Chimeric Therapeutics (CHM) NWR Virtual Healthcare Conference summary

Pipeline focus and clinical progress

• Pipeline consolidated to two core assets: CHM CDH17 (CAR T therapy) and CHM CORE-NK (off-the-shelf NK cell therapy), with capital focused on advancing these through phase I and into phase II.

• Three Phase 1 clinical trials underway at six leading US centers under three FDA INDs.

• CHM CDH17 has shown strong preclinical results, with animal models demonstrating complete tumor obliteration in several cancer types.

• Phase I for CHM CDH17 is nearing completion, with 12 patients enrolled and 11 treated; manufacturing success rate remains at 100%.

• Dose escalation is ongoing, with Dose Level 3 (450 million cells) open and several patients wait-listed; results from Dose Level 3 are expected soon.

Regulatory milestones and manufacturing

• CHM CDH17 received FDA IND in November 2023, Fast Track Designation in 2025, and Orphan Drug Designation at the end of 2025.

• Fast Track and Orphan Drug status provide regulatory support and potential tax benefits, enhancing partnership appeal.

• Manufacturing operations have maintained FDA GMP compliance, with all 12 runs successful and no safety or off-target issues reported.

• Automation and cost reduction in manufacturing are being explored to improve efficiency.

Clinical outcomes and patient impact

• Several patients have achieved chemotherapy-free, progression-free survival, including one at 15 months and others at 9 and 6 months.

• All Dose Level 2 patients have achieved stable disease by their first scan at day 28.

• Younger patient demographics (median age 45) are benefiting, aligning with rising colon cancer rates in this group.

• Four complete responses and one partial response observed in frontline and relapsed/refractory AML patients in CORE-NK trials.