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]

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 only one FDA-approved therapy for first-line EGFR exon 20 mutations and none for EGFR PACC mutations, indicating a significant unmet need in the market [6] Core Findings from the Conference Call 1. **Clinical Data Presentation**: 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] 2. **CNS Activity**: ORIC-114 demonstrates profound CNS activity, which is critical due to the high prevalence of brain metastases in these populations [5][8] 3. **Safety Profile**: ORIC-114 has a favorable safety profile with a lack of significant off-target toxicities, such as cardiac, hepatic, and hematological issues commonly seen with competitor drugs [5][18] 4. **Preferred Dose**: The preferred dose for future development is 80 milligrams once daily, based on clinical trial data showing better safety and efficacy compared to the 120 milligram dose [5][42] 5. **Efficacy Results**: - In the second-line cohort, the best objective response rate (ORR) was 45% with a disease control rate of 100% [21] - In the first-line cohort, the best ORR was 67% with a disease control rate of 93% [26] - For patients with CNS disease, the intracranial ORR was 100% for those with measurable lesions [28] Additional Important Insights - **Enrollment Strategy**: ORIC Pharmaceuticals allowed enrollment of patients with active brain metastases from the beginning of the trial, which is a differentiating factor compared to competitors [16][59] - **Long-term Follow-up**: The next planned update for ORIC-114 is in mid-2026, ahead of potential phase 3 registrational trials [42] - **Regulatory Considerations**: The company is confident in the FDA's acceptance of the 80 mg dose based on the robust dataset generated [50] Conclusion - ORIC-114 is positioned as a potential best-in-class treatment for patients with EGFR mutations in NSCLC, with strong clinical data supporting its efficacy and safety profile, particularly in patients with CNS involvement [39][42]

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]

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]

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]

Core Insights - ORIC Pharmaceuticals announced two late-breaking oral presentations at the ESMO Asia Congress 2025, focusing on enozertinib (ORIC-114) data from a Phase 1b trial targeting therapeutic resistance in NSCLC [1][2][3] Presentation Details - The mini-oral presentation will cover data on previously treated patients with EGFR atypical mutant NSCLC, scheduled for December 5, 2025, at 11:38 a.m. SGT [2] - The proffered paper oral presentation will focus on previously treated and treatment-naïve patients with EGFR exon 20 mutant NSCLC, scheduled for December 6, 2025, at 10:02 a.m. SGT [3] Company Overview - ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to overcoming resistance in cancer, with a focus on developing enozertinib (ORIC-114) and ORIC-944 for various cancers [5]

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]

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]

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 dropping 4.5% to close at $10.65. The company has seen a 16% decline in stock price over the past month [5][8]

Core Insights - ORIC Pharmaceuticals announced a poster presentation at the ESMO Asia Congress 2025, focusing on data from a Phase 1b trial of enozertinib (ORIC-114) for patients with HER2 exon 20 mutant NSCLC [1][2] Presentation Details - The poster presentation is titled "Enozertinib (ORIC-114), a Highly Selective, Brain Penetrant EGFR and HER2 Inhibitor, in Patients with HER2 Exon 20 Mutant NSCLC: Randomized Dose Optimization" [2] - Presentation number is 981P, scheduled for December 5, 2025, from 5:15 to 6:15 p.m. SGT [2] Conference Call and Webcast - ORIC will host a conference call and webcast on December 6, 2025, at 8:00 p.m. ET, allowing for live Q&A participation [3] - A live webcast and audio archive will be available on ORIC's investor website for 90 days following the presentation [3] Company Overview - ORIC Pharmaceuticals is a clinical stage biopharmaceutical company focused on overcoming resistance in cancer [4] - Key product candidates include ORIC-944 for prostate cancer and enozertinib (ORIC-114) targeting various mutations across multiple cancers [4]