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]

Endocrine Disruptors Overview - Endocrine disruptors are molecules capable of disrupting the hormonal system [8] - Hormones are chemical substances produced by glands that act as keys interacting with specific receptors [8][9] - These disruptors can interfere with hormone effects, leading to various health risks [11] Health Risks Associated with Endocrine Disruptors - Potential health risks include hypertension, cancers (prostate, testicles, breast, ovaries), masculinization in women, and feminization in men [12][13] - Sperm count has decreased by half from 1978 to 2020 [13] - Endocrine disruptors can affect puberty, potentially causing precocious puberty in young girls [14] Sources and Presence of Endocrine Disruptors - Common sources include bisphenol, phthalates in plastics, parabens, heavy metals, preservatives (BHA, BHT), and pesticides [18] - Found in medications, plastic packaging, canned goods, paints, and cosmetics [18][19] - Present in food items like corn, rice, dried/smoked fish, and fresh tomatoes, as shown by studies in Burkina Faso [21] Mitigation Strategies - Reduce exposure by being cautious with street medications and natural aphrodisiacs [23] - Pay attention to pesticides in food and choose cosmetics carefully [23][24] - Be mindful of plastic packaging and food additives [24] - Adopt new behaviors and pass them on to children [25] Other Disruptors - Alcohol, excess sugar and fat, mycotoxins, shisha, and cigarettes (containing approximately 280 different molecules in their smoke) are also disruptors [25]

Access the on-demand webcast here HOUSTON, June 05, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the release of its Soft Tissue Sarcoma (STS) Lung Mets KOL Webcast discussing the final data from its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastase ...

- ASCO Presentation Supports SLS009 as a Potential Targeted Therapy for ASXL1 Mutated Colorectal Cancer – - 22,500 New Cases of Colorectal Cancer with High Microsatellite Instability per Year in the US: 55% ASXL1m Frequency – NEW YORK, June 02, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced preclinical eff ...

Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency (EMA) approval adds nine additional countries to the Company’s ongoing MIRACLE trial; Authorization granted in all EU countries requested Company to host conference call and webcast today, May 14th at 8:30 AM E ...

Core Insights - Silexion Therapeutics Corp. has made significant advancements in its preclinical pipeline for SIL204, demonstrating efficacy against both primary tumors and metastases in orthotopic models, which could represent a paradigm shift in treating KRAS-driven cancers [1][2] - The company has strengthened its financial position by raising over $9 million in gross funds during Q1 2025, enhancing its ability to advance its clinical development pipeline [1][2] Recent Milestones & Business Highlights - Positive data from orthotopic pancreatic cancer models showed that SIL204 reduced primary tumor growth by approximately 70% in the AsPC-1 model and 80% in the BxPC-3 model by day 28, along with significant reductions in metastases [5] - A single systemic dose of SIL204 maintained effective drug levels for over 56 days, indicating potential for long-term therapeutic exposure [5] - An expanded dual-route development strategy for SIL204 was unveiled, integrating systemic and intratumoral administration to target both primary tumors and metastatic progression [5] - A strategic collaboration with Catalent was announced to conduct formulation development and clinical manufacturing activities for SIL204 [5] Financial Results Highlights - Cash and cash equivalents increased to $6.2 million as of March 31, 2025, from $1.2 million as of December 31, 2024, primarily due to successful financing activities [10] - Total operating expenses for Q1 2025 were $1.7 million, compared to $1.3 million in Q1 2024, with research and development expenses decreasing to $0.6 million [6][10] - The net loss for Q1 2025 was $1.7 million, compared to $1.4 million for the same period in 2024, attributed to higher general and administrative expenses [10][14]

Core Insights - Erasca, Inc. is advancing its RAS-targeting franchise with the clearance of IND for ERAS-0015 and submission for ERAS-4001, with initial Phase 1 monotherapy data expected in 2026 [2][6][7] - The company reported a robust cash position of $411 million as of March 31, 2025, extending its cash runway guidance to the second half of 2028 [4][8] - The R&D expenses decreased to $26 million for Q1 2025, down from $28.6 million in Q1 2024, indicating improved cost management [9] RAS-Targeting Franchise - The RAS-targeting franchise includes two promising product candidates: ERAS-0015, a pan-RAS molecular glue, and ERAS-4001, a pan-KRAS inhibitor, both showing differentiated therapeutic potential in preclinical models [2][3] - The AURORAS-1 Phase 1 trial will evaluate ERAS-0015 in patients with RAS-mutant solid tumors, while the BOREALIS-1 Phase 1 trial will assess ERAS-4001 in patients with KRAS-mutant solid tumors [6][7] Financial Highlights - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $411.1 million, a decrease from $440.5 million at the end of 2024, but sufficient to fund operations into H2 2028 [8][16] - The net loss for Q1 2025 was $31 million, or $(0.11) per share, an improvement from a net loss of $35 million, or $(0.23) per share, in Q1 2024 [10][17] Strategic Decisions - The company has strategically decided to focus on its RAS-targeting franchise while exploring partnership opportunities for naporafenib, which has contributed to extending its cash runway [2][4]

Core Insights - Olema Pharmaceuticals reported financial and operational results for Q1 2025, highlighting progress in its clinical pipeline and financial position [1][2]. Recent Progress - The pivotal Phase 3 OPERA-02 trial of palazestrant in combination with ribociclib for frontline metastatic breast cancer is on track for initiation in 2025, supported by updated efficacy data from the ongoing Phase 1b/2 study [6]. - The OPERA-01 trial of palazestrant monotherapy in 2/3L metastatic breast cancer continues to advance, with top-line data expected in 2026 [6]. - New preclinical data for OP-3136, a KAT6 inhibitor, was presented at AACR, showing anti-tumor activity in various solid tumor models, with ongoing Phase 1 trial recruitment [6][7]. Financial Results - As of March 31, 2025, Olema had $392.7 million in cash, cash equivalents, and marketable securities [5]. - The net loss for Q1 2025 was $30.4 million, a slight decrease from $31.0 million in Q1 2024, attributed to higher interest income offset by increased clinical development spending [8]. - GAAP R&D expenses were $30.6 million for Q1 2025, up from $29.9 million in Q1 2024, primarily due to increased clinical operations and development activities [9]. - Non-GAAP R&D expenses were $27.3 million for Q1 2025, compared to $26.5 million in Q1 2024 [10]. Anticipated Upcoming Events - The company plans to present a trial-in-progress poster for OPERA-01 at the ASCO Annual Meeting in June and report top-line data in 2026 [7]. - The initiation of the OPERA-02 trial is expected in 2025 [7].

Core Insights - Revolution Medicines, Inc. reported financial results for Q1 2025, highlighting progress in clinical trials and strategic priorities for the year [1][30][31] Clinical Development - The company is executing pivotal trials for daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC), with strong enrollment in the U.S. and initiation in the EU and Japan [1][2] - Plans are underway to advance daraxonrasib into first-line metastatic and earlier-line randomized pivotal trials for PDAC, expected to start in the second half of 2025 [3] - The company anticipates initiating pivotal combination trials for elironrasib and zoldonrasib in 2026 [4] - Recent data from zoldonrasib and elironrasib monotherapy in KRAS G12D and G12C mutant NSCLC patients show promising tolerability and antitumor activity [5][16] Combination Therapies - Clinical updates indicate encouraging results for combinations of daraxonrasib with pembrolizumab and elironrasib with pembrolizumab in NSCLC [6][19] - The combination of elironrasib with daraxonrasib demonstrated preliminary antitumor activity in patients previously treated with a KRAS G12C(OFF) inhibitor, with an objective response rate (ORR) of 62% [27][29] Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling $2.1 billion [31][42] - Research and development expenses increased to $205.7 million from $118.0 million year-over-year, primarily due to clinical trial and manufacturing costs [32] - General and administrative expenses rose to $35.0 million from $22.8 million, attributed to personnel-related costs and commercial preparation activities [33] - The net loss for Q1 2025 was $213.4 million, compared to a net loss of $116.0 million in Q1 2024 [34] Strategic Initiatives - The company is enhancing its commercialization capabilities, appointing Anthony Mancini as chief global commercialization officer to strengthen its strategy in the U.S. and evaluate options for international reach [10][11] - Revolution Medicines is focused on advancing its pipeline of RAS(ON) inhibitors, with plans for future clinical development of RMC-5127, a G12V-selective inhibitor [37]

REDWOOD CITY, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that it will report financial results for the first quarter of 2025 on Wednesday, May 7, 2025, after market close. At 4:30 p.m. ET that day (1:30 p.m. PT), members of Revolution Medicines’ senior management team will host a webcast to discuss the financial results for the quarter and pr ...