Q1 2025 MiNK Therapeutics Inc Earnings Call
Okay.
Operator: Thank you for standing by.
Rochelle: Thank you for standing by my name is Rochelle, and I will be your country operator today.
Operator: My name is Rochelle, and I will be your conference operator today.
Operator: At this time, I would like to welcome everyone to the MiNK Therapeutics First Quarter 2025 Financial Results. After the speaker remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again.
Rochelle: At this time I would like to welcome everyone.
Speaker Change: <unk> Therapeutics first quarter 259, sorry, we don't.
Speaker Change: After the Speakers' remarks, there will be a question and answer session.
Speaker Change: I'd like to ask a question during the day and simply press Star followed by the number one on your telephone keypad.
Speaker Change: If you would like to withdraw your question Brash Star one again I will now turn the call.
Operator: I will now turn the conference call to Jennifer Buell, Head of Investor Relations. Please go ahead.
Speaker Change: Yes.
Speaker Change: Jack.
Speaker Change: Head of Investor Relations. Please go ahead.
Jennifer Buell: 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 overlooking statements, including those related to our clinical development, regulatory and commercial plans, timelines for data release, and partnership opportunities.
Speaker Change: Thank you operator, and thank you all for joining US today today's call is being webcast and will be available on our web site for replay.
Speaker Change: I'd like to remind you that this call.
Speaker Change: These statements, including those related to our clinical development regulatory and commercial.
Speaker Change: Timelines for data release and partnership opportunities.
Jennifer Buell: These statements are subject to risks and uncertain Please refer to our SEC filings available on our website for a detailed description of these risks.
Speaker Change: These statements are subject to risks and uncertainties. Please refer to our SEC filings available on our website for a detailed description of these risks.
Jennifer Buell: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, and Christine Klaskin, Principal Financial and Accounting Officer. Now I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter.
Speaker Change: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, and Christine class skin principal financial and accounting officer now I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter.
Speaker Change: Yeah.
Zack Armen: Thanks very much, Zack. I appreciate it.
Speaker Change: Thanks, very much I appreciate it and thank you all for joining US today. This quarter, we've made meaningful progress towards our mission and that's delivering scalable durable off the shelf I N K T cell therapies to patients with solid tumors and other immune related diseases and.
Jennifer Buell: And thank you all for joining us today. This quarter, we've made meaningful progress towards our mission, and that's delivering scalable, durable, off-the-shelf INKT cell therapies to patients with solid tumors and other immune-related diseases. In the first Q of 2025, we executed across three critical areas, and those include clinical progress. We presented new data in solid tumors, specifically in second-line gastric cancer at the inaugural AACRIO conference. And we showed immune activation and very early clinical activity and responses in patients who were otherwise refractory to checkpoint-modulating antibodies. On the capital side, we've continued to reduce our operating cash burn and operate extremely efficiently with a further reduction of about 47% year-on-year, preserving our ability to invest in our core programs. We've been able to continue to advance our clinical trials through external financing, and those include the advancement of our second-line gastric cancer and also the development of two programs, one in ARDS and the other in GVHC, which I'll talk about in just a moment.
Speaker Change: In the first Q of 2025, we executed across three critical areas and those include clinical progress we presented new data in solid tumors, specifically in second line gastric cancer at the inaugural AACE, Our I O conference and we showed immune activation and very early clinical activity and responses and.
Speaker Change: Patients, who are otherwise refractory to checkpoint modulating antibodies.
Speaker Change: On the capital side, we've continued to reduce our operating cash burn and operate extremely efficiently with a further reduction of about 47% year on year preserving our ability to invest in our core programs. We've been able to continue to advance their clinical trials do external financing and those include the advancement of our second line gas.
Speaker Change: Stroke cancer and also the development of two programs one in a R. D S and the other in Gvhd, which I'll talk about in just a moment.
Jennifer Buell: Strategic Momentum. We are advancing confidential discussions for proposals, each of which could extend our runway and accelerate our impact, and I'm gonna go into those in detail in just a moment. Partnering, as you know, is core to our strategy, and it has been. It's essential to unlocking the full potential of our technology, our INKT platform in oncology, in immunology, inflammatory diseases, and, of course, our next-generation engineered cell therapy. Our platform is really broad and deep. It allows us to take full advantage of what these cells can do. And we remain at the forefront of advancing INKT cell biology off the shelf in patients with immune related conditions.
Speaker Change: Strategic momentum.
Speaker Change: We are advancing confidential discussions for proposals each of which could extend our runway and accelerate our impact and I'm going to go into those in 17 in detail just a moment.
Speaker Change: Partnering as you know is core to our strategy and it has been it's essential to unlocking the full potential of our technology, our I N K cheaper platform in oncology and immunology inflammatory diseases and of course, our next generation engineered cell therapy.
Speaker Change: Our platform is really broad and deep is allows us to take full advantage of what these cells can do and we remain at the forefront of advancing I N K T cell biology off the shelf and patients with immune related condition.
Jennifer Buell: And today I'm pleased to share that we have three distinct proposals, each aligned with one of our key therapeutic areas. In oncology and cancer, we're focusing on advancing 797 and solid tumor cancers, building on the momentum from our gastric and testicular cancer program. I'll highlight a little bit more about some upcoming data in testicular cancer, but in the meantime, we did just recently present data at AACR that I'll share with you in a few moments.
Speaker Change: And today I'm pleased to share that we have three distinct proposals each aligned with one of our key therapeutic areas.
Speaker Change: Oncology and cancer, we're focusing on advancing 797 and solid tumor cancers building on the momentum.
Speaker Change: Gotcha, and particular cancer program.
Speaker Change: Highlight a little bit more about some upcoming data and testicular cancer, but in the meantime, we did just recently present data and at ACR that I'll share with you in a few moments.
Jennifer Buell: Proposal on Immunology and Inflammatory Conditions. This supports our development of INKT cells in acute inflammation, such as respiratory distress, as well as inflammatory conditions such as graft-versus-host disease, an area of great interest to our team. And a proposal on our next generation pipeline. This encompasses our CAR-INKT therapy, our TCR-INKT therapy, and our proprietary neoantigen discovery platform with the aim of creating highly targeted, off-the-shelf immune therapies. These transactions and proposals are not exclusive. In fact, Given their distinct focus areas and complementary capabilities of these proposed partners, these proposals may be mutually reinforcing, each bringing differentiated capital, infrastructure, and scientific expertise to accelerate progress within their respective domains.
Speaker Change: Proposal on immunology and inflammatory condition.
Speaker Change: This supports our development of I N K T cells and acute inflammation.
Speaker Change: Such as respiratory distress as.
Speaker Change: As well as inflammatory conditions, such as graft versus host disease, an area of great interest to our team.
Speaker Change: And our proposal in our next generation pipeline. This encompasses our car I N K T therapy or T. C. R. I N K T therapy in our proprietary neo antigen discovery platform with the aim of creating highly targeted off the shelf immune therapies.
Speaker Change: These transactions and proposals are not exclusive in fact give.
Speaker Change: Given their distinct focus areas and complementary capabilities of these proposed partners.
Speaker Change: These proposals may be mutually reinforce it reinforcing each bringing differentiated capital infrastructure and scientific expertise to accelerate progress within their respective domains.
Jennifer Buell: Taken together, these proposals reflect strong external conviction in the value of our INKT platform and represent a rare opportunity to diversify capital, reduce dilution, and accelerate development in multiple high-impact areas for MiNK. We're engaging with focus and urgency, and expect to advance one or more of these in the very near term.
Speaker Change: Taken together these proposals reflect strong external conviction in the value of our I N K T platform and represent a rare opportunity to diversify capital reduce dilution and accelerates development in multiple high impact areas from ink.
Speaker Change: We're engaging with focus and urgency and expect to advance one or more of these in the very near term. We'll continue to keep you abreast and we plan to host a more formal presentation regrouping with our key stakeholders to be able to announce these and in due course.
Jennifer Buell: We'll continue to keep you abreast, and we plan to host a more formal presentation regrouping with our key stakeholders to be able to announce these in due course. Now, I'm going to turn and highlight a couple of key elements of our programs and our progress to date. In solid tumors, we're particularly encouraged by the continued momentum in our solid tumor program.
Speaker Change: Now I'm going to turn and highlight a couple of key elements of our programs and our progress to date.
Speaker Change: Solid tumors, we're particularly encouraged by the continued momentum in our solid tumor program and as I mentioned at the ESCO G. I N E. C. R. I O inaugural meetings, we presented new data from our phase two investigator sponsored trial, that's being housed at memorial Sloan Kettering under the leadership of Doctor Julina Egencia, he and the chief of gastrointestinal.
Jennifer Buell: And as I mentioned, at the ASCO GI and AACRIO inaugural meetings, we presented new data from our Phase II investigator-sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Jelena Jantjikian, the Chief of Gastrointestinal Oncology. This study is evaluating L-O-I-N-K-Ts, or Agent 797, in combination with two differentiated checkpoint-modulating antibodies, botansilinab and balacilinab, on top of standard-of-care chemotherapy in patients with second-line advanced gastric cancer. This is a population with no effective therapies in the second-line setting. The data demonstrate that INK T-cells, when delivered systemically, they rapidly traffic to the tumor microenvironment, where they engage both innate and adaptive immune pathways.
Speaker Change: In College age.
Speaker Change: This study is evaluating allo I N K t's or agent 787 in combination with two differentiated checkpoint modulating antibodies, but and some of them have been bounced filling up on top of standard of care chemotherapy in patients with second line advanced gastric cancer. This is a population with no effective therapies in the second line setting.
Speaker Change: The data demonstrate that I N K T cells when deliveries systemically.
Speaker Change: Rapidly traffic to the tumor microenvironment, where they engage both innate and adaptive immune pathways. This is different than what you see with conventional T cells and NK cell technology.
Jennifer Buell: This is different than what you see with conventional T-cells and NK cell technology. This activity, what we've observed is that we were looking at tumors that effectively were in immune desert, no CD8 T-cells, therefore, no ability to immunologically manage the cancer. And what we observed is upon systemic infusion of 797, we can transform a cold tumor into an immunologically active or hot tumor, promoting these very important CD8 T-cells. Infiltration, Activating Dendritic Cells, and Reversing Immune Exhaustion. And these are in cancers that are resistant to PD-1 blockade. These findings support our core thesis, INKT cells act as immunologic first responders, initiating multi-layered anti-tumor responses through direct tumor killing or cytotoxicity and immune orchestration.
Speaker Change: This activity what we've observed is that we were looking at tumors that effectively were in immune desert no CDA T cells. Therefore, no ability to immunologically manage the cancer and what we observed is upon systemic infusion of 787, we can transform a cold tumor into an immune.
Speaker Change: Logically active or hot tumor promoting these very important CDA T cells.
Speaker Change: Infiltration activating dendritic cells.
Speaker Change: And reversing immune exhaustion and these are in cancers that are resistance to PD one blockade.
Speaker Change: These findings support our core thesis I N K T cells Act as immunologic first responders initiating multi layered anti tumor responses through direct tumor, killing or cytotoxicity and immune orchestration.
Jennifer Buell: We anticipate sharing additional updated clinical updates later this year and the beginning of next year.
We anticipate sharing additional updated clinical updates later this year and the beginning of next year.
Speaker Change: Yeah.
Jennifer Buell: In parallel, we expect a peer-reviewed publication describing a complete response in a patient with metastatic testicular cancer. This patient was treated on our phase one trial with 797, and they were treated with 797, our alloy NKTs, alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and PIDGET-based regimens prior to enrolling in the trial. Following a single infusion of Agent 797, the patient achieved a durable, complete clinical, radiological, and biochemical remission. Treatment was delivered without lymphodepletion or HLA matching and showed no evidence of cytokine release syndrome or GVHD.
Speaker Change: In parallel we expect to peer reviewed publication, describing a complete response in a patient with metastatic testicular cancer. This patient was treated in our phase one trial with 787 and they were treated with 787, our alloy NK Ts alone in this setting the patient had progressed through platinum based chemotherapy.
Speaker Change: And stem cell transplantation radiation and checkpoint and pitch it based regimens prior to enrolling in the trial.
Speaker Change: Following a single infusion of agents 797, the patient achieved a durable complete clinical radiological and Biochemicals remission.
Speaker Change: Treatment was delivered without them for depletion or HLA matching and showed no evidence of cytokine release syndrome or gvhd.
Jennifer Buell: The post-treatment analysis reveals elevated interferon gamma. We're observing some robust tumor activity by immune effector cells, and we're also observing peripheral persistence. Our cells still continue to persist beyond six months, which give us a large therapeutic window to continue to dose these patients. This case exemplifies the unique biology of INKT cells, their ability to rapidly home to tumors, dismantle immunosuppressive barriers, and activate both NK and CD8 T cells. even in tumors previously unresponsive to immune therapy.
Speaker Change: Yes.
Speaker Change: The post human analysis revealed elevated interferon gamma we're observing some robust tumor activity by immune effector cells and we're also observing peripheral persistence ourselves still continue to persist beyond six months, which give us the large therapeutic window to continue to dose these patients.
Speaker Change: This case exemplifies the unique biology of I N K T cells their ability to rapidly home consumers dismantle immuno suppressive barriers and activate both NK.
Speaker Change: And see the eight T cells.
Speaker Change: Even in tumors previously unresponsive immune therapy.
Jennifer Buell: Alongside our gastric cancer findings, this finding reinforces INKT cells as a novel, off-the-shelf immune therapy platform with the potential to deliver durable benefit in hard-to-treat solid tumors.
Speaker Change: Alongside our gastric cancer findings this finding reinforces I didn't take T cells as a novel off the shelf immune therapy platform with the potential to deliver durable benefit in hard to treat solid tumors.
Jennifer Buell: Beyond oncology, we're continuing to advance 797 in immune-related diseases, such as acute respiratory distress syndrome and graft-versus-host disease. Our INKT platform showed early on and continues to show compelling promise in immune-mediated diseases where inflammation, immune dysregulation, and poor treatment options converge to create really devastating clinical realities for patients. In ARDS, a life-threatening condition, with no FDA-approved therapies, Agent 797 has shown the potential to change the treatment paradigm. As we published in Nature Communications and presented at the American Thoracic Society, our data demonstrated improved survival in meaningful inflammatory control in critically ill ventilated patients, many of whom would otherwise face mortality rates exceeding 70%.
Speaker Change: Beyond oncology, we're continuing to advance 787 and immune related diseases, such as respiratory distress acute respiratory distress syndrome, and graft versus host disease.
Speaker Change: Our I NK platform showed early on and continues to show compelling promise in immune mediated diseases, where inflammation immune dysregulation and poor treatment options converge to create really devastating clinical reality for patients.
Speaker Change: And <unk> a life threatening condition with no FDA approved therapies agents 787 has shown the potential to change the treatment paradigm.
Speaker Change: As we published in nature Communications and presented at the American Thoracic Society, our data demonstrated improved survival and meaningful inflammatory control and critically ill ventilated patients many of whom would otherwise face mortality rate exceeding 70%. We on the other hand observed served.
Jennifer Buell: We, on the other hand, observed survival rates exceeding 70%, truly pathbreaking. Our signals observed in a high-risk ICU population is a powerful indication of INKT's steroid-resistant anti-inflammatory activity and their ability to reduce secondary infections and their impact on pulmonary function and immune tonology.
Speaker Change: Ivo rate exceeding 70% truly path path breaking.
Speaker Change: Our signals observed in a high risk ICU population is a powerful indication of I N K t's steroid resistant.
Speaker Change: Hi inflammatory activity.
Speaker Change: And their ability to reduce secondary infections and their impact on pulmonary function and immune technology.
Jennifer Buell: Consistent with the new leadership and priorities at the FDA, we are working urgently to make our therapies accessible through well-designed clinical trials, compassionate use programs, and accelerated development pathways that reflect the seriousness and unmet nature of these conditions. The agency's increased receptivity to novel immune-based approaches, especially in indications like ARDS, give us further confidence in our regulatory path forward.
Speaker Change: Consistent with the new leadership and priorities at the FDA, we are working urgently to make our therapies accessible through well designed clinical trials compassionate use programs and accelerated development pathways that reflect the seriousness and unmet nature of these conditions the agencies increased receptivity to novel immune based approaches.
Speaker Change: <unk>, especially in indications like a rds give us further confidence in our regulatory path forward.
Jennifer Buell: In graft-versus-host disease, we're prepared to initiate a phase one trial, a 797 of patients undergoing allogeneic bone marrow transplant.
Speaker Change: And graft versus host disease, we're prepared to initiate a phase one trial of 787 in patients undergoing allogeneic bone marrow transplant.
Jennifer Buell: We've spoken to you about this before, and as you know, advancing this program has been, in part, contingent upon securing financing to be able to advance this really responsibly and efficiently. GVAC remains one of the most severe and unpredictable complications of transplants, often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our INKT approach, which requires no lymphodepletion, no genetic matching, and poses minimal to no risk of GVHD itself, is uniquely suited for this setting. The trial will be supported primarily through external partnerships, allowing us to advance this high-impact program with minimal capital outlay.
Speaker Change: Spoken to you about this before and as you know advancing this program has been in part contingent upon securing financing to be able to advance its really responsibly and inefficiently Gvhd remains one of the most severe and unpredictable complications of transplant.
Speaker Change: Often leaving to most often leading to multi organ damage prolonged hospitalization poor quality of life and disease progression.
Speaker Change: Our I N K T approach, which requires no lymphoid depletion no genetic matching and pose is minimal to no risk of gvhd itself is uniquely suited for this setting.
Speaker Change: The trial will be supported primarily through external partnerships, allowing us to advance Italian pack program with minimal capital outlay.
Jennifer Buell: Further reinforcing the momentum, we were recently selected for probable funding by the National Institute of Allergy and Infectious Diseases. We expect the formal award, we were recently notified just a couple of weeks ago that we expect the formal award by June.
Speaker Change: Further reinforcing the momentum we were recently selected for probable funding by the National Institute of allergy and infectious diseases.
Speaker Change: We expect the formal award we were recently notified just a just a couple of weeks ago that we expect the formal award by June.
Jennifer Buell: This would provide critical, non-dilutive funding and a strong endorsement from one of the world's most respected federal research agencies. And with this award, MiNK will launch a collaboration of preclinical and clinical research with our colleagues and scientific advisors at University of Wisconsin. Together, ARDS and TBHC represent a large, underserved market where MiNK's INKT platform can deliver outsized impact. We remain committed to advancing these programs rapidly, guided by scientific conviction and a growing mandate to bring transformative immune-based therapies to patients in need. And on the operational efficiency side, we have been continuing to expand our work in the field by reducing and reducing operating burn.
Speaker Change: Would provide critical non dilutive funding and a strong endorsement from one of the world's most respected well respected federal research agencies with this and with this award.
Speaker Change: Lunch, a collaboration of preclinical and clinical research with our colleagues in scientific advisers at University of Wisconsin.
Speaker Change: Together are D. S. In gvhd represent a large underserved markets were mixed I think if he platform can deliver outsized impact we remain committed to advancing these programs rapidly guided by scientific conviction and a growing mandate to bring transformative immune based therapies to patients in need.
Speaker Change: And on the operational efficiency side.
Speaker Change: We have been continuing to expand our work in the field by reducing <unk> and reducing operating burn.
Jennifer Buell: We have continued to retain our top scientific leaders. We continue to internalize operational execution of our programs, including data management and clinical research activities, which has allowed us to operate far more efficiently in a far less capital-intensive way.
Speaker Change: We have continued to retain our top scientific leaders.
Speaker Change: We continue to internalize operational execution of our programs, including data management and clinical research activities, which has allowed us to operate far far more efficiency and at the far less capital intensive way.
Jennifer Buell: These actions further reflect our commitment to financial discipline and operational focus.
Speaker Change: These actions further reflect our commitment to financial discipline and operational focus with that I'll turn the call over to Christine to review of the financials.
Christine Klaskin: With that, I'll turn the call over to Christine for review of the financial. Thank you, Jen. We ended the quarter with a cash balance of $3.2 million. Cash used in operations for the three months ended March 31, 2025, was $1.3 million. This is reduced from $2.5 million for the same period in 2024. Our net loss for the first quarter of 2025 was $2.8 million, or $0.70 per share. This compares to $3.8 million, or $1.10 per share, for the first quarter of 2024.
Christine Class: Thank you Jim.
Christine Class: We ended the quarter with a cash balance of $3 $2 million.
Christine Class: Cash used in operations for the three months ended March 31, 2025 was $1.3 million. This is reduced from $2 $5 million for the same period in 2024.
Christine Class: Our net loss for the first quarter of 2025 was $2 $8 million or <unk> 70 per share. This compares to $3 $8 million or $1 10 per share for the first quarter of 2024.
Operator: Thank you, and operator, we are now ready to take questions. At this time, I would like to remind everyone, in order to ask a question, press star, then the number 1 on your telephone keyboard. We will pause for just a moment to compile the Q&A roster.
Christine Class: Thank you and operator, we are now ready to take questions.
Christine Class: Yes.
Christine Class: At this time I would like to remind everyone in order to ask a question press star and the number one on your telephone.
Speaker Change: Dual class for just a moment to co piles roster.
Emily Bodnar: Your first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead. Hi, good morning. Thanks for taking my questions.
Speaker Change: Your first question comes from the line of.
Speaker Change: Emily Bodnar with H C. Wainwright. Please go ahead.
Emily Bodnar: Hi, good morning, Thanks for taking my questions.
Emily Bodnar: I guess first one on the testicular patient, congrats on the CR there. Are you able to say how long after treatment was initiated that the CR was observed?
Speaker Change: First one on the testicular appears Sharon congrats on let's see are there are.
Speaker Change: Are you ever going to say how long after treatment was initiated the CR was observed.
Jennifer Buell: And if you can comment on, I guess, your overall plan in testicular cancer going forward and if there's any other indications that you're still looking at. Emily, thanks for the question, and this is this publication is expecting out somewhat imminently, and that information will be in the publication. But I can share with you, this is a unique case, and it exemplifies the value of immune therapy. It's not surprising that in the twelve month follow up period, the patient actually had disease stabilization and we were monitoring the patient and not not less than a year after that.
Speaker Change: If you can comment on I guess, your overall plan and testicular cancer going forward and if there's any other indications, but you're still looking at.
Speaker Change: And we thank you for the question and this is this publication is expecting out somewhat imminently and that information will be in the publication, but I can share with you. This is a unique case and it exemplifies the value of immune therapy, it's not surprising that in the 12 month follow up period, the patient actually had disease stabilization.
Speaker Change: And we were monitoring the patient and not not less than a year. After that so it 24 months. The patients came back into see the P. I of the study with a complete remission and no. Other treatment. So this patient had been treated by the investigator continued its clinical treatment with the investigator clinical observations with NN.
Jennifer Buell: So, in twenty-four months, the patient came back in to see the PI of the study with a complete remission and no other treatment. So, this patient had been treated by the investigator, continued his clinical treatment with the investigator, clinical observations, with no additional treatment put into the patient after the single infusion, and the complete response was formally designated at month twenty-four after the initial treatment of F797. And in addition, the patient had multiple lesions. The disease was really quite widespread, and you'll see this outlined in the paper. And what was really quite intriguing was disease reduction really in all of the lesions, including the liver, and that's a very important biomarker for us.
Speaker Change: No additional treatment put into the patient after the single infusion and the complete response was formerly designated month 24. After the initial treatment of a F 707.
Speaker Change: And in addition, the patient had multiple lesions disease was really quite widespread and youll see this outlined in the paper.
Speaker Change: And what was really quite intriguing was disease reduction really in all of the lesions, including the liver and that's a very important.
Speaker Change: Biomarker for US we are seeing activity of NK T and active disease in the liver we've observed this in our phase one study. We've also observed it in our gastric cancer trial and now we've observed it with as testicular cancer case.
Jennifer Buell: We are seeing activity of INKTs and active disease in the liver. We've observed this in our phase one study. We've also observed it in our gastric cancer trial, and now we've observed it with this testicular cancer case. The patient has a lung mat that appears to be indolent at this point, that he does not want to undergo a biopsy, but the disease appears, the nodule appears to have nothing but dead tissue based on all of the scanning that has been completed.
Speaker Change: The patient has a lung met that appears to be indolent at this point that he does not want to undergo a a biopsy, but the disease appears to the nodule appears to have nothing but dead tissue.
Speaker Change: Based on all of the scanning that has been completed so we're really quite enthusiastic about this and that has.
Jennifer Buell: So we're really quite enthusiastic about this, and it has encouraged us to continue to do another survival sweep and clinical interrogation of other patients on the trial. What we found to be most intriguing when we presented the data, we presented essentially with a median of 12 months of follow-up, and we had some responses in the trial, but predominantly we saw long-term disease stabilization, and this includes in patients with pancreatic cancer, non-small cell lung cancer, testicular cancer, appendiceal, and gastric. And those observations, when we stopped, we concluded the follow-up period of the trial, we may be underestimating the ultimate clinical benefit of INKT cells.
Speaker Change: Encouraged us to continue to do another survival sweep in clinical interrogation of other patients on the trial.
Speaker Change: We found to be most intriguing when we presented the data we presented essentially with a median of 12 months of follow up and we had some responses in the trial, but predominantly we saw long term disease stabilization and this includes in patients with pancreatic cancer and non small cell lung cancer.
Testicular cancer Appendiceal and in gastric.
Speaker Change: And those observations when we stopped that you know we concluded the follow up period of the trial, we may be underestimating, the ultimate clinical benefit of buying K T cells. So we'll be getting a further clinical sweep of these patients are in.
Emily Bodnar: So we'll be getting a further clinical sweep of these patients and updating the field on the findings. Okay, great.
<unk> the fields on the findings.
Speaker Change: Okay great.
Emily Bodnar: And on the Phase 2 gastric trial, are you still kind of on track for initial advocacy data in the second half of this year? That's what we're on target to do. They're continuing to enroll, and we'll be in touch with Dr. Janjigian about the soonest presentation. So we have been looking at some GI-specific conferences as well as some of the major So it will be no later than early next year. That would be the latest, but we're still on track. We're still targeting to get something out by the end of this year. Okay, great.
On the phase two gastric trial are.
Speaker Change: Are you still kind of on track for initial efficacy data in the second half of this year.
Speaker Change: That's what we're on target to do Theyre, continuing to enroll and where we'll be in touch with doctors and check in about the soonest presentation. So we are we have been looking at some Gi specific conferences as well as some of the major oncology conferences for an update and a clinical presentation. It's ultimately within her discretion. So it.
Speaker Change: It will be no later than early next year that would be the latest but we're still on track, we're still targeting to get something out by the end of this year.
Speaker Change: Okay, great are likely.
Emily Bodnar: Lastly, I'm just curious in terms of the funding that you mentioned from the NIAID, if you've kind of heard of any changes or delays in government funding going forward? Yeah, absolutely. All this new news lately. Well, I'm with you. So, we had heard of a delay. We expected this at the beginning of the year. So, the six-month delay is, you know, the delays that we have seen globally have impacted us. However, we were reassured to get a formal notification from NIAID that we can expect to hear that we had probable funding and can expect to hear conclusively in June.
Speaker Change: I'm just curious in terms of the funding that you mentioned from Benoit, if you've kind of heard of any changes or delays in government funding just with all the news lately.
Speaker Change: [laughter] well.
Speaker Change: So we had heard of a delay we expected this at the beginning of the year. So there's six months delay is.
Speaker Change: The delays that we've seen globally have impacted us however were where we were reassured to get a formal notification from <unk> that we.
Speaker Change: We can expect to hear that we have probable funding and can expect to hear conclusively in June.
Jennifer Buell: NIAID has not been as heavily impacted as some of the other agencies. And so, this for us is a high priority for the government and for the agency, graft-versus-host disease. And our technology presents a really novel way of addressing this problem with engraftment success and reduction in GVHC and better clinical outcomes. So, we're optimistic, and the most recent correspondence from the government continues to boost our optimism. Okay, great.
Speaker Change: That has not been as heavily impacted as some of the other agencies and so this for US is a high priority for the government and for the agency graft versus host disease, and and our technology presents a really novel way of addressing this problem within graph mint's success and reduction of Gvhd and better.
Speaker Change: Clinical outcomes.
Speaker Change: We're optimistic in the most recent correspondence from from the government continues to boost our optimism.
Emily Bodnar: Thanks for doing the questions.
Speaker Change: Okay, great. Thanks for taking my questions.
Operator: Thank you. Again, if you would like to ask a question, press star 1 on your telephone cable.
Speaker Change: Thank you.
Speaker Change: Again, if you would like to ask a question.
Speaker Change: Brushed started one on your telephone capesize.
Matt Phipps: Your next question comes from the line of Matt Phipps with William Blair. Please go ahead. Thanks for the update.
Speaker Change: Your next question comes from the line of Max.
Speaker Change: With William Blair. Please go ahead.
Speaker Change: Yeah.
Speaker Change: Hum.
Speaker Change: One and thanks for the I'm just wondering if maybe just go over some of the details of that you guys do Charlie is still planning on those at all.
Matt Phipps: I was wondering if maybe just go over some of the details of the GVHD trial. Are you still planning on folks in acute patients and maybe any thoughts on kind of prior treatments or what type of patients you'll be looking to enroll? Thanks so much, Matt. So there are two places where we will ultimately be studying in GVHD.
Speaker Change: Acute patients and maybe any thoughts on kind of prior treatments or what type of patients you will be looking to rule.
Speaker Change: Yeah.
Speaker Change: Thanks, So much Matt. So there are two places where we will ultimately be studying in gvhd and the first with this financing supports and with the priority at University of Wisconsin to bring this forward and this is under the leadership of a journey gumpert Who's a scientific adviser and wrote the seminal paper on the mechanism of banking fees in Gvhd.
Jennifer Buell: And the first with this financing support and with the priority at University of Wisconsin to bring this forward.
Jennifer Buell: And this is under the leadership of Jenny Gumpers, who's a scientific advisor and wrote the seminal paper on the mechanism of INKTs and GVHD. The opportunity for us in steroid refractory acute GVHD represents a very fast path forward. We have identified and developed a Phase I program for that. We have also developed a Phase I program for prophylaxis, and that's engraftment success and a reduction in GVHD. And in that disease setting, we have a pathway that may be even faster. Both of these will be going to the regulators for a discussion with them imminently, and then we will choose the priority program to advance.
Speaker Change: And the opportunity for us in steroid refractory acute gvhd represents a very fast.
Speaker Change: Path forward.
Speaker Change: We have identified and developed a phase one program for that we have also developed a phase one program for for prophylaxis and that's been Grafman success.
Speaker Change: And a reduction in gvhd and in that disease, setting, we have a pathway that maybe even faster.
Speaker Change: Both of these will be going to the regulators for a discussion with them imminently.
Speaker Change: And then we will choose our priority programs to advance, but both opportunities for us I'm Gonna have Thiago pavano who's been working with the investigators and the clinical development of the speak just a little bit more to the enrichment that we're planning at this time.
Thiago Favano: But both opportunities for us, I'm going to have Thiago Favano, who has been working with the investigators in the clinical development of this, speak just a little bit more to the enrichment that we're planning at this time.
Thiago Favano: Hi, thanks for your question. So, for the phase one, we're going to explore not only GVHD, but also a few other complications of transplants that still represent an unmet need, even though we do have available treatment and drugs for prevention. But the other effects, they still represent an unmet need. So, based on prior robust literature and some of our own studies, we expect the NKGs not only to prevent or combat GVHD, but also to prevent infections, contribute to a better engraftment, and better engraftment, and also prevent, maintain a graft-versus-leukemia effect to prevent disease relapse. So, we all know that under treatment of GVHD, patients get immunosuppressed, and that makes it easier for them to have relapse or infections, which is a major complication.
Thiago Pavano: Hi, Thanks for your question so for the phase one.
Speaker Change: We're going to explore not only gvhd, but also.
Thiago Pavano: A few other complications of transplants.
Thiago Pavano: Two represents an unmatched needs, even though we do have available treatments and drugs for prevention, but the other.
Thiago Pavano: In fact, these two represents an unmet need so Dave.
Thiago Pavano: Based on prior robust literature, and some of our own studies, we expect yankees' not only to prevent our combat gvhd.
Thiago Pavano: But also.
Thiago Pavano: To prevent infections contributes to a better than graphs make faster and better and grassroots.
Thiago Pavano: And and also prevents maintaining grant fast leukemia effect, you will prevent the disease relapse, but we all know that under treatment of gvhd patients get the immuno suppressed.
Thiago Pavano: And that makes it easier for them to have a relapse or infections, which is a major complication.
Jennifer Buell: And we, in this phase one, we are going to observe all these other effects on top of preventing GVHD, which paves the way for phase two and two studies, as Jen explained. We will explore in treatment of steroid refractory GVHD, and then another opportunity in prevention, which represents an even faster way for approval.
Thiago Pavano: And we just phase one we are gone.
Thiago Pavano: Observed.
All of these other effects on top of preventing gvhd, which paves the way for phase two into Jan.
Thiago Pavano: Explained we will explore in.
Thiago Pavano: Treatment of steroid refractory Gvhd, and then another opportunity and prevention, which represents an even faster rate for approval.
Jennifer Buell: and Matt I'm going to add something to this. There are two things happening in parallel. One is the funding opportunity and if the award is as we anticipate it will be, which is the full committed funding, then we will have an opportunity to, in our own hands, interrogate both prophylaxis as well as mitigation in steroid refractory patients. And so that's why we've developed two programs to be able to do that. In the case that we can fund independently with the grant funding one program, there's a strategic collaborator who's at the table right now and has shared a proposal with us to advance the other, which would be the prophylaxis.
Matt: And Matt I'm going to add something to this.
Matt: There are two things happening in parallel one is the funding opportunity and if the the award is as we anticipate it will be which is the full committed funding then we will have an opportunity to in our own hands interrogate both prophylactic as well as a mitigation there in steroid refractory page.
Matt: <unk>.
Matt: And so that's why we've developed two programs to be able to do that.
Matt: In the case that we can fund independently with the grant funding one program. There is a strategic collaborator who is at the table right now and has shared a proposal with us too.
Matt: Advance the other which the prophylactic setting.
Matt Phipps: Great. Okay. Thanks for the updates, John.
Speaker Change: Okay. Thanks Peter.
Operator: Thank you. That ends the Q&A session.
Matt: Thank you Matt.
Speaker Change: Yeah.
Speaker Change: And.
Jennifer Buell: I will now turn the call back over to Jennifer Buell for closing remarks. Please go ahead. Thank you, operator. Thank you all for joining us today. We look forward to interacting with you in the upcoming days.
Speaker Change: I will now turn the call back over to Jennifer Buell for closing remarks.
Speaker Change: Go ahead.
Jennifer Buell: Thank you operator, thank you all for joining US today, we look forward to interacting with you in the upcoming days.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
Jennifer Buell: Ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.
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