Latest news with #iNKT
Business Insider
12-07-2025
- Business
- Business Insider
Why Is MiNK Therapeutics Stock (INKT) Up 190% Today?
MiNK Therapeutics (INKT) stock rocketed higher on Friday after the clinical-stage biopharmaceutical company announced the publication of a complete remission in Oncogene. This case saw a patient with metastatic, treatment-refractory testicular cancer undergo a complete, durable remission with the use of agenT-797, the company's allogeneic iNKT cell therapy. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Investors will note that the patient has been in complete remission for two years with no signs of the cancer returning. Additionally, he underwent several therapies before MiNK Therapeutics' that failed to eliminate the cancer. He reached complete remission after a single treatment with agenT-797 alongside nivolumab. Dr. Benjamin Garmezy, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at SCRI Oncology Partners, said, 'We observed a remarkable response in a patient who had exhausted standard and experimental treatments, offering compelling evidence to further pursue clinical studies of iNKT cell therapies in solid tumors.' MiNK Therapeutics Stock Movement Today MiNK Therapeutics stock was up 192.63% in pre-market trading on Friday, following a 6.16% rally yesterday. The shares were also up 10.9% year to date, but have fallen 30.98% over the past 12 months. Today's rally came with heavy trading of INKT stock, as some 5 million shares changed hands, compared to a three-month daily average of about 10,930 units. Is MiNK Therapeutics Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for MiNK Therapeutics is Moderate Buy, based on two Buy ratings over the past three months. With that comes an average INKT stock price target of $35, representing a potential 352.78% upside for the shares.
Time of India
11-07-2025
- Business
- Time of India
Biotech breakthrough? INKT stock skyrockets 530% after cell therapy cures testicular cancer
MiNK Therapeutics (NASDAQ: INKT) saw its stock price soar by over 530% today—hitting a peak of $65.55 —after the company revealed a potential breakthrough in cancer treatment. What triggered INKT's insane stock rally? MiNK announced that one patient with advanced, treatment-resistant testicular cancer experienced a complete and durable remission after receiving just a single infusion of its experimental off-the-shelf iNKT cell therapy, agenT‑797, alongside nivolumab (an immune checkpoint inhibitor). Even more impressive? That patient has remained completely disease-free for more than two years, according to data just published in the journal Oncogene by Nature . How did the treatment work—and why is it such a big deal? No chemo or radiation was needed—just a single dose of engineered iNKT cells, which are a rare type of immune cell known for attacking both tumors and viruses. The therapy was well-tolerated with no signs of graft-versus-host disease or cytokine storm , common side effects in other cell therapies. These infused donor cells persisted in the patient's body for six months , continuing to fight the cancer. Why is Wall Street going wild? This isn't just another biotech announcement—this is a first-of-its-kind human result. Investors are reacting to the possibility that agenT-797 could be a scalable, off-the-shelf alternative to expensive and complicated CAR-T therapies. And because the treatment worked in a solid tumor (traditionally harder to treat with cell therapies), the implications go far beyond just testicular cancer. How did AgenT-797 help a testicular cancer patient become disease-free? The standout case that grabbed attention involved a testicular cancer patient who had exhausted all available treatments, including both standard and experimental options. After receiving AgenT-797, the patient achieved complete remission, with no signs of the disease returning even after 24 months. Live Events Dr. Benjamin Garmezy, Assistant Director of Genitourinary Research at Sarah Cannon Research Institute, described the result as a breakthrough. "We observed a remarkable response in a patient who had exhausted standard and experimental treatments," Garmezy said, as quoted in Oncogene . He added that the case highlights the "powerful potential of iNKT cells" in tackling aggressive cancers where traditional therapies fall short. What makes MiNK's iNKT platform different from other cancer treatments? MiNK's cell therapy, AgenT-797, is not like the typical personalized cell treatments that need to be customized for each patient. It's an allogeneic, or off-the-shelf product—ready for use without waiting for a patient's cells to be engineered. This iNKT cell platform targets solid tumors in a way that activates both innate and adaptive immunity, making it potentially effective against cancers that have been resistant to traditional therapies and even immunotherapy. The company believes this case sets a precedent that could expand the use of iNKT-based therapies in treating other solid tumors beyond testicular cancer. Is AgenT-797 showing results in other types of cancer too? Yes. Another case report, also published in Oncogene , involved a metastatic gastric cancer patient. After a single infusion of AgenT-797 combined with Opdivo—a widely used cancer immunotherapy from Bristol-Myers Squibb—the patient experienced a 42% tumor reduction and over nine months of progression-free survival. These results support the ongoing Phase II trial of AgenT-797 in second-line gastric cancer, which is actively enrolling participants. The promising early outcomes are likely to boost interest and investment in this trial as it moves forward. What about other cancers? MiNK also released encouraging data from an ongoing Phase 2 gastric cancer trial, where agenT-797 showed: Stronger immune activation, and Improved patient survival rates, even in very aggressive tumor types. Is this too good to be true? As always in biotech, one patient does not make a cure. Despite the euphoria, there are a few things to keep in mind: Pros Cons Potentially revolutionary treatment for solid tumors Still very early-stage: just one case of remission No major side effects like GvHD or cytokine storm Limited data; needs larger clinical trials Off-the-shelf therapy = easier to scale than CAR-T MiNK is a small-cap company with limited cash runway What does MiNK Therapeutics' financial health look like right now? As of March 31, 2025, MiNK reported having $3.2 million in cash on hand. While that's a relatively modest amount for a biotech company in active clinical development, the positive clinical results and surging stock price may open new doors for funding or partnerships in the near future. In the past year, INKT stock has moved in a range between $4.56 and $13.79. But today's pre-market rally to $21 marks a dramatic leap, signaling growing investor confidence in the company's science and potential market opportunity. Why does this matter for the future of cancer immunotherapy? The testicular cancer case treated with AgenT-797 offers real-world proof that iNKT cell therapies might have the power to treat cancers that don't respond to anything else. This could change how certain solid tumors are treated, especially in patients with few remaining options. Testicular cancer, though rare—it affects roughly 1 in 250 males in their lifetime according to the American Cancer Society—can become especially difficult to treat when it spreads or resists standard therapies. If MiNK's approach proves consistently effective, it may redefine what's possible in advanced cancer care. MiNK Therapeutics' iNKT-based AgenT-797 therapy is gaining momentum after helping a testicular cancer patient achieve long-term remission, with stock soaring as investors take notice. With ongoing trials in gastric cancer and solid tumors, and early signs of effectiveness, MiNK is now at the center of conversations around the future of off-the-shelf cell therapies in oncology. What's next for MiNK and agenT-797? MiNK is now focused on: Expanding clinical trials for solid tumors and hematologic cancers Securing more funding and possibly Big Pharma partnerships Advancing agenT-797 toward FDA approval MiNK also recently received NIAID funding to study their iNKT therapy in graft-versus-host disease, opening more doors for future applications. FAQs: Q1. What is MiNK Therapeutics' AgenT-797 used for? AgenT-797 is used to treat advanced cancers like testicular and gastric tumors using iNKT cell therapy. Q2. Why did MiNK Therapeutics stock surge 500%? The stock jumped after a testicular cancer patient fully recovered using MiNK's cell therapy, AgenT-797.
Yahoo
11-07-2025
- Business
- Yahoo
MiNK Therapeutics Announces Publication of Complete Remission Following Allogeneic iNKT Cell Therapy in Metastatic Testicular Cancer
New report adds to growing evidence of iNKT cell therapy's potential in solid tumors NEW YORK, July 11, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced the publication of another landmark case in Nature's Oncogene describing a complete and durable remission in a patient with metastatic, treatment-refractory testicular cancer, following treatment with agenT-797, MiNK's allogeneic iNKT cell therapy. Complete remission after failure on platinum-based chemotherapy, autologous stem cell transplant, and multiple ICIs (anti–PD-1, anti–CTLA-4, and anti–TIGIT) The publication, titled 'Salvage therapy with allogeneic invariant natural killer T cells in a heavily pre-treated germ cell tumor,' presents a patient case from MiNK's clinical trial (NCT05108623). The patient had progressed after multiple lines of therapy—including platinum-based chemotherapy, autologous stem cell transplant, and multiple immune checkpoint inhibitors (anti–PD-1, anti–CTLA-4, and anti–TIGIT)—and received a single infusion of agenT-797 alongside nivolumab. The patient achieved a complete clinical, radiologic, and biochemical remission, with no evidence of disease over two years later. Donor iNKT cells were detectable up to six months post-infusion, and treatment was well-tolerated with no cytokine release syndrome (CRS) or graft-versus-host disease (GVHD). 'This case exemplifies the powerful potential of iNKT cells in treating even the most challenging cancers,' said Dr. Benjamin Garmezy, Assistant Director of Genitourinary Research for Sarah Cannon Research Institute at SCRI Oncology Partners. 'We observed a remarkable response in a patient who had exhausted standard and experimental treatments, offering compelling evidence to further pursue clinical studies of iNKT cell therapies in solid tumors.' Durable Responses & Immune Activation in Solid Tumors with Allo-iNKT Therapy These findings are part of a growing body of clinical evidence supporting the potential of agenT-797 in solid tumors. At the 2025 inaugural AACR Immuno-Oncology meeting, MiNK presented data from its Phase 2 trial in 2L gastric cancer, demonstrating immune activation, increased tumor infiltration, and early signals of tumor control in patients previously refractory to checkpoint inhibitors. Notably, extended survival beyond 12 months was observed in several patients—an outcome rarely seen in this setting. These clinical observations were further reinforced in a separate peer-reviewed case report published in Oncogene, which described a patient with metastatic gastric cancer who achieved a 42% tumor reduction and more than nine months of progression-free survival following a single infusion of agenT-797 in combination with nivolumab. Together, these data highlight the potential of agenT-797 to reshape the tumor microenvironment and deliver durable clinical activity, even in heavily pretreated, immunotherapy-resistant cancers. The ongoing Phase 2 trial in gastric cancer (NCT06251973) is actively enrolling, with additional readouts expected in upcoming months. You can access the full publication here. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company advancing a new class of allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK's proprietary platform is designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. The company's lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical development for graft-versus-host disease (GvHD), solid tumors, and severe pulmonary inflammation. MiNK is also advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools that enable highly specific immune targeting across tumor and tissue types. With a scalable manufacturing process and a differentiated mechanism that bridges innate and adaptive immunity, MiNK is committed to delivering accessible, durable, and broadly applicable immune reconstitution therapies. For more information, visit or follow us on X @MiNK_iNKT. Information important to investors is routinely posted to our website and social media channels. About AgenT-797 AgenT-797 is an allogeneic invariant natural killer T (iNKT) cell therapy that harnesses the dual power of innate and adaptive immunity. iNKTs function as 'master regulators,' combining the cytotoxic capabilities of NK cells with T-cell–like antigen recognition and memory. This unique biology enables a robust, pathogen-agnostic immune response that can be directed against hard-to-treat tumors. Manufactured by MiNK Therapeutics in Lexington, MA, agenT-797 is a scalable, off-the-shelf product designed to provide accessible, transformative treatment options. In clinical trials, agenT-797 can bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers (Cytryn et al., AACR IO 2024; Oncogene, 2024), as well as reduce inflammation in critically ill patients with severe respiratory pathology (Nature Communications, 2024). Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Agenus with no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. CONTACT: Investor Contact 917-362-1370 investor@ Media Contact 781-674-4428 communications@
Yahoo
02-06-2025
- Business
- Yahoo
MiNK Therapeutics Awarded Prestigious NIAID Grant to Advance Allo-iNKT Cell Therapy for Prevention of GvHD in Stem Cell Transplant Patients
Non-dilutive NIH funding supports development of MiNK's allogeneic iNKT platform for immune regulation in high-risk HSCT settings NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced it has been awarded a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH). The grant will support development of MiNK's allo-iNKT cell therapy platform for the prevention and treatment of graft-versus-host disease (GvHD) following hematopoietic stem cell transplantation (HSCT), in collaboration with the University of Wisconsin. 'This non-dilutive funding from NIAID underscores the growing recognition of iNKT cells as a unique and powerful modality in immune regulation,' said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. 'The work led by Dr. Gumperz and her team at the University of Wisconsin has provided important mechanistic insights into how allo-iNKT cells may not only prevent graft-versus-host disease (GvHD) but also improve the success of engraftment. Through our preclinical and clinical collaboration, we aim to address the needs of the nearly 50% of patients undergoing allogeneic stem cell transplants who are at risk for this serious and potentially life-threatening complication. This award both validates the promise of our iNKT platform and accelerates its development in a high-priority area of unmet medical need.' GvHD is a severe immune complication that can occur after allogeneic HSCT, often leading to multi-organ damage and high mortality. iNKT cells are uniquely suited for this setting due to their natural ability to regulate immune responses, promote tissue repair, and suppress inflammatory pathways. 'Our partnership with MiNK unites their cutting-edge iNKT manufacturing with our deep expertise in transplant immunology at the University of Wisconsin-Madison,' said Jenny E. Gumperz, PhD, Professor of Medical Microbiology & Immunology, University of Wisconsin School of Medicine and Public Health. 'iNKT cells can calm the destructive allo-immune response that drives GvHD, while preserving the patient's ability to fight infection—a balance current therapies struggle to achieve. NIAID's support allows us to speed this science toward the clinic and, ultimately, give transplant patients a safer path to long-term survival.' About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision-targeted immune technologies. MiNK's proprietary platform is designed to restore immune balance and drive cytotoxic immune responses across cancer, immune-mediated diseases, and pulmonary immune failure. MiNK's lead asset, AGENT-797, is an off-the-shelf, allogeneic iNKT cell therapy currently in clinical development for the treatment of graft-versus-host disease (GvHD), solid tumors, and critical pulmonary immune collapse. MiNK is also advancing a pipeline of T cell receptor (TCR)-based therapies and neoantigen discovery tools that enable tumor- and tissue-specific immune activation with broad potential application. With a scalable, cryopreserved manufacturing process and a differentiated mechanism that bridges innate and adaptive immunity, MiNK is committed to developing next-generation immune reconstitution therapies that are accessible, durable, and applicable across a wide range of indications. For more information, visit or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential, anticipated benefit, plans and timelines of iNKT cells, as well as the collaboration between MiNK and Agenus. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K, Form 10-Q and the S-1 Registration Statement filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK and Agenus with no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact917-362-1370 investor@ Media Contact781-674-4428communications@ Gumpertz et al., Harnessing invariant natural killer T cells to control pathological inflammation. Frontiers. 2022. Gumpertz et al., iNKT cells coordinate immune pathways to enable engraftment in nonconditioned hosts. Life Sciences Alliance. 2021.
Yahoo
16-05-2025
- Business
- Yahoo
Q1 2025 Mink Therapeutics Inc Earnings Call
Jennifer Buell; Independent Director; Mink Therapeutics Inc Christine Klaskin; Independent Director; Mink Therapeutics Inc Operator Thank you for standing by. My name is Rosell, and I will be your conference operator today. 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 start, followed by the number one on your telephone keypad. If you would like to withdraw your question, press start one again. I will now turn the conference call to Jack Jennifer Ball, head of investor relations, 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 those related to our clinical development, regulatory and commercial plans, timelines for data release and partnership opportunities. 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. 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 Doctor Bell to highlight our progress from this quarter. Jennifer Buell Thanks very much, Jack. 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 iNKT cell therapies to patients with solid tumors and other immune-related diseases. In the Q1 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 AACR IO conference, and we showed immune activation and very early clinical activity and responses in patients who were otherwise refractory to checkpoint modulating the capital side, we continue 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 GvHD, which I'll talk about in just a moment. 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 some detail, just a as 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 today I'm pleased to share that we have 3 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 programs. 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 ACR that I'll share with you in a few 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 neo antigen discovery platforms 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 reinforced reinforcing, each bringing differentiated capital, infrastructure, and scientific expertise to accelerate progress within their respective together, these proposals reflect strong external conviction in the value of our iNKT platform and represent a rare opportunity to diversify capital, reduce pollution, 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. 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 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, and as I mentioned at the ASCO GI and AACR IO inaugural meetings, we presented new data from our phase 2 investigator sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian, the chief of gastrointestinal study is evaluating HLA NKTs or agenT-797, in combination with two differentiated checkpoint modulating antibodies, botensilimab and balstilimab. 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 iNKT cells when delivered systemically, they 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 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 PD1 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. We anticipate sharing additional updated clinical updates later this year in the beginning of next 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 1 trial with 797, and they were treated with 797, or alloy iNKTs alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and idget-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 lymph depletion or HLA matching and showed no evidence of cytokine relief syndrome or 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 6 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 ho to tumors, dismantle immunosuppressive barriers, and activate both NK and CD8 T cells. Even in tumors previously unresponsive to immune 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 and hard to treat solid tumors. Beyond oncology, we're continuing to advance 797 in immune-related diseases such as respiratory distress, acute respiratory distress syndrome, and graft versus host disease. Our INKP 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 ARDS, a life-threatening condition with no FDA approved therapies, AgenT-797 is 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 and meaningful inflammatory control and critically ill ventilated patients, many of whom would otherwise face mortality rates exceeding 70%. We, on the other hand, observed survival rates exceeding 70%, truly 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. 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 graft versus host disease, we're prepared to initiate a phase 1 trial, a 797 of patients undergoing allergenic bone marrow transplant. We've spoken to you about this before, and as advancing this program has been in part contingent upon securing financing to be able to advance this really responsibly and efficiently. TBHC remains one of the most severe and unpredictable complications of transplants. Often leading to often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our iNKT approach, which requires no lymph depletion, 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 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. 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, MIC will launch a collaboration of pre-clinical and clinical research with our colleagues and scientific advisors at the University of ARDS and TVVHC represent a large underserved market where MP 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. 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 efficiency in a far less capital-intensive actions further reflect our commitment to financial discipline and operational focus. With that, I'll turn the call over to Christine for a review of the financials. Christine Klaskin Thank you, Jen. We ended the quarter with a cash balance of USD3.2 million cash used in operations for the three months ended March 31, 2025, was USD1.3 million. This is reduced from USD2.5 million for the same period in 2024. Our net loss for the first quarter of 2025 was USD2.8 million or USD0.70 per share. This compares to USD3.8 million or USD1.10 per share for the first quarter of 2024. Thank you. And operator, we are now ready to take questions. Operator At this time, I would like to remind everyone in order to ask a question, press star, then the number one in your telephone keypad. We will pause for just a moment to compile the roster. Your first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead. Hi, good morning. Thanks for taking my questions. This 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 and if you can comment on, I guess your overall plan in testicular cancer going forward and if there's any other indication that you're still looking at. Jennifer Buell 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 12 month follow up period, the patient actually had disease stabilization, and we were monitoring the patient and not less than a year after that, so 24 months, the patients 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 24 after the initial treatment of 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. We are seeing activity by NKTs in 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 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 to the nodule appears to have nothing but dead tissue. Based on all of the scanning that has been completed. 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 appendiceal and gastric. But in those observations when we stopped the, we concluded the follow up period of the trial, we may be underestimating the ultimate clinical benefit of iNKT cells. So, we'll be getting a further clinical sweep of these patients and updating the field on the findings. Okay, great. And on the phase two gastric trial, are you still kind of on track for initial efficacy data in the second half of this year? Jennifer Buell 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 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 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. Lastly, I'm just curious in terms of the funding that you mentioned from the NAYA if you've kind of heard of any changes or delays in government funding just with all this new news lately. Jennifer Buell Well, I'm with you. We, so we had heard of a delay. We expected this at the beginning of the year. So, the 6-month delay is, the delays that we have seen globally have impacted us. However, we're, we were reassured to get a formal notification from NAYA that we can expect to hear that we had probable funding and can expect to hear conclusively in June. NAYA 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 GvHD and better clinical outcomes. So, we're optimistic and the most recent correspondence from the government continues to boost our optimism. Okay great. Thanks for taking the questions. Thank you. Operator Again, if you would like to ask a question, press star one in your telephone cable. Your next question comes from the line of Max with William Blair. Please go ahead. And, one, thanks for the update, wondering if, maybe just go over some of the details of the GVAC trial. Are you still planning on booking acute patients and maybe any thoughts on kind of prior treatments or what type of patients you'll be looking to enroll. Jennifer Buell Yeah. Thanks so much, Matt. So, there are two places where we will ultimately be setting into GvHD, and the first with this financing support and with the priority at University of Wisconsin to bring this forward, 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. That's what we have identified and developed a phase one program for that. We have also developed a phase one 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, but both opportunities for us, I'm going to have Tiago Favano, who's 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. Hi, thanks for your question. So, for the phase one, we're going to explore not only the 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 unmet needs. So based on prior robot literature and some of our own studies, we expect the Ng not only to prevent or combat GvHD, but also to prevent infections, contribute to a better engraftment, faster and better engraftment. And and also prevent maintaining leukemia effects to prevent disease relapse. So we all know that on the treatment of GvHD patients get immunosuppressed and that makes it easier for them to have relapse or infections, which is a major we in this phase one, we are going to observe all these other effects on top of preventing the GvHD. Which paved the way for phase 2 that Jen explained, we will explore in treatment of steroid refractor GvHD and then another opportunity in prevention which represents an even faster way for approval. Jennifer Buell Thanks. And then, I'm going to add something to this. The, 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 is the prophylactic study. Okay, thanks for your please, Jen. Jennifer Buell Thank you, Matt. Operator That ends the session. I will now turn the call back over to Jennifer Buell for closing remark. Please 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. 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