- 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
"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
Recent Corporate Highlights
- Upcoming oral presentation at
American Society of Clinical Oncology (ASCO) Annual Meeting: OnJune 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 inApril 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 onApril 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
- 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
Research and Development (R&D) Expenses: R&D expenses for the first quarter of 2026 were
General and Administrative (G&A) Expenses: G&A expenses for the first quarter of 2026 were
Net Loss: Net loss attributable to common stockholders was
2026 Financial Guidance
Based on cash, cash equivalents and marketable securities as of
About
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
Investor Contact:
Cdugan@immuneering.com
Media Contact:
Peg.rusconi@deerfieldgroup.com
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||
| (Unaudited) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Operating expenses | |||||||
| Research and development | $ | 10,645,222 | $ | 11,471,693 | |||
| General and administrative | 4,682,495 | 4,005,642 | |||||
| Amortization of intangible asset | 7,317 | 7,317 | |||||
| Total operating expenses | 15,335,034 | 15,484,652 | |||||
| Loss from operations | (15,335,034 | ) | (15,484,652 | ) | |||
| Other income (expense) | |||||||
| Interest income | 1,360,404 | 438,520 | |||||
| Other income, net | 513,735 | — | |||||
| Net loss | $ | (13,460,895 | ) | $ | (15,046,132 | ) | |
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.21 | ) | $ | (0.42 | ) | |
| Weighted-average common shares outstanding, basic and diluted | 64,658,809 | 35,529,652 | |||||
| Other comprehensive loss: | |||||||
| Unrealized loss from marketable securities | (322,337 | ) | — | ||||
| Comprehensive Loss | $ | (13,783,232 | ) | $ | (15,046,132 | ) | |
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (Unaudited) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 47,321,566 | $ | 128,645,025 | |||
| Marketable securities | 109,372,057 | 44,186,244 | |||||
| Prepaids and other current assets | 4,715,535 | 3,414,685 | |||||
| Total current assets | 161,409,158 | 176,245,954 | |||||
| Marketable securities, non-current | 41,950,745 | 44,183,186 | |||||
| Property and equipment, net | 937,008 | 938,481 | |||||
| 6,690,431 | 6,690,431 | ||||||
| Intangible asset, net | 313,830 | 321,147 | |||||
| Right-of-use assets | 3,230,489 | 3,322,249 | |||||
| Other assets | 278,129 | 283,562 | |||||
| Total assets | $ | 214,809,790 | $ | 231,985,010 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 1,453,158 | $ | 1,542,737 | |||
| Accrued expenses | 3,064,066 | 7,842,367 | |||||
| Other liabilities | 44,191 | 291,513 | |||||
| Lease liabilities | 412,835 | 397,104 | |||||
| Total current liabilities | 4,974,250 | 10,073,721 | |||||
| Long-term liabilities: | |||||||
| Lease liabilities, net of current portion | 3,317,369 | 3,427,321 | |||||
| Total liabilities | 8,291,619 | 13,501,042 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Preferred stock, | — | — | |||||
| Class A common stock, | 64,689 | 64,648 | |||||
| Class B common stock, | — | — | |||||
| Additional paid-in capital | 500,475,466 | 498,658,072 | |||||
| Accumulated other comprehensive income (loss) | (241,005 | ) | 81,332 | ||||
| Accumulated deficit | (293,780,979 | ) | (280,320,084 | ) | |||
| Total stockholders' equity | 206,518,171 | 218,483,968 | |||||
| Total liabilities and stockholders' equity | $ | 214,809,790 | $ | 231,985,010 | |||
Source: