Latest news with #JenniferBuell
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02-06-2025
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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.
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16-05-2025
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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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Yahoo
15-05-2025
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MiNK Therapeutics Reports Q1 2025 Results and Highlights Clinical & Strategic Progress
Clinical data builds with CR in testicular cancer, enrollment in Phase 2 gastric trial, and new data in PD-1–resistant tumors Near-term capital transactions poised to bolster liquidity NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced its financial results for the first quarter of 2025 and provided a business update highlighting continued clinical progress and strategic developments across its iNKT platform. The company will host a conference call and webcast today at 8:30 a.m. ET. 'This quarter marks a turning point in the evolution of MiNK. Our platform is demonstrating the power of iNKT cells to transform immune responses in both cancer and inflammatory diseases,' said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. 'With late-stage strategic discussions underway across oncology, immunology, and next-generation engineered cell therapies, MiNK is positioned to unlock the full value of our technology. These partnerships—alongside our clinical advances and expanded access to non-dilutive capital—will allow us to deliver off-the-shelf iNKT therapies to patients with urgency, focus, and scale.' Key Highlights from Q1 2025 Strategic and Business Development Advanced discussions on distinct transactions aligned with core areas of MiNK's platform--oncology, immune-mediated diseases, and next-generation engineered cell therapies--designed to broaden MiNK's reach while preserving optionality and shareholder value. Clinical Progress in Cancer, Immunity, and Inflammation MiNK continues to expand the clinical and strategic value of its iNKT platform across solid tumors and immune-mediated diseases. At AACR IO and ASCO GI, MiNK presented new data showing that agenT-797, in combination with checkpoint inhibitors and chemotherapy, drives rapid tumor infiltration, CD8+ T cell activation, and immune reprogramming in PD-1–resistant gastroesophageal cancers—a population with limited therapeutic options. A Phase 2 trial (NCT06251973), led by Memorial Sloan Kettering Cancer Center, is actively enrolling in second-line gastric cancer. A peer-reviewed publication expected in the first half of 2025 will detail a complete remission in a patient with metastatic testicular cancer treated in MiNK's Phase 1 trial with a single infusion of agenT-797—achieved without lymphodepletion, HLA matching, or toxicity. This case reinforces the differentiated potential of MiNK's off-the-shelf iNKT platform in solid tumors that are refractory to standard treatments and immunotherapy. In ARDS, MiNK's iNKT therapy continues to demonstrate survival benefit and inflammatory control, as published in Nature Communications and presented at the American Thoracic Society. The company is pursuing broader patient access through clinical trials and compassionate use programs. In parallel, MiNK has been selected for probable funding by NIAID to support its allogeneic iNKT program in GvHD, with a formal award expected by June 2025. This recognition adds a critical source of non-dilutive capital and external validation of MiNK's leadership in inflammation and immune modulation. Together, these programs represent high-value expansion opportunities across MiNK's core verticals: solid tumors, inflammatory disease, and next-generation engineered cell therapies. Financial Highlights MiNK 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 compared to $2.5 million for the same period in 2024. Net loss for the first quarter of 2025 was $2.8 million, or $0.70 per share, compared to $3.8 million, or $1.10 per share, for the first quarter of 2024. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) March 31, 2025 December 31, 2024 Cash and cash equivalents $ 3,235 $ 4,577 Total assets 4,267 5,721 Other Financial Information (in thousands) (unaudited) Three months ended March 31, 2025 2024 Cash used in operations $ 1,341 $ 2,542 Non-cash expenses 835 650 Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) Three months ended March 31, 2025 2024 Operating expenses: Research and development $ 1,262 $ 2,550 General and administrative 1,271 1,280 Change in fair value of related party note 168 Operating loss 2,701 3,830 Other income, net 66 (17 ) Net loss $ 2,767 $ 3,813 Per common share data, basic and diluted: Net loss $ (0.70 ) $ (1.10 ) Weighted average number of common shares outstanding, basic and diluted 3,965 3,464 Conference Call Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada) Conference ID: 9822477 Webcast A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company's website at and via About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. 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. 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) and to combat 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, 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 Contact 917-362-1370 investor@ Media Contact 781-674-4428 communications@
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18-03-2025
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MiNK Therapeutics Reports Fourth Quarter & Full Year 2024 Results and Highlights Business Progress
NEW YORK, March 18, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced its financial results for the fourth quarter and full year 2024, highlighting significant business progress and clinical advancements. The company will host a conference call and webcast at 8:30 a.m. ET. 'Throughout 2024, MiNK advanced its mission to bring off-the-shelf iNKT cell therapies to patients fighting hard-to-treat cancers and severe immune-related disorders,' said Dr. Jennifer Buell, President and Chief Executive Officer of MiNK Therapeutics. 'We made significant clinical strides, strengthened our manufacturing foundation, and forged strategic alliances. Through disciplined capital management, we are positioned to scale efficiently and seize new collaboration opportunities for value creation. With our rapid AI-driven drug discovery platform generating a world-class library of phosphorylated neoantigens and proprietary TCRs, MiNK is uniquely poised to progress a new standard in oncology and beyond.' Operational Highlights Clinical Advancements Expanding Benefit in Where Standards Fail: Presentations at leading oncology conferences—including AACR IO, ASCO GI, and SITC—demonstrated that AgenT-797 enhanced immune activation, improved checkpoint inhibitor efficacy, and augmented bispecific engagers in heavily pretreated patients and preclinical models. A Phase 2 Investigator-Sponsored Trial (Memorial Sloan Kettering Cancer Center) in second-line advanced gastric cancer (NCT06251973) is actively enrolling. Early data suggest promising activity when combining AgenT-797 with botensilimab/balstilimab (BOT/BAL) and chemotherapy. Immunologic Activity in Inflammatory Lung Conditions (): Published results in Nature Communications and presented at the American Thoracic Society (ATS) showed AgenT-797's potential in acute respiratory distress, with an approximately 80% survival rate among VV ECMO patients versus 10% in hospital controls. Late-stage trials are designed and planned for upcoming discussion with the regulatory agencies. Next-Generation iNKT Programs PRAME-TCR iNKTs: Demonstrated high specificity and potent tumor-killing against intracellular cancer targets resistant to conventional therapies. MiNK's expertise in accessing a proprietary library of phosphorylated peptides and personalized neoantigens supports the generation of high-quality TCRs. MiNK-215 (IL-15 Armored CAR-iNKT): Robust anti-tumor activity in models of metastatic colorectal cancer, reshaping the immunosuppressive tumor microenvironment. These data, including exciting findings from AACR IO on the importance of neoantigen targeting, underscore MiNK's commitment to evolving next-generation iNKT treatments that could potentially tackle the most challenging cancer types. Strategic Growth and Manufacturing Optimization MiNK's state-of-the-art manufacturing process enables the production of billions of donor-derived iNKT cells per run, scalable to support rapid global distribution, aimed at reducing logistical hurdles, cost, and enhancing patient access. In October 2024, MiNK entered into a research collaboration with Autonomous Therapeutics to develop precision RNA-iNKT therapies for metastatic tumors. This collaboration is actively underway. In 2024, MiNK raised $5.8M in private financing and is prioritizing externally funded clinical trials to effectively sustain and advance its iNKT cell programs. 'We believe MiNK Therapeutics is on solid footing to pioneer the next generation of cell therapies,' added Dr. Buell. 'We will continue to pair scientific discipline with operational rigor, a strategy designed to enable value-inflection in 2025 and beyond.' Financial Highlights We ended the year with a cash balance of $4.6 million. Cash used in operations for the three and twelve months ended December 31, 2024, was $1.7 million, and $9.6 million, respectively, compared to $3.0 million and $15.8 million for the same periods in 2023. Net loss for the year ended December 31, 2024 was $10.8 million, or $2.86 per share, compared to net loss for the same period in 2023 of $22.5 million or $6.54 per share. Summary Consolidated Financial Information Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) December 31, 2024 2023 Cash and cash equivalents $ 4,577 $ 3,367 Total assets 5,721 4,552 Other Financial Information (in thousands) (unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Cash used in operations $ 1,728 $ 3,036 $ 9,555 $ 15,763 Non-cash expenses 757 1,155 770 3,798 Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) Three months ended December 31, Year ended December 31, 2024 2023 2024 2023 Operating expenses: Research and development $ 1,406 $ 3,311 $ 6,336 $ 15,490 General and administrative 809 2,189 4,314 7,431 Change in fair value of related party note 288 - 638 - Operating loss 2,503 5,500 11,288 22,921 Other income, net (39 ) (41 ) (503 ) (463 ) Net loss $ 2,464 $ 5,459 $ 10,785 $ 22,458 Per common share data, basic and diluted: Net loss $ 0.62 $ 1.58 $ 2.86 $ 6.54 Weighted average number of common shares outstanding, basic and diluted 3,957 3,456 3,773 3,436 Conference Call Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada) Conference ID: 8023784 Webcast A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company's website at and via About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. 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. 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) and to combat 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, 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 Contact 917-362-1370 investor@ Media Contact 781-674-4428 communications@ in to access your portfolio
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24-02-2025
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MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting
Addition of AgenT-797 with Checkpoint Inhibitors, BOT/BAL, and Chemotherapy Demonstrates Robust Immune Activation, Offering Potential to Overcome Refractory Gastric Cancers NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today presented new translational data from its ongoing Phase 2 study of allo-iNKTs, agenT-797, at the American Association for Cancer Research (AACR) IO Annual Meeting in Los Angeles, California. The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastroesophageal cancer (NCT06251973). 'We are encouraged by these latest data that demonstrate a powerful synergy between MiNK's allo-iNKT cells, checkpoint inhibitors, and approved chemotherapy, sparking robust immune reactivation and clinical activity in otherwise unresponsive tumors,' said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. 'These findings underscore our unique position in the cell therapy space, highlighting iNKT cells' potential to transform both access and efficacy for patients. By intensifying immunologic activity, reinvigorating memory T cells, and driving anti-tumor immune cells into the tumor microenvironment, this combination has the potential to deliver durable clinical benefits. We are excited to further investigate the clinical impact of this promising combination.' Highlights: Combinations Optimize Anti-tumor Immunity Early induction with MiNK's allogeneic iNKT product, agenT-797, drove broad immune activation—a hallmark of potential durable responses. Investigators report significant increase in interferon-gamma (IFNγ) levels, along with enhanced tumor infiltration by T cells and antigen-presenting cells (APCs), signaling robust systemic immune engagement. These biomarkers typically correlate with improved clinical outcomes and a sustained anti-tumor immune response, reinforcing the potential of this combination in solid cancers. Treatment Sequencing Matters The most pronounced immune expansion and strong peripheral memory T-cell activation were seen when agenT-797 was given concurrently with checkpoint inhibitors and before standard chemotherapy. This underscores the critical importance of treatment sequencing, positioning early allo-iNKT induction as a key driver of therapeutic benefit. Strategic Advantages Allogeneic, Off-the-Shelf Platform: MiNK's scalable manufacturing process generates billions of donor-derived iNKT cells in a single run, yielding thousands of doses for rapid global distribution. This approach reduces logistical hurdles and lowers costs, enabling greater patient access worldwide. Differentiated Pipeline: MiNK's iNKT platform supports expansion into additional hard-to-treat cancers, creating significant opportunities for pipeline breadth, partnerships, and long-term growth. Presentation Details: Abstract Title: Biomarker analysis from Phase 2 study of AgenT-797 (invariant natural killer T-cells), botensilimab (a Fc-enhanced CTLA-4 Inhibitor) with balstilimab (anti-PD-1) in PD-1 refractory gastroesophageal cancer (GEC) Presenting Author: Dr. Samuel Cytryn, Memorial Sloan Kettering Cancer Center, New York, New York Oral Session: Proffered Papers, Session 2; 1:39-1:45 p.m. PST Poster Session: Poster Session, A; 1:45-4:45 p.m. PST Date: Monday, February 24th The presentation will be available on the publications page of the MiNK website at following the start of the conference session. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. 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. 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) and to combat inflammation in critically ill patients with severe respiratory pathology (Nature Communications. 2024). About Botensilimab (BOT) and Balstilimab (BAL) Botensilimab (BOT) is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to 'cold' tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Both molecules are manufactured by Agenus. 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 Contact 917-362-1370 investor@ Media Contact 781-674-4428 communications@
