– NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients – – Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse – – FDA grants full approval of KOMZIFTI ahead of PDUFA target action date – – Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily administration, and ease of co-administration with common supportive medica ...

Core Viewpoint - Nuvectis Pharma, Inc. is advancing its clinical-stage biopharmaceutical efforts, particularly focusing on the NXP900 program, which aims to address unmet medical needs in oncology through innovative precision medicines [1][2]. Financial Results - As of September 30, 2025, the company reported cash and cash equivalents of $35.4 million, an increase of $16.9 million from $18.5 million at the end of 2024, primarily due to a public offering and the use of an At-the-Market facility [3]. - The net loss for the third quarter of 2025 was $7.5 million, compared to $4.2 million for the same period in 2024, marking an increase of $3.4 million, largely due to a one-time milestone expense of $2.0 million for NXP900 and $0.7 million for a clinical study [4]. - Research and development expenses were $5.8 million for the third quarter of 2025, up from $2.8 million in the same quarter of 2024, reflecting an increase of $3.0 million [5]. - General and administrative expenses rose to $2.0 million in the third quarter of 2025 from $1.5 million in the same quarter of 2024, an increase of $0.5 million [5]. - Interest income for the third quarter of 2025 was $0.3 million, compared to $0.2 million in the same period of 2024 [6]. Business Progress - The Phase 1b program for NXP900 has been initiated, with the single-agent study currently underway, aiming to provide preliminary evidence of clinical efficacy in advanced cancers [8]. - The Phase 1a dose escalation study for NXP900 has been successfully completed, demonstrating robust pharmacodynamic responses at clinically relevant doses [8]. - A clinical drug-drug interaction study in healthy volunteers has also been successfully completed, supporting the strategy for combination therapy [8]. - The company expects its cash runway to support operations into the third quarter of 2027 [8]. Company Overview - Nuvectis Pharma, Inc. focuses on developing innovative precision medicines for serious oncology conditions, with its lead program NXP900 being an oral small molecule inhibitor targeting SRC Family of Kinases [9].

Core Insights - Kura Oncology has received a $30 million milestone payment from Kyowa Kirin for the dosing of the first patient in the second Phase 3 trial of ziftomenib, bringing total milestone payments received to $105 million, with expectations of up to $315 million in additional near-term milestones [1][2]. Group 1: Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3]. - The company is developing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemia (AML), and is pioneering advancements in menin inhibition for both acute leukemias and solid tumors [3]. Group 2: Clinical Trials - The KOMET-017 trial consists of two independent, global, randomized double-blind, placebo-controlled Phase 3 trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged AML [2]. - Kura believes that KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings [2].

Core Insights - Nuvectis Pharma, Inc. is advancing its lead program NXP900, a precision medicine targeting SRC/YES1 inhibition for oncology applications, with recent positive results from Phase 1a studies [1][2][3] Clinical Development - The Phase 1a dose escalation and drug-drug interaction studies for NXP900 have shown a favorable safety profile, with common adverse events being Grade 1-2 diarrhea, fatigue, and nausea [5] - NXP900 demonstrated a robust pharmacodynamic response at doses of 150 mg/day and above, indicating its potential effectiveness [5] - The ongoing Phase 1b study is evaluating NXP900 as a monotherapy in patients with advanced solid tumors exhibiting specific genomic alterations [5] Mechanism of Action - NXP900 operates through a unique mechanism that inhibits both the catalytic and scaffolding functions of SRC kinases, leading to comprehensive shutdown of the signaling pathway [3][2] - Preclinical data presented at the conference supports the biomarker patient selection strategy for the Phase 1b program [2] Future Directions - The company is preparing to initiate the combination portion of the Phase 1b program and will provide clinical data updates as the program progresses [2] - Nuvectis is also considering next steps for NXP800, another investigational drug targeting recurrent, platinum-resistant ovarian cancer [3]

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]