Q3 2025 Immuneering Corp Earnings Call
Speaker #1: Welcome to the Immunering Conference Call to discuss the company's third quarter 2025 financial results and share investigator-presented clinical case studies. In pancreatic patients, at this time, all participants are in listen-only mode.
Speaker #1: management's prepared remarks, we will hold a Q&A session. To Following ensure that we have ample time to address everyone's question, we would like to ask each person to limit themselves to one question and one follow-up.
Speaker #1: As a reminder, this call is being recorded today. Wednesday, November 12, 2025. I would now like to turn the call conference over to Lawrence Watts of New Street Investor
Speaker #1: Relations. Thank you,
Speaker #2: Operator. Joining us on the call today from Immuneering are Chief Executive Officer Ben Zeskind, Chief Scientific Officer Brett Hall, Chief Medical Officer Igor Marchansky, Chief Accounting Officer and Treasurer Mallie Morales, and Chief Business Officer EB Breakwood.
Speaker #2: During this call, management and our two investigators will refer to slides that you can find in the updated version of our corporate deck available in PDF on our IR website.
Speaker #2: Throughout this call, management will be making forward-looking statements, including statements related to its Phase 2A trial of a Tevimet nib, as well as the timing of additional data from the study and the company's development plans.
Speaker #2: Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties.
Speaker #2: Factors that could cause these results to be different from these statements include factors the company describes in its security filings including its annual report on Form 10-K and our quarterly reports on Form 10-Q.
Speaker #2: Immunering undertakes no duty or obligation to update any forward-looking statements as a result of new information due to events or changes in its expectations.
Speaker #2: With that, I will turn the call over to Ben Zeskind, Chief Executive Officer of Immuneering.
Speaker #2: Ben. Thank you,
Speaker #3: Lawrence. Good afternoon, everyone, and thank you for your interest in Immunering. We do not always hold quarterly calls, but we try to do so when we have something interesting to share.
Speaker #3: And today, we are very fortunate to be joined by two investigators from our Phase 2A trial. They will walk us through two remarkable case studies of first-line pancreatic cancer patients treated with Tevimet nib in combination with FOLFIRINOX.
Speaker #3: The investigators are Dr. Alison J. Ocean, Professor of Clinical Medicine at the Weill Medical College of Cornell University, and Dr. Gregory Bhatta, Associate Professor of Medicine at the Moore's Cancer Center at UC San Diego.
Speaker #3: Doctors Ocean and Bhatta are, of course, busy individuals who explain to start the call with their respective case studies after which we will let them get back to their patients and then we will share a summary of the third quarter and why it was so transformational for Immunering.
Speaker #3: In September, we shared an update on 34 first-line pancreatic cancer patients treated with Tevimet nib in combination with gemcitabine and nab-paclitaxel. With remarkable overall survival, we're as excited as ever about the overall survival we are seeing in that cohort, and we are very excited to share an update soon.
Speaker #3: We're currently planning to do so in the first half of 2026, possibly at a major medical meeting. Today, we wanted to talk about patients from a different arm of our study, a study of first-line pancreatic cancer patients treated with a Tevimet nib in combination with FOLFIRINOX.
Speaker #3: FOLFIRINOX is also a standard-of-care chemotherapy in the first-line setting. Compared with gemcitabine and nab-paclitaxel, it has shown slightly longer survival in pivotal studies but with harsher side effects.
Speaker #3: So it is typically given to younger, higher fitness patients at centers that are well equipped to manage the harsher side effects. A Tevimet nib in combination with gemcitabine nadpaclitaxel remains our top priority because the chemotherapy itself is so much better tolerated, and the overall survival we have reported is so encouraging.
Speaker #3: That being said, down the road, the ability to combine a Tevimet nib with FOLFIRINOX may ultimately give oncologists more options. And certainly, when we see remarkable outcomes in this cohort, it just lends further robustness to the data we have previously reported and highlights the Tevimet nib's potential to drive differentiated outcomes for cancer patients.
Speaker #3: With that introduction, let me hand the call over to Dr. Ocean who will walk you through the first case study.
Speaker #4: Thank you, Ben. My name is Dr. Alison Ocean, and I'm a medical oncologist and attending physician in gastrointestinal oncology at New York Presbyterian Hospital Weill Cornell Medical Center.
Speaker #4: I am also an investigator in Immunoering's Phase 2A study of Tevimet nib and an occasional paid consultant to Immunoering. In my career, I have treated a large number of pancreatic cancer patients, and I can assure you the unmet need here is vast.
Speaker #4: The case study I'm about to walk you through comes from the arm studying a Tevimet nib in combination with FOLFIRINOX in first-line pancreatic cancer.
Speaker #4: So this case study involves a 71-year-old female patient with metastatic pancreatic cancer with a KRAS G12d mutation who is currently being treated with daily a Tevimet nib plus FOLFIRINOX.
Speaker #4: Initially, she was unable to tolerate irinotecan so her chemo now is essentially FOLFOX. The patient has now been on treatment for approximately five months and remains on treatment.
Speaker #4: The patient's target lesion located in the liver steadily reduced over the course of three scans to the point of being undetectable for an unconfirmed complete response.
Speaker #4: On the right, you see the combination of a Tevimet nib with FOLFIRINOX led to, at the first scan, an unconfirmed partial response with a 54% reduction in some of the longest diameters and then that partial response confirmed with an 81% reduction in some of the longest diameters at the second scan.
Speaker #4: By the third and most recent scan, the patient had a 100% reduction in their sum of longest diameters. In other words, the lesion was rendered undetectable for a complete response that is technically considered unconfirmed until we see it repeat at a second scan.
Speaker #4: Importantly, the patient has seen improved quality of life, stable weight, and describes feeling extremely well. In fact, she tells me she has never felt better.
Speaker #4: This is not surprising because our institution's experience with the Tevimet nib has generally been one of good tolerance in the trial patients. It is very unusual to see a complete response with chemotherapy alone in a non-BRCA mutated adenocarcinoma patient like this one.
Speaker #4: So I believe a Tevimet nib has made a real difference for this patient. Our institution has treated several patients in various arms of the Tevimet nib trial, including a combination of a Tevimet nib with gemcitabine nadpaclitaxel and we are very excited that it is moving into a planned Phase 3 study.
Speaker #4: This is a huge area of unmet need, so potential advancements like this are even more meaningful. With that, let me hand things over to Dr. Bhatta, who will walk you through a second case study.
Speaker #5: Thank you, Dr. Ocean. My name is Gregory Bhatta and I'm a medical oncologist who specializes in treating solid tumor cancers of the gastrointestinal system.
Speaker #5: At the University of California, San Diego. I'm also an investigator for Immunering's Phase 2A study. In my career, I have also treated a large number of pancreatic cancer patients.
Speaker #5: The patient in this case study is again from the arm studying a Tevimet nib in combination with FOLFIRINOX in first-line pancreatic cancer patients. For this case study, the patient was a 61-year-old female patient with biopsy-confirmed metastatic pancreatic cancer to the lung.
Speaker #5: And it confirmed KRAS G12d mutation. The patient initially achieved an unconfirmed partial response and then stabilized for about five to six months. During that time, the primary lesion in the pancreas continued to shrink, achieving a 56% reduction by around seven months.
Speaker #5: The patient's response made her a candidate for treatment with curative intent. The remaining primary lesion was irradiated and then the patient underwent a Whipple procedure to remove the remaining pancreatic lesion.
Speaker #5: And is now restarted treatment on a Tevimet nib monotherapy in the post-surgical setting. At the time of this call, the patient has now been on Tevimet nib, either in combination or as a monotherapy, for over 14 months.
Speaker #5: And has experienced great quality of life and stable weight. Much like the patient, Dr. Ocean spoke about. Let me take a moment to talk about how rare that sequence of events is.
Speaker #5: Patients are not typically eligible for surgery once their condition has turned metastatic. However, in this case, combination treatment with Tevimet nib and FOLFIRINOX was deemed so successful that surgery, preceded by radiation with curative intent, was considered a viable option.
Speaker #5: I believe a Tevimet nib helped us convert this patient to a surgical candidate with curative intent. An outcome that I have rarely seen with chemotherapy alone.
Speaker #5: And today, the patient has no radiologic evidence of new disease. Now, while the patient has to be censored from survival measurements, the patient continues to do well, approximately 14 months after starting treatment.
Speaker #5: And remains on a Tevimet nib monotherapy treatment. Our site has also treated many other patients with the Tevimet nib and we have seen other responses that would be unexpected with chemotherapy alone.
Speaker #5: A Tevimet nib's tolerability is also unexpectedly good, even relative to RAS inhibitors. We are very excited for the planned Phase 3 study of Tevimet nib in combination with gemcitabine and paclitaxel.
Speaker #5: And with that, let me hand the call back over to
Speaker #5: Ben.
Speaker #6: Thank
Speaker #6: you, Dr. Bhatta. Let me take this opportunity to thank both you and Dr. Ocean for taking time out of your busy schedules to join us and provide your insights.
Speaker #6: We're very grateful to have both of you involved in our ongoing studies and for everything that you do every day for patients with cancer.
Speaker #6: And with that, we'll let you get back to your important work. What I take from the two case studies just presented is several fold.
Speaker #6: Firstly, that these impressive results we are seeing for a Tevimet nib in combination with FOLFIRINOX provide another pillar of robustness supporting the extraordinary overall survival we presented for a Tevimet nib plus modified gemcitabine nadpaclitaxel in September.
Speaker #6: Secondly, that patients dosed with a Tevimet nib plus FOLFIRINOX could potentially provide additional optionality alongside our top priority planned pivotal program for a Tevimet nib plus modified gemcitabine nadpaclitaxel.
Speaker #6: Thirdly, we believe the tolerability of Tevimet nib is going to be a real differentiator. Of course, the most important differentiator is extraordinary overall survival.
Speaker #6: And when you layer onto that, Dr. Bhatta saying if patient has experienced great quality of life, and Dr. Ocean saying her patient has never felt better, it really gives you a sense of what we mean when we say we want to keep patients alive and help them thrive.
Speaker #6: These patients are clearly thriving and we couldn't be happier for them. Now, let me take a step back and just recap why the third quarter of 2025 was truly transformational for Immunering.
Speaker #6: In September, we announced extraordinary overall survival data in 34 first-line pancreatic cancer patients treated with a Tevimet nib in combination with gemcitabine nadpaclitaxel. And strengthened our balance sheet with 225 million dollars of cumulative financing including a $25 million strategic investment from Sanofi.
Speaker #6: Importantly, these achievements extend our cash runway into 2029 and fund the top-line readout of our planned pivotal program for a Tevimet nib plus modified gemcitabine nadpaclitaxel along with our clinical work in lung cancer and preclinical work in other areas.
Speaker #6: In September, we reported 86% overall survival at nine months in 34 first-line pancreatic cancer patients treated with a Tevimet nib plus modified gemcitabine nadpaclitaxel with a nine-month median follow-up.
Speaker #6: For context, the standard of care reports approximately 47% overall survival in nine months. We are excited to share an update on a Tevimet nib in combination with gemcitabine nadpaclitaxel and currently plan to do so in the first half of 2026, possibly at a major medical meeting.
Speaker #6: We also made progress across a number of other fronts in the third quarter. In July, the US Patent Office granted our US composition of matter patent for a Tevimet nib, which is expected to provide exclusivity into 2042 with potential eligibility for patent term extension.
Speaker #6: We have patent applications pending that extend exclusivity into late 2044. Then, in August, we announced a clinical supply agreement with Eli Lilly intended to evaluate a Tevimet nib in combination with Olomuracib, a second-generation KRAS G12c inhibitor in a planned Phase 2A trial in lung cancer patients who have progressed on prior therapy.
Speaker #6: Remember that earlier this year, we also announced a clinical trial agreement with Regeneron intended to evaluate a Tevimet nib in combination with Libtayo and anti-TD1 inhibitor in advanced lung cancer.
Speaker #6: Together, we believe these agreements position us to demonstrate a Tevimet nib's combinability across a variety of tumor types. Potentially expanding its market opportunity beyond the already considerable unmet need in first-line pancreatic cancer.
Speaker #6: A Tevimet nib's durability and tolerability make it ideal for a wide variety of combinations across many different types of cancer. Before I cover the multitude of catalysts we believe we have coming up, let me quickly turn things over to Mallory to walk you through our third quarter financial
Speaker #6: update. Thank
Speaker #7: you, Ben. Our third quarter financial results press release issued post-market this afternoon covers our financial results in detail. So I will not go through them at length on this call.
Speaker #7: What I will highlight, however, is our significantly improved cash position. Which was bolstered by three successful offerings that took place in August and September.
Speaker #7: Namely, a $25 million private placement in August, a $175 million underwritten offering of Class A common stock in September, coupled with a $25 million private placement of Class A common stock to Sanofi.
Speaker #7: As a result, our cash and cash equivalents as of September 30th, 2025, were $227.6 million. Compared with $36.1 million as of December 31st, 2024.
Speaker #7: Based on management's current operating plans, the company now expects its cash runway to be sufficient to fund operations into 2029. With that, let me hand the call back over to Ben.
Speaker #1: Thank you, Mallory. In terms of upcoming near-term milestones, in the fourth quarter of 2025, we expect feedback from regulatory agencies and continued preparations to begin dosing patients in the pivotal trial of a Tevimet nib in combination with gemcitabine nadpaclitaxel in first-line pancreatic cancer patients.
Speaker #1: In the second quarter of 2026, we plan to announce updated circulating tumor DNA data on acquired alterations at a major scientific meeting. In the first half of 2026, we plan to report updated survival data from first-line pancreatic cancer patients treated with a Tevimet nib plus modified gemcitabine nadpaclitaxel potentially at a major medical meeting.
Speaker #1: In mid-2026, we expect to dose the first patient in the pivotal Phase 3 trial of a Tevimet nib in combination with modified gemcitabine nadpaclitaxel in first-line pancreatic cancer.
Speaker #1: Pending regulatory feedback, and in the second half of 2026, we expect to dose the first patient in the trial of a Tevimet nib in combination with Libtayo in non-small cell lung cancer.
Speaker #1: Our third-quarter press release includes a detailed list of the near-term catalysts we have coming up, each one an opportunity to create value for our shareholders and each one a step forward in helping patients live longer and feel better.
Speaker #1: Coming out of the third quarter, we have never been better capitalized nor have we ever had more evidence of a Tevimet nib's ability to shrink tumors slowly and surely with remarkable durability and tolerability.
Speaker #1: In summary, then, I could not be more proud of the benefits we're delivering for patients, and I could not be more excited about what the coming weeks and months will bring for Immuneering.
Speaker #1: With that, we're happy to take questions. Operator.
Speaker #8: Thank you. And we will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad to join the queue.
Speaker #8: If you would like to withdraw your question, simply press star one again. If you're called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question.
Speaker #8: Just a reminder, we ask that you please limit yourself to one question and one follow-up only. And after that, you can just simply join the queue again.
Speaker #8: Thank you. And your first question comes from Jay Olson from Oppenheimer. Please go ahead.
Speaker #8: ahead. Oh, hey,
Speaker #9: guys. Congrats on all the progress and thank you for providing this update. We had a couple of questions. To start, can you talk about, based on these new case studies, and the plain safety profile for Tevi, are you considering opportunities for PDAC in the adjuvant setting?
Speaker #9: And then we had a follow-up if we could.
Speaker #1: Hey, Jay. Thanks for the question. Right now, our top priority is the first-line setting in the combination of a Tevimet nib with the modified gemcitabine nadpaclitaxel.
Speaker #1: I mean, I think the overall survival that we announced in September, 86% overall survival at nine months is just so remarkable and the tolerability that we saw with only two categories of adverse events.
Speaker #1: At the grade three level in more than 10% of the patients. So that's really our top priority, but I think you're absolutely right. There's a wide range of potential opportunities kind of down the road a little bit and certainly adjuvant is one that we're thinking carefully about among others.
Speaker #1: So no decisions to report there today, but certainly I think you're absolutely right. There's a lot of potential in a lot of different areas and I think first-line pancreatic cancer is really just the beginning for a Tevimet nib, but it's our top priority and it's the place we're going to start.
Speaker #9: Okay. Understood. Thank you for that. And maybe just to follow up, recognizing that you're prioritizing the combo of a Tevi with gem nadpac. Given these new case studies and again, the clean safety, would you consider it potentially combining a Tevi with 5FU-based
Speaker #9: regimens?
Speaker #1: Yeah, it's absolutely something that
Speaker #1: we're thinking about, Jay, for all the reasons you pointed out. Again, it's not currently our top priority. The top priority certainly remains the Tevimet nib combination with the modified gemcitabine nadpaclitaxel in first-line pancreatic cancer.
Speaker #1: Just because we see such exciting overall survival there. But I think part of the reason for sharing these cases today, number one, they kind of further validate the data that we presented with gemcitabine nadpaclitaxel in September.
Speaker #1: They show that we can combine with FOLFIRINOX, which not everyone can. And I think to your point, that certainly demonstrates the potential for greater optionality down the road.
Speaker #1: So it's certainly something that we're thinking about and considering. And I think these cases also really emphasize what a differentiator tolerability is for a Tevimet nib, right?
Speaker #1: I mean, you heard Dr. Bada saying his patient has experienced great quality of life. You heard Dr. Ocean saying her patient has never felt better.
Speaker #1: And so I think that does really give you a sense of the tolerability and it creates a lot of potential options down the road, whether it's combining with FOLFIRINOX, going into the adjuvant setting, and many more.
Speaker #1: So you're absolutely right. There's a lot of possibilities for that, but our top priority remains the first-line setting in combination with gemcitabine nadpaclitaxel.
Speaker #9: Okay. Thank you. That makes perfect sense. Maybe if I could sneak in one last
Speaker #9: question. Sure. Just based on the totality of data that you've shared, so far, and the differentiated profile for a Tevi that's emerged, can you just update us on your latest thoughts about where a Tevi fits into the competitive landscape in PDAC?
Speaker #1: Yeah. I think the overall survival that we shared in the first-line setting is extraordinary, right? I mean, and look, we welcome every company that's working in pancreatic cancer.
Speaker #1: This is a huge unmet need. That's not going to be solved by any one company alone. But certainly, we believe we're the company that's going to solve it first and best in the first-line setting.
Speaker #1: Right? There's not another company working in this pathway that we're aware of that's shared first-line overall survival data. And first-line is the real prize.
Speaker #1: In pancreatic cancer, because sadly, about half the patients don't make it out of the first-line setting. So we really hear over and over from oncologists that you're first shot is your best shot.
Speaker #1: And first-line pancreatic cancer is the real prize here. We're the only company in this pathway that we're aware of that's shared overall survival data in the first-line setting.
Speaker #1: I think our overall survival data is extraordinary. I mean, to have 86% overall survival at nine months in the data we shared in September, that's a 39-point separation from the pivotal study of standard of care, gemcitabine nadpaclitaxel.
Speaker #1: So we believe that kind of overall survival is going to be hard to beat, right? I mean, there's just not a lot of room above that curve to decisively beat it.
Speaker #1: And to the extent another company could match it—and we certainly don't know of anyone that we think could—but if to the extent another company could match it, then I think it would come down to tolerability.
Speaker #1: And I think we show clear differentiation on tolerability, certainly from anything else in this pathway, right? I mean, I think you heard Dr. Bada say that directly—kind of unexpectedly good tolerability, even relative to RAS inhibitors.
Speaker #1: So, I think we're the frontrunners in first-line. We've shared survival data. That's the gold standard; that's what matters most. And we don't think anyone's going to beat that.
Speaker #1: And even if they could match it, we think we'd win on tolerability. So we're we feel very good about where we sit in the competitive
Speaker #1: landscape. Great.
Speaker #9: Congrats again on all the progress, and thanks for taking the questions.
Speaker #1: Thank you, Jay.
Speaker #2: And your next question comes from Andrew Barrons from Engineering. Please go ahead.
Speaker #2: ahead.
Speaker #10: Hi. This is
Speaker #10: Emily on for Andy from Leerank. So yeah, congrats on the data, and those case studies. I guess I'm kind of curious, do you have any plans to share the full data from that FOLFIRINOX combination cohort in the near term?
Speaker #10: And then sort of looking ahead, if this data from that cohort continues to look robust, do you have any plans to try and get a compendia listing for this combination so it could be potentially used and reimbursed in the future?
Speaker #10: Thank
Speaker #10: you. Yeah.
Speaker #1: Hey, Emily. Great question. And certainly, you and Andy are affiliated with Leerank. I think our numbers at Engineering, but we're not breaking any news on that today.
Speaker #1: You and Andy work for Leerank, but just joking around. I think the, yeah, we're not guiding to timing yet in terms of when we might share data from the FOLFIRINOX arm because it's just currently not our top priority.
Speaker #1: Right? Our top priority is first-line pancreatic cancer in combination with gemcitabine nadpaclitaxel, where we're just seeing this extraordinary 86% overall survival at nine months in the data we announced in September.
Speaker #1: So that's the top priority. But I think what we shared today certainly further validates those data we shared in September. I think it really creates a lot of additional optionality for us that we can combine with FOLFIRINOX, and we can see these remarkable outcomes.
Speaker #1: So, we're still considering that relative to everything else. So, certainly can't guide on that today. But it's great to see how well these patients are doing, and great to hear Dr. Bada and Dr. Ocean talk about how truly rare these kinds of outcomes are with chemotherapy alone.
Speaker #1: I mean, to have a complete response in pancreatic cancer is just remarkable. And to, I mean, to be able to have a patient that can go on from metastatic disease to be able to go on to surgery with curative intent, these are really just exciting outcomes.
Speaker #1: And we're really happy about them. So yeah, very
Speaker #1: exciting. Thanks so
Speaker #10: much.
Speaker #1: Thank you,
Speaker #1: Emily.
Speaker #2: And your next
Speaker #2: question. Comes from Greg Savanavej. From Mizoho, please go ahead.
Speaker #11: Hi. Good afternoon. Thanks for taking my questions. And congrats on the newer data as well. I was curious given that you've provided some timing with regards to a new study with your combination with Regeneron Liptio that I think the comment was you'd be able to start that sometime in the second half of 2026.
Speaker #11: Given that you also have a very interesting collaboration with Lilly, two questions. One, do you think, based on what you know today, whether that study too can get started in 2026, or do you think that's more of a 2027 timeline?
Speaker #11: And then also related, how do you see on the assumption that they're both going into non-small cell lung cancer? How do you see kind of the differential positioning between those two combinations?
Speaker #11: And then a last question is with regards to your cash runway, which is out to 2029, and congrats on the success with the financings, but what do you particularly or specifically funded for in terms of clinical development, clinical trials, pipeline advancement, just trying to get a sense of what you're currently funded for?
Speaker #1: Hey, Greg.
Speaker #1: Thanks for the questions. We appreciate Thanks. it. So you're absolutely right. We gave new guidance today on the timing of the study of atevimatinib in combination with Regeneron's anti-PD-1 Liptio in lung cancer.
Speaker #1: And we said not just I think you used the word start, but we specifically said we're going to dose the first patient in the second half of 2026.
Speaker #1: And I think that's important. Different companies use kind of ambiguous words that can mean really mean very different things around trial timing, but dosing the first patient is just a really clear and unambiguous milestone.
Speaker #1: So that's why we're we like to be clear with that. So absolutely, dosing the first patient in that study in the second half of 2026.
Speaker #1: And we're really excited about that because of all the preclinical data, both from us and from real luminaries in the immunotherapy field like Jed Walchuk, who has a paper showing that pulsatile inhibition of MET can really enhance the activity of immunotherapy in a lung cancer model, in a preclinical setting.
Speaker #1: So really, really excited about that study and looking forward to dosing that first patient. With regard to our agreement with Eli Lilly, to evaluate atevimatinib in combination with olomuracib, you'll recall we that agreement is much more recent.
Speaker #1: Right? So while we had announced a Regeneron agreement in February, that one we announced over the summer, towards the end of the summer. So it's just a little early to guide on that yet.
Speaker #1: So we're just not going to guide on the timing of the patient first patient dose but certainly in due time, you can expect guidance on that.
Speaker #1: In terms of the kind of the dynamic between those two, look, I mean, there's, again, a cancer obviously, vast unmet need in lung the olomuracib is a KRAS G12C inhibitor.
Speaker #1: So that trial would be focused on patients with a KRAS G12C mutation. Whereas the use of immunotherapy would potentially address a different population of patients.
Speaker #1: So I think it's early to really comment further on that. But I will say we think atevimatinib with its ability to durably inhibit the MAP kinase pathway with this really kind of excellent tolerability that I think you just heard about from two of the investigators, we think it's really a an attractive backbone frankly for combinations with a wide variety of agents.
Speaker #1: And we've shared preclinical data on quite a few. And our exploring quite a few more. So there's just really a broad potential for combinations here.
Speaker #1: And we don't think of these two as kind of just the beginning of the potential for atevimatinib. So just really excited for what we'll be able to do for patients, with what we believe we'll be able to do for patients with lung cancer, colorectal cancer, melanoma—just a really vast number of types of cancer that are frequently driven by the MAP kinase pathway.
Speaker #1: So, we are really excited about the breadth of our cash guidance there. With regard to our runway into 2029, we are certainly funded to conduct the Phase 3 studies as we have laid out to conduct these studies in lung cancer.
Speaker #1: And then to advance our preclinical pipeline as well. Right? So keep in mind that atevimatinib is the first and most advanced of our pipeline of deep cyclic inhibitors.
Speaker #1: But cyclic inhibitors against a we're pursuing and developing deep variety of targets and oncology and a variety of pathways. So we're certainly excited to continue that work because I think the ability that atevimatinib has demonstrated of deep cyclic inhibitors to mitigate resistance mechanisms to durably do so with just really inhibit tumors and to remarkable tolerability.
Speaker #1: I mean, to hear a cancer patient say they've never felt better as Dr. Roshan mentioned is just really remarkable. So we're excited for that preclinical pipeline as well.
Speaker #1: Thank you, Greg. And your next question. Comes from Ami Fadia from Needham and Company. Please go
Speaker #2: Thanks. Good evening. I have a couple of
Speaker #2: on the data that we've seen so far with the combinations with ahead. FOLFIRI and GenMAPAC, given the theme safety profile of atevi, what type of patients would you consider as being best suited for the combination with FOLFIRI instead of GenMAPAC?
Speaker #2: And then I think as we sort of think about the first-line PDAC positioning, how do you see the safety profile translating into the durability of benefit?
Speaker #2: And you mentioned earlier that you're going to be presenting some additional circulating DNA data next year. If you could sort of talk to how what you've learned from the ctDNA analysis so far and how that might contribute to the overall durability of benefit particularly in the first-line setting.
Speaker #2: you. Thank
Speaker #1: Yeah. Thanks, Ami. Great questions. So you're right. Certainly, I think we've demonstrated clearly the ability to combine with FOLFIRINOX, with gemcitabine, MAPAC with Taxol, and with a clean safety profile.
Speaker #1: In first-line pancreatic cancer patients. And we think that really that really means atevimatinib could help really broad set of patients in the first-line setting in pancreatic cancer.
Speaker #1: And in fact, one of the things that's nice about our trial is we don't have to do any genetic testing. Right? So there have been trials of ARAS inhibitors where they have to confirm the presence of a RAS mutation.
Speaker #1: And we just haven't we don't need to do that because atevimatinib targets MAC, which is further downstream in the pathway. And so it blocks a wide variety of mutations that drive this pathway.
Speaker #1: And I think that's important for durability because, again, with RAS inhibitors, and maybe this is a good segue to your next question, with RAS inhibitors, you often see resistance mechanisms.
Speaker #1: You see with RAS inhibitors progression that can sometimes come from, say, KRAS amplifications or BRAF mutations. That's been reported to be common. And atevimatinib being further downstream at MAC, it blocks those kind of mechanisms.
Speaker #1: Right? So the acquired alteration data that we've shared previously that's in our public deck, we saw no acquired alterations in RAS genes in very few in the MAP kinase pathway at all.
Speaker #1: So what this tells us is atevimatinib is effectively blocking all the lanes of the highway, if you will, it's blocking a lot of the MAP kinase pathway.
Speaker #1: And it's just it's very hard for the tumor to get around atevimatinib using the MAP kinase pathway. And that's just not the case for RAS inhibitors based on the data that's out there.
Speaker #1: So I think that alone by virtue of the target lens durability and then, of course, the fact that atevimatinib is a deep cyclic inhibitor and has this pulsatile mechanism, I think that also really helps to mitigate resistance.
Speaker #1: Right? Because instead of providing the tumor with just a steady constant signal that frankly makes it easy for the tumor to adapt, we have this pulsatile approach where we hit the tumor very hard and then release.
Speaker #1: And that it basically keeps the tumor off balance, if you will. It makes it harder for the tumor to adapt and get around the treatment.
Speaker #1: And this was a design goal from the very beginning. Right? I mean, we started this company around the goal of driving overall survival. And so things like mitigating resistance, things like tolerability, like counteracting muscle wasting, I mean, these were the priorities from the beginning.
Speaker #1: And I think that's why we really developed this differentiated class in deep cyclic inhibitors and why we're seeing such differentiated survival like the 86% overall survival at nine months and the atevimatinib in combination with gemcitabine, MAPAC with Taxol that we announced in September.
Speaker #1: So
Speaker #1: with that, thank you, Ami. Thank
Speaker #2: you.
Speaker #1: Yeah. Next
Speaker #1: question. There are no
Speaker #3: further questions at this time. And now I would like to turn the call back over to Ben Zeskind. For the closing remarks, please go ahead.
Speaker #1: Great. Well, I want to thank everyone for joining our call today, and we would particularly like to thank all the patients and investigators involved in our ongoing studies.