ORIC® Pharmaceuticals Provides Operational Highlights for 2025 and Anticipated Upcoming Milestones

Announced rinzimetostat (ORIC-944) Phase 1b data that continue to demonstrate potential best-in-class efficacy and safety in mCRPC; selected provisional RP2Ds and initiated dose optimization in combination with AR inhibitors

Presented potential best-in-class enozertinib Phase 1b data demonstrating highly competitive systemic and intracranial activity in NSCLC patients with EGFR exon 20 and EGFR PACC mutations; selected Phase 3 monotherapy dose

Raised $244 million from top-tier healthcare specialist funds; Cash and investments of $413 million expected to provide runway into 2H 2028 and beyond anticipated primary endpoint readout for rinzimetostat Phase 3 study

Expect to report multiple clinical data readouts for rinzimetostat and enozertinib in 2026, ahead of potential initiation of multiple registrational trials

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced operational highlights for 2025 and anticipated upcoming milestones.

"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 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 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.

About ORIC Pharmaceuticals, Inc.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 and atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of rinzimetostat (ORIC-944) and enozertinib; the potential advantages of rinzimetostat and enozertinib; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-class properties of rinzimetostat and enozertinib; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC's clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational trials; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company's chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC's ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC's plans to develop and commercialize its product candidates; the potential for clinical trials of rinzimetostat, enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC's operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC's license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC's product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC's ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC's reliance on third parties, including contract manufacturers and contract research organizations; ORIC's ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on November 13, 2025, and ORIC's future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

Contact:

Dominic Piscitelli, Chief Financial Officer

[email protected]

[email protected]