Company: IMRX
Filing Date: 2025-09-24
Form Type: 8-K
Source: 0001104659-25-092957
Chunk: 6

Company: Immuneering Corp
Filing Date: 2025-09-24
Form: 8-K
Item: Item 8.01
Chunk 6
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 clinical trial of atebimetinib does not include a head-to-head comparison
against any other agents, and caution should be exercised when comparing data across trials.

The Company also announced that, as of the Cutoff Date, atebimetinib
in combination with mGnP continued to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse
events (“ TEAEs”) observed in 10% or greater of patients in the 320 mg ITT Population consisted of Anemia (eight patients
or 24%) and Neutropenia (six patients or 18%). Grade>3 TEAEs observed in less than
10% of patients in the 320 mg ITT Population consisted of Fatigue (6%), Vomiting (3%), Febrile Neutropenia (3%), Hypokalemia (3%) and
Nausea (3%). No Grade 5 TEAEs were observed in this patient population and no new safety signals were identified.

The Company expects the following near-term anticipated milestones
related to atebimetinib:

  Regulatory                                                                           
  feedback on its pivotal Phase 3 clinical trial plans in the fourth quarter of 2025.  
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  An                                                                                                                                          

  Subject                                                                                                                                       
  to the regulatory feedback described above, the initiation of a pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line  
  pancreatic cancer by the end of 2025, and the dosing the first patient therein by mid-2026.                                                   
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  Subject                                                                                                                                       

On August 21, 2025, the Company entered into a securities purchase
agreement (the “ Prior Purchase Agreement”) with certain investors (the “ Prior PIPE Investors”), pursuant to which
the Company sold securities to the Prior PIPE Investors in a private placement. Each of the Prior PIPE Investors is party to a confidentiality
agreement with the Company, pursuant to which the Company disclosed certain information to such Prior PIPE Investors. Pursuant to the
terms of the Prior Purchase Agreement, each Prior PIPE Investor agreed, severally and not jointly, that neither it nor any affiliate acting
on its behalf would execute any purchases or sales of any of the Company’s securities during the period commencing on August 21,
202