Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026 Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026 Preliminary cash and investments of $439.0 million as o ...

Summary of Cullinan Therapeutics FY Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS: CGEM) - **Focus**: Development of transformative medicines for cancer and autoimmune diseases - **Pipeline Strategy**: Concentrates on molecules that are either first in class or best in class, with a focus on clinically validated targets and substantial market opportunities [5][6] Key Pipeline Developments - **Current Pipeline**: Updated to include relatively de-risked molecules, with three out of four being T-cell engagers [5][6] - **Discontinued Programs**: CLN-617 (IL-2, IL-12 fusion protein) and CLN-619 (MICA/MICB antibody) were discontinued due to not meeting internal criteria [6] - **Highlighted Programs**: - **CLN-978**: A CD19 x CD3 T-cell engager aimed at autoimmune diseases, with a dedicated immunology team managing a global development program across three indications [6][7] - **CLN-049**: A potential first-in-class FLT3 x CD3 T-cell engager for AML, showing a 30% composite complete response rate in initial data [8][16] - **Zipalertinib**: An EGFR tyrosine kinase inhibitor for non-small cell lung cancer, with an NDA submission expected by the end of the year [10][11] Market Opportunities and Validation - **Autoimmune Diseases**: The scientific community recognizes CD19 as a high-impact target, and T-cell engagers are seen as a new treatment modality [8] - **Oncology**: The development and regulatory path for AML is clear, with a focus on broad applicability across AML patient populations [14][20] - **Cash Position**: As of September, the company reported approximately $475 million in cash, providing a runway into 2029 without immediate capital raising needs [11][12] Clinical Insights - **Patient Population for CLN-049**: Enrolled patients are treatment-experienced with high-risk genetic abnormalities, showing a need for improved therapies [17][18] - **Durability of Response**: Some complete responses observed out to six months, with ongoing studies expected to provide more data [19] - **Safety Profile**: Initial dose escalation studies show mild adverse events, with a favorable therapeutic index compared to other therapies [22][23] Future Development Strategy - **Regulatory Pathway**: Clear and capital-efficient pathway to approval for CLN-049, with potential for accelerated approval based on single-arm studies [20] - **T-cell Engager Advantages**: T-cell engagers are positioned as next-generation therapies with the potential to displace existing treatments, including monoclonal antibodies [38] Conclusion - **Strategic Positioning**: Cullinan Therapeutics is well-resourced and positioned to advance its pipeline with multiple catalysts on the horizon, aiming to address significant unmet needs in both oncology and autoimmune diseases [12][39]

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced new data from the REZILIENT2 study of zipalertinib, targeting advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations and CNS involvement [1][2] Group 1: Study Overview - The REZILIENT2 study is a Phase 2b clinical trial evaluating zipalertinib's safety and efficacy in patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or other uncommon mutations [6][9] - The study includes four cohorts, with one specifically focusing on patients with active brain metastases [6][8] Group 2: Patient Demographics and Treatment - As of February 2025, 32 patients were enrolled in the CNS involvement cohort, with a median of 2 prior lines of therapy [4][5] - Patients received zipalertinib at a dosage of 100 mg orally twice daily, with 21 patients having ex20ins mutations and 13 having other uncommon mutations [4][5] Group 3: Efficacy and Safety Data - Preliminary results indicated a 31.3% intracranial objective response rate and a 68.8% intracranial disease control rate among evaluable patients [7] - The median duration of response for intracranial activity was 8.1 months, while the systemic objective response rate was 27.6% with a median duration of 7.6 months [7] - Zipalertinib was well tolerated, with treatment-related adverse events of grade 3 or higher occurring in 25% of patients, including anemia and interstitial lung disease [5]

Company Overview - Cullinan Therapeutics, Inc. (NASDAQ: CGEM) is a biopharmaceutical company that employs a modality-agnostic approach to drug development, targeting biological mechanisms in oncology and autoimmune conditions [1] Business Strategy - The company selects the most effective modality for each therapeutic target, indicating a flexible strategy that adapts to various treatment needs [1] Partnerships - Cullinan Therapeutics engages in partnerships to enhance its drug development capabilities, which may provide additional resources and expertise [1]

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced positive results from the REZILIENT1 trial for zipalertinib in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations [1][4] - The trial results will be presented at the 2025 ASCO Annual Meeting [1] Company Overview - Taiho Oncology specializes in developing and commercializing orally administered anti-cancer agents, focusing on solid tumors and hematological malignancies [9] - Cullinan Therapeutics is dedicated to creating new standards of care in cancer and autoimmune diseases, with a diversified portfolio of clinical-stage assets [11] Clinical Trial Details - REZILIENT1 is a Phase 1/2 global study evaluating the efficacy and safety of zipalertinib in patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations [5] - The primary endpoints of the trial were overall response rate (ORR) and duration of response (DOR) [5] Efficacy Results - Zipalertinib demonstrated a confirmed ORR of 35.2% overall, with a median DOR of 8.8 months and progression-free survival of 9.4 months [8] - In patients who received prior platinum-based chemotherapy, the ORR was 40% with a median DOR of 8.8 months [8] - Subgroup analyses showed a confirmed ORR of 30% and median DOR of 14.7 months in patients who had prior amivantamab [8] Safety Profile - The safety profile of zipalertinib was manageable and consistent with previously reported data [8]

Core Insights - Cullinan Therapeutics has received approval from the European Medicines Agency (EMA) for CLN-978, with Phase 1 studies in rheumatoid arthritis and Sjögren's disease set to begin in Q2 2025 [1][6] - The company is advancing its clinical development of CLN-978 across multiple autoimmune diseases and expects to share initial clinical data in systemic lupus erythematosus (SLE) by the end of 2025 [2] - The pivotal Phase 2b study of zipalertinib has met its primary endpoint, with results to be presented at the 2025 ASCO Annual Meeting [3] Immunology - CLN-978 is being developed for systemic lupus erythematosus, rheumatoid arthritis, and Sjögren's disease, with ongoing Phase 1 studies in the U.S., Europe, and Australia [6] - The company plans to initiate a Phase 1 study for active, difficult-to-treat rheumatoid arthritis in Germany and Italy in Q2 2025 [6] - A Phase 1 study for active, moderate to severe Sjögren's disease is also set to begin in the U.S. in Q2 2025 [6] Oncology - The pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib has met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC [3][6] - The company plans to submit a New Drug Application (NDA) for relapsed/refractory EGFR ex20ins NSCLC in the second half of 2025 [6] - Development of CLN-619 in gynecological cancers has been discontinued due to preliminary results not meeting internal advancement thresholds [6] Financial Performance - As of March 31, 2025, the company reported cash and investments totaling $567.4 million, providing a runway into 2028 [3][11] - Research and development expenses for Q1 2025 were $41.5 million, up from $30.6 million in Q1 2024 [11][14] - The net loss attributable to Cullinan for Q1 2025 was $48.5 million, compared to $37.1 million for the same period in 2024 [11][14]