Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rateCAMBRIDGE, Mass., April 23, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that results from the REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (ex20ins) who have received prior therapy will b ...

Core Insights - Cullinan Therapeutics has received approval from the European Medicines Agency (EMA) to initiate a clinical trial for CLN-978, a bispecific T cell engager targeting rheumatoid arthritis and systemic lupus erythematosus [1][3]. Company Overview - Cullinan Therapeutics, Inc. is a biopharmaceutical company focused on developing targeted therapies for autoimmune diseases and cancer, with a diversified portfolio of clinical-stage assets [6][7]. Product Details - CLN-978 is a novel CD19xCD3 bispecific T cell engager designed to target B cells effectively, including those with low CD19 levels, and offers a subcutaneous delivery option [4]. - The clinical trial for CLN-978 will assess its safety, pharmacokinetics, pharmacodynamics, and effects on disease activity in patients with difficult-to-treat rheumatoid arthritis [2][3]. Market Context - Rheumatoid arthritis affects approximately 5.3 million adults across several countries, with a significant unmet need for effective treatments as many patients do not achieve remission with current therapies [5].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39856 CULLINAN THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporati ...

Financial Performance - Cash and investments totaled $606.9 million as of December 31, 2024, providing a runway into 2028[2] - Net loss attributable to Cullinan was $47.6 million for Q4 2024, compared to $23.8 million for Q4 2023, and $167.4 million for the full year 2024, up from $153.2 million in 2023[11] - Total assets increased to $621.8 million as of December 31, 2024, from $484.2 million in 2023[14] - Total stockholders' equity rose to $590.3 million as of December 31, 2024, compared to $453.9 million in 2023[14] Research and Development - Research and development expenses for Q4 2024 were $40.5 million, up from $34.8 million in Q4 2023, while full-year R&D expenses decreased to $142.9 million from $148.2 million[11] - The pivotal Phase 2b study of zipalertinib met its primary endpoint, with full results expected mid-year 2025 and NDA submission planned for H2 2025[2] - Initial clinical data from the global Phase 1 study of CLN-978 in systemic lupus erythematosus is expected in Q4 2025[1] - The company plans to initiate a Phase 1 study in rheumatoid arthritis in Q2 2025, in collaboration with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore[5] - Enrollment continues in the Phase 1 study of CLN-619 for solid tumors and hematological malignancies, with initial data expected in Q2 2025[8] General and Administrative Expenses - General and administrative expenses for Q4 2024 were $14.6 million, compared to $10.6 million in Q4 2023, with full-year G&A expenses increasing to $54.0 million from $42.5 million[11]

Core Insights - Cullinan Therapeutics is advancing its clinical programs with significant updates expected in 2025, particularly for CLN-978 and zipalertinib [2][5] - The company reported a cash position of $606.9 million as of December 31, 2024, providing financial stability into 2028 [10][13] Immunology - CLN-978, a CD19 T cell engager, is the first and only development-stage therapy in autoimmune diseases with FDA IND clearance, with initial clinical data for systemic lupus erythematosus (SLE) expected in Q4 2025 [2][5] - A Phase 1 study for rheumatoid arthritis is set to begin in Q2 2025, in collaboration with institutions in Germany and Italy [5] Oncology - Zipalertinib's pivotal Phase 2b study met its primary endpoint, with full results anticipated mid-year 2025 and a New Drug Application (NDA) submission planned for H2 2025 [2][5] - The company continues to enroll patients in the Phase 1 study of CLN-619 for solid tumors and hematological malignancies, with initial data expected in Q2 2025 [5] Financial Performance - Research and development expenses for Q4 2024 were $40.5 million, up from $34.8 million in Q4 2023, while full-year R&D expenses decreased to $142.9 million from $148.2 million [10][14] - General and administrative expenses rose to $14.6 million in Q4 2024 from $10.6 million in Q4 2023, with full-year G&A expenses increasing to $54.0 million from $42.5 million [10][14] - The net loss attributable to Cullinan was $47.6 million for Q4 2024, compared to $23.8 million in Q4 2023, and $167.4 million for the full year 2024, up from $153.2 million in 2023 [10][14]

CAMBRIDGE, Mass., Jan. 30, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Guggenheim Securities SMID Cap Biotech Conference, being held in New York on February 5 and 6, 2025. The fireside chat is scheduled for Wednesday, February 5, ...

TOKYO, PRINCETON, N.J. and CAMBRIDGE, Mass., Jan. 28, 2025 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy, met its primary endpoint of overall response rate. The ...

Core Insights - Cullinan Therapeutics (NASDAQ: CGEM) is a multifocal biotech company focused on precision medicine and immunotherapy [1] - The company has experienced a significant decline in market sentiment, with a drop of approximately 60% from its recent high over the past six months [1] Company Overview - Cullinan Therapeutics is engaged in various programs within the fields of precision medicine and immunotherapy [1] - The company aims to educate investors on the scientific aspects of its business and the importance of due diligence in biotech investments [1] Market Performance - The stock of Cullinan Therapeutics has faced a substantial downturn, reflecting negative market sentiment and investor concerns [1]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-39856 | --- | --- | |----------------------------------------------------------------------------|------------------------- ...

Financial Performance - Cullinan Therapeutics reported a net loss of $40.6 million ($0.69 per share) for Q3 2024, compared to a net loss of $39.2 million ($0.91 per share) in Q3 2023[8]. - Research and development expenses increased to $35.5 million in Q3 2024 from $33.8 million in Q3 2023, while general and administrative expenses rose to $13.3 million from $11.0 million in the same period[8]. - The company had a cash position of $639.0 million as of September 30, 2024, which is expected to provide runway into 2028 based on its current operating plan[8]. - Total assets increased to $653.3 million as of September 30, 2024, up from $484.2 million at the end of 2023[13]. Clinical Development - Cullinan has secured FDA clearance for its IND application and HREC approval in Australia to initiate a global Phase 1 study for CLN-978 in systemic lupus erythematosus, with initial clinical data expected in Q4 2025[1][2]. - The pivotal Phase 2b study of zipalertinib was completed ahead of schedule, with results anticipated in mid-2025[1][5]. - Initial expansion cohort data for CLN-619 in endometrial and cervical cancers is expected to be shared in Q2 2025[1][4]. - The company plans to initiate a sponsored clinical trial for rheumatoid arthritis in Q2 2025, collaborating with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore[3]. - Cullinan presented positive results for zipalertinib, showing an objective response rate of approximately 40% in patients with EGFR ex20ins NSCLC[5]. Strategic Initiatives - The company added two experts to its Scientific Advisory Board to strengthen its capabilities in rheumatology and immunology[7].