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- Lunit SCOPE HER2 and Lunit SCOPE ER/PR significantly improve pathologist concordance and accuracy, paving the way for improved breast cancer molecular subtype analysis for informed decision-making and precision patient care SEOUL, South Korea, March 14, 2024 /PRNewswire/ -- Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the publication of a new study featuring Lunit SCOPE HER2 and Lunit SCOPE ER/PR, Lunit's AI-powered analyzer of human epidermal growth factor receptor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR). Continue Reading Lunit SCOPE The study, in collaboration with Prof. So-Woon Kim from Kyung Hee University College of Medicine and Prof. Minsun Jung from Yonsei University College of Medicine, was recently published in the Breast Cancer Research (BCR), an international peer-reviewed journal. The study aimed to evaluate the role of Lunit SCOPE in enhancing pathologists' consistency and accuracy of breast cancer molecular subtype classification, including expression levels of HER2, ER, and PR. Breast cancer treatment strategies and clinical outcome predictions heavily rely on the accurate determination of these receptors' expression levels. However, conventional immunohistochemistry (IHC) analysis poses challenges to classification accuracy. There can be variability in interpretation among pathologists, especially when dealing with intermediate expressions. The study highlights Lunit SCOPE HER2 and Lunit SCOPE ER/PR, developed using a dataset of thousands of HER2, ER, and PR-stained IHC breast cancer whole-slide images. An external validation cohort of 201 breast cancer cases underwent analysis using these AI analyzers. Results from the study demonstrated a significant increase in agreement among pathologists on the status of HER2, ER, and PR, especially in cases with intermediate weakly positive expressions. Notably, AI assistance led to an increase in agreement on HER2 status from 49.3% to 74.1%, ER from 93.0% to 96.5%, and PR from 84.6% to 91.5%. This improvement was particularly pronounced in intermediate weakly positive cases with HER2 2+ and HER2 1+, showing concordance increases from 46.2% to 68.4% and 26.5% to 70.7%, respectively. Consequently, with AI assistance, the agreement among pathologists in classification of breast cancer molecular subtypes saw an increase from 58.2% to 78.6%. The study concludes that Lunit SCOPE HER2 and Lunit SCOPE ER/PR significantly improve pathologists' concordance in classifying breast cancer molecular subtypes. These solutions hold immense potential in enhancing treatment strategies and ensuring more accurate and personalized approaches for patients. "In this study, not only do we validate the performance of Lunit SCOPE HER2 and Lunit SCOPE ER/PR, but we also reveal the potential application of AI biomarkers in predicting treatment responses, particularly for HER2-targeted therapies. We also expect this breakthrough to open new avenues for future drug development," said Brandon Suh, CEO of Lunit. "At Lunit, we enhance healthcare providers' accuracy and concordance, and we empower them to make informed decisions that directly impact patients' lives. Our mission is to transform the landscape of personalized cancer diagnostics and therapeutics." About Lunit Founded in 2013, Lunit is a deep learning-based medical AI company on a mission to conquer cancer. We are committed to harnessing AI to ensure accurate diagnosis and optimal treatment for each cancer patient using AI-powered medical image analytics and AI biomarkers. As a medical AI company grounded on clinical evidence, our findings are presented in major peer-reviewed journals, such as the Journal of Clinical Oncology and the Lancet Digital Health, and global conferences, including ASCO and RSNA. After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 3,000+ hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea, with offices and representatives worldwide. For more information, please visit lunit.io. About Lunit SCOPE Lunit SCOPE is a suite of AI-powered software that analyzes tissue slide images for digital pathology and AI biomarker development, aiming to optimize workflow and facilitate more accurate and predictive clinical data for clinicians and researchers. Lunit SCOPE platform offers multiple AI-powered tissue analysis products and assays that can streamline digital pathology workflow and diagnostics and enhance the drug development process. Lunit SCOPE IO analyzes the tumor microenvironment (TME) based on H&E analysis and provides AI-based predictive clinical outcome information. In addition, AI-driven Immunohistochemistry (IHC) slide analysis services are offered through products such as Lunit SCOPE PD-L1, Lunit SCOPE HER2, Lunit SCOPE ER/PR, and others. SOURCE Lunit

­Trial will evaluate IDE161, IDEAYA's investigational PARG inhibitor, in combination with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with MSI-high and MSS endometrial cancer Potential first-in-class PARG inhibitor, in combination with anti-PD-1 therapy, targets two complementary mechanisms of anti-tumor immune response in endometrial cancer IDEAYA will sponsor the clinical trial and Merck will provide KEYTRUDA SOUTH SAN FRANCISCO, Calif., March 12, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) to evaluate IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with KEYTRUDA® (pembrolizumab) Merck's anti-PD-1 therapy, in patients with microsatellite instability-, or MSI-, high and microsatellite stable, or MSS, endometrial cancer, in a Phase 1 clinical trial. "We are excited to enter this collaboration as it allows study within and beyond the homologous recombination deficient (HRD) setting in endometrial cancer," said Darrin Beaupre, M.D., Ph.D., Chief Medical Officer, IDEAYA Biosciences. "We are very pleased to collaborate with Merck on this trial evaluating IDE161 in combination with KEYTRUDA in patients with MSI-high and MSS endometrial cancer. IDEAYA's IDE161 combination strategy is focused on advancing multiple high conviction rational combinations, including beyond the HRD biomarker setting," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. IDE161 is a small molecule inhibitor targeting PARG, that is being evaluated in a Phase 1 clinical trial, which is currently in its monotherapy expansion stage. The trial is strategically focused on estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (Her2-) breast cancer with HRD, as well as other solid tumors with HRD, such as endometrial cancer, colorectal cancer and prostate cancer. In parallel, IDEAYA is continuing with a Phase 1 dose optimization. Of note, multiple partial responses by RECIST 1.1. and tumor shrinkage in priority solid tumor types were observed early in the Phase 1 dose escalation and dose expansion. IDE161 received the U.S. Food & Drug Administration Fast-Track designation for BRCA1/2 ovarian and breast cancers. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Under the clinical trial collaboration and supply agreement, Merck will provide KEYTRUDA to IDEAYA, which will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies. The mechanistic rationale and preclinical data to support the IDE161 and PD-1 clinical combination will be provided as part of a future R&D update. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related the potential therapeutic benefits of IDE161 in combination with KEYTRUDA. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's recent Annual Report on Form 10-K filed on February 20, 2024 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Andres Ruiz Briseno SVP, Head of Finance and Investor Relations [email protected] SOURCE IDEAYA Biosciences, Inc.

Presented compelling clinical results for palazestrant both as a monotherapy and in combination with CDK4/6 inhibitors, ribociclib and palbociclib, in Q4 2023 Initiated OPERA-01 pivotal Phase 3 monotherapy trial in Q4 2023; top-line results expected in 2026 60-patient Phase 2 studies in combination with each of ribociclib and palbociclib are fully enrolled; palazestrant-ribociclib clinical update to be presented at ESMO Breast Cancer Annual Congress 2024, May 15-17, 2024, in Berlin Cash, cash equivalents and marketable securities of $261.8 million as of December 31, 2023 SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema”, “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “In 2023 we demonstrated the unique opportunity ahead for palazestrant to make a meaningful impact on improving treatment options for women with ER+/HER2- breast cancer. We believe palazestrant’s activity on both wild-type and ESR1-mutant breast cancer, and its ability to safely combine with ribociclib, result in a highly differentiated pro this emerging new class of estrogen receptor-targeting therapies,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We have recently completed enrollment in our 60-patient Phase 2 study of 120 mg palazestrant in combination with 600 mg ribociclib, and we are looking forward to sharing an update on this study at the 2024 ESMO Breast Cancer Annual Congress. Beyond palazestrant, we recently declared a development candidate for our KAT6 program, OP-3136, and we are advancing towards an IND filing by the end of this year. Our mission at Olema is to improve the lives of women living with cancer and we are very pleased with the progress we are making.” Recent Corporate Highlights Presented interim clinical results of palazestrant in combination with CDK4/6 inhibitors ribociclib and palbociclib at the 2023 San Antonio Breast Cancer Symposium (SABCS), showing no significant drug-drug interaction, no dose-limiting toxicities and a tolerability pro with the FDA-approved labels of ribociclib or palbociclib plus an endocrine therapy. Presented palazestrant monotherapy Phase 2 clinical results at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, as an oral presentation demonstrating compelling activity in both wild-type and ESR1-mutant tumor types. Initiated OPERA-01, our pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer, including dosing first patients and activating multiple trial sites globally. Nominated OP-3136, an orally bioavailable KAT6 inhibitor, as a development candidate. OP-3136 demonstrated potent anti-tumor activity alone and in combination with both palazestrant and CDK4/6 inhibitors in preclinical ER+ breast cancer models. Announced the expansion of Olema's clinical collaboration with Novartis Institutes for BioMedical Research, Inc. (Novartis), increasing the size of the ongoing Phase 1/2 clinical study testing palazestrant in combination with ribociclib to approximately 60 patients. This study is fully enrolled. Completed a combined financing for up to $180 million including an equity private placement of approximately $130 million of common stock as well as a new senior secured credit facility with an aggregate principal amount of up to $50 million with Silicon Valley Bank (SVB), $25 million of which is currently available. Upcoming Milestones Present interim Phase 2 clinical results of palazestrant in combination with ribociclib at ESMO Breast Cancer Annual Congress 2024, May 15-17, 2024, in Berlin, Germany. Initiate Phase 1b/2 clinical study of palazestrant in combination with mTOR inhibitor, everolimus, in Q3 2024. File an Investigational New Drug, or IND, application with the FDA for OP-3136, a KAT6 inhibitor, in late 2024, and advance clinical development. Prepare for pivotal Phase 3 first-line trial in combination with CDK4/6 inhibitor, ribociclib. Fourth Quarter and Full-Year 2023 Financial Results Cash, cash equivalents and marketable securities as of December 31, 2023, were $261.8 million. Net loss was $26.8 million and $96.7 million for the quarter and year ended December 31, 2023, respectively, as compared to $26.2 million and $104.8 million for the quarter and year ended December 31, 2022, respectively. The increase in net loss for the fourth quarter was primarily related to increased spending on clinical operations and development-related activities, including personnel-related expenses, as Olema continues to advance palazestrant into late-stage clinical trials. This increase was offset by decreased spending on general and administrative activities and higher interest income earned from marketable securities. The decrease in net loss for the full year 2023 was primarily due to higher interest income earned from marketable securities. GAAP research and development (R&D) expenses were $25.9 million and $86.1 million for the quarter and year ended December 31, 2023, respectively, as compared to $21.6 million and $82.3 million for the quarter and year ended December 31, 2022, respectively. The increase in R&D expenses was primarily a result of increased spending on clinical operations and development-related activities including personnel-related costs as Olema continues to advance palazestrant into late-stage clinical development, which were offset by decreased spending on research-related activities. Non-GAAP R&D expenses were $23.0 million and $74.4 million for the quarter and year ended December 31, 2023, respectively, excluding $2.9 million and $11.8 million non-cash stock-based compensation expense, respectively. Non-GAAP R&D expenses were $18.2 million and $69.8 million for the quarter and year ended December 31, 2022, respectively, excluding $3.4 million and $12.5 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. GAAP G&A expenses were $4.5 million and $18.8 million for the quarter and year ended December 31, 2023, respectively, as compared to $5.6 million and $24.7 million for the quarter and year ended December 31, 2022, respectively. The decrease in G&A expenses was primarily due to decreased spending on corporate- and legal-related costs, and personnel-related expenses. Non-GAAP G&A expenses were $3.1 million and $13.3 million for the quarter and year ended December 31, 2023, respectively, excluding $1.4 million and $5.5 million non-cash stock-based compensation expense respectively. Non-GAAP G&A expenses were $4.1 million and $18.3 million for the quarter and year ended December 31, 2022, excluding $1.5 million and $6.4 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release. About Palazestrant (OP-1250) Palazestrant (OP-1250) is a novel, orally-available small molecule with dual activity as both a complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD). It is currently being investigated in patients with recurrent, locally advanced or metastatic ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. In clinical studies, palazestrant completely blocks ER-driven transcriptional activity in both wild-type and mutant forms of metastatic ER+ breast cancer and has demonstrated anti-tumor activity along with attractive pharmacokinetics and exposure, favorable tolerability, CNS penetration, and combinability with CDK4/6 inhibitors. Palazestrant has been granted U.S. Food and Drug Administration (FDA) Fast Track designation for the treatment of ER+/HER2- metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a CDK4/6 inhibitor. It is currently being evaluated both as a single agent in an ongoing Phase 3 clinical trial, OPERA-01, and in Phase 2 combination studies with CDK4/6 inhibitors (palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib). For more information, please visit . About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for women living with cancer. Olema is advancing a pipeline of novel therapies by leveraging our deep understanding of endocrine-driven cancers, nuclear receptors, and mechanisms of acquired resistance. In addition to our lead product candidate, palazestrant (OP-1250), a proprietary, orally-available complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), Olema is developing a potent KAT6 inhibitor. Olema is headquartered in San Francisco and has operations in Cambridge, Massachusetts. For more information, please visit us at . Non-GAAP Financial Information The results presented in this press release include both GAAP information and non-GAAP information. As used in this release, non-GAAP R&D expense is defined by Olema as GAAP R&D expense excluding stock-based compensation expense, and non-GAAP G&A expense is defined by Olema as GAAP G&A expense excluding stock-based compensation expense. We use these non-GAAP financial measures to evaluate our ongoing operations and for internal planning and forecasting purposes. We believe that non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental informational purposes only, has limitations as an analytical tool, and should not be considered in isolation or as a substitute for financial information presented in accordance with GAAP. Other companies, including companies in our industry, may calculate similarly titled non-GAAP measures differently or may use other measures to evaluate their performance, all of which could reduce the usefulness of our non-GAAP financial measures as tools for comparison. Investors are encouraged to review the related GAAP financial measures and the reconciliation of these non-GAAP financial measures to their most directly comparable GAAP financial measures and not rely on any single financial measure to evaluate our business. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Words such as “anticipate,” "believe,” “could,” “expect,” “goal,” “may,” “potential,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These statements include those related to Olema’s financial condition and resources, results of operations, cash position, the timeline of Olema’s pivotal Phase 3 monotherapy clinical trial (OPERA-01), the timelines for initiation and enrollment for potential clinical studies and for results of clinical trials of palazestrant (OP-1250) as a monotherapy and in combination trials, potential beneficial characteristics, including but not limited to safety, tolerability, efficacy and therapeutic effects of palazestrant, the potential of palazestrant to improve treatment options or outcomes for women living with ER+/HER2- breast cancer, palazestrant’s combinability with other drugs, and the sufficiency and timing of Olema’s preclinical program, including the potential beneficial characteristics of its KAT6 inhibitor compounds, its applicability to breast and other cancers and the timing of a potential IND application. Because such statements deal with future events and are based on Olema’s current expectations, they are subject to various risks and uncertainties, and actual results, performance or achievements of Olema could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, those discussed in the section titled “Risk Factors” in Olema’s Annual Report on Form 10-K for the year ended December 31, 2023, and future filings and reports that Olema makes from time to time with the U.S. Securities and Exchange Commission. Except as required by law, Olema assumes no obligation to update these forward-looking statements, including in the event that actual results differ materially from those anticipated in the forward-looking statements. Olema Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets Data (in thousands) December 31, December 31, 2023 2022 Cash, cash equivalents and marketable securities $ 261,807 $ 204,421 Total assets 276,945 215,645 Total current liabilities 21,621 16,549 Total liabilities 23,050 18,099 Total stockholders’ equity 253,895 197,546 Total liabilities and stockholders’ equity $ 276,945 $ 215,645 Olema Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (In thousands, except share and per share data) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development (1) $ 25,872 $ 21,584 $ 86,140 $ 82,274 General and administrative (2) 4,544 5,635 18,821 24,714 Total operating expenses 30,416 27,219 104,961 106,988 Loss from operations (30,416 ) (27,219 ) (104,961 ) (106,988 ) Other income (expense): Interest income 3,551 973 8,325 2,228 Other income (expense): 93 67 (19 ) (27 ) Total other income 3,644 1,040 8,306 2,201 Net loss $ (26,772 ) $ (26,179 ) $ (96,655 ) $ (104,787 ) Net loss per share, basic and diluted $ (0.49 ) $ (0.65 ) $ (2.14 ) $ (2.62 ) Weighted average shares used to compute net loss per share, basic and diluted 54,783,945 40,188,466 45,247,098 39,995,460 Reconciliation of GAAP to Non-GAAP Information (In thousands) Three Months Ended December 31, Twelve Months Ended December 31, 2023 2022 2023 2022 (1) Research and development reconciliation GAAP research and development (3) $ 25,872 $ 21,584 $ 86,140 $ 82,274 Less: share-based compensation expense 2,911 3,374 11,769 12,462 Non-GAAP research and development $ 22,961 $ 18,210 $ 74,371 $ 69,812 (2) General and administrative reconciliation GAAP general and administrative $ 4,544 $ 5,635 $ 18,821 $ 24,714 Less: share-based compensation expense 1,440 1,487 5,487 6,367 Non-GAAP general and administrative $ 3,104 $ 4,148 $ 13,334 $ 18,347 (3) Research and development expenses for the twelve-months ended December 31, 2022 include an $8.0 million upfront payment in connection to the Aurigene Agreement. IR and Media Contact: Geoffrey Mogilner, Vice President, Investor Relations and Communications ir@olema.com