ORIC Pharmaceuticals Reports 55% PSA50 Response, Raises $244M Extending Cash Runway
ORIC’s Phase 1b dose exploration of rinzimetostat in mCRPC showed 55% PSA50 and 20% PSA90 response rates with ctDNA reductions in 76% of patients. The company raised $244 million and held $413 million cash at Sept 30, 2025, extending its cash runway into 2H 2028 ahead of planned Phase 3 trials.
1. Rinzimetostat Phase 1b Data Demonstrate Best-in-Class Potential
ORIC reported that in the Phase 1b dose exploration study of rinzimetostat (ORIC-944) in metastatic castration-resistant prostate cancer, 55% of patients (11/20) achieved a confirmed ≥50% reduction in PSA and 20% (4/20) achieved a ≥90% reduction. Circulating tumor DNA (ctDNA) responses were rapid and deep, with 76% of evaluable patients (13/17) achieving >50% ctDNA reduction and 59% (10/17) achieving ctDNA clearance. Both combination regimens with apalutamide or darolutamide were well-tolerated, with the majority of treatment-related adverse events Grade 1 or 2 and no unexpected safety signals, supporting long-term dosing and selection of provisional Phase 2 doses for global registrational studies.
2. Enozertinib Phase 1b Data Highlight Brain-Penetrant Activity
At the ESMO Asia Congress, ORIC presented Phase 1b data for enozertinib in NSCLC patients harboring EGFR exon 20 or PACC mutations. In the second-line setting, systemic objective response rates exceeded competitor benchmarks. In first-line patients, enozertinib achieved a 67% ORR in EGFR exon 20 and an 80% ORR in EGFR PACC cohorts. Intracranial responses were 100% in both mutation cohorts among patients with measurable CNS disease, including those with active brain metastases. The safety profile showed low discontinuation rates and no significant off-target toxicities. ORIC also announced a collaboration with Johnson & Johnson to evaluate enozertinib in combination with subcutaneous amivantamab in first-line EGFR exon 20 NSCLC.
3. Strengthened Balance Sheet Extends Runway Into 2H 2028
ORIC closed a $244 million private placement with top-tier healthcare specialist funds in May 2025 and supplemented that with at-the-market offerings through year-end, bringing total cash, cash equivalents and investments to $413 million as of September 30, 2025. Management indicated that this funding position is sufficient to support ongoing Phase 3 efforts for rinzimetostat, Phase 1b and upcoming registrational trials for enozertinib, and multiple value-inflection clinical data readouts through the second half of 2028.
4. Anticipated Milestones for 2026
ORIC expects to report combination dose optimization data for rinzimetostat with androgen receptor inhibitors in the first quarter of 2026 and to initiate its first global Phase 3 trial in mCRPC in the first half. For enozertinib, ORIC plans to release first-line monotherapy and combination data with subcutaneous amivantamab in the second half of 2026, as well as first-line data in the PACC mutation cohort. These milestones, coupled with data timing, set the stage for potential registrational filings and upcoming program updates later in the year.