Participants

Jennifer Buell; President, Chief Executive Officer, Director; Mink Therapeutics Inc

Presentation

Operator

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 Nins 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 CC 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 M. Klaskin, principal financial and accounting officer; Doctor Nils Redcliff, director of research and doctor Paul Ibbett scientist at bank.
Now, I'd like to turn the call over to Dr Buell to highlight our progress from this quarter.

Jennifer Buell

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 iNKT's.
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.
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.
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 a large part of 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 strain this position, we will continue to identify additional areas for cost containment and efficiency.
I'd like to begin the call today with a with a by informing you of a key addition to our leadership team.
Just a couple of weeks ago, we welcomed Dr Robert or Bob Cadle to our board of directors, Doctor Cadle. Doctor Cale's decades of experience in public health and biodefense, including his role as Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services brings immense strategic value to me.
Dr Kle, 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 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 two trial for second line gastric advanced Gastric Cancer memorial, Sloan Kettering Cancer Center.
This trial incorporates go com B cell 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 at a major oncology conference in early 2025.
Furthermore, data presented last week at the Society for Immune Therapy of Cancer or CSY annual meeting showcased wonderful progress of our IT cell therapy programs highlighting the significant potential of 797 to expand the benefit of immune checkpoint inhibitors as well as by specific engager in areas where we have seen these approaches fall short in the clinic.
Additionally, we presented data on our novel frame TCR designed to address the unmet needs of intracellular targeting to eradicate frame expressing tumors.
These findings underscore the unique mechanisms of iNKT cells highlight the activity of our platform to create high group of medicines quickly and show that we can enhance the effectiveness of commonly used therapies through strategic synergistic combination.
These advancements offer promising new strategies for patients with challenging diseases to provide more detail on our findings presented at city.
I'd like to turn the call over to Doctor Neil's R requests and doctor Paul Latte to give you an overview.

Thank you, Jen.
At 50 last weekend, we continued building on our phase one data which demonstrated that agent 797, whether used as a monotherapy or in combination with anti PD one therapies like Iul or palisi achieved durable disease control in heavily breed quality.
Our new preclinical data presented at expanded on those findings and demonstrate mechanistically that agent 797, an immune shape on therapy reinvigorated killing by T cells by engaging and activating the important subset mylo cells.
This year, we also demonstrated that agent 797 when combined with five specific engages, charting antigens such as MC 16, her 240 80.2 and DLL three resulted in increased eell activation. More effective tumors are killing compared to T cells from the periphery and the secretion of pro IFFL.
For time, this data shows the position of a 97 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 Doctor Paul Iva to discuss our claim to R I MP program.

Thank you, Neil. We are excited to present our prime targeted TCR iNKT cell therapy at 50 last week. This next generation allogeneic off the shelf therapy offers a gene editing free approach that can be administered without lymphodeletion or GDH To overcome the limitations of conventional T cell therapies in prone positive solid tumors like non small cell lung cancer, ovarian cancer, melanoma, and sarcoma.
Our preclinical studies show that pro TCR iNKT are highly scalable, exhibit precise and potent pro specific tumor cell killing and retain the full activity of their natural and varant TCR iNKT by leveraging the dual functionality of these iron hades which bridge innate and adaptive immunity.
This therapy represents a promising option for improving treatment outcome for patients facing difficult to treat cancers.

Jennifer Buell

Thank you, Mills and Paul and an important component of our program and our progress that was also presented at SITC is an expanded glimpse of data from our phase one study 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 to see long term disease stabilization and a lack of progression in the patients treated these data further underscore the, 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 in a program to advance inkt cells agent 797 in patients with graft versus host disease.
And please 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 GVHD. A significant complication following allogeneic hematopoietic stem cell transplantation.
These and other factors that affect transplant outcomes such as chronic C DH D 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 iNKT, in fact, mitigate graft versus host disease biologically and immunologically.
This is particularly impactful for patients who experience severe GVHD, which can affect major organs and lead to high morbidity and mortality.
Our ongoing implementation of a phase one trial in collaboration with leading institutions in the US and Europe target patients who have undergone hematic stem cell transplant and are at a high risk for developing G DH D and other undesired outcomes.
We are currently in the activation phase. After having defined the optimal protocol design and in parallel with the phase one clinical study activation, we are further advancing preclinical investigations in collaboration with Dr Jenny Bumper's Laboratory at the University of Wisconsin School of Medicine and Public Health.
This project will conduct three clinical studies to evaluate 797 defy in reducing and eliminating graph versus host disease and improving immune engraftment post stem cell transplantation.
We expected 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 RN A or ENCRN A technology with Ming Science A T cell therapy 215 and agent 797.
And 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 ashore, 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 cell therapy platform.
Thank you to the entire 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, John MC 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 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 and nine months ended September 30 2024 was $1.8 million or 5¢ per share and $8.3 million or 22¢ per share respectively.
This compares to $5.1 million or 15¢ per share and $17 million or 50¢ per share for the same period in 2023.
I will now turn the call back over to the operator for questions.

Question and Answer Session

Operator

Emily Bondnar from HC Wainwright line is open.

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 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 end points 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.

Jennifer Buell

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.
And 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 doing, conducting an induction period with the cells alone and then adding in the combination with spot val 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 of 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 Doctor Yelena Jen and her team.
But we're quite enthusiastic about some of the observations that we're seeing to date. Not only with a clinical activity but also with 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, 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, but the donor drive 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 make 215 program towards IND. And we're also continuing as you've seen from the 60 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 sci scientific endeavors.

Okay, great. Thanks for the call.
Thank you.

Operator

Jack Allen ; Robert W. Baird & Co., Inc.

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 end points for the graph versus host disease program and maybe what you'd like to see from from this trial. Thank you.

Jennifer Buell

Hi, Charlie. Thanks. 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 in 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.
She's at Moffitt at this time. So we're continuing to advance on the design to get this trial through the activation period and into a first demand which we plan to do on next year.
So when we look at this intended target population, which is now patients undergoing stem cell transplantation with elevated risk factors for acute gvhd.
The eligibility will include patients that receive allogenic stem cells with identified risk markers to ensure, you know, organ function, minimal active infections at the end of treatment. When you look at the landscape of trials here of the intended patient population that is 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 about a set, some patients will get jathi 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 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 irora success and mitigate the risk of GvHD.
The likely control arm will certainly be physicians choice but very likely heavily be lean. The immuno corticosteroid, that's what's most widely used in this syndication. So we will be providing more color, particularly around the launch of the program.
Sharing with you the sites that have been selected, the leadership of the trial and the more formal design in our next earnings call.
Great. Thank you for the call.

Thank you.

Operator

Thank you seeing as there are no more questions in the queue that includes our question and answer session. I will now turn the call back over to Jennifer Buell for closing rewards.
Thank you operator and thank you all again for your continued support. Looking forward to our next call. Take care.
Ladies and gentlemen, that includes today's call. Thank you all for joining. Have a pleasant day.