ORIC® Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates

Rhea-AI Summary

ORIC Pharmaceuticals reported Q1 2025 financial results and operational updates. The company highlighted $223.8 million in cash and investments, expected to fund operations into 2027. Key developments include: (1) Presented preclinical data for ORIC-944 showing synergistic activity with AR inhibitors in prostate cancer, (2) Established clinical trial collaboration with Johnson & Johnson for ORIC-114 in combination with amivantamab for NSCLC treatment, (3) Plans to initiate Phase 3 trials for ORIC-944 in mCRPC in 1H 2026 and ORIC-114 in NSCLC later in 2026. Financial results showed R&D expenses of $24.6 million (up from $22.0M YoY) and G&A expenses of $8.1 million (up from $7.0M YoY). The company expects five data readouts across both clinical programs over the next 15 months.

Positive

• Strong cash position of $223.8M expected to fund operations into 2027
• Clinical trial collaboration secured with Johnson & Johnson for ORIC-114
• Five data readouts expected across clinical programs in next 15 months
• Preclinical data shows synergistic activity of ORIC-944 with AR inhibitors
• Phase 3 trials planned for both lead programs in 2026

Negative

• Increased R&D expenses by $2.7M YoY to $24.6M
• Higher G&A expenses, up $1.0M YoY to $8.1M

Insights

Biotech Financial Analyst

ORIC extends cash runway with $224M, partners with J&J, and accelerates two oncology programs toward registrational trials in 2026.

ORIC's Q1 2025 financial update reveals a strengthened position across multiple fronts. With $223.8 million in cash and investments, the company has extended its runway into 2027 (from previous guidance of late 2026), providing substantial operational flexibility through multiple clinical inflection points including potential Phase 3 initiations for both lead programs in 2026.

The clinical trial collaboration with Johnson & Johnson for ORIC-114 represents a significant strategic partnership that enables evaluation of ORIC's drug in combination with subcutaneous amivantamab for first-line EGFR exon 20 mutation NSCLC. This collaboration not only provides external validation but enhances ORIC's focused strategy on first-line NSCLC treatment.

For ORIC-944, the preclinical data presented at AACR 2025 demonstrating synergistic activity with AR inhibitors in prostate cancer models provides scientific rationale supporting its ongoing clinical development. The company reports "encouraging early safety and efficacy data" from ongoing dose escalation trials.

The five data readouts anticipated over the next 15 months create a catalyst-rich period ahead. ORIC has established clear development timelines: ORIC-944's first Phase 3 trial in mCRPC expected to initiate in 1H 2026, followed by ORIC-114's registrational development later that year.

The modest increase in quarterly R&D expenses to $24.6 million (from $22.0 million in Q1 2024) reflects disciplined spending while advancing clinical programs. The focused registrational strategy for both lead assets indicates efficient execution on clinical development plans while maintaining financial discipline.

Oncology Research Analyst

ORIC advances novel cancer treatments with promising combinations for prostate and lung cancers, backed by J&J collaboration.

ORIC's Q1 update reveals substantial progress in its targeted oncology pipeline addressing significant unmet clinical needs. ORIC-944, a PRC2 inhibitor, represents a mechanistically novel approach in prostate cancer treatment. The preclinical data presented at AACR 2025 demonstrated synergistic activity and improved progression-free survival when combined with androgen receptor pathway inhibitors, providing important scientific validation for this combination approach in metastatic castration-resistant prostate cancer (mCRPC).

For ORIC-114, the brain-penetrant EGFR/HER2 inhibitor, the strategic focus on first-line NSCLC with EGFR exon 20 insertion mutations addresses a patient population with historically limited treatment options and poor prognosis. The collaboration with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab is particularly significant, as amivantamab was the first FDA-approved treatment specifically for this mutation subtype. Testing this combination in the first-line setting rather than after progression represents a potential paradigm shift in managing this difficult-to-treat cancer subset.

The well-structured clinical development roadmap includes five data readouts scheduled across both programs over the next 15 months, creating multiple opportunities to demonstrate clinical benefit. The progression toward registrational trials for both programs in 2026 suggests confidence in the preliminary clinical signals observed to date.

ORIC's focused approach targeting specific molecular drivers of resistance in well-defined patient populations aligns perfectly with the precision medicine paradigm that has transformed oncology treatment. The reported "encouraging early safety and efficacy data" for ORIC-944, while preliminary, supports continued development of this novel combination therapy.

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, May 05, 2025 (GLOBE NEWSWIRE) -- 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:

• ORIC-944 (mCRPC):
  • 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)
• ORIC-114 (NSCLC):
  • 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.
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 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, 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.

Contact:
Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com

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 (Unaudited) (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

FAQ

What is ORIC Pharmaceuticals' (ORIC) cash position as of Q1 2025?

ORIC reported cash, cash equivalents and investments of $223.8 million as of March 31, 2025, expected to fund operations into 2027.

What are the key milestones expected for ORIC-944 in prostate cancer treatment?

ORIC expects combination dose escalation data in 1H 2025, updated data in 2H 2025, dose optimization data in Q4 2025/Q1 2026, and plans to initiate Phase 3 trial in 1H 2026.

What is the collaboration between ORIC Pharmaceuticals and Johnson & Johnson for ORIC-114?

ORIC established a clinical trial collaboration to evaluate ORIC-114 in combination with subcutaneous amivantamab for first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations.

How much did ORIC's R&D and G&A expenses increase in Q1 2025?

R&D expenses increased by $2.7M to $24.6M, and G&A expenses increased by $1.0M to $8.1M compared to Q1 2024.

When does ORIC Pharmaceuticals plan to initiate Phase 3 trials for its lead programs?

ORIC plans to initiate Phase 3 trial for ORIC-944 in mCRPC in first half of 2026, and registrational development of ORIC-114 in first-line NSCLC later in 2026.