Olema Pharmaceuticals (OLMA) FY Conference June 11, 2025 08:00 AM ET Speaker0 Alright. Good morning. It is my pleasure to introduce Shane Kovac, COO and CFO of OLima as our next speaker. Shane, welcome. Thanks for hosting us. Yeah. This is my time hosting OLima at the Goldman Sachs conference, so, absolutely enjoy having you back. So before I kick off with the q and a, I'm gonna turn it to you for opening remarks. Speaker1 Well, I think, we're at a we're at a very interesting time for Olima. As you know, dr ...

Olema Pharmaceuticals (OLMA) 2025 Conference June 04, 2025 11:40 AM ET Speaker0 Good afternoon. How are you? Thank you for joining us on the next panel discussion here. I am very fortunate to have the CEO of Olima Pharmaceuticals here, Sean Bowen. Sean is continuing to work on developing and executing on his breast cancer drug, palazestrin. Obviously we just came away from ASCO and continue to learn more about the developments in breast cancer. And so I would love, Sean, maybe just to give a snapshot view. ...

Poster Presentation Details Title: OPERA-01: A randomized, open-label, phase 3 study of palazestrant (OP-1250) monotherapy vs standard-of-care endocrine therapy for patients with ER+, HER2- advanced breast cancer after endocrine and CDK4/6 inhibitor therapy Abstract Number: TPS1131 Poster Number: 104b Poster Session: Breast Cancer – Metastatic Date/Time: June 2, 2025 from 9:00am–12:00pm CT / 10:00am–1:00pm ET "Metastatic breast cancer treatment continues to be challenged by resistance mechanisms resulting i ...

纪要涉及的公司 Olema Pharmaceuticals (OLMA) 纪要提到的核心观点和论据 OPRA 1 试验 - **试验阶段与进度**：OPRA 1 是 valsestrant 治疗二线和三线 HER2 阳性或阴性转移性乳腺癌的 3 期试验，已启动超一年，第一部分剂量范围试验去年底完成，正在收集数据以选择后续剂量，完成并公布剂量后将进入第二部分，仍有望在 2026 年获得顶线数据 [6][7][8]。 - **剂量选择与后续试验**：第一部分将患者随机分为每日 40 - 120 毫克、40 - 90 毫克的 palazestrant 组和对照组，数据用于选择最终剂量 90 或 120 毫克；第二部分将以选定剂量随机分组，再招募 390 名患者 [7][8]。 - **数据时间线**：今年下半年有望明确 2026 年数据读出的具体时间，期间激活更多试验点和国家以加速后续招募 [9]。 与其他试验对比及 PALA 优势 - **其他试验数据影响**：EMBER 3 和 Veritec 2 试验数据对 OPRA 1 有参考价值，EMBER 3 试验设计复杂，在 ESR1 野生型无活性，突变型有适度活性；Veritec 2 数据周末公布，初步显示结果与 EMERAL 类似 [17][18]。 - **PALA 差异化优势**：OPRA 1 是唯一有机会在两方面实现差异化的试验，在 ESR1 突变型人群中 PFS 改善明显（7.3 个月），在野生型中也有超 5 个月的 PFS，而其他试验在野生型中未显示活性 [18][19]。 - **控制臂预期**：OPRA 1 控制臂与 Emerald 更接近，预计控制臂 PFS 在 2 - 3 个月，但最终结果需参考 Veritec 2 周末公布的数据 [20][22]。 PALA 分子特性与对比 - **分子特性**：palazestrant 是完整的雌激素受体拮抗剂（CRAN），通过结合剩余受体并锁定其非活性构象来阻止雌激素和雌激素受体介导的生长和增殖信号 [24][25]。 - **与其他分子对比**：VECTEG 和 SURDU 是 SERMs，非完整拮抗剂，在突变型中为部分拮抗剂，在野生型中可能为部分激动剂；emblunestrin 虽是 CRAN，但暴露不足，PK 特性导致其暴露量低于 palazestrant [25][26][27]。 PALA 与 ribo 联合数据 - **数据更新与成熟度**：3 月会议更新数据显示，所有患者和先前 CDK4/6 治疗人群的中位 PFS 分别为 13.8 个月和 13.1 个月；今年下半年医学会议有望公布更成熟数据，PFS 可能有一定变化，且有部分一线患者数据值得关注 [30][31][32]。 - **不同患者群体研究**：EMBER 3 联合治疗在野生型中有更多活性，PALA 单药治疗也有一定活性，联合治疗在野生型和突变型患者中的效果值得研究，但一线患者中 ESR1 突变罕见，二线数据对一线的参考意义不明确 [33][34]。 前线试验与 Serena 6 数据 - **前线试验原理**：前线治疗中，40 - 50% 的患者为预 ESR1 突变型，使用不允许突变克隆生长的分子可延长 PFS，OPRA 2 试验将对此进行验证 [38][39]。 - **Serena 6 数据影响**：Serena 6 试验结果为阳性，若数据有说服力，将增强对所有前线试验（PERSERVERA、Serena 4、OPRA 2）的信心，也会影响 PERSEVIR 试验中 PALA 与 ribo 联合治疗的预期 [40][41][43]。 OPRA 2 试验计划 - **启动时间与条件**：计划今年下半年启动 OPRA 2 试验，关键条件是 OPRA 1 第一部分确定剂量，还需完成监管互动和最终确定试验设计 [44]。 - **试验地点与招募**：可使用 OPRA 1 部分试验点，因患者群体不同，也会有新试验点；尚未确定招募 1000 名患者的时间 [46][47]。 市场机会 - **二线和三线市场**：二线和三线野生型市场机会约 50 亿美元，市场规模取决于 PFS 时长和对突变型的治疗效果，若能在野生型中显示活性并获得标签，将有显著差异化机会 [49]。 - **前线市场**：前线市场机会受前线试验结果影响，若试验成功，PALA 与 ribo 联合治疗有较大潜力 [38][49]。 Cat 6 抑制剂项目 - **与 Pfizer 药物对比**：Cat 6 是表观遗传靶点，Pfizer 已证明概念，其分子对 Cat 5 和 Cat 8 有更多活性，而公司药物更具针对性，避免可能的毒性，且在临床前模型中与 palazestrant 联合效果更佳 [53][54]。 - **项目进展与数据预期**：目前处于单药剂量递增阶段，进展顺利，有望年底获得数据，确定推荐的 2 期剂量和安全性数据后将开展与 fulvestrant 和 palazestrant 的联合试验 [55][57]。 - **其他肿瘤探索**：在非小细胞肺癌、去势抵抗性前列腺癌和卵巢癌中显示活性，单药剂量递增试验允许非小细胞肺癌和去势抵抗性前列腺癌患者参与，将探索这些肿瘤的治疗路径 [59][60]。 其他重要但是可能被忽略的内容 - **ASCO 会议**：本周末将在 ASCO 展示试验进展海报，主要面向研究人员、潜在受试者和乳腺癌倡导人士，但对投资者了解公司和 palazestrant 也有帮助 [12][13]。 - **投资者认知**：投资者常将同类药物归为一类，但公司认为 palazestrant 的分子特性、联合能力和高暴露量等是有意义的差异化因素，公司专注乳腺癌且有完善管线，定位良好 [61][62]。

Olema Pharmaceuticals, Inc. (OLMA) closed the last trading session at $5.08, gaining 2.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $24.71 indicates a 386.4% upside potential.The average comprises seven short-term price targets ranging from a low of $18 to a high of $30, with a standard deviation of $4.64. While the lowest estimate indicates an increase of 254.3% from the cur ...

Olema Pharmaceuticals (OLMA) FY 2025 Conference May 20, 2025 01:30 PM ET Speaker0 Hi, everyone. Good afternoon. Thanks for joining us at the HC Wainwright BioConnect Conference. I'm pleased to introduce Sean Bowen, who's the chief executive officer of Olima Therapeutics, and I am Emily Bodner, equity research analyst at H. C. Wainwright. Sean, maybe to start off, if you could walk us through a bit about the background on Olima, your lead asset, palisestra, and and the transforming landscape in the ER positi ...

Table of Contents 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: 001-39712 OLEMA PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 13, 2025 Olema Pharmaceuticals, Inc. (Exact name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporation) 780 Brannan Street San Francisco, California 94103 (Address of Principal Executive Offices) (Zip Code) Registrant's Telephone Number, Including Area Cod ...

Pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib in frontline metastatic breast cancer on track for initiation in 2025, supported by promising updated efficacy data from ongoing Phase 1b/2 studyPivotal Phase 3 OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance with top-line data anticipated in 2026; trial-in-progress poster to be highlighted at ASCO Annual MeetingPreclinical data for OP-3136 presented at AACR demonstrating anti-tumor ...

Activity in preclinical models of ovarian, prostate, and non-small cell lung cancer supports potential utility of OP-3136, a KAT6 inhibitor, in indications beyond breast cancerPatient recruitment ongoing in Phase 1 trial of OP-3136 as a monotherapy and in combination regimens in multiple solid tumor typesData to be presented at 2025 AACR Annual Meeting SAN FRANCISCO, April 25, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (("Olema" or "Olema Oncology", NASDAQ:OLMA), a clinical-stage biopharmaceutical ...