Full Press Release Details
ORIC Pharmaceuticals Announces Focused Registrational Clinical Development Plans for Lead Programs, Extended Cash Runway, and Updated Corporate Milestones
Anticipated registrational development plans for ORIC-944 and
ORIC-114 prioritized to focus on indications with strongest clinical validation and highest unmet need
ORIC-944 initiation of first Phase 3 trial in mCRPC expected in 1H 2026; ORIC-114 registrational development plans to focus on 1L NSCLC with anticipated initiation in 2026
Favorable enrollment across both programs allows for accelerated/augmented corporate milestones, including combination dose escalation data
in mCRPC expected in 1H 2025 and 2H 2025, and comprehensive NSCLC data expected in 2H 2025 that includes 1L EGFR exon 20
cash runway extended into 2027 under refined operating plan
SOUTH SAN FRANCISCO and SAN DIEGO, CA February 25, 2025
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced focused registrational clinical development plans for its two
lead programs, an extension of projected cash runway into 2027 (from previous guidance of late 2026), and accelerated/augmented corporate milestones.
Based on the initial data we have generated with ORIC-944 and ORIC-114
and recent clinical data reported with other programs in mCRPC and NSCLC, we have refined our registrational plans to focus on the most promising opportunities for both programs, stated Jacob M. Chacko, M.D., president and chief executive
officer. For ORIC-944, based on both internal and external data that validate the combination of PRC2 inhibitors with AR inhibitors in mCRPC, we intend to initiate our first Phase 3 trial in 1H 2026. For
ORIC-114, we intend to initiate registrational trial(s) in 2026 with a focus on areas of highest unmet need in first-line NSCLC settings. With these focused registrational plans, we have extended our projected
cash runway into 2027.
Registrational Clinical Development Plans and Updated Corporate Milestones:
ORIC-944: a potent and selective allosteric inhibitor of PRC2
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2
Corporate Highlights:
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) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the
EED subunit, being developed for prostate cancer, and (2) ORIC-114, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across
multiple genetically defined cancers. Beyond these two product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has
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, statements regarding the continued clinical development of ORIC-944 and ORIC-114; statements regarding the potential of ORIC-944 and
ORIC-114; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and
timelines for ORIC-944, ORIC-114 and ORIC s other programs; the potential advantages of ORIC-944, ORIC-114 and ORIC s other programs; plans underlying ORIC s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of Phase 3 or
registrational studies; ORIC s projected cash runway; 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 ORIC s
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 titled Risk Factors in ORIC s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC ) on
February 18, 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.
Dominic Piscitelli, Chief Financial Officer