Core Insights - Aptose Biosciences Inc. is a clinical-stage precision oncology company focused on developing tuspetinib (TUS) as a frontline therapy for newly diagnosed acute myeloid leukemia (AML) [1][4] Group 1: Shareholder Meeting Outcomes - Shareholders voted to appoint Ernst & Young LLP as the independent registered public accounting firm for the Company [2] - The appointment of EY is expected to enhance the Company's growth and commitment to transparency due to their expertise in the life sciences sector [2] Group 2: Funding and Financial Updates - Aptose has received an additional US$1.5 million in funding from Hanmi Pharmaceutical Co. Ltd. as part of an US$8.5 million loan facility agreement [3] - To date, the Company has received a total of US$7.1 million under the Loan Agreement to support the clinical development of tuspetinib [3]

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8][17] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8][17] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9][17] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Core Insights - Acrivon Therapeutics is advancing two clinical-stage assets, ACR-368 and ACR-2316, both demonstrating anti-tumor activity in clinical studies [1][2] - The company utilizes its proprietary AI-driven Generative Phosphoproteomics AP3 platform to enhance drug design and development [1][10] - As of June 30, 2025, Acrivon has $147.6 million in cash and equivalents, expected to fund operations until Q2 2027 [1][9] Clinical Development - ACR-368 is in a registrational-intent Phase 2b trial for endometrial cancer, showing deep and durable responses in patients previously treated with chemotherapy and anti-PD-1 therapy [2][7] - ACR-2316, a WEE1/PKMYT1 inhibitor, is in a Phase 1 trial, with initial clinical activity observed in several solid tumor types, including confirmed partial responses in endometrial cancer [4][12] Financial Performance - For Q2 2025, Acrivon reported a net loss of $21.0 million, compared to a net loss of $18.8 million in Q2 2024 [8] - Research and development expenses increased to $16.2 million in Q2 2025 from $15.0 million in Q2 2024, primarily due to increased personnel for clinical trials [8] - General and administrative expenses remained stable at $6.5 million for Q2 2025, compared to $6.4 million in Q2 2024 [9] Upcoming Milestones - The company plans to provide updates on the registrational-intent trial for ACR-368 and report initial clinical data from the Phase 1 study of ACR-2316 in the second half of 2025 [14] - Acrivon is also advancing a new cell cycle drug discovery program targeting an undisclosed target towards development candidate nomination in 2025 [14]

Core Insights - Nuvectis Pharma, Inc. has provided final clinical data from the Phase 1b study of NXP800 in recurrent, platinum-resistant, ARID1a-mutated ovarian cancer and is progressing towards the initiation of the Phase 1b program for NXP900 [1][4] Group 1: NXP800 Clinical Data - In the Phase 1b study, 17 patients were treated with NXP800 at a target dose of 75 mg/day, with data available for 13 patients, resulting in 2 partial responses and 3 stable diseases [2][6] - Thrombocytopenia was identified as a key toxicity but was managed effectively by switching to an intermittent dosing schedule [2][6] - The company will not pursue further development of NXP800 in ovarian cancer but will explore its potential in other cancer types such as endometrial and prostate cancers [2][4] Group 2: NXP900 Development - The NXP900 DDI study has been successfully completed, supporting its potential combination with EGFR and ALK inhibitors in non-small cell lung cancer [3][6] - The Phase 1a dose-escalation study for NXP900 evaluated doses from 20 to 300 mg/day, with no dose-limiting toxicity reached, and demonstrated a robust pharmacodynamic response at doses of 150 mg/day and higher [3][6] - The initiation of the Phase 1b study for NXP900 is expected in the coming weeks, aiming to evaluate its safety and efficacy as a single agent and in combination with other anti-cancer agents [3][6] Group 3: Company Strategy and Future Outlook - The CEO of Nuvectis emphasized the decision to focus on advancing NXP900 due to the challenges and resource requirements associated with further developing NXP800 in ovarian cancer [4] - The company believes that NXP800 remains an active agent and will evaluate its feasibility in other cancer types in the coming months [4][6] - Nuvectis Pharma is positioned to leverage the therapeutic potential of NXP900 as it moves forward with its clinical programs [4][5]

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 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]