Oric Pharmaceuticals Inc

11/13/2025 | Press release | Distributed by Public on 11/13/2025 15:21

Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

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.

Oric Pharmaceuticals Inc published this content on November 13, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 13, 2025 at 21:21 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]