IMRX
ImmuneeringBDocument history
Earnings documents stored for IMRX.
Investor releaseQuarter not tagged2026-08-05Immuneering Reports Second Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports Second Quarter 2026 Financial Results and Provides Business Updates
- 17.3 month median overall survival in 55 first-line pancreatic cancer patients treated with atebimetinib in combination with chemotherapy, reported in oral presentation at ASCO Annual Meeting on June 1 - - Phase 3 MAPKeeper 301 trial is underway, with patients being dosed and over 30 study locations posted to date - - Peer-reviewed publication in Cancer Research details atebimetinib’s broad, durable preclinical activity, and favorable tolerability across RAS- and RAF-mutant tumors, along with preservation of body mass - - Ended Q2 2026 with $182.7 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the second quarter ended June 30, 2026, and provided business updates. “At a time when first-line pancreatic cancer patients finally have treatment options, the 17.3 month median overall survival reported at ASCO for atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in our single-arm Phase 2a study stands out as potentially best-in-class. Equally important in our Phase 2a data presented at ASCO is that 84% of evaluable patients treated with atebimetinib + mGnP were weight stable or gained weight at three months, and only two categories of treatment related adverse events occurred at a grade 3 or higher in at least 10% of patients. In other words, debilitating side effects may not have to be a given for patients. With over 30 study locations already posted on clinicaltrials.gov, and newly published preclinical data in the peer reviewed journal Cancer Research supporting atebimetinib’s unique mechanism of action, we believe our Phase 3 MAPKeeper 301 study represents a compelling and differentiated option for first-line pancreatic cancer patients.” Recent Corporate Highlights: Dosing patients in the Company’s pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line pancreatic cancer. In June, Immuneering announced it had dosed the first patient in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer patients. Presented compelling Phase 2a data at the ASCO 2026…Read full documentShow less
- 17.3 month median overall survival in 55 first-line pancreatic cancer patients treated with atebimetinib in combination with chemotherapy, reported in oral presentation at ASCO Annual Meeting on June 1 - - Phase 3 MAPKeeper 301 trial is underway, with patients being dosed and over 30 study locations posted to date - - Peer-reviewed publication in Cancer Research details atebimetinib’s broad, durable preclinical activity, and favorable tolerability across RAS- and RAF-mutant tumors, along with preservation of body mass - - Ended Q2 2026 with $182.7 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, Aug. 05, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the second quarter ended June 30, 2026, and provided business updates. “At a time when first-line pancreatic cancer patients finally have treatment options, the 17.3 month median overall survival reported at ASCO for atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in our single-arm Phase 2a study stands out as potentially best-in-class. Equally important in our Phase 2a data presented at ASCO is that 84% of evaluable patients treated with atebimetinib + mGnP were weight stable or gained weight at three months, and only two categories of treatment related adverse events occurred at a grade 3 or higher in at least 10% of patients. In other words, debilitating side effects may not have to be a given for patients. With over 30 study locations already posted on clinicaltrials.gov, and newly published preclinical data in the peer reviewed journal Cancer Research supporting atebimetinib’s unique mechanism of action, we believe our Phase 3 MAPKeeper 301 study represents a compelling and differentiated option for first-line pancreatic cancer patients.” Recent Corporate Highlights: Dosing patients in the Company’s pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line pancreatic cancer. In June, Immuneering announced it had dosed the first patient in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer patients. Presented compelling Phase 2a data at the ASCO 2026 Annual Meeting, demonstrating 17.3 month median overall survival and a favorable tolerability profile in 55 first-line pancreatic cancer patients, together with 84% of evaluable patients weight stable or gaining weight at 3 months. The Phase 2a trial is evaluating atebimetinib in combination with mGnP with results reported as of an April 24, 2026 data cutoff. Appointed Andrew Gengos as Chief Financial Officer. In June, Immuneering announced the appointment of Andrew Gengos as Chief Financial Officer. Mr. Gengos most recently served as Chief Financial Officer and Head of Corporate Development at Terns Pharmaceuticals, which Merck & Co., Inc. acquired for $6.7 billion. Mr. Gengos will oversee financial strategy, capital allocation, investor relations, business development, and corporate development activities. Published new findings in Cancer Research detailing atebimetinib’s broad, durable preclinical activity and favorable tolerability across RAS- and RAF-mutant tumors via Deep Cyclic Inhibition. In July, Immuneering announced the publication of an article in Cancer Research, a leading peer-reviewed journal of the American Association for Cancer Research, characterizing the differentiated mechanism and broad preclinical activity of atebimetinib. The article, “Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass,” reports that atebimetinib demonstrated broad antitumor activity across RAS- and RAF-mutant models while resisting RAF-mediated bypass signaling, a key mechanism associated with resistance to other MEK inhibitors. Atebimetinib’s ability to preserve body mass in a preclinical model of cancer cachexia was also highlighted in the article. Presented Genetic Data at AACR demonstrating mechanism to improve durability and survival, supporting use of atebimetinib in first-line pancreatic cancer and beyond. In April, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments. Anticipated Upcoming Milestones 2H 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer, with a preliminary data readout expected in late-2027. Q4 2026: Additional preclinical data of atebimetinib in combination with anti-PD-1 in non-small cell lung cancer. Mid-2027: Begin IND-enabling studies for our next DCI product candidate program. Mid-2028: Topline data readout from the MAPKeeper 301 trial. Second Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2026 were $182.7 million, compared with $217.0 million as of December 31, 2025. Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2026 were $14.0 million, compared with $10.5 million for the second quarter of 2025. The change in R&D expenses was primarily attributable to increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs, partially offset by reduced spend related to the envometinib program. General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2026 were $5.0 million, compared with $4.3 million for the second quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased software costs supporting the general and administrative functions of the business. Net Loss: Net loss attributable to common stockholders was $17.3 million, or $0.27 per share, for the second quarter ended June 30, 2026, compared to $14.4 million, or $0.40 per share, for the second quarter ended June 30, 2025. 2026 Financial Guidance Based on cash, cash equivalents and marketable securities as of June 30, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029. About Immuneering Corporation Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The Company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical stage programs. For more information, please visit www.immuneering.com.Forward-Looking StatementsThis press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and its potential to deliver overall survival with both durability and tolerability; the timing of dosing and preliminary readout of the planned Phase 2 lung cancer trial and the Phase 3 topline readout of the MAPKeeper 301 trial; the timing of beginning IND-enabling studies in a second DCI program; our operating plans and anticipated cash runway, and the potential ability of the three design mechanisms of atebimetinib to shrink tumors durably, improve overall survival and overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we are a late-stage clinical oncology company with a limited operating history and have not completed any registrational clinical trials; we have incurred significant losses, are not currently profitable and may never become profitable; limitations on our cash runway and potential increases in expenditures; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and changing regulatory standards, and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including the uncertainty of whether positive preclinical or early clinical efficacy and safety results are confirmed in later-stage trials, potential delays in activation of trial sites or enrollment of trial participants, or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2026, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor Contact:Laurence WattsNew Street Investor [email protected] Media Contact:David [email protected]
Investor releaseQuarter not tagged2026-05-15Immuneering Reports First Quarter 2026 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports First Quarter 2026 Financial Results and Provides Business Updates
- New survival data from Phase 2a clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer to be presented in an oral session at 2026 ASCO Annual Meeting - - Pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line metastatic pancreatic cancer now recruiting (NCT07562152),with first patient dosing on track for mid-2026 - - 27 months progression-free survival to date in a third-line pancreatic cancer patient receiving atebimetinib monotherapy, with an ongoing 85% reduction in tumor burden – - Ended Q1 2026 with $198.6 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. "We are excited that new survival data from 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP in our Phase 2a clinical trial will be reported in an oral presentation at the ASCO Annual Meeting on June 1st,” said Ben Zeskind, Chief Executive Officer of Immuneering. “We believe the upcoming presentation at ASCO is an excellent opportunity to build on the recent momentum in second-line pancreatic cancer and demonstrate atebimetinib’s potential to provide a differentiated first-line option for patients. Our Phase 3 study of atebimetinib + mGnP in first-line pancreatic cancer patients, MAPKeeper 301, is now recruiting patients, and we remain on track to dose the first patient by mid-2026. Our Phase 2 lung cancer trial is on track to dose the first patient in the second half of the year. I believe we are entering a new era in cancer care where treatments have the potential to drive longer survival with fewer harsh side effects, and that atebimetinib will play an important role in that future." Recent Corporate Highlights Upcoming oral presentation at American Society of Clinical Oncology (ASCO) Annual Meeting: On June 1, 2026, Dr. Peter Vu, MD, MHA, UC San Diego Health, will present new survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in Immuneering’s Phase 2…Read full documentShow less
- New survival data from Phase 2a clinical trial evaluating atebimetinib + mGnP in first-line metastatic pancreatic cancer to be presented in an oral session at 2026 ASCO Annual Meeting - - Pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line metastatic pancreatic cancer now recruiting (NCT07562152),with first patient dosing on track for mid-2026 - - 27 months progression-free survival to date in a third-line pancreatic cancer patient receiving atebimetinib monotherapy, with an ongoing 85% reduction in tumor burden – - Ended Q1 2026 with $198.6 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the first quarter ended March 31, 2026, and provided business updates. "We are excited that new survival data from 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP in our Phase 2a clinical trial will be reported in an oral presentation at the ASCO Annual Meeting on June 1st,” said Ben Zeskind, Chief Executive Officer of Immuneering. “We believe the upcoming presentation at ASCO is an excellent opportunity to build on the recent momentum in second-line pancreatic cancer and demonstrate atebimetinib’s potential to provide a differentiated first-line option for patients. Our Phase 3 study of atebimetinib + mGnP in first-line pancreatic cancer patients, MAPKeeper 301, is now recruiting patients, and we remain on track to dose the first patient by mid-2026. Our Phase 2 lung cancer trial is on track to dose the first patient in the second half of the year. I believe we are entering a new era in cancer care where treatments have the potential to drive longer survival with fewer harsh side effects, and that atebimetinib will play an important role in that future." Recent Corporate Highlights Upcoming oral presentation at American Society of Clinical Oncology (ASCO) Annual Meeting: On June 1, 2026, Dr. Peter Vu, MD, MHA, UC San Diego Health, will present new survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in Immuneering’s Phase 2a clinical trial. The oral presentation at the 2026 ASCO Annual Meeting utilizes a data cutoff in April 2026. Pivotal Phase 3 MAPKeeper 301 trial now recruiting: The global randomized Phase 3 trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) versus modified gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic cancer (NCT07562152) is now recruiting patients across multiple clinical sites. The company remains on track to dose the first patient by mid-2026. New genetic data from atebimetinib-treated patients demonstrating the mechanism’s potential to improve durability and survival: At the 2026 American Association of Cancer Research (AACR) Annual Meeting on April 20, 2026, Immuneering presented new genetic data in a poster presentation demonstrating a key mechanism that may improve durability and survival, supporting the use of atebimetinib as a first-line treatment in pancreatic cancer and beyond. The circulating tumor DNA (ctDNA) data from 123 atebimetinib-treated patients showed that acquired MAPK pathway alterations were rarely seen. These findings suggest that Deep Cyclic Inhibitors have the potential to overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients, while potentially preserving sensitivity to subsequent treatments. 27 months progression free survival to date in a third-line pancreatic cancer patient treated with atebimetinib monotherapy: The company provided an update on a third-line pancreatic cancer patient, with over 18 centimeters of tumors at baseline, who began receiving atebimetinib monotherapy 27 months ago. The patient continues on treatment, with an 85% reduction in tumor burden as of the most recent scan, with complete resolution of four lesions: a bone lesion, two liver lesions, and a non-target pancreatic lesion. The patient has gained 23 pounds over the course of treatment and reported improved quality of life with no grade 3 adverse events. A detailed description of the case is planned for submission to a medical journal. Anticipated Near-Term Milestones Immuneering remains on track to achieve several near-term anticipated milestones related to atebimetinib, including: Q2 2026: Report updated survival data from an expanded cohort totaling 55 first-line pancreatic cancer patients treated with atebimetinib + mGnP at the 2026 ASCO annual meeting. Mid-2026: Dose the first patient in pivotal Phase 3 MAPKeeper 301 clinical trial of atebimetinib + mGnP in first-line pancreatic cancer. 2H 2026: Dose the first patient in trial of atebimetinib + Libtayo® in RAS-mutant first-line non-small cell lung cancer. First Quarter 2026 Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2026 were $198.6 million, compared with $217.0 million as of December 31, 2025. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were $10.6 million, compared with $11.5 million for the first quarter of 2025. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the envometinib (IMM-6-415) program, partially offset by increased clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were $4.7 million, compared with $4.0 million for the first quarter of 2025. The increase in G&A expenses was primarily attributable to employee related costs and increased professional fees in connection with the general and administrative functions supporting the Company's business. Net Loss: Net loss attributable to common stockholders was $13.5 million, or $0.21 per share, for the first quarter ended March 31, 2026, compared to $15.0 million, or $0.42 per share, for the first quarter ended March 31, 2025. 2026 Financial Guidance Based on cash, cash equivalents and marketable securities as of March 31, 2026, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029. About Immuneering Corporation Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and its potential to deliver overall survival with both durability and tolerability; the timing of dosing of the planned MAPKeeper 301 trial and Phase 2 lung cancer trial; the content and timing of the upcoming 2026 oral presentation at ASCO; and the potential ability of the three design mechanisms of atebimetinib to shrink tumors durably, improve overall survival and overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in activation of trial sites or enrollment of trial participants, or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended March 31, 2026, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor Contact: Courtney Dugan [email protected] Media Contact: Peg Rusconi [email protected]
Investor releaseQuarter not tagged2026-03-06Immuneering Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
- 64% overall survival observed at 12 months in ongoing Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients, well above the standard of care benchmark from GnP of 35% overall survival; On track for expanded pancreatic cancer cohort data readout in first half of 2026 - - On track to dose first patient in pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in patients with first-line metastatic pancreatic cancer in mid-2026 - - Dosing in Phase 2 trial of atebimetinib + Libtayo® in patients with first-line RAS-mutant non-small cell lung cancer expected to begin in second half of 2026 - - Ended 2025 with $217 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates. “2025 was a transformative year for Immuneering. We reported 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP, well above the benchmark for GnP standard of care. We designed atebimetinib with three mechanisms well-established to improve survival, and we believe these survival gains are driven by atebimetinib shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize combinability and performance status," said Ben Zeskind, Ph.D., Chief Executive Officer of Immuneering. “We also made rapid progress in preparation for our pivotal Phase 3 trial in first-line pancreatic cancer patients, MAPKeeper 301, having secured alignment with both the FDA and EMA on our trial design, and we are on track to dose the first patient mid-year. With cash runway expected into 2029, uniquely encouraging clinical data, and a solid pipeline, we are strongly positioned to deliver on our mission to help patients live longer and feel better.” Recent Corporate Highlights Reported 64% Overall Survival at 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In January, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combinati…Read full documentShow less
- 64% overall survival observed at 12 months in ongoing Phase 2a trial of atebimetinib + mGnP in first-line pancreatic cancer patients, well above the standard of care benchmark from GnP of 35% overall survival; On track for expanded pancreatic cancer cohort data readout in first half of 2026 - - On track to dose first patient in pivotal Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in patients with first-line metastatic pancreatic cancer in mid-2026 - - Dosing in Phase 2 trial of atebimetinib + Libtayo® in patients with first-line RAS-mutant non-small cell lung cancer expected to begin in second half of 2026 - - Ended 2025 with $217 million in cash, cash equivalents and marketable securities with anticipated runway into 2029 - NEW YORK, March 06, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates. “2025 was a transformative year for Immuneering. We reported 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP, well above the benchmark for GnP standard of care. We designed atebimetinib with three mechanisms well-established to improve survival, and we believe these survival gains are driven by atebimetinib shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize combinability and performance status," said Ben Zeskind, Ph.D., Chief Executive Officer of Immuneering. “We also made rapid progress in preparation for our pivotal Phase 3 trial in first-line pancreatic cancer patients, MAPKeeper 301, having secured alignment with both the FDA and EMA on our trial design, and we are on track to dose the first patient mid-year. With cash runway expected into 2029, uniquely encouraging clinical data, and a solid pipeline, we are strongly positioned to deliver on our mission to help patients live longer and feel better.” Recent Corporate Highlights Reported 64% Overall Survival at 12 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In January, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 13.4 months median follow up. Immuneering reported 64% overall survival (OS) observed at 12 months as of the December 15, 2025 data cutoff date. Atebimetinib (320mg dosed once daily) + mGnP was observed to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at or above the grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy), in comparison to toxicity profiles for other combinations in the front line pancreatic cancer setting, which demonstrate significantly more grade 3 and higher adverse events. No head-to-head clinical trial has been conducted evaluating atebimetinib and other candidates or products. Differences exist between trial designs, subject characteristics and other factors, and caution should be exercised when comparing data across studies. Secured Alignment with FDA and EMA on pivotal Phase 3 Atebimetinib Trial for First-Line Metastatic Pancreatic Cancer Patients: In December, Immuneering announced that it expected to dose the first patient in its planned global pivotal Phase 3 registrational trial, MAPKeeper 301, in first-line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone. The Company remains on track with this guidance. Notably, the Company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the proposed Phase 3 trial. Added to the Nasdaq Biotechnology Index (NBI): On December 22, 2025, Immuneering was added to the Nasdaq Biotechnology Index. Anticipated Near-Term Milestones Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including: Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting. 1H 2026: Report updated survival data from over 50 first-line pancreatic cancer patients treated with atebimetinib + mGnP. Mid-2026: Dose first patient in pivotal Phase 3 MAPKeeper clinical trial of atebimetinib + mGnP in first-line pancreatic cancer. 2H 2026: Dose first patient in trial of atebimetinib + Libtayo® in RAS-mutant first-line non-small cell lung cancer. Fourth Quarter and Full Year 2025 Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2025 were $217.0 million, compared with $36.1 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2025 were $9.3 million compared to $14.9 million for the fourth quarter of 2024. Full year 2025 R&D expenses were $42.0 million compared to $48.0 million for full year 2024. R&D expenses for the fourth quarter and full year 2025 decreased compared to the same respective periods in 2024, primarily driven by reduced spend related to the Company's product candidate envometinib (IMM-6-415) and certain pre-clinical activities, in addition to decreased personnel related costs. This was partially offset by increased clinical and regulatory consulting resources utilized during the period to support atebimetinib's ongoing development and regulatory readiness activities. General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2025 were $4.5 million compared to $3.7 million for the fourth quarter of 2024. Full year 2025 G&A expenses were $17.3 million compared to $16.1 million for full year 2024. G&A expenses for the fourth quarter and full year 2025 increased compared to the same respective periods in 2024, primarily driven by increased employee-related costs and external professional fees, in addition to increased public filing costs associated with the Company's various financing efforts. Net Loss: Net loss attributable to common stockholders was $11.6 million, or $0.18 per share, for the quarter ended December 31, 2025, compared to $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024. Net loss attributable to common stockholders for full year 2025 was $56.0 million, or $1.27 per share, compared to $61.0 million, or $2.04 per share, for full year 2024. 2026 Financial Guidance Based on cash, cash equivalents and marketable securities as of December 31, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029. About Atebimetinib Atebimetinib is the first in a new category of oral drug candidates, Deep Cyclic Inhibitors (DCIs), designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Each of these mechanisms has been well established to improve survival in published studies. DCIs challenge the conventional model of sustained or continuous inhibition in oncology. Whereas most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily, DCIs are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably. Moreover, DCIs aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events. Atebimetinib targets MEK, a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers. Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit. About Immuneering Corporation Immuneering is a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. The company expects to dose the first patient in mid-2026 in MAPKeeper 301, a globally randomized pivotal Phase 3 trial evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and its potential to deliver overall survival with both durability and tolerability; the ability of the three design mechanisms of atebimetinib to improve overall survival; the timing of commencing dosing in the Phase 3 trial; the ability of atebimetinib + mGnP to deliver a more durable and compounding benefit, including compared to standard of care; the timing, venue and content of future data releases and presentations and for the phase 2 results to continue to trend positively; and the timing for the initiation of additional atebimetinib clinical trial combination arms, including in non-small cell lung cancer. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the period ended December 31, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Investor Contacts: Courtney Dugan [email protected] Media Contact: Gina Nugent [email protected]
Investor releaseQuarter not tagged2025-11-14Immuneering (IMRX) Q3 2025 Earnings Transcript
Motley Fool
Immuneering (IMRX) Q3 2025 Earnings Transcript
Image source: The Motley Fool. Wednesday, Nov. 12, 2025 at 4:30 p.m. ET Chief Executive Officer — Benjamin Zeskind Chief Financial Officer — Mallory Morales Investigator — Dr. Allison J. Ocean Investigator — Dr. Gregory Bata Need a quote from a Motley Fool analyst? Email [email protected] 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-l…Read full documentShow less
Image source: The Motley Fool. Wednesday, Nov. 12, 2025 at 4:30 p.m. ET Chief Executive Officer — Benjamin Zeskind Chief Financial Officer — Mallory Morales Investigator — Dr. Allison J. Ocean Investigator — Dr. Gregory Bata Need a quote from a Motley Fool analyst? Email [email protected] 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. Ever feel like you missed the boat in buying the most successful stocks? Then you’ll want to hear this. On rare occasions, our expert team of analysts issues a “Double Down” stock recommendation for companies that they think are about to pop. If you’re worried you’ve already missed your chance to invest, now is the best time to buy before it’s too late. And the numbers speak for themselves: Nvidia: if you invested $1,000 when we doubled down in 2009, you’d have $502,636!* Apple: if you invested $1,000 when we doubled down in 2008, you’d have $52,025!* Netflix: if you invested $1,000 when we doubled down in 2004, you’d have $624,230!* Right now, we’re issuing “Double Down” alerts for three incredible companies, available when you join Stock Advisor, and there may not be another chance like this anytime soon. See the 3 stocks » *Stock Advisor returns as of November 10, 2025 This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Immuneering (IMRX) Q3 2025 Earnings Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2025-11-13Immuneering Reports Third Quarter 2025 Financial Results and Provides Business and Clinical Updates
GlobeNewswire
Immuneering Reports Third Quarter 2025 Financial Results and Provides Business and Clinical Updates
- Announced extraordinary 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP - - Raised $225 million of financing, including $25 million private placement with Sanofi - - Cash runway extended into 2029, including through topline readout of planned Phase 3 trial of atebimetinib + mGnP in first-line pancreatic cancer - - Granted U.S. composition of matter patent for atebimetinib that is expected to provide exclusivity into 2042 - - New reports of first-line pancreatic cancer patients with excellent responses to atebimetinib + FOLFIRINOX, including a patient with a complete response and a responding patient who was able to advance to radiation and surgery with curative intent - - Conference call scheduled for today, November 12, 2025, at 4:30 pm ET - NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX) a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the third quarter ended September 30, 2025, and provided business and clinical updates. "The third quarter was truly transformational for Immuneering. We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data. I'm excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer," said Ben Zeskind, Ph.D., CEO of Immuneering. “Today, we are also thrilled to share two remarkable examples of patients treated with atebimetinib in combination with FOLFIRINOX, one with a complete response, and another who had responded so well that they were able to pursue radiation and surgery with curative intent. Importantly, these patients are not among the ones we discussed in September. Looking ahead, we are excited to share updated survival data from our study of atebimetinib + mGnP in first-line pancreatic cancer patients in the first half of next year, and to begin dosing patients in our Phase 3 study of atebimetinib + mGnP by mid-next year. In summary, I have never been more excited about our company's future, and our potential to help cancer patients live…Read full documentShow less
- Announced extraordinary 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP - - Raised $225 million of financing, including $25 million private placement with Sanofi - - Cash runway extended into 2029, including through topline readout of planned Phase 3 trial of atebimetinib + mGnP in first-line pancreatic cancer - - Granted U.S. composition of matter patent for atebimetinib that is expected to provide exclusivity into 2042 - - New reports of first-line pancreatic cancer patients with excellent responses to atebimetinib + FOLFIRINOX, including a patient with a complete response and a responding patient who was able to advance to radiation and surgery with curative intent - - Conference call scheduled for today, November 12, 2025, at 4:30 pm ET - NEW YORK, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX) a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive, today reported financial results for the third quarter ended September 30, 2025, and provided business and clinical updates. "The third quarter was truly transformational for Immuneering. We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data. I'm excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer," said Ben Zeskind, Ph.D., CEO of Immuneering. “Today, we are also thrilled to share two remarkable examples of patients treated with atebimetinib in combination with FOLFIRINOX, one with a complete response, and another who had responded so well that they were able to pursue radiation and surgery with curative intent. Importantly, these patients are not among the ones we discussed in September. Looking ahead, we are excited to share updated survival data from our study of atebimetinib + mGnP in first-line pancreatic cancer patients in the first half of next year, and to begin dosing patients in our Phase 3 study of atebimetinib + mGnP by mid-next year. In summary, I have never been more excited about our company's future, and our potential to help cancer patients live longer and feel better." Corporate Highlights Reported Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In September, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 9 months median follow up. Immuneering reported an extraordinary 86% overall survival (OS) observed at 9 months. Atebimetinib (320mg dosed once-daily) + mGnP was reported to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy). Closed $175 Million Underwritten Public Offering and Concurrent $25 Million Private Placement to Sanofi: In September, the Company closed an underwritten public offering of 18,959,914 shares of its Class A common stock at an offering price of $9.23 per share. The gross proceeds from the public offering were approximately $175 million, before deducting underwriting discounts and commissions and offering expenses payable by Immuneering. The Company also announced that Sanofi purchased 2,708,559 shares of Immuneering’s Class A common stock at a purchase price of $9.23 per share, for gross proceeds of approximately $25 million before deducting placement agent discounts and commissions and placement expenses payable by Immuneering, in a separate private placement transaction that closed concurrently with the public offering. Closed $25 Million Private Placement: In August, the Company announced that it had entered into a definitive securities purchase agreement for a private placement of securities to top-tier institutional and other accredited investors that resulted in up front gross proceeds to the Company of approximately $25 million, before deducting fees and expenses. Announced Clinical Supply Agreement with Lilly to Evaluate Atebimetinib in Combination with Olomorasib: In August, the Company announced a clinical supply agreement with Eli Lilly and Company for its second-generation KRAS G12C inhibitor, olomorasib. The supply agreement intends to support the evaluation of Immuneering’s lead product candidate, atebimetinib, in combination with olomorasib in a planned Phase 2a clinical trial in patients with locally advanced or metastatic KRAS G12c-mutant non-small cell lung cancer (NSCLC) who have progressed on prior therapy. In February 2025, Immuneering announced a clinical trial agreement with Regeneron Pharmaceuticals similarly intended to evaluate atebimetinib in combination with the anti-PD-1 therapy Libtayo® in a planned clinical trial in patients with advanced non-small cell lung cancer. Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the Company announced the United States Patent and Trademark Office (USPTO) granted the Company a composition of matter patent for atebimetinib. U.S. Patent No. 12,351,566, titled: “MEK Inhibitors and Therapeutic Uses Thereof”, that includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements. New Case Study of a Patient with Complete Response: A 71-year-old female patient with metastatic pancreatic cancer is being treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The patient has been on treatment for approximately five months. During that time the patient’s target lesion, located in the liver, reduced steadily over the course of three scans to the point of being undetectable, for an unconfirmed complete response. The patient remains on treatment to date, feels extremely well, and has experienced improved quality of life and stable weight. The investigator commented “It is very unusual to see a complete response with chemotherapy alone in a non-BRCA-mutated adenocarcinoma patient like this one. I believe atebimetinib has made a real difference here.” New Case Study of a Patient with Excellent Response Warranting Treatment with Curative Intent: Dr. Gregory Botta, a medical oncologist who specializes in treating solid tumor cancers of the gastrointestinal system at the University of California San Diego (UCSD), described a 61-year-old female patient with metastatic pancreatic cancer treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The treatment resulted in greater than 56% reduction in the primary tumor after 7 months to the point that treatment with radiation and surgery with curative intent was possible. The patient remains on atebimetinib adjuvant therapy and continues to do well with great quality of life and stable weight approximately 14 months after starting treatment. Dr. Botta commented “Rarely do metastatic pancreatic cancer patients improve to the point that surgery with curative intent is a possibility. 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 - and today the patient has no radiological evidence of new disease.” “These case studies add to the growing body of evidence suggesting atebimetinib’s ability to produce transformative outcomes for cancer patients, including those with metastatic pancreatic cancer, and lend further robustness to the data we announced in September from a separate group of patients treated with atebimetinib in combination with mGnP chemotherapy,” said Dr. Igor Matushansky, Chief Medical Officer of Immuneering. Near-Term Milestone Expectations Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including to: Q4 2025: Receive feedback from regulatory agencies and continue preparations to begin dosing patients in the pivotal trial of atebimetinib + mGnP Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting 1H 2026: Report updated survival data from first-line pancreatic cancer patients treated with atebimetinib + mGnP, potentially at a major medical meeting Mid-2026: Dose first patient in pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer 2H 2026: Dose first patient in trial of atebimetinib in combination with Libtayo in non-small cell lung cancer Third Quarter 2025 Financial Highlights Cash Position: Cash, and cash equivalents as of September 30, 2025 were $227.6 million, compared with $36.1 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $10.9 million, compared with $11.3 million for the third quarter of 2024. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, partially offset by higher clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs. General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $4.5 million, compared with $4.0 million for the third quarter of 2024. The increase in G&A expenses was primarily attributable to increased public filing costs associated with the Company’s various financing efforts. Net Loss: Net loss attributable to common stockholders was $15.0 million, or $0.38 per share, for the third quarter ended September 30, 2025, compared to $14.6 million, or $0.49 per share, for the third quarter ended September 30, 2024. Financial Guidance Based on cash, and cash equivalents as of September 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029. Conference Call Immuneering will host a conference call and live webcast today, November 12, 2025 at 4:30 pm ET. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 7742025, or from the webcast link in the investors section of the company’s website: https://ir.immuneering.com/news-events/events-presentations A webcast replay will be available in the investor relations section on the company’s website for 90 days following completion of the call. About Immuneering Corporation Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve durability and tolerability across many cancer indications, including MAPK pathway-driven tumors such as pancreatic cancer. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) or FOLFIRINOX in first-line pancreatic cancer; the treatment potential of our pipeline product candidates in other types of cancer; the plans and objectives of Company management for future operations, including with respect to the timing, planning, enrollment and execution of additional atebimetinib combination trials and a potential pivotal trial of atebimetinib in combination with mGnP; the timing for release of additional results from the Phase 2a portion of the atebimetinib trial; the timing and substance of regulatory feedback on pivotal trial plans; expectations regarding our cash runway; the expected expiration of our issued and pending patents and additional planned patent applications, including the U.S. composition of matter patent covering atebimetinib; our ability to obtain patent term extension on our U.S. composition of matter patent. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended September 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Sarah Fox 646-218-6009 [email protected] Investor Contact: Laurence Watts 619-916-7620 [email protected]
TranscriptFY2025 Q32025-11-12FY2025 Q3 earnings call transcript
Earnings source - 33 paragraphs
FY2025 Q3 earnings call transcript
Welcome to the Immuneering Corporation 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 questions, 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 conference over to Laurence Watts of New Street Investor Relations.
Thank you, Operator. Joining us on the call today from Immuneering Corporation are Chief Executive Officer, Benjamin Zeskind, Chief Scientific Officer, Brett Hall, Chief Medical Officer, Igor Marchanski, Chief Accounting Officer and Treasurer, Mallory Morales, and Ibi Brakewood, our Chief Business Officer.
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?
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.
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.
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.
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.
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.
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?
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.
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.
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.
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?
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.
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?
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.
Great. Congrats again on all the progress, and thanks for taking the questions.
Thank you, Jay. And your next question comes from Andrew Berens from Immuneering. Please go ahead.
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.
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.
Thanks so much.
Thank you, Emily. And your next question comes from Greg from Mizuho. Please go ahead.
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.
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.
Thank you, Greg.
And your next question comes from Ami Fadia from Needham and Company. Please go ahead.
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.
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.
With that, thank you, Ami.
Yeah. Next question.
There are no further questions at this time.
And now I would like to turn the call back over to Benjamin Zeskind for the closing remarks. Please go ahead.
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.
Investor releaseQuarter not tagged2025-11-05Immuneering to Report Third Quarter 2025 Financial Results and Provide New Clinical Case Studies, on Wednesday, November 12, 2025
GlobeNewswire
Immuneering to Report Third Quarter 2025 Financial Results and Provide New Clinical Case Studies, on Wednesday, November 12, 2025
- New case studies on first-line pancreatic cancer patients treated with atebimetinib in combination with FOLFIRINOX to be shared by trial investigators – - Conference call scheduled for Wednesday, November 12, 2025, at 4:30 pm ET - NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced that the company will report third quarter 2025 financial results and trial investigators will provide case studies from first-line pancreatic cancer patients treated in the company’s Phase 2a study of atebimetinib in combination with FOLFIRINOX, on Wednesday, November 12, 2025, after the close of market. Immuneering will host a conference call and webcast at 1:30 pm PT / 4:30 pm ET on the same day. Individuals interested in listening to the live conference call may do so through this webcast link or by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 7742025. A webcast replay will be available from the “Investors” section of the Company’s website here. To access the replay, please register via the webcast link on the Events page. The webcast will be available for one year following the completion of the call. About Immuneering Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Media Contact: Carson Creehan 202-878-8330 [email protected] Investor Contact: Laurence Watts 619-916-7620 [email protected]
Investor releaseQuarter not tagged2025-08-27Eli Lilly (LLY) Advances Obesity Drug Orforglipron With Positive Phase 3 Results
Simply Wall St.
Eli Lilly (LLY) Advances Obesity Drug Orforglipron With Positive Phase 3 Results
Eli Lilly announced positive results from the Phase 3 ATTAIN-2 trial for orforglipron, a potential treatment for obesity and type 2 diabetes, achieving key endpoints such as significant weight loss. Additionally, a clinical supply agreement with Immuneering for olomorasib, targeting lung cancer, marks continued innovation. Despite these promising advancements, LLY traded flat over the last week, aligning with broader market trends, as the overall market performance remained steady. These company developments, while significant, coincided with President Trump's actions concerning the Federal Reserve, which have stirred broader economic considerations. Eli Lilly has 2 weaknesses (and 1 which is potentially serious) we think you should know about. Explore 24 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. Eli Lilly's recent achievements with the ATTAIN-2 trial and the clinical supply agreement signify strong potential for revenue and earnings growth. Positive trial outcomes for obesity and type 2 diabetes treatments like orforglipron may bolster future revenue streams, augmenting the projected annual revenue growth rate of 14%. Additionally, the agreement with Immuneering could enhance Eli Lilly's innovative capacity in the oncology space, potentially boosting its forecast earnings growth of 21.2% annually over the next three years. Over the past five years, Eli Lilly's total shareholder return, encompassing both share price appreciation and dividends, surged by a very large 399.25%. Despite the impressive long-term performance, the stock dipped 14.6% over the past year, underperforming relative to the broader US Pharmaceuticals industry. This historical context shows the company’s strong track record over the longer term, though recent market dynamics have posed some challenges. With the current share price at US$695.33, a significant gap remains to the consensus analyst price target of US$887.60. This target reflects expectations of robust growth driven by advancements in key drug segments and manufacturing expansions. Analysts project revenue could reach US$88.9 billion and earnings could hit US$34 billion by 2028 if these growth drivers materialize. However, as analysts have varying perspectives, it's important fo…Read full documentShow less
Eli Lilly announced positive results from the Phase 3 ATTAIN-2 trial for orforglipron, a potential treatment for obesity and type 2 diabetes, achieving key endpoints such as significant weight loss. Additionally, a clinical supply agreement with Immuneering for olomorasib, targeting lung cancer, marks continued innovation. Despite these promising advancements, LLY traded flat over the last week, aligning with broader market trends, as the overall market performance remained steady. These company developments, while significant, coincided with President Trump's actions concerning the Federal Reserve, which have stirred broader economic considerations. Eli Lilly has 2 weaknesses (and 1 which is potentially serious) we think you should know about. Explore 24 top quantum computing companies leading the revolution in next-gen technology and shaping the future with breakthroughs in quantum algorithms, superconducting qubits, and cutting-edge research. Eli Lilly's recent achievements with the ATTAIN-2 trial and the clinical supply agreement signify strong potential for revenue and earnings growth. Positive trial outcomes for obesity and type 2 diabetes treatments like orforglipron may bolster future revenue streams, augmenting the projected annual revenue growth rate of 14%. Additionally, the agreement with Immuneering could enhance Eli Lilly's innovative capacity in the oncology space, potentially boosting its forecast earnings growth of 21.2% annually over the next three years. Over the past five years, Eli Lilly's total shareholder return, encompassing both share price appreciation and dividends, surged by a very large 399.25%. Despite the impressive long-term performance, the stock dipped 14.6% over the past year, underperforming relative to the broader US Pharmaceuticals industry. This historical context shows the company’s strong track record over the longer term, though recent market dynamics have posed some challenges. With the current share price at US$695.33, a significant gap remains to the consensus analyst price target of US$887.60. This target reflects expectations of robust growth driven by advancements in key drug segments and manufacturing expansions. Analysts project revenue could reach US$88.9 billion and earnings could hit US$34 billion by 2028 if these growth drivers materialize. However, as analysts have varying perspectives, it's important for investors to evaluate these projections within the broader market context. Jump into the full analysis health report here for a deeper understanding of Eli Lilly. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include LLY. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]
Investor releaseQuarter not tagged2025-08-14Immuneering Reports Second Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports Second Quarter 2025 Financial Results and Provides Business Updates
- Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance - - Exceptional 94% overall survival (OS) observed at 6 months in ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N = 34) - - Newly issued U.S. composition of matter patent for atebimetinib expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension - - Request for End of Phase 2 meeting has been submitted to the FDA; pivotal trial expected to initiate in 2026 - CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today reported financial results for the second quarter ended June 30, 2025, and provided several business updates. “We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our exceptional 6-month overall survival data in first-line pancreatic cancer patients is generating strong interest from leading pharmaceutical companies and top-tier investors, and we look forward to sharing the latest results.” “We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications,” Zeskind concluded. Corporate Highlights Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In J…Read full documentShow less
- Company now plans to share updated OS and PFS data from first-line pancreatic cancer patients (N = 34) treated with atebimetinib + mGnP in Q3 2025, earlier than prior guidance - - Exceptional 94% overall survival (OS) observed at 6 months in ongoing Phase 2a trial of atebimetinib plus modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N = 34) - - Newly issued U.S. composition of matter patent for atebimetinib expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension - - Request for End of Phase 2 meeting has been submitted to the FDA; pivotal trial expected to initiate in 2026 - CAMBRIDGE, Mass., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today reported financial results for the second quarter ended June 30, 2025, and provided several business updates. “We are excited to announce updated OS and PFS data from our ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the coming weeks. Last quarter we reported an exceptional 94% OS observed at 6 months in first-line pancreatic cancer patients treated with atebimetinib in combination with mGnP. To put that in perspective, in the pivotal study of standard of care GnP, the 6-month OS was only 67%, and dropped rapidly to only 50% by 8.5 months,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our exceptional 6-month overall survival data in first-line pancreatic cancer patients is generating strong interest from leading pharmaceutical companies and top-tier investors, and we look forward to sharing the latest results.” “We are busy preparing for our Phase 3 pivotal trial, and have now submitted our end of phase 2 meeting request to FDA. In addition, the granting of our composition of matter patent for atebimetinib by the United States Patent and Trademark Office (USPTO) was an important milestone for our company. We expect the long patent runway we are forging for atebimetinib will support our efforts to maximize its therapeutic potential across multiple indications,” Zeskind concluded. Corporate Highlights Reported Positive Overall Survival Data for Atebimetinib from Ongoing Phase 2a Trial in First-Line Pancreatic Cancer Patients: In June, Immuneering shared exceptional data from its ongoing Phase 2a trial of atebimetinib in combination with modified mGnP in first-line pancreatic cancer. The company reported that 94% OS and 72% PFS were observed at 6 months (n=34; patients treated at the 320 mg once-daily dose of atebimetinib), with median OS and PFS not yet reached. A markedly favorable tolerability profile was also observed. All results were reported using a data cutoff date of May 26, 2025. Subject to regulatory feedback, the company plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026. Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the company was granted a composition of matter patent for atebimetinib by the USPTO, which is expected to provide exclusivity into 2042, with subsequent opportunity for patent term extension. The patent is the first granted in the U.S. for a deep cyclic inhibitor, a once-daily pill that aims to drive longer-lasting benefit by outpacing resistance mechanisms that cause cancer drugs to stop working. Additional patent applications for atebimetinib are pending, directed to compounds, pharmaceutical compositions, and methods of use, with expiration expected into 2044. Third-Line Pancreatic Cancer Patient Passes 18-month Mark on Atebimetinib Monotherapy: Today, Immuneering is providing an update on a pancreatic cancer patient in the third-line setting who has received atebimetinib monotherapy for more than 18 months as a participant in the company’s Phase 1 trial and who remains on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on atebimetinib monotherapy at 240 mg once daily and has maintained a partial response, including a 34% reduction in target lesions (RECIST sum of longest diameters) for a confirmed partial response, and a 96% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with a ~16% weight gain observed. Near-Term Milestone Expectations Immuneering is planning for several near-term milestones related to atebimetinib, including to: Announce updated OS and PFS data from first-line pancreatic cancer patients (n = 34) treated with atebimetinib + mGnP in Q3 2025 Receive regulatory feedback on pivotal study plans in Q4 2025 Initiate pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026 Initiate additional atebimetinib clinical trial combination arms in 2026 Second Quarter 2025 Financial Highlights Cash Position: Cash and cash equivalents as of June 30, 2025 were $26.4 million, compared with $36.1 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses for the quarter ended June 30, 2025 were $10.5 million, compared with $10.7 million for the quarter ended June 30, 2024. The decrease in R&D expenses was primarily attributable to decreases in spend for preclinical programs, decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, offset by higher clinical costs related to the Company’s lead atebimetinib program. General and Administrative (G&A) Expenses: G&A expenses for the quarter ended June 30, 2025 were $4.3 million, compared with $4.3 million for the quarter ended June 30, 2024. The second quarter of 2025 costs were consistent with the comparable prior period. Net Loss: Net loss attributable to common stockholders was $14.4 million, or $0.40 per share, for the quarter ended June 30, 2025, compared to $14.1 million, or $0.47 per share, for the quarter ended June 30, 2024. 2025 Financial Guidance Based on cash and cash equivalents as of June 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026. About Immuneering Corporation Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. The Company’s lead product candidate, atebimetinib (IMM-1-104), is an oral, once-daily deep cyclic inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer; the treatment potential of our pipeline product candidates in other types of cancer; the plans and objectives of Company management for future operations, including with respect to the timing, planning, enrollment and execution of additional atebimetinib combination trials and a potential pivotal trial of atebimetinib in combination with mGnP; the timing for release of additional results from the Phase 2a portion of the atebimetinib trial; the timing and substance of regulatory feedback on pivotal trial plans; expectations regarding our cash runway; the expected expiration of our issued and pending patents and additional planned patent applications, including the U.S. composition of matter patent covering atebimetinib; our ability to obtain patent term extension on our U.S. composition of matter patent; and our expectations for a long patent runway we are forging for atebimetinib will support our efforts to maximize its full therapeutic potential, extending to many different cancer types and combinations. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Gina Nugent [email protected] Investor Contact: Laurence Watts 619-916-7620 [email protected]
Investor releaseQuarter not tagged2025-05-06Immuneering Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports First Quarter 2025 Financial Results and Provides Business Updates
- Progression-free survival data from more than 30 patients with first line pancreatic cancer in the ongoing Phase 2a trial of IMM-1-104 trial planned for announcement in 2Q’25 - - Reported positive data from the Company’s ongoing Phase 2a trial of lead program IMM-1-104, including encouraging responses in combination with chemotherapy in first-line pancreatic cancer, and as monotherapy in second-line pancreatic cancer - - Announced clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® (cemiplimab) in non-small cell lung cancer - - Named industry veteran Dr. Igor Matushansky as Chief Medical Officer, to lead clinical efforts as the Company ramps up planning for Phase 3 trial in first line pancreatic cancer - - Cash runway extended into 2026 - CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today reported financial results for the first quarter ended March 31, 2025, and provided several business updates. “In Q1, we showed that IMM-1-104 can drive exceptional efficacy for patients with pancreatic cancer, including a third-line monotherapy patient with over 13 months progression-free survival, a second-line monotherapy patient with a confirmed partial response, and a first-line combination therapy patient with a confirmed complete response. These outcomes are particularly striking given the excellent tolerability observed with IMM-1-104. In January, we reported encouraging overall response rates and disease control rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer. We are excited to share survival data in a larger group of patients in the coming weeks,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our corporate progress in Q1 has matched the pace of our clinical progress. We announced a clinical supply agreement with Regeneron, expanded our cash runway into 2026, and hired an outstanding Chief Medical Officer as we plan for the initiation of a Phase 3 trial in first-line pancreatic cancer patients,” Zeskind concluded. Corporate Highlights Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: In April, Immuneering provided an update on a…Read full documentShow less
- Progression-free survival data from more than 30 patients with first line pancreatic cancer in the ongoing Phase 2a trial of IMM-1-104 trial planned for announcement in 2Q’25 - - Reported positive data from the Company’s ongoing Phase 2a trial of lead program IMM-1-104, including encouraging responses in combination with chemotherapy in first-line pancreatic cancer, and as monotherapy in second-line pancreatic cancer - - Announced clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® (cemiplimab) in non-small cell lung cancer - - Named industry veteran Dr. Igor Matushansky as Chief Medical Officer, to lead clinical efforts as the Company ramps up planning for Phase 3 trial in first line pancreatic cancer - - Cash runway extended into 2026 - CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today reported financial results for the first quarter ended March 31, 2025, and provided several business updates. “In Q1, we showed that IMM-1-104 can drive exceptional efficacy for patients with pancreatic cancer, including a third-line monotherapy patient with over 13 months progression-free survival, a second-line monotherapy patient with a confirmed partial response, and a first-line combination therapy patient with a confirmed complete response. These outcomes are particularly striking given the excellent tolerability observed with IMM-1-104. In January, we reported encouraging overall response rates and disease control rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer. We are excited to share survival data in a larger group of patients in the coming weeks,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Our corporate progress in Q1 has matched the pace of our clinical progress. We announced a clinical supply agreement with Regeneron, expanded our cash runway into 2026, and hired an outstanding Chief Medical Officer as we plan for the initiation of a Phase 3 trial in first-line pancreatic cancer patients,” Zeskind concluded. Corporate Highlights Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: In April, Immuneering provided an update on a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for more than 13 months and is still on treatment. The patient – who previously experienced disease progression on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily and maintained stable disease including a RECIST SLD change of -28% and a 91% reduction in peak CA 19-9 levels. Treatment continued to be well tolerated by the patient, with approximately 16% weight gain. Dr. Igor Matushansky Named as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, an industry veteran with extensive global oncology drug development expertise and experience in clinical treatment of cancer patients, has been appointed the Company’s Chief Medical Officer. In this role, Dr. Matushansky is directing Immuneering’s clinical activities and is providing medical and operational leadership for the company’s development programs, including the ongoing Phase 2a trial of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer. Clinical Trial Supply Agreement Announced with Regeneron for Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the evaluation of IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC). Provided a Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced positive data updates from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104 and confirmed plans to expand the Phase 2a trial to include additional combination arms. Near-Term Milestone Expectations IMM-1-104 Initial progression-free survival data from the IMM-1-104 Phase 2a trial expected in the second quarter of 2025. Additional IMM-1-104 combination arms in planning. Initiation of Phase 3 trial of IMM-1-104+mGnP in first-line pancreatic cancer planned for 2026. First Quarter 2025 Financial Highlights Cash Position: Cash and cash equivalents as of March 31, 2025, were $35.9 million, compared with $36.1 million as of December 31, 2024. Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2025 were $11.5 million compared with $11.2 million for the first quarter of 2024. The increase in R&D expenses was primarily attributable to higher clinical costs related to the Company’s lead program. General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2025 were $4.0 million compared with $4.1 million for the first quarter of 2024. The decrease in G&A was primarily attributable to a decrease in the Company’s employee-related costs in connection with the general and administrative functions supporting the business. Net Loss: Net loss attributable to common stockholders was $15.0 million, or $0.42 per share, for the first quarter ended March 31, 2025, compared to $14.3 million, or $0.49 per share, for the first quarter ended March 31, 2024. 2025 Financial Guidance Based on cash and cash equivalents, as of March 31, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026. About Immuneering Corporation Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of IMM-1-104, alone or in combination with other agents, including chemotherapy; the plans and objectives of Company management for future operations, including with respect to the timing, planning and execution of additional IMM-1-104 combination trials and a potential pivotal trial of IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel; the timing for release of additional results from the Phase 2a portion of the trial for IMM-1-104, including progression free survival data; and expectations regarding our cash runway. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the three months ended March 31, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Jenna Urban [email protected] Investor Contact: Laurence Watts 619-916-7620 [email protected]
Investor releaseQuarter not tagged2025-03-21Immuneering Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
GlobeNewswire
Immuneering Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates
- Reported positive data updates from its ongoing Phase 2a trial of lead program IMM-1-104, including encouraging responses in combination with chemotherapy in first-line pancreatic cancer - - Announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® (cemiplimab) in non-small cell lung cancer - - Additional IMM-1-104 Phase 2a data updates and initiation of new IMM-1-104 combination arms expected in 2025; planning underway for potential IMM-1-104 global pivotal trial - - Named industry veteran Dr. Igor Matushansky as Chief Medical Officer - - Cash runway extended into 2026 - CAMBRIDGE, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates. “We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) and an observed ORR of 50% for IMM-1-104 in combination with modified FOLFIRINOX (mFFX). Historic benchmarks for either chemotherapy agent alone are 23% ORR and 32% ORR, respectively. IMM-1-104 in combination with each of mGnP and mFFX was observed to be generally well tolerated. Based on these promising results, we have begun planning for a potential IMM-1-104 global pivotal trial in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer, as we aim to get this exciting potential new treatment option to patients as quickly as possible,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequen…Read full documentShow less
- Reported positive data updates from its ongoing Phase 2a trial of lead program IMM-1-104, including encouraging responses in combination with chemotherapy in first-line pancreatic cancer - - Announced a clinical trial supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo® (cemiplimab) in non-small cell lung cancer - - Additional IMM-1-104 Phase 2a data updates and initiation of new IMM-1-104 combination arms expected in 2025; planning underway for potential IMM-1-104 global pivotal trial - - Named industry veteran Dr. Igor Matushansky as Chief Medical Officer - - Cash runway extended into 2026 - CAMBRIDGE, Mass., March 20, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business updates. “We were delighted to report updates from our ongoing Phase 2a trial of IMM-1-104 in January 2025 demonstrating excellent response rates for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients. Highlights of these data included an observed ORR of 43% and DCR of 86% for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel (mGnP) and an observed ORR of 50% for IMM-1-104 in combination with modified FOLFIRINOX (mFFX). Historic benchmarks for either chemotherapy agent alone are 23% ORR and 32% ORR, respectively. IMM-1-104 in combination with each of mGnP and mFFX was observed to be generally well tolerated. Based on these promising results, we have begun planning for a potential IMM-1-104 global pivotal trial in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer, as we aim to get this exciting potential new treatment option to patients as quickly as possible,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. “Importantly, the results demonstrated with IMM-1-104 to date point to its potential combinability, set to continue with our recently announced plans to study IMM-1-104 in combination with a BRAF inhibitor in melanoma, with a G12C inhibitor in non-small cell lung cancer, and with a PD-1 inhibitor in both melanoma and non-small cell lung cancer. We subsequently announced a clinical trial supply agreement with Regeneron for Libtayo in combination with IMM-1-104 in patients with non-small cell lung cancer and aim to get these new trials up and running this year. In support of these plans, we were pleased to announce that Dr. Igor Matushansky has joined Immuneering as Chief Medical Officer to oversee clinical activities, including medical and operational leadership for our development programs." Zeskind concluded: “As we look ahead to the rest of the year – with our cash balance recently fortified – we expect multiple data events, beginning with an update from our IMM-1-104 Phase 2a trial in the second quarter of 2025. We are continuing to build a growing data set that we believe positions our lead asset with the potential to offer an improved profile in comparison to current MEK inhibitors, which currently represents an existing approximately $2.4 billion annual global opportunity in the aggregate.” Corporate Highlights Phase 1 Pancreatic Cancer Patient Passes 13-month Mark on IMM-1-104 Monotherapy: Today, Immuneering provided a case study update for a Phase 1 pancreatic cancer patient in the third-line setting who has been receiving IMM-1-104 monotherapy for over 13 months so far. The patient – who previously progressed on first-line FOLFIRINOX and second-line Gem/Cis/nab-Pac – has been on IMM-1-104 monotherapy at 240 mg once daily. As of the most recent available scan, the patient has maintained stable disease with a RECIST SLD change of -24.2%. In addition to a 91% reduction in peak CA 19-9 levels, IMM-1-104 has been well tolerated by the patient, who has reported improved quality of life and approximately 12% weight gain. Named Dr. Igor Matushansky as Chief Medical Officer: In March, Immuneering announced that Igor Matushansky, MD, PhD, joined the company as Chief Medical Officer. In this role, Dr. Matushansky will direct Immuneering’s clinical activities, providing medical and operational leadership for the company’s development programs including the ongoing Phase 2a study of IMM-1-104 in pancreatic cancer, lung cancer, and melanoma, and plans to initiate a pivotal Phase 3 clinical trial in pancreatic cancer. Announced Clinical Trial Supply Agreement with Regeneron Pharmaceuticals to Evaluate IMM-1-104 in Combination with Libtayo (cemiplimab): In February, Immuneering announced a clinical trial supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo. The agreement supports the intended evaluation of Immuneering’s lead product candidate, IMM-1-104, in combination with Libtayo in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC). Positive Data Update from Three Pancreatic Cancer Arms of Ongoing Phase 2a Trial of IMM-1-104: In January, Immuneering announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include additional combination arms. Launched Pancreatic Cancer Advisory Board: In December, Immuneering announced the formation of its Pancreatic Cancer Advisory Board. The advisory board, which comprises world-renowned oncology clinical researchers, will provide strategic medical and clinical guidance to the company as its pipeline, including lead clinical program IMM-1-104, continues to advance. FDA Fast Track Designation for IMM-1-104 in Advanced Melanoma: In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. FDA Orphan Drug Designation for IMM-1-104 in the Treatment of Pancreatic Cancer: In October 2024, the FDA granted Orphan Drug designation to IMM-1-104 in the treatment of pancreatic cancer. Near-Term Milestone Expectations IMM-1-104 Further IMM-1-104 Phase 2a data expected in the second quarter of 2025. Initiation of Phase 2a arm of IMM-1-104 in combination with Libtayo in NSCLC planned for 2025. Initiation of Phase 2a arm of IMM-1-104 in combination with a G12C inhibitor in NSCLC planned for 2025. Initiation of Phase 2a arm of IMM-1-104 in combination with a PD-1 inhibitor in melanoma planned for 2025. Initiation of Phase 2a arm of IMM-1-104 in combination with a BRAF inhibitor in melanoma planned for 2025. Fourth Quarter and Full Year 2024 Financial Highlights Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2024, were $36.1 million, compared with $85.7 million as of December 31, 2023. These amounts exclude net proceeds of $13.7 million from the Company’s ATM facility raised in January 2025. Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2024 were $14.9 million compared with $11.9 million for the fourth quarter of 2023. Full year 2023 R&D expenses were $48.0 million compared to $41.6 million for full year 2023. The increase in fourth quarter and full year 2024 R&D expenses as compared to the same respective periods of 2023 was primarily attributable to higher clinical costs related to the Company’s lead IMM-1-104 program and increased personnel to support ongoing research and development activities. General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2024 were $3.7 million compared with $4.4 million for the fourth quarter of 2023. Full year 2024 G&A expenses were $16.1 million compared to $16.8 million for full year 2023. The decrease in fourth quarter and full year 2024 G&A expenses as compared to the same respective periods of 2023 was primarily due to lower external professional fees and a reduction in employee-related costs, partially offset by higher stock-based compensation related to the general and administrative functions supporting the business. Net Loss: Net loss attributable to common stockholders was $18.1 million, or $0.58 per share, for the quarter ended December 31, 2024, compared to $15.1 million, or $0.52 per share, for the quarter ended December 31, 2023. Net loss attributable to common stockholders for full year 2024 was $61.0 million, or $2.04 per share, compared to $53.5 million, or $1.88 per share, for full year 2023. 2025 Financial Guidance Based on cash and cash equivalents as of December 31, 2024, plus proceeds from the Company’s subsequent utilization of its ATM facility, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2026. About Immuneering Corporation Immuneering is a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients. The Company’s lead product candidate, IMM-1-104, is an oral, once-daily deep cyclic inhibitor of MEK designed to improve tolerability and expand indications to include RAS-driven tumors such as most pancreatic cancers. IMM-1-104 is currently in a Phase 1/2a trial in patients with advanced solid tumors including pancreatic cancer. IMM-6-415 is an oral, twice-daily deep cyclic inhibitor of MEK currently in a Phase 1/2a trial in patients with advanced solid tumors harboring RAS or RAF mutations. The company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of IMM-1-104, alone or in combination with other agents, including chemotherapy, checkpoint inhibitors and BRAF inhibitors; the plans and objectives of Company management for future operations, including with respect to the planning and execution of additional IMM-1-104 combination trials and potential pivotal trial of IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel; the timing for release of additional results from the Phase 2a portion of the trial for IMM-1-104; and expectations regarding our cash runway. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the annual period ended December 31, 2024, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Jenna Urban [email protected] Investor Contact: Laurence Watts 619-916-7620 [email protected]

