On January 12, 2026 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported operational highlights for 2025 and anticipated upcoming milestones.
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"2025 was a transformative and highly productive year for ORIC, marked by meaningful progress across our pipeline, including data that further strengthened our conviction in the potential best-in-class profiles of rinzimetostat in prostate cancer and enozertinib in lung cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "We also bolstered our leadership team and substantially extended our cash runway into 2H 2028 in anticipation of these programs advancing towards registrational studies and, ultimately, commercialization."
2025 Key Accomplishments
Rinzimetostat: a potent and selective allosteric inhibitor of PRC2
Completed Phase 1b dose exploration in prostate cancer and selected provisional recommended Phase 2 doses (RP2Ds) of rinzimetostat to be tested in combination with the approved doses of darolutamide and apalutamide in dose optimization.
Reported potential best-in-class efficacy and safety dose exploration data in combination with darolutamide and apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
PSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
Broad and deep PSA responses that compare favorably to competitor PRC2 inhibitors, with 55% of patients (11/20) achieving a PSA50 response (confirmed in 40%), and 20% of patients (4/20) achieving a PSA90 response (all confirmed).
Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% (13/17) achieving > 50% ctDNA reduction, and 59% (10/17) achieving ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.
Both combination regimens demonstrated a clearly differentiated safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition.
Presented preclinical data at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrating potential utility of rinzimetostat combined with AR inhibition in castration-sensitive prostate cancer and combined with KRAS inhibition in KRAS G12C-mutant NSCLC and colorectal cancer models.
Enozertinib: a brain-penetrant inhibitor that selectively targets EGFR exon 20 and EGFR PACC mutations
Reported potential best-in-class efficacy and safety data from a Phase 1b trial of enozertinib at the ESMO (Free ESMO Whitepaper) Asia Congress 2025 in NSCLC patients with EGFR exon 20 and EGFR PACC mutations. Data demonstrated:
Systemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
Highly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
Convincing 1L CNS activity, with 100% intracranial ORR in EGFR exon 20 and 100% intracranial ORR in EGFR PACC in patients with measurable CNS disease, including in patients with active brain metastases.
Competitive safety profile, with no significant off-target toxicity, resulting in low rate of treatment discontinuations.
Announced a clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate enozertinib in combination with amivantamab and hyaluronidase-lpuj subcutaneous injection (SC amivantamab) for the 1L treatment of NSCLC patients with EGFR exon 20 mutations.
Announced publication in Cancer Research of preclinical data demonstrating enozertinib’s exquisite selectivity, strong potency, brain-penetrance, and anti-tumor activity across a broad range of EGFR atypical mutant models, including intracranial lung cancer xenografts.
Corporate Highlights:
Announced the appointment of Kevin Brodbeck, PhD, to the newly established role of Chief Technical Officer (CTO).
Strengthened cash position and extended runway with $244 million in gross proceeds raised from new and existing top-tier healthcare specialist funds via private placement in May 2025 and under the ATM (at-the-market) program throughout 2025.
Anticipated Program Milestones:
ORIC anticipates the following upcoming milestones:
Rinzimetostat in mCRPC:
1Q 2026: Combination dose optimization data with AR inhibitor
1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
2H 2026: Program update
Enozertinib in NSCLC:
2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
2H 2026: 1L EGFR PACC monotherapy data
Financial Guidance
As of September 30, 2025, cash, cash equivalents and investments totaled $413.0 million, which the company expects will be sufficient to fund its operating plan into 2H 2028, beyond several potential value inflection points, including anticipated primary endpoint readout from first Phase 3 trial of rinzimetostat.
Presentation and Webcast
Jacob M. Chacko, M.D., president and chief executive officer, will present a company overview at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2025, at 9:45 a.m. PT. A live webcast will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.
(Press release, ORIC Pharmaceuticals, JAN 12, 2026, View Source [SID1234661964])