Core Insights - CLN-049 monotherapy shows promising efficacy in patients with relapsed/refractory acute myeloid leukemia (R/R AML), achieving a 31% complete response (CR) rate at the highest tested dose of 12 µg/kg [1][5][12] - The drug has received Fast Track designation from the U.S. FDA, indicating its potential to address unmet medical needs in AML treatment [1][12] - An in-person event will be held by the company to discuss the clinical data presented at the 67th American Society of Hematology Annual Meeting [1][8] Efficacy Results - As of August 2025, 45 patients were enrolled in the Phase 1 study, with 41 patients being evaluable for efficacy [3] - The CR/CRh rate at the highest dose of 12 µg/kg was 31%, with anti-leukemic activity observed at doses ≥6 µg/kg [5][6] - Among patients achieving a CR/CRh response at doses ≥6 µg/kg, 63% had a duration of response exceeding 16 weeks [4][6] Safety Profile - The safety profile of CLN-049 is favorable, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%) and infusion-related reactions (33.3%) [13] - Most adverse events were Grade 1 or 2, with no Grade 3 cytokine release syndrome observed [13] Target Population - CLN-049 targets FLT3-expressing leukemia cells, applicable to both mutated and non-mutated forms, making it relevant for a broad population of AML patients [10][13] - The drug shows particular promise for patients with TP53-mutated AML, with a 50% CR/CRh response rate observed in this subgroup at the highest dose [13] Future Development - The development of CLN-049 will continue under FDA Fast Track designation, with ongoing dose escalation and planned expansion cohorts in early 2026 [7][12]

Core Insights - The FDA has granted Fast Track designation to CLN-049 for treating relapsed/refractory acute myeloid leukemia (AML), highlighting the urgent need for new treatment options in this area [1][2] - Initial results from the Phase 1 study of CLN-049 indicate meaningful efficacy, including complete responses, suggesting its potential as a novel immunotherapeutic approach for AML [2][4] - CLN-049 is a bispecific T cell engager designed to target FLT3-expressing leukemia cells, making it applicable to a broad population of AML patients regardless of FLT3 mutational status [4][5] Company Overview - Cullinan Therapeutics, Inc. is focused on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [8] - The company is advancing its clinical-stage pipeline with a rigorous scientific approach aimed at delivering new standards of care for patients [8] Industry Context - Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, with approximately 22,000 new diagnoses annually in the U.S. and around 11,000 deaths [6] - Despite recent advances, the five-year survival rate for patients with relapsed or refractory AML is 10% or less, indicating a significant unmet medical need for effective therapies [7] - Currently, there are no approved immunotherapies for AML, underscoring the critical demand for innovative treatment options [7]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Chijet Motor Company, Inc. (CJET) is up 40% at $2.67 - JX Luxventure Group Inc. (JXG) is up 19% at $4.12 - Inspire Medical Systems, Inc. (INSP) is up 15% at $103.50 - Epsium Enterprise Limited (EPSM) is up 15% at $4.14 - Oscar Health, Inc. (OSCR) is up 12% at $15.13 - Green Dot Corporation (GDOT) is up 11% at $13.21 - Butterfly Network, Inc. (BFLY) is up 6% at $2.82 - Cullinan Therapeutics, Inc. (CGEM) is up 5% at $10.00 - Vir Biotechnology, Inc. (VIR) is up 5% at $5.99 - Nvni Group Limited (NVNI) is up 5% at $3.17 [3] Premarket Losers - Clearside Biomedical, Inc. (CLSD) is down 69% at $0.82 - Twin Hospitality Group Inc. (TWNP) is down 20% at $2.84 - Shuttle Pharmaceuticals Holdings, Inc. (SHPH) is down 15% at $1.35 - Mobile-Network Solutions (MNDR) is down 12% at $4.16 - Waldencast plc (WALD) is down 10% at $2.75 - authID Inc. (AUID) is down 9% at $1.21 - EZGO Technologies Ltd. (EZGO) is down 6% at $1.98 - SciSparc Ltd. (SPRC) is down 5% at $2.34 - Twin Vee Powercats Co. (VEEE) is down 5% at $1.70 - Agape ATP Corporation (ATPC) is down 5% at $1.22 [4]

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 - Cullinan Therapeutics, Inc. is actively participating in investor conferences and hosting an event at the 2025 ASH Annual Meeting to showcase its advancements in therapies for autoimmune diseases and cancer [1][4] Company Overview - Cullinan Therapeutics, Inc. (Nasdaq: CGEM) focuses on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [3] - The company is committed to delivering new standards of care through a clinical-stage pipeline built on rigorous scientific approaches and purposeful innovation [3] Upcoming Events - The management team, including CEO Nadim Ahmed and CMO Jeffrey Jones, will participate in fireside chats at the Stifel 2025 Healthcare Conference on November 11, 2025, and the Guggenheim 2nd Annual Healthcare Innovation Conference on November 12, 2025 [4] - An in-person event for analysts and institutional investors is scheduled for December 8, 2025, during the ASH Annual Meeting, following the presentation of Phase 1 study results for CLN-049 in patients with AML or MDS [4]

Financial Performance - The company has not generated any revenue from product sales since its inception and does not expect to do so in the near future [92]. - The company has a history of significant operating losses and negative cash flows from operations since its inception [87]. - The net loss for Q3 2025 was $50.610 million, compared to a net loss of $40.560 million in Q3 2024, reflecting an increase of $10.050 million (24.8%) [100]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $137.641 million, compared to $108.677 million in the same period of 2024, an increase of $28.964 million (26.7%) [111]. Cash and Investments - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $332.6 million, with an accumulated deficit of $537.4 million [87]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments totaling $332.6 million, with long-term investments and interest receivable of $142.9 million [106]. - The company has an at-the-market equity offering program allowing for the sale of up to $125.0 million in common stock, with $85.6 million remaining as of September 30, 2025 [110]. Research and Development - Research and development expenses increased by $6.5 million (18.3%) in Q3 2025 compared to Q3 2024, totaling $41.968 million, driven by clinical development costs and additional headcount [100][101]. - For the nine months ended September 30, 2025, research and development expenses rose by $42.0 million (41.0%) to $144.457 million, primarily due to a one-time upfront licensing fee of $20.0 million for velinotamig [101]. - The company is evaluating CLN-049 in an ongoing Phase 1 clinical trial for relapsed/refractory acute myeloid leukemia, with updated results expected at the 2025 ASH Annual Meeting [86]. - The company plans to share initial safety and B cell depletion data for CLN-978 in systemic lupus erythematosus and rheumatoid arthritis in the first half of 2026 [78]. - The Phase 2b portion of the REZILIENT1 trial for zipalertinib met its primary endpoint, and Taiho plans to initiate a rolling submission of a new drug application by the end of 2025 [78]. Licensing and Collaborations - The company entered into a license agreement with Genrix for velinotamig, paying an upfront fee of $20.0 million in June 2025 [88]. - The company entered into a licensing agreement with Genrix in June 2025, paying an upfront fee of $20.0 million for the exclusive rights to develop and commercialize velinotamig [108]. - The company has payment obligations contingent upon future events under various license and collaboration agreements, including milestone and royalty payments [122]. Risks and Future Funding - The company is subject to risks common to early-stage biotechnology companies, including reliance on third parties and the need for additional capital to fund operations [89]. - Future funding requirements may increase significantly due to ongoing research, clinical trials, and potential acquisitions to expand the product pipeline [119]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute current ownership interests [121]. Operating Expenses - Total operating expenses for Q3 2025 were $55.595 million, up $6.740 million (13.8%) from $48.855 million in Q3 2024 [100]. Intellectual Property - The company has a controlling interest in the worldwide intellectual property rights for CLN-619 (99%), CLN-049 (98%), and CLN-617 (96%) as of September 30, 2025 [83]. Accounting Policies - There have been no material changes to the company's critical accounting policies since the 2024 10-K [125]. - Recently issued and adopted accounting pronouncements that may impact financial position are disclosed in the quarterly report [126]. - The company is electing scaled disclosure requirements available to smaller reporting companies regarding market risk [127].

Clinical Development - CLN-049 demonstrated a ~30% complete response rate in heavily pretreated patients with relapsed/refractory AML, with updated results to be presented at the 2025 ASH Annual Meeting[1] - The company plans to share initial clinical data for CLN-978 in autoimmune diseases in the first half of 2026[2] - The Phase 1 OUTRACE Program for CLN-978 is currently enrolling patients across multiple studies[6] - Taiho plans to initiate a rolling submission of an NDA for zipalertinib by year-end 2025, following a positive pre-NDA meeting with the FDA[3] - The core pipeline is now focused on T cell engagers, with discontinued programs CLN-619 and CLN-617[3] Financial Performance - Cash and investments totaled $475.5 million as of September 30, 2025, providing a runway into 2029[1] - Research and development expenses increased to $42.0 million for Q3 2025, compared to $35.5 million in Q3 2024[7] - General and administrative expenses were $13.6 million for Q3 2025, slightly up from $13.3 million in Q3 2024[7] - Net loss attributable to Cullinan was $50.6 million for Q3 2025, compared to $40.6 million for the same period in 2024[7] - Total stockholders' equity decreased to $451.4 million as of September 30, 2025, down from $590.3 million at the end of 2024[14]

Core Insights - Cullinan Therapeutics is focusing on high-conviction clinical stage programs, particularly CLN-049 and CLN-978, with promising data expected to be presented at upcoming conferences [2][3] - The company has discontinued the CLN-619 and CLN-617 programs based on emerging clinical data, streamlining its pipeline towards T cell engagers [3] - As of September 30, 2025, Cullinan reported cash and investments totaling $475.5 million, providing a financial runway into 2029 [1][12] Clinical Programs - CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrated a ~30% complete response rate in heavily pretreated patients with relapsed/refractory acute myeloid leukemia (AML) [1][12] - Initial data for CLN-978, targeting systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), is expected to be shared in the first half of 2026 [1][6] - The Phase 1 OUTRACE Program for CLN-978 is currently enrolling patients across multiple studies [6] Financial Performance - Research and development expenses for Q3 2025 were $42.0 million, up from $35.5 million in Q3 2024 [12][15] - General and administrative expenses were $13.6 million for Q3 2025, slightly higher than $13.3 million in Q3 2024 [12][15] - The net loss attributable to Cullinan for Q3 2025 was $50.6 million, compared to $40.6 million for the same period in 2024 [12][16] Strategic Focus - The company is strategically concentrating resources on T cell engagers, which are seen as having transformative potential in immunology and oncology [3][2] - A positive pre-NDA meeting with the FDA has set the stage for a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins non-small cell lung cancer (NSCLC) by year-end 2025 [3][7]

Core Insights - CLN-049 has shown promising anti-leukemic activity in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), achieving a composite complete response (CRc) rate of approximately 30% at clinically active doses [1][11] - The drug demonstrated a manageable safety profile across all assessed doses, with the most common treatment-emergent adverse events being cytokine release syndrome (40%) and infusion-related reactions (35%) [12][7] - Cullinan Therapeutics plans to present updated clinical data at the 67th American Society of Hematology (ASH) Annual Meeting on December 8, 2025 [1][3] Company Overview - Cullinan Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing first- or best-in-class therapies for autoimmune diseases and cancer [15] - The company is advancing its pipeline with a focus on T cell engagers, which are established in oncology and are now being explored for autoimmune diseases [15] Clinical Study Details - The Phase 1 study of CLN-049 enrolled 40 patients (34 with AML and 6 with MDS) and assessed safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy [10][4] - The study included patients who had received a median of 2 prior therapies, indicating a heavily pretreated population [4] Efficacy Results - At the highest target dose of 12 μg/kg, the CRc rate was 31% and the overall response rate (ORR) was 69% [11] - Responses were observed in patients with AML regardless of baseline genetic risk, including those with TP53 mutations, where 4 out of 5 patients showed responses [11][2] Safety Profile - The safety profile of CLN-049 was deemed manageable, with no treatment discontinuations due to adverse events [12][7] - Grade ≥3 treatment-emergent adverse events included febrile neutropenia and white blood cell count decrease, each occurring in 17.5% of patients [12]

Core Insights - Cullinan Therapeutics is presenting new preclinical data for CLN-978, a bispecific T cell engager targeting autoimmune diseases, at the ACR Convergence 2025 [1][5] - CLN-978 has shown robust B cell depletion and T cell activation in patients with autoimmune diseases [2] - The drug demonstrated dose-dependent B cell depletion in nonhuman primates, indicating potential for significant clinical efficacy [3] - In murine models, CLN-978 treatment resulted in reduced circulating B cells and disease-modifying effects in systemic lupus erythematosus [4] Company Overview - Cullinan Therapeutics is focused on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [7] - The company is advancing global clinical programs for CLN-978 in rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus, with active trials in multiple countries [5][6] - CLN-978 is designed for high affinity binding to CD19, allowing it to target B cells effectively, including those with low CD19 levels [6]