MiNK Therapeutics Q2 2024 Earnings Call Transcript

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Provided by Quartr
August 13, 2024

There are 11 speakers on the call.

Operator

Good day and thank you for standing by. At this time, I would like to welcome everyone to Seres Therapeutics Second Quarter 2024 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Session.

Operator

Thank you. I would now like to turn the conference over to Doctor. Carlo Tanzi, Investor Relations. Please go ahead.

Speaker 1

Thank you and good morning. Our press release with the company's Q2 2024 financial results and a business update became available at 7 am Eastern Time this morning and can be found on the Investors and News section of the company's website. The company has also posted an updated corporate presentation to the website. I'd like to remind you that we will be making forward looking statements including related to the financial terms, timing and completion of the sale of Vals assets to Nestle Health Science, the receipt of future payments and the use of proceeds of the transaction, the timing and results of clinical studies and data readouts development plans and commercial opportunities operating plans and our future cash runway our planned strategic focus and other statements which are not historical fact. Actual results may differ materially.

Speaker 1

On today's call with prepared remarks, I'm joined by Eric Schaff, Seres' President and CEO Morella Thorell, CFO Doctor. Lisa Von Mollke, Chief Medical Officer Doctor. Matthew Henn, Chief Scientific Officer and Doctor. Terry Young, Chief Commercial and Strategy Officer. With that, I'll pass the call to Eric.

Speaker 2

Thank you, Carlo, and good morning, everyone. Last week, we announced our agreement to sell Sirius VAST assets and commercial rights to Nestle Health Science in exchange for substantial immediate and future financial consideration. We held a call at that time to review the agreements and the deal terms and to provide a high level view of our planned corporate strategy to advance our live biotherapeutics, drug candidates, which are consortia of bacterial strains cultivated from clonal master cell banks and rationally designed and optimized to target disease relevant pathways. Today's call will focus on our SER-one hundred and fifty five program and the clinical data we look forward to obtaining next month and more broadly our strategy moving forward. Later in the call, we will provide a review of our 2nd quarter financial results.

Speaker 3

I'll walk you through these developments and illustrate how we're paving the way for MACE success. We'll begin with our operation operational and financial progress. Our lead program 797 is an allogeneic unmodified INKT cell therapy currently advancing in a Phase 2 trial for second line gastric cancer and acute respiratory disease syndrome or ARDS. On gastric cancer, second line gastric is a challenging condition with a poor prognosis and a high mortality rate. Patients undergoing second line therapy for advanced gastric or gastroesophageal junction cancer typically have a median overall survival only 4 to 10 months, depending on factors such as performance status and treatment regimen.

Speaker 3

In parallel, 797 is also being evaluated for ARDS. This is a rapidly progressive and life threatening condition with a mortality rate of approximately 40%. Our commitment to addressing these critical unmet medical needs underscores the potential of 797 to provide meaningful therapeutic benefits in both oncology and respiratory care. Let me begin with our program in ARDS. This is a rapidly progressive form of respiratory failure with alarmingly high mortality rates.

Speaker 3

The prevalence of ARDS has been growing, particularly in younger populations, and this is likely exacerbated by the aftermath of the COVID-nineteen pandemic. This condition represents a significant burden on healthcare systems globally given its high incidence and severe outcomes. The urgency to address ARDS has been underscored by the most recent announcement from the Biomedical Advanced Research and Development Authority or BARDA, which has committed almost $120,000,000 to a randomized Phase 2 program focused on critical outcomes such as survival and ventilator free days. This substantial investment highlights the critical need for innovative and effective treatment in this challenging disease setting. The BARDA program is expected to evaluate 3 therapeutic options, 2 of which are monoclonal antibodies and have already been disclosed with the 3rd agent not yet announced.

Speaker 3

Our published data from the Phase onetwo trial of 797 demonstrates a 75% survival rate and significant improvement in ventilator free days for patients with ARVS suggesting that IMKT cells could play a pivotal role in ARVS management. These promising results indicate that 797 can be seamlessly incorporated into standard treatment protocols and provide potential for substantial clinical benefit. At the recent American Thoracic Society or ATS Annual Meeting, we presented additional compelling data. This is from our expanded access program building on our findings from our Phase 1 and 2 clinical trial, showing the clinical efficacy of 797 in a critically ill immune compromised transplant patient with severe COVID-nineteen induced respiratory distress. Following a single administration of 7,977 similar to the dosing in our clinical trial.

Speaker 3

This patient experienced a rapid reduction in inflammatory cytokines leading to a successful excavation and rapid discharge from the hospital. With nearly 600,000 individuals in the United States alone affected by acute respiratory distress, about 30% to 40% of those patients with severe acute respiratory conditions annually, the burden on our healthcare system is a mess. The promising results of 797s potential is an important therapy to contribute to eliminating or mitigating ARDS and this has broader regulatory and healthcare implications. Maine Therapeutics is among a select group of a few companies advancing therapies in this challenging disease setting. And our early data suggests that 797 could be one of the most promising candidates in the field.

Speaker 3

Now I'm going to be transitioning to another disease setting that we feel is a significant priority for us and for patients and building on the promising findings and immune optimization with our therapy. We're excited to announce the upcoming launch of a Phase 1 trial in steroid refractory acute graft versus host disease and improved outcomes in allogeneic hematopoietic stem cell transplantation. Our investigator sponsored trial will include 2 leading hematology centers, 1 in the U. S. And 1 in Europe and represents a critical step in broadening the therapeutic applications of our INKT cell platform in regions where patients have limited effective treatment options.

Operator

GvHD is

Speaker 3

a serious and potentially life threatening gene therapy is designed to modulate this immune response, aiming to reduce the incidence and severity of GvHD, while preserving the graft versus tumor or disease effect. The trial will also explore other important endpoints such as disease recurrence, infections and improved engraftment, which INK T cells may positively influence. We're currently collaborating with our partnering institutions and investigators to finalize the study design with plans to activate the sites to readiness this year with first dosing by late year or very early in 2025. Now another important initiative we have ongoing in oncology is our program of 797 advancing in a Phase 2 trial in second line gastric cancer. This trial is currently underway at Memorial Sloan Kettering Cancer Hospital under the leadership of Doctor.

Speaker 3

Yelena Jinji Yan. She's a Chief of Gastrointestinal Oncology and internationally recognized expert in gastric cancer. Our studies evaluating the potential of 797 in combination with Agenesis next generation checkpoint inhibitors, botanselimab and valsilumab, which have shown very promising anti tumor responses in a number of disease settings. Our collaboration represents a critical opportunity to explore the synergistic benefit of INKT cell therapy with advanced checkpoint inhibitors, potentially offering a powerful new treatment modality for patients with advanced gastric cancer. This is a condition with historically limited therapeutic options.

Speaker 3

And as I mentioned earlier, survival between 4 10 months in these patients. Enrollment is actively underway and the 1st cohort of patients are now exceeding 3 to 6 months of follow-up in the trial and showing very exciting signals of clinical activity where the majority of patients have already demonstrated some semblance of benefit in this population. We're very optimistic about the balance of clinical activity and tolerability of these combinations. We expect to see data presentation at a major oncology conference this year or very early in 2025. Now I will turn the call over to Doctor.

Speaker 3

Marc Van Dyke, our Chief Scientific Officer and he'll review our earlier stage programs that are advancing. Marc?

Speaker 4

Thank you, Jen. Turning to our preclinical pipeline, we are rapidly advancing MYC-two fifteen. And it's a LUKEN-fifteen arm with fat CAR targeting fat targeting CAR in variant natural killer T cell therapy. That's a mouthful, but it's targeting tumor stroma. This therapy has demonstrated very promising preclinical activity against solid tumors, including microsatellite stable colorectal cancer liver metastases and non small cell lung cancer.

Speaker 4

The strategic focus on targeting Fab expression tumors stems from the overexpression of Fab in the tumor microenvironment, which plays a key role in supporting tumor growth and suppressing immune responses. By disrupting this environment, MINTOON 5 is designed to enhance immune mediated tumor destruction, offering a novel approach to combating these resistant cancers. Our team is dedicated in bringing this innovative therapy into the clinical arena, which with plans to file an IND in 2025. We're developing a robust preclinical package that will allow us to identify and enrich a biomarker based patient population, facilitating more rapid signal signal detection and development. The potential for MINX-two fifteen to disrupt the treatment landscape in solid tumors is significant, particularly as we continue to see breakthroughs in CAR T therapies.

Speaker 4

Our manufacturing is led by Joy Zhao, who is driving our efforts to fully develop MYK215 manufacturing in house. By leveraging our state of the art facilities, we aim to maximize scale and performance, ensuring the efficient production of high quality allogeneic cell therapies. Our partnership with a leading lentiviral vector producer utilizing their novel technology ensures a seamless and efficient production process for our lentiviral vectors, critical for the development of MYC215. The recent approval of an allogeneic cell therapy in solid cancer marks a significant milestone in the field and serves as a relevant benchmark for MYC. This approval highlights the growing acceptance and potential of allogeneic therapies reinforcing our confidence in the regulatory pathway for MYN215.

Speaker 4

Additionally, the anticipated success in CAR T treatments for the advanced solid tumor malignancies emphasizing the potential for MYNX INK T cell therapy to contribute to significant treatment advances. Our research and development teams continue to push forward our pipeline of next generation cell therapies. These include T cell receptor based therapies and bispecific cell engagers, which have the potential to address gaps in traditional therapies and can be combined with more advanced assets such as AZ-seven ninety seven. Our partnership with immune scape is now well underway and centers around the discovery and development of T cell receptors to a specific class of pentumor neoantigens. We believe that our invariant NK T cells are ideal allogeneic hosts for these pentumor neoantigen TCRs and offer the potential to develop cost effective off the shelf allogeneic TCR based cell therapies.

Speaker 4

In parallel, we are continuing to advance our proprietary PRAME TCR IKT program. We've also investigated combining AGEN-seven ninety seven with bispecific cell engagers. AGEN 797 is administered without lymphodepletion, has shown activity in solid tumor settings and we have in non HLA matched patients for up to 6 months. We have compelling in vitro data on the combination of HLA cell engages, our own as well as 3rd party engages. And we believe that the combination of AGEN-seven ninety seven and cell engages, specifically in absence of lymphodepletion, will significantly enhance tumor penetration, counteract local immune suppression and improve overall efficacy.

Speaker 4

We plan to present preclinical data from some of these programs at a key meeting later this year. I'll now turn it back to Jen for some closing remarks.

Speaker 3

Jen? Thank you very much, Mark. Appreciate it. And this is as you can see, we have an incredibly efficient platform in which we've been able to not only advance clinical programs, but also some highly innovative next generation technologies. And as we advance these programs, which you can see, we're also very committed to fiscal conservatism ensuring that we leverage mechanism available to advance our therapies highly efficiently.

Speaker 3

Our strategy includes pursuing non dilutive funding sources and these include some of the grant funding programs that are currently underway, as well as strategic partnership to maintain our financial health while bringing these deserving therapies to the forefront of treatment options. Our approach will not only accelerate the development of INKT cell therapies, but also preserve value during this unusual time in biotech. So I want to thank you for your continued support, and I'm going to turn the call over to Christine to review our financials. Christine?

Speaker 5

Thank you, Jim. We ended the quarter with a cash balance of $9,300,000 which reflects cash used in operations for the quarter of $2,300,000 This is a reduction from the $2,600,000 used for the Q1 of this year. And as Jen mentioned earlier, an almost 50% reduction from prior year. Our net loss for the 3 6 months ended June 30, 2024 was $2,700,000 or $0.07 per share and $6,500,000 or $0.18 per share. This compares to $6,200,000 or $0.18 per share and $11,900,000 or $0.35 per share for the same periods in 2023.

Speaker 5

I will now turn the call back to the operator for questions.

Speaker 6

Thank you. So the floor is now open for your questions. So for this Our first question comes from Emily Bodner from H. C. Wainwright.

Speaker 7

Hi, good morning. Thanks for taking the questions. First one, just to confirm, so the GVHD study that you're planning to initiate, it sounds like that's going to be funded with external capital. Is that correct? And then second question, when you say you're seeing early signs of activity in the gastric cancer study, could you provide any more context to what you're kind of seeing and how that might compare to just standard of care chemo alone?

Speaker 7

Thanks.

Speaker 3

Thank you very much for your questions, Emily. Your first for the GVAC program, yes, this will be supported by external funding to advance the program. And secondly, in gastric, now I given that Doctor. Jinjigian is planning to present these results at a major conference, I'm hesitant to say any more than at least in the cohort that we have now observed and fully enrolled that's beyond 3 to 6 months of follow-up. We are seeing some very exciting signals of clinical benefit that do exceed what our expectations are with Ramtek on its own.

Speaker 3

And as you can imagine, given the number of patients, thousands of patients have been dosed with the chemotherapy, we have a strong sense of what that arm, how it will perform and we're seeing performance far beyond that at this point in the trial.

Speaker 7

Okay, great. Thank you. That's helpful.

Speaker 6

Our next question comes from Jack Allen from Baird.

Speaker 8

I wanted to dive a little bit more deeply into the gastric update that we expect. I guess, I understand you don't want to make too many comments ahead of the scientific presentation. But, can you just remind us about the different cohorts in this study and any comments on where patients were enrolled as it relates to those cohorts to date? And then on the graft versus host disease trial, very exciting news to see that get underway. I just wanted to see if you had any more comments as it relates to the size of that study and when we can expect initial data from that trial?

Speaker 3

Certainly. Thanks, Douglas, for your questions. On the gastric program, this was this is a program in which we have a very heavy translational component as well as clinical components. So looking at very traditional endpoints, response rates, tumor reduction, overall survival in this population, as well as some of the translational markers. And to do so, what we have embarked on is a trial that allows us to interrogate INKTs as an induction and INKTs on top of standard of care chemo, Ramtats, as well as INKTs in combination with BotVal and chemo.

Speaker 3

And we have representative patients in each of those treatment considerations. So the data that you will see will give some semblance not only of translational mechanisms that are our preclinical data has really supported, the importance of the our preclinical data has really supported the importance of INKTs in this particular disease setting. And what we've observed is that preclinically, we know that INKTs may uniquely transform the landscape that will enable engraftment success and also mitigate and prevent GVHD. This is such a growing problem impacting over 50% of patients that are undergoing stem cell transplantation. And we believe that these cells can deliver benefit both in adult patients as well as in pediatric patients.

Speaker 3

And you may know that there is a mesenchymal stem cell approved in Europe and not yet in the U. S. That has demonstrated some important benefit, particularly in pediatric populations, specifically where GVHD is organ based. And we think that our cells may even be able to expand benefit beyond the observations today certainly beyond ruxolitinib as well as beyond some of the available cell approaches given the mechanism of action. We will be activating the trial.

Speaker 3

We're working aggressively to do so this year. Ideally, we will have some patients who can start enrolling in this calendar year. Otherwise, it will be very early next year. The endpoints are rapid in this with response rates and protection and mitigation within about a 28 day window. So we would expect to have data from the trial in 2025, probably in the second half of the trial of the year.

Speaker 8

Got it. Great. Thank you so much for that update. And then maybe just one last question more broad, but as it relates to securing additional non dilutive sources of capital, I just want to know any comments you have around appetite for partnerships and things of that nature?

Speaker 3

Yes. Partnering is actually really core to our strategy and it will be important not only to expand our bandwidth, but also our global presence. So we continue to have very active interactions with potential partners who share our vision and also have the bandwidth to do to deliver in regions of the world where we do not yet have a footprint, but also to help us accelerate the development of these cells.

Speaker 8

Got it. Thanks so much. And congratulations again on the progress. Thank you.

Speaker 6

Our next question comes from Matt Mamtani from B. Riley.

Speaker 9

Good morning, team. Thanks for taking our questions and congrats on the progress. So in regards to the 797 combination work with Bard Bell, sort of informing also your future combination work you may pursue with decell engagers. Could you maybe just talk a little bit more about that? And is there any specific tumor surface antigen modalities, T cell engagers that you have in mind?

Speaker 9

And then the second question about the 215 IND filing plans escalated to early 2025. Would love to hear the initial Phase 1 protocol plan you're looking to submit with your IND filing. And any color on what dose levels you're looking to produce? And how might you be thinking of manufacturing given you've invested it in house in developing this modality?

Speaker 3

Excellent. Okay, Mayank, I'm going to start with the second question and I'll turn it over to Mark. And we also have Doctor. Drey Zhao here on manufacturing for 215. So on the latter, so 215, this is a program, as you know, we now have a new investor who has joined us and partnered with us to accelerate the development of this program.

Speaker 3

We're doing so actively. We had already generated quite a bit of preclinical work to support our IND filing. We're expanding that to bolster our initial clinical protocol, which will allow us to identify patients most likely to respond and deliver therapy at an effective starting dose. That's our that's really our highest priority at this moment in order to accelerate the development of this important Our preclinical data, which we've now presented publicly in a number of locations as it's continued to build and evolve and what we've most recently demonstrated is that the 215 program not only can benefit in organoid models, colorectal cancer, but also penetrate metastatic liver disease in those human like models. This has increased our imperative for identifying patients most likely to benefit and those will be very likely be patients with BAP expressing tumors.

Speaker 3

Now we will be somewhat in a Phase 1 trial, somewhat inclusive to identify exploratory signals. But we will be really focused in order to identify patients where we believe that we can measure some of the biomarkers, elimination of the Fab expressing tumor cells and the immune enhancing potential of this therapy to really deliver the benefit that we think is possible. We will be manufacturing this program in house and Doctor. Zhao and her team are working very aggressively to do so. Our process development, analytic development work is actively underway for release spec criterion and that we're just now in the process of finalizing some of the work that's necessary for the transaction and then we'll be transferring it in house to produce the material.

Speaker 3

Importantly, we have been delivering 797 in our own hands and we've optimized the protocol to be able to deliver really robust billions of cells per donor. We are able to scale the cells and we've publicly talked about this where we can scale the cells without exhaustion really capitalizing on the possibility. We will plan to leverage that platform in order to now deliver our engineered CAR, INKT platform. So that's the 215 program. Looking forward to getting that into the clinic.

Speaker 3

We're going to be wrapping up some of the preclinical data that will allow us to get there at a dose that we think will be quite impactful and in a population that we believe will benefit. Now on the engagers, I'm really glad that you asked this. We have done a lot of work in our own hands with engagers, with the concept that engagers need more and we're seeing that in the landscape. And I think we may have in a very important recipe for success here for T cell engagers. And I'm going to turn it over to Mark Van Dyke to tell you a bit more.

Speaker 4

Yes. Thanks, Jan. So engagers are interesting. I mean, there's quite a lot of development in the cell engager space more and more so also in solid tumor space. We've seen some success with one approval.

Speaker 4

And I think we can increase the efficacy enormously by adding an allogeneic cell therapy component in the form of INK T cells. And I say this specifically because ENGAGES are sort of they induce the local the central immune response and they are they need to pull T cells into the tumor, but there's a lot of resistance in the tumor. And INK T cells are they're very good at entering sites where T cells cannot easily go as well as overcoming local immune suppression. That's the reason to build 215. That's the reason why 797 has shown activity in gastric cancer.

Speaker 4

And we believe that combining bispecific cell engagers for solid tumors with AGEN-seven ninety seven or later with 215 really starts to add those 2 efficacy mechanisms together to have a much higher impact than either 1 or cell engagers alone can actually achieve. And the other really differentiating component is that 797 is applied without lymphodepletion, and that's essential for maximizing the immune response of the patient's own immune system. So that combination, non lymphodepleting INK T cells plus cell engagers, we believe has an enormous potential for solid tumor treatment. That's what we're exploring with both our own cell engager program, but also looking at cell engagers that are out there. And we have quite a lot of data that we hope to share at a conference later this year.

Speaker 9

Got it. Thank you for that comprehensive answer. And then just if I could squeeze one more in, Jen, on the couple of options for non dilutive financing, are you able to talk to the scale and scope and in terms of what remains to kind of get that through the finish line, that would be helpful. And thanks again for taking my questions.

Speaker 3

Thanks, Mayank. With respect as you're seeing with some of the non dilutive grant funding support that we have been able to garner to support our trials in immune related diseases as well as in oncology. You can see how the excitement of these cells and their potential is shared with a number of groups, a diverse set of groups who are very intrigued by advancing the technology. That has allowed us to continue to really prioritize the development of data that will help us to continue to advance some of the discussions that are actively underway. So I hesitate to give any additional color except to say that the interest of what these cells can do have been coming inbound from pharma groups who are interested in expanding the footprint of their cell therapy programs as well as those looking to get into the space.

Speaker 3

There's quite a bit of interest in the autoimmunity, the GvHD data as well as on the engineered portfolio with the preponderance of additional interest with the preponderance of additional interest and respiratory diseases coming from a very focused group of pharma companies. So I'm going to leave it at that just to simply say for us the most important thing is regional infrastructure and global footprint that can allow us to accelerate the development of these important therapies. And that's been driving our prioritization of the conversations that we're having now and some of which we'll expand on in the next couple of weeks. And ideally, we will be able to have some of these advanced far enough by the end of this year or early next year.

Speaker 6

Our next question comes from Matthew Pipes of William Blair.

Speaker 10

Hi, thanks for taking my questions. Jen, glad to see the GVHD trial getting started. Just wondering if you could give some details steroid refractory, but will you allow for other lines of prior therapy? And is this going to be a single ascending dose, multiple ascending dose? Can you give us any details on the dosing schemes?

Speaker 3

Yes. Thanks so much, Matt. On the dosing scheme, at this point, we have been able to administer the cells beyond one dose. And we are very pleased that we can do so tolerably in populations of patients that we wanted to monitor really quite closely. So we can administer the cells.

Speaker 3

We do not see any enhanced cell reactivity or rejection and administering beyond one dose. We would look at this from a target dosing standpoint, we've generated quite a bit of data now beyond 80 patients in dose finding. And I think we have quite a bit of confidence that 1,000,000,000 cells is our target dose. We wouldn't want to start very much lower than that. We may do a step down dose in the CVAT trial.

Speaker 3

However, we may not need to. So we're negotiating that currently, and we would look at about 1,000,000,000 cells. We would do a single, a single dose as well as we would explore if a second dose or a third dose is necessary. I'm not sure that it will be. We will be open and we're finalizing those design elements right now with some regulatory interactions.

Speaker 3

We are open to other lines of therapy. We want to be sure to have the right reference so that in our trial, which even in the Phase 1, we may contemplate we're contemplating right now a reference group that would allow us to accelerate the development by demonstrating if we're looking at 40% to 50% or higher in response rates compared to what we're seeing at 30% with some of the available therapeutic approaches. We want to keep the prior lines of therapy relatively clear, so that we have a homogeneous population even in a Phase 1 setting that will allow us to advance very quickly into a randomized Phase 2.

Speaker 6

There are no further questions. So I'll turn the call back over to Doctor. Jennifer Buell.

Speaker 3

Thank you very much everyone. I want to thank my team as well as for those on the line for your continued support. Appreciate it.

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Key Takeaways

  • The company agreed to sell its Sirius VAST assets to Nestlé Health Science in exchange for substantial immediate and future payments, refocusing efforts on its live biotherapeutics pipeline.
  • Its lead candidate, SER-797, is in Phase 2 trials for second-line gastric cancer and ARDS, with Phase 1/2 ARDS data showing a 75% survival rate and significant ventilator-free day improvements.
  • BARDA committed nearly $120 million to a randomized Phase 2 ARDS program evaluating SER-797 alongside monoclonal antibodies, underscoring the urgency to address the condition’s high mortality and healthcare burden.
  • A Phase 1 trial in steroid-refractory acute GvHD is set to launch at leading U.S. and European centers with external funding, targeting a first dose by late 2024 or early 2025 and response rate endpoints within 28 days.
  • Preclinical work on an allogeneic CAR-iNKT candidate, MYK-215, targeting FAP-expressing solid tumors is advancing toward a 2025 IND, supported by in-house manufacturing scale-up and promising in vitro and organoid results.
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Earnings Conference Call
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