Q3 2024 MiNK Therapeutics Inc Earnings Call
Thank you for standing by.
Speaker Change: I would like to welcome everyone to the <unk> Therapeutics third quarter 2024 financial results.
Speaker Change: I'd now like to turn the call over to Al let say a buffer from next corporate communications. Please go ahead.
Speaker Change: Thank you operator, and thank you all for joining US today today's call is being webcast and will be available on our web site for replay.
Speaker Change: Just to remind you that this call will include forward looking statements, including those related to our clinical development regulatory and commercial plans.
Speaker Change: For data releases and partnership opportunities.
Speaker Change: These statements are subject to risks and uncertainties. Please refer to our SEC filings available on our website for a detailed description of these risks.
Speaker Change: Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer, Christine Clarke, and principal financial and Accounting Officer, Dr. Radcliffe Director of research and Dr. Paul E that scientists.
Speaker Change: Now I'd like to turn the call over to the Doctor Butyl highlight our progress from this quarter.
Speaker Change: Thank you Elisa good morning, and thank you all for joining us today.
Doctor Butyl: 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 step class of T cells. These allogeneic invariant natural killer T cells or I N K T's.
Doctor Butyl: 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 solid tumor cancers and other immune related diseases.
Doctor Butyl: Importantly, we have the capacity to truly democratize access to these innovative therapies, enabling their development and applications beyond rare disease settings, and expanding the treatment possibilities for a much broader patient population and much broader set of diseases.
Doctor Butyl: 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 well. This is a large part of cost offset by external funding of our clinical programs. We've continued to develop manufacturing efficiencies that review started.
Doctor Butyl: Cost of goods and increased scale and production capacity, we remain acutely aware of our cash position and while we look forward to strengthen that position. We will continue to identify additional areas for cost containment and efficiency.
Speaker Change: I'd like to begin the call today with the with it by informing you of a key addition to our leadership team.
Speaker Change: Just a couple of weeks ago, we welcomed Dr Robert or Bob headwinds to our board of directors Dr. Cabell, The Doctor Catholic 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.
Speaker Change: <unk> services.
Speaker Change: Advanced strategic value to me.
Speaker Change: Dr. Cadillac spearheaded critical initiatives and pandemic preparedness emergency response coordination and medical countermeasure development.
Speaker Change: His insight into public private partnerships and comprehensive health strategy will be invaluable as we expand the application of our I N K T cell platform, particularly in tackling infectious disease and high impact health challenges.
Speaker Change: 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 seven nice Devin is progressing in a phase two trial in second line gastric advanced gastric cancer at Memorial Sloan Kettering Cancer Center.
Speaker Change: This trial incorporates selamat Gulf fill about chemotherapy on top of our ion K T cell therapy.
Speaker Change: Data from the first half of the patient cohorts, Trinidad indicate very promising signals of efficacy or activity compared to existing treatment option.
Speaker Change: We look very forward to presenting these data at a major oncology conference in early 2025.
Speaker Change: Furthermore, data presented last week at the society for immunotherapy of cancer or <unk> annual meeting showcase wonderful progress of our I N J T cell therapy programs, highlighting the significant potential of 787 to expand the benefit of immune checkpoint inhibitors as well as by specific engaged here.
Speaker Change: In areas, where we have seen these approaches fall short in the clinic.
Speaker Change: Additionally, we presented data on our novel frame TCR designed to address the unmet needs of intracellular targeting to eradicate cream expressing tumor <unk>.
Speaker Change: These findings underscore the unique mechanisms of I N T cells highlighted the activity of our platform to create high throughput medicines quickly.
Speaker Change: It shows that we can enhance the effectiveness of commonly used therapies through strategic synergistic combination.
Speaker Change: These advancements offered promising new strategies for patients with challenging diseases.
Speaker Change: To provide more detail on our findings presented at city I'd like to turn the call over to Dr. <unk> and Dr. <unk>, followed that to give you an overview.
Speaker Change: Yes.
Speaker Change: Thank you John.
Speaker Change: Since the last weekend, we continue building on our phase one data, which demonstrated that agent 707, whether use us as monotherapy or in combination with anti PD, one therapies like for Pam.
Actually durable disease control in heavily pretreated patients.
Speaker Change: Our new preclinical data presented at <unk> expanded on those findings.
Speaker Change: <unk>, mechanistically, aged 707 and immune checkpoint therapy.
Speaker Change: Killing by itself that's useful.
<unk> and activating the orphan subsets.
This year, we also demonstrated that Egypt 707, when combined with Bispecific engages targeting pathogen such as 16 are too.
Speaker Change: <unk> fee resulted in increase.
Speaker Change: Felicia more effective tumor cell, killing compared to T cells from the periphery.
Speaker Change: This accretion I'll call it volatile.
This data shows the positional Asia seven ethical.
Speaker Change: This shows a combination regimens for solid tumors with the potential to amplify the impact of existing treatments.
Now I'll hand, it over to Dr. Paul is that fair.
Dr. Paul: Thank you Joe.
Dr. Paul: Alright.
We are excited to present, our prime targets as TCR T cell therapy could see last week.
Dr. Paul: Generation allogeneic off the shelf therapy. After the gene editing for your products that can be administered without me for vacation or gtx date to overcome the limitations of conventional <unk>.
Dr. Paul: T cell therapy in private positive solid tumors.
Dr. Paul: The lung cancer.
Dr. Paul: Goodbye.
Our preclinical studies show the price.
Dr. Paul: CCR entities.
Paul.
Dr. Paul: It is precise and Tyson specific gene Mccarthy, Kevin Ascertaining, the selectivity of that natural and battery Tcl.
Dr. Paul: Leveraging digital functionality.
Dr. Paul: Which bridge, a ninth and adaptive immunity based therapy.
Dr. Paul: The option for increasing treatment outcome.
Speaker Change: I think difficult to treat.
Speaker Change: Thank you Nils and Paul.
Speaker Change: And an important component of our program and our progress. It was also presented at 50.
Speaker Change: An expanded glimpse of data from our phase one study, where we have continued to ascertain data and heavily pretreated patients.
Speaker Change: 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 to see long term disease stabilization and a lack of progression in the patients treated.
Speaker Change: These data further underscore the persistence of these cells and the immune modulation that they hadn't used clinically.
Speaker Change: As we mentioned during our last call.
Speaker Change: In addition to the program that we have advancing in gastric cancer already activated and enrolling with enrollment.
Speaker Change: It's a complete by mid next year. We've also identify expert investigators and a program to advance <unk> T cell <unk> <unk> seven in patients with graft versus host disease.
And I'm pleased to provide a brief update on the enhancements that we've made in this program since our last engagement.
Speaker Change: We are focusing primarily on the prevention and treatment of acute gvhd, a significant complication following allogeneic hematopoietic stem cell transplantation.
These and other factors that affect transplant outcomes, such as chronic gvhd disease recurrence and post transplant infection.
Speaker Change: Lead candidate <unk> 787 has demonstrated the potential to modulate immune responses effectively without triggering graft versus host reaction.
Speaker Change: And in fact, what we have observed pre clinically as well as in some of our preliminary data through our collaboration is that I N K T's and staff mitigate graft versus host disease biologically and immunologically.
Speaker Change: This is particularly impactful for patients experienced severe gvhd, which can affect major Oregon and lead to high morbidity and mortality.
Speaker Change: Our ongoing implementation of a phase one trial in collaboration with leading institutions in the U S and Europe target patients, who have undergone hematopoietic stem cell transplant, and having a high risk for developing gvhd and other undesired outcomes.
Speaker Change: We are currently in the activation phase after having to find the optimal protocol design.
Speaker Change: And in parallel with the phase one clinical study activation. We are further advancing preclinical investigations in collaboration with Dr. <unk> Laboratory at the University of Wisconsin School of Medicine and public health.
Speaker Change: This project will conduct preclinical studies to evaluate 797% efficacy in reducing and eliminating graft versus host disease, and improving immune grassman post stem cell transplantation.
Speaker Change: We expect that this product to receive feedback from submitted grant funding.
Speaker Change: Later this month.
Speaker Change: And finally earlier this quarter, we announced a collaboration with our partners therapeutics.
Combining their encrypted RNA or <unk>.
Speaker Change: Any technology with Min, Zhang J T cell therapy to one five and <unk> 787.
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 and remain focused on accelerating our program to bring new 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 <unk>.
Speaker Change: T cell therapy platform.
Speaker Change: Thank you to the entire 19 and our partners for their continued dedication and support I'll now turn the call over to Chris to review our financials.
Chris: Thank you Jim.
Chris: <unk> ended the quarter with a cash balance of $6 3 million.
Reflecting cash used in operations for the three and nine months ended September 2024 3 million.
Chris: And $7 $8 million respectively.
Chris: This is significantly reduced from cash used in operations of $7 8 million and $12 7 million for the same periods in 2023.
Chris: Net loss for the three and nine months ended September 32024 was $1 $8 million or <unk> <unk> per share.
Chris: $8 3 million.
Or <unk> 22 per share respectively.
Chris: This compares to $5 1 million.
Chris: Or <unk> 15 per share and $17 million or <unk> 50 per share for the same periods in 2023.
Speaker Change: I will now turn the call back over to the operator for questions.
Speaker Change: Thank you.
Speaker Change: As a reminder, if you'd like to ask a question. Please press star and the number one on your telephone keypad.
Speaker Change: We will pause for just a moment to compile the roster.
Speaker Change: Thank you we will begin our question and answer session.
Your first question comes from the line of Emily <unk> from H C. Wainwright.
Speaker Change: Your line is open.
Speaker Change: Hi, good morning, Thanks for taking the questions I guess first one maybe just comment on how enrollment has been going in the phase two gastric study relative to your internal expectations.
Speaker Change: 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.
Speaker Change: What are the main factors that are driving that and what are you kind of prioritizing on the R&D program. Thank you.
Speaker Change: Yeah.
Thank you very much for your call.
Speaker Change: Your questions and continued support in the gastric trial of course progressing relatively rapidly I would say and this is the second line setting and patients are getting multiple.
Speaker Change: A combination of multiple agents, which is first of its kind and we started out by doing conducting an induction period with the cells alone and then adding in the combination with popped out and subsequently standard of care chemotherapy.
Speaker Change: I'm supposed to halfway done with enrolment at this point and given that we started essentially in the ended 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 update at the upcoming conference that will take place early in 2025.
Speaker Change: And I'll leave it there because it is and I S T and the data in the presentation will be in the hands of Dr. Galena Egencia gained in Virginia, but we're quite.
Speaker Change: Quite enthusiastic about some of the observations that we're seeing to date.
Speaker Change: Not only with our clinical activity, but also with with Tolerability and that type of a combination which in the setting of second line gastric cancer. There is nothing for these patients have to have something that actually can have disease modulating properties.
Speaker Change: On top of standard of care is quite exciting for us so more to come on this enrollment continues and so we'll 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 midyear next year.
Speaker Change: Regarding the R&D expenses Youre 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 in manufacturing so.
Speaker Change: But the donor drive product, we have a couple of obligations, which include accessing the donor and then conducting.
Speaker Change: Viral testing for regulatory purposes to ensure clear and ship and those are somewhat costly what we've been able to do with our manufacturing now is to really exploit and exponentiation scalability with a single donor. So we've really the dos reduced our costs are starting to cereal.
Speaker Change: I shall manufacturing right now and that has made an enormous.
Speaker Change: The impact financially for us so while we continue the activities, we're advancing our <unk> program choice A&D and we're also continuing as you've seen from this should be posters, new innovations in our pipeline that address areas of unmet need. We are also reducing costs associated with our operational expenses in particular, they're giving our.
Speaker Change: <unk> innovation, that's where we're having the highest return for our Cheyenne scientific endeavors.
Speaker Change: Okay, great. Thanks for the color.
Speaker Change: Thank you.
Speaker Change: Thank you.
Our next question comes from the line of Jack Allen from Baird.
Speaker Change: Your line is open.
Speaker Change: Hi, this is <unk>.
Speaker Change: Charlie on for Jack Thank you for taking the question.
Speaker Change: We're just wondering if you could provide any more color on the trial design and endpoints for graft versus host disease program, and maybe what you'd like to see from from this trial. Thank you.
Speaker Change: Hi, Charlie Thanks, Thanks for your call and inquiry and I'll tell you. This is we are going to be hosting one lead investigators on the trial in a subsequent call because I would like to have.
Speaker Change: And all of you have an opportunity to actually hear directly from the designer <unk> and this is a world expert she's done quite a bit of work with cell therapies in patients with graft versus host disease and she is at moffitt at this time. So we're continuing to advance on the designed to get this trial through the activation period into a first in man, which we plan to do.
Speaker Change: Next year. So when we look at this intended target population, which is now patients undergoing stem.
Speaker Change: Stem cell transplantation with elevated risk factors for acute gvhd.
Speaker Change: The eligibility will include patients that received allogeneic stem cells with identified risk markers to ensure Oregon function minimal active infections at the end of treatment. When you look at the landscape of trials here of it intended patient population is very similar to this.
Speaker Change: There aren't very many therapies at this point patients are predominantly managed with standard of care corticosteroids.
Speaker Change: Some patients will get about is that some patients will get jackoby, but to a much lesser extent and still more than half of those patients will progress to acute gvhd, which is incredibly problematic in both patient population. So from some of the design of this program.
Speaker Change: We are going to really and based on the mechanism of action of the shelves.
Speaker Change: To mitigate not only improving backend success and mitigate the risk of gvhd and the likely control arm will certainly be physician's choice, but very likely heavily be.
Speaker Change: That's the best corticosteroid, that's what's most widely used in the syndication. So we will be providing more color, particularly around the launch of the program.
Speaker Change: Sharing with you the sites that have been left with the leadership of the trial and the more formal design in our next earnings call.
Speaker Change: Great. Thank you for the color.
Speaker Change: Thank you.
Speaker Change: Thank you.
Speaker Change: 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 Bewley for closing remarks.
Jennifer Bewley: Thank you operator, and thank you all again for your continued support looking forward to our next call take care.
Speaker Change: Ladies and gentlemen that concludes today's call. Thank you all for joining have a pleasant day.
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