On March 6, 2026 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided business updates.

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"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.

(Press release, Immuneering, MAR 6, 2026, View Source [SID1234663332])