Immuneering Corp Q4 FY2022 earnings call

• Ben Zeskind introduced the company's 15-year history and discussed the universal-RAS approach to cancer treatment, emphasizing deep cyclic inhibition to target cancer cells while sparing healthy cells.
• Brett Hall highlighted the unique approach using translational bioinformatics and humanized 3D tumor growth assays, shared preclinical data on IMM-1-104 showing 85% response in RAS-mutant models, and discussed IMM-6-415's progress towards IND filing.
• Scott Barrett detailed the Phase 1/2a trial for IMM-1-104, including enrollment criteria (any RAS mutation), trial design, and expected data readouts.
• Mallory Morales provided financial highlights, noting cash runway extends to Q4 2024, and discussed financial results for Q4 2022 and full year 2022.

As of December 31, 2022, Immuneering's cash, cash equivalents, and marketable securities were $105.5 million, down from $150.2 million as of December 31, 2021. Operating expenses for the fourth quarter of 2022 were $14 million, compared to $11.1 million in the fourth quarter of 2021. Full year 2022 operating expenses were $51.9 million, versus $34.8 million in 2021. Net loss attributable to common stockholders was $13.2 million for the quarter ended December 31, 2022, compared to $10.8 million in the same quarter of 2021. Full year 2022 net loss was $50.5 million, compared to $33.5 million in 2021. The company's sole focus is on oncology, with the oncology pipeline being the main segment.

• Management expects cash, cash equivalents, and marketable securities to fund operations into the fourth quarter of 2024.
• For IMM-1-104: Expect initial PK and safety data in mid-2023, initial pharmacodynamics and updated PK/safety data in the second half of 2023, and a recommended Phase 2 Dose (RP2D) in mid-2024.
• IMM-6-415 is on track to file an IND by the end of 2023.

• Factors from the Form 1-K filed with the SEC, including risks related to clinical trial outcomes, regulatory approval processes, competition in the biotech space, and the uncertainty of achieving expected clinical and commercial success for their programs.

Q: Can you comment on how many patients have been dosed in the 104 trials so far? And what is the extent of the data that will be presented in the mid-2023 update?

A: Ben Zeskind mentioned they provided detailed guidance and are excited to share initial PK and safety data in mid-2023 as outlined.

Q: What additional preclinical data are you collecting right now for IMM-6-415? How are you thinking about your clinical development program and the potential design of a Phase 1 trial?

A: Ben Zeskind stated IMM-6-415 is on track to file the IND by the end of 2023, with initial focus on monotherapy and the trial design evolving, focusing on integrating multiple aspects of the MAP kinase pathway.

Q: Based on what you’ve seen, which mutations do you expect to be particularly challenging or relatively easier to treat?

A: Brett Hall explained that drivers for resistance to IMM-1-104 are related to mutation profiles in parallel pathways, with broad activity observed across RAS mutations, and detailed the response profiles in different tumor models from 3D tumor growth assays.