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].

Financial Performance - ORIC Pharmaceuticals reported a net loss of $91.5 million for the nine months ended September 30, 2024, with an accumulated deficit of $526.5 million[44]. - Net loss for Q3 2024 was $34.6 million, compared to a net loss of $25.5 million in Q3 2023, representing an increase of $9.1 million (35.7%)[52]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $84.6 million, compared to $61.4 million in the same period of 2023, an increase of $23.2 million (37.8%)[62]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $126.0 million, compared to $85.2 million in the same period of 2023, an increase of $40.8 million (47.8%)[64]. - The company has not generated any revenue to date and will require substantial additional capital to fund operations and product development[58]. Research and Development - The company has initiated a Phase 1b trial for ORIC-114, targeting advanced solid tumors with EGFR and HER2 alterations, and expects to report updated data in the first half of 2025[42]. - ORIC-944 demonstrated a clinical half-life of approximately 20 hours and a favorable safety profile in a Phase 1b trial for advanced prostate cancer, with ongoing combination studies initiated in 2024[42]. - ORIC-533 is in a Phase 1b trial for relapsed/refractory multiple myeloma, with initial data reported at the ASH annual meeting in December 2023[42]. - Research and development expenses are expected to increase significantly as the company advances its product candidates through clinical trials[48]. - Research and development expenses for Q3 2024 were $31.2 million, an increase of $8.8 million (39.3%) from $22.4 million in Q3 2023[53]. - For the nine months ended September 30, 2024, research and development expenses totaled $82.1 million, up $21.4 million (35.2%) from $60.7 million in the same period of 2023[53]. - The company expects research and development expenses to increase substantially as it continues to invest in product candidates and clinical trials[54]. General and Administrative Expenses - General and administrative expenses are anticipated to rise substantially due to increased headcount to support ongoing research and development[49]. - General and administrative expenses for Q3 2024 were $7.1 million, an increase of $0.8 million (12.7%) from $6.3 million in Q3 2023[55]. - For the nine months ended September 30, 2024, general and administrative expenses were $21.2 million, up $2.6 million (13.9%) from $18.7 million in the same period of 2023[56]. Capital and Funding - The company raised $125 million through a private placement of 12.5 million shares at $10.00 per share, closing on January 23, 2024[44]. - A previous private placement on June 27, 2023, raised $85 million from the sale of 9.29 million shares at $7.00 per share[44]. - The company has entered into an "at the market" sales agreement to sell up to $200 million of common stock[44]. - Current cash and investments are expected to fund operations into late 2026, but additional funding will be necessary for future commercialization efforts[60]. - The company has cash equivalents and investments totaling $282.4 million as of September 30, 2024, including interest-bearing money market funds and U.S. Treasury securities[67]. Market and Economic Conditions - Inflation has increased costs related to labor, clinical trials, and manufacturing, but the company does not believe it significantly impacted its results of operations[69]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of the company's cash equivalents and investments[67]. - The company invests in high-quality marketable debt instruments with maturity dates generally less than two years to preserve principal and liquidity[67]. Company Classification and Accounting - The company has elected not to use the extended transition period for emerging growth companies, which means its financial statements may not be comparable to others that do[66]. - The company will remain an emerging growth company until it exceeds $1.235 billion in annual revenue or meets other specified criteria[66]. - The company is classified as a smaller reporting company and may continue to take advantage of scaled disclosures as long as certain revenue and stock value thresholds are met[66]. - There have been no significant changes in the company's critical accounting policies since the last annual report[65]. Strategic Focus - ORIC Pharmaceuticals is focused on developing therapies that counter resistance mechanisms in cancer, leveraging expertise in hormone-dependent cancers and precision oncology[41].

Financial Performance - ORIC Pharmaceuticals reported cash and investments of $282.4 million as of September 30, 2024, expected to fund operations into late 2026[6] - The net loss for Q3 2024 was $34.6 million, compared to a net loss of $25.5 million in Q3 2023, reflecting a 35.0% increase in losses[14] - The total operating expenses for the nine months ended September 30, 2024, were $103.3 million, compared to $79.4 million for the same period in 2023, a 30.1% increase[14] Research and Development - Research and development (R&D) expenses increased to $31.2 million for Q3 2024, up from $22.4 million in Q3 2023, representing a 39.2% increase[7] - ORIC-114 is advancing towards registrational studies, with updated Phase 1b data expected in the first half of 2025[3] - ORIC-944 initiated dosing in combination with NUBEQA® and ERLEADA® in ongoing Phase 1b trials for prostate cancer in early 2024[4] - The company entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support ORIC-944 trials[4] - ORIC-114 demonstrated potential best-in-class properties in preclinical data presented at the EORTC-NCI-AACR Conference[2] Administrative Expenses - General and administrative (G&A) expenses rose to $7.1 million for Q3 2024, compared to $6.3 million in Q3 2023, a 12.7% increase[8] Leadership Changes - The leadership team was expanded with the appointment of Keith Lui as Senior Vice President of Commercial and Medical Affairs[5]

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 04, 2024 (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 management will participate in the following investor conferences in November: Guggenheim’s Inaugural Healthcare Innovation Conference – Participating in a fireside chat on Monday, November 11, 2024, at 10:30 a.m. ETJefferies London Healthcare Conferenc ...

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 01, 2024 (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 on November 1, 2024 (the “Grant Date”), ORIC granted a total of 61,800 non-qualified stock options and 10,400 restricted stock units to two new non-executive employees who began their employment with ORIC in October 2024. These inducement grants were gra ...

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Oct. 09, 2024 (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 the company will present a poster at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics to be held October 23-25, 2024, in Barcelona, Spain. Poster presentation details: Title: ORIC-114, a highly selective, brain penetrant EGFR an ...

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Sept. 06, 2024 (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 on September 3, 2024 (the "Grant Date"), ORIC granted a total of 173,200 non-qualified stock options and 28,900 restricted stock units to three new nonexecutive employees who began their employment with ORIC in August 2024. These inducement grants were ...