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SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, March 25, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced that a preclinical abstract highlighting the potential of ORIC-944, a potent and selective allosteric inhibitor of PRC2 to treat prostate cancer, has been accepted for poster presentation at the 2025 American Association for Cancer Research (AACR) Annual Me ...

Core Insights - ORIC Pharmaceuticals is focusing on registrational development plans for its lead programs, ORIC-944 and ORIC-114, targeting indications with strong clinical validation and high unmet needs [1][3] - The initiation of the first Phase 3 trial for ORIC-944 in metastatic castration-resistant prostate cancer (mCRPC) is expected in the first half of 2026, while ORIC-114's registrational trials for first-line non-small cell lung cancer (NSCLC) are anticipated to start in 2026 [1][3] - The company has extended its projected cash runway into 2027, allowing for accelerated corporate milestones [2][6] Registrational Development Plans - ORIC-944 is a potent allosteric inhibitor of PRC2, with a Phase 3 trial initiation planned for mCRPC in 1H 2026 [4] - ORIC-114 is an irreversible EGFR/HER2 inhibitor, with registrational trials focused on first-line NSCLC expected to begin in 2026 [5][7] Corporate Highlights - As of December 31, 2024, ORIC had cash, cash equivalents, and investments totaling $256 million, with an extended cash runway into 2027 based on a refined operating plan [6] - Favorable enrollment trends for both ORIC-944 and ORIC-114 are expected to lead to accelerated data reporting, including dose escalation data for ORIC-944 in 1H 2025 and comprehensive NSCLC data in 2H 2025 [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ 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) (State or other jurisdiction of incorporatio ...

Financial Position - ORIC Pharmaceuticals reported cash and investments of $256 million as of December 31, 2024, expected to fund operations into late 2026[12]. - The company secured $125 million in financing during 2024, extending its cash runway into late 2026[2]. - The total stockholders' equity increased to $243.1 million as of December 31, 2024, up from $224.1 million in 2023[16]. Research and Development Expenses - Research and development (R&D) expenses for Q4 2024 were $32.0 million, up from $24.5 million in Q4 2023, representing a 29% increase[12]. - For the full year 2024, R&D expenses totaled $114.1 million, compared to $85.2 million in 2023, marking a 34% increase[12]. General and Administrative Expenses - General and administrative (G&A) expenses for Q4 2024 were $7.6 million, compared to $6.9 million in Q4 2023, an increase of 10%[12]. Net Loss - The net loss for Q4 2024 was $36.3 million, compared to a net loss of $28.3 million in Q4 2023, reflecting a 28% increase in losses[18]. Clinical Programs and Trials - ORIC anticipates seven data readouts across ORIC-114 and ORIC-944 clinical programs over the next 18 months, with potential registrational trials starting in 2H25 and early 2026[1]. - ORIC-944 is being evaluated in combination with apalutamide and darolutamide in ongoing Phase 1b trials for metastatic castration-resistant prostate cancer (mCRPC)[7]. - ORIC-114 is in clinical collaboration with Johnson & Johnson for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations[3].

Core Insights - ORIC Pharmaceuticals reported encouraging early safety and efficacy data for ORIC-944 in combination with androgen receptor inhibitors for metastatic castration-resistant prostate cancer (mCRPC) [1] - The company entered a clinical trial collaboration with Johnson & Johnson to evaluate ORIC-114 in combination with amivantamab for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations [1][5] - ORIC anticipates seven data readouts across its clinical programs over the next 18 months, with potential registrational trials starting in the second half of 2025 and early 2026 [1][2] - The company has a cash position of $256 million, expected to fund operations into late 2026 [1][11] Clinical Developments - ORIC-114 is being developed as a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor for NSCLC [3] - ORIC-944 is a potent and selective allosteric inhibitor of PRC2, currently in trials for prostate cancer [4] - The company has initiated multiple cohorts for ORIC-114 and ORIC-944, with ongoing trials showing promising results [2][5] - Preclinical data presented at major conferences indicate the potential best-in-class properties of both ORIC-114 and ORIC-944 [5][6] Financial Performance - For Q4 2024, ORIC reported R&D expenses of $32 million, up from $24.5 million in Q4 2023, reflecting increased external expenses and personnel costs [11] - General and administrative expenses for Q4 2024 were $7.6 million, compared to $6.9 million in Q4 2023 [11] - The total net loss for the year ended December 31, 2024, was $127.8 million, compared to $100.7 million for the previous year [16]

Core Insights - ORIC Pharmaceuticals, Inc. has announced early Phase 1b combination data for ORIC-944 and operational highlights for 2024, indicating progress in its clinical programs and collaborations [2][3] Clinical Development - ORIC-944 is being evaluated in combination with apalutamide for metastatic castration-resistant prostate cancer (mCRPC), showing promising early safety and efficacy data [1][4] - The company has initiated multiple cohorts for ORIC-114 in non-small cell lung cancer (NSCLC) and ORIC-944 in mCRPC, with expectations for seven data readouts over the next 18 months [3][12] - ORIC-944 demonstrated a clinical half-life of approximately 20 hours and a favorable safety profile, with deep prostate-specific antigen (PSA) decreases observed in patients [4][7] Financial Position - As of September 30, 2024, ORIC had cash, cash equivalents, and investments totaling $282.4 million, which is expected to fund operations into late 2026 [10] - The company completed a $125 million private investment in public equity (PIPE) financing, strengthening its cash position [3][12] Strategic Collaborations - ORIC has entered into clinical trial collaboration and supply agreements with Johnson & Johnson and Bayer to support ongoing trials for ORIC-944 and ORIC-114 [1][12] - The collaborations aim to evaluate ORIC-114 in combination with amivantamab for first-line treatment of NSCLC patients with specific mutations [1][12] Upcoming Milestones - The company anticipates initiating registrational trials for ORIC-114 in the second half of 2025 and for ORIC-944 in early 2026 [1][3][12] - Key upcoming data milestones include various cohorts for ORIC-114 and ORIC-944, with specific timelines outlined for 2025 and 2026 [12]

Core Insights - ORIC Pharmaceuticals is set to initiate a Phase 1b combination trial of ORIC-114 and subcutaneous amivantamab for first-line treatment of advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations in Q1 2025, with initial data expected in mid-2026 [1][3] Company Overview - ORIC Pharmaceuticals is a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance [1][6] - The company is dedicated to improving patients' lives by overcoming resistance in cancer, with product candidates including ORIC-114 and ORIC-944 [6] Product Details - ORIC-114 is a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor that targets EGFR exon 20, HER2 exon 20, and EGFR atypical mutations, showing promise for systemic and CNS antitumor activity [5][6] - The company has selected two provisional recommended Phase 2 doses (RP2D) for ORIC-114 at 80 mg and 120 mg QD, which are being evaluated in dose expansion cohorts [4] Trial Information - Under the supply agreement with Johnson & Johnson, ORIC will conduct and sponsor the trial while Johnson & Johnson will provide SC amivantamab [2] - The primary objectives of the trial include determining the RP2D for the combination and assessing efficacy and safety [3]

Company Overview - ORIC Pharmaceuticals, Inc. is a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance [3] - The company has two main clinical stage product candidates: ORIC-114, targeting EGFR and HER2 mutations in genetically defined cancers, and ORIC-944, an allosteric inhibitor for prostate cancer [3] - ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms [3] Upcoming Event - Jacob M. Chacko, M.D., the CEO of ORIC, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference on January 14, 2025, at 11:15 a.m. PT [1] - A live webcast of the presentation will be available on the company's investor website, with a replay accessible for 90 days post-event [2]

Core Viewpoint - ORIC Pharmaceuticals is a small-cap pharmaceutical company with a focus on developing potentially "best-in-class" treatments, despite facing a challenging year with a -4% return in 2024. Analysts remain optimistic about the stock, with a significant price target increase anticipated [1][2]. Drug Candidates - ORIC has two leading drug candidates: ORIC-114, targeting cancers from EGFR and HER2 mutations, particularly in non-small cell lung cancer (NSCLC), and ORIC-944, aimed at treating prostate cancer by inhibiting the Polycomb Repressive Complex 2 (PRC2) [3][5]. - ORIC-114 has shown promising initial results, with 18 out of 27 patients experiencing a 75% or greater reduction in mutant EGFR gene molecules within four weeks [11][12]. - ORIC-944 is designed to enhance the effectiveness of existing prostate cancer treatments, working alongside AR-inhibitors that collectively generate around $10 billion in annual sales [7][9]. Collaborations and Market Position - ORIC has established collaboration agreements with major pharmaceutical companies like Johnson & Johnson and Bayer to improve their AR-inhibitors with ORIC-944, while Pfizer is also developing a PRC2 inhibitor, which adds confidence to ORIC-944's potential [8][9]. - The strategy of collaboration rather than competition aligns ORIC with the interests of larger companies, incentivizing them to support ORIC's success in the market [9]. Financial Position - The company has over $282 million in cash, providing sufficient funding until late 2026, alleviating immediate concerns about capital raising and shareholder dilution [13].