Immuneering - Earnings Call - Q3 2025

Executive Summary

• Q3 2025 was transformational: Immuneering reported extraordinary clinical durability (86% 9‑month OS in first‑line PDAC on atebimetinib + mGnP), secured $225M in equity financing (including a $25M Sanofi private placement), obtained a composition-of-matter patent for atebimetinib, and extended cash runway into 2029.
• EPS beat by a penny: Q3 EPS of $0.38 loss vs S&P Global consensus of $0.388 loss; operating trends were stable with R&D $10.9M and G&A $4.5M. EPS consensus from S&P Global data.*
• Multiple near-term catalysts: regulatory feedback on the pivotal PDAC trial plan in Q4 2025; updated survival data in 1H 2026; first patient dosing in the pivotal Phase 3 mid‑2026; first patient dosing in Libtayo combo NSCLC in 2H 2026.
• Investigators highlighted exceptional case outcomes with atebimetinib + FOLFIRINOX (one complete response; another converted to surgery with curative intent), reinforcing the tolerability/quality-of-life narrative and broad combinability potential.

What Went Well and What Went Wrong

What Went Well

• Strong survival durability in first‑line PDAC: 86% OS at 9 months (atebimetinib + mGnP, n=34, median follow‑up 9 months); CEO emphasized “I have never been more excited about our company's future”.
• Capital and runway: Closed $175M offering, $25M private placement to Sanofi, plus earlier $25M private placement; cash rose to $227.6M and runway extended into 2029.
• Clinical anecdotes reinforce differentiation: Unconfirmed complete response and a metastatic patient converted to surgery with curative intent on atebimetinib + FOLFIRINOX; investigators cited “unexpectedly good” tolerability and “never felt better” patient experience.

What Went Wrong

• No revenue; continued operating losses: Net loss was $15.0M in Q3 (similar to prior quarters), reflecting development-stage profile with ongoing OpEx.
• Limited near‑term disclosure for FOLFIRINOX arm: Management did not guide timing to share full cohort data; priority remains mGnP combo pivotal program.
• Dilution risk highlighted: Shares outstanding rose materially with financings (63.48M issued/outstanding at 9/30/25 vs 31.05M at 12/31/24) to fund the platform and Phase 3.

Transcript

Operator (participant)

Welcome to the Immuneering 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. Following management's prepared remarks, we will hold a Q&A session. To 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. 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 Relations.

Lawrence Watts (CEO and Founder)

Thank you, 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 Mallory Morales, and E.B. Brakewood, our Chief Business Officer. 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. Throughout this call, management will be making forward-looking statements, including statements related to its phase II-A trial of the atebimetinib, 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-K and our quarterly reports on Form 10-Q. Immuneering undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I will turn the call over to Ben Zeskind, Chief Executive Officer of Immuneering. Ben.

Ben Zeskind (CEO)

Thank you, Lawrence. Good afternoon, everyone, and thank you for your interest in Immuneering. We do not always hold quarterly calls, but we try to do so when we have something interesting to share. Today, we are very fortunate to be joined by two investigators from our phase II-A 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. Allyson J. Ocean, Professor of Clinical Medicine at the Weill Medical College of Cornell University, and Dr. Gregory Botta, Associate Professor of Medicine at the Moores Cancer Center at UC San Diego.

Doctors Ocean and Botta are, of course, busy individuals, so we plan 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 Immuneering. 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'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. 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 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. It is 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 atebimetinib with FOLFIRINOX may ultimately give oncologists more options. 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.

Allyson Ocean (Professor of Clinical Medicine)

Thank you, Ben. My name is Dr. Allyson 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's phase II-A study of atebimetinib and an occasional paid consultant to Immuneering. 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. 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 with a 54% reduction in sum of longest diameters, and then that partial response confirmed with an 81% reduction in sum of 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 a 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.

Botta, who will walk you through a second case study.

Gregory Botta (Medical Oncologist and Associate Professor of Medicine)

Thank you, Dr. Ocean. My name is Gregory Botta, and 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's phase II-A study. In my career, I have also treated a large number of pancreatic cancer patients. The patient in this case study is 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 biopsy-confirmed metastatic pancreatic cancer to the lung, 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.

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 and has now restarted treatment on a atebimetinib monotherapy in the post-surgical setting. At the time of this call, the patient has now been on a atebimetinib either in combination or as a monotherapy for over 14 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. 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 atebimetinib helped us convert this patient to a surgical candidate with curative intent, an outcome that I have rarely seen with chemotherapy alone. Today, the patient has no radiologic evidence of new disease. While the patient has to be censored from survival measurements, the patient continues to do well approximately 14 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. With that, let me hand the call back over to Ben.

Ben Zeskind (CEO)

Thank you, Dr. Botta. 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. 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. 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. When you layer onto that, Dr. Botta 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, 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 Immuneering.

In September, we announced extraordinary overall survival data in 34 first-line pancreatic cancer patients treated with atebimetinib in combination with gemcitabine 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 at nine months.

We are excited to share an update on atebimetinib in combination with gemcitabine nab-paclitaxel and currently plan to do so in the first half of 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 into late 2044. In August, we announced a clinical supply agreement with Eli Lilly intended to evaluate atebimetinib in combination with Olomorasib, a second-generation KRAS G12C inhibitor, in a planned phase II-A 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-PD-1 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. atebimetinib'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 update.

Mallory Morales (Chief Accounting Officer and Treasurer)

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 30th, 2025, were $227.6 million, compared with $36.1 million as of December 31st, 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.

Ben Zeskind (CEO)

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 atebimetinib in combination with gemcitabine nab-paclitaxel in first-line pancreatic cancer patients. 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 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 nab-paclitaxel in first-line pancreatic cancer, pending regulatory feedback.

In the second half of 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. With that, we're happy to take questions. Operator.

Operator (participant)

Thank you. 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. 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. Just a reminder, we ask that you please limit yourself to one question and one follow-up only. After that, you can just simply join the queue again. Thank you. Your first question comes from Jay Olson from Oppenheimer. Please go ahead.

Jay Olson (Research Analyst)

Oh, hey, 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 clean safety profile for atebi, are you considering opportunities for PDAC in the adjuvant setting? We had a follow-up if we could.

Ben Zeskind (CEO)

Hey, Jay. Thanks for the question. 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 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 at the grade 3 level in more than 10% of the patients. That's really our top priority. I think you're absolutely right. There's a wide range of potential opportunities kind of down the road a little bit. Certainly, adjuvant is one that we're thinking carefully about among others. No decisions to report there today. Certainly, I think you're absolutely right. There's a lot of potential in a lot of different areas.

I think first-line pancreatic cancer is really just the beginning for atebimetinib. It is our top priority, and it is the place we are going to start.

Jay Olson (Research Analyst)

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

Ben Zeskind (CEO)

Yeah. It's absolutely something that 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 atebimetinib in combination with the modified gemcitabine nab-paclitaxel in first-line pancreatic cancer, just because we see such exciting overall survival there. 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. I think, to your point, that certainly demonstrates the potential for greater optionality down the road. It's certainly something that we're thinking about and considering. I think these cases also really emphasize what a differentiator tolerability is for atebimetinib, right? I mean, you heard Dr. Botta saying his patient has experienced great quality of life.

You heard Dr. Ocean saying her patient has never felt better. I think that does really give you a sense of the tolerability. It creates a lot of potential options down the road, whether it's combining with FOLFIRINOX, going into the adjuvant setting, and many more. You're absolutely right. There's a lot of possibilities for that. Our top priority remains the first-line setting in combination with gemcitabine nab-paclitaxel.

Jay Olson (Research Analyst)

Okay. Thank you. That makes perfect sense. Maybe if I could sneak in one last question.

Ben Zeskind (CEO)

Sure.

Jay Olson (Research Analyst)

Just based on the totality of data that you've shared so far and the differentiated profile for Tevid that's emerged, can you just update us on your latest thoughts about where Tevid fits into the competitive landscape in PDAC?

Ben Zeskind (CEO)

Yeah. I think the overall survival that we shared in the first-line setting is extraordinary, right? I mean, look, we welcome every company that's working in pancreatic cancer. This is a huge unmet need that's not going to be solved by any one company alone. Certainly, we believe we're the company that's going to solve it first and best in the first-line setting, right? There's not another company working in this pathway that we're aware of that's shared first-line overall survival data. First-line is the real prize in pancreatic cancer because, sadly, about 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. 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 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 nab-paclitaxel. 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. 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. I think we show clear differentiation on tolerability, certainly from anything else in this pathway, right?

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

Jay Olson (Research Analyst)

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

Ben Zeskind (CEO)

Thank you, Jay.

Operator (participant)

Your next question comes from Andrew Berens from Immuneering. Please go ahead.

Hi. This is Emily on for Andy from Leerink. 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? 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? Thank you.

Ben Zeskind (CEO)

Yeah. Hey, Emily, great question. Certainly, you and Andy are affiliated with Leerink. I think I know for sure you said Immuneering, but we're not breaking any news on that today. You and Andy work for Leerink, just joking around. I think 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 data we announced in September. That's the top priority. 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.

We're still considering that relative to everything else. Certainly can't guide on that today. It's great to see how well these patients are doing. Great to hear Dr. Botta 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. 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, and we're really happy about them. Yeah, very exciting.

Thanks so much.

Thank you, Emily.

Operator (participant)

Your next question comes from Greg Silvanouve from Mizuho. Please go ahead.

Greg Silvanouve (VP and Equity Research Analyst)

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 2026, 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 positioning between those two combinations?

A last question is with regards to your cash runway, which is out to 2029, and congrats on the success with the financings. What are 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. Thanks.

Ben Zeskind (CEO)

Hey, Greg. Thanks for the questions. We appreciate it. You're absolutely right. We gave new guidance today on the timing of the study of atebimetinib in combination with Regeneron's anti-PD-1 Libtayo in lung cancer. 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. I think that's important. Different companies use kind of ambiguous words that can really mean very different things around trial timing. Dosing the first patient is just a really clear and unambiguous milestone. That's why we like to be clear with that. Absolutely, dosing the first patient in that study in the second half of 2026.

We're really excited about that because of all the preclinical data, both from us and from the luminaries in the immunotherapy field, like Jedd Wolchok, who has a paper showing that pulsatile inhibition of MEK can really enhance the activity of immunotherapy in a lung cancer model in a preclinical setting. 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 Olomorasib, you'll recall that agreement is much more recent, right? While we had announced a Regeneron agreement in February, that one we announced over the summer, towards the end of the summer. It's just a little early to guide on that yet. We're just not going to guide on the timing of the first patient dose.

Certainly, in due time, you can expect guidance on that. In terms of kind of the dynamic between those two, look, I mean, there's, again, a vast unmet need in lung cancer. Obviously, the Olomorasib is a KRAS G12C inhibitor. 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. I think it's early to really comment further on that. 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, we think it's really an attractive backbone, frankly, for combinations with a wide variety of agents. We have shared preclinical data on quite a few and are exploring quite a few more.

There is just really a broad potential for combinations here. We think of these two as kind of just the beginning of the potential for atebimetinib. 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. Really excited about the breadth there. With regard to our cash guidance with runway into 2029, we're certainly funded to conduct the phase III as we've laid out to conduct these studies in lung cancer and to advance our preclinical pipeline as well, right? Keep in mind that atebimetinib is the first and most advanced of our pipeline of deep cyclic inhibitors.

We're pursuing and developing deep cyclic inhibitors against a variety of targets in oncology and a variety of pathways. We're certainly excited to continue that work because I think the ability that atebimetinib has demonstrated of deep cyclic 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. We're excited for that preclinical pipeline as well. Thank you, Greg.

Operator (participant)

Your next question comes from Ami Fadia from Needham & Company. Please go ahead.

Ami Fadia (Analyst)

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 theme safety profile of atebi, what type of patients would you consider as being best suited for the combination with FOLFIRINOX instead of gemcitabine nab-paclitaxel? 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? You mentioned earlier that you're going to be presenting some additional circulating tumor DNA data next year. If you could sort of talk to 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.

Ben Zeskind (CEO)

Yeah. Thanks, Ami. Great questions. You're right. Certainly, 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. We think that really means atebimetinib could help a really broad set of patients in the first-line setting in pancreatic cancer. In fact, one of the things that's nice about our trial is we don't have to do any genetic testing, right? There have been trials of, say, RAS inhibitors where they have to confirm the presence of a RAS mutation. We just haven't—we don't need to do that because atebimetinib targets MEK, which is further downstream in the pathway. It blocks a wide variety of mutations that drive this pathway.

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. 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 a atebimetinib being further downstream at MEK, it blocks those kind of mechanisms, right? The acquired alteration data that we've shared previously that's in our public deck, we saw no acquired alterations in RAS genes and very few in the MAP kinase pathway at all. What this tells us is a atebimetinib is effectively blocking all the lanes of the highway, if you will. It's blocking a lot of the MAP kinase pathway. It's very hard for the tumor to get around a atebimetinib using the MAP kinase pathway.

That is just not the case for RAS inhibitors based on the data that is out there. I think that alone, by virtue of the target lesion's durability, and then, of course, the fact that atebimetinib is a deep cyclic inhibitor and has this pulsatile mechanism, 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, we have this pulsatile approach where we hit the tumor very hard and then release. That basically keeps the tumor off balance, if you will. It makes it harder for the tumor to adapt and get around the treatment. This was a design goal from the very beginning, right? I mean, we started this company around the goal of driving overall survival.

Things like mitigating resistance, things like tolerability, like counteracting muscle wasting, I mean, these were the priorities from the beginning. 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 in atebimetinib in combination with gemcitabine nab-paclitaxel, that we announced in September. With that.

Ami Fadia (Analyst)

Thank you.

Ben Zeskind (CEO)

Thank you, Amy. Yeah. Next question.

Operator (participant)

There are no further questions at this time. I would like to turn the call back over to Ben Zeskind for the closing remarks. Please go ahead.

Ben Zeskind (CEO)

Great. I want to thank everyone for joining our call today. We would particularly like to thank all the patients and investigators involved in our ongoing studies. We very much look forward to updating everyone on our future progress. Thank you, everyone.