Mink Therapeutics Inc (INKT) 2024 Q1 法說會逐字稿

Good morning and welcome to Mink Therapeutics first quarter 2024 conference call and webcast.

(Operator Instructions) Please note, this event is being recorded.

If anyone has any objections, you may disconnect at this time.

I would now like to turn the conference over to Zach Armen from Mink's Investor Relations.

Zach, 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 time lines as well as time lines for data release and partnership opportunities and other updates.

These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more detail 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 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, MiNK-215.

I will also discuss our strengthened 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 2 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 for SAP in solid tumors MiNK-215 is our lead program from our discovery pipeline that we are particularly excited about.

And this investment underscores the 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 and start 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 to one size ability to eradicate tumors and human organoid models of colorectal cancer with liver mets.

These recent advancements builds on our prior findings and position two one five is an important component in addressing the urgent need for effective treatments in colorectal cancer.

This is now the leading cause of death in men under 50 and the second in women in that same age category.

Our findings show that administration of MiNK-215 not only improves immune-mediated tumor destruction, but also targets and depletes immune suppressive staff expressing stellate cells, thereby enabling increased immune filtration or CD8 T cell infiltration into the tumor.

More simply, this mechanism enhances the body's ability to mount a robust T cell response against liver mets, which can be further amplified by the combination with immune checkpoint inhibitors while Mark is going to go through this in more detail, our scientists demonstrated this benefit with the combination of MiNK-215 and a Genesis late-stage antibodies, cell and cell map a multifunctional T-cell activator and balstilimab, a PD-1 antagonist, which are advancing in late-stage clinical trials.

These were the data that were presented at AACR and Mark will highlight these in just a few moments.

Now I will turn to our lead program 797.

And as a reminder, this is our allogeneic unmodified iNKT cell therapy, advancing in Phase 2 clinical trials in February, we achieved a significant milestone for this program with the launch of the Phase 2 investigator-sponsored study and externally funded program in second-line gastric cancer.

This pivotal trial is evaluating the combination of 797 with boat until NAB and Dow Stelmach.

And these are this combination is on top of standard of care.

Chemotherapy study is led by Dr. Elena Jinji.

Again, She's the Chief of Gastrointestinal Oncology at Memorial Sloan Kettering Cancer Center.

And the program is supported and funded by Stand Up to Cancer in organizations dedicated to funding and developing the most innovative and promising cancer research enrollment in the trials actively underway.

We eagerly anticipate initial data from the trial, which we expect later this year.

Beyond cancer we've also continued to advance 797 and pulmonary diseases, specifically in severe respiratory distress.

This is a condition affecting over 600,000 individuals annually in the US alone.

Most recently, the full data set from our Phase 1 clinical trial was published in Nature Communications.

Just this just a couple of months ago, these data highlighted clinical activity, an important role that iNKT cells play in this disease.

There are currently no effective or active or approved therapies for patients with severe respiratory distress.

We are excited to share additional updates from seven nine seven at the upcoming American Seresto Thoracic Society 2024 Annual Meeting for the ATS meeting in San Diego, California on May 21, statutory TAM in critical care and pulmonology experts will presented data from the continued dosing of patients with severe respiratory distress through our compassionate and expanded access mechanisms.

For latest case is a patient following renal transplant, who was diagnosed with severe acute respiratory distress and treated with 797 under emergency use.

While the data have not yet been disclosed and will be disclosed at the conference.

This presentation further supports our previously published data and underscore the significant unmet need and severe respiratory distress.

We're excited about the potential of iNKT cells to make a meaningful difference in the lives of these patients, and we expect further updates on this program in the months ahead.

Overall, the progress we've made this quarter position us to accelerate the development of our iNKT cell platform and programs.

And these include programs that are actively advancing in the clinic as well as our lead discovery programs will also expand and continue our in-house manufacturing of iNKT cells, setting the stage for an exciting year in 2024 with 797 and pulmonary respiratory distress and the advancement of our Phase 2 trial in gastric cancer.

We continue to be unwavering in our commitment to improving patient outcomes, and we deeply appreciate your continued support and now going to turn the call over to Dr. Marc Van Dijk to provide deeper insight into the MiNK-215 program.

Marc?

Good morning, everyone.

I'm Marc Van Dijk, who will provide some further insight into the unique properties and finishing potential of R&D T cell-based cancer therapies, which are uniquely designed to maximize efficacy in 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 on iNKT cell therapy agent seven eight seven rapidly translate from the bloodstream to essential tissues such as the liver analogs.

Importantly, T cells remain active and detectable for up to six months post infusion.

This prolonged presence is elemental as it significantly amplifies the body's own immune response and harnessing 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 subjects of our news this week and differentiated first class armored CAR iNKT therapy targeting fibroblast activating protein or fat.

For short, this therapy is specifically engineered to counteract the challenging immune suppressive environment found in epithelial origin tumors, including colorectal and non-small cell lung cancer.

In preclinical models, we've previously reported that meaningful and five showed robust efficacy in small cell lung cancer models, resulting in substantial tumor elimination in the lung and improved survival compared to T cells in the lung.

These findings were commensurate with restoring the killing capacity of partially exhausted T cells and increase in T cell infiltration, which is consistent with the National Properties of native iNKT cells.

We further reported, I think two and five specifically targeted and eliminated paper expressing cancer-associated fibroblasts, thereby disrupting the tumor promoting stromal network and reducing immune suppression in the local tumor microenvironment.

You've recently expanded upon this data at the recent AACR meeting.

Agenda already alluded to in April of this year where we showcase next to one five effectiveness in an advanced preclinical organoid model for colorectal cancer, liver metastases, liver metastases are notorious for limiting the success of conditional immunotherapies in patients with microsatellite stable colorectal cancer.

These tumor nonmetastatic typically creates an immune excluded environment characterized by a lack of T cells in an abundance of immune suppressive cells, which conventional treatments struggled to overcome mentor and five and IL. 15 armored CAR iNKT-cell therapy targeting fab is designed to overcome these challenges, not only remodels the tumor stroma to facilitate deeper T-cell infiltration, but also enhances the immune system's ability overall to fight cancer more effectively.

Our preclinical results have shown that mid-25 can trigger significant tumor reduction and even our indication at an industry event resistant model of liver metastases and generally alluded it showed that it can deplete cash sort of SAP expressing stellate cells, which is appealing the suppressive component of these liver metastases.

And this provides new hope for patients who currently have very limited options.

Our team is committed to advancing this innovative therapy to the clinical stage and with the recently announced financial backing and the relentless efforts of our research and development teams are on track to accelerate R&D funding to early 2025 and aim to produce clinical grade material as early as this year.

This underscores our commitment to not just in health and science, but also to bring potentially life-saving treatments to patients as quickly as possible.

I'll now turn the call over to Christine Klaskin to go over our financials.

Christine?

A cash balance of $5.8 million.

This is prior to the receipt of the funds Jen mentioned earlier, cash used in operations for the three months ended March 31, 2024 is $2.5 million compared to [$4 million] and 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.

Thank you.

(Operator Instructions) And your first question comes from the line of Emily Bodnar with HC.

Wainwright.

Please go ahead.

Hi, good morning.

Thanks for taking the questions.

On a few from me.

I guess.

So first on that if you can maybe comment on how the enrollment in the Phase two gastric study 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 on given your operating expenses have decreased and 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.

Thank you.

Emily.

Thank you very much for your question.

And we'll start with your first question, which is that enrollment into the Phase 2 gastric cancer trials?

And maybe just as a reminder, this trial did not require us to do or to wait to have 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.

Sales plus bought down sales plus back down and ram cap standard of care in second-line gastric cancer, we have been able to dose.

We have not specified 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 it activity so that we can 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 cohort and deepen signals in the areas that we see the most profound benefit.

We do believe that mechanistically that the combination of both iNKTs with standard of care may or 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 involved, 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 of enrollment in the first quarter of this year, we started enrolling in February.

We've been able to bring in patients, as I mentioned really quite quickly.

So we'll have the mature data to present it at a late year conference on the second half of this year.

And additional information will be elucidated during those presentations.

And so I think that addressed here enrollment in the Phase 2 and the number of patients, while we haven't been discreet about the total number of patients in each one of the arms, we will have exposure as a proportion of patients on each of the arms with the largest proportion of patients on the multi combo, which is iNKT cell, they then 797 less boat and so on that and still I-Mab to that, the multifunctional, an immune activator that also binds to CTLA-4 from a Genesis cell.

Still I-Mab is a Genesis PD-1 and then, of course, standard of care REMS taxed in this in this patient population.

Financially, I'm going to conclude your questions with the your financial question, which is the allocation of funds.

So our our operational efficiency really was in large part to the reduction that we saw this year, in particular, at least in the first quarter is largely driven by the external funding of the Phase 2 gastric cancer trial.

So our main has been had been executing on a number of trials of sponsor driven trials Phase one trial in ARDS., also our Phase 1 trial in solid tumor cancers.

And we had also a Gen seven and seven in the multiple myeloma study what we have been able to now continue to pursue is expand on the cohorts that we're really most excited about.

The Phase 2 trial in gastric cancer is funded through standard to Cantor story and Tory Costa Foundation, which is essentially the designated foundation that is focused on accelerating effective therapies for patients with gastric cancer, Dr. Elena Genting and the chief at Memorial Sloan Kettering is the leader of that dream team.

It's called And this is the trial where she's been then focusing her efforts to expand cheap therapeutic options for patients with second-line gastric cancer.

That has resulted in the most significant reduction in our operating expenses to expand that trial and to have it off the cost of that through non-dilutive external parties.

Additionally, our ARDS. programs are an area of great interest to us, as I mentioned earlier, and we have not only concluded and published our Phase 1 study.

We're continuing to treat patients under compassionate access.

While we are preparing to launch a randomized Phase 2 trial, which we will be conducting with non-dilutive financing support as well as some support from our our own team.

So it will be a joint program largely externally financed, and it will be conducted through a large platform trial.

And that will allow us to also continue to control our operating expenses.

So our focus will be on really delivering the Phase 2 gastric cancer study and retaining the data this year and developing a pathway to advance that program as quickly as possible.

We also in parallel, we'll be expanding our our signal in acute respiratory distress, severe and a large randomized clinical trial that will be largely externally financed high priority for the company.

The signals that we observed that we published in Nature Communications showed the two pronounced benefit that we believe these cells can bring to patients that showed rapid innovation, whereas the virus prevention of secondary infections and we saw survival rates that exceeded 75% in a population of patients historically saw a mortality rate that exceeded about 65%.

So this is a dramatic improvement over what's been available to patients, which is currently critical steroids.

And that's where we're focusing our effort at this point in the clinic.

Additionally, as I mentioned earlier, our discovery programs and our pipeline continue to mature.

And during our last call, which was our 2023 annual summary and Mark Van Dyke presented how we're advancing our TCR portfolio through a partnership with immune escape.

We will be, as I just announced today and yesterday morning, we'll be advancing our make two one five programs will our new investment, which will allow us to accelerate the development of is very promising.

Armored stop CAR iNKT., and we're looking to generate clinical grade material is early as this year and get it into the clinic as quickly as possible with us imperative to tried to do so by early 2025.

I hope that answers your question.

Yes, very helpful.

Thank you.

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

Please go ahead.

Thank you so much.

I guess the first question I had was on the 215 program.

As you would look to advance that asset into a chronic, what sorts of solid tumors do you expect this study done?

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 things sit in graft versus host disease as well?

Excellent.

Look, let's start with the first, which is two one five.

Now as weak 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 can the best fit and most impactful in the clinic.

Obviously, stop expressing tumors would be our area of great interest.

We will explore the asset more broadly, but with an emphasis and SAP expressed in colorectal cancers, this is an area of high unmet need.

We know that this disease is really growing in prevalence and incident in the younger population, and there's an urgent need to move therapy forward as quickly as possible on the preclinical data we presented at AACR really demonstrates the potential of this molecule on SAP expressing colorectal cancer, similar leaks.

We shared some very exciting data in a SAP expressing non-small cell lung cancer, a 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 we're currently observing in patients with data expressing tumors in lung as well as in colorectal.

So that's where we're starting.

Of course, we will interrogate.

So the molecule and a couple of other disease indications expressing fab sarcoma represents another one, but this is an opportunity for us to pursue an even optimize and accelerate development by the identification of patients with TAP 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 things sit as it relates to securing that external funding?

What are the potential aspects that need to be buttoned up there before you have that funding and then on graft versus host disease.

I believe there's 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 as an 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 and graft versus host disease.

We are pursuing an investigator-sponsored trial.

This is an area of courses of unmet need and that 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, and they have a pretty profound effect in not only mitigating, but then and preventing graft versus host disease and 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 will be necessary to launch it.

During this time, we are being really quite prudent about our focused efforts and the clinical programs that we're advancing.

But we will continue to find ways to get graft versus host and advancing in this is that 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 it at this time.

Got it.

That makes a lot of sense.

Congratulations again on the progress, and thanks for taking the questions.

Thanks, So much Jack.

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

Please go ahead.

On the SAP car, I know in a lot of the preclinical work you've 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 is and it has to be combined for SIL. 15 addition is something that can drive enough activity or again, I really should think about this being combined with other things.

And Matt, this is an excellent question, and we have invited a couple of special guests onto the call today through our leading up this effort that includes the interrogation of two one five as a monotherapy and the kind of efficacy that we're observing with the molecule in that capacity, which would be really important milestone 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 or may not take.

So there are three people on the line and you'll be familiar with with them.

And this is Dr. Dan Chan, who is the Head of Discovery at a Genesee, one of the inventors on book and sell I-Mab and leading up our discovery in combination.

Our efforts at Agennix, Dr. Nils request with who you may not have met before knows, he's an accomplished scientist who joined us from MD Anderson Cancer Center peers, Associate Professor there.

And prior to that, he was at well Cornell working in the radiation oncology department.

And he's his and his emphasis is really on optimizing immune biology and determinants of how to modulate the tumor microenvironment and enhance efficacy.

L&A is also our Head of Discovery in our Cambridge UK site for make therapeutics.

And this team together, I've 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 South expressing tumors, which would give us the most rapid development path forward and 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 that he could work with Elodie and Nils and give you some color on this a deeper response to your question.

Thank you.

For the question.

So to the first part, we do expect monotherapy activity with mean 2.5 and for several reasons, based on the preclinical data first, in preclinical models, we observe direct tumor killing asap expressing cells, including SAP, expressing consciously fibroblast and tumor cells.

In turn, we've observed that post there was a massive infiltration of T cells within the tumor microenvironment was particularly evident in cold tumors like liver metastases or other tumors that we've tested.

So we do expect monotherapy activity given the ability to promote T cell infiltration and remodel the tumor microenvironment to enhance T-cell responsiveness.

We expect this to be an ideal combination partner with both Pall, particularly in areas where and we have seen a known responsiveness to PD-1 CTLA-4 and the two, which includes both the liver metastases model as well as pancreatic models in situations where the tumors are refractory to both by adding nine k.

T.s, including being 2.5 can open up a response to checkpoint therapy in the promote monotherapy activity as well.

Thank you again, Matt, did you have any other questions from SAP?

No thats it for me.Thank you.

And with that on, 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, and 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.

I appreciate your time today.

Ladies and gentlemen, that concludes today's call, and thank you all for joining.

You may now disconnect.