Cullinan Oncology(CGEM) - 2025 Q2 - Quarterly Results

Executive Summary Cullinan Therapeutics announced Q2 2025 financial results, pipeline updates for CLN-978, velinotamig, and zipalertinib, and new board appointments Corporate Update & Q2 2025 Financial Results Announcement Cullinan Therapeutics announced Q2 2025 financial results, pipeline advancements for CLN-978 and velinotamig, zipalertinib's pivotal results, and new board appointments - CLN-978 program is actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease[1] - BCMA-directed bispecific T cell engager velinotamig was in-licensed from Genrix Bio[1] - Zipalertinib REZILIENT1 pivotal results were shared at ASCO 2025 and published in the Journal of Clinical Oncology[1] - The company appointed Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., to its Board of Directors[1] CEO Commentary CEO Nadim Ahmed emphasized strong execution in immunology and oncology pipelines, highlighting CLN-978, velinotamig, zipalertinib, and a robust cash position - Strong execution in advancing the CLN-978 program across three active studies in SLE, RA, and Sjögren's disease[2] - The addition of velinotamig further solidified leadership in T cell engager development for autoimmune diseases[2] - Pivotal Phase 2b REZILIENT1 study results for zipalertinib were shared at the 2025 ASCO Annual Meeting[3] - Cash and investments totaled $510.9 million as of June 30, 2025, providing a runway into 2028[3] Portfolio Highlights Cullinan Therapeutics provided updates on its diverse immunology and oncology clinical-stage programs, detailing progress and upcoming milestones Immunology Programs The immunology pipeline is advancing with CLN-978 in multiple Phase 1 studies and the in-licensed velinotamig for autoimmune diseases CLN-978 (CD19xCD3 bispecific T cell engager) CLN-978 is actively enrolling in global Phase 1 studies for SLE, RA, and Sjögren's disease, with initial SLE data expected in Q4 2025 - Global Phase 1 study in SLE is enrolling in the United States, Europe, and Australia, with initial safety and B cell depletion data from Part A expected in Q4 2025[4] - Phase 1 study in active, difficult-to-treat rheumatoid arthritis is enrolling in Europe, with initial data expected during the first half of 2026[4] - Global Phase 1 study in active, moderate to severe Sjögren's disease is enrolling in the U.S. and active in Europe[4] Velinotamig (BCMAxCD3 bispecific T cell engager) Cullinan licensed velinotamig globally (ex-Greater China) for $20 million upfront, with Genrix Bio initiating a Phase 1 study in China by late 2025 - An exclusive global (ex-Greater China) license agreement was made with Genrix Bio for velinotamig, including an upfront license fee of $20 million[7] - Genrix Bio is eligible for up to $292 million in development and regulatory milestones, plus up to an additional $400 million in sales-based milestones, and tiered royalties[7] - Genrix Bio plans to initiate a Phase 1 study in autoimmune diseases in China by the end of 2025[7] Oncology Programs The oncology pipeline advanced with zipalertinib's pivotal results and upcoming NDA, alongside ongoing enrollment for CLN-049, CLN-619, and CLN-617 Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology Zipalertinib's pivotal REZILIENT1 results were published, with Taiho planning an NDA submission by late 2025 and frontline study enrollment completion in H1 2026 - Pivotal Phase 2b REZILIENT1 results were shared at the 2025 ASCO Annual Meeting and published in the Journal of Clinical Oncology[7] - Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025[7] - Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026[7] - Initial data from REZILIENT2 cohorts (uncommon EGFR mutations, active brain metastases) will be shared at IASLC 2025 WCLC and ESMO Congress 2025[7] CLN-049 (FLT3xCD3 bispecific T cell engager) Enrollment for CLN-049 continues in Phase 1 studies for AML/MDS, with clinical data anticipated in Q4 2025 - Enrollment continues in the Phase 1 study for relapsed/refractory AML or MDS, with clinical data expected in Q4 2025[10] - Enrollment also continues in the Phase 1 study for patients with measurable minimal residual disease in AML[10] CLN-619 (Anti-MICA/MICB monoclonal antibody) CLN-619 enrollment continues in Phase 1 expansion cohorts for NSCLC and relapsed/refractory multiple myeloma - Enrollment continues in Phase 1 expansion cohorts for NSCLC and in the Phase 1 study for relapsed/refractory multiple myeloma[10] CLN-617 (IL-2 and IL-12 cytokine fusion protein) Enrollment for CLN-617 continues in its Phase 1 study for patients with advanced solid tumors - Enrollment continues in the Phase 1 study for patients with advanced solid tumors[10] Corporate Updates Cullinan Therapeutics announced new appointments to its Board of Directors, bringing significant expertise in immunology and oncology Board of Directors Appointments Cullinan appointed Drs Mittie Doyle and Andrew Allen to its Board, effective August 7, 2025, while Drs Martin and Ryan resigned - Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025[8] - Dr. Doyle brings extensive immunology clinical development expertise, and Dr. Allen brings extensive oncology clinical development experience[8] - Anne-Marie Martin, Ph.D., and David Ryan, M.D., resigned from Cullinan's Board of Directors effective August 7, 2025[8] Financial Results Cullinan Therapeutics reported its Q2 2025 financial performance, detailing cash position, operating expenses, and net loss Second Quarter 2025 Financial Summary Cullinan reported a $510.9 million cash position as of June 30, 2025, with increased R&D expenses and a widened net loss for Q2 2025 Key Financial Highlights for Q2 2025 | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------- | :------------------ | :------------------ | :------------------ | | Cash Position (as of June 30) | $510.9 | N/A | N/A | | R&D Expenses | $61.0 | $36.3 | +$24.7 (+68.0%) | | G&A Expenses | $14.8 | $13.8 | +$1.0 (+7.2%) | | Net Loss | $(70.1) | $(42.0) | $(28.1) (-66.9%) | - Cash, cash equivalents, short- and long-term investments, and interest receivable totaled $510.9 million as of June 30, 2025, providing runway into 2028[11] Selected Condensed Consolidated Balance Sheet Data As of June 30, 2025, Cullinan's cash, investments, total assets, and stockholders' equity all decreased compared to December 31, 2024 Selected Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :------------------------------------------ | :-------------- | :------------------ | :------------------ | | Cash, cash equivalents, investments, and interest receivable | $510,898 | $606,917 | $(96,019) | | Total assets | $520,329 | $621,824 | $(101,495) | | Total current liabilities | $28,058 | $30,647 | $(2,589) | | Total liabilities | $28,183 | $31,496 | $(3,313) | | Total stockholders' equity | $492,146 | $590,328 | $(98,182) | Consolidated Statements of Operations Total operating expenses significantly increased for Q2 and H1 2025, primarily due to higher R&D, leading to a widened net loss Consolidated Statements of Operations (Three Months Ended June 30, in thousands, except per share amounts) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------------------------ | :-------------- | :-------------- | :------------------ | | Research and development | $61,030 | $36,259 | +$24,771 (+68.3%) | | General and administrative | $14,768 | $13,768 | +$1,000 (+7.3%) | | Total operating expenses | $75,798 | $50,027 | +$25,771 (+51.5%) | | Loss from operations | $(75,798) | $(50,027) | $(25,771) (-51.5%) | | Interest income | $5,924 | $8,071 | $(2,147) (-26.6%) | | Net loss attributable to Cullinan | $(70,055) | $(42,028) | $(28,027) (-66.7%) | | Basic and diluted net loss per share (Common stock) | $(1.07) | $(0.68) | $(0.39) (-57.4%) | Consolidated Statements of Operations (Six Months Ended June 30, in thousands, except per share amounts) | Metric | H1 2025 (in thousands) | H1 2024 (in thousands) | Change (YoY) | | :------------------------------------------ | :-------------- | :-------------- | :------------------ | | Research and development | $102,489 | $66,905 | +$35,584 (+53.2%) | | General and administrative | $28,305 | $26,111 | +$2,194 (+8.4%) | | Total operating expenses | $130,794 | $93,016 | +$37,778 (+40.6%) | | Loss from operations | $(130,794) | $(93,016) | $(37,778) (-40.6%) | | Interest income | $12,504 | $13,764 | $(1,260) (-9.2%) | | Net loss attributable to Cullinan | $(118,556) | $(79,176) | $(39,380) (-49.7%) | | Basic and diluted net loss per share (Common stock) | $(1.81) | $(1.43) | $(0.38) (-26.6%) | About Cullinan Therapeutics Cullinan Therapeutics is a biopharmaceutical company focused on developing transformative clinical-stage assets for autoimmune diseases and cancer Company Overview Cullinan Therapeutics is a biopharmaceutical company developing a diversified portfolio of clinical-stage assets for autoimmune diseases and cancer - Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating new standards of care for patients[12] - The company has strategically built a diversified portfolio of clinical-stage assets targeting autoimmune diseases and cancer[12] - It is anchored in deep expertise in oncology, immunology, and translational medicine to develop transformative therapeutics[12] Forward-Looking Statements This section provides a standard disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties Disclaimer and Risk Factors This disclaimer highlights that forward-looking statements are subject to known and unknown risks and uncertainties, with no obligation to update them - The press release contains forward-looking statements regarding preclinical and clinical developments, therapeutic potential, R&D activities, future data presentations, and cash runway[13] - Forward-looking statements are subject to known and unknown risks and uncertainties, including regulatory timing, clinical trial success, intellectual property, manufacturing, and global economic conditions[14][15] - The company disclaims any obligation to update such forward-looking statements, except as required by law[15] Contacts This section provides contact information for investor relations and media inquiries Investor and Media Relations Contact details are provided for investor relations and media inquiries - Investors Contact: Nick Smith, +1 401.241.3516, nsmith@cullinantx.com[20] - Media Contact: Rose Weldon, +1 215.801.7644, rweldon@cullinantx.com[20]