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.

Summary of Oric Pharmaceuticals (ORIC) FY Conference Call Company Overview - **Company**: Oric Pharmaceuticals (ORIC) - **Industry**: Clinical stage oncology, focusing on small molecule treatments for solid tumors, specifically prostate cancer, lung cancer, and breast cancer [2][3] Key Programs and Pipeline - **ORIC-944**: An allosteric PRC2 inhibitor in combination with AR inhibitors for prostate cancer [3][4] - **ORC-114**: A brain-penetrant EGFR HER2 exon 20 inhibitor for non-small cell lung cancer mutations [4][63] Clinical Development and Data - **Upcoming Studies**: Plans to initiate two Phase III studies in 2026 for ORIC-944 and ORC-114 [4][88] - **Recent Data**: Initial data from a Phase 1b study showed a PSA 50 response of 47% and a PSA 90 response of 24% in combination with AR inhibitors, which is favorable compared to Pfizer's data [18][20] - **Safety Profile**: ORIC-944 demonstrated a lower incidence of treatment-related adverse events compared to Pfizer's PRC2 inhibitor, with a diarrhea rate of 53% and only one grade three event [19][20] Competitive Landscape - **Market Opportunity**: Prostate cancer represents a significant market with approximately 40,000 to 50,000 patients in metastatic CRPC annually [34] - **Comparison with Competitors**: ORIC-944 aims to differentiate itself from Pfizer's mebrometostat by having a longer half-life (20 hours vs. 2 hours) and a potentially better safety profile [12][33][34] - **Other Competitors**: Awareness of several other PRC2 inhibitors in development, including those from Novartis and various companies in China, which may not be optimized for prostate cancer [40][41] Future Expectations and Updates - **Next Updates**: Anticipated updates on ORIC-944 in the second half of 2025, with a focus on PSA response and safety [51][56] - **Phase III Study Timeline**: Expected to start the Phase III study for ORIC-944 in the first half of 2026 [57][88] Financial Position - **Recent Financing**: Raised $125 million in a PIPE financing, extending cash runway into the second half of 2027 [88] - **Cash Management**: The cash runway includes funding for both assets and assumes no strategic partnerships, covering all costs associated with the upcoming Phase III studies [88] Additional Insights - **Combination Studies**: ORIC-114 is being studied in combination with amivantamab, which may provide synergistic effects due to its unique mechanism of action [80][84] - **Patient Population**: ORIC's studies allow for patients with active metastases, which is a differentiating factor compared to other trials that have stringent inclusion criteria [67][72] This summary encapsulates the key points discussed during the conference call, highlighting Oric Pharmaceuticals' strategic focus, clinical advancements, competitive positioning, and financial outlook.

Summary of Oric Pharmaceuticals (ORIC) 2025 Conference Call Company Overview - **Company Name**: Oric Pharmaceuticals (ORIC) - **Focus**: Development of small molecule drugs targeting solid tumors, specifically in lung cancer, prostate cancer, and breast cancer [4][5] Key Programs - **ORIC-944**: A PRC2 inhibitor for prostate cancer, currently in combination studies with two androgen receptor inhibitors (apalutamide and darolutamide) [5][6] - **ORIC-114**: A brain-penetrant inhibitor targeting lung cancer populations, including EGFR exon 20, EGFR atypicals, and HER2 exon 20 [6] Clinical Data and Comparisons - **Prostate Cancer Data**: - ORIC-944 showed a confirmed PSA 50 response rate of 47% compared to Pfizer's mevremetostat at 34% [10][13] - Confirmed PSA 90 response rate for ORIC-944 was 24% versus Pfizer's 12% [11][13] - Safety profile of ORIC-944 demonstrated lower rates of gastrointestinal toxicity compared to Pfizer's drug [14][15] Safety and Efficacy - **Toxicity Comparison**: ORIC-944 exhibited significantly lower rates of GI toxicity and anemia compared to Pfizer's data, which reported high rates of diarrhea and dysgeusia [14][15] - **Dosing Strategy**: ORIC-944 has a longer half-life allowing for once-daily dosing, while Pfizer's drug requires twice-daily dosing [26][27] Future Development Plans - **Phase III Study**: Planned to start in the first half of 2026, focusing on both post-abiraterone and post-AR inhibitor populations [33][44] - **Data Updates**: Two additional data updates expected later in 2025, focusing on dose escalation and optimization [34][36] Market Position and Strategy - **Competitive Landscape**: ORIC aims to close the timeline gap with Pfizer, emphasizing that being a second entrant in a large market can still yield significant commercial opportunities [60][61] - **Partnerships**: Strong relationships with Janssen and Bayer for drug supply and insights into clinical development [51][52] Financial Position - **Cash Position**: As of March, ORIC reported a pro forma cash position of $349 million, providing a runway into the second half of 2027 [73] Additional Insights - **ctDNA as a Biomarker**: ORIC is exploring ctDNA as a potential better marker for long-term durability compared to PSA activity [40][41] - **Focus on Frontline Opportunities**: ORIC is prioritizing frontline strategies for ORIC-114, aiming for robust data in competitive populations [63][64] Conclusion - ORIC Pharmaceuticals is positioned to advance its clinical programs with promising early data, a strong financial position, and strategic partnerships, while navigating a competitive landscape in oncology.

Group 1: ESSA Pharma Inc. (NASDAQ:EPIX) - The class period for the lawsuit is from December 12, 2023, to October 31, 2024, with a lead plaintiff deadline of March 25, 2025 [2] - The complaint alleges that defendants made materially false and misleading statements regarding the efficacy of masofaniten in combination with enzalutamide for treating prostate cancer [2] - Key allegations include that the combination treatment had no clear efficacy benefit over enzalutamide alone and that the M-E Combination Study was unlikely to meet its primary endpoint [2] Group 2: Cardlytics, Inc. (NASDAQ:CDLX) - The class period for the lawsuit is from March 14, 2024, to August 7, 2024, with a lead plaintiff deadline of March 25, 2025 [3] - The lawsuit claims that defendants made false statements regarding the company's ability to increase billings in line with rising consumer engagement [3] - Allegations include that changes to Cardlytics' Ads Decision Engine led to "underdelivery" of budgets and customer billing estimates, resulting in misleading positive statements about the company's prospects [3] Group 3: Novo Nordisk A/S (NYSE:NVO) - The class period for the lawsuit is from November 2, 2022, to December 19, 2024, with a lead plaintiff deadline of March 25, 2025 [4] - The complaint alleges that defendants created a false impression of reliable information regarding the success of the phase 3 CagriSema study on obesity [4] - Key points include that the optimistic claims about achieving at least 25% weight loss were misleading and that the study's flexible protocol limited its ability to provide effective weight loss data [4] Group 4: Crocs, Inc. (NASDAQ:CROX) - The class period for the lawsuit is from November 3, 2022, to October 28, 2024, with a lead plaintiff deadline of March 24, 2025 [6] - The lawsuit alleges that defendants misrepresented the revenue growth of HEYDUDE, claiming it was driven by management's decision to stock wholesalers aggressively, regardless of retail demand [6]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of ESSA Pharma Inc. during the specified Class Period of the upcoming lead plaintiff deadline on March 25, 2025, for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors who bought ESSA Pharma Inc. securities between December 12, 2023, and October 31, 2024, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties can join by submitting a form or contacting the law firm [2][5]. - The lead plaintiff must file a motion with the Court by March 25, 2025, to represent other class members in the litigation [2]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions [3]. - The firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time and has been ranked highly for its performance in this area since 2013 [3]. - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering funds for clients [3]. Group 3: Case Allegations - The lawsuit alleges that ESSA Pharma Inc. failed to disclose critical information regarding the efficacy of masofaniten in combination with enzalutamide, misleading investors about its effectiveness in treating prostate cancer [4]. - It is claimed that the M-E Combination Study was unlikely to meet its primary endpoint, leading to overstated clinical and commercial prospects for masofaniten [4]. - The public statements made by the defendants were deemed materially false and misleading, resulting in investor damages when the true information became public [4].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased securities of ESSA Pharma Inc. during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1][2]. Group 1: Class Action Details - Investors who purchased ESSA Pharma securities between December 12, 2023, and October 31, 2024, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [1]. - A class action lawsuit has already been filed, and interested parties can join by submitting a form or contacting the law firm [2][5]. - The deadline to move the Court to serve as lead plaintiff is March 25, 2025 [2]. Group 2: Law Firm Credentials - Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company at the time [3]. - The firm was ranked No. 1 by ISS Securities Class Action Services for the number of settlements in 2017 and has consistently ranked in the top 4 since 2013, recovering hundreds of millions for investors [3]. - In 2019, the firm secured over $438 million for investors, showcasing its effectiveness in litigation [3]. Group 3: Case Allegations - The lawsuit alleges that ESSA Pharma failed to disclose critical information regarding the efficacy of masofaniten in combination with enzalutamide, leading to misleading public statements [4]. - Specific claims include that the combination treatment had no clear efficacy benefit over enzalutamide alone and was less effective in treating prostate cancer than previously stated [4]. - The lawsuit asserts that the M-E Combination Study was unlikely to meet its primary endpoint, resulting in overstated clinical and commercial prospects for masofaniten [4].

Core Viewpoint - The Gross Law Firm has issued a notice to shareholders of ESSA Pharma Inc. regarding a class action lawsuit due to alleged misleading statements related to the efficacy of masofaniten in combination with enzalutamide for prostate cancer treatment [1][2]. Group 1: Allegations - The complaint alleges that during the class period from December 12, 2023, to October 31, 2024, the defendants made materially false and misleading statements about masofaniten's efficacy [2]. - It is claimed that masofaniten in combination with enzalutamide did not demonstrate a clear efficacy benefit over enzalutamide alone, contrary to what was communicated to investors [2]. - The M-E Combination Study was unlikely to meet its prespecified Phase 2 primary endpoint, indicating that the clinical and commercial prospects of masofaniten were overstated [2]. Group 2: Class Action Details - The deadline for shareholders to register for the class action is March 25, 2025, and they are encouraged to register without delay [3]. - Once registered, shareholders will receive updates through a portfolio monitoring software regarding the status of the case [3]. - There is no cost or obligation for shareholders to participate in this class action [3]. Group 3: Law Firm Background - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and fraud [4]. - The firm aims to ensure that companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [4].