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ORIC Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates Announced focused registrational clinical development plans for lead programs, extended cash runway, and accelerated/augmented cor

Key Takeaway: ORIC Pharmaceuticals reported strong first-quarter 2025 financial results and progress in clinical development plans for its lead drug candidates, ORIC-944 and ORIC-114. The company announced a collaboration with Johnson & Johnson to study ORIC-114 for non-small cell lung cancer, alongside promising preclinical findings for ORIC-944 in a prostate cancer trial. With an expected total of five data readouts planned over the next 15 months, ORIC aims to initiate registrational trials for both programs in 2026. The company's cash reserves are projected to sustain operations into 2027, showcasing a solid financial position.

Market Sentiment Analysis

POSITIVE FACTORS

  • Announced focused registrational clinical development plans for lead programs.
  • Presented promising preclinical data for ORIC-944 at a major oncology meeting.
  • Entered a clinical trial collaboration with Johnson & Johnson for ORIC-114.
  • Extended cash runway into 2027, indicating financial stability.

Full Press Release Details

ORIC Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates
Announced focused registrational clinical development plans for lead programs, extended cash runway, and accelerated/augmented corporate milestones
Presented preclinical data supporting potential best-in-class profile of ORIC-944 in combination with AR inhibitors to treat prostate cancer at the 2025 AACR Annual Meeting
Announced clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations
Expects to report five data readouts across ORIC-944 and ORIC-114 clinical programs over the next 15 months, with potential initiation of registrational trials for both programs in 2026
Cash and investments of approximately $224 million expected to fund operating plan into 2027
SOUTH SAN FRANCISCO and SAN DIEGO, CA May 5, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter ended March 31, 2025.
In the first quarter, we made significant progress across our pipeline, announced focused registrational development plans for our two lead programs, extended our cash runway, and accelerated key corporate milestones, stated Jacob M. Chacko, M.D., president and chief executive officer. Looking ahead, we expect to share multiple clinical data updates across both programs over the next fifteen months. We remain on track to initiate the first Phase 3 trial of ORIC-944 in mCRPC in the first half of 2026, with registrational development of ORIC-114 in first-line NSCLC expected to begin later that year.
First Quarter 2025 and Other Recent Highlights
ORIC-944: a potent and selective allosteric inhibitor of PRC2
-Reported encouraging early safety and efficacy data in ongoing dose escalation trial for ORIC-944 in combination with apalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).
-Presented preclinical ORIC-944 data demonstrating synergistic activity and improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in models of prostate cancer at the 2025 AACR Annual Meeting.
-Announced updated program milestones and development plans to initiate first Phase 3 registrational trial for ORIC-944 in mCRPC in 1H 2026.
ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor
-Announced a clinical trial collaboration and supply agreement with Johnson & Johnson and initiated a trial to evaluate ORIC-114 in combination with subcutaneous (SC) amivantamab for the 1L treatment of patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
-Announced updated program milestones and registrational development plans to focus ORIC-114 in 1L NSCLC and plans to initiate first Phase 3 trial in 2026.
Corporate Highlights:
-Extended projected cash runway into 2027 (from previous guidance of late 2026), and accelerated/augmented corporate milestones, based upon favorable enrollment and focused registrational clinical development plans for two lead programs.
Anticipated Program Milestones:
ORIC anticipates the following upcoming milestones:
1H 2025: Combination dose escalation data with AR inhibitors(s)
2H 2025: Updated combination dose escalation data with AR inhibitors(s)
4Q 2025 / 1Q 2026: Combination dose optimization data with AR inhibitor(s)
2H 2025: 1L EGFR exon 20, 2L EGFR exon 20, 2L+ HER2 exon 20 and 2L+ EGFR atypical data
Mid-2026: 1L EGFR exon 20 combination with SC amivantamab and 1L EGFR atypical data
First Quarter 2025 Financial Results
-Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $223.8 million as of March 31, 2025, which is expected to fund the current operating plan into 2027.
-R&D Expenses: Research and development (R&D) expenses were $24.6 million for the three months ended March 31, 2025, compared to $22.0 million for the three months ended March 31, 2024, an increase of $2.7 million. The increase was due to a net increase in external expenses related to the advancement of product candidates, as well as higher personnel costs, including additional non-cash stock-based compensation.
-G&A Expenses: General and administrative (G&A) expenses were $8.1 million for the three months ended March 31, 2025, compared to $7.0 million for the three months ended March 31, 2024, an increase of $1.0 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation.
About ORIC Pharmaceuticals, Inc.
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; the potential of ORIC-944 and ORIC-114; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; advantages of ORIC-944 in preclinical models, including synergies with ARPIs and improved PFS; the development plans and timelines for 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 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 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC ) on May 5, 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
ORIC PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
March 31, 2025 December 31, 2024
(unaudited)
Assets
Current assets:
Cash, cash equivalents and short-term investments $ 203,723 $ 255,960
Prepaid expenses and other current assets 7,710 6,290
Total current assets 211,433 262,250
Long-term investments 20,039
Property and equipment, net 3,021 2,924
Other assets 8,365 8,968
Total assets $ 242,858 $ 274,142
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 5,160 $ 1,548
Accrued liabilities 12,457 23,298
Total current liabilities 17,617 24,846
Other long-term liabilities 5,503 6,174
Total liabilities 23,120 31,020
Total stockholders' equity 219,738 243,122
Total liabilities and stockholders' equity $ 242,858 $ 274,142
ORIC PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
Three Months Ended March 31,
2025 2024
Operating expenses:
Research and development $ 24,640 $ 21,960
General and administrative 8,078 7,030
Total operating expenses 32,718 28,990
Loss from operations (32,718 ) (28,990 )
Other income, net 2,697 3,979
Net loss $ (30,021 ) $ (25,011 )
Other comprehensive loss:
Unrealized loss on investments (170 ) (420 )
Comprehensive loss $ (30,191 ) $ (25,431 )
Net loss per share, basic and diluted $ (0.42 ) $ (0.37 )
Weighted-average shares outstanding, basic and diluted 71,040,580 67,349,551

Frequently Asked Questions

What is ORIC-944 used for?

ORIC-944 is an allosteric inhibitor being developed for metastatic castration resistant prostate cancer.

What recent collaboration did ORIC Pharmaceuticals announce?

ORIC Pharmaceuticals announced a clinical trial collaboration with Johnson & Johnson to evaluate ORIC-114 for NSCLC.

How much cash does ORIC have to fund operations?

ORIC has approximately $224 million to fund its operating plan into 2027.

When will ORIC-944's Phase 3 trial begin?

The first Phase 3 trial of ORIC-944 is expected to start in the first half of 2026.

What are the R&D expenses for ORIC in Q1 2025?

R&D expenses for Q1 2025 were $24.6 million, an increase from $22.0 million in Q1 2024.

Last updated: May 5, 2025