Tovecimig Clinical Trial Results (COMPANION-002 Study) - The COMPANION-002 study is a Phase 2/3 registrational-intent study in patients with BTC who have received one prior line of therapy[9] - In the Intent-to-Treat population, the Overall Response Rate (ORR) for Tovecimig + Paclitaxel was 17.1% (19 out of 111 patients) compared to 5.3% (3 out of 57 patients) for Paclitaxel alone, with a two-sided p-value of 0.031[12] - The Complete Response (CR) rate in the Tovecimig + Paclitaxel arm was 0.9% (1 out of 111 patients), while the Partial Response (PR) rate was 16.2% (18 out of 111 patients)[12] - Stable Disease (SD) was observed in 44.1% of patients (49 out of 111) in the Tovecimig + Paclitaxel arm compared to 33.3% (19 out of 57) in the Paclitaxel arm[12] - Progressive Disease (PD) was observed in 16.2% of patients (18 out of 111) in the Tovecimig + Paclitaxel arm compared to 42.1% (24 out of 57) in the Paclitaxel arm[12] Tovecimig Development and Potential - Tovecimig is a bispecific antibody targeting DLL4 and VEGF-A, designed to disrupt tumor vessel formation and angiogenesis[6, 7] - The company anticipates top-line Phase 2/3 data for PFS, OS, and DoR in Q4 2025[25] - Tovecimig has the potential to become a standard of care in 2L BTC, with PFS, OS and DoR data expected in Q4 2025[18] Market and Unmet Needs - There are significant unmet needs in current treatments for BTC, with approximately 85% of 2L patients having limited treatment options[19, 20] - Incidence of BTC is significant, with an estimated ~23,000 cases annually[22] - Projected ~100,000 incidence of liver and intrahepatic bile duct cancer by 2040[23]

Financial Data and Key Metrics Changes - The company reported cash of $1 billion at the end of Q1 2025, an increase from $992 million at the end of 2024, bolstered by a $150 million equity financing completed in February 2025 [34][36] - GAAP revenue for Q1 2025 was $8 million, down from $36 million in Q4 2024, primarily driven by collaboration with Gilead [35] - The company expects to recognize GAAP revenue of $75 million to $90 million for the full year 2025 [35] Business Line Data and Key Metrics Changes - The late-stage portfolio is focused on the casdadefan program, which is the top priority, with ongoing data generation expected to reinforce its advantages over competitors [4][5] - The Fc silent anti-TIGIT antibody, domvanilumab, is advancing towards its first Phase III study readout, expected in 2026 [14] - The PRISM-one trial of QEMLi, a small molecule CD73 inhibitor, is enrolling rapidly and is anticipated to be fully enrolled by the end of 2025 [16] Market Data and Key Metrics Changes - The addressable patient population for the IO naive setting is approximately 13,000 in the U.S. and 20,000 in other major markets, with a combined market opportunity estimated at $5 billion [30][31] - TKI-based regimens dominate the clear cell RCC market, holding approximately 65% share in the first line and 75% in the second line settings [31] Company Strategy and Development Direction - The company aims to develop casdadefan in TKI-free regimens, targeting earlier lines of RCC treatment to improve patient quality of life [11][12] - Collaborations with AstraZeneca are focused on combining casdadefan with their anti-PD-1/CTLA-4 bispecific antibody for first-line RCC, marking a strategic move towards TKI-free options [12][96] - The company is prioritizing late-stage programs while maintaining a sustainable pipeline with minimal investment in early-stage programs [43] Management's Comments on Operating Environment and Future Outlook - Management remains focused on execution amidst a tumultuous macro environment, ensuring resource deployment reflects ongoing assessments of priorities [4][5] - The company anticipates a steady flow of data for casdadefan over the next couple of years, reinforcing its competitive position [5][10] - Management expressed confidence in the ability to fund operations through pivotal readouts, with a strong balance sheet supporting ongoing development [34][36] Other Important Information - The company is exploring additional cohorts in the ARC20 study to evaluate casdadefan in various settings, including TKI-free regimens [13][19] - The competitive landscape for anti-TIGIT antibodies has shifted, with the company and AstraZeneca's candidates dominating the Phase III landscape [15] Q&A Session Summary Question: Can you elaborate on pipeline reprioritization and the adenosine inhibitor program? - Management confirmed that while there is a path forward for the adenosine modulator, current plans do not include moving forward with it at this time, focusing instead on late-stage programs like casdadefan [39][41] Question: What should be expected in the ASCO presentation versus the abstract? - Management indicated that the ASCO presentation will feature more recent data, including safety and efficacy for a population of about 40 patients, with compelling results anticipated [44][46] Question: What is the plan for the Peak One study and its primary endpoint? - Management stated that it is too early to provide specific timelines for the Peak One study's PFS primary endpoint, but they expect rapid enrollment and are focused on collecting OS data as a key secondary endpoint [66][68] Question: Will the company consider commercialization partnerships post-Peak One? - Management expressed intent to commercialize casdadefan independently, with potential consideration for a partner in Europe, emphasizing confidence in their capabilities [108]

Core Insights - ORIC Pharmaceuticals announced focused registrational clinical development plans for its lead programs, ORIC-944 and ORIC-114, and extended its cash runway into 2027, indicating a strong operational outlook [1][4][11] - The company expects to report five data readouts across its clinical programs over the next 15 months, with the initiation of registrational trials for both programs anticipated in 2026 [1][2][6] Financial Highlights - As of March 31, 2025, ORIC reported cash and investments totaling approximately $224 million, which is expected to fund its operating plan into 2027 [1][11] - Research and development (R&D) expenses for Q1 2025 were $24.6 million, an increase from $22.0 million in Q1 2024, attributed to higher external expenses and personnel costs [11][15] - General and administrative (G&A) expenses rose to $8.1 million in Q1 2025 from $7.0 million in Q1 2024, primarily due to increased personnel costs [11][15] Clinical Development Updates - ORIC-944, an allosteric inhibitor of PRC2, is set to initiate its first Phase 3 trial in metastatic castration-resistant prostate cancer (mCRPC) in the first half of 2026 [2][6] - ORIC-114, an irreversible EGFR/HER2 inhibitor, is being evaluated in a clinical trial in combination with subcutaneous amivantamab for first-line treatment of non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations [1][6] Upcoming Milestones - The company anticipates several key milestones, including combination dose escalation data for ORIC-944 in 1H 2025 and updated combination dose optimization data in 4Q 2025/1Q 2026 [11] - For ORIC-114, data for first-line EGFR exon 20 and other mutations is expected in 2H 2025, with additional data anticipated in mid-2026 [11]