UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 23, 2026
ORIC Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|
|
|
Delaware |
|
001-39269 |
|
47-1787157 |
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
240 E. Grand Ave, 2nd Floor
South San Francisco, CA 94080
(Address of principal executive offices, including zip code)
(650) 388-5600
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
|
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
|
|
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
Common stock, par value $0.0001 per share |
|
ORIC |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 23, 2026, ORIC Pharmaceuticals, Inc. (the “Company”), issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
|
|
|
Exhibit No. |
|
Description |
|
|
|
99.1 |
|
Press Release dated February 23, 2026 |
104 |
|
Cover Page Interactive Data File (embedded with the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ORIC PHARMACEUTICALS, INC. |
|
|
|
|
Date: February 23, 2026 |
|
|
|
By: |
|
/s/ Dominic Piscitelli |
|
|
|
|
|
|
Dominic Piscitelli Chief Financial Officer |
|
|

|
Exhibit 99.1 |
ORIC® Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Updates
Reported rinzimetostat (formerly 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 $264 million from top-tier healthcare specialist funds; Cash and investments 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 and SAN DIEGO, CA – February 23, 2026 – 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 and year ended December 31, 2025.
“2025 was a transformational year for ORIC highlighted by clinical data that further demonstrated 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. “Those data, along with substantially extended cash runway, position us well for 2026 and beyond as we advance our programs towards registrational studies.”
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 with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Data demonstrated:
oPSA responses and ctDNA reductions across all rinzimetostat dose levels and at comparable rates in combination with apalutamide or with darolutamide.
oBroad 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).
oRapid 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.
oBoth 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:
oSystemic activity in 2L EGFR exon 20 and pretreated EGFR PACC exceeding competitor benchmarks.
oHighly competitive preliminary 1L systemic activity, with 67% ORR in EGFR exon 20 and 80% ORR in EGFR PACC.
oConvincing 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.
oCompetitive 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 antitumor activity across a broad range of EGFR exon 20 and PACC mutant models.
Anticipated Program Milestones:
ORIC anticipates the following upcoming milestones:
−1Q 2026: Combination dose optimization data with AR inhibitor
−1H 2026: Initiate first global Phase 3 registrational trial in mCRPC
−2H 2026: 1L EGFR exon 20 monotherapy data and combination data with SC amivantamab
−2H 2026: 1L EGFR PACC monotherapy data
Fourth Quarter and Full Year 2025 Financial Results
•Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $392.3 million as of December 31, 2025, which includes net proceeds of $124.4 million from a private placement financing in May 2025 and $117.6 million from the company’s ATM program in 2025. Subsequent to the quarter ended December 31, 2025, the company raised an additional $20.0 million in net proceeds from a healthcare specialist fund under the ATM program resulting in proforma cash and investments of $412.3 million as of December 31, 2025. The company expects its cash and investments to fund the current operating plan into 2H 2028.
•R&D Expenses: Research and development (R&D) expenses were $25.9 million for the three months ended December 31, 2025, compared to $32.0 million for the three months ended December 31, 2024, a decrease of $6.1 million. For the year ended December 31, 2025, R&D expenses were $109.8 million compared to $114.1 million for the same period in 2024, a decrease of $4.3 million. The decreases were due to lower rinzimetostat drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs, including additional non-cash stock-based compensation, and costs related to the advancement of enozertinib.
•G&A Expenses: General and administrative (G&A) expenses were $8.7 million for the three months ended December 31, 2025, compared to $7.6 million for the three months ended December 31, 2024, an increase of $1.1 million. For the year ended December 31, 2025, G&A expenses were $33.2 million compared to $28.8 million for the same period in 2024, an increase of $4.4 million. The increases were primarily due to higher personnel costs and professional services, 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) 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 EGFR PACC mutations, being developed for NSCLC. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on February 23, 2026, 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)
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2025 |
|
|
2024 |
|
Assets |
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and short-term investments |
$ |
281,488 |
|
|
$ |
255,960 |
|
Prepaid expenses and other current assets |
|
6,978 |
|
|
|
6,290 |
|
Total current assets |
|
288,466 |
|
|
|
262,250 |
|
|
|
|
|
|
|
Long-term investments |
|
110,762 |
|
|
|
— |
|
Property and equipment, net |
|
2,415 |
|
|
|
2,924 |
|
Other assets |
|
7,247 |
|
|
|
8,968 |
|
Total assets |
$ |
408,890 |
|
|
$ |
274,142 |
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
3,824 |
|
|
$ |
1,548 |
|
Accrued liabilities |
|
16,593 |
|
|
|
23,298 |
|
Total current liabilities |
|
20,417 |
|
|
|
24,846 |
|
|
|
|
|
|
|
Other long-term liabilities |
|
4,111 |
|
|
|
6,174 |
|
Total liabilities |
|
24,528 |
|
|
|
31,020 |
|
|
|
|
|
|
|
Total stockholders' equity |
|
384,362 |
|
|
|
243,122 |
|
Total liabilities and stockholders' equity |
$ |
408,890 |
|
|
$ |
274,142 |
|
ORIC PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
25,856 |
|
|
$ |
31,970 |
|
|
$ |
109,818 |
|
|
$ |
114,072 |
|
General and administrative |
|
8,695 |
|
|
|
7,600 |
|
|
|
33,186 |
|
|
|
28,823 |
|
Total operating expenses |
|
34,551 |
|
|
|
39,570 |
|
|
|
143,004 |
|
|
|
142,895 |
|
Loss from operations |
|
(34,551 |
) |
|
|
(39,570 |
) |
|
|
(143,004 |
) |
|
|
(142,895 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
4,046 |
|
|
|
3,263 |
|
|
|
13,536 |
|
|
|
15,048 |
|
Net loss |
$ |
(30,505 |
) |
|
$ |
(36,307 |
) |
|
$ |
(129,468 |
) |
|
$ |
(127,847 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments |
|
171 |
|
|
|
(343 |
) |
|
|
407 |
|
|
|
121 |
|
Comprehensive loss |
$ |
(30,334 |
) |
|
$ |
(36,650 |
) |
|
$ |
(129,061 |
) |
|
$ |
(127,726 |
) |
Net loss per share, basic and diluted |
$ |
(0.30 |
) |
|
$ |
(0.51 |
) |
|
$ |
(1.47 |
) |
|
$ |
(1.83 |
) |
Weighted-average shares outstanding, basic and diluted |
|
102,585,754 |
|
|
|
70,652,013 |
|
|
|
87,793,801 |
|
|
|
69,727,940 |
|