Emily Bodnar - H.C. Wainwright:.

Thank you for standing by. I would like to welcome everyone to the MiNK Therapeutics Third Quarter 2024 Financial Results. I would now like to turn the call over to Alexa Buffa from MiNK's Corporate Communications. 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, time for data releases, 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, Christine Klaskin, Principal Financial and Accounting Officer, Dr. Nils Rutquist [ph], Director of Research, and Dr. Paul Ibbett, Scientist at MiNK.

Now, I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter..

Thank you, Alexa. Good morning, and thank you all for joining us today. Today, we will share progress and updates from the third quarter of this year, highlighting developments we've made in advancing our platform, actualizing the potential of this powerful subclass of T-cells, these allogeneic Invariant Natural Killer T-cells, or INKTs.

With our fully integrated discovery platform, engineering expertise and manufacturing innovation, we're poised to deliver what we believe to be the most scalable and transformative cell therapy platform for patients facing cellular tumor cancers and other immune-related diseases.

Importantly, we have the capacity to truly democratize access to these innovative therapies, enabling their development and application beyond rare disease settings and expanding the treatment possibilities for a much broader patient population and much broader set of diseases.

We've been able to make this progress with even further operating efficiencies and reductions in operating burn by nearly an additional 60% at the same time from last year alone.

While this is in large part a cost offset by external funding of our clinical programs, we've continued to develop manufacturing efficiencies that reduce our cost of goods and increase scale and production capacity.

We remain acutely aware of our cash position, and while we look forward to strengthening this position, we will continue to identify additional areas for cost containment and efficiency. I'd like to begin the call today by informing you of a key addition to our leadership team. Just a couple of weeks ago, we welcomed Dr.

Robert or Bob Kadlec to our Board of Directors. Dr. Kadlec's decades of experience in public health and biodefense, including his role as Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services brings immense strategic value to MiNK. Dr.

Kadlec spearheaded critical initiatives in pandemic preparedness, emergency response coordination, and medical countermeasure development.

His insights into public-private partnerships and comprehensive health strategies will be invaluable as we expand the application of our iNKT cell platform, particularly in tackling infectious disease and high-impact health challenges.

In addition to strengthening our leadership, we've made advancements in our clinical programs and advancements in our preclinical progress. On the clinical front, our lead program, 797, is progressing in a Phase 2 trial for second-line gastric -- advanced gastric cancer at Memorial Sloan Kettering Cancer Center.

This trial incorporates flotetuzumab, valfilumab [ph], chemotherapy, on top of our iNKT cell therapy. Data from the first half of the patient cohorts treated indicate very promising signals of efficacy or activity compared to existing treatment options. We look very forward to presenting these data in a major oncology conference in early 2025.

Furthermore, data presented last week at the Society for Immunotherapy of Cancer, or SITC, annual meeting showcased wonderful progress of our iNKT cell therapy program, highlighting the significant potential of 797 to expand the benefit of immune checkpoint inhibitors, as well as bi-specific engagers in areas where we have seen these approaches fall short in the clinic.

Additionally, we presented data on our novel PRAME-TCR, designed to address the unmet needs of intracellular targeting to eradicate PRAME-expressing tumors.

These findings underscore the unique mechanisms of iNKT cells, highlight the activity of our platform to create high-throughput medicines quickly, and show that we can enhance the effectiveness of commonly used therapies through strategic synergistic combinations.

These advancements offer promising new strategies for patients with challenging diseases. To provide more detail on our findings presented at SITC, I'd like to turn the call over to Dr. Nils Rutquist and Dr. Paul Abbott to give you an overview.

Nils?.

Thank you, Jen. At SITC last weekend, we continued building on our Phase 1 data, which demonstrated that agents 797, whether used as a monotherapy or in combination with anti-PE1 therapies like nivolumab or pembrolizumab, achieved durable disease control in heavily pre-treated polytumor patients.

Our new preclinical data presented at SITC expanded on those findings and demonstrated mechanistically that agents 797 and immune checkpoint therapies reinvigorated killing by exposed T-cells by engaging and activating the important subset myeloma cells.

This year, we also demonstrated that agents 797, when combined with bi-specific agents, targeting antigens such as MUC16, HER2, Claudin 18.2, and DLL3, resulted in increased T-cell activation, more effective tumor cell killing compared to T-cells from the periphery, and the secretion of pro-inflammatory cytokines.

This data shows the position of agents 797 as a compelling addition to combination regimens for solid tumors with the potential to amplify the impact of existing treatments. Now, I'll hand it over to Dr. Paul Ibbett to discuss our PRAME-TCR- iNKT program..

Thank you, Nils. We are excited to present our PRAME-targeted TCR-iNKT T-cell therapy at SITC last week.

This next-generation, allogeneic, off-the-shelf therapy offers a gene-editing-free approach that can be administered without lymphodocytin or GvHD to overcome the limitations of conventional T-cell therapies in PRAME-positive solid tumors like non-small-cell lung cancer, ovarian cancer, melanoma, and sarcoma.

Our pre-clinical studies showed that PRAME TCR-iNKT are highly scalable, exhibit precise and potent PRAME-specific tumor cell killing, and retain the full activity of their natural and variant TCRs.

By leveraging the dual functionality of these iNKTs, which bridge innate and adaptive immunity, this therapy represents a promising option for improving treatment outcomes for patients facing difficult-to-treat cancer..

Thank you, Nils and Paul. An important component of our program and our progress that was also presented at SITC is an expanded glimpse of data from our Phase 1 studies, where we have continued to ascertain data on heavily pretreated patients who are now beyond a median of 12 months of overall survival follow-up.

What we've observed is that we've continued to see long-term disease stabilization and a lack of progression in the patients treated. These data further underscore the persistence of these cells and the immune modulation that they induce clinically.

As we mentioned during our last call, in addition to the program that we have advancing in gastric cancer already activated and enrolling with enrollment expected to complete by mid-next year, we've also identified expert investigators and a program to advance iNKT cells, Agent 797, in patients with graft-versus-host disease.

And I'm pleased to provide a brief update on the advancements that we've made in this program since our last engagement.

We are focusing primarily on the prevention and treatment of acute GvHC, a significant complication following allogeneic hematopoietic stem cell transplantation, and other factors that affect transplant outcomes, such as chronic GvHC, disease recurrence, and post-transplant infection.

Our lead candidate, Agent 797, has demonstrated the potential to modulate immune responses effectively without triggering graft-versus-host reactions.

And in fact, what we have observed pre-clinically, as well as in some of our preliminary data through our collaboration, is that iNKTs, in fact, mitigate graft-versus-host disease biologically and immunologically.

This is particularly impactful for patients who experience severe GvHC, which can affect major organs and lead to higher morbidity and mortality. Our ongoing implementation of a Phase 1 trial in collaboration with leading institutions in the U.S.

and Europe target patients who have undergone hematopoietic stem cell transplant and are at a high risk for developing GvHC and other undesired outcomes. We are currently in the activation phase after having defined the optimal protocol design.

And in parallel with the Phase 1 clinical study activation, we are further advancing pre-clinical investigations in collaboration with Dr. Jenny Dunford's [ph] laboratory at the University of Wisconsin School of Medicine and Public Health.

This project will conduct pre-clinical studies to evaluate 797's efficacy in reducing and eliminating graft-versus-host disease and improving immune engraftment post-stem cell transplantation. We expect that this project to receive feedback from submitted grant funding later this month.

And finally, earlier this quarter, we announced a collaboration with Autonomous Therapeutics. By combining their encrypted RNA or encRNA technology with MiNK iNKT T-cell therapies, 215 and Agent 797, we aim to develop innovative solutions for targeting metastatic cancer cells more effectively.

This partnership represents a significant step forward in enhancing clinical outcomes and delivering better patient care through cutting-edge technology. We're encouraged by our progress this quarter. We remain focused on accelerating our programs to bring these therapies to patients in need.

And at the same time, of course, we continue to prioritize our financial discipline and explore strategic initiatives to strengthen our financial position. Our goal is to ensure we have the necessary resources to support our growth and the development of our iNKT T-cell therapy platform.

Thank you to the entire MiNK team and our partners for your continued dedication and support. I'll now turn the call over to Chris to review our financials..

Thank you, Jen. MiNK ended the quarter with a cash balance of $6.3 million, reflecting cash used in operations for the three months and nine months ended September 2024 of $3 million and $7.8 million, respectively. This is significantly reduced from cash used in operations of $7.8 million and $12.7 million for the same periods in 2023.

Net loss for the three months and nine months ended September 30, 2024 was $1.8 million, or $0.05 per share, and $8.3 million, or $0.22 per share, respectively. This compares to $5.1 million, or $0.15 per share, and $17 million, or $0.050 per share, for the same periods in 2023. I will now turn the call back over to the operator for questions..

Thank you. [Operator Instructions]. We will begin our question-and-answer session. And your first question comes from the line of Emily Bodnar from H.C. Wainwright. Line's open..

Hi. Hi. Good morning. Thanks for taking the questions.

I guess first one, maybe just comment on how enrollment's been going in the Phase 2 gastric study relative to your internal expectations and kind of frame how we should be thinking about the data update in early 2025 in terms of how many patients we might see and what kind of endpoints you might release? And maybe just on the financial side, for R&D expenses, it looks like that's been declining quite significantly this year.

What are the main factors that are driving that, and what are you kind of prioritizing on the R&D front right now? Thank you..

Emily, thank you very much for your call and your questions and continued support. And the gastric trial, it's, of course, progressing relatively rapidly, I would say. This is a second-line setting and patients are getting multiple -- a combination of multiple agents, which is first of its kind.

And we started out by conducting an induction period with the cells alone and then adding in the combination with BOT/BAL and subsequently standard of care chemotherapy. We're close to halfway done with enrollment at this point.

And given that we started essentially in the end of the first quarter of 2024, we have some patients that have quite a bit of mature data. So we will be looking forward to some informative updates at the upcoming conference that'll take place early in 2025.

And I'll leave it there because it is an IST and the data and the presentation will be in the hands of Dr. Yelena Janjigian and her team.

But we're quite enthusiastic about some of the observations that we're seeing to-date, not only with clinical activity, but also with tolerability in that type of a combination, which in the setting of second-line gastric cancer, there is nothing for these patients.

So to have something that actually can have disease modulating properties and on top of standard of care is quite exciting for us. So more to come on this. Enrollment continues. And so we'll give an update at the trial that will also give you insights into where we are with enrollment and where we will be by mid-year next year.

Regarding the R&D expenses, you're right. And we've been doing an immense amount of work to really maximize our efficiencies that we have internally. And part of that is scalability and manufacturing.

So with the donor-derived product, we have a couple of obligations, which include accessing the donor and then conducting viral testing for regulatory purposes to ensure clearance. And those are somewhat costly. What we've been able to do with our manufacturing now is to really exploit and exponentiate the scalability with a single donor.

So we've really reduced our cost of starting material for cell manufacturing right now. And that's made an enormous impact financially for us. So while we continue the activities, we're advancing our MiNK-215 program towards IND.

And we're also continuing, as you've seen from the SITC posters, new innovations in our pipeline that address areas of unmet need. We are also reducing costs associated with our operational expenses and particularly giving our manufacturing innovation. That's where we're having the highest return for our scientific endeavors..

Okay, great. Thanks for the color..

Thank you..

Thank you. Our next question comes from the line of Jack Allen from Baird. Your line's open..

Hi, this is Charlie on for Jack. Thank you for taking the question. We were just wondering if you could provide any more color on the trial design and endpoints for the graft-versus-host disease program and maybe what you'd like to see from this trial. Thank you..

Hi, Charlie. Thanks for your call and inquiry. I'll tell you, this is -- we are going to be hosting one of the lead investigators on the trial at a subsequent call because I would like to have all of you have an opportunity to actually hear directly from the designer here.

And this is a world expert who's done quite a bit of work with cell therapies and patients with the graft-versus-host disease. And she's at Moffitt at this time.

So we're continuing to advance on the design to get this trial through the reactivation period and into a first-in-man, which we plan to do next year, [indiscernible] going to hematopoietic stem cell transplantation with elevated risk factors for acute GvHD.

The eligibility will include patients that receive allogeneic stem cells with identified risk markers to ensure organ function, minimal active infections at the end of treatment. When you look at the landscape of trials here of an intended patient population that's very similar to this, there aren't very many therapies at this point.

Patients are predominantly managed with standard of care corticosteroids. Some patients will get a BATACET, some patients will get JAPA-C, but to a much lesser extent, and still more than half of those patients will progress to acute GvHD, which is incredibly problematic in this patient population.

So from the design of this program, we are going to really, and based on the mechanism of action of these cells, look to mitigate not only improving the effectiveness of corticosteroids, that's what's most widely used in this syndication.

So we will be providing more color, particularly around the launch of the program, bearing with you the sites that have been selected, the leadership of the trial, and the more formal design in our next earnings fall..

Great. Thank you for the color..

Thank you..

Thank you. Seeing as there are no more questions in the queue that concludes our question-and-answer session. I will now turn the call back over to Jennifer Buell for closing remarks..

Thank you, operator, and thank you all again for your continued support. Looking forward to our next call. Take care..

Ladies and gentlemen, that concludes today's call. Thank you all for joining. Have a pleasant day..