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ORIC Pharmaceuticals, Inc. (ORIC) Discusses Enozertinib Phase Ib Results and Differentiation in EGFR-Mutated Non-Small Cell Lung Cancer Transcript
Seeking Alpha· 2025-12-07 06:38
Core Insights - ORIC Pharmaceuticals provided an update on the Enozertinib program during a conference call, focusing on data from an ongoing Phase Ib study in non-small cell lung cancer patients [2] Group 1: Company Updates - The conference call was led by Dominic Piscitelli, Chief Financial Officer, who welcomed participants and highlighted the recent press releases regarding updated data from the Enozertinib study [2] - The press release containing the updated data is available on the investor page of ORIC Pharmaceuticals' website [2] Group 2: Future Outlook - The company indicated that forward-looking statements would be made during the call, based on current expectations and projections about future events [3] - There is a disclaimer regarding the potential differences between actual results and those indicated by forward-looking statements, with a reference to risk factors in recent SEC filings [3]
Germanium Mining Corp. Enhances Visibility of Germanium Project Portfolio Through Awareness Initiatives
Thenewswire· 2025-12-07 06:25
VANCOUVER, BRITISH COLUMBIA, DECEMBER 6th, 2025 – GERMANIUM MINING CORP.(“GERMANIUM MINING”, “GMC”, OR THE “COMPANY”) (CSE: GMC; OTCQB: EMSKF; FSE: 1I30) is pleased to announce that the Company has entered into agreements with several specialized firms to support its awareness and PR initiatives. These engagements are intended to enhance visibility of both the strengthening global Germanium market and the Company’s 100% interest in the Lac du Km 35 Germanium Property in Quebec, Canada, as well as its portfo ...
Oric Pharmaceuticals (NasdaqGS:ORIC) Update / Briefing Transcript
2025-12-07 02:00
Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company**: ORIC Pharmaceuticals (NasdaqGS:ORIC) - **Focus**: Development of ORIC-114 for non-small cell lung cancer (NSCLC) patients with EGFR mutations Key Industry Insights - **Target Population**: Patients with EGFR exon 20 and EGFR PACC mutations, which occur annually in approximately 9,000 patients in the U.S. alone [6] - **Market Opportunity**: There is currently one FDA-approved therapy for first-line EGFR exon 20 and none for EGFR PACC mutation, indicating a significant unmet need in these populations [6] Core Findings from ORIC-114 Program Update - **Clinical Data**: ORIC-114 has shown highly competitive response rates in both pre-treated and front-line settings for EGFR exon 20 and EGFR PACC mutations [42] - **CNS Activity**: ORIC-114 demonstrates profound CNS activity, critical due to the high prevalence of brain metastases in these populations [5][42] - **Safety Profile**: The drug has a lack of significant off-target toxicities, such as cardiac, hepatic, and hematological liabilities, which are common with competitor inhibitors [5][42] Clinical Trial Highlights - **Phase 1b Study**: Conducted at 39 major academic centers across 10 countries, enrolling over 300 patients [16] - **Preferred Dose**: 80 mg once daily has been selected as the preferred dose for future development based on safety and efficacy observations [5][42] - **Efficacy Results**: - **Second-line Cohort**: 45% confirmed objective response rate (ORR) at 80 mg, with a 100% disease control rate [21] - **First-line Cohort**: 67% ORR with a 93% disease control rate, demonstrating strong efficacy even in patients with brain metastases [26] - **CNS-specific Responses**: 100% intracranial ORR in patients with measurable CNS disease [28] Important Considerations - **Patient Enrollment**: Unlike competitors, ORIC allowed enrollment of patients with active brain metastases from the beginning of the trial, reflecting confidence in ORIC-114's CNS penetrance [59] - **Regulatory Insights**: The FDA prefers to see CNS activity demonstrated in patients with active and measurable brain metastases, which ORIC-114 has achieved [62] - **Future Development**: Plans to continue enrollment and long-term follow-up in frontline populations, with the next update expected in mid-2026 ahead of potential phase 3 trials [42] Conclusion - ORIC-114 is positioned as a potential best-in-class treatment for patients with EGFR-mutated NSCLC, with strong clinical data supporting its efficacy and safety profile, particularly in addressing CNS metastases [42][57]
Oric Pharmaceuticals (NasdaqGS:ORIC) Update / Briefing Transcript
2025-12-07 02:00
Oric Pharmaceuticals (NasdaqGS:ORIC) Update / Briefing December 06, 2025 08:00 PM ET Speaker2Good day, and thank you for standing by. Welcome to the ORIC ORIC-114 Program Update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising that your hand has been raised. To withdraw ...
ORIC® Pharmaceuticals Presents Potential Best-in-Class Profile for Enozertinib with Robust Systemic and CNS Activity in 1L and 2L NSCLC Patients with EGFR Exon 20 Mutations at the ESMO Asia Congress 2025
Globenewswire· 2025-12-06 01:00
Core Insights - ORIC Pharmaceuticals announced promising data from a Phase 1b trial of enozertinib (ORIC-114) for treating NSCLC patients with EGFR exon 20 mutations, showing a 67% overall response rate (ORR) and 100% intracranial ORR in treatment-naïve patients with active brain metastases [1][2][16] - The drug demonstrated a 45% ORR in previously treated (2L) patients, surpassing competitor benchmarks, and exhibited a competitive safety profile with manageable on-target toxicity [1][4][5] - The company plans to continue enrollment and follow-up in 1L patients at a selected dose of 80 mg once daily, with the next update expected in mid-2026 ahead of a potential Phase 3 trial [1][12] Trial Design and Patient Demographics - The Phase 1b trial is evaluating enozertinib in patients with locally advanced or metastatic NSCLC with EGFR exon 20 mutations, allowing enrollment of patients with active untreated brain metastases [3] - As of August 29, 2025, 45 2L patients were dosed, with 38% having brain metastases at baseline [4] - In the 1L cohort, 33 patients were dosed, with 39% presenting with brain metastases [7] Safety and Efficacy Analysis - Preliminary safety analysis indicated that enozertinib was well tolerated, with most treatment-related adverse events (TRAEs) being Grade 1 or 2, and only a small number of patients discontinuing treatment due to TRAEs [5][9] - In the 80 mg cohort, 67% of responders remained on treatment at a median follow-up of over 30 weeks, while in the 120 mg cohort, 80% of patients underwent early dose reductions due to TRAEs [8][10][16] - The drug showed strong systemic and CNS antitumor activity, with 100% disease control rate (DCR) in patients with brain metastases [8][16] Next Steps and Future Plans - The company has selected 80 mg QD oral enozertinib as the dose for potential Phase 3 development, with ongoing enrollment and follow-up in 1L EGFR exon 20 patients [12] - A conference call and webcast is scheduled for December 6, 2025, to discuss the trial results and future plans [13]
ORIC® Pharmaceuticals Presents Enozertinib Data in NSCLC Patients with HER2 Exon 20 Mutations at the ESMO Asia Congress 2025
Globenewswire· 2025-12-05 06:00
Core Insights - ORIC Pharmaceuticals announced data from a Phase 1b trial of enozertinib (ORIC-114) for treating NSCLC patients with HER2 exon 20 mutations, showing a 35% overall response rate (ORR) and 100% disease control rate (DCR) in the 80 mg cohort [1][8] - The trial included patients with active brain metastases, and the safety profile was manageable with a low discontinuation rate due to treatment-related adverse events (TRAEs) [1][4] - Enrollment for the HER2 exon 20 patient population has been completed, with no further development planned, while the 80 mg dose has been selected for potential Phase 3 development based on preliminary data [6][8] Trial Design and Patient Demographics - The Phase 1b trial evaluated enozertinib in patients with locally advanced or metastatic NSCLC with HER2 exon 20 mutations, allowing for patients with untreated brain metastases [2] - As of the cutoff date, 49 patients were dosed, with 80% having received prior chemotherapy and 35% having undergone HER2 targeted therapy [3] Safety and Efficacy Analysis - Enozertinib was well tolerated, with most TRAEs being Grade 1 or 2, and only 2 patients discontinued treatment due to TRAEs [4] - Tumor responses were noted in both dosing cohorts, with deeper regressions observed in the 80 mg cohort, potentially due to fewer dose reductions [5] Next Steps and Future Development - The company plans to continue enrollment and follow-up in 1L NSCLC patients with EGFR exon 20 and other mutations, with updates expected in mid-2026 [6] - The 80 mg QD oral enozertinib has been selected for potential Phase 3 development based on the trial results [6] Conference Call and Webcast - ORIC will host a conference call and webcast on December 6, 2025, to discuss the trial results and future plans [7]
ORIC® Pharmaceuticals Presents Potential Best-in-Class Profile for Enozertinib with Robust Systemic and CNS Activity in 1L and Previously Treated NSCLC Patients with EGFR Atypical Mutations at the ESMO Asia Congress 2025
Globenewswire· 2025-12-05 02:45
Core Insights - Enozertinib (ORIC-114) shows promising preliminary systemic activity with an 80% overall response rate (ORR) and a 100% intracranial ORR in first-line (1L) NSCLC patients with EGFR P-loop and alpha C-helix compressing (PACC) mutations [1][8] - The drug demonstrates a competitive safety profile with manageable on-target toxicity and no significant off-target toxicity, leading to a low discontinuation rate [1][5] - The company plans to continue enrollment and follow-up in 1L EGFR PACC patients, with the next update expected in mid-2026 ahead of a potential Phase 3 trial [1][9] Efficacy and Safety Data - In a Phase 1b trial, enozertinib was evaluated in patients with locally advanced or metastatic NSCLC with EGFR atypical mutations, allowing for patients with active untreated brain metastases [3] - As of the August 29, 2025 cutoff, 47 patients were dosed, with 36% confirmed ORR and 91% disease control rate (DCR) in previously treated patients with EGFR atypical mutations [4][7] - The most common treatment-related adverse events (TRAEs) were Grade 1 or 2, including diarrhea, paronychia, and stomatitis, with no treatment discontinuations due to TRAEs [5] Future Development Plans - The 80 mg once daily dose of enozertinib has been selected for potential Phase 3 development based on preliminary data [9] - The company will host a conference call and webcast on December 6, 2025, to discuss the findings and future plans [10] Company Overview - ORIC Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing treatments that address mechanisms of therapeutic resistance in cancer [11] - The company is also developing ORIC-944, an allosteric inhibitor for prostate cancer, alongside enozertinib for multiple genetically defined cancers [11]
ORIC® Pharmaceuticals Announces Enozertinib (ORIC-114) Late-Breaking Oral Presentations in EGFR Atypical and EGFR exon 20 NSCLC at the ESMO Asia Congress 2025
Globenewswire· 2025-12-03 21:01
SOUTH SAN FRANCISCO and SAN DIEGO, Dec. 03, 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 two late-breaking oral presentations highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025 taking place December 5-7, 2025 in Singapore. The mini-oral presentation will focus on data in previously treated patients with EGFR ...
Oric Pharmaceuticals (NasdaqGS:ORIC) FY Conference Transcript
2025-12-03 17:17
Summary of Oric Pharmaceuticals FY Conference Call (December 03, 2025) Company Overview - Oric Pharmaceuticals is a clinical stage oncology company focused on overcoming resistance in cancer, specifically targeting prostate cancer, lung cancer, and breast cancer [2][3] Key Accomplishments in 2025 - Two data updates on ORIC-944, an allosteric PRC2 inhibitor for prostate cancer - Upcoming significant update on ORIC-114 at ESMO Asia - Successfully raised capital, providing a cash runway into the second half of 2028 [3] ORIC-944 Developments - ORIC-944 is being studied in combination with apalutamide and daralutamide for prostate cancer - Recent data showed PSA 50 response rate of 40% and PSA 90 response rate of 20%, slightly outperforming Pfizer's data [5][8] - Safety profile of ORIC-944 is favorable, with significantly lower rates of on-target toxicity compared to Pfizer's agent [5][9] Market Context and Competition - The prostate cancer market is substantial, with multiple AR inhibitors (enzalutamide, apalutamide, daralutamide) generating significant revenues [7][21] - Even if ORIC-944 enters the market later, there is ample opportunity due to the large patient population [22] Future Plans for ORIC-944 - Phase 3 study planned for the first half of 2026, focusing on post-ABI and post-ARPI patient populations [17][18] - The company aims to retain operational control while considering potential partnerships in the future [23] ORIC-114 Developments - ORIC-114 targets EGFR exon 20 mutations in lung cancer, with a focus on CNS activity, which is a key differentiator [26] - Upcoming data presentations at ESMO Asia will include results from various patient populations, with benchmarks set for response rates [30][31] Market Opportunity for ORIC-114 - The lung cancer market for targeted therapies remains significant, with unmet needs in specific mutation subsets [33] - The potential patient population for ORIC-114 is estimated at 10-12,000 annually in the U.S., indicating a multi-billion dollar market opportunity [34] Conclusion - Oric Pharmaceuticals is well-positioned with promising data for both ORIC-944 and ORIC-114, targeting large and unmet needs in oncology - The company is strategically planning its next steps while maintaining a focus on safety and efficacy to differentiate its products in competitive markets [22][34]
Top 3 Health Care Stocks That May Rocket Higher In December - Larimar Therapeutics (NASDAQ:LRMR), ORIC Pharmaceuticals (NASDAQ:ORIC)
Benzinga· 2025-12-03 11:45
Core Insights - The health care sector is experiencing a trend of oversold stocks, presenting potential buying opportunities for undervalued companies [1][2] Group 1: Oversold Stocks - Larimar Therapeutics Inc (NASDAQ:LRMR) has an RSI of 29.9, with shares falling 12.1% to close at $3.12. The company reported a wider-than-expected quarterly loss but highlighted positive long-term data from a clinical study [3][8] - Perrigo Company PLC (NYSE:PRGO) also has an RSI of 29.9, with shares declining 1.7% to close at $13.61. The company reported mixed third-quarter results and lowered its FY25 adjusted EPS guidance, despite gaining market share in several categories [4][8] - ORIC Pharmaceuticals Inc (NASDAQ:ORIC) has an RSI of 29.6, with shares falling 4.5% to close at $10.65. The company has seen a 16% decline in stock price over the past month [5][8]