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Nuvectis Pharma to Present at the H.C. Wainwright BioConnect Investor Conference
Globenewswire· 2025-05-16 20:35
Core Insights - Nuvectis Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative precision medicines for oncology, addressing serious unmet medical needs [1][3] - The company is developing two clinical-stage drug candidates: NXP800 and NXP900, with NXP800 in a Phase 1b trial for platinum-resistant, ARID1a-mutated ovarian carcinoma and cholangiocarcinoma, and NXP900 in a Phase 1a dose escalation study [3] Event Details - Nuvectis Pharma will present at the 3rd Annual H.C. Wainwright Global BioConnect Investor Conference on May 20, 2025, from 10:30 to 11:00 a.m. ET [2]
Nuvectis Pharma, Inc. Reports First Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-05-06 12:00
Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical programs, particularly NXP900 and NXP800, while reporting a financial update for Q1 2025, highlighting increased cash reserves and ongoing clinical trials [2][3][4]. Financial Results - Cash and cash equivalents increased to $29.9 million as of March 31, 2025, from $18.5 million as of December 31, 2024, due to a public offering that generated net proceeds of $14.0 million [3]. - The net loss for Q1 2025 was $5.3 million, compared to a net loss of $4.2 million in Q1 2024, reflecting an increase of $1.1 million [4]. - Research and development expenses rose to $3.7 million in Q1 2025 from $2.7 million in Q1 2024, an increase of $1.0 million [5]. - General and administrative expenses were $1.9 million for Q1 2025, up from $1.7 million in Q1 2024, an increase of $0.2 million [5]. Clinical Development Updates - NXP900 is in the Phase 1a dose escalation study, showing a robust pharmacodynamic response and acceptable safety profile in patients with advanced cancers [2][8]. - The Phase 1b study for NXP900 will enroll patients with specific genetic alterations to evaluate its therapeutic potential [2]. - NXP800 is currently in a Phase 1b study for platinum-resistant, ARID1a mutated ovarian cancer, with updates expected in the coming months [2][8]. Company Overview - Nuvectis Pharma focuses on developing innovative precision medicines for serious oncology conditions, with two clinical-stage drug candidates: NXP800 and NXP900 [7]. - NXP800 is an oral small molecule GCN2 activator, while NXP900 is an oral small molecule inhibitor targeting SRC Family of Kinases [7][9].
OnKure Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-05-06 11:30
Core Insights - OnKure Therapeutics is making progress in its PIKture-01 trial, with additional data expected in the second half of 2025, including mature single-agent and initial combination data [1][2] - The company plans to expand its PI3Ka franchise with a pan-mutant selective development candidate announcement anticipated in Q2 2025 [1][3] - As of March 31, 2025, OnKure has approximately $96.7 million in cash and cash equivalents, which is expected to fund operations through multiple anticipated milestones into Q4 2026 [1][4] Business Highlights and Upcoming Milestones - The PIKture-01 trial Part A has completed dose escalation, with only one patient experiencing dose-limiting toxicities at the highest dose level [3] - Preliminary data from Part A showed that OKI-219 was well tolerated across all dose levels, with no significant adverse events reported [3] - In Part B of the PIKture-01 trial, OnKure is actively enrolling patients to evaluate OKI-219 in combination with fulvestrant for treating PI3Kα mutated HR+/HER2- metastatic breast cancer, with initial combination data expected in the second half of 2025 [6] Financial Results - Research and development expenses for Q1 2025 were $13.0 million, an increase from $8.6 million in Q1 2024, primarily due to higher personnel-related costs and clinical trial expenses [5] - General and administrative expenses for Q1 2025 were $4.0 million, up from $1.3 million in Q1 2024, driven by increased personnel-related costs and legal expenses [7] - The net loss for Q1 2025 was $15.9 million, compared to a net loss of $9.5 million in Q1 2024, with a net loss per share of $1.19 [8][16]
OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Newsfilter· 2025-03-10 20:05
Core Insights - OnKure Therapeutics reported a net loss of $17.4 million for Q4 2024, with cash and cash equivalents of approximately $110.8 million expected to fund operations through multiple clinical readouts into Q4 2026 [1][5][10] Business Highlights - The company is advancing three PI3Ka inhibitor programs, with one in clinical development and another expected to be announced in Q2 2025 [2][6] - OnKure plans to report additional data from the OKI-219 program and initiate new clinical trials in 2025 [3][6] Financial Performance - R&D expenses for Q4 2024 were $14.4 million, up from $8.8 million in Q4 2023, primarily due to increased clinical trial and personnel-related costs [8] - General and Administrative expenses rose to $4.3 million in Q4 2024 from $1.1 million in Q4 2023, driven by higher personnel and consulting costs [9] - The net loss per share for Q4 2024 was $1.37, compared to $30.14 per share in Q4 2023 [10][18] Clinical Trials Update - The PIKture-01 trial's Part A monotherapy showed encouraging preliminary safety and tolerability data, with no significant adverse events reported [7][6] - Patient dosing for Part B of the PIKture-01 trial has begun, evaluating OKI-219 in combination with fulvestrant for specific breast cancer mutations [7][6] Strategic Developments - OnKure completed a merger with Reneo Pharmaceuticals on October 4, 2024, and raised $65 million in financing, subsequently changing its name and ticker symbol [6]