Core Insights - Olema Pharmaceuticals reported financial and operational results for Q2 2025, highlighting a focus on advancing its clinical programs for breast cancer therapies [1][5][6]. Recent Progress - The company achieved regulatory alignment on the selected dose for the pivotal palazestrant program and is accelerating enrollment in the OPERA-01 trial, with top-line data expected in the second half of 2026 [2][8]. - Olema is also advancing OP-3136, a KAT6 inhibitor, which is generating strong interest and enrollment in its Phase 1 study [2][9]. Financial Results - As of June 30, 2025, Olema had cash, cash equivalents, and marketable securities totaling $361.9 million [5][19]. - The net loss for Q2 2025 was $43.8 million, an increase from $30.4 million in Q2 2024, primarily due to a one-time milestone payment of $10 million and increased R&D spending [6][20]. - GAAP R&D expenses were $43.9 million for Q2 2025, up from $29.1 million in Q2 2024, reflecting ongoing late-stage clinical trials [7][20]. Anticipated Upcoming Events - Enrollment in the OPERA-01 trial is ongoing, with top-line data expected in the second half of 2026, while the OPERA-02 trial is set to initiate in Q3 2025 [8][9]. - Mature data from the Phase 1b/2 study of palazestrant in combination with ribociclib will be presented at ESMO 2025 [9]. Company Overview - Olema Oncology is focused on developing targeted therapies for breast cancer, with its lead candidate, palazestrant, currently in a pivotal Phase 3 trial [13][14]. - The company is also developing OP-3136, which has shown significant anti-proliferative activity in preclinical studies [15].

Palazestrant (OP-1250) Development - Olema aims to establish Palazestrant as a best-in-class backbone therapy for ER+/HER2- breast cancer, both as a monotherapy and in combination with other anti-tumor agents[8] - The pivotal Phase 3 OPERA-01 clinical trial of Palazestrant as a monotherapy is ongoing, with top-line results expected in 2026[16, 37] - A pivotal Phase 3 OPERA-02 clinical trial of Palazestrant in combination with ribociclib is planned for initiation in 2025[3, 14, 16, 37, 88] - Palazestrant monotherapy Phase 2 data showed a median PFS of 73 months in 2/3L ±CT ESR1-mutant patients and 55 months in 2/3L ±CT ESR1-wild-type patients[45, 46, 47] - Palazestrant, at 120mg in combination with ribociclib, showed a 6-month PFS rate of 74% in all patients and 68% in patients with prior CDK4/6i[75, 80] OP-3136 (KAT6 Inhibitor) Development - Olema is advancing the clinical development of OP-3136, a potential best-in-class KAT6 inhibitor, in breast and other solid tumor cancers[10] - The FDA has cleared the Investigational New Drug (IND) application for OP-3136, and a Phase 1 clinical trial has been initiated[16, 100] - Preclinical data demonstrates that OP-3136 shows synergistic activity in combination with palazestrant[112] Market and Financial Position - The estimated global market for ER+/HER2- metastatic breast cancer is greater than $20 billion[35] - The U S market potential for Palazestrant in the 2/3L setting is estimated at $3-5 billion[63] - Olema has a strong capital position with $3927 million[13]

Summary of Olema Pharmaceuticals (OLMA) FY Conference Call Company Overview - **Company**: Olema Pharmaceuticals (OLMA) - **Date of Conference**: June 11, 2025 - **Key Speaker**: Shane Kovac, COO and CFO Key Points Industry and Company Developments - Olema is at a pivotal moment in drug development, with significant clinical data expected in the next 12 to 18 months [2] - The company is focusing on its phase two ribociclib and palazestrant combination study, with updated data presentation anticipated later this year [2][6] - The cat six program is progressing well, currently in phase one dose escalation, with potential data readouts expected this year [3] - The OPRA o one phase three trial is pivotal, with a potential filing for approval in late 2026 or early 2027 if successful [4] Clinical Trials and Data - Olema has signed a significant agreement with Novartis to support the OPRA two study, which focuses on frontline metastatic breast cancer [4] - The company aims to achieve at least a six-month progression-free survival (PFS) benefit over the control arm in the OPRA two trial, with data expected around late 2028 [5] - Olema believes it has a best-in-class molecule, palazestrant, showing superior efficacy in both mutant and wild-type populations compared to competitors [6][7] Stock Performance and Market Position - Despite positive developments and impressive data presentations, Olema's stock price has fallen below $5, attributed to negative market reactions to competitors' data [18][22] - The company has created significant value over the past year, with successful FDA interactions and trial initiations [20][22] - Olema's stock is currently trading around cash value, indicating a potential buying opportunity for investors [22] Competitor Analysis - Competitors such as AMPER three, Veritec two, and SERENNA six have reported mixed results, impacting market perceptions of Olema [18][19] - Olema differentiates itself by allowing prior fulvestrant use in its trials, potentially leading to a more favorable patient population compared to competitors [35] - The company is optimistic about its competitive edge due to its unique pharmacological profile and dosing strategy [64] Future Outlook - Olema is focused on generating new data and enrolling patients in the coming months, with the next twelve months expected to be critical for the company [67] - The breast cancer market is significant, and Olema aims to compete against major players like Roche and AstraZeneca [68] - The success of upcoming trials, including OPRA o two, is crucial for establishing Olema's position in the market [60] Conclusion - Olema Pharmaceuticals is positioned for potential growth with its innovative drug candidates and strategic partnerships, despite current stock price challenges and competitive pressures [68][69]

Summary of Olema Pharmaceuticals (OLMA) Conference Call Company Overview - **Company**: Olema Pharmaceuticals - **Lead Asset**: Palazestrant, a complete estrogen receptor antagonist - **Current Development Stage**: Enrolling in phase three clinical trials for breast cancer treatment Key Points and Arguments 1. **Clinical Trials**: Olema is currently enrolling a phase three program for palazestrant, focusing on advanced ER-positive, HER2-negative breast cancer that has not received prior treatment in the metastatic setting [2][5] 2. **Efficacy Data**: - Palazestrant has shown a median progression-free survival (PFS) of 13.1 months in patients who progressed on CDK4/6 inhibitors plus an aromatase inhibitor, compared to a standard of care PFS of approximately 5.5 months [7][11] - In a phase two trial, palazestrant demonstrated better activity in the ESR1 mutant subset, achieving 7.3 months PFS [4][17] 3. **Combination Studies**: Olema is also testing palazestrant in combination with ribociclib, showing favorable tolerability and enhanced activity compared to other agents in the same class [6][8] 4. **Market Confusion**: The market is currently confused due to mixed results from other studies in the same class, such as Veritat II and Ember three, which have shown varying PFS outcomes [11][12] 5. **Predictive Confidence**: The CEO emphasized the importance of using prior clinical trial data to predict outcomes, arguing that palazestrant's design addresses weaknesses seen in other agents [13][15] 6. **Upcoming Data**: Olema anticipates a top-line PFS readout from its phase three study next year, with ongoing updates on enrollment data expected later this year [71][72] Additional Important Insights 1. **Regulatory Pathways**: The CEO discussed the complexities of regulatory pathways for competing drugs, particularly highlighting the challenges faced by Lilly's Ember three trial [20][22] 2. **Patient Population**: The discussion highlighted that a significant portion of patients in the Serena six study had already been on therapy for extended periods, which may affect the outcomes of first-line studies [36][38] 3. **Future Studies**: Olema is preparing for upcoming phase three readouts from Roche and AstraZeneca, which could impact market perceptions of the entire class of drugs [57][59] 4. **Cat6 Inhibitor**: Olema is also in phase one dose escalation for a Cat6 inhibitor, with potential data presentation expected next year [94][96] This summary encapsulates the critical aspects of Olema Pharmaceuticals' current position in the breast cancer treatment landscape, focusing on the development and potential of palazestrant, while also addressing market dynamics and future expectations.

Core Insights - Olema Pharmaceuticals has aligned with the FDA to select a 90 mg dose of palazestrant for the Phase 3 OPERA-01 trial in ER+/HER2- metastatic breast cancer [1][2] - The OPERA-01 trial results are expected to be presented at the ASCO Annual Meeting from May 30 to June 3, 2025, with top-line data anticipated in 2026 and a potential commercial launch in 2027 [2][4] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company focused on developing targeted therapies for breast cancer, particularly through its lead product candidate, palazestrant (OP-1250) [4][5] - Palazestrant is a novel small molecule that acts as both a complete estrogen receptor antagonist and a selective estrogen receptor degrader, currently being evaluated in multiple clinical trials [3][5] Clinical Trials - The OPERA-01 trial is a randomized, open-label Phase 3 study comparing palazestrant monotherapy to standard endocrine therapy for patients with advanced ER+/HER2- breast cancer [2][4] - Palazestrant has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after endocrine therapy and at least one line of treatment with a CDK4/6 inhibitor [3][4]

Summary of Olema Pharmaceuticals (OLMA) FY Conference Call - May 27, 2025 Company Overview - **Company**: Olema Pharmaceuticals (OLMA) - **Focus**: Development of palazestrant, a complete estrogen receptor antagonist, for the treatment of breast cancer Key Points Clinical Trials and Data - **OPRA O1 Trial**: - Focuses on palazestrant for second and third line HER2 negative metastatic breast cancer - Enrollment for the dose-ranging part completed late last year, with data collection ongoing [6][8] - Top-line data expected in 2026, with more precise timelines to be provided in the second half of 2025 [8][10] - **ASCO Presentation**: - A trial progress poster will be presented, focusing on part two of the OPRA O1 trial, which may attract interest from investors and potential trial participants [12][14] - **Comparison with Other Trials**: - Data from EMBER three and Veritec two trials will be analyzed to assess palazestrant's potential for success [16][18] - OPRA O1 aims to show better progression-free survival (PFS) in ESR1 mutant and wild-type populations compared to existing therapies [19][20] Market Potential - **Market Opportunity**: - The second and third line treatment market for wild-type patients is estimated at $5 billion, depending on PFS duration [49] - Differentiation in the mutant population could enhance market capture [49] Cat 6 Inhibitor Program - **Mechanism**: - Cat 6 is an epigenetic target that affects chromatin structure, potentially enhancing the efficacy of anti-estrogen therapies [52][53] - **Preclinical Data**: - Olema's Cat 6 inhibitor shows promising preclinical results, particularly in combination with palazestrant, which may enhance anti-tumor activity [54][58] - **Future Data**: - Data from monotherapy dose escalation may be available by the end of 2025, with ongoing trials in various solid tumors [57][59] Differentiation and Competitive Landscape - **Molecular Characteristics**: - Palazestrant is positioned as a complete estrogen receptor antagonist, distinguishing it from other SERDs and SERMs in the market [24][25] - **Investor Perception**: - The company believes that investors may overlook the unique molecular properties and potential of palazestrant compared to other drugs in the same class [61][62] Pipeline and Future Directions - **Upcoming Trials**: - The initiation of the OPRA O2 trial is expected in the second half of 2025, contingent on data from OPRA O1 [44][48] - **Broader Applications**: - Interest in exploring Cat 6 inhibitors in non-small cell lung cancer and castration-resistant prostate cancer [59] Conclusion - Olema Pharmaceuticals is advancing its clinical trials for palazestrant, with significant market potential in breast cancer treatment. The company is also exploring innovative approaches with its Cat 6 inhibitor program, positioning itself as a key player in the oncology space. Investors are encouraged to consider the unique attributes of Olema's therapies as they differentiate from competitors.

Core Viewpoint - Olema Pharmaceuticals, Inc. (OLMA) shows significant upside potential with a mean price target of $24.71, indicating a 386.4% increase from the current price of $5.08 [1] Price Targets - The average price target consists of seven estimates ranging from a low of $18 to a high of $30, with a standard deviation of $4.64, suggesting variability in analyst opinions [2] - The lowest estimate indicates a potential increase of 254.3%, while the highest suggests a 490.6% upside [2] - A low standard deviation indicates a higher agreement among analysts regarding price movement [9] Analyst Sentiment - Analysts are optimistic about OLMA's earnings prospects, as indicated by a positive trend in earnings estimate revisions [4][11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 25.4%, with five estimates moving higher and no negative revisions [12] Zacks Rank - OLMA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting strong potential for upside [13]

Financial Data and Key Metrics Changes - The company is currently conducting a phase three pivotal trial focused on hormone receptor positive, HER2 negative breast cancer, with the lead asset being palisestrant [2][3] - The ongoing phase three trial is a monotherapy trial in the second and third line setting, with top-line results expected next year [3] - The company plans to initiate a first-line trial in the second half of the year, which will include ribociclib [3][4] Business Line Data and Key Metrics Changes - The company has two clinical stage assets: palisestrant in phase three and OP3136, a CAT6 inhibitor, in phase one dose escalation [4] - The phase two data for palisestrant showed a progression-free survival (PFS) of 7.3 months in the ESR1 mutant population, which is significantly better than the control arm [13] - The combination of ribociclib and palisestrant is expected to show favorable results compared to other combinations, with a median PFS of 15 months reported [20][21] Market Data and Key Metrics Changes - The company is competing in a rapidly evolving market for oral SERDs, with recent trials showing benefits primarily in ESR1 mutant patients [6][7] - The company aims to differentiate palisestrant by demonstrating its efficacy in both mutant and wild-type populations [13][18] Company Strategy and Development Direction - The company is focused on advancing its clinical trials and establishing palisestrant as a competitive treatment option in the breast cancer market [2][3] - The strategy includes a combination approach with ribociclib and palisestrant, which is expected to enhance treatment outcomes [20][21] - The company is also exploring the potential of OP3136 in various cancer types, including castration-resistant prostate cancer and non-small cell lung cancer [42][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the efficacy of palisestrant in the first-line setting, particularly for treatment-naive patients [25] - The company anticipates that the upcoming data updates will provide further insights into the performance of its assets and their potential market impact [33][34] Other Important Information - The company has a clinical collaboration with Novartis for the supply of ribociclib, which is a key component of its trials [30] - The company is preparing for potential data updates and has several catalysts expected later this year [34][46] Q&A Session Summary Question: How does palisestrant differentiate from other oral SERDs? - Management highlighted that palisestrant is a complete estrogen receptor antagonist, unlike others that are partial agonists, which may limit their efficacy in certain populations [6][7] Question: What are the expectations for the OPERA one trial design? - The trial is designed to test both mutant and wild-type populations separately, allowing for a more targeted statistical analysis [18] Question: How does the combination of ribociclib and palisestrant compare to other treatments? - The combination is expected to show significantly better results than existing treatments, with a median PFS of 15 months compared to 5 months in previous studies [20][21]

Financial Performance - Olema reported net losses of $30.4 million for Q1 2025, compared to $31.0 million for Q1 2024, with an accumulated deficit of $465.5 million as of March 31, 2025[135]. - The net loss for Q1 2025 was $30.4 million, compared to a net loss of $31.0 million in Q1 2024, reflecting an improvement of $0.6 million[158]. - General and administrative expenses for Q1 2025 were $4.2 million, a decrease of $0.2 million from $4.5 million in Q1 2024, mainly due to a reduction in non-cash stock-based compensation[156]. - Research and development expenses for Q1 2025 were $30.6 million, an increase of $0.7 million from $29.9 million in Q1 2024, primarily due to increased spending on clinical operations and personnel-related costs[155]. - The company has not generated any revenue from product sales since inception and expects to incur significant operating losses for the foreseeable future[165]. - The company has not generated any revenue from product sales to date and does not expect meaningful revenue until regulatory approval and commercialization of product candidates occur[168]. Research and Development - The ongoing Phase 3 clinical trial of palazestrant (OP-1250) is expected to yield top-line results in 2026[128]. - The median progression-free survival (mPFS) for patients treated with palazestrant and ribociclib was reported at 13.8 months, with 40 out of 56 patients having prior treatment with a CDK4/6 inhibitor[131]. - Olema's second product candidate, OP-3136, has entered Phase 1 clinical trials after receiving IND clearance from the FDA in late 2024[132]. - Olema plans to continue its research and development efforts for palazestrant and OP-3136, as well as seek regulatory approvals for successful candidates[139]. - The company anticipates increased research and development and general administrative costs as it conducts additional studies and trials for its product candidates[165]. Funding and Capital Requirements - The company expects to require substantial additional funding to support ongoing operations and product development[138]. - The company entered into a loan agreement increasing the credit facility from $50.0 million to $100.0 million, with $25.0 million currently available[160]. - The company raised approximately $250.0 million through a private placement of common stock in November 2024, netting approximately $237.0 million after expenses[161]. - Future capital requirements will depend on various factors, including the pace of development efforts and the ability to establish collaborations on favorable terms[174]. - The company may need to rely on additional financing through equity offerings, debt financings, collaborations, and licensing arrangements[172]. Cash Flow and Liquidity - As of March 31, 2025, the company had $392.7 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $465.5 million[159]. - As of March 31, 2025, the company expects its cash, cash equivalents, and marketable securities will fund its operating plan for at least the next 12 months[169]. - Net cash used in operating activities for the three months ended March 31, 2025, was $43.979 million, compared to $23.496 million for the same period in 2024[175]. - Net cash used in investing activities for the three months ended March 31, 2025, was $45.083 million, primarily due to purchases of marketable securities[178]. - Net cash provided by financing activities for the three months ended March 31, 2025, was $0.222 million, mainly from the exercise of stock options[179]. Operational Outlook - The company anticipates significant and increasing operating losses as it advances its product candidates and operates as a public entity[137]. - Olema relies on third parties for manufacturing and does not plan to establish its own manufacturing facilities[134]. - The company anticipates significant commercialization expenses if marketing approval for product candidates is obtained[171]. - The company has no outstanding debt as of March 31, 2025, and currently has no financing commitments expected to affect liquidity over the next five years[167]. - There were no material changes to critical accounting policies and market risk disclosures during the three months ended March 31, 2025[181][182].

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Item 2.02 Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Olema Pharmaceuticals, Inc. announced Q1 2025 financial results via a press release (Exhibit 99.1), furnished but not 'filed' - The company reported its financial results for the quarter ended March 31, 2025[6](index=6&type=chunk) - The press release (Exhibit 99.1) containing the financial results is furnished and not deemed 'filed' for liability purposes under the Securities Exchange Act of 1934[6](index=6&type=chunk)[7](index=7&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists exhibits filed with the Form 8-K, primarily Exhibit 99.1, the press release of financial results Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release, dated May 13, 2025, of Olema Pharmaceuticals, Inc. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |