti viral vectors critical for the development of inventory.

Speaker Change: The recent approval of an allogeneic cell therapies for cancer marks a significant milestone in the field and Sirius as a relevant benchmark for me.

Marcus Dijk: This approval highlights the growing acceptance and potential of allogeneic therapies, reinforcing our confidence in the regulatory pathway for MiNK 2 and 5. Additionally, the anticipated success in CAR-T treatments for advanced solar tumor malignancies emphasizes the potential for MINK's INKT cell therapy to contribute to significant development.

Speaker Change: This approval highlights the growing acceptance and potential of allogeneic therapies, reinforcing our confidence in the regulatory pathway for mutual funds.

Speaker Change: Additionally, the anticipated succession car T treatments with a volatile of tumor malignancies emphasizes the potential for mix T cell therapy to contribute to significant treatment results.

Speaker Change: Our research and development teams continue to push forward our pipeline of next generation cell therapies. These include T cell receptor based therapies and by specific cell engages which have the potential to address gaps in traditional therapies and can be combined with more advanced sufficient aged seven months.

Marcus Dijk: [inaudible] Our research and development teams continue to push forward our pipeline of next-generation cell therapies. These include T-cell receptor-based therapies and bi-specific cell engagements, which have the potential to address gaps in traditional therapies and can be combined with more advanced, Our partnership at Immunoscape is now well underway and centers around the discovery and development of T cell receptors to a specific class of pan-tumor neoantibodies. We believe that our invariant NKT cells are ideal LGNA hosts for these pan-tumer, neo-entering TCRs and offer the potential to develop cost-effective off-the-shelf LGNAG TCR-based cells.

Speaker Change: Our partnership at immune escape is now well underway and incentives around the discovery and development of T cell receptors to a specific clause from tumor neo antigens.

Speaker Change: We believe that are in very in St. J T cells are ideal LNG. They hosts for these tumor neo antigens TCR.

Speaker Change: With the potential to develop cost effective off the shelf allogeneic TCR based cell therapies.

Speaker Change: In parallel we are continuing to advance our proprietary <unk> TCR T program.

Speaker Change: We have also investigated combining agents 770, <unk> bi specific cell engages.

Marcus Dijk: [inaudible] We've also investigated combining Agent 707 with bi-specific selling gauges. Agent 797 is administered without a lymphatic lesion, has shown activity in solar tumor settings, and we have detected circulating Agent 797 in normal HLA by mass patients for up to six months.

Speaker Change: 707 is administered with US lymphoid accretion has shown activity in solid tumor settings, and we have detected circulating agent settlements and normal HLA matched patients.

Speaker Change: Up to six months.

Marcus Dijk: We have compelling in vitro data on the combination of Agent 797 and cell engages, our own as well as third-party engages, and we believe that the combination of Agent 797 and cell engages, specifically in the absence of lymphoid depletion, will significantly enhance tumor penetration, counteract local immune suppression, and improve overall efficacy. We plan to present preclinical data from some of these programs at a key meeting later this year. I'll now turn it back to Jennifer for some closing remarks. Jen?

Speaker Change: We have compelling in vitro data on the combination of agent seven nine and 770 interest on our own as well as third party engages and we believe that the combination of <unk> 707, and selling interest specifically in absence of LIFO depletion will significantly enhance tumor penetration.

Speaker Change: Local immune suppression and improve overall efficacy.

Speaker Change: We plan to present preclinical data from some of these programs is a key meeting later this year.

Speaker Change: I'll now turn it back to Jim for some closing remarks.

Jim: Thank you very much I appreciate it and this is as you can see we have an incredibly efficient platform and which we've been able to not only advanced clinical programs, but also some highly innovative next generation technologies and as we advance these programs, which you can see we're also.

Jennifer Buell: Thank you very much Mark. I appreciate it. And this is, as you can see, we have an incredibly efficient platform on which we've been able to not only advance clinical programs but also some highly innovative next-generation technologies. And as we advance these programs, which you can see, we're also very committed to fiscal conservatism, ensuring that we leverage every mechanism available to advance our therapies highly efficiently. Our strategy includes pursuing non-diluted funding sources, and these include some of the grant funding programs that are currently underway, as well as strategic partnerships to maintain our financial health while bringing these deserving therapies to the forefront of treatment options.

Jim: Very committed to fiscal Conservatives, and ensuring that we leverage every mechanism available to advance therapies highly efficiently.

Jim: Our strategy includes pursuing non dilutive funding sources and these include some of the grant funding programs that are currently underway.

Jim: As well as strategic partnerships to maintain our financial health, while bringing these deserving therapy to the forefront of treatment options.

Jennifer Buell: Our approach will not only accelerate the development of INKT South Air Force but also preserve value during this unusual time and biotech. So, thank you for your continued support, and I'm going to turn the call over to Christine to review our financial results. Christine. Thank you, Jim. We ended the quarter with a cash balance of $9.3 million, which reflects cash used in operations for the quarter of $2.3 million.

Jim: Our approach will not only accelerate the development of I N K T cell therapies, but also preferred.

Jim: Preserve value during.

Speaker Change: This unusual time in biotech so got it.

Jim: Thank you for your continued support and I'm going to turn the call over to Christine to review our financials Christine.

Christine Classic: Thank you Jim.

Christine Classic: We ended the quarter with a cash balance of $9 3 million.

Christine Classic: Which reflects cash used in operations for the quarter up $2 3 million.

Christine Klaskin: This is a reduction from the 2.6 million dollars used for the first quarter of this year, and as Jen mentioned earlier, an almost 50% reduction from the prior year. Our net loss for the three and six months ended June 30, 2024, was $2.7 million or $0.07 per share and $6.5 million or $0.18 per share.

Christine Classic: This is a reduction from the $2 $6 million used for the first quarter of this year and as John mentioned earlier, and almost 50% reduction from prior year.

John: Our net loss for the three and six months ended June 32024 was $2 $7 million or <unk> <unk> per share and $6 $5 million or <unk> 18 per share.

Christine Klaskin: This compares to $6.2 million, or $0.18 per share, and $11.9 million, or $0.35 per share, for the same period in 2023. I will now turn the call back to the operator for questions. Thank you. The floor is now open to your questions. To ask a question this time, please press start and the number one on your telephone keypad.

John: This compares to $6 $2 million or <unk> 18 per share and $11 9 million.

John: Or <unk> 35 per share for the same periods in 2023.

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

Speaker Change: Thank you. So the floor is now open for your questions. So to ask a question just time. Please press Star then the number one on your telephone keypad.

Operator: So for this Q&A, we'll be provided the opportunity to ask one question and one further follow-up question. We'll just pause for just a moment to compile the Q&A roster. Our first question comes from Emily Bodnar from H&W. Hi, good morning.

Speaker Change: So for this Q&A will be provided the opportunity to ask one question on further follow up questions.

Speaker Change: We'll just pause for just a moment to compile the Q&A roster.

Speaker Change: Our first question comes from Emily Button.

Emily Button: From HC Wainwright.

Emily Button: Hi, good morning, Thanks for taking the questions chosen just to confirm so the gvhd study that you're planning for.

Emily Bodnar: Thanks for taking the questions. First, I'm just to confirm that the GBHC study that you're planning to initiate sounds like that's going to be funded with external capital. Is that correct?

Speaker Change: It sounds like Thats going to be funded with external capital as well.

Speaker Change: And then second question.

Speaker Change: When you say you are seeing early signs of activity in the gastric cancer study could you provide any more context.

Speaker Change: What youre kind of seeing and how that might compare to just standard of care chemo alone.

Speaker Change: Thank you very much for your questions. Emily Your first part of the Gvhd program. Yes. This will be supported by external funding to advance the program and secondly in gastric now I guess.

Jennifer Buell: And then, second question, when you say you're seeing early signs of activity in the gastric cancer study, can you provide any more context to what you're kind of seeing and how that might compare to just standard of care chemo alone? Thank you very much for your questions, Emily. Your first, for the GBHD program, yes, this will be supported by external funding to advance the program. And secondly, in gastric, now I'm, given that Dr. Janjikian is planning to present these results at a major conference, I'm hesitant to say any more than, at least in the cohort that we have now observed and fully enrolled. It's beyond three to six months of follow-up.

Dr. <unk>: And then that Dr. <unk> is planning to present these results at a major conference.

Speaker Change: I'm hesitant to say any more than at least in the cohort that we have now observed and fully enrolled it's beyond three to six months of follow up we are seeing some very exciting signals of clinical benefit that do exceed what our expectations are with Ram tax.

Jennifer Buell: We are seeing some very exciting signals of clinical benefit that do exceed what our expectations are for RAM tax on its own. And as you can imagine, given the number of patients, thousands of patients have been dosed with the chemotherapy, we have a strong sense of how that arm will perform. And we're seeing performance far beyond that at this point in the trial.

Speaker Change: And as you can imagine given the number of patients thousands of patients have been dosed with the chemotherapy. We have a strong sense of what that arm, how it will perform and we're seeing performance far beyond that at this point in the trial.

Speaker Change: Okay, great. Thank you helpful.

Emily Bodnar: Okay, great. Thank you. That's all.

Speaker Change: Our next question comes from Jack Cohen from Baird.

Jack Allen: Our next question comes from Jack Allen from VAERS. OK. Thanks so much for taking the questions, and congratulations on the progress. I wanted to dive a little bit more deeply into the gastric update that we expect. I guess I understand you don't want to make too many comments ahead of the scientific presentation, but can you just remind us about the different cohorts in this study and any comments on where patients were enrolled as compared to those cohorts to date?

Jack Cohen: Alright, thanks, so much for taking the questions and congratulations on the progress.

Jack Cohen: Does that have a little bit more deeply into the gastric update that we expect I guess I understand you don't want to make too. Many comments ahead of the scientific presentation, but can.

Speaker Change: Could you just remind us about the different cohorts in this study and any comments on where patients were enrolled as it relates to those cohorts to date and then on the graft versus host disease trial, very exciting news to see that get underway.

Jack Allen: And then on the graft-versus-host disease trial: very exciting news to see that get underway. I just wanted to see if you had any more comments as it relates to the size of that study and when we can expect initial data from that trial. Certainly, Jack, thanks so much for your questions.

Speaker Change: Just wanted to see jet anymore comments as it relates to the size of that study and what we can expect initial data from that trial.

Speaker Change: Certainly thanks, thanks that with Jack for your questions.

Jennifer Buell: On the gastric program, this is a program in which we have a very heavy translational component as well as clinical components. So we are looking at very traditional endpoints, response rates, tumor reduction, overall survival in this population, as well as some of the translational markers. And to do so, what we have embarked on is a trial that allows us to investigate INKT, which is an induction therapy, and the INKTs on top of standard of care chemo, Rantat, as well as INKTs in combination with Botval and Chemo.

Speaker Change: The gastric program. This was this is a program in which we have a very heavy translational component as well as clinical component. So looking at very traditional endpoints response rate tumor reduction overall survival in this population.

Speaker Change: As well as some of the translational markers and so do you. So what we have embarked on as a child that allows us to interrogate iron <unk> as an injection.

Speaker Change: And <unk> on top of standard of care Chemo Ram tax.

Speaker Change: As well as <unk> in combination with <unk> and chemo.

Speaker Change: And we have representative patients in each of those treatment considerations. So the data that you will see we will give some stuff was not only a translation all mechanisms that are happening, but also clinical outcomes in those populations.

Jennifer Buell: And we have representative patients in each of those treatment considerations, so the data that you will see will give some semblance not only of translational mechanisms that are happening but also clinical outcomes in those populations.

Jennifer Buell: So this is a program that we are as excited as you are, Jack, to get this underway. Our preclinical data has really supported the importance of INKTs in this particular disease setting. And what we've observed is that preclinically, we know that INKTs may uniquely transform the landscape that will enable engraftment success and also mitigate and prevent GVHD. This is such a growing problem, impacting over 50% of patients that are undergoing stem cell transplantation.

Jack Cohen: So this is a program that we are as excited as you are Jack to get this underway. This is our preclinical data has really supported.

Jack Cohen: The importance of <unk> in this particular disease setting and what we've observed is that pre clinically.

Jack Cohen: We know that <unk> may uniquely transform the the.

Jack Cohen: Landscape that will enable an grafman success and also mitigated and prevent gvhd. This is such a growing problem impacting over 50% of patients that are undergoing stem cell transplantation.

Jack Cohen: We believe that these cells.

Jennifer Buell: We believe that these cells.., can deliver benefit both in adult patients as well as in pediatric patients, and you may know that there is a mesenchymal stem cell approved in Europe, not yet in the U.S., that has demonstrated some important benefit, particularly in pediatric populations, specifically where GVHD is organ-based, and we think that our cells may even be able to expand benefit beyond the observations today, certainly beyond fluxolytinib, as well as beyond some of the available cell approaches, given the mechanism of action.

Jack Cohen: Can deliver benefit both in adult patients as well as in pediatric patients and you may know that there is a mesenchymoma stem cell approved in Europe are not yet in the U S that has demonstrated that an important benefit, particularly in pediatric populations, specifically, where gvhd is Oregon based and we think that ourselves made.

Jack Cohen: And then be able to expand benefit beyond the observations today certainly beyond <unk>.

Speaker Change: As well as beyond some of the available cell approaches given the mechanism of action, we will be activating the trial, we're working aggressively to do so this year ideally we will have some patients who cannot start enrolling them in this calendar year otherwise it will be very early next year, the endpoints of rapid and this with response.

Jack Allen: We will be initiating the trial; we're working aggressively to do so this year; ideally, we will have some patients who can start enrolling this calendar year; otherwise, it will be very early next year. The endpoints are rapid in this, with response rates and protection and mitigation within about a 28-day window, so we would expect to have data from the trial in 2025, probably in the second half of the year. I got it.

Jack Cohen: Rates and for.

Jack Cohen: For protection and mitigation within about a 28 day window. So we would expect to have data from the trial in 2025, probably in the second half of the child.

Jack Cohen: Sure.

Speaker Change: Got it great. Thank you so much for that update and then maybe just one last question more broad but.

Jennifer Buell: Great. Thank you so much for that update. And then maybe just one last question, more broad, but as it relates to securing additional non-dilutive sources of capital, I'd just love to hear any comments you have around appetite for partnerships and things of that nature.

Speaker Change: As it relates to securing additional non dilutive sources of capital.

Speaker Change: Wanted to hear any comments you have around the appetite for partnerships and bringing leverage here.

Speaker Change: Yes, partnering is actually really core to our strategy and it will be important not only to expand our bandwidth, but also our global presence. So we continue to have very active interactions with potential partners, who share our vision and also have the bandwidth to do.

Jennifer Buell: Partnering is actually really core to our strategy, and it will be important not only to expand our bandwidth but also our global presence. So we continue to have very active interactions with potential partners who share our vision and also have the bandwidth to deliver in regions of the world where we do not yet have a footprint. And they will also help us accelerate the development of these cells. Thank you so much, and congratulations again on the progress. Thank you. Our next question comes from Mayank Mamtani from C Riley. Good morning, team.

Speaker Change: Due to deliver in regions of the world, but we do not yet have a footprint.

Speaker Change: But also to help us accelerate the development of these cells.

Speaker Change: Yeah.

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

Speaker Change: Thank you.

Matt <unk>: Our next question comes from Matt <unk> from B Riley.

Mayank Mamtani: Thanks for taking our questions and congratulations on the progress. So, in regards to the 797 combination work with BodBell, sort of forming the basis for your future combination work you may pursue with T-cell engagers. Could you maybe just talk a little bit more about that? And if there are any specific tumor surface antigens, you know, modalities, or T-cell engagers that you have in mind?

Matt <unk>: Good morning team, thanks for taking our questions and congrats on the progress. So in regards to the 797 combination work with <unk>.

Matt <unk>: <unk> been following onto your futures.

Speaker Change: So the combination will you may proceed with diesel engages could you could you maybe just talk a little bit more about that in Germany.

Speaker Change: Specific tumor surface antigen.

Speaker Change: Yes.

Modalities 70 acres that you have in mind and then the second question about <unk>.

Mayank Mamtani: And then the second question about the 215 IND filing plans for actually early 2025. We'd love to hear, you know, the initial phase one protocol plan you're looking to submit with your IND filing and any color on what those levels you're looking to produce and how might you be thinking of manufacturing given, you know, you've invested a ton in-house in developing this monad. Excellent. Okay, Mayank, I'm going to start with the second question, and I'll turn it over to Mark.

Speaker Change: <unk> R&D filing plans activity too.

Speaker Change: Hi.

Speaker Change: Would love to hear the initial phase one protocol Glenn you are looking to submit with your R&D filing.

Speaker Change: Any color on what those levels are you looking to go to you.

Speaker Change: Produce and how might you be thinking off manufacturing.

Speaker Change: Given you're investing is done in house.

Speaker Change: Developing this modality.

Speaker Change: Excellent Okay, My I'm going to start with the second question and I'll turn it over to Mark and we also have Dr. Dre Joe here.

Jennifer Buell: And we also have Dr. Zhao here on manufacturing for 215. So on the ladder, so 215, this is a program, as you know, we now have a new investor who has joined us and partnered with us to accelerate the development of this program. We're doing so actively.

Speaker Change: Manufacturing for tier one five so on the ladder so to one five.

Speaker Change: This is a program as you know we now have.

Speaker Change: New Investor, who has joined US and partnered with us to accelerate the development of this program. We're doing so actively we had already generated quite a bit of preclinical work to support our IND filing we're expanding that to bolster our initial clinical protocol, which will allow us to identify patients most likely to respond and.

Jennifer Buell: We had already generated quite a bit of preclinical work to support our IND filing, and we're expanding that to bolster our initial clinical protocol, which will allow us to identify patients most likely to respond and deliver therapy at an effective starting dose. That's really our highest priority at this moment in order to accelerate the development of this important therapy. Our preclinical data, which we've now presented publicly in a number of locations as it's continued to build and evolve, and what we've most recently demonstrated is that the 215 program not only benefits in organoid models, such as colorectal cancer, but also penetrates metastatic liver disease in those human-like models.

Speaker Change: Deliberate therapy at an effective starting dose that's our that's really our highest priority at this moment in order to accelerate the development of this important therapy, our preclinical data, which we've now presented publicly at a number of.

Speaker Change: Hub locations as it's continued to build and evolve and what we most recently demonstrated is at the tier one five program not only can can benefit.

Oregon rate models.

Speaker Change: Colorectal cancer, but also penetrate metastatic liver disease in those human like models.

Jennifer Buell: This has increased our imperative for identifying patients most likely to benefit, and those will be very likely to be patients with BAP-expressing tumors. Now, we will be somewhat in a phase one trial, somewhat inclusive to identify exploratory signals, but we will be really focused in order to identify patients where we believe that we can measure some of the biomarkers, elimination of the BAP-expressing tumor cells, and the immune-enhancing potential of this therapy to really deliver the benefit that we think is possible.

This has increased our imperative for identifying patients most likely to benefit and those will be very likely to be patients with <unk> expressing tumors now we will be somewhat in a phase one trial somewhat inclusive to identify exploratory signals, but we will be really focused in order to identify patients where we believe that.

Speaker Change: We can measure some of the biomarkers elimination of the fab expressing tumor cells.

Speaker Change: Z immune enhancing potential of this therapy two to really deliver the benefit that we think is possible. We will be manufacturing this program in house, and and and Dr. Zhao and her team are working very aggressively to do so our process development analytical development work is actively underway for release that criterion.

Jennifer Buell: We will be manufacturing this program in-house, and Dr. Zhao and her team are working very aggressively to do so. Our process development, and analytic development work is actively underway for release spec criterion, and we're just now in the process of finalizing some of the work that's necessary for the transduction, and then we'll be transferring it in-house to produce the material.

Speaker Change: And that we're just now in the process of.

Speaker Change: Finalizing some of the work that's necessary for the transaction and then we'll be transferring it in house to produce the material.

Jennifer Buell: Importantly, we have been delivering 797 in our own hands, and we've optimized the protocol to be able to deliver really robust billions of cells per donor. We are able to scale the cells, and we've publicly talked about this, where we can scale the cells without exhaustion, really capitalizing on the possibility. We will plan to leverage that platform in order to now deliver our engineered CAR-INKT platform. So that's the 215 program.

Speaker Change: Fortunately, we have been delivering 797 in our own hands and we've optimized the protocol can be able to deliver really robust billions of cells per donor, we're able to scale the cells and we've publicly talked about this where we can scale the cells without exhaustion really capital.

Speaker Change: Rising on the possibility, we will plan to leverage that platform in order to now deliver our engineered car <unk> platform.

Speaker Change: So that's the <unk> five program, we're looking forward to getting that into the clinic, we're going to be wrapping up some of the preclinical data that will allow us to get there at a dose that we think will be quite impactful and in a population that we believe will benefit now on the engagements I'm really glad that you asked this we have done a lot of work in our own hands with engage areas with the.

Jennifer Buell: We're looking forward to getting that into the clinic. We're going to be wrapping up some of the preclinical data that will allow us to get there at a dose that we think will be quite impactful and in a population that we believe will benefit. Now on the engagers, I'm really glad that you asked this.

Jennifer Buell: We have done a lot of work in our own hands with engagers, with the concept that engagers need more, and we're seeing that in the landscape. And I think we may have a very important recipe for success here for T cell engagers, and I'm going to turn it over to Mark Gundyke to tell you a bit more. Yeah, thanks, Jan. So, engagers are interesting.

The concept that it gateways need more and we're seeing that in the landscape and I think we may have in a very important recipe for success here for T cell engages and I'm going to turn it over to Mark <unk> to tell you a bit more.

Mark Vendetti: Yeah. Thanks, Shannon so engages our interesting I mean, there's quite a lot of development in the <unk> space more and more so also in the solid tumor space. We've seen some success with one approval.

Marcus Dijk: I mean, there's quite a lot of development in the cell engagement space, and more and more so in the solar tumor space. We've seen some success with one approval. And I think we can increase the efficacy enormously by adding an allogeneic cell therapy component in the form of INKT cells. And I say this specifically because engages are, sort of, they induce the local and central immune responses, and they are, they need to pull T cells into the tumor.

Speaker Change: I think we can increase the efficacy.

Mark Vendetti: Enormously by adding an allogeneic cell therapy component of any form of <unk> T cells.

Mark Vendetti: So it is specifically because engages our sort of induce a local <unk> SM.

Mark Vendetti: A central immune response.

Mark Vendetti: Okay.

Mark Vendetti: They need to put T cells into the tumor, but theres a lot of resistance in the tumor T cells.

Marcus Dijk: But there's a lot of resistance in the tumor. And INKT cells are, you know, they're very good at entering sites where T cells cannot easily go, as well as overcoming local immune suppression. That's the reason to build 215.

Speaker Change: They are very good.

<unk> sites, where T cells cannot easily go as well as overcoming local immune suppression does the reason to build to imply and Thats. The reason why seven months of them.

Marcus Dijk: That's the reason why 797 has shown activity in gastric cancer. And we believe that combining bi-specific cell engagement for solar tumors with agent 797, or later with 215, really starts to add those two efficacy mechanisms together to have a much higher impact than either one or selling gauges alone can actually achieve. And the other really differentiating component is that 797 is applied without a link to depletion, and that's essential for maximizing the immune response of the patient's own immune system. So that combination, molding for depleting, INK T-cells plus cell engages, we believe has enormous potential for solid tumor treatment.

Speaker Change: Showing activity in gastric cancer, and we believe that combining.

Speaker Change: But specific cell engages for solid tumors with <unk> 707 correlated with <unk>.

Speaker Change: It really starts to add those two efficacy negatives together to have a much higher impact from either one or cell engages alone can be achieved.

Operator: Good morning and welcome to MiNK Therapeutic's second quarter of 2024 conference call and webcast. All participants will be in listen only mode until question and answer session. Please note this event is being recorded.

Speaker Change: The other really differentiating component is at 707 applied without an equal depletions, that's essential for maximizing the immune response of the patient's own immune system. So that combination mostly for the meeting.

Operator: If anyone has any objection, we're now disconnect at this time.

Zack Armen: I would now like to turn the conference over to Zack Armen from MiNK's investor relations. Zack, please go ahead. Thank you operator. And thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development regulatory and virtual 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 filing, you know, hold on our website for more details on Israel.

Speaker Change: T cells plus cell engages we believe has enormous potential for solid tumor treatments.

Marcus Dijk: So that's what we're exploring with both our own Cell Engager program and also looking at cell engages that are out there. And we have quite a lot of preclinical data that we hope to share at a conference later this year. Got it. Thank you for that comprehensive answer. And then, just if I could squeeze one more in.

Speaker Change: So thats why we are exploring with both our own cell engage a program, but also looking at selling agents that are out there and we have quite a lot of.

Speaker Change: Data that we hope to share their conference later this year.

Mayank Mamtani: Jen, on the couple of options for non-targeted financing, are you able to talk about the scale and scope and in terms of what remains to kind of get that through the finish line? That would be helpful. Thanks again for taking the time.

Speaker Change: Got it. Thank you for that comprehensive answer and then just if I could squeeze one more in Jim on the.

Speaker Change: Couple of options for non dilutive financing.

Speaker Change: We do talk to.

Speaker Change: The scale and scope.

Speaker Change: And.

Speaker Change: In terms of what remains.

Zack Armen: Joining me today are Dr. Jen Vuel, President and Chief Executive Officer. Dr. Barkpin and I, Chief Executive Officer. Dr. Joey Zhao, Head of CNC and Christine Klaskin, Principal Financial and Accountant Officer.

Speaker Change: Kind of.

Speaker Change: Yes, that's true.

Speaker Change: The finish line that would be helpful and thanks again for taking my questions.

Speaker Change: Thanks, My answer with respect as you're seeing with some of the non dilutive grant funding support that we have been able to garner.

Jennifer Buell: With respect, as you can see from some of the non-dilutive grant funding support that we have been able to garner to support our trials in immune-related diseases, as well as in oncology, you can see how the excitement of these cells and their potential is shared with a number of groups, a diverse set of groups who are very intrigued by advancing the technology. That has allowed us to continue to really prioritize the development of data that will help us to continue to advance some of the discussions that are actively underway.

Dr. Jen Vuel: Now I'd like to turn the call over to Dr. Vuel to highlight our progress on the sport. Thank you Zack.

Speaker Change: To support our trials and immune related diseases as well as in oncology.

Dr. Jen Vuel: Good morning. And thanks for joining us today. I'm excited to share the strides we've made in the first half of 2024, as we continue to align our achievements with our long-term strategic goals. And for those of you new to this story at MINK, our mission is focused on delivering the immune potent potential of invariant, natural killer T cells to tackle diseases of the immune system and cancer. Today I'll be highlighting our latest clinical development, particularly in our lead programs.

Speaker Change: You can see how the excitement of the cells in their potential is shared with a number of groups a diverse set of groups who are very intrigued by advancing the technology that has allowed us to continue to really prioritize the development of data that will help us to continue to advance.

And some of the discussions that are actively underway.

Dr. Jen Vuel: Agents 797. These are our native unmodified INKT cells and MINK 215, our armored, fast-car INKT. Additionally, I'll discuss that we've fortified our financial foundation setting the stage for sustained innovation and growth. We've made substantial progress in streamlining our operations to optimize our financials in this market. In this quarter, we continue to generate critical data from our ongoing clinical programs. We continue to advance our R&D efforts and ensure efficient in-house manufacturing, all the while appreciating further reductions to our operating burn.

Jennifer Buell: So, I hesitate to give any additional color, except to say that the interest in what these cells can do has been coming inbound from pharma groups who are interested in expanding the footprint of their cell therapy programs, as well as those looking to get into the space. There's quite a bit of interest in the autoimmunity, and the GVHD data, as well as in the engineered portfolio, with the preponderance of additional interest in respiratory diseases coming from a very focused group of pharma companies.

Speaker Change: So I hesitate to give any additional color except to say that the interest of what these cells can do.

Speaker Change: Has been.

Speaker Change: Coming inbound from pharma groups, who are interested in expanding the footprint of their cell therapy programs as well as those looking to get into the space.

Speaker Change: There is quite a bit of interest in the.

Speaker Change: Auto immunity the gvhd.

Speaker Change: <unk> data as well as on the engineered portfolio with the preponderance of additional interest and respiratory disease is coming from a very focal focus group.

Dr. Jen Vuel: Now reduce more than 50% from this time last year mainly from the internalization of key activities. These reductions have been a result of the internalization of our efforts and continues external financial support to advance our exciting programs. I'll walk you through these developments and illustrate how we're paying the way to make success. We'll begin with our operational and financial progress. Our lead program, 797's an allogeneity unmodified INKT cells therapy currently advancing in a phase 2 trial for second-line gastric cancer and acute respiratory disease syndrome or ARVS.

Speaker Change: Pharma companies, so I'm going to leave it at that just to simply say for us. The most important thing is.

Jennifer Buell: I'm going to leave it at that, just to simply say, for us, the most important thing is regional infrastructure and a global footprint that can allow us to accelerate the development of these important therapies. That's been driving our prioritization of the conversations that we're having now, some of which we'll expand on in the next couple of weeks. Ideally, we will be able to have some of these advanced far enough by the end of this year or early next year. Understandable, thank you. Our next question comes from Matthew Phipps from William Blair. Hi, thanks for taking my questions, Jen.

Bill: Regional infrastructure and global footprint that can allow us to accelerate the development of these important therapies and that's been driving our prioritization of the conversations that we're having now and some of which bill will expand on in the next couple of weeks.

Bill: Ideally, we will be able to.

Bill: <unk> done some of these advanced far enough by the end of this year or early next year.

Speaker Change: Understood. Thank you.

Dr. Jen Vuel: On gastric cancer, second-line gastric is a challenging condition with a poor prognosis and a high mortality rate. Patients undergoing second-line therapy for advanced gastric or gastroesophageal junction cancer typically have a median overall survival of only 4 to 10 months, depending on factors such as performance status and treatment regimen. In parallel, seven-nine-seven is also being evaluated for ARDS. This is a rapidly progressive and likes the right and in condition with the mortality rate of approximately 40%. Our commitment to addressing these critical unmet medical needs underscores the potential of seven-nine-seven to provide meaningful therapeutic benefits in both oncology and respiratory care.

Speaker Change: Our next question comes from Matthew <unk> of William Blair.

Speaker Change: Okay.

Matthew Phipps: Glad to see the GVHD trial getting started. Just wondering if you could give some details, steroid refractory, but will you allow for other lines of prior therapy? And is this going to be a single ascending dose, or multiple ascending doses? Can you give us any details on the dosing scheme? Thanks so much, Matt.

Matthew: Hi, Thanks for taking my questions John glad to see the Gvhd trial.

Matthew: Started just wondering if you can give some detail steroid refractory, but will you allow for other lines of prior therapy and is this going to be a single ascending dose multiple ascending dose can you give us any details on the dosing schemes.

John: Yeah. Thanks, so much Matt and the dosing scheme.

Jennifer Buell: On the dosing scheme, at this point, we have been able to administer the cells beyond one dose, and we are very pleased that we can do so tolerably in populations of patients that we wanted to monitor really quite closely. So we can administer the cells. We do not see any enhanced cellular reactivity or rejection when administered beyond one dose. Therefore, we would look at this from a target dosing standpoint. We've generated quite a bit of data now beyond 80 patients in dose finding, and I think we have quite a bit of confidence that a billion cells is our target dose. We wouldn't want to start very much lower than that.

Speaker Change: At this point, we have been able to administer the cells.

Speaker Change: And beyond one dose.

Speaker Change: Very pleased that we can do so tolerably and and populations of patients that.

Speaker Change: We wanted to monitor really quite closely so we can administer the cells, we do not see any enhanced allo reactivity or rejection and administering beyond windows.

Dr. Jen Vuel: Let me begin with our program in ARDS. This is a rapidly progressive form of respiratory failure with alarmingly high mortality rates, the prevalence of ARDS has been growing, particularly in younger populations. And this is likely exacerbated by the aftermath of the COVID-19 pandemic. This condition represents a significant burden on healthcare systems globally given its high incidence into their outcomes. The urgency to address ARDS has been underscored by the most recent announcement from the biomedical advanced research and development authority of BARDA, which has committed almost $120 million to a randomized-based program focused on critical outcomes such as survival and ventilator-free days.

Speaker Change: Would look at that.

Speaker Change: From a target dosing standpoint, we've generated quite a bit of data now beyond 80 patients.

Speaker Change: Dose finding and I think we have quite a bit of confidence that 1 billion cells as our target dose we wouldn't want to start very much lower than that we may do a step down dose and then in the Gvhd trial. However, we may not need to so we're negotiating that currently and we would look at about 1 billion cells, we would do with single.

Jennifer Buell: We may do a step-down dose in the TBHC trial. However, we may not need to. So we're negotiating that currently, and we would look at about a billion cells. We would do a single dose as well as explore if a second dose or a third dose is necessary. I'm not sure that it will be.

Speaker Change: Paul.

A single dose as well as we would explore.

Dr. Jen Vuel: This substantial investment highlights the critical needs for innovative and effective treatment in this challenging disease settings. The BARDA program's expected to evaluate three therapeutic options, two of which are monoclonal antibodies and have already been disclosed with the third agent not yet announced. Our published data from the phase one, two trials of seven-nine-seven demonstrates a 75 percent survival rate and significant improvement in ventilator-free days for patients with ARDS, suggesting that IMKT cells could play a pivotal role in ARDS management.

Paul: Second dose or doses necessary I'm not sure that it will be.

Jennifer Buell: We will be open, and we're finalizing those design elements right now with some regulatory interactions. We are open to other lines of therapy, We want to be sure to have the right reference so that in our trial, which even in phase 1, we may contemplate, we're contemplating right now, a reference group that would allow us to accelerate the development by demonstrating, you know, if we're looking at 40 to 50% or higher, and response rates compared to what we're seeing at 30% with some of the available therapeutic approaches. We want to keep the prior lines of therapy relatively clear so that we have a homogeneous population, even in a phase 1 setting, that will allow us to advance very quickly into a randomized phase 2.

Paul: We will we will be open and we're finalizing those design elements right now with some regulatory interactions. We are open to two other lines of therapy, we want to be sure. They have the right reference so that in our trial, which even in the phase one we may contemplate we're contemplating right now.

Paul: A reference group that would allow us to accelerate the development by demonstrating.

Paul: Looking at 40% to 50% or higher and response rates compared to what we're seeing is 30% and with some of the available therapeutic approaches we want to keep the prior lines of therapy relatively.

Dr. Jen Vuel: These promising results indicate that seven-nine-seven can be seamlessly incorporated into standard treatment protocols and provide potential for substantial clinical benefits. At the recent American thoracic society or ATS annual meeting, we presented additional compelling data. This is from our expanded access program building on our findings from our phase one into clinical trials showing the clinical efficacy of seven-nine-seven in a critically ill, immune-compromised transplantation with severe COVID-19-induced respiratory distress. Following a single administration of seven-nine-seven similar to the dosing in a clinical trial, this patient experienced a rapid reduction in planetary cytokines leading to successful excavation and rapid discharge from the hospital.

Speaker Change: Clear so that we have a homogeneous population even in a phase one setting that will allow us to advance very quickly into a randomized phase two.

Operator: Okay, great. There are no further questions. So I'll turn the call back over to Dr. Jennifer Buell. Thank you very much, everyone. I want to thank my team as well as those on the line for your continued support. This concludes today's call. You may now disconnect. Thanks for watching!

Speaker Change: Okay, great. Thank you.

Speaker Change: There are no further questions. So I'll turn the call back over to Dr. Jennifer Buell.

Jennifer Buell: Thank you very much everyone I want to thank my team as well as for those on the line for your continued support I appreciate it.

Speaker Change: Concludes today's call you may now disconnect.

Dr. Jen Vuel: With nearly 600,000 individuals in the United States alone affected by acute respiratory distress, about 30 to 40 percent of those patients with severe acute respiratory conditions, annually, the burden on our health care system is immense. The promising results with seven-nine-seven underscores potential is an important therapy to contribute to eliminating or mitigating ARDS and that has broader regulatory and healthcare implications. Main therapeutic is among the select groups of a few companies advancing therapies in this challenging disease setting and our early data suggests that seven-nine-seven could be one of the most promising candidates in the field.

Speaker Change: Okay.

Speaker Change: [music].

Dr. Jen Vuel: Now I'm going to be transitioning to another disease setting that we feel is a significant priority for us in patients and building on the promising findings and immune optimization with our therapy.

Dr. Jen Vuel: We're excited to announce the upcoming on a Phase 1 trial in Stereo Repractory Acute Grafers Systems Disease, and improved outcomes in allogeneity to medipolytic stem cell transplantation. Our investigator's sponsor trial long played two leading hematology centers, one in the U.S., and one in Europe, and represented critical steps in broadening the therapeutic applications of our INKT self-platform and region's locations have limited effective treatment options.

Dr. Jen Vuel: GDHD is a serious and potentially life-threatening complication of bone marrow transplants, where donor immune cells attack the recipient's body. Our INKT self-therapy is designed to modulate this immune response, aiming to reduce the incidence and severity of GDHD while preserving the Grafers' tumor or disease effects. The trial will also explore other important endpoints such as disease recurrence infections and improved ingrassment, which INKT self-made positively influenced. We're currently collaborating with our partnering institutions and investigators to finalize the study design of plans to activate the science to readiness this year with first dosing by late year or very early in 2025.

Dr. Jen Vuel: Now, another important initiative we have ongoing in oncology is our program of 797 advancing in a phase 2 trial and second-line gastric cancer. The trial is currently underway in Memorialstone, Kettering Cancer Hospital under the leadership of Dr. Yelena Dengi-Dian. She's a chief of gastrointestinal oncology and internationally recognized expert in gastric cancer. Our study is evaluating the potential of 797 in combination with the genesis next-generation checkpoint inhibitors, potent zelina, and bowel cellina, which have shown very promising and high tumor responses in a number of disease settings.

Dr. Jen Vuel: Our collaboration represents a critical opportunity to explore the synergistic benefit of INKT self-therapy with advanced checkpoint inhibitors, potentially offering the powerful new treatment modality for patients with advanced gastric cancer. This is a condition with historically limited therapeutic options and as I mentioned earlier, survival between 4 and 10 months in these stations. Enrollment is actively underway and the first cohort of patients are now exceeding three to six months of follow-up in the trial and showing very exciting signals of clinical activity where the majority of patients have already demonstrated some semblance of benefit in this population. We're very optimistic about the balance of clinical activity and tolerability of these combinations.

Dr. Jen Vuel: We expect to see data presentation in a major oncology conference this year or very early in 2025.

Dr. Mark Fendi: Now I will turn the call over to Dr. Mark Fendi, or she's scientific officer and he'll review our earlier stage programs that are advancing. Mark. Thank you, Jen. Telling to our clinical pipeline, we are rapidly advancing MiX-155. It's a look in 15-armored fat-targeting car in very natural-tilities of therapy. That's a mouthful, but it's targeting tumor stroma. This therapy has demonstrated very promising presence of activity against solar tumors, including micro-setlights, stable, colorectal cancer, liver metastasis.

Dr. Mark Fendi: [inaudible] with plans to file 90 in 2025. We're developing a robust, preclinical package that will allow us to identify and enrich a biomarker-based patient population, facilitating more rapid signals such as six signal detection and development. The potential for Minto and Five to disrupt the treatment landscape in solar tumors is significant, particularly as we continue to see breakthroughs in R.T, therapies.

Dr. Mark Fendi: A manufacturing is led by Joyce Owl, who's driving our efforts to fully develop Minto and Five manufacturing in-house. By leveraging our state-of-the-art facilities, we aim to maximize scaling performance and ensuring the efficient production of high-quality allergic-naked cell therapies. Our partnership with a leading Lentiviral vector producer utilizing their novel technology ensures a seamless and efficient production process for our Lentiviral vectors, critical for the development of Minto and Five. The reason the approval of an allergy-naked cell therapy in solar cancer marks a significant milestone in the field and serves as a relevant benchmark for Minto.

Dr. Mark Fendi: This approval highlights the growing acceptance and potential of allergy-naked therapies reinforcing our confidence in the regulatory pathway for Minto and Five. Additionally, the anticipated success in CAR-T treatments for advanced solar tumor malignancies emphasised in the potential from Link's INK-T cell therapy to contribute to significant treatment advances. Our research and development teams continue to push forward our pipeline of next-generation cell therapies. These include T-cell receptor-based therapies and bi-specific cell engages, which have the potential to address gaps in traditional therapies and can be combined with more advanced assets such as AZ-797.

Dr. Mark Fendi: Our partnership with Immuniscape is now well underway and centers around the discovery and development of T-cell receptors to a specific class of pan-tumor new antigens. We believe that our invariant NK-T cells are ideal allergy-naked hosts for these pan-tumor new antigens TCRs and offer the potential to develop cost-effective off-the-shelf allergy-naked TCR-based cell therapies. In parallel, we are continuing to advance our proprietary frame TCR-I-K-T program. We've also investigated combining agent-797 with bi-specific cell engages.

Dr. Mark Fendi: Agent-797 is administered without lymphatic lesion, has shown activity in solar tumor settings, and we have detected circulating agent-797 in non-HLA-matched patients for up to six months. We have compelling evietro data on the combination of agent-797 with cell engages, our own as well as good party engages, and we believe that the combination of agent-797 and cell engages, specifically in absence of lymphatic lesion, will significantly enhance tumor penetration, counteract local immune suppression, and improve all We plan to present preclinical data from some of these programs at a key meeting later this year.

Dr. Jen Vuel: I'll now turn it back to Jim for some closing remarks. Yeah. Thank you very much Mark. Appreciate it. And this is, as you can see, we have an incredibly efficient platform in which we've been able to not only advance clinical programs, but also some highly innovative next generation technologies. And as we advanced these programs, which you can see, we're also very committed to fiscal conservatism, and sharing that we leverage every mechanism available to advance our therapies highly efficiently.

Dr. Jen Vuel: Our strategy includes pursuing non-deleter funding sources, and these include some of the grant funding programs that are currently underway, as well as strategic partnerships to maintain our financial health while bringing these deserving therapies to the forefront of treatment options. Our approach will not only accelerate the development of INKT South Air Force, but also to preserve value during this unusual time and biotech.

Christine Klaskin: Thank you for your continued support, and I'm going to turn the call over to Christine to review our financial Christine. Thank you, Jim. We ended the quarter with a cash balance of $9.3 million, which reflects cash used in operations for the quarter of $2.3 million. This is a reduction from the $2.6 million used for the first quarter of this year, and as Jen mentioned earlier, an almost 50% reduction from prior year.

Christine Klaskin: Our net loss to the three and six months ended June 30, 2024, was $2.7 million, or $7 cents per share, and $6.5 million, or $18 cents per share. This compares to $6.2 million, or $18 cents per share, and $11.9 million, or $3.5 cents per share, for the same period in 2023.

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

Operator: So the floor is now open for your questions. So to ask a question this time, please first start in the number one on your telephone keypad. So for this Q&A, we will be provided the opportunity to ask one question and one further follow-up question.

Operator: We'll just pause for just a moment to compile the Q&A roster.

Emily Bodnar: Our first question comes from Emily Budger from H&W. Right. Hi, good morning. Thanks for taking the questions.

Dr. Jen Vuel: First, I'm just to confirm, so the TBHB study that you're planning to initiate, that sounds like that's going to be funded with external capital, is that correct? And then the second question, when you say you're seeing early signs of activity in the gastric cancer study, can you provide any more context to what you're kind of seeing and how that might compare to just standard of care chemo alone? Thank you very much for your questions, Emily.

Dr. Jen Vuel: I'm your first for the GBHD program. Yes, this will be supported by external funding to advance the program. And secondly, in gastric. Now, I'm giving that Dr. Genjigian is planning to present these results at a major conference. I'm hesitant to say any more than at least in the cohort that we have now observed and fully enrolled. It's beyond three to six months of follow-up. We are seeing some very exciting signals of clinical benefit that do exceed what our expectations are with ram tax on its own.

Dr. Jen Vuel: And as you can imagine, given the number of patients, thousands of patients have endorsed with the chemotherapy, we have a strong sense of what that arm, how it will perform. And we're seeing performance on that at this point in the child. Thank you.

Jack Allen: Our next question comes from Jack Allen from there. Thanks so much for taking the questions and congratulations on the progress. I want to do that a little bit more deeply into the gastric updates that we expect. I guess I understand you don't want to make too many comments ahead of the scientific presentation. But could you just remind us about the different cohorts in the study and any comments on where patients were enrolled as it relates to those cohorts to date.

Jack Allen: And then on the the graph versus host of these trial, very exciting news to see that got underway. I just wanted to see if you had any more comments as it relates to the size of that study and what we can expect initial data from that trial.

Dr. Jen Vuel: Certainly, thanks, thanks, it was Jack for your questions on the gastric program. This was, this is a program in which we have a very heavy translational component as well as clinical components. So looking at very traditional endpoints, response rate, team reduction, overall survival and population, as well as some of the translational markers and to do so, what we have embarked on as a trial that allows us to interrogate INKT is an induction.

Dr. Jen Vuel: And, and INKT is on top of standard of care chemo rampats, as well as INKT's in combination with botbal and chemo. And we have representative patients and each of those treatment considerations. So the data that you will see will give some semblance not only of translational mechanisms that are happening, but also clinical outcomes in those populations.

Dr. Jen Vuel: GDHT, so this is a program that we are as excited as you are Jack to get this underway. This is our pre-clinical data has really supported the importance of INKT's in this particular disease setting and what we've observed is that pre-clinically, we know that INKT's may uniquely transform the, the landscape that will enable engraftment success and also mitigate and prevent GVHT. This is such a growing problem impacting over 50% of patients that are undergoing stem cell transplantation, but we believe that these cells can deliver benefit both in adult patients, as well as in pediatric patients.

Dr. Jen Vuel: And you may know that there is a mesenchymal stem cell approved in Europe and not yet in the U.S, that has demonstrated some important benefit, particularly in pediatric population specifically where GVHT is organ-based. And we think that our cells may even be able to expand benefit beyond the observations today, certainly beyond books of litunib, as well as beyond some of the available cell approaches given the mechanism of action.

Jack Allen: We will be activating the trial. We're working aggressively to do so this year. Ideally, we will have some patients who can start enrolling in this calendar year. Otherwise, it will be very early next year. The endpoints are rapid in this with response rates and protection and mitigation within about a 28-day window. So we would expect to have data from the trial in 2025, probably in the second half of the year. Got it. Great. Thank you so much for that update.

Jack Allen: And then maybe just one last question.

Dr. Jen Vuel: More broad, but as it relates to securing additional non-deludive sources of capital, I just hope to hear any kinds of you have around pediatric partnerships and things of that nature. Yes, partnering is actually really core to our strategy, and it will be important not only to expand our bandwidth, but also our global presence. So we continue to have very active interactions with potential partners who share our vision and also have the bandwidth to deliver in regions of the world where we do not yet have a footprint, but also to help us accelerate the development of these cells. Thank you.

Mayank Mamtani: Our next question comes from me, Mamtani from Steve Riley.

Mayank Mamtani: A good morning team. Thanks for taking our questions and congrats on the progress. So in regards to the 797 combination work with Baud Bell, sort of informing also your future combination work, you may perceive with T selling ages. Could you maybe just talk a little bit more about that. And if there are any specific to most of the transition, you know, modalities, T selling ages that you have in mind.

Dr. Jen Vuel: And then the second question about the 215 and the filing plans actually to, you know, 2025. We would love to hear, you know, the initial base on protocol plan, you're looking to submit with your ID filing and any color on what those levels you're looking to produce produce and and how might you be thinking of manufacturing. Given, you know, you invested it down in house in developing this one. Excellent.

Dr. Jen Vuel: Okay, my I'm going to start with the second question and I'll turn it over to Mark and we also have Dr. Joe here on manufacturing for 215. So on the ladder, so 215. This is a program as you know, we now have a new investor who has joined us and partnered with us and accelerate the development of this program we're doing so actively. We had already generated quite a bit of preclinical work to support our ID filing.

Dr. Jen Vuel: We're expanding that to bolster our initial clinical protocol, which will allow us to identify patients, most likely to respond and deliver therapy and an effective starting dose. That's our, that's really our highest priority at this moment in order to accelerate the development of this important therapy, our preclinical data, which we've now presented publicly in a number of locations as it's continued to build and evolve and what we've most recently demonstrated is that the 215 program not only can can benefit in organoid models, colorectal cancer, but also penetrate metastatic liver disease in those human like models.

Dr. Jen Vuel: This has increased our imperative for identifying patients most likely to benefit and those will be very likely to be patients with that expressing tumors. Now we will be somewhat in a phase one trial, someone inclusive to identify exploratory signals, but we will be really focused. In order to identify patients where we believe that we can measure some of the biomarkers elimination of the fat expressing tumor cells and the immune enhancing potential of this therapy to really deliver the benefit that we think is possible.

Dr. Jen Vuel: We will be manufacturing this program in house and Dr. Zhao and her team are working very aggressively to do so our process development analytic development work is actively underway for release spec criteria. And that we're just now in the process of finalizing some of the work that's necessary for the transaction and then we'll be transferring it in house to produce the material. Importantly, we have been delivering 797 in our own hands and we've optimized the protocol to be able to deliver really robust billions of cells per donor.

Dr. Jen Vuel: We are able to scale the cells and we've publicly talked about this where we can scale the cells without exhaustion really capitalizing on the possibility. We will plan to leverage that platform in order to now deliver our engineered car I and KT platform.

Dr. Jen Vuel: So that's the 215 program. We're looking forward to getting that into the clinic. We're going to be wrapping up some of the preclinical data that will allow us to get there at a dose that we think will be quite impactful and in a population that we believe will benefit.

Dr. Mark Fendi: Now on the engages, I'm really glad that you asked this. We have done a lot of work in our own hands with engages with the the concept that engages need more and we're seeing that in the landscape.

Dr. Mark Fendi: And I think we may have in a very important recipe for success here 40 cell engages and I'm going to turn it over to Mark Bandai to tell you a bit more. Yeah, thanks, Ian. So, engages are interesting. I mean, there's quite a lot of development in the cell-engaging space, more and more so also in the solar tumor space. We've seen some success, we'd want approval. And I think we can increase the efficacies enormously by adding an allergenic cell therapy component in a form of INK T cells.

Dr. Mark Fendi: And I say this specifically because engages are, sort of, they induce the local, the central immune response, and they need to pull T cells into the tumor. But there's a lot of resistance in the tumor. INK T cells are very good at entering sites where T cells cannot easily go, as well as overcoming local immune suppression. That's the reason to build two on five. That's the reason why 797 has shown activity in gastric cancer.

Dr. Mark Fendi: And we believe that combining bi-specific cell engages for solar tumors with agent 797, or later with 2 on 5, really starts to add those to efficacy mechanisms together to have a much higher impact than either one or seven gauges alone can achieve. And the other really differentiating component is that 797 is applied without leapordepletion, and that's essential for maximizing the immune response of the patient's own immune system. So that combination, mostly for the treating INK T cells plus cell engages we believe has a enormous potential for solar tumor treatment. So that's why we're exploring with both our own cell engageer program, but also looking at cell engages that are out there.

Mayank Mamtani: And we have, you know, quite a lot of presented data that we hope to share at a conference later this year. Got it. Thank you for that comprehensive answer.

Dr. Jen Vuel: And then just if I could squeeze one more in, Jen, on the couple of options for non-dality financing, are you able to talk to, you know, the scale and scope and in terms of what remains, you know, to kind of get that through the finish line, that would be helpful. And thanks again for taking a question. Thanks, Ma'am. With respect, as you're seeing with some of the non-delutive grant funding supports that we have been able to garner to support our trials in immune-related diseases as well as in oncology, you can see how the excitement of these cells and their potential is shared with a number of groups, a diverse set of groups who are very intrigued by advancing the technology.

Dr. Jen Vuel: That has allowed us to continue to really prioritize the development of data that will help us to continue to advance some of the discussions that are actively underway. So I hesitate to give any additional color except to say that the interest of what these cells can do have been coming inbound from pharma groups who are interested in expanding the footprints of their cell therapy programs as well as those looking to get into the space.

Dr. Jen Vuel: There's quite a bit of interest in the auto-immunity of the GVHD data as well as on the engineered portfolio with the preponderance of additional interest and respiratory diseases coming from a very focus group of pharma companies. I'm going to leave it just to simply say for us the most important thing is regional infrastructure and global footprints that can allow us to accelerate the development of these important therapies and that's been driving our prioritization of the conversations that we're having now and some of which will expand on the next couple of weeks. And I'm ideally we will be able to have some of these advanced pharma by the end of this year or early next year.

Matthew Phipps: Thank you.

Matthew Phipps: Our next question comes from Matthew Phipps.

Dr. Jen Vuel: I will end here. I thanks for taking my questions, Jen. Glad to see the GVST trial getting started. Just wondering if you get some details, steroid refractive, but will you allow for other lines of prior therapy? And is this going to be a single sending dose, multiple sending dose? Can you give us any details on the dosing schemes?

Dr. Jen Vuel: Thanks so much, Matt. And on the dosing scheme, at this point, we have been able to administer the cells and beyond one dose. And we are very pleased that we can do so tolerably in populations of patients that we wanted to monitor really quite closely. So we can administer the cells. We do not see any enhanced cell reactivity or rejection and administering beyond one dose. We would look at this from a target dosing standpoint.

Dr. Jen Vuel: We've generated quite a bit of data now beyond 80 patients in dose finding. And I think we have quite a bit of confidence that a billion cells is our target dose. We wouldn't want to start very much lower than that. We made you a step down dose in the CDT trial. However, we may not need to. So we're negotiating that currently. And we would look at about a billion cells. We would do a single dose as well as we would explore a second dose or a third dose is necessary.

Dr. Jen Vuel: I'm not sure that it will be. We will be open. And we're finalizing those design elements right now with some regulatory interactions. We are open to other lines of therapy. We want to be sure to have the right reference so that in our trial, which even in the phase one, we may contemplate, we're contemplating right now a reference group that would allow us to accelerate the development by demonstrating. You know, if we're looking at 40 to 50% or higher in response rates compared to what we're seeing is 30% with some of the available therapeutic approaches. We want to keep the prior lines of therapy relatively clear so that we have a homogeneous population even in a phase one setting that will allow us to advance very quickly into a randomized phase two.

Matthew Phipps: Okay. Great.

Operator: Thank you.

Dr. Jen Vuel: There are no further questions.

Dr. Jen Vuel: So I'll turn the call back over to Dr. Jennifer view. Thank you very much, everyone. I want to thank my team as well as for those on the line for your continued support. Appreciate it. It leads to this call.

Operator: You may now disconnect.