Chimeric Therapeutics (CHM) investor relations material

Clinical program progress

• Four Phase 1 clinical trials are ongoing across three assets under three FDA INDs at four leading US centers, with a focus on CHM CDH17 and CHM CORE-NK.

• CHM CDH17, an autologous CAR-T cell therapy, is in Phase 1/2 trials for colorectal, gastric, and neuroendocrine cancers at four sites, with 10 patients recruited, eight treated, and 10/10 successful GMP manufacturing runs.

• Fast track designation was achieved from the FDA in April 2024, and orphan designation is under review.

• CHM CORE-NK, an off-the-shelf allogeneic NK cell product, is being tested in investigator-initiated and Phase 1b trials at MD Anderson and Case Western, with dose escalation completed and first-line dosing underway.

CHM CDH17 clinical results and next steps

• Dose level 1 (50 million cells) is completed, dose level 2 (150 million cells) recruitment is ongoing, and dose level 3 recruitment is underway; both lower dose levels have demonstrated safety, with tumor shrinkage and stable disease observed.

• Tumor shrinkage up to 37% and persistence of CAR-T cells for over 200 days have been observed, with no off-target effects or safety issues reported.

• Mixed responses are due to regulatory definitions; some lesions shrink >30%, but not all meet criteria for partial response.

• Phase 1 is expected to conclude in FY26, with Phase 2 ready to start without further FDA review.

• Commercial interest is high due to the large market and unique CAR-T targeting CDH17.

CHM CORE-NK trial updates

• Dose escalation is complete; first-line dosing is underway at MD Anderson, with seven of 20 patients treated.

• Four complete responses and one partial response have been observed, with no safety issues to date.

• The trial is the only known first-line cell therapy study in this setting, aiming to complete dosing in FY26.

• Response rates exceed 50%, surpassing historical benchmarks for standard therapy in AML.

• Regulatory and manufacturing challenges are being addressed, with ongoing updates expected mid-next year.