Good morning, and welcome to MiNK Therapeutics First Quarter 2024 Conference Call and Webcast. [Operator Instructions] Please note, this event is being recorded. [Operator Instructions] I would now like to turn the conference over to Zack Armen from MiNK's Investor Relations. Zack, please go ahead.

Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities, among other updates. These statements are subject to risks and uncertainties, and we refer you to our SEC filings, available on our website for more details on these risks. Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer; Dr. Marc van Dijk, Chief Scientific Officer; and Christine Klaskin, Principal Financial and Accounting Officer. Now I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter.

Thank you, Zack. It's a privilege to connect with all of you this morning to discuss our achievements in the first quarter, and the milestones that advance our long-term strategic goals. Today, I will highlight our latest clinical advancements, notably in our leading programs, agenT-797 and MiNK-215. I will also discuss our strength and financial foundation and outline our plans for sustained innovation and growth. Let's start by our progress in streamlining operations and our financials. This quarter, we focused on advancing our pipeline, improving our operational efficiency and fortifying our financial health. Since this time last year, we have successfully reduced our operating expenses by over 45%, through improved manufacturing efficiency, strategic infrastructure alignment and, most critically, the external non-dilutive financing to support our ongoing Phase II trial in second-line gastric cancer. This financial prudence has enabled us to allocate resources more effectively towards accelerating our key clinical programs. Importantly, yesterday, we announced an investment of $5.8 million at a 25% premium, from a new investor committed to our vision. This funding will be dedicated to support the rapid advancement of MINK-215, our innovative CAR-iNKT cell therapy, targeting fibroblast activation protein, or FAP, in solid tumors. MiNK-215 is our lead program from our discovery pipeline that we are particularly excited about. And this investment underscores unique potential of the program. We previously presented data at the American Society of Cell and Gene Therapy showing exciting preclinical activity of MiNK-215 in FAP expressing non-small cell lung cancer tumors. More recently, as a matter of fact, just this past month at the American Association of Cancer Research, or AACR, Annual Meeting, our scientists presented compelling data, demonstrating 215's ability to eradicate tumors in human organoid models of colorectal cancer with liver mets. These recent advancements build on our prior findings and…

Thank you, Jen. Good morning, everyone. I'm Marc van Dijk, and I will provide some further insight into the unique properties and promising potential of our iNKT cell-based cancer therapies, which are uniquely designed to maximize efficacy on solid tumors to two key differentiators -- actually three: targeted tissue homing, relief of immune suppression, and the avoidance of lymphodepletion, and the latter is very, very important for the overall outcome of cancer treatment in our opinion. Our clinical data covering 80 patients across cancer and severe pulmonary disease, indicates that our lead iNKT T cell therapy, agenT-797, rapidly translocate from the bloodstream to essential tissues such as the liver and the lungs. Importantly, these cells remain active and detectable for up to 6 months, post infusion. This prolonged presence is elemental as it significantly amplifies the body's own immune response, enhancing the potential for durable therapeutic effects in cancer and other immune-related diseases. Turning to our latest advancements, I'd like to focus on MiNK-215, the subject of our news this week and differentiated first-class armored CAR-iNKT therapy, targeting fibroblast activating protein, or FAP for short. This therapy is specifically engineered to counteract the challenging immunosuppressive environment found in epithelial origin tumors, including colorectal and non-small cell lung cancer. In preclinical models, we've previously reported that MiNK-215 showed robust efficacy in small cell lung cancer models, resulting in substantial tumor elimination in the lung and improved survival compared to T cell alone. These findings were commensurate with restoring the killing capacity of partially exhausted T cells and increasing T cell infiltration, which is consistent with the natural properties of native iNKT cells. We further reported that MiNK-215 specifically targeted and eliminated type expressing cancer-associated fibroblasts, thereby disrupting the tumor promoting stromal network, and reducing immune suppression in the local tumor microenvironment.…

Cash balance of $5.8 million. This is prior to the receipt of the funds Jen mentioned earlier. Cash used in operations for the 3 months ended March 31, 2024 was $2.5 million, compared to $4.4 million for the same period in 2023. Net loss for the first quarter of 2024 was $3.8 million or $0.11 per share, compared to a net loss of $5.7 million or $0.17 per share for the first quarter of 2023. I will now turn the call back over to the operator for questions.

[Operator Instructions] And your first question comes from the line of Emily Bodnar with H.C. Wainwright.

A few for me, I guess. So first one, if you can maybe comment on how the enrollment in the Phase II [Gastric cancer trial] has been going so far since you enrolled the first patient in February. And then could you maybe clarify how many patients are expected to be treated with each of the three treatment arms in that study? And then last question is a bit of a financial question. But given your operating expenses have decreased quite a bit this quarter, could you maybe just comment on what your current priorities are pipeline-wise and which indications you're kind of focusing on, and which ones are kind of taking more of a back burner at the moment?

Emily, thank you very much for your question. We'll start with your first question, which is about enrollment into the Phase II gastric cancer trial. So maybe just as a reminder, this trial did not require us to do -- to wait to do essentially a 28-day wait between patients. So we were able to enroll patients very quickly, into the trial and continue to do so. And that allows us to get exposure to patients that will get the cells alone, the cells plus [indiscernible] -- the cells plus [indiscernible] and [ RamTex ] standard of care in second line gastric cancer. We have been able to dose -- we have not specified on publicly yet the number of patients in each cohort. But suffice it to say, we will have a requisite number of patients that will not only allow us to demonstrate safety of each of these products alone and in combination, but also activity so that we could decouple where we see the most pronounced benefit for patients. And essentially, in about a 40-patient study, we will be able to tease out contribution of components to some extent as we start to expand the cohorts and deepen signals in the areas that we see the most profound benefit. We do believe that mechanistically that the combination of [indiscernible] with standard of care, may not only be quite beneficial to patients, but also quite tolerable. And we've been able to demonstrate that so far in the first patients who have been enrolled. We do have patients that have been exposed to all five agents and those patients are tolerating the combinations quite well, and we're pretty excited to share an update on those, which we expect will be the second half of this year. Given the pace…

Your next question comes from the line of Jack Allen with Baird.

I guess the first question I had was on the 215 program. As you just look to advance that asset into the clinic, what sort of solid tumors do you expect to study that? And how do you think about the clinical development there? And then I have a few follow-ups on both the ARDS program and then also a question about where you think you sit in graft versus host disease as well?

Excellent. Well, Jack, let's start with the first, which is 215. Now, as we approach the clinic, we've been able to interrogate a lot of preclinical functionality of the molecule and determine where we believe this could be best fit and most impactful in the clinic. Obviously, FAP expressing tumors would be our area of great interest. We will explore the asset more broadly, but with an emphasis and FAP expressing colorectal cancers. This is an area of high unmet need. We know that the disease is really growing in prevalence and incidents in a younger population, and there's an urgent need to move therapy forward as quickly as possible. And the preclinical data we presented at AACR, really demonstrates the potential of this molecule in FAP expressing colorectal cancer. Similarly, we shared some very exciting data in a FAP expressing non-small cell lung cancer, preclinical models. Those are some very obvious unmet areas of need where we believe there's not only a development opportunity, but we have a molecule that can actually biologically address the gap that we're currently observing in patients with FAP expressing tumors in lung as well as in colorectal. So that's where we're starting. Of course, we will interrogate the molecule and a couple of other disease indications, expressing FAP sarcoma represents another one. But this is an opportunity for us to pursue and even optimize and accelerate development by the identification of patients with FAP expressing tumors with a large emphasis in non-small cell lung cancer and colorectal cancer.

Got it. That's great color. And then as it relates to ARDS, where do you think it fits as it relates to securing that external funding, what are the potential aspects that need to be buttoned out there before you have that funding? And then on graft versus host disease, I believe there was also a previous discussion of an external program there. I'd love to hear any updates, as it relates to that getting off the ground as well.

Absolutely. So on the external funding, we have the platform trial identified and the team that essentially is responsible for the operational execution of that platform trial is -- and has already designed the protocol and started activating centers. We have agreed to the terms of the contract, and we're just making some final modifications with respect to the budget allocation over time, which we expect we should wrap up sometime, even as early as by the end of this week. That's our goal to do so, and then we would be announcing it shortly thereafter. On graft versus host disease, we are pursuing an investigator-sponsored trial. This is an area, of course, of unmet need. And Jack, you did a brilliant job in summarizing not only the potential of the cells in this indication, we've also deepened our own scientific insights into how these molecules and these cells may actually have a profound effect, in not only mitigating but then preventing graft versus host disease in patients who are undergoing hematopoietic stem cell transplantation. We have not yet announced the launch of that program. So we have designed the program, but we have not yet accumulated the financing that would be necessary to launch it. So during this time, we are being really quite prudent about our focused efforts in the clinical programs that we're advancing. But we will continue to find ways to get graft versus host advancing. And this is a priority for us to be able to do so, but it's not an area that, at this very moment, we can allocate capital to doing at this time.

Got it. That makes a lot of sense. Congratulations again on the progress.

Your next question comes from the line of Matt Phipps with William Blair.

On the FAP CAR, I know in a lot of the preclinical work you have done, you've combined it with other therapies, including other kind of a TCR directed T cells. And just curious how you think of a monotherapy activity of this or if it isn't and has to be combined, whether the IL-15 addition is something that can drive enough activity or again, really should think about this being combined with other things.

Matt, this is an excellent question. And we have invited a couple of special guests onto the call today, who are leading up this effort that includes the interrogation of 215 as a monotherapy and the kind of efficacy that we're observing with the molecule in that capacity, which would be really important milestones for us, to demonstrate monotherapy activity. And in the case that we may need to expand that and address other tumor escape mechanisms, we are in parallel exploring where those optimal combinations may take. So there are three people on the line, and you'll be familiar with them. And this is Dr. Dan Chen. He's the Head of Discovery at Agenus, one of the inventors on botensilimab and leading up our discovery in combination efforts at Agenus. Dr. Nils Rudqvist, who you may not have met before. Nils is an accomplished scientist who joined us from MD Anderson Cancer Center. He was associate professor there. And prior to that, he was at Weill Cornell working in the Radiation and Oncology Department. And his emphasis is really on optimizing immune biology and determinants of how to modulate the tumor microenvironment and enhance efficacy. Eleni is also our Head of Discovery in our Cambridge U.K. site for MiNK Therapeutics. And this team together has been working to address exactly this question. I'm going to turn it to Dan just to lead in and give you a quick review of how we're thinking about this. And from my perspective, our goal will be to launch, interrogate monotherapy activity, particularly in FAP expressing tumors, which would give us the most rapid development path forward, and identify areas, where we want to expand efficacy with combinations. And I'll turn it over to Dan to give you some deeper insight and he could work with Eleni and Nils and give you a deeper response to your question.

Thank you for the question. So to the first part, we do expect monotherapy activity with MiNK-215 and for several reasons based on the preclinical data. First, in preclinical models, we observed direct tumor killing of FAP expressing cells, including FAP expressing cancer [indiscernible] fibroblast and tumor cells. In turn, we've observed that post -- there was a massive infiltration of T cells within the two microenvironment, which is particularly evident in cold tumors, like liver metastases or other tumor models that we've tested. So we do expect monotherapy activity, given the ability to promote T cell infiltration and we've modeled the two macro environment to enhance T-cell responsiveness, we expect this to be an ideal combination partner with [indiscernible], particularly in areas where we have seen nonresponsiveness to PD-1, CTLA-4, which includes both the liver metastases model as well as pancreatic models, in situations where the tumors are refractory to [indiscernible], adding iNKTs, including MiNK-215, can open up a response to checkpoint therapy and indeed promote monotherapy activity as well.

Thank you, Dan. Matt, did you have any other questions?

No, that's it for me. Thank you.

Okay. And with that, that concludes our Q&A session. I will now turn the conference back over to Jennifer Buell for closing remarks.

Thank you very much, and thank you all for joining us today. We look forward to continuing to keep you updated on our progress and advancements with a real focus on advancing our clinical stage programs, continuing to strengthen our financial foundation, and deliver innovative medicines to patients with cancer and other immune-mediated diseases. And I appreciate your time today.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.