IMRX Immuneering Corporation

 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize more effective and better tolerated therapies for cancer patients, today announced a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab). The supply agreement supports the 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) in Immuneering’s ongoing Phase 2a clinical trial of IMM-1-104 in advanced solid tumors.

“We are excited to announce this collaboration, which is the first that Immuneering has entered with IMM-1-104. Regeneron is a global leader in cancer research and development, and the combination of IMM-1-104 and Libtayo in advanced non-small cell lung cancer has the potential to address unmet needs for patients with this disease,” said E.B. Brakewood, Chief Business Officer of Immuneering.

“Preclinical data presented at the American Association for Cancer Research (AACR) 2023 annual meeting supports the dual-targeting potential of IMM-1-104 in combination with immuno-oncology agents, including PD-1 inhibitors, to both break tumor MAPK addiction and enhance anti-tumor immunity,” said Brett Hall, Ph.D., Chief Scientific Officer of Immuneering. Under the terms of the clinical supply agreement, Immuneering will sponsor the planned studies and Regeneron will provide Libtayo. Immuneering will maintain global development and commercialization rights to IMM-1-104. Regeneron develops and commercializes Libtayo globally.

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 several early-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: Immuneering’s plans to develop, manufacture and commercialize IMM-1-104 alone or in combination; the treatment potential of IMM-1-104, alone or in combination; and the timing, design, enrollment and conduct of the Phase 2a clinical trial of IMM-1-104.

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 Immuneering’s 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; that Immuneering has incurred significant losses, is not currently profitable and may never become profitable; Immuneering’s projected cash runway; Immuneering’s need for additional funding and ability to continue as a going concern; Immuneering’s unproven approach to therapeutic intervention; Immuneering’s 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; Immuneering’s reliance on third parties and collaborators to conduct its clinical trials, manufacture its product candidates, and develop and commercialize its product candidates, if approved; failure to compete successfully against other drug companies; protection of Immuneering’s proprietary technology and the confidentiality of Immuneering’s trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of Immuneering’s intellectual property; Immuneering’s 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 Immuneering Corporation’s Quarterly Report on Form 10-Q for the period ended September 30, 2024, and its 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 Immuneering management's estimates as of the date of this press release. While Immuneering may elect to update such forward-looking statements at some point in the future, except as required by law, Immuneering disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Immuneering’s views as of any date subsequent to the date of this press release.

Media Contact for Immuneering:Gina Nugentgina@nugentcommunications.com

Investor Contact for Immuneering:Laurence Watts619-916-7620laurence@newstreetir.com