– Revumenib abstracts highlight compelling results in acute leukemia across the frontline and R/R setting and multiple genetic populations, including mNPM1, KMT2Ar, and NUP98r – – Axatilimab abstracts highlight the robust responses observed in different organs and subgroups of patients with chronic GVHD in the AGAVE-201 trial – NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced ...

Core Insights - The Leukemia & Lymphoma Society (LLS) has partnered with Kroger's Dallas Division to raise funds for The Dare to Dream Project, aimed at improving treatments for pediatric blood cancer patients and providing support for their families [1][2][4] Group 1: The Dare to Dream Project - The Dare to Dream Project is a $175 million campaign focused on funding pediatric blood cancer research, advocating for healthcare policy changes, and expanding support services for affected children and families [8] - Only 5% of cancer drugs have been approved for first-time use in children, and 80% of childhood cancer survivors face chronic health issues due to their treatments [3] Group 2: Fundraising Efforts - From May 14 to June 3, 2025, Kroger encourages customers to donate at checkout in 110 stores across North and East Texas and Louisiana to support LLS's Dare to Dream Project [2] - Funds raised will exclusively benefit the life-saving work of The Dare to Dream Project, helping to ensure better treatment outcomes for children with blood cancer [1][2] Group 3: LLS's Commitment - LLS is pioneering pediatric blood cancer research, including the establishment of the first-ever pediatric AML Data Commons and the launch of the LLS PedAL Master Clinical Trial [4] - The organization has been dedicated to improving the quality of life for blood cancer patients and their families for over 75 years [6]

Core Insights - Atossa Therapeutics has reported promising results from the Phase 2 Endocrine Optimization Pilot sub-study, demonstrating the bioactivity of low-dose (Z)-endoxifen in treating stage II/III ER+/HER2- breast cancer [1][4] Group 1: Study Results - No participants achieved a pathologic complete response (pCR), with residual cancer burden (RCB) classes indicating moderate to extensive disease [3] - The study showed a median Ki-67 suppression from 10.5% at baseline to 5% by Week 3, with 65% of patients achieving Ki-67 ≤ 10% [6] - Median functional tumor volume decreased by 77.7% from baseline to surgery, with the longest tumor diameter reduced by 36.8% [6] Group 2: Drug Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that can inhibit and potentially degrade estrogen receptors, showing activity in resistant tumors [5] - The drug targets PKCβ1, an oncogenic signaling protein, at clinically achievable blood levels, and offers comparable or superior bone protection compared to tamoxifen [5] Group 3: Future Directions - Atossa is enrolling participants in an additional I-SPY2 cohort testing (Z)-endoxifen at a 40 mg daily dose, with top-line data expected in 2026 [4] - The company is focused on developing (Z)-endoxifen for metastatic breast cancer, supported by a growing intellectual property portfolio [8]

Core Insights - IO Biotech is advancing its pipeline of immune-modulatory cancer vaccines, with a pivotal Phase 3 trial expected to read out in Q3 2025 [1][5][6] - The company aims to submit a Biologics License Application (BLA) for its lead candidate, Cylembio, in 2025, with a potential launch in the US in 2026 [2][6] - IO Biotech was recognized as one of the most innovative biotechnology companies by Fast Company, ranking 9th in the biotechnology category [5][6] Financial Performance - For Q1 2025, the company reported a net loss of $22.4 million, compared to a net loss of $19.5 million in Q1 2024 [13] - Research and development expenses increased to $16.4 million in Q1 2025 from $14.3 million in Q1 2024 [13] - Cash and cash equivalents decreased to $37.1 million as of March 31, 2025, down from $60.0 million at the end of 2024 [13] Clinical Trials and Developments - The pivotal Phase 3 trial (IOB-013/KN-D18) is evaluating Cylembio in combination with Merck's KEYTRUDA for advanced melanoma, with 407 patients enrolled [11] - Initial data from the perioperative Phase 2 trial (IOB-032/PN-E40) is expected in the second half of 2025 [6][13] - The company completed enrollment in its ongoing clinical trials, which include studies for various solid tumors [9][14][15] Upcoming Events - IO Biotech will participate in TD Cowen's 6th Annual Oncology Innovation Summit on May 27, 2025, and the Jefferies Global Healthcare Conference on June 4, 2025 [5][6]

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 ...

GRAIL (GRAL) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants None - ExecutiveBob Ragusa - CEO & Board MemberHarpal Kumar - President Biopharma Business & EuropeJoshua Ofman - PresidentAaron Freidin - Chief Financial OfficerSubbu Nambi - Managing DirectorDoug Schenkel - Managing Director Conference Call Participants Tejas Savant - Executive Director & Senior Healthcare Equity AnalystKyle Mikson - Managing Director & Senior Research Analyst Operator Good day, ladies and gentlemen, and welc ...

GRAIL (GRAL) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Speaker0 Good day, ladies and gentlemen, and welcome to the GRAIL First Quarter twenty twenty five Earnings Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. Grail Investor Relations, please begin. Speaker1 Thanks, operator, and thanks, everyone, for joining us today. On today's call are Bob Bergu ...

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 Viewpoint - Tempest Therapeutics, Inc. reported promising developments in its clinical-stage oncology programs, particularly highlighting the amezalpat program's potential as a cancer therapy and ongoing efforts to maximize stockholder value through strategic alternatives [2][5]. Recent Highlights - The amezalpat program demonstrated its ability to reduce immunosuppression and activate the immune system against tumors, supported by positive randomized Phase 2 data [2]. - Tempest received Orphan Drug designation from the FDA for TPST-1495 for familial adenomatous polyposis (FAP) and for amezalpat for hepatocellular carcinoma (HCC) [5][6]. - The company is preparing for a Phase 2 trial of TPST-1495, expected to begin in 2025, emphasizing innovative cancer prevention strategies [6]. Financial Results - For the first quarter of 2025, Tempest reported a net loss of $10.9 million, or $3.16 per share, compared to a net loss of $7.9 million, or $4.62 per share, in the same period of 2024 [6][15]. - Research and development expenses increased to $7.6 million from $4.3 million year-over-year, primarily due to costs associated with preparing for a pivotal Phase 3 trial of amezalpat [6][7]. - The company ended the quarter with $21.5 million in cash and cash equivalents, down from $30.3 million at the end of 2024, mainly due to cash used in operating activities [6][12]. Corporate Developments - The company announced plans to explore a full range of strategic alternatives to advance its clinical-stage programs and maximize stockholder value [6]. - A reduction in force was completed on April 30, 2025, as part of its strategic initiatives [6].

Core Viewpoint - Intensity Therapeutics, Inc. reported its first quarter 2025 financial results and provided updates on its clinical studies, particularly focusing on the INVINCIBLE-3 and INVINCIBLE-4 studies for its lead product candidate INT230-6, which targets various cancer types [1][7]. Corporate Update - The INVINCIBLE-4 Study is a Phase 2 trial assessing the efficacy of INT230-6 in combination with standard of care for early-stage operable triple-negative breast cancer, with a primary endpoint of pathological complete response rate [2]. - The study is currently recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France, with authorization from the European Medicines Agency [3]. - The INVINCIBLE-3 Study is a Phase 3 trial evaluating INT230-6 as a monotherapy for certain soft tissue sarcoma subtypes, with a planned enrollment of 333 patients across eight countries [4]. - The Company paused new site activations and patient enrollments for the INVINCIBLE-3 Study due to funding constraints, having previously enrolled 23 patients [5]. Financial Results - For the first quarter of 2025, research and development expenses were $2.2 million, down from $2.8 million in the same period of 2024, while general and administrative expenses decreased to $1.2 million from $1.9 million [8][10]. - The overall net loss for the quarter was $3.3 million, an improvement from a net loss of $4.6 million in the first quarter of 2024 [11]. - As of March 31, 2025, the Company had cash and cash equivalents totaling $0.9 million, a decrease from $2.6 million at the end of 2024 [11][17]. Product Information - INT230-6 is designed for direct intratumoral injection and combines two anti-cancer agents, cisplatin and vinblastine, with a penetration enhancer to improve drug distribution within tumors [12]. - The drug aims to elicit both local tumor control and systemic immune responses without the immunosuppression typically associated with systemic chemotherapy [13].