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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025


☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________ to _________

Commission File Number: 001-39269

ORIC PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)


Delaware	47-1787157
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
240 E. Grand Ave, 2nd Floor South San Francisco, CA	94080
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (650) 388-5600

Not applicable

(Former name, former address, and former fiscal year, if changed since last report)

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, $0.0001 par value per share

     ORIC

     The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

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. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 5, 2025, the registrant had 97,389,279 shares of common stock, $0.0001 par value per share, outstanding.

Table of Contents


		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)	1
	Balance Sheets	1
	Statements of Operations and Comprehensive Loss	2
	Statements of Stockholders’ Equity	3
	Statements of Cash Flows	5
	Notes to Unaudited Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	19
Item 4.	Controls and Procedures	19

PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	21
Item 1A.	Risk Factors	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	76
Item 3.	Defaults Upon Senior Securities	76
Item 4.	Mine Safety Disclosures	76
Item 5.	Other Information	76
Item 6.	Exhibits	77
SIGNATURES		78

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this quarterly report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this quarterly report on Form 10-Q include, but are not limited to, statements about:

•

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

•

the timing, progress and results of preclinical studies and clinical trials for ORIC-944, enozertinib (formerly ORIC-114) and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;

•

the timing, scope or likelihood of regulatory filings and approvals;

•

the potential benefits of and activity under the company’s collaboration, licenses and other third-party agreements;

•

our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;

•

our manufacturing, commercialization, and marketing capabilities and strategy;

•

our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;

•

the need to hire additional personnel and our ability to attract and retain such personnel;

•

our expectations regarding the impact of a global pandemic or other public health emergencies on our business;

•

the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;

•

our expectations regarding the approval and use of our product candidates in combination with other drugs;

•

our competitive position and the success of competing therapies that are or may become available;

•

our estimates of the number of patients that we will enroll in our clinical trials;

•

the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;

•

our ability to obtain and maintain regulatory approval of our product candidates;

•

our plans relating to the further development of our product candidates, including additional indications we may pursue;

•

existing regulations and regulatory developments in the United States, Europe and other jurisdictions;

•

our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ORIC-944, enozertinib and other product candidates we may develop, including the extensions of existing patent terms where available, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;

•

our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;

•

our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

•

the pricing and reimbursement of ORIC-944, enozertinib and other product candidates we may develop, if approved;

•

the rate and degree of market acceptance and clinical utility of ORIC-944, enozertinib and other product candidates we may develop, if approved;

•

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

•

our expectations regarding the impacts of our strategic pipeline prioritization and reduction in workforce;

•

our financial performance;

•

the period over which we estimate our existing cash, cash equivalents and investments will be sufficient to fund our operating plan;

•

the impact of laws and regulations;

•

our expectations regarding the periods during which we will qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act), a smaller reporting company, as defined in the Securities Exchange Act of 1934, as amended, or a non-accelerated filer; and

•

our anticipated use of our existing resources.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this quarterly report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this quarterly report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this quarterly report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

iii

Part I – FINANCIAL INFORMATION

Item 1. Financial Statements.

ORIC PHARMACEUTICALS, INC.

BALANCE SHEETS

(in thousands, except share and per share amounts)



	September 30, 2025			December 31, 2024
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	49,668		$	59,406
Short-term investments		237,472			196,554
Prepaid expenses and other current assets		8,454			6,290
Total current assets		295,594			262,250

Long-term investments		125,908			—
Property and equipment, net		2,559			2,924
Other assets		7,131			8,968
Total assets	$	431,192		$	274,142

Liabilities and Stockholders' Equity

Current liabilities:
Accounts payable	$	2,900		$	1,548
Accrued liabilities		17,279			23,298
Total current liabilities		20,179			24,846

Other long-term liabilities		4,094			6,174
Total liabilities		24,273			31,020

Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; 200,000,000 shares authorized; no shares issued and outstanding at September 30, 2025 and December 31, 2024		—			—
Common stock, $0.0001 par value; 1,000,000,000 shares authorized; 97,278,032 and 71,021,855 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		11			7
Additional paid-in capital		1,068,030			805,510
Accumulated deficit		(661,737	)		(562,774	)
Accumulated other comprehensive income		615			379
Total stockholders' equity		406,919			243,122
Total liabilities and stockholders' equity	$	431,192		$	274,142

See accompanying notes to unaudited financial statements.

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Operating expenses:
Research and development	$	28,773		$	31,202		$	83,962		$	82,102
General and administrative		7,898			7,116			24,491			21,223
Total operating expenses		36,671			38,318			108,453			103,325
Loss from operations		(36,671	)		(38,318	)		(108,453	)		(103,325	)

Other income, net		4,084			3,752			9,490			11,785
Net loss	$	(32,587	)	$	(34,566	)	$	(98,963	)	$	(91,540	)
Other comprehensive income:
Unrealized gain on investments		428			978			236			464
Comprehensive loss	$	(32,159	)	$	(33,588	)	$	(98,727	)	$	(91,076	)
Net loss per share, basic and diluted	$	(0.33	)	$	(0.49	)	$	(1.20	)	$	(1.32	)
Weighted-average shares outstanding, basic and diluted		98,953,331			70,542,684			82,808,969			69,417,672

See accompanying notes to unaudited financial statements.

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

(in thousands, except share amounts)


	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Shares		Amount		Capital		Deficit			Income (Loss)			Equity
Balance at December 31, 2024		71,021,855	$	7	$	805,510	$	(562,774	)	$	379		$	243,122
Exercise of common stock options		53,009		—		253		—			—			253
Issuance of common stock upon vesting of RSUs		3,647		—		—		—			—			—
Stock-based compensation expense		—		—		6,554		—			—			6,554
Unrealized loss on investments		—		—		—		—			(170	)		(170	)
Net loss		—		—		—		(30,021	)		—			(30,021	)
Balance at March 31, 2025		71,078,511	$	7	$	812,317	$	(592,795	)	$	209		$	219,738
Issuance of common stock and pre-funded warrants, net		14,980,313		2		133,267		—			—			133,269
Exercise of common stock options		7,812		—		34		—			—			34
Issuance of common stock upon vesting of RSUs		17,752		—		—		—			—			—
Issuance of common stock from ESPP		102,940		—		757		—			—			757
Stock-based compensation expense		—		—		6,574		—			—			6,574
Unrealized loss on investments		—		—		—		—			(22	)		(22	)
Net loss		—		—		—		(36,355	)		—			(36,355	)
Balance at June 30, 2025		86,187,328	$	9	$	952,949	$	(629,150	)	$	187		$	323,995
Issuance of common stock, net		10,930,032		1		108,702		—			—			108,703
Exercise of common stock options		144,301		1		748		—			—			749
Issuance of common stock upon vesting of RSUs		16,371		—		—		—			—			—
Stock-based compensation expense		—		—		5,631		—			—			5,631
Unrealized gain on investments		—		—		—		—			428			428
Net loss		—		—		—		(32,587	)		—			(32,587	)
Balance at September 30, 2025		97,278,032	$	11	$	1,068,030	$	(661,737	)	$	615		$	406,919

See accompanying notes to unaudited financial statements.

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited)

(in thousands, except share amounts)


	Common Stock				Additional Paid-in		Accumulated			Accumulated Other Comprehensive			Total Stockholders'
	Shares		Amount		Capital		Deficit			Income (Loss)			Equity
Balance at December 31, 2023		54,865,553	$	6	$	658,751	$	(434,927	)	$	258		$	224,088
Issuance of common stock, net		12,500,000		1		124,831		—			—			124,832
Exercise of common stock options		51,540		—		198		—			—			198
Issuance of common stock upon vesting of RSUs		3,245		—		—		—			—			—
Stock-based compensation expense		—		—		4,958		—			—			4,958
Unrealized loss on investments		—		—		—		—			(420	)		(420	)
Net loss		—		—		—		(25,011	)		—			(25,011	)
Balance at March 31, 2024		67,420,338	$	7	$	788,738	$	(459,938	)	$	(162	)	$	328,645
Exercise of common stock options		71,936		—		293		—			—			293
Issuance of common stock upon vesting of RSUs		10,780		—		—		—			—			—
Issuance of common stock from ESPP		169,249		—		523		—			—			523
Stock-based compensation expense		—		—		4,996		—			—			4,996
Unrealized loss on investments		—		—		—		—			(94	)		(94	)
Net loss		—		—		—		(31,963	)		—			(31,963	)
Balance at June 30, 2024		67,672,303	$	7	$	794,550	$	(491,901	)	$	(256	)	$	302,400
Exercise of pre-funded warrants		2,857,104		—		—		—			—			—
Exercise of common stock options		26,435		—		126		—			—			126
Issuance of common stock upon vesting of RSUs		3,341		—		—		—			—			—
Stock-based compensation expense		—		—		5,056		—			—			5,056
Unrealized gain on investments		—		—		—		—			978			978
Net loss		—		—		—		(34,566	)		—			(34,566	)
Balance at September 30, 2024		70,559,183	$	7	$	799,732	$	(526,467	)	$	722		$	273,994

See accompanying notes to unaudited financial statements.

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)


	Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(98,963	)	$	(91,540	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		900			803
Stock-based compensation expense		18,759			15,010
Accretion of discount on investments, net		(2,060	)		(6,469	)
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(325	)		(1,211	)
Accounts payable and accrued other liabilities		(6,798	)		(1,201	)
Net cash used in operating activities		(88,487	)		(84,608	)

Cash flows from investing activities:
Acquisitions of property and equipment		(485	)		(969	)
Purchases of investments		(354,530	)		(217,294	)
Maturities of investments		190,000			197,745
Net cash used in investing activities		(165,015	)		(20,518	)

Cash flows from financing activities:
Proceeds from issuance of common stock and pre-funded warrants		244,369			125,000
Issuance costs associated with financings		(2,397	)		(168	)
Proceeds from issuance of common stock under ESPP		757			523
Proceeds from stock option exercises		1,035			617
Net cash provided by financing activities		243,764			125,972

Net (decrease) increase in cash, cash equivalents and restricted cash		(9,738	)		20,846

Cash, cash equivalents and restricted cash at beginning of period		59,897			23,875
Cash, cash equivalents and restricted cash at end of period	$	50,159		$	44,721

The following table provides a reconciliation of cash, cash equivalents and restricted cash within the balance sheets to the amounts shown in the statements of cash flows above, in thousands:


	September 30,
	2025		2024
Cash and cash equivalents	$	49,668	$	44,230
Restricted cash included in other assets		491		491
Total cash, cash equivalents and restricted cash	$	50,159	$	44,721

See accompanying notes to unaudited financial statements.

ORIC PHARMACEUTICALS, INC.

NOTES TO UNAUDITED FINANCIAL STATEMENTS

1. Description of the Business

ORIC Pharmaceuticals, Inc. (ORIC or the Company) is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. The Company was incorporated in Delaware in August 2014 and has offices in South San Francisco and San Diego, California. The Company’s principal operations are in the United States and the Company operates in one segment.

Since inception, the Company has devoted its primary efforts to raising capital, internal research and development activities and business development efforts, and has incurred significant operating losses and negative cash flows from operations. In August 2020, the Company licensed from Mirati Therapeutics, Inc. (Mirati) development and commercialization rights to an allosteric inhibitor program directed towards the polycomb repressive complex 2 (PRC2) and in October 2020, the Company licensed from Voronoi Inc. (Voronoi) development and commercialization rights to a brain-penetrant, orally bioavailable, irreversible inhibitor designed to selectively target epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) with high potency against exon 20 insertion mutations.

As of September 30, 2025, the Company had an accumulated deficit of $661.7 million. Through September 30, 2025, all of the Company’s financial support has been provided by proceeds from the issuance of common stock and convertible preferred stock.

As the Company continues its expansion, it may seek additional financing and/or strategic investments, however, there can be no assurance that any additional financing or strategic investments will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it will most likely be required to reduce its plans and/or certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. The accompanying financial statements do not include any adjustments that might be necessary if it were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of the issuance of these financial statements.

Strategic Pipeline Prioritization

On August 12, 2025, the Company announced a strategic pipeline prioritization to focus operational and financial resources on the continued advancement of its two lead clinical programs, ORIC-944 and enozertinib (formerly ORIC-114). This initiative has resulted in a substantial decrease in preclinical research, primarily from the elimination of the Company’s discovery research group. This resulted in an approximately 20% workforce reduction and the Company has incurred a one-time cost of approximately $1.9 million primarily related to termination benefits, including severance and healthcare-related benefits. The workforce reduction was substantially completed in the third quarter of 2025.

Private Placements

On May 23, 2025, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 14,130,313 shares of common stock at a price of $6.50 per share and pre-funded warrants to purchase 5,100,532 shares of common stock at a purchase price of $6.4999 per pre-funded warrant, resulting in gross proceeds of $125.0 million. The purchase price per share represents a premium of approximately 18% to ORIC’s 10-day trailing volume-weighted average stock price as of deal signing on May 23, 2025. The pre-funded warrants have an exercise price of $0.0001 per share of common stock, were immediately exercisable and will remain exercisable until exercised in full. After deducting expenses related to the private placement of $0.6 million, the net proceeds to the Company from the private placement were $124.4 million. The private placement closed on May 29, 2025. On June 11, 2025, the Company filed a Form S-3 registering the shares sold in the private placement. The Form S-3 was declared effective by the Securities and Exchange Commission (SEC) on June 20, 2025.

On January 20, 2024, the Company entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 12,500,000 shares of common stock at a price of $10.00 per share, resulting in gross proceeds of $125.0 million. The purchase price per share represents a premium to ORIC's 5-day trailing average stock price at the time of sale. After deducting expenses related to the private placement of $0.2 million, the net proceeds to the Company from the private placement were $124.8 million. The private placement closed on January 23, 2024. On January 26, 2024, the Company filed a Form S-3 registering the shares sold in the private placement. The Form S-3 was declared effective by the SEC on February 2, 2024.

At-The-Market Sales Agreement and Offering

The Company previously entered into an “at the market” (ATM) sales agreement with Jefferies LLC as the Company’s sales agent, to sell shares of the Company’s common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, the Company filed a Form S-3ASR and prospectus supplement, to allow the Company to sell from time to time up to $200.0 million of shares of the Company’s common stock in negotiated transactions or transactions deemed to be an ATM offering. During the three

months ended September 30, 2025, the Company raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $108.7 million through the sale of 10,930,032 shares at a weighted average purchase price of $10.10. During the nine months ended September 30, 2025, the Company raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $117.6 million through the sale of 11,780,032 shares at a weighted average purchase price of $10.13. The Company did not raise proceeds under an ATM offering in 2024.

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the SEC on Form 10-Q and Rule 10-01 of Regulation S-X. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP, have been omitted. The accompanying unaudited financial statements include all known adjustments necessary for a fair presentation of the results as required by GAAP. These adjustments consist primarily of normal recurring accruals and estimates that impact the carrying value of assets and liabilities. Operating results for the interim period are not necessarily indicative of future results.

The accompanying unaudited financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K filed with the SEC. Furthermore, the Company’s significant accounting policies are disclosed in the audited financial statements for the periods ended December 31, 2024 and 2023, included in the Company’s Annual Report on Form 10-K. Since the date of those financial statements, there have been no changes to its significant accounting policies.

Segment Reporting

The Company’s chief operating decision maker (CODM) is the Company’s Chief Executive Officer. The CODM is assisted in their responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting of executives, an executive vice president, a senior vice president and a vice president.

The Company views its operations and manages its business as one operating segment, focused on the research and development of innovative therapies designed to counter the resistance mechanisms in cancer. Segment profit or loss is measured as the Company’s net loss as reported on the Company’s Statement of Operations and Comprehensive Loss. The Company monitors its cash and cash equivalents, short-term investments and long-term investments as reported on the Company’s Balance Sheets to determine funding for its research and development.

The CODM assesses Company performance through the achievement of pre-clinical and clinical research goals. In addition to the Company’s Statement of Operations and Comprehensive Loss, the CODM is regularly provided with budgeted and forecasted expense information which is used to determine the Company’s liquidity needs and cash allocation.

Recently Issued Accounting Pronouncements

In November 2024, the FASB issued Accounting Standards Update (ASU) 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220 -40): Disaggregation of Income Statement Expenses, which is intended to enhance expense disclosures by requiring additional information about specific expense categories in the notes to the financial statements. The standard is effective, as clarified by ASU 2025-01, for annual periods beginning after December 15, 2026, and interim reporting periods within annual reporting periods beginning after December 15, 2027, with early adoption permitted. The standard may be adopted prospectively or retrospectively. The Company is currently evaluating the impact of the standard on its financial statements and related disclosures.

3. License Agreements and Clinical Development Collaborations

Johnson & Johnson collaborations

On August 29, 2024, the Company entered into a clinical supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), to evaluate enozertinib in combination with subcutaneous (SC) amivantamab, Johnson & Johnson’s fully-human EGFR-MET bispecific antibody. The Company will continue to conduct and sponsor the ongoing Phase 1b clinical trial, and Johnson & Johnson will provide SC amivantamab for the trial. The Company maintains full economic ownership and control of enozertinib.

On July 10, 2024, the Company entered into a clinical trial collaboration and supply agreement with Johnson & Johnson, to evaluate ORIC-944 in combination with Erleada® (apalutamide), Johnson & Johnson’s androgen receptor (AR) inhibitor. The Company will continue to conduct and sponsor the ongoing Phase 1b trial, and Johnson & Johnson will provide apalutamide for the trial. The Company maintains full economic ownership and control of ORIC-944.

Bayer collaboration

On May 14, 2024, the Company entered into a clinical trial collaboration and supply agreement with Bayer Consumer Care AG (Bayer), as amended effective October 23, 2024, to evaluate ORIC-944 in combination with Nubeqa® (darolutamide), Bayer’s AR inhibitor. The Company will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer will provide darolutamide for the trial. The Company maintains full economic ownership and control of ORIC-944.

Voronoi License Agreement

On October 19, 2020, the Company entered into a license and collaboration agreement (Voronoi License Agreement) with Voronoi. The Voronoi License Agreement gives the Company access to Voronoi’s preclinical stage EGFR and HER2 exon 20 insertion mutation program, including a lead product candidate now designated as enozertinib. Under the Voronoi License Agreement, Voronoi granted the Company an exclusive, sublicensable license under Voronoi’s rights to certain patent applications directed to certain small molecule compounds that bind to EGFR and HER2 with one or more exon 20 insertion mutations and certain related know-how, in each case, to develop and commercialize certain licensed compounds and licensed products incorporating any such compound in the ORIC Territory, defined as worldwide other than in the People’s Republic of China, Hong Kong, Macau and Taiwan. Pursuant to an amendment to the Voronoi License Agreement that the Company entered into with Voronoi on March 20, 2024, the Company also obtained the right to conduct and control certain clinical trials for the licensed products at specified clinical sites within Voronoi’s territory to support the development and commercialization of licensed products in the ORIC Territory. Under the Voronoi License Agreement, Voronoi had the right to perform certain mutually agreed upon development activities. Except for Voronoi's right to participate in such development activities, the Company is wholly responsible for development and commercialization of licensed products in the ORIC Territory. In addition, the Company is obligated to use commercially reasonable efforts to develop and commercialize at least one licensed product in certain major markets in the ORIC Territory.

The Company’s financial obligations under the Voronoi License Agreement included an upfront payment of $5.0 million in cash and the issuance to Voronoi of 283,259 shares of the Company’s common stock, valued at approximately $6.8 million, issued pursuant to a stock issuance agreement entered into between the parties on October 19, 2020. The number of shares issued pursuant to the stock issuance agreement was based on a price of $28.24 per share, representing a premium of 25% to the 30-day trailing volume weighted average trading price of the Company’s common stock. The shares were issued in a private placement in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended (Securities Act), for transactions by an issuer not involving any public offering.

Under the Voronoi License Agreement, Voronoi was responsible for certain research and development costs up to a predetermined threshold. Upon achievement of the predetermined threshold in the second quarter of 2022, Voronoi chose to opt out of participation in and funding of future development activities. The Company is also obligated to make milestone payments to Voronoi upon the achievement of certain events. Upon the achievement of certain development and regulatory milestones with respect to the first licensed product, the Company is obligated to pay Voronoi up to a maximum of $111.0 million. Upon the achievement of certain commercial milestones with respect to the first licensed product, the Company is obligated to pay Voronoi up to a maximum of $225.0 million. If the Company pursues a second licensed product, the Company could pay Voronoi up to an additional $272.0 million in success-based milestones. In addition, the Company is obligated to pay royalties on net sales of licensed products in the ORIC Territory. In the third quarter of 2022, the Company made a development milestone payment to Voronoi in the amount of $5.0 million, which was recorded in acquired in-process research and development expense.

Unless earlier terminated, the Voronoi License Agreement will continue in effect until the expiration of all royalty payment obligations. Following the expiration of the Voronoi License Agreement, the Company will retain its licenses under the intellectual property Voronoi licensed to it on a royalty-free basis. The Company and Voronoi may each terminate the Voronoi License Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. Voronoi may also terminate the agreement if the Company discontinues development of licensed products for a specified period of time. The Company also has the right to terminate the Voronoi License Agreement without cause by providing prior notice to Voronoi.

If Voronoi terminates the Voronoi License Agreement for cause, or if the Company terminates the Voronoi License Agreement without cause, then the Company is obligated to grant a nonexclusive license to Voronoi under certain of the Company’s patents and know-how and to assign to Voronoi certain of its regulatory filings for licensed compounds and licensed products.

Mirati License Agreement

On August 3, 2020, the Company entered into a license agreement (Mirati License Agreement) with Mirati. Under the Mirati License Agreement, Mirati granted the Company a worldwide, exclusive, sublicensable, royalty-free license under Mirati’s rights to certain patents and patent applications directed to certain small molecule compounds that bind to and inhibit PRC2 and certain related know-how, in each case, to develop and commercialize certain licensed compounds and licensed products incorporating any such compounds. Under the Mirati License Agreement, the Company is wholly responsible for development and commercialization of licensed products. In addition, the Company is obligated to use commercially reasonable efforts to develop and commercialize at least one licensed product in certain major markets.

The Company’s financial obligation under the Mirati License Agreement was an upfront payment of 588,235 shares of ORIC common stock, valued at approximately $13.0 million based upon the closing price of the Company’s common stock on the acquisition date. The number of shares issued was based on a price of $34.00 per share, representing a premium of 10% to the 60-day trailing volume-weighted average trading price of the Company’s common stock. The shares were issued in a private placement in reliance on Section 4(a)(2) of the Securities Act for transactions by an issuer not involving any public offering. During the eighteen-month period following the date of the agreement, Mirati was subject to certain transfer restrictions, and the parties agreed to negotiate and enter into a registration rights agreement, with respect to the shares. The Company is not obligated to pay Mirati milestones or royalties.

Unless earlier terminated, the Mirati License Agreement will continue in effect on a country-by-country and licensed product-by-licensed product basis until the later of (a) the expiration of the last valid claim of a licensed patent covering such licensed product in such country or (b) ten years after the first commercial sale of such licensed product in such country. Following the expiration of the Mirati License Agreement, the Company will retain its licenses under the intellectual property Mirati licensed to it on a royalty-free basis. ORIC and Mirati may each terminate the Mirati License Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. Mirati may terminate the agreement if the Company challenges any of the patent rights licensed to the Company by Mirati or it discontinues development of licensed products for a specified period of time. The Company also has the right to terminate the Mirati License Agreement without cause by providing prior notice to Mirati.

On October 8, 2023, Bristol Myers Squibb (BMS) and Mirati announced that they entered into a definitive merger agreement under which BMS through a subsidiary will acquire all of the outstanding shares of Mirati common stock. The Mirati License Agreement continued in effect upon consummation of the transaction, which closed on January 23, 2024.

4. Property and Equipment, net

Property and equipment, net consisted of the following (in thousands):


	September 30, 2025			December 31, 2024
Lab equipment	$	7,666		$	7,386
Leasehold improvements		2,065			2,043
Computer hardware and software		292			274
Furniture and fixtures		697			697
Total property and equipment, gross		10,720			10,400
Less accumulated depreciation		(8,161	)		(7,476	)
Total property and equipment, net	$	2,559		$	2,924

5. Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):



	September 30, 2025		December 31, 2024
Accrued clinical and manufacturing costs	$	6,207	$	11,808
Accrued compensation		6,873		7,648
Operating lease liabilities - short-term		3,301		3,183
Other accruals		898		659
Total accrued liabilities	$	17,279	$	23,298

6. Investments

The Company's available-for-sale investments consisted of the following (in thousands):


September 30, 2025	Amortized Cost		Unrealized Gains		Unrealized Losses		Estimated Fair Value
Short-term
U.S. treasury securities	$	237,107	$	365	$	—	$	237,472
Short-term investments	$	237,107	$	365	$	—	$	237,472

Long-term
U.S. treasury securities	$	125,658	$	250	$	—	$	125,908
Long-term investments	$	125,658	$	250	$	—	$	125,908

December 31, 2024
Short-term
U.S. treasury securities	$	196,175	$	379	$	—	$	196,554
Short-term investments	$	196,175	$	379	$	—	$	196,554

The Company has determined that there were no material declines in fair value of its investments due to credit-related factors as of September 30, 2025 and December 31, 2024. Credit loss is limited due to the nature of the investments.

7. Fair Value Measurements

The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair-value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices in active markets;

Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

The carrying amounts of the Company’s interest receivable, included in prepaid expenses and other current assets, accounts payable and accrued liabilities are generally considered to be representative of their fair value because of their short-term nature. The Company’s investments, which may include money market funds and available-for-sale investments consisting of U.S. treasury securities, certificates of deposit and high-quality, marketable debt instruments of corporations and government sponsored enterprises, are measured at fair value in accordance with the fair value hierarchy.

Following are the major categories of assets measured at fair value on a recurring basis (in thousands):


	Fair Value Measurements
	Fair Value		Level 1		Level 2		Level 3		Total
September 30, 2025
Money market funds (1)	$	49,668	$	49,668	$	—	$	—	$	49,668
U.S. treasury securities		363,380		363,380		—		—		363,380
Total	$	413,048	$	413,048	$	—	$	—	$	413,048
December 31, 2024
Money market funds (1)	$	59,406	$	59,406	$	—	$	—	$	59,406
U.S. treasury securities		196,554		196,554		—		—		196,554
Total	$	255,960	$	255,960	$	-	$	—	$	255,960

(1) Included in cash and cash equivalents in accompanying balance sheets.

No transfers between levels occurred during either of the reporting periods presented.

8. Stockholders’ Equity and Stock-Based Compensation

As of September 30, 2025, there were 2,024,183 shares available for future issuance under the 2020 Equity Incentive Plan and 775,977 shares available for future issuance under the 2022 Inducement Equity Incentive Plan. The 2020 Equity Incentive Plan provides for the grants of stock options and other equity-based awards to employees, non-employee directors and consultants of the Company. The 2022 Inducement Equity Incentive Plan provides for the grants of equity-based awards to individuals not previously employees or non-employee directors of the Company.

The table below summarizes the total stock-based compensation expense included in the Company’s statements of operations and comprehensive loss for the periods presented (in thousands):


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Research and development	$	2,434	$	2,105	$	8,245	$	6,381
General and administrative		3,197		2,951		10,514		8,629
Total stock-based compensation expense	$	5,631	$	5,056	$	18,759	$	15,010

Stock Options

The following table summarizes the stock option activity for the nine months ended September 30, 2025:


	Options			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value (in thousands)
Outstanding at December 31, 2024		11,249,452		$	5.87
Granted		3,446,898		$	8.40
Exercised		(205,122	)	$	5.05
Forfeited and cancelled		(360,560	)	$	7.82
Outstanding at September 30, 2025		14,130,668		$	6.45		7.3	$	80,297
Exercisable at September 30, 2025		8,174,330		$	5.28		6.3	$	56,790

The fair value of stock option awards to employees, executives, directors, and other service providers was estimated at the date of grant using the Black-Scholes-Merton option pricing model with the following assumptions:


	Nine Months Ended September 30,
	2025	2024
Risk-free interest rate	3.87% - 4.43%	3.69% - 4.64%
Expected volatility	83.11% - 85.76%	85.41% - 86.31%
Expected term (in years)	5.50 - 6.08	5.50 - 6.08
Expected dividend yield	0%	0%

The Company recognized stock-based compensation expense related to the vesting of stock options of $4.7 million and $4.2 million during the three months ended September 30, 2025 and 2024, respectively, and $15.7 million and $12.4 million during the nine months ended September 30, 2025 and 2024, respectively. Total unrecognized compensation expense related to outstanding unvested stock-option awards as of September 30, 2025, was $34.9 million, which is expected to be recognized over a weighted-average remaining service period of 2.6 years.

Restricted Stock Units

The following table summarizes the restricted stock unit activity for the nine months ended September 30, 2025:


	Number of Shares			Weighted- Average Grant-Date Fair Value
Outstanding at December 31, 2024		462,507		$	8.46
Granted		575,284		$	8.52
Vested		(37,770	)	$	8.14
Forfeited		(54,076	)	$	8.14
Outstanding at September 30, 2025		945,945		$	8.53

The Company recognized stock-based compensation expense related to the vesting of restricted stock units of $0.7 million and $0.6 million during the three months ended September 30, 2025 and 2024, respectively, and $2.5 million and $1.9 million during nine months ended September 30, 2025 and 2024, respectively. Total unrecognized compensation expense related to restricted stock units as of September 30, 2025, was $5.6 million, which is expected to be recognized over a weighted-average remaining service period of 1.8 years.

Employee Stock Purchase Plan

The Company recognized stock-based compensation expense related to the Employee Stock Purchase Plan (ESPP) of $0.2 million and $0.3 million during the three months ended September 30, 2025 and 2024, respectively, and $0.6 million and $0.7 million during the nine months ended September 30, 2025 and 2024, respectively.

Pre-funded Warrants

In May 2025, the Company completed a private placement in which it sold 14,130,313 shares of common stock together with pre-funded warrants to purchase 5,100,532 shares of common stock with an exercise price of $0.0001 per share of common stock. Each pre-funded warrant was immediately exercisable and will remain exercisable until exercised in full. The Company performed an assessment upon issuance of the pre-funded warrants to determine proper classification in the financial statements based on the specific terms of the pre-funded warrants. The Company determined the pre-funded warrants met all the criteria for equity classification and recorded them in additional paid-in capital. All pre-funded warrants remained outstanding as of September 30, 2025.

Net Loss per Share

The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been anti-dilutive:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Options to purchase common stock		14,130,668		11,102,253		14,130,668		11,102,253
Non-vested restricted stock units		945,945		726,035		945,945		726,035
Total		15,076,613		11,828,288		15,076,613		11,828,288

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited financial statements and related notes included elsewhere in this quarterly report on Form 10-Q and our audited financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission on February 18, 2025. This discussion contains forward-looking statements that involve risks and uncertainties, including those described in the section titled “Special Note Regarding Forward-Looking Statements.” Our actual results and the timing of selected events could differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those set forth under the section titled “Risk Factors” included elsewhere in this report.

Overview

ORIC Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer.

Our fully integrated research and development team is advancing a diverse pipeline of innovative clinical therapies designed to counter resistance mechanisms in cancer by leveraging our expertise within three specific areas: hormone-dependent cancers, precision oncology and key tumor dependencies.

Our clinical stage product candidates include:

•

ORIC-944, an allosteric inhibitor of the PRC2 via the embryonic ectoderm development (EED) subunit, for which we licensed development and commercialization rights from Mirati with the Mirati License Agreement. We filed and cleared an Investigational New Drug (IND) with the Food and Drug Administration (FDA) for ORIC-944 in the fourth quarter of 2021. We completed a Phase 1b trial of ORIC-944 as a single-agent, in patients with advanced prostate cancer and reported initial Phase 1b data from this trial in January 2024, demonstrating potential best-in-class drug properties, including an approximate 20-hour clinical half-life, robust target engagement and a favorable safety profile. In July 2024, we announced that in the first half of 2024 we initiated dosing of ORIC-944 in combination with apalutamide as well as in combination with darolutamide, as part of the ongoing Phase 1b trial in patients with metastatic castration resistant prostate cancer (mCRPC). We also announced that we entered into clinical trial collaboration and supply agreements with Janssen Research & Development, LLC, a Johnson and Johnson company (Johnson & Johnson) and Bayer Consumer Care AG (Bayer), to evaluate ORIC-944 in combination with Erleada® (apalutamide), Johnson & Johnson’s androgen receptor (AR) inhibitor and Nubeqa® (darolutamide), Bayer’s AR inhibitor. In the first half of 2025, we reported Phase 1b combination data from the dose exploration cohort of ORIC-944 in combination with apalutamide and with darolutamide in 17 patients with mCRPC. In November 2025, we announced the completion of the dose exploration portion of the Phase 1b trial and the selection of provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg QD of ORIC-944 in combination with 600 mg BID of darolutamide; and 600 mg, 800 mg and 1,200 mg QD of ORIC-944 in combination with 240 mg QD of apalutamide. Also, in November 2025, we reported Phase 1b dose exploration data in 20 patients with mCRPC, which included the 17 patients reported earlier this year, who were treated with ORIC-944 in combination with 240 mg QD of apalutamide or with 600 mg BID of darolutamide. The November 2025 data set (cutoff date of September 22, 2025) demonstrated PSA responses and circulating tumor DNA (ctDNA) reductions across all ORIC-944 dose levels and at comparable rates in combination with apalutamide or with darolutamide. Broad and deep PSA responses were demonstrated, with 55% of patients achieving a PSA50 response rate (confirmed in 40%), and 20% of patients achieving a PSA90 response rate (all confirmed). Rapid and deep ctDNA responses were observed in patients across a breadth of AR mutations and other gene alterations, with 76% of patients achieving greater than 50% ctDNA reduction, and 59% of patients achieving ctDNA clearance. Both combination regimens demonstrated a 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. Only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide. We expect to report dose optimization data in the first quarter of 2026, and we expect to initiate our first global Phase 3 registrational trial for ORIC-944 in mCRPC in the first half of 2026.

•

Enozertinib (formerly ORIC-114), a brain-penetrant, orally bioavailable, irreversible inhibitor that selectively targets EGFR exon 20, EGFR atypical, and HER2 exon 20 mutations, for which we licensed development and commercialization rights from Voronoi with the Voronoi License Agreement. In the fourth quarter of 2021, we filed a Clinical Trial Application (CTA) in South Korea for enozertinib, which was cleared in the first quarter of 2022. We also filed and cleared an IND with the FDA for enozertinib in the third quarter of 2022. We are enrolling a Phase 1b

trial of enozertinib as a single-agent, in patients with advanced solid tumors with EGFR exon 20 insertion mutations, EGFR atypical mutations, or HER2 exon 20 insertion mutations, which allows enrollment of patients with CNS metastases that are either treated or untreated but asymptomatic. We reported initial Phase 1b data from this trial at the European Society for Medical Oncology Congress in October 2023, which demonstrated both systemic and intracranial activity across multiple dose levels in a heavily pre-treated patient population. In April 2024, we announced the selection of two provisional recommended Phase 2 dose (RP2D) levels of enozertinib at 80 mg and 120 mg daily QD. We expect to report a comprehensive data update during the fourth quarter of 2025 that will include enozertinib in the first-line EGFR exon 20 monotherapy cohort, the 2L+ EGFR atypical cohort and cohorts for 2L EGFR exon 20 and 2L+ HER2 exon 20. In January 2025, we announced that we entered into a clinical trial and supply agreement with Johnson & Johnson, to evaluate enozertinib in combination with subcutaneous (SC) amivantamab for the first line treatment of patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, and we initiated a Phase 1b trial in the first quarter of 2025. Initial data from this trial in addition to enozertinib data as a monotherapy in first-line EGFR atypical mutations are expected in mid-2026. We also expect to initiate Phase 3 trial(s) for enozertinib in first-line NSCLC in 2026, in EGFR exon 20, EGFR atypical, and/or HER2 exon 20 mutations.

Beyond these clinical stage product candidates, we have historically engaged in the research and development of multiple discovery stage precision medicines targeting other hallmark cancer resistance mechanisms. On August 12, 2025, we announced a strategic pipeline prioritization to focus operational and financial resources on the continued advancement of our two lead clinical programs, ORIC-944 and enozertinib. This initiative has resulted in a substantial decrease in preclinical research, primarily from the elimination of our discovery research group.

We have incurred significant losses since the commencement of our operations. Our net loss for the nine months ended September 30, 2025, was $99.0 million and we had an accumulated deficit of $661.7 million as of September 30, 2025. Our losses and accumulated deficit have resulted primarily from costs incurred in connection with research and development activities including in-licensing and to a lesser extent from general and administrative costs associated with our operations. We expect to incur significant losses for the foreseeable future, and we anticipate these losses will increase significantly as we continue our development of ORIC-944 and enozertinib and any future product candidates through preclinical development and into clinical trials as we seek regulatory approval for these product candidates. Our net losses may fluctuate significantly from period to period, depending on the timing of and expenditures on our planned research and development activities.

Components of Operating Results

Research and Development Expenses

Research and development expenses account for a significant portion of our operating expenses and consist primarily of external and internal costs incurred in connection with the discovery and development of our product candidates.

External expenses include:

•

payments to third parties in connection with the clinical development of our product candidates, including contract research organizations (CROs) and consultants;

•

the cost of manufacturing products for use in our preclinical studies and clinical trials, including payments to contract manufacturing organizations (CMOs) and consultants;

•

payments to third parties in connection with the preclinical development of our product candidates, including outsourced professional scientific development services, consulting research fees and sponsored research arrangements with third parties;

•

laboratory supplies; and

•

allocated facilities, depreciation and other expenses, which include direct or allocated expenses for IT, rent and maintenance of facilities.

We may also incur in-process research and development expense as we acquire or in-license assets from other parties. Technology acquisitions are expensed or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. Acquired in-process research and development costs that have no alternative future use are immediately expensed.

Internal expenses include employee-related costs such as salaries, related benefits and non-cash stock-based compensation expense for employees engaged in research and development functions.

We expense research and development costs in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our

estimate of the level of service that has been performed at each reporting date. We track external costs by program, clinical or preclinical. We do not track internal costs by program because these costs are deployed across multiple programs and, as such, are not separately classified.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect that our research and development expenses will increase substantially in the foreseeable future as we continue to invest in research and development activities related to developing our product candidates, including investments in manufacturing, advance our programs into later stages of development, conduct additional clinical trials, maintain, expand, protect and enforce our intellectual property portfolio, and hire additional personnel.

The successful development of our product candidates is highly uncertain, and we do not believe it is possible at this time to accurately project the nature, timing and estimated costs of the efforts necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. To the extent our product candidates continue to advance into clinical trials, as well as advance into larger and later-stage clinical trials, our expenses will increase substantially and may become more variable. We are also unable to predict when, if ever, we will generate revenue from our product candidates to offset these expenses. Our expenditures on current and future preclinical and clinical development programs are subject to numerous uncertainties in timing and cost to completion. The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, including:

•

the timing and progress of preclinical and clinical development activities;

•

the number and scope of preclinical and clinical programs we decide to pursue;

•

our ability to maintain our current research and development programs and to establish new ones;

•

establishing an appropriate safety profile with IND-enabling toxicology studies;

•

successful patient enrollment in, and the initiation and completion of, clinical trials;

•

the successful completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

•

the receipt of regulatory approvals from applicable regulatory authorities;

•

the timing, receipt and terms of any marketing approvals from applicable regulatory authorities;

•

our ability to establish licensing or collaboration arrangements;

•

the performance of our future collaborators, if any;

•

obtaining and retaining research and development personnel;

•

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

•

development and timely delivery of commercial-grade product formulations that can be used in our planned clinical trials and for commercial launch;

•

obtaining, maintaining, defending and enforcing patent claims and other intellectual property rights;

•

launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and

•

maintaining a continued acceptable safety profile of our products following approval.

Any changes in the outcome of any of these factors could significantly impact the costs, timing and viability associated with the development of our product candidates.

On August 12, 2025, we announced a strategic pipeline prioritization to focus operational and financial resources on the continued advancement of our two lead clinical programs, ORIC-944 and enozertinib. This initiative has resulted in a substantial decrease in preclinical research, primarily from the elimination of our discovery research group. This resulted in an approximately 20% workforce reduction and we have incurred a one-time cost of approximately $1.9 million primarily related to termination benefits, including severance and healthcare-related benefits. The workforce reduction was substantially completed in the third quarter of 2025.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries, related benefits and stock-based compensation expense for personnel in executive, finance and administrative functions. General and administrative expenses also include allocated facilities, depreciation and other expenses, which include direct or allocated expenses for rent and maintenance of facilities and insurance, not

otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We expect that our general and administrative expenses will increase substantially in the foreseeable future as we increase our headcount to support the continued research and development of our programs and the growth of our business.

Other Income, Net

Other income, net primarily consists of interest income generated from our interest-bearing money market accounts and investments.

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

The following table summarizes our results of operations (in thousands):


	Three Months Ended September 30,									Nine Months Ended September 30,
	2025			2024			Change			2025			2024			Change
Operating expenses:
Research and development	$	28,773		$	31,202		$	(2,429	)	$	83,962		$	82,102		$	1,860
General and administrative		7,898			7,116			782			24,491			21,223			3,268
Total operating expenses		36,671			38,318			(1,647	)		108,453			103,325			5,128
Loss from operations		(36,671	)		(38,318	)		1,647			(108,453	)		(103,325	)		(5,128	)

Other income, net		4,084			3,752			332			9,490			11,785			(2,295	)

Net loss	$	(32,587	)	$	(34,566	)	$	1,979		$	(98,963	)	$	(91,540	)	$	(7,423	)

Research and Development Expenses

Research and development expenses were $28.8 million for the three months ended September 30, 2025, compared to $31.2 million for the same period in 2024, a decrease of $2.4 million. The decrease was driven by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs, offset by higher personnel costs of $2.7 million, including additional non-cash stock-based compensation of $0.3 million, and costs related to the advancement of enozertinib.

For the nine months ended September 30, 2025, research and development expenses were $84.0 million, compared to $82.1 million for the same period in 2024, an increase of $1.9 million. The increase was driven by higher personnel costs of $7.6 million, including additional non-cash stock-based compensation of $1.9 million, and costs related to the advancement of enozertinib, offset by lower ORIC-944 drug manufacturing costs and lower costs from discontinued programs.

The following table summarizes our external and internal costs for the three and nine months ended September 30, 2025 and 2024 (in thousands):


	Three Months Ended September 30,							Nine Months Ended September 30,
	2025		2024		Change			2025		2024		Change
External costs:
ORIC-944	$	5,559	$	11,251	$	(5,692	)	$	17,613	$	23,449	$	(5,836	)
enozertinib		9,031		7,686		1,345			24,204		21,141		3,063
Preclinical, other unallocated and discontinued costs		3,839		4,578		(739	)		12,037		14,982		(2,945	)
Total external costs		18,429		23,515		(5,086	)		53,854		59,572		(5,718	)
Internal costs		10,344		7,687		2,657			30,108		22,530		7,578
Total research and development expenses	$	28,773	$	31,202	$	(2,429	)	$	83,962	$	82,102	$	1,860

General and Administrative Expenses

General and administrative expenses were $7.9 million for the three months ended September 30, 2025, compared to $7.1 million for the same period in 2024, an increase of $0.8 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $0.2 million.

For the nine months ended September 30, 2025, general and administrative expenses were $24.5 million, compared to $21.2 million for the same period in 2024, an increase of $3.3 million. The increase was primarily due to higher personnel costs and professional services, including additional non-cash stock-based compensation of $1.9 million.

Liquidity and Capital Resources

Sources of Liquidity

On May 23, 2025, we entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 14,130,313 shares of common stock at a price of $6.50 per share and pre-funded warrants to purchase 5,100,532 shares of common stock at a purchase price of $6.4999 per pre-funded warrant, resulting in gross proceeds of $125.0 million. The private placement closed on May 29, 2025.

We previously entered into an ATM sales agreement with Jefferies LLC as our sales agent, to sell shares of our common stock. On March 11, 2024, pursuant to the terms of the ATM sales agreement, we filed a Form S-3ASR and prospectus supplement, to allow us to sell from time to time up to $200.0 million of shares of our common stock in negotiated transactions or transactions deemed to be an ATM offering. During the three months ended September 30, 2025, we raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $108.7 million through the sale of 10,930,032 shares at a weighted average purchase price of $10.10. During the nine months ended September 30, 2025, we raised net proceeds in ATM offerings, including participation from healthcare specialist funds, of approximately $117.6 million through the sale of 11,780,032 shares at a weighted average purchase price of $10.13.

On January 20, 2024, we entered into a securities purchase agreement with a select group of institutional and accredited healthcare specialist investors for the private placement of 12,500,000 shares of common stock at a price of $10.00 per share, resulting in gross proceeds of $125.0 million. The private placement closed on January 23, 2024.

Future Funding Requirements

To date, we have not generated any revenue. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if at all, that will occur. We will continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. Moreover, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development of and seek regulatory approvals for our product candidates. Further, we are subject to all the risks incident in the development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. Our expenses will increase if, and as, we:

•

advance our product candidates through preclinical and clinical development;

•

seek regulatory approvals for any product candidates that successfully complete clinical trials;

•

seek to develop additional product candidates;

•

establish a sales, marketing, medical affairs and distribution infrastructure to commercialize any product candidates for which we may obtain marketing approval and intend to commercialize on our own or jointly;

•

expand our operational, financial and management systems and increase personnel, including personnel to support our development, manufacturing and commercialization efforts and our operations as a public company;

•

maintain, expand, protect and enforce our intellectual property portfolio; and

•

acquire or in-license other product candidates and technologies.

We expect our current cash, cash equivalents and investments will be sufficient to fund our current operating plan into the second half of 2028. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our common stock, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with

third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts.

We have based our projections of operating capital requirements on our current operating plan, which is based on several assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our working capital requirements. Our future funding requirements will depend on many factors, including:

•

the scope, progress, results and costs of researching and developing our product candidates, and conducting preclinical studies and clinical trials;

•

the costs, timing and outcome of regulatory review of our product candidates;

•

the costs of future activities, including product sales, medical affairs, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval;

•

the costs of manufacturing commercial-grade products and sufficient inventory to support commercial launch;

•

the revenue, if any, received from commercial sale of our products, should any of our product candidates receive marketing approval;

•

the cost and timing of hiring new employees to support our continued growth;

•

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

•

the ability to establish and maintain collaborations on favorable terms, if at all;

•

the extent to which we acquire or in-license other product candidates and technologies; and

•

the timing, receipt and amount of sales of, or milestone payments related to or royalties on, our current or future product candidates, if any.

A change in the outcome of any of these or other factors with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plan may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plan.

Cash Flows

The following table summarizes the sources and uses of our cash (in thousands):


	Nine Months Ended September 30,
	2025			2024
Net cash used in operating activities	$	(88,487	)	$	(84,608	)
Net cash used in investing activities		(165,015	)		(20,518	)
Net cash provided by financing activities		243,764			125,972
Net (decrease) increase in cash, cash equivalents and restricted cash	$	(9,738	)	$	20,846

Operating Activities

Net cash used in operating activities during the nine months ended September 30, 2025, of $88.5 million was attributable to our net loss of $99.0 million and $7.1 million in changes to working capital, offset by non-cash expenses of $17.6 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Net cash used in operating activities during the nine months ended September 30, 2024, of $84.6 million was attributable to our net loss of $91.5 million and $2.4 million in changes to working capital, offset by non-cash expenses of $9.3 million, which were primarily driven by stock-based compensation offset by accretion of discount on investments.

Investing Activities

Net cash used in investing activities during the nine months ended September 30, 2025, of $165.0 million was primarily attributable to purchases of investments, net of maturities.

Net cash used in investing activities during the nine months ended September 30, 2024, of $20.5 million was primarily attributable to purchases of investments, net of maturities.

Financing Activities

Net cash provided by financing activities during the nine months ended September 30, 2025, of $243.8 million was attributable to net proceeds received from our private placement in May 2025 of $124.4 million, net proceeds from our ATM offerings of $117.6 million and proceeds received from stock option exercises and common stock issued under our ESPP.

Net cash provided by financing activities during the nine months ended September 30, 2024, of $126.0 million was attributable to net proceeds received from our private placement in January 2024 of $124.8 million and proceeds received from stock option exercises and common stock issued under our ESPP.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States (US GAAP). The preparation of these financial statements in conformity with US GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, expenses, and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses. Actual results may differ materially from these estimates under different assumptions or conditions. There have been no significant changes in our critical accounting policies as discussed in our Annual Report on Form 10-K for the year ended December 31, 2024.

Emerging Growth Company and Smaller Reporting Company Status

Section 107 of the JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition time to comply with new or revised accounting standards as applicable to public companies. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected not to use the extended transition, which election is irrevocable. As a result, our financial statements may not be comparable to other emerging growth companies that elect to take advantage of the extended transition period.

We are also a smaller reporting company as defined in the Securities Exchange Act of 1934, as amended (Exchange Act). We may take advantage of certain of the scaled disclosures available to smaller reporting companies.

We will remain an emerging growth company and a smaller reporting company until December 31, 2025. Beginning with our Quarterly Report on Form 10-Q for the quarter ending March 31, 2026, we will no longer be permitted to take advantage of the reduced reporting requirements applicable to smaller reporting companies, but will remain a non-accelerated filer through 2026.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Interest Rate Risk

The primary objective of our investment activities is to preserve principal and liquidity while at the same time maximizing the income we receive without significantly increasing risk. To achieve this objective, we may invest in money market funds, U.S. Treasury notes, and high-quality marketable debt instruments of corporations and government sponsored enterprises with contractual maturity dates of generally less than two years, in accordance with an investment policy approved by our audit committee. Some of the financial instruments that we invest in could be subject to market risk, meaning that a change in prevailing interest rates may cause the value of the instruments to fluctuate. For example, if we purchase a security that was issued with a fixed interest rate and the prevailing interest rate later rises, the value of that security will probably decline. To minimize this risk, we intend to maintain a portfolio which may include a variety of securities, including money market funds, government debt securities, certificates of deposit and commercial paper, all with various maturity dates. As of September 30, 2025, we had cash, cash equivalents and investments of $413.0 million, consisting of interest-bearing money market funds, certificates of deposit, securities issued by the U.S. Treasury and marketable debt instruments of government-sponsored enterprises. Due to the nature of our cash equivalents and investments, an immediate 100 basis point change in interest rates would not have a material effect on their fair market value.

Inflation generally affects us by increasing our cost of labor, clinical trial and manufacturing costs. We do not believe that inflation, interest rate changes or exchange rate fluctuations had a significant impact on our results of operations for any periods presented herein.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time period specified in

the SEC's rules and forms, and that such information is accumulated and communicated to management including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. As of September 30, 2025, we carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2025.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of our business. We are not currently a party to any material litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

Item 1A. Risk Factors.

Risk factors

You should carefully consider the risks described below, as well as the other information in this quarterly report on Form 10-Q, including our financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and in our other public filings in evaluating our business. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations and the market price of our common stock.

Risk factor summary

The following summarizes the most material risks that make an investment in our securities risky or speculative. If any of the following risks occur or persist, our business, financial condition, results of operations and prospects could be materially harmed and the market price of our common stock could significantly decline:

Risks related to our financial position and need for additional capital

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our limited operating history;

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our past and anticipated future net losses;

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uncertainty related to our ability to generate revenue and achieve profitability; and

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our need for substantial additional capital to finance our operations.

Risks related to development and commercialization of our product candidates

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our substantial dependence on our product candidates;

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our challenges in developing and commercializing additional product candidates;

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limitations in regulatory approval processes and product candidate approvals;

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our clinical trials that may fail to satisfactorily demonstrate safety and efficacy;

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our product candidates that may cause significant adverse events, toxicities or other undesirable side effects;

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potentially negative clinical trial results and challenges related to FDA, European Medicines Agency (EMA) and other regulatory requirements;

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deficiencies in audits and verification procedures of our clinical trial data;

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adverse effects due to third parties investigating the same product candidates as us in the same or different territories or indications;

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potential delays or difficulties in enrollment and/or maintenance of patients in clinical trials;

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the impact of global pandemics or other public health emergencies on our operations;

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our inability to develop effective companion diagnostic tests for our product candidates, if necessary;

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unexpected difficulties in developing our potential programs;

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profitability challenges related to our focus on developing our product candidates for particular indications;

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significant competition in the markets in which we operate;

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production difficulties encountered by our third-party manufacturers;

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changes in methods of product candidate manufacturing or formulation;

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market unacceptance of our product candidates in the medical community;

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limited market opportunities for our product candidates;

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our inability to augment our product pipeline through acquisitions and in-licenses;

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potential for unfavorable third-party coverage and reimbursement practices of our product candidates; and

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limitations of our product liability and insurance coverage.

Risks related to regulatory, legal and other compliance matters

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difficulties in our ability to obtain regulatory approval of our product candidates;

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FDA, EMA and other regulatory authorities’ unacceptance of data from trials conducted outside their jurisdiction;

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our inability to obtain and maintain regulatory approval of our product candidates in various jurisdictions;

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burdens related to post-marketing regulatory requirements and oversight of our product candidates;

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impacts of regulatory authorities’ enforcement of laws and regulations prohibiting promotion of off-label uses;

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challenges related to FDA approval of required companion diagnostic tests;

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challenges related to our ability to obtain Fast Track designation from the FDA for our product candidates;

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limitations to our ability to obtain orphan drug designation or maintain orphan drug exclusivity for our product candidates;

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any delays or barriers to secure approval for accelerated registration pathways;

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changes to current regulations and future legislation that impact us adversely;

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inadequate funding of regulatory agencies that may hinder timely product development or commercialization;

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potential misconduct or noncompliance with regulatory standards by our employees and certain third parties;

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any potential incompliance with U.S. healthcare laws and requirements;

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any potential incompliance with environmental, health and safety laws and regulations;

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any potential incompliance with anti-bribery, anti-corruption, export (including data export), trade sanctions and import laws or regulations; and

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any potential incompliance with enhanced trade tariffs, import restrictions, export restrictions, Chinese regulations or other trade barriers.

Risks related to employee matters and management of our growth

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challenges to our ability to attract and retain highly skilled executive officers and employees;

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difficulties in our ability to sell or market our product candidates;

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our potential inability to grow and manage growth of our organization;

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security or data privacy breaches or incidents impacting our internal systems or those of commercial third parties;

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natural disasters and other catastrophic events that may cause damage or disruption;

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the SEC civil enforcement action against one of our officers;

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our potential inability to use our net operating losses and tax credits to offset future taxable income;

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changes in tax laws and additional effort and expenses incurred as a result;

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complexities related to contracting with foreign third parties or international marketing of our product candidates;

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international military conflicts, and any resulting trade war, could result in increased manufacturing costs; and

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inflation may adversely affect us by increasing our costs.

Risks related to intellectual property

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challenges to our ability to protect our intellectual property and proprietary technologies;

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the potentially narrow scope of patent protection we receive;

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potential threats to our competitive advantage;

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our ability to operate without infringing intellectual property rights and claims of infringement by third parties;

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our potential inability to obtain or maintain rights to our product candidates through acquisitions and in-licenses;

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costs associated with protecting or enforcing our patents and our licensors’ patents;

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intellectual property litigation that may lead to unfavorable publicity;

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unfavorable outcomes from necessary derivation proceedings;

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patent reform legislation and related uncertainties and costs;

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changes in U.S. and international intellectual property laws and related challenges;

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claims challenging ownership of our intellectual property, including internationally;

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patent terms and access to extensions that may not adequately protect our competitive position;

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our patent protection and dependence on compliance with various regulations;

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potentially limited name recognition in our markets that depend on protection of our trademarks and trade names;

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difficulties in protecting confidentiality of our trade secrets;

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claims of wrongful disclosure of our confidential information or trade secrets;

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claims of wrongful hiring or disclosure or use of competitors’ confidential information or trade secrets;

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our product development and commercialization rights that are subject to unfavorable terms and conditions of licensors;

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potential business relationship disruptions due to failure to comply with license agreement obligations;

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our patent protection and prosecution that may be dependent on third parties; and

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intellectual property discovered through government funding and potential limits on our exclusive rights.

Risks related to dependence on third parties

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our dependence on third-party suppliers and the loss of these third-party suppliers or their inability to supply us could harm our business;

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our dependence on third parties for production, preclinical studies and clinical trials of our product candidates;

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acquisitions or strategic partnerships that may increase capital requirements, dilution and debt;

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failure to establish commercially reasonable collaborations; and

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difficulties related to collaborations for development and commercialization of product candidates.

Risks related to the securities markets and ownership of our common stock

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market conditions and price that may limit your ability to sell our common stock;

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the volatility of our stock price;

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adverse or misleading industry analyst publications regarding our business or market;

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significant fluctuations in our operating results;

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principal stockholders and management that may exert significant control over stockholder approval matters;

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large sales of our stock that could cause our stock price to fall;

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limitations related to our status as an emerging growth company and our status as a smaller reporting company and our transition after we no longer meet the requirements of such statuses;

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failure of our internal controls that could impair our ability to produce accurate financial statements;

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limitations of our disclosure controls and procedures;

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liabilities related to securities litigation;

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our intention not to pay dividends;

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provisions of our certificate of incorporation and bylaws that may prevent or delay a change in control; and

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exclusive forum provisions in our bylaws that may limit stockholder ability to obtain a favorable judicial forum.

Risks related to our financial position and need for additional capital

We have a limited operating history, have not initiated or completed any large-scale or pivotal clinical trials, and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and likelihood of success and viability.

We are a clinical-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We commenced operations in 2014, have no products approved for commercial sale and have not generated any revenue. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. We have initiated clinical trials for a limited number of our product candidates. To date, we have devoted substantially all of our resources to research and development activities, including with respect to the preclinical and clinical development of ORIC-944, enozertinib (formerly ORIC-114) and our other product candidates, in-licensing of external programs, business planning, establishing and maintaining our intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations.

We have not yet demonstrated our ability to successfully initiate and complete any large-scale or pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer operating history.

In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by clinical-stage biopharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research and development focus to a company capable of supporting commercial activities. We have not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.

We have incurred significant net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future.

We have incurred significant net losses since our inception, have not generated any revenue from product sales to date and have financed our operations principally through public offerings and private placements of our common stock, convertible preferred stock and other derivative securities. Our net loss was $99.0 million for the nine months ended September 30, 2025, and as of September 30, 2025, we had an accumulated deficit of $661.7 million. We expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to develop and market additional potential products.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the performance of our stock.

Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the development and commercialization of our product candidates.

Our business depends entirely on the successful development and commercialization of product candidates. We have no products approved for commercial sale and do not anticipate generating any revenue from product sales for the next several years, if ever. Our ability to generate revenue and achieve profitability depends significantly on our ability, or any current or future collaborator’s ability, to achieve several objectives, including:

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successful and timely completion of preclinical and clinical development of ORIC-944, enozertinib and our other future product candidates;

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establishing and maintaining relationships with CROs and clinical sites for the clinical development of ORIC-944, enozertinib and our other future product candidates;

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timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;

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developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale;

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establishing and maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for our product candidates, if approved;

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successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;

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a continued acceptable safety profile following any marketing approval of our product candidates;

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commercial acceptance of our product candidates by patients, the medical community and third-party payors;

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satisfying any required post-marketing approval commitments to applicable regulatory authorities;

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identifying, assessing and developing new product candidates;

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obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and internationally;

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protecting our rights in our intellectual property portfolio;

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defending against third-party interference or infringement claims, if any;

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entering into, on favorable terms, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

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obtaining coverage and adequate reimbursement by third-party payors for our product candidates;

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addressing any competing therapies and technological and market developments; and

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Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Oric Pharmaceuticals, Inc. 10-Q