LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announced that it has been selected as a winner of the 2025 Clinical Trials Arena Excellence Awards, receiving the Research and Development Award for Advanced Prostate Cancer. Kairos earned this recognition for its work advancing ENV105 (carotuximab), a firstinclass CD105targeting monoclonal antibody designed to modulate resistance pathways in me ...

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]

Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company Name**: ORIC Pharmaceuticals - **Ticker**: NasdaqGS:ORIC - **Focus**: Development of small molecule drugs in oncology, specifically targeting solid tumors like prostate cancer and lung cancer [2][3] Key Points and Arguments Lead Programs - ORIC is currently focused on two lead programs in prostate cancer and lung cancer, both in dose optimization and expected to start pivotal phase three studies in 2026 [2][3] ORIC-944 Program - Recent data showed encouraging results for the ORIC-944 program, particularly in combination with apalutamide and daralutamide, with impressive PSA response rates [3][4] - ORIC-944 has a 20-hour half-life compared to Pfizer's memoremedistat, which has a five-hour half-life, suggesting a potential safety advantage [3][19] - The ability to clear ctDNA was observed in 59% of patients, which correlates strongly with long-term outcomes like PFS and OS [5][9] Safety Profile - The safety profile of ORIC-944 appears favorable, with only one grade 3 adverse event reported in 20 patients, compared to multiple grade 3 events in Pfizer's studies [13][15] - A clean safety profile is crucial for future development, especially in earlier lines of treatment for prostate cancer [14][15] Market Opportunity - The metastatic CRPC market is estimated at approximately 50,000 patients, with a total addressable market (TAM) of about $3.5 billion in the US for each of the post-AR inhibitors and post-abiraterone populations [29][30] - Historical data suggests that even with an undifferentiated profile, a second-to-market drug can capture about 35% of the market [30] Future Development Plans - ORIC plans to submit dose optimization data to regulators in early 2026 to align on pivotal study design [25][26] - The first phase three study is expected to start in the first half of 2026, with primary readout anticipated in the second half of 2027 [27][28] Pipeline Asset ORIC-114 - ORIC-114 is focused on non-small cell lung cancer, with updates expected at ESMO Asia in December, including data from multiple cohorts [35] - The drug is designed to be CNS-penetrant, which may lead to longer PFS outcomes for patients with brain metastases [36][37] Financial Position - As of the third quarter, ORIC had $413 million in cash and investments, providing a runway into the second half of 2028, covering pivotal studies for both ORIC-944 and ORIC-114 [42] Additional Important Information - ORIC maintains strong relationships with Bayer and Johnson & Johnson, which are crucial for future collaborations [31][32] - The company is exploring the potential of PRC2 inhibitors in other oncology indications beyond prostate cancer, including breast cancer and lung cancer [33][34]

Core Insights - ORIC Pharmaceuticals announced additional efficacy and safety data from the Phase 1b trial of ORIC-944 in combination with androgen receptor inhibitors for metastatic castration-resistant prostate cancer (mCRPC) [1][2] Efficacy Data - The trial demonstrated a 55% PSA50 response rate and a 20% PSA90 response rate among patients [6] - Rapid and deep circulating tumor DNA (ctDNA) reductions were observed in 76% of patients, with 59% achieving ctDNA clearance, indicating potential long-term treatment benefits [1][7] - PSA responses and ctDNA reductions were consistent across all ORIC-944 dose levels and in combination with both apalutamide and darolutamide [4][5] Safety Profile - The combination of ORIC-944 with apalutamide or darolutamide showed a safety profile compatible with long-term dosing, with most adverse events being Grade 1 or 2 [8] - As of the cutoff date, only one patient experienced a Grade 3 treatment-related adverse event, with no Grade 4 or 5 adverse events reported [8] Next Steps - ORIC has selected provisional recommended Phase 2 doses for ORIC-944 to be tested in combination with darolutamide and apalutamide, with ongoing enrollment in the dose optimization portion of the trial [9] - Preliminary dose optimization data is expected to be announced in Q1 2026, ahead of initiating the first global Phase 3 registrational trial in mCRPC in the first half of 2026 [2][9] Company Overview - ORIC Pharmaceuticals is focused on developing treatments that address mechanisms of therapeutic resistance in cancer, with ORIC-944 being an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) [11]

Summary of Oric Pharmaceuticals FY Conference Call Company Overview - **Company**: Oric Pharmaceuticals (NasdaqGS:ORIC) - **Industry**: Clinical stage oncology - **Mission**: Overcoming Resistance in Cancer - **Focus Areas**: Prostate cancer, lung cancer, and breast cancer - **Clinical Programs**: - **ORIC-944**: Allosteric PRC2 inhibitor for prostate cancer in combination with apalutamide and daralutamide - **ORIC-114**: Selective brain penetrant EGFR HER2 exon 20 program for non-small cell lung cancer [2][3] Financial Position - **Cash and Investments**: $436 million as of Q2, providing a runway into the second half of 2028, assuming success in clinical programs [3] Clinical Development Insights - **ORIC-944**: - Targets AR-dependent tumors transitioning to AR-independent states, aiming to resensitize them to AR inhibitors [4] - Clinical data from competitors (e.g., Pfizer) shows significant improvements in progression-free survival (PFS) with PRC2 inhibitors [6][7] - Pfizer's data indicated a tripling of PFS benefit in certain patient populations, validating the mechanism [7][8] - **Physician Feedback**: - Positive feedback on the randomized control study by Pfizer, indicating a promising profile for new agents in prostate cancer [10][11] - **Comparative Data**: - ORIC-944 shows higher PSA response rates and better safety profiles compared to Pfizer's mevrometostat [13][14] - ORIC-944 designed specifically for prostate cancer with optimized drug properties [14][15] Market Opportunity - **Prostate Cancer Market**: - Significant unmet need with a large patient population; existing AR inhibitors generated $11 billion in sales last year [16][17] - Even with a similar profile to competitors, the market opportunity remains substantial due to the high number of patients [17][18] Phase III Trials - **Timeline**: Planning to start the first phase III study in the first half of next year, approximately 18 months behind Pfizer [18][32] - **Patient Population**: Focus on post-abiraterone patients, with expectations for FDA labeling to reflect this [33][34] EGFR Program (ORIC-114) - **Upcoming Updates**: Data expected at ESMO Asia, focusing on three patient populations: EGFR exon 20, HER2 exon 20, and EGFR atypical [38] - **Benchmarks**: Expected response rates of 35% for EGFR exon 20 and atypicals, and 50% for HER2 exon 20 in second-line settings [39] Combination Therapy - **Amivantamab Collaboration**: Exploring combination therapy with Amivantamab, leveraging its success in classical EGFR settings [42][43] - **Rationale**: Aiming for dual inhibition of EGFR to manage safety and potentially extend PFS and overall survival [43] Conclusion - Oric Pharmaceuticals is positioned to capitalize on significant market opportunities in oncology, particularly in prostate cancer and lung cancer, with promising clinical data and a strong financial position to support ongoing and future trials. The company is focused on differentiating its therapies through optimized drug properties and strategic collaborations.

Summary of Kairos Pharma Conference Call Company and Industry - **Company**: Kairos Pharma (NYSEAM: KAPA) - **Industry**: Oncology, specifically focusing on prostate cancer treatment Key Points and Arguments 1. **Phase II Trial Update**: The conference call discussed the interim efficacy analysis for the Phase II trial of ENV-105 (Carotuximab) in combination with apalutamide for advanced prostate cancer treatment [2][5][7] 2. **Unmet Need**: There are approximately 1,000,000 new prostate cancer diagnoses annually in the U.S., with a significant unmet need for effective treatments as resistance to current hormone therapies develops [5][6] 3. **Safety and Efficacy**: The interim safety analysis indicated that ENV-105 was well tolerated with no dose-limiting toxicities or unexpected adverse events reported among the first 10 patients [6][7] 4. **Efficacy Results**: The interim efficacy analysis showed a median progression-free survival (PFS) of 13.7 months for the combination therapy, which is significantly higher than previous benchmarks [22][24][70] 5. **Comparison with Other Treatments**: The PFS of 13.7 months compares favorably to other treatments, such as cabazitaxel (8 months) and lutetium (11.6 months) [22][41][70] 6. **Mechanism of Action**: ENV-105 is a neutralizing antibody that blocks CD105, which is elevated in cancer cells and associated fibroblasts, potentially resensitizing patients to hormone therapies [17][18] 7. **Clinical Implications**: The data suggests that ENV-105 may provide a new treatment option for patients who have previously failed hormone therapies, with manageable side effects [39][42] 8. **Expert Panel Insights**: Key opinion leaders discussed the potential of ENV-105 to resensitize patients to androgen receptor pathway inhibitors, which is a significant advancement in prostate cancer treatment [44][46][60] Other Important but Possibly Overlooked Content 1. **Patient Selection**: The trial specifically excluded patients who had received more than two different AR pathway inhibitors or previous chemotherapy to ensure a more homogeneous patient population [58][60] 2. **Toxicity Management**: The side effects observed, such as nosebleeds and hypertension, were manageable and comparable to other treatments in the field [30][39] 3. **Future Research Directions**: The company is collecting biospecimens to further investigate biomarkers that may predict treatment efficacy, which could enhance patient selection and treatment outcomes in future studies [92][94] 4. **Regulatory Considerations**: The discussion highlighted the lack of a standardized treatment protocol for prostate cancer, emphasizing the need for individualized treatment plans based on patient-specific factors [53][60] This summary encapsulates the critical insights from the conference call, focusing on the advancements in prostate cancer treatment through Kairos Pharma's ENV-105 and its implications for future therapies.

Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company Name**: ORIC Pharmaceuticals - **Ticker**: NasdaqGS:ORIC - **Focus**: Oncology, specifically small molecule drug development for solid tumors, with a focus on lung cancer and prostate cancer [3][4] Key Programs ORIC-944 (Prostate Cancer) - **Mechanism**: Small molecule inhibitor of PRC2, targeting the EED subunit, in combination with androgen receptor (AR) inhibitors [4][8] - **Current Status**: In dose optimization, aiming to start Phase 3 studies next year [4][26] - **Efficacy**: Early data shows a confirmed PSA 50 response rate of 47% and a PSA 90 response rate of 24%, outperforming Pfizer's data [20][21] - **Safety Profile**: ORIC-944 shows a differentiated safety profile with less toxicity compared to Pfizer's Mezigdomide, particularly in terms of hematologic and gastrointestinal toxicity [22][23] - **Half-Life**: ORIC-944 has a 20-hour half-life, allowing for once-daily dosing, which is expected to reduce Cmax-related toxicities [15][16] ORIC-114 (Lung Cancer) - **Focus**: Developed for non-small cell lung cancer, targeting multiple genetic mutations including EGFR exon 20 and HER2 exon 20 [49][50] - **Differentiation**: Emphasizes safety, tolerability, and CNS activity, which is crucial as many lung cancer patients present with brain metastases [52][53] - **Upcoming Data**: Substantial data readouts expected in the second half of this year and early next year, with a focus on three cohorts of patients [55][56] Financial Position - **Funding**: The company is well-funded, with a cash runway extending past the Phase 3 data readouts for both programs [4][72] - **Market Opportunity**: The prostate cancer market is significant, with an estimated $3.5 billion treatable market in the U.S. for the targeted populations [47][48] Competitive Landscape - **Comparison with Pfizer**: ORIC-944 is positioned as a potential competitor to Pfizer's Mezigdomide, with expectations of capturing 35% to 40% market share as a second entrant [46][48] - **AR Inhibitors**: ORIC has supply agreements with apalutamide and darolutamide, both of which are viewed as having similar efficacy but better safety profiles compared to enzalutamide [39][40] Upcoming Milestones - **Data Updates**: Incremental updates expected in the second half of this year, with a more substantial update in Q1 2026 [28][30] - **Phase 3 Study**: Plans to initiate a pivotal study for ORIC-944 in the first half of next year, with a focus on the CRPC setting [34][66] Conclusion - **Investor Attention**: ORIC Pharmaceuticals is positioned for significant data releases and has a strong financial foundation, making it a company to watch in the oncology space over the next 6 to 12 months [75][76]

Summary of ORIC Pharmaceuticals Conference Call Company Overview - **Company**: ORIC Pharmaceuticals - **Focus**: Development of small molecule drugs targeting resistance in oncology, specifically for solid tumors like prostate and lung cancer Key Programs - **Lead Programs**: - **ORIC-944**: A small molecule PRC2 inhibitor for castration-resistant prostate cancer (CRPC), currently in dose optimization and expected to enter phase three studies next year - **ORIC-114**: A small molecule TKI targeting non-small cell lung cancer (NSCLC) with brain metastases, also in dose optimization Core Insights - **Market Potential**: The combined market for AR inhibitors in prostate cancer is approximately $7 billion in the U.S. alone, with each patient population (post-abiraterone and post-ARPI) representing about $3.5 billion [doc id='36'][doc id='37'] - **Comparison with Competitors**: ORIC-944 has a 20-hour half-life and better drug properties compared to Pfizer's Mavrimodastat, which has a 4-5 hour half-life. ORIC-944 shows higher PSA response rates (47% confirmed PSA 50 rate vs. Pfizer's 34%) and lower toxicity [doc id='10'][doc id='13'][doc id='14'] - **Safety Profile**: ORIC-944 exhibits a lower incidence and severity of toxicities compared to Pfizer's drug, with no reported alopecia, which is significant for prostate cancer patients [doc id='15'] Clinical Data and Updates - **Phase One Data**: ORIC-944 showed promising early efficacy with a small sample size (n=17), indicating potential for longer-term durability [doc id='12'][doc id='13'] - **Upcoming Updates**: The second half of the year will provide incremental updates on dose selection and rationale for ORIC-944, with a more substantial update expected in Q1 2026 [doc id='24'][doc id='30'] Competitive Landscape - **CNS Activity**: ORIC-114 is positioned as a CNS-active agent, which is crucial as many lung cancer patients present with brain metastases. This could lead to longer progression-free survival [doc id='42'][doc id='43'] - **Market Dynamics**: The AR inhibitor market is large, with significant sales from existing drugs. ORIC aims to capture market share through better efficacy and safety profiles [doc id='36'][doc id='39'] Financial Position - **Cash Runway**: ORIC ended Q2 with $436 million in cash, providing a runway into the second half of 2028, which covers the phase three readouts for both ORIC-944 and ORIC-114 [doc id='56'] Strategic Considerations - **Partnership Opportunities**: ORIC is open to various forms of partnerships, including drug supply agreements and potential collaborations for broader development, especially for ORIC-944 in CSPC [doc id='54'] Conclusion - ORIC Pharmaceuticals is advancing its lead programs with promising clinical data and a strong financial position, positioning itself competitively in the oncology market, particularly in prostate and lung cancer treatments. The company is focused on optimizing its drug candidates while preparing for upcoming phase three studies.

Financial Data and Key Metrics Changes - ORIC Pharmaceuticals is in a strong financial position with $436 million in cash, providing a runway into the second half of 2028, assuming full success in ongoing programs [57][58][60] - The company completed a PIPE financing of $125 million and drew down an additional $119 million from an ATM, indicating robust capital management [56][57] Business Line Data and Key Metrics Changes - ORIC-944, a small molecule inhibitor targeting the PRC2 complex, is in dose optimization and is expected to start phase three studies next year [4][5] - ORIC-114 is also progressing, with updates expected in the second half of the year for various patient cohorts [50][51] Market Data and Key Metrics Changes - The prostate cancer market is significant, with androgen receptor inhibitors collectively generating over $10 billion in annual sales, growing at solid double-digit rates [8] - ORIC-944 aims to differentiate itself in this competitive landscape by demonstrating better drug properties compared to Pfizer's Mevrimetastat [10][12] Company Strategy and Development Direction - The company is focused on advancing its clinical pipeline, particularly ORIC-944 and ORIC-114, with plans to initiate phase three studies in the first half of 2026 [31][38] - ORIC Pharmaceuticals is not waiting for phase three data from competitors and is moving forward with its own studies to capitalize on market opportunities [46][60] Management's Comments on Operating Environment and Future Outlook - Management believes that the probabilities for success in PRC2 drug development have increased, especially with the limited number of PRC2 inhibitors in late-stage development [63] - The company is confident in its ability to capture a significant market share even as a second mover, given the expected differentiation in safety and efficacy profiles [45][46] Other Important Information - ctDNA is being explored as a biomarker for long-term durability outcomes, with expectations for substantial decreases in ctDNA levels among patients [32][33] - The company is strategically focusing on first-line treatments for ORIC-114, moving away from second-line settings for commercial and cost reasons [50] Q&A Session Summary Question: What updates can be expected for ORIC-944 and ORIC-114? - The next update for ORIC-944 will be operational in nature, focusing on the rationale for dose optimization, while ORIC-114 will have updates on various patient cohorts in the second half of the year [25][50] Question: How does ORIC-944 compare to Mevrimetastat? - ORIC-944 has shown promising early data with higher PSA response rates compared to Mevrimetastat, indicating potential for better efficacy [19][24] Question: What is the expected cash runway for the company? - The company has a cash runway through the second half of 2028, which supports ongoing development for both ORIC-944 and ORIC-114 [57][58] Question: What is the strategy for launching ORIC-944? - The company aims to minimize the timeline gap with competitors and is focused on starting phase three studies without waiting for competitor data [46][60] Question: What is the expected efficacy benchmark for ORIC-114? - The company aims for a top-line objective response rate (ORR) of around 55% for monotherapy and 65% for combination therapy with Mavantamib in first-line settings [54]

Summary of Oric Pharmaceuticals Conference Call Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Industry**: Biotechnology, specifically oncology - **Focus**: Development of small molecule drugs targeting solid tumors, particularly prostate cancer and lung cancer [4][5] Key Pipeline Developments - **ORIC-944**: A PRC2 inhibitor in combination with AR inhibitors (apalutamide and darolutamide) for prostate cancer, currently in dose optimization and preparing for Phase 3 studies [5][6][7] - **ORIC-114**: A brain-penetrant small molecule targeting lung cancer, focusing on patient populations with EGFR exon 20, atypical mutations, and HER2 exon 20, also in dose optimization [5][6][7] Financial Position - The company has strengthened its balance sheet through capital raising, providing a cash runway until 2028, which covers the primary data readouts for both programs [7][8] Market Opportunity - The prostate cancer market is significant, with existing AR inhibitors (enzalutamide, apalutamide, darolutamide) showing strong efficacy but limited options for patients who progress on these therapies [11][12][13] - ORIC-944 aims to resensitize patients to AR inhibitors, potentially improving progression-free survival (PFS) outcomes [13][14] Competitive Landscape - Current AR inhibitors have similar efficacy profiles, but ORIC-944's better tolerability and dosing regimen (once daily with a 20-hour half-life) may provide a competitive edge [20][21][23] - The company aims to differentiate itself through improved drug properties and potentially better patient outcomes [25][26] Clinical Data Insights - Early clinical data showed ORIC-944 achieving higher rates of confirmed PSA50 (47%) and PSA90 (24%) compared to Pfizer's data (34% and 12%, respectively) [37][38] - The drug's toxicity profile appears favorable, with lower incidence and severity of expected toxicities compared to competitors [39][40] Future Plans - The company plans to initiate the first Phase 3 study in the first half of next year, selecting one AR inhibitor (either apalutamide or darolutamide) for the trial [49][50] - Upcoming updates will provide clarity on dosing regimens and additional clinical data, including ctDNA metrics [46][48] ORIC-114 Development - ORIC-114 (enozertinib) targets EGFR exon 20, atypical mutations, and HER2 exon 20, with a focus on CNS activity and a clean safety profile [57][64] - The company has made strategic decisions to prioritize first-line settings over second-line due to market size and cost considerations [69] Regulatory Considerations - The company is observing regulatory feedback from the FDA regarding competitive products in the space, particularly concerning atypical mutations [74][75] Conclusion Oric Pharmaceuticals is positioned to make significant advancements in oncology with its innovative drug candidates, particularly ORIC-944 and ORIC-114, while maintaining a strong financial position and strategic focus on market opportunities. The upcoming clinical data and Phase 3 study initiation will be critical in determining the company's trajectory in the competitive oncology landscape.