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Date

Wednesday, Nov. 12, 2025 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Benjamin Zeskind
  • Chief Financial Officer — Mallory Morales
  • Investigator — Dr. Allison J. Ocean
  • Investigator — Dr. Gregory Bata

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Takeaways

  • Cash and equivalents -- $227.6 million as of Sept. 30, 2025, up from $36.1 million at Dec. 31, 2024, following $225 million in recent financings, including a $25 million private placement to Sanofi.
  • Cash runway -- Management projects sufficient capital to fund operations into 2029, supporting the pivotal Phase III program, additional clinical trials, and preclinical development.
  • Overall survival (OS) -- 86% OS at nine months for 34 first-line pancreatic cancer patients treated with atebimetinib plus modified gemcitabine nab-paclitaxel; standard of care is approximately 47% at the same timepoint.
  • Phase 2a case study (Ocean) -- One 71-year-old metastatic pancreatic cancer patient achieved a 100% reduction in target lesion size, resulting in an unconfirmed complete response after sequential reductions of 54% and 81% on earlier scans, with improved quality of life reported.
  • Phase 2a case study (Bata) -- A 61-year-old metastatic pancreatic cancer patient achieved a 56% reduction in the primary pancreatic lesion over seven months, enabling eligibility for curative Whipple surgery, and continues on atebimetinib monotherapy with no radiologic evidence of new disease after more than 14 months.
  • Tolerability -- Both investigators described atebimetinib’s tolerability as "unexpectedly good," including stable weight and high reported quality of life in difficult-to-treat patient populations.
  • Regulatory updates -- Planned pivotal Phase III trial for atebimetinib with gemcitabine nab-paclitaxel in first-line pancreatic cancer is scheduled to dose its first patient in mid-2026, pending regulatory feedback.
  • Pipeline progress -- Clinical supply agreements announced in the third quarter include collaborations with Eli Lilly to combine atebimetinib and olomirafen (KRAS G12Ci) in lung cancer, and Regeneron to combine with Libtayo (anti-PD1) for NSCLC, with first patient dosing in the Libtayo study expected in 2026.
  • Patent portfolio -- U.S. Patent Office granted a composition of matter patent for atebimetinib in July 2025, providing exclusivity through 2042, with other applications pending to extend exclusivity to late 2044.
  • Survival resistance mechanisms -- Management stated acquired resistance in the MAP kinase and RAS pathway was minimal among treated patients, citing absence of acquired RAS gene alterations and limited MAP kinase pathway mutations in circulating tumor DNA analysis to date.

Summary

Immuneering Corporation (IMRX 2.57%) reported material advancements across clinical, financial, and regulatory fronts with data suggesting significant overall survival benefit for atebimetinib-based therapy in first-line pancreatic cancer. The company’s strengthened balance sheet, fueled by $225 million in third-quarter financings and strategic investment from Sanofi, extends its cash runway into 2029, securing multiyear operational visibility and funding for key clinical programs. Management highlighted case studies demonstrating potential for long-term response and conversion of metastatic patients to surgical eligibility, uncommon in this indication. Notably, pipeline expansion activities progressed through new clinical collaborations with Eli Lilly and Regeneron that position atebimetinib for combinatorial approaches in lung cancer and other solid tumors.

  • CEO Zeskind said, "We're the only company in this pathway that we're aware of that's shared overall survival data in the first-line setting." for pancreatic cancer, characterizing first-line as "the real prize here."
  • Management noted plans to provide updates on the 34-patient first-line pancreatic cohort in 2026 at a potential major meeting and expects regulatory feedback for the pivotal program within the next year.
  • Intellectual property exclusivity for atebimetinib now secures market protection until at least 2042, with further extension pending ongoing patent applications.
  • Cash raised in the third quarter specifically supports advancement of pivotal trials, combination studies in lung cancer, and preclinical pipeline activities targeting additional oncology indications.
  • Management described atebimetinib’s mechanism as a "deep cyclic" MEK inhibitor, noting that its action inhibits multiple resistance pathways, as evidenced by minimal acquired target gene alterations detected.

Industry glossary

  • Atebimetinib: Immuneering’s proprietary dual-MEK inhibitor in advanced clinical development for RAS/RAF-mutated cancers.
  • FOLFIRINOX: A chemotherapy regimen combining folinic acid, fluorouracil, irinotecan, and oxaliplatin, used as standard of care for pancreatic cancer in select patients.
  • Gemcitabine nab-paclitaxel: A chemotherapy combination used as first-line therapy for pancreatic cancer; nab-paclitaxel is an albumin-bound form of paclitaxel.
  • KRAS G12D mutation: A specific, common oncogenic alteration in the KRAS gene seen in pancreatic and other cancers.
  • Whipple procedure: Surgical removal of the head of the pancreas (pancreaticoduodenectomy), performed as potential curative intervention in eligible pancreatic cancer patients.
  • Deep cyclic inhibitor: A class of targeted agents, including atebimetinib, designed for periodic ('pulsatile') inhibition of oncogenic pathways, aiming to limit resistance and toxicity.
  • NSCLC: Non-small cell lung cancer, a broad category of lung cancers distinct from small cell subtype.
  • Circulating tumor DNA (ctDNA): Fragments of tumor-derived genetic material detectable in blood, used to monitor tumor mutations and resistance mechanisms.

Full Conference Call Transcript

Benjamin Zeskind: During this call, management and our two investigators will refer to slides you can find in the updated version of our corporate deck available in PDF on our IR website. Throughout this call, management will be making forward-looking statements, including statements related to its Phase IIa trial of atezvastib as well as the timing of additional data from the study and the company's development plans. 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.

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-Ks and our quarterly reports on Form 10-Q. Immuneering Corporation undertakes no duty or obligation to update any forward statements as a result of new information, future events, or changes in its expectations. With that, I will turn the call over to Benjamin Zeskind, Chief Executive Officer of Immuneering Corporation. Ben?

Benjamin Zeskind: Thank you, Laurence. Good afternoon, everyone, and thank you for your interest in Immuneering Corporation. We do not always hold quarterly calls, but we try to do so when we have something interesting to share. And today, we are very fortunate to be joined by two investigators from our Phase 2a trial, who will walk us through two remarkable case studies of first-line pancreatic cancer patients treated with atebimetinib in combination with FOLFIRINOX. The investigators are Dr. Allison J. Ocean, Professor of Clinical Medicine at the Weill Medical College of Cornell University, and Dr. Gregory Bata, Associate Professor of Medicine at the Moores Cancer Center at UC San Diego.

Doctors are, of course, busy individuals who plan to start the call with their respective case studies, after which we will let them get back to their patients. Then we will share a summary of the third quarter and why it was so transformational for Immuneering Corporation. In September, we shared an update on 34 first-line pancreatic cancer patients treated with atebimetinib in combination with gemcitabine nab-paclitaxel, with remarkable overall survival. We are as excited as ever about the overall survival we are seeing in that cohort, and we are very excited to share an update soon. We are currently planning to do so in 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 atebimetinib in combination with FOLFIRINOX. FOLFIRINOX is also a standard of care chemotherapy in the first-line setting. Compared with gemcitabine nab-paclitaxel, it has shown slightly longer survival in pivotal studies but with harsher side effects. So it's typically given to younger, higher fitness patients at centers that are well equipped to manage the harsher side effects. Atebimetinib in combination with gemcitabine nab-paclitaxel remains our top priority because the chemotherapy itself is so much better tolerated and the overall survival we have reported is so encouraging.

That being said, down the road, the ability to combine atezvimetinib 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 atebimetinib's potential to drive differentiated outcomes for cancer patients. With that introduction, let me hand the call over to Dr. Ocean, who will walk you through the first case study.

Dr. Allison Ocean: Thank you, Ben. My name is Dr. Allison Ocean, and I'm a medical oncologist and attending physician in gastrointestinal oncology at New York Presbyterian Hospital Weill Cornell Medical Center. I am also an investigator in Immuneering Corporation's Phase 2a study of atebimetinib and an occasional paid consultant for Immuneering Corporation. In my career, I have treated a large number of pancreatic cancer patients, and I can assure you the unmet need here is vast. The case study I'm about to walk you through comes from the arm studying atebimetinib in combination with FOLFIRINOX in first-line pancreatic cancer.

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 atebimetinib plus FOLFIRINOX. 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. 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.

On the right, you see the combination of atebimetinib with FOLFIRINOX led to, at the first scan, an unconfirmed partial response, 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. 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. 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. This is not surprising because our institution's experience with atebimetinib 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. So I believe atebimetinib has made a real difference for this patient. Our institution has treated several patients in various arms of the atebimetinib trial, including the combination of atebimetinib with gemcitabine nab-paclitaxel, and we are very excited that it is moving into a planned Phase III study. 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. Bata, who will walk you through a second case study.

Dr. Gregory Bata: Thank you, Dr. Ocean. My name is Gregory Bata. I'm a medical oncologist who specializes in treating solid tumor cancers of the gastrointestinal system at the University of California San Diego. I'm also an investigator for Immuneering Corporation's Phase 2a study. In my career, I have also treated a large number of pancreatic cancer patients. The patient in this case study, again from the arm studying atebimetinib in combination with FOLFIRINOX in first-line pancreatic cancer patients. For this case study, the patient was a 61-year-old female patient with confirmed metastatic pancreatic cancer to the lung and a 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. The patient's response measure at 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 and has now restarted treatment on atebimetinib monotherapy in the post-surgical setting. At the time of this call, the patient has now been on atebimetinib either in combination or as a monotherapy for over fourteen months 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.

Patients are not typically eligible for surgery once their condition has turned metastatic. But in this case, combination treatment with atebimetinib and FOLFIRINOX was deemed so successful that surgery, preceded by radiation, with curative intent was considered a viable option. I believe that atebimetinib helped us convert this patient to a surgical candidate with curative intent, an outcome that I have rarely seen with chemotherapy alone. 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 fourteen months after starting treatment and remains on atebimetinib monotherapy treatment.

Our site has also treated many other patients with atebimetinib, and we have seen other responses that would be unexpected with chemotherapy alone. Atebimetinib's tolerability is also unexpectedly good, even relative to RAS inhibitors. We are very excited for the planned Phase III study of atebimetinib in combination with gemcitabine nab-paclitaxel. And with that, let me hand the call back over to Ben.

Benjamin Zeskind: Thank you, Dr. Bata. 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. 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. And with that, let you get back to your important work. What I take from the two case studies just presented is several fold. Firstly, that these impressive results we are seeing for atebimetinib in combination with FOLFIRINOX provide another pillar of robustness supporting the extraordinary overall survival we presented for atebimetinib plus modified gemcitabine nab-paclitaxel in September.

Secondly, that patients dosed with atebimetinib plus FOLFIRINOX could potentially provide additional optionality alongside our top priority planned pivotal program for atebimetinib plus modified gemcitabine nab-paclitaxel. Thirdly, we believe the tolerability of atebimetinib is going to be a real differentiator. Of course, the most important differentiator is extraordinary overall survival. And when you layer onto that, Dr. Bata saying a 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. These patients are clearly thriving, we couldn't be happier for them.

Now, let me take a step back and just recap why 2025 was truly transformational for Immuneering Corporation. In September, we announced extraordinary overall survival data in 34 first-line pancreatic cancer patients treated with atebimetinib in combination with gemcitabine and nab-paclitaxel and strengthened our balance sheet with $225 million of cumulative financing, including a $25 million strategic investment from Sanofi. Importantly, these achievements extend our cash runway into 2029 and fund the top-line readout of our planned pivotal program for atebimetinib plus modified gemcitabine nab-paclitaxel, along with our clinical work in lung cancer and preclinical work in other areas.

In September, we reported 86% overall survival at nine months in 34 first-line pancreatic cancer patients treated with atebimetinib plus modified gemcitabine nab-paclitaxel, with a nine-month median follow-up. For context, the standard of care reports approximately 47% overall survival in nine months. We are excited to share an update on atebimetinib in combination with gemcitabine nab-paclitaxel and currently plan to do so in 2026, possibly at a major medical meeting. We also made progress across a number of other fronts in the third quarter. In July, the U.S. Patent Office granted our U.S. Composition of Matter patent for atebimetinib, which is expected to provide exclusivity into 2042 with potential eligibility for patent term extension.

We have patent applications pending that extend exclusivity until late 2044. Then in August, we announced a clinical supply agreement with Eli Lilly intended to evaluate atebimetinib in combination with olomiraciv, a second-generation KRAS G12 inhibitor, in a planned Phase 2a trial in lung cancer patients who have progressed on prior therapy. Remember that earlier this year, we also announced a clinical trial agreement with Regeneron intended to evaluate atebimetinib in combination with Libtayo, an anti-PD1 inhibitor, in advanced lung cancer. Together, we believe these agreements position us to demonstrate atebimetinib's combinability across a variety of tumor types, potentially expanding its market opportunity beyond the already considerable unmet need in first-line pancreatic cancer.

It's having that the 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 update.

Mallory Morales: Thank 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. 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. 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. As a result, our cash and cash equivalents as of September 30, 2025, were $227.6 million compared with $36.1 million as of December 31, 2024.

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.

Benjamin Zeskind: Thank you, Mallory. In terms of upcoming near-term milestones, in 2025, we expect feedback from regulatory agencies and continued preparations to begin dosing patients in the pivotal trial of atebimetinib in combination with gemcitabine nab-paclitaxel in first-line pancreatic cancer patients. In 2026, we plan to announce updated circulating tumor DNA data on acquired alterations at a major scientific meeting. In 2026, we plan to report updated survival data from first-line pancreatic cancer patients treated with atebimetinib plus modified gemcitabine nab-paclitaxel, potentially at a major medical meeting. In mid-2026, we expect to dose the first patient in the pivotal Phase III trial of atebimetinib in combination with modified gemcitabine and paclitaxel in first-line pancreatic cancer, pending regulatory feedback.

And in 2026, we expect to dose the first patient in the trial of atebimetinib in combination with Libtayo in non-small cell lung cancer. 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. Coming out of the third quarter, we have never been better capitalized, nor have we ever had more evidence of atebimetinib's ability to shrink tumors slowly and surely with remarkable durability and tolerability.

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 Corporation. With that, we're happy to take questions. Operator?

Operator: Thank you. And we will now begin the question and answer session. If you would like to ask a question, please press 1 on your telephone keypad to join the queue. If you would like to withdraw your question, simply press 1 again. If you are 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. 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. Thank you. And your first question comes from Jay Olson from Oppenheimer.

Please go ahead.

Jay Olson: Oh, hey, guys. Congrats on all the progress, and thank you for providing this update. Had a couple of questions. To start, can you talk about, based on these new case studies, and the clean safety profile, for atebimetinib, are you considering opportunities for PDAC in the adjuvant setting? And then we had a follow-up if we could.

Benjamin Zeskind: Hey, Jay. Thanks, thanks for the question. You know, right now, our top priority is the first-line setting and the combination of atebimetinib with the modified gemcitabine nab-paclitaxel. I mean, I think the, you know, the overall survival that we announced in September, 86% overall survival at nine months, is just so remarkable. And the, you know, the tolerability that we saw with only two categories of adverse events at the Grade 3 level in more than ten percent of patients. So that's really our top priority, but, you know, 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. 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 you know, I think first-line pancreatic cancer is really just the beginning for atebimetinib, but it's, you know, it's our top priority, and it's a place we're gonna start.

Jay Olson: Okay. Understood. Thank you for that. And maybe just to follow-up, recognizing that you're prioritizing the combo of atebimetinib with gemcitabine nab-paclitaxel. Given these new case studies and again, the clean safety, would you consider potentially combining atebimetinib with 5-FU based regimens?

Benjamin Zeskind: Yeah. It's absolutely something that we're thinking about, Jay. For all the reasons you pointed out. You know, again, it's not currently our top priority. The top priority certainly remains the atebimetinib combination with the modified gemcitabine nab-paclitaxel in first-line pancreatic cancer. Just because, you know, we see such exciting overall survival there. But we're, you know, 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 nab-paclitaxel in September. 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.

So, you know, it's certainly something that we're thinking about and considering. You know, I think these cases also really emphasize what a differentiator tolerability is for atebimetinib. Right? I mean, you heard Dr. Bata saying his patient has experienced great quality of life. You heard Dr. Ocean saying her patient has never felt better. And so I think that does really give you a sense of the tolerability and, you know, it creates a lot of potential options down the road, whether it's combining with FOLFIRINOX, going into the adjuvant setting, and many more. So, you're absolutely right. There's a lot of possibilities for that.

But, you know, our top priority remains the first-line setting in combination with gemcitabine nab-paclitaxel.

Jay Olson: Okay. Thank you. That makes perfect sense. Maybe if I could sneak in one last question. Sure. Just based on the totality of data that you've shared so far and the differentiated profile for atebimetinib that's emerged. Can you just update us on your latest thoughts about where atebimetinib fits into the competitive landscape in PDAC?

Benjamin Zeskind: Yeah. I think the overall survival that we shared in the first-line setting is extraordinary. Right? I mean, you know, and look. We welcome every company that's working in pancreatic cancer. This is a huge unmet need that's not gonna be solved by any one company alone. But, certainly, we believe we're the company that's gonna solve it first and best in the first-line setting. Right? There's, you know, 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 in pancreatic cancer because sadly, half the patients don't make it out of the first-line setting.

We really hear over and over from oncologists that your first shot is your best shot, 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. I think our overall survival data is extraordinary. I mean, to have 86% overall survival in nine months in the data we shared in September, that's a 39% separation from the pivotal study of standard of care. Your differentiation on tolerability certainly from, you know, from anything else in this pathway. Right? And, I mean, I think you heard Dr.

Bata say that directly, you know, kind of unexpectedly good tolerability even relative to RAF inhibitors. So, you know, I think we're the front runners in first-line. You know, we've shared survival data. That's the gold standard. That's what matters most. And you know, we don't think anyone's gonna beat that. Even if they could match it, we think we'd win on tolerability. So we feel very good about where we sit in the competitive landscape.

Jay Olson: Great. Congrats again on all the progress, and thanks for taking the questions.

Benjamin Zeskind: Thank you, Jay. And your next question comes from Andrew Berens from Immuneering. Please go ahead.

Emily: Hi. This is Emily on for Andy, from Leerink. So, yeah, congrats on the data and those case studies. I guess I'm kinda curious, do you have any plans to share the full data from that FOLFIRINOX combination cohort in the near term? And then, you know, 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, you know, used and reimbursed in the future? Thank you.

Benjamin Zeskind: Yeah. Hey, Emily. Great question. And certainly, you and Andy are affiliated with Leerink. I think I appreciate Immuneering Corporation, but we're not breaking any news on that today. And Andy works for Leerink, but, just joking around. You know, 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. Right? Our top priority is first-line pancreatic cancer in combination with gemcitabine nab-paclitaxel where we're just seeing this extraordinary 86% overall survival in nine months in the, you know, in the data we announced in September. So that's the top priority.

But, you know, I think what we shared today certainly further validates those data we shared in September. You know, I think it really creates a lot of additional optionality for us that we, you know, we can combine with FOLFIRINOX, and we can see these remarkable outcomes. So you know, we're still considering that relative to everything else. So certainly can't guide on that today. But it's, you know, it's great to see how well these patients are doing and, you know, great to hear Dr. Bata and Dr. Ocean talk about how truly rare these kind of outcomes are with chemotherapy alone. I mean, to have a complete response in pancreatic cancer is just remarkable.

And 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 and we're really happy about them. So yeah. Very excited.

Emily: Thanks so much.

Benjamin Zeskind: Thank you, Emily. And your next question comes from Greg from Mizuho. Please go ahead.

Greg: 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's Libtayo that I think the comment was you'd be able to start that sometime in the second half of 2026. 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 '26, or do you think that's more of a 2027 timeline?

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 like positioning between those two combinations? And then a last question is, with regards to your runway, which is out to 2029, and congrats on the success with the financings. But what do you particularly or specifically fund for in terms of clinical development, clinical trials, pipeline advancement? Just trying to get a sense of what you're currently funded for. Thanks.

Benjamin Zeskind: Hey, Greg. Thanks, thanks for the questions. We appreciate it. So you're absolutely right. We, you know, we gave new guidance today on the timing of the study of atebimetinib in combination with Regeneron's anti-PD1 Libtayo in lung cancer. 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 2026. And, you know, I think that's important. Different companies use kind of ambiguous words that can really mean very different things around trial timing, but dosing the first patient is just a really clear and unambiguous milestone. So, you know, that's why we like to be clear with that.

So absolutely, dosing the first patient in that study in the second half of 2026. And we're really excited about that because of all the preclinical data, both from us and from the luminaries in the immunotherapy field. Like, Wolchuk, who, you know, 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. So really excited about that study and looking forward to dosing that first patient. With regard to our agreement with Eli Lilly, to evaluate atebimetinib in combination with olomirafen. You'll recall we, you know, that agreement is much more recent. 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. So we're just not gonna guide on the timing of the first patient dosed. But, certainly in due time, you can expect guidance on that. You know, in terms of the kind of the dynamic between those two, look, I mean, you know, there's, again, a vast unmet need in lung cancer. You know, obviously, the olomirafen is a KRAS G12C inhibitor, so that trial would be focused on patients with a KRAS G12C mutation.

Whereas, you know, the use of immunotherapy would potentially address, you know, a different population of patients. So, you know, I think it's early to really comment further on that, but I will say we think atebimetinib 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. You know, we think it's really an attractive backbone, frankly, for combinations with a wide variety of agents. And, you know, we've shared preclinical data on quite a few and are exploring quite a few more.

So there's just really a broad potential for combinations here, and we don't, you know, we think of these two as kind of just the beginning of the potential for atebimetinib. So just really excited for what we'll be able to do for patients with, you know, 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. So really excited about the breadth there.

And then, you know, with regard to our cash guidance with runway into 2029, we're certainly funded to conduct Phase III as we've laid out to conduct these studies in lung cancer and then to advance our preclinical pipeline as well. Right? So keep in mind that atebimetinib is the first and most advanced of our pipeline of deep cyclic inhibitors, but we're pursuing and developing deep cyclic inhibitors against a variety of targets in oncology and a variety of pathways.

So we're, you know, we're certainly excited to continue that work because I think the ability that atebimetinib has demonstrated of deep CYP1 inhibitors to mitigate resistance mechanisms to durably inhibit tumors and to do so with just really remarkable tolerability. I mean, to hear a cancer patient say they've never felt better as Dr. Ocean mentioned, is just really remarkable. So we're excited for that preclinical pipeline as well.

Greg: Thank you, Greg.

Operator: And your next question comes from Ami Fadia from Needham and Company. Please go ahead.

Ami Fadia: Thanks. Good evening. I have a couple of questions. Firstly, based on the data that we've seen so far with the combinations with FOLFIRINOX and gemcitabine nab-paclitaxel, given the clean safety profile of atebimetinib, what type of patients would you consider, you know, as being best suited for the combination with FOLFIRINOX instead of gemcitabine nab-paclitaxel? And then, you know, as I think as we sort of think about the first-line PDAC positioning, you know, how do you see the safety profile translating into the durability of benefit? And, you know, you mentioned earlier that you're gonna be presenting some additional circulating DNA data next year.

If you could sort of talk to how you know, 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. Thank you.

Benjamin Zeskind: Yeah. Thanks, Ami. Great questions. So you're right. Certainly, you know, I think we've demonstrated clearly the ability to combine with FOLFIRINOX, with gemcitabine nab-paclitaxel, and with a clean safety profile in first-line pancreatic cancer patients. And we think that really means that atebimetinib could help a really broad set of patients in the first-line setting in pancreatic cancer. And in fact, one of the things that's nice about our trial is, you know, we don't have to do any genetic testing. Right?

So that, you know, there have been trials of BRAF inhibitors where they, you know, they have to confirm the presence of a RAS mutation, and we just haven't we don't need to do that because atezvimetinib targets MEK, which is further downstream in the pathway. And so, you know, it blocks a wide variety of mutations that drive this pathway. And I think that's important for durability because, again, with RAS inhibitors, and maybe this is a good segue to your next question. You know, with RAS inhibitors, you often see resistance mechanisms. You know, 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, you know, atebimetinib being further downstream at MEK, you know, it blocks those kinds of mechanisms. Right? So the acquired alteration data that we've shared previously that's in our public deck, you know, we saw no acquired alterations in RAS genes and very few in the MAP kinase pathway at all. So what this tells us is, you know, atebimetinib is effectively blocking all the lanes of the highway, if you will. It's, you know, it's blocking a lot of the MAP kinase pathway, it's just it's very hard for the tumor to get around atebimetinib using the MAP kinase pathway. And that's just not the case for RAS inhibitors based on the data that's out there.

So, you know, I think that alone by virtue of the target lends durability, and then, of course, the fact that atebimetinib is a deep cyclic inhibitor and has this pulsatile mechanism, you know, I think that also really helps to mitigate resistance. Right? Because instead of providing the tumor with just a steady constant signal that frankly makes it easy for the tumor to adapt. You know, we have this pulsatile approach where we hit the tumor very hard, and then release. And that, you know, it basically keeps the tumor off balance. If you will. It makes it harder for the tumor to adapt and get around the treatment.

And this, you know, 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, you know, things like mitigating resistance, things like tolerability, like counteracting muscle wasting. I mean, these were the priorities from the beginning. And, you know, I think that's why we really developed this differentiated class in deep signaling inhibitors and why we're seeing such differentiated survival like the 86% overall survival at nine months and the atebimetinib in combination with gemcitabine nab-paclitaxel that we announced in September.

Ami Fadia: With that, thank you, Ami.

Operator: Yeah. Next question.

Mallory Morales: There are no further questions at this time.

Operator: And now I would like to turn the call back over to Benjamin Zeskind for the closing remarks. Please go ahead.

Benjamin Zeskind: Great. I want to thank everyone for joining our call today. And we'd like to thank all the patients and investigators involved in our ongoing studies. And we very much look forward to updating everyone on our future progress. Thank you, everyone.