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ORIC Stock Surges on Upbeat Initial Data From Prostate Cancer Study
ZACKS· 2025-05-29 16:55
Core Viewpoint - ORIC Pharmaceuticals' shares increased over 20% in pre-market trading following the announcement of promising preliminary efficacy and safety data for its prostate cancer treatment candidate, ORIC-944 [1] Group 1: Study Results - ORIC-944 is being evaluated in a phase Ib study in combination with J&J's Erleada and Bayer's Nubeqa for treating metastatic castration-resistant prostate cancer (mCRPC) [2] - The study reported that 59% of the 17 previously-treated mCRPC patients showed a 50% drop in PSA levels (PSA50 response), with a confirmed PSA50 rate of 47% [4] - Additionally, 24% of patients demonstrated a 90% drop in PSA levels (PSA90 response), all of which were confirmed [4] - PSA responses were consistent across all dosage levels and combinations with either Erleada or Nubeqa, indicating a well-tolerated safety profile with mild to moderate adverse events [6] Group 2: Future Plans - ORIC Pharmaceuticals aims to complete the phase Ib dose exploration by mid-2025 and plans to test two potential recommended phase II doses in the second half of 2025 [7] - The results from the dose optimization phase will inform the best ORIC-944 dose for the first global phase III study, expected to start in the first half of 2026 [8] Group 3: Financial Aspects - ORIC Pharmaceuticals announced a $125 million private placement to fund operations through the second half of 2027, covering expenses until the primary endpoint data readout from the phase III mCRPC study [9]
ORIC Pharmaceuticals Touts Positive Efficacy, Safety Data From Early-Stage Prostate Cancer Candidate, Raises Capital
Benzinga· 2025-05-29 15:15
Core Insights - ORIC Pharmaceuticals Inc. released preliminary efficacy and safety data from its ongoing Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors for metastatic castration-resistant prostate cancer (mCRPC) [1][2] - The company announced a $125 million private placement financing to extend its cash runway into the second half of 2027 [3] Preliminary Activity Analysis - 59% of patients (10 out of 17) achieved a PSA50 response, with a confirmed PSA50 response rate of 47% (8 out of 17) [4] - 24% of patients (4 out of 17) achieved a PSA90 response, all of which were confirmed [4] - PSA responses were consistent across all ORIC-944 dose levels and in combination with both apalutamide and darolutamide [4] Preliminary Safety Analysis - ORIC-944 combined with apalutamide or darolutamide has been generally well tolerated, with most adverse events being Grade 1 or 2 [1] - Adverse events are consistent with PRC2 and AR inhibition [1] Future Plans - The company plans to evaluate two candidate RP2Ds for each combination in the dose optimization portion of the trial in the second half of 2025 [1] - Data from the dose optimization will inform the choice of ORIC-944 dose for the first global Phase 3 registrational trial in mCRPC, expected to start in the first half of 2026 [2] Financial Update - The company will sell approximately 19.2 million shares in a private placement at $6.50 per share [3] - ORIC stock was up 24.7% at $7.44 during the premarket session following the announcement [3]
Oric Pharmaceuticals (ORIC) Update / Briefing Transcript
2025-05-28 21:30
Summary of Oric Pharmaceuticals (ORIC) Update / Briefing May 28, 2025 Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Focus**: Development of ORIC-944, a potential best-in-class PRC2 inhibitor for metastatic castration-resistant prostate cancer (mCRPC) in combination with androgen receptor inhibitors (ARIs) like apalutamide and darolutamide [3][6][10] Key Points and Arguments Clinical Pipeline and Study Updates - ORIC is advancing two key programs with multiple data readouts expected in 2025 and early 2026, aiming for Phase 3 trials initiation in 2026 [6][10] - The ongoing Phase 1b study of ORIC-944 is focused on its combination with epalutamide and darolutamide in mCRPC patients [3][6] - Initial data indicates a favorable safety and activity profile for ORIC-944, with a focus on overcoming resistance in prostate cancer [8][10] Mechanism and Rationale - ORIC-944 is designed to address limitations of first-generation PRC2 inhibitors, showing improved potency and tolerability [7][13] - The combination of PRC2 inhibitors with ARIs is supported by biological rationale to delay or overcome resistance in prostate cancer [7][15] - Preclinical data shows ORIC-944 enhances AR signaling and luminal cell state markers, increasing sensitivity to AR inhibition [15][19] Efficacy and Safety Data - In the study, 17 patients with mCRPC showed a 59% PSA50 response rate and a 24% PSA90 response rate, with responses confirmed one month later [29][30] - The safety profile of ORIC-944 was generally well tolerated, with most adverse events being grade one or two, primarily mild gastrointestinal issues [31][32] - The combination therapy demonstrated a wide therapeutic window, with doses as low as 400 mg showing efficacy [30][31] Market Opportunity - The global market for AR inhibitors reached approximately $11 billion, with significant potential for PRC2 inhibitors to enhance treatment durability and outcomes [38][42] - ORIC-944 targets an addressable market opportunity of over $7 billion annually in the U.S. for mCRPC patients treated with AR inhibitors [42] Expansion Opportunities - ORIC-944 may have potential applications in other cancers, including breast and colorectal cancers, due to shared reliance on PRC2 mechanisms [44][48] - Future studies will explore ORIC-944 in earlier stages of prostate cancer and in combination with other therapies [48] Additional Important Content - The company completed a $125 million PIPE financing, extending its cash runway into the second half of 2027 [50] - The competitive landscape includes comparisons with Pfizer's mebrametostat, with ORIC-944 showing promising early efficacy and safety data [85][88] - The decision on which AR inhibitor to combine with for Phase 3 trials will be based on overall data and strategic considerations [79][80] This summary encapsulates the critical insights from the conference call, highlighting the company's strategic direction, clinical advancements, and market potential for ORIC-944 in prostate cancer treatment.
ORIC® Pharmaceuticals Announces $125 Million Private Placement Financing
Globenewswire· 2025-05-28 20:05
Core Points - ORIC Pharmaceuticals, Inc. has announced a private placement of approximately 19.2 million shares at a price of $6.50 per share, representing an 18% premium to its 10-day trailing volume-weighted average price as of May 23, 2025 [1][2] - The financing is expected to generate gross proceeds of approximately $125 million, which will fund the company's operating plan into the second half of 2027 and support the primary endpoint readout from the first ORIC-944 Phase 3 trial in prostate cancer [1][3] Financing Details - The financing is led by SR One and includes participation from various institutional investors such as Point72, Viking Global Investors, Venrock Healthcare Capital Partners, New Enterprise Associates (NEA), Nextech, Vivo Capital, and NEXTBio Capital [1][2] - The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable [1] Use of Proceeds - ORIC intends to utilize the net proceeds from the financing for research and development of its clinical-stage product candidates, working capital, and general corporate purposes [3] - The combined proceeds from this financing and existing cash, cash equivalents, and marketable securities are expected to be sufficient to fund the current operating plan through the anticipated primary endpoint readout from the ORIC-944 Phase 3 trial [3] Company Overview - ORIC Pharmaceuticals is focused on developing treatments that address mechanisms of therapeutic resistance in cancer, with key product candidates including ORIC-944 for prostate cancer and ORIC-114 for multiple genetically defined cancers [6] - The company operates from offices in South San Francisco and San Diego, California [6]
ORIC® Pharmaceuticals Announces Potentially Best-In-Class Preliminary Efficacy and Safety Data from Ongoing Phase 1b Trial of ORIC-944 in Combination with AR Inhibitors for the Treatment of Patients with mCRPC
GlobeNewswire· 2025-05-28 20:05
Core Insights - ORIC Pharmaceuticals announced promising preliminary efficacy and safety data for ORIC-944 in combination with androgen receptor inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC) [1][3] - The company reported a 59% PSA50 response rate and a 24% PSA90 response rate in the ongoing Phase 1b trial, indicating substantial clinical activity [1][6] - A concurrent financing of $125 million is expected to extend the company's cash runway into the second half of 2027, supporting further development of ORIC-944 [10] Efficacy Data - The Phase 1b trial showed a confirmed PSA50 response rate of 47% and a PSA90 response rate of 24%, with responses observed across all dose levels of ORIC-944 [1][6][7] - The majority of patients are still ongoing with treatment, with several approaching one year or more on therapy [1][7] Safety Profile - ORIC-944 demonstrated a favorable safety profile, with most adverse events classified as Grade 1 or 2, primarily mild to moderate gastrointestinal issues [2][8] - Diarrhea was the most common treatment-related adverse event, occurring in 53% of patients, with only one Grade 3 event reported [8] Trial Design and Next Steps - The ongoing Phase 1b trial is designed to explore different doses of ORIC-944 in combination with apalutamide and darolutamide, with the primary objective of determining the recommended Phase 2 dose [4][9] - Following the completion of the dose exploration phase, the company plans to evaluate candidate doses for optimization in the second half of 2025, leading to a global Phase 3 trial expected to start in the first half of 2026 [9] Corporate Update - The $125 million financing is anticipated to close on May 29, 2025, and will support the company's operations through the primary endpoint readout of the first Phase 3 trial [10]
ORIC® Pharmaceuticals to Present Initial Data from Phase 1b Trial of ORIC-944 in Combination with Androgen Receptor Inhibitors in Patients with mCRPC
Globenewswire· 2025-05-27 12:00
Core Insights - ORIC Pharmaceuticals, Inc. is set to present initial data from the Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors for metastatic castration resistant prostate cancer on May 28, 2025 [1] Company Overview - ORIC Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing treatments that address mechanisms of therapeutic resistance in cancer [4] - The company's product candidates include ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) for prostate cancer, and ORIC-114, which targets specific mutations in various cancers [4] Product Details - ORIC-944 has shown potential best-in-class drug properties, including a clinical half-life of approximately 20 hours and a favorable safety profile [3] - The ongoing Phase 1b trial is evaluating ORIC-944 in combination with ERLEADA (apalutamide) and NUBEQA (darolutamide) for metastatic castration resistant prostate cancer [3]
Oric(ORIC) - 2025 Q1 - Quarterly Report
2025-05-05 20:20
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 March 31, 2025 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) Delaware 47-1787157 ( ...
Oric(ORIC) - 2025 Q1 - Quarterly Results
2025-05-05 20:10
Presented preclinical data supporting potential best-in-class profile of ORIC-944 in combination with AR inhibitors to treat prostate cancer at the 2025 AACR Annual Meeting Announced clinical trial collaboration and supply agreement with Johnson & Johnson to evaluate ORIC-114 in combination with subcutaneous amivantamab for the first-line treatment of NSCLC patients with EGFR exon 20 insertion mutations Exhibit 99.1 ORIC® Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates A ...
ORIC® Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Updates
Globenewswire· 2025-05-05 20:05
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]
ORIC® Pharmaceuticals Presents Preclinical Data to Support the Potential of ORIC-944 as a Best-in-Class PRC2 Inhibitor for the Treatment of Prostate Cancer at the 2025 American Association for Cancer Research (AACR) Annual Meeting
Globenewswire· 2025-04-28 20:30
Core Insights - ORIC Pharmaceuticals, Inc. presented preclinical data on ORIC-944, a selective allosteric inhibitor of PRC2, at the 2025 AACR Annual Meeting, showing improved progression-free survival (PFS) when combined with androgen receptor pathway inhibitors (ARPIs) in prostate cancer models [1][2][6] Group 1: ORIC-944 Overview - ORIC-944 is characterized as a potent and selective allosteric inhibitor of PRC2, demonstrating best-in-class properties in preclinical studies, including favorable pharmacokinetics and a clinical half-life of approximately 20 hours [3][6] - The drug is currently being evaluated in a Phase 1b trial in combination with ERLEADA (apalutamide) and NUBEQA (darolutamide) for prostate cancer [3][6] Group 2: Clinical Implications - The data presented indicate that ORIC-944 enhances PFS in both castration-sensitive and castration-resistant prostate cancer models, suggesting its potential to reverse the evolution of prostate cancer [2][6] - ORIC-944 demonstrated transcriptional and antitumor synergy with ARPIs, reinforcing its role in blocking prostate tumor adaptation and restoring luminal features [6] Group 3: Company Background - ORIC Pharmaceuticals is focused on developing treatments that address mechanisms of therapeutic resistance in cancer, with ORIC-944 and ORIC-114 as key product candidates [4]