Bezuclastinib Program - Bezuclastinib is a potential best-in-class selective KIT mutant inhibitor, showing promise in pre-clinical studies and Phase 1/2 trials for GIST patients[10, 115] - KIT mutations drive up to 80% of GIST and over 90% of SM cases[27] - Bezuclastinib exhibits minimal brain penetration, with a brain to plasma ratio of 007, compared to 20 for avapritinib[37] - Cogent is conducting a Phase 2 clinical study (APEX) of Bezuclastinib in patients with Advanced Systemic Mastocytosis, with initial clinical results expected in 1H 2022[47, 48] FGFR2 Program - FGFR2 and FGFR3 are collectively altered in up to 41% of cancers[55] - Cogent is developing FGFR2 selective inhibitors with a target profile of <10 nM FGFR2 Cell IC50 and >200 nM FGFR1 Cell IC50[64] - CGT0292, a lead compound, demonstrates ~30x selectivity between FGFR1 and FGFR2 in cellular assays[80] - CGT0292 does not show serum phosphorus increase at a 5 mg/kg dose in the SD Rat Model of Hyperphosphatemia[84] ErbB2 Program - Significant unmet need remains for patients with non-exon 20 ErbB2 mutations[95] - Cogent is developing an ErbB2 mutant selective drug which covers key mutations while sparing wtEGFR, with a target Mutant Cell IC 50 of <10 nM and EGFR WT Cell IC 50 of >200 nM[104, 105] - Cogent has identified several novel series with promising enzyme selectivity for ErbB2 over EGFR WT[114] Financial Status - Cogent Biosciences had a cash balance of $2197 million as of December 31, 2021[12, 117]

Core Insights - Kura Oncology and Kyowa Kirin announced the acceptance of an abstract for the KOMET-001 trial of ziftomenib for R/R NPM1-m AML for oral presentation at the ASCO Annual Meeting in June 2025 [1][2] - Ziftomenib is the only investigational therapy with Breakthrough Therapy Designation from the FDA for treating R/R NPM1-m AML, which represents about 30% of AML cases [2][7] - The trial achieved its primary endpoint of complete remission and was well-tolerated with limited myelosuppression [2][3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational therapy [7] - Kyowa Kirin is a Japan-based Global Specialty Pharmaceutical Company with over 70 years of experience in drug discovery and biotechnology innovation [8] Trial Details - The KOMET-001 trial is designed to assess the clinical activity, safety, and tolerability of ziftomenib in patients with R/R NPM1-m AML [2] - Positive topline results were previously announced, indicating a statistically significant primary endpoint achievement [2] - A trial-in-progress abstract for the KOMET-015 trial will also be presented at the ASCO Annual Meeting [3][4] Upcoming Events - Kura will host a virtual investor event on June 2, 2025, to discuss the trial results and provide insights from company management and investigators [5][6]

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]

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].

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]

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]

Table of Contents As filed with the Securities and Exchange Commission on August 1, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 APTOSE BIOSCIENCES INC. (Exact Name of Registrant As Specified In Its Charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Canada 2836 98-1136802 Classification Code Number) (I.R.S. Employer Identification Number) 66 ...