Earnings summaries and quarterly performance for Cullinan Therapeutics.
Executive leadership at Cullinan Therapeutics.
NA
Nadim Ahmed
Detailed
President and Chief Executive Officer
CEO
CS
Corinne Savill
Detailed
Chief Business Officer
JS
Jacquelyn Sumer
Detailed
Chief Legal and Compliance Officer and Secretary
JJ
Jeffrey Jones
Detailed
Chief Medical Officer
JM
Jennifer Michaelson
Detailed
Chief Scientific Officer
MK
Mary Kay Fenton
Detailed
Chief Financial Officer
Board of directors at Cullinan Therapeutics.
Research analysts covering Cullinan Therapeutics.
Recent press releases and 8-K filings for CGEM.
CG Oncology Reports 2025 Year-End Financial Results and Provides Business Updates
CGEM
Earnings
Guidance Update
Board Change
- CG Oncology reported cash, cash equivalents, and marketable securities of approximately $903.0 million as of February 26, 2026, which is anticipated to be sufficient to fund operations into the first half of 2029.
- For the full year 2025, the company reported a net loss attributable to common stockholders of $161.0 million, or ($2.08) per share.
- Research and Development (R&D) expenses were $116.6 million for the full year 2025, while General and Administrative (G&A) expenses were $73.5 million for the same period.
- The company expects topline data from its PIVOT-006 Phase 3 trial and first results from the CORE-008 Cohort CX Phase 2 trial in the first half of 2026.
14 hours ago
Cullinan Therapeutics Provides 2026 Pipeline Catalysts and Strategic Updates
CGEM
Product Launch
New Projects/Investments
Guidance Update
- Cullinan Therapeutics expects multiple catalysts in 2026 for its oncology and autoimmune pipelines, including updates for CLN-978, CLN-049, and zipalertinib.
- For CLN-049 (AML), dose expansion cohorts are set to begin in Q2 2026, with a dose escalation data update in the second half of 2026, and a frontline combination study starting by the end of 2026. The relapsed/refractory segment alone is projected as a billion-dollar opportunity.
- Partner Taiho is anticipated to complete the rolling NDA submission for zipalertinib in Q1 2026 and finish enrollment in its frontline study in the first half of 2026. This partnership includes $130 million in regulatory milestones and a 50/50 US profit share.
- The company maintains a strong financial position with over $430 million in cash as of the end of December 2025, extending its operational runway into 2029.
Feb 19, 2026, 3:00 PM
Cullinan Therapeutics Outlines 2026 Pipeline Catalysts and Financial Position
CGEM
New Projects/Investments
Guidance Update
- Cullinan Therapeutics anticipates multiple catalysts in 2026 across its pipeline, particularly for its high-priority T-cell engagers, CLN-978 and CLN-049. The company plans to present the first company-sponsored data for its CD19 T-cell engager, CLN-978, throughout 2026.
- For CLN-049, a FLT3 x CD3 T-cell engager for AML, Cullinan plans to initiate dose expansion cohorts in Q2 2026 and provide a data update from the dose escalation study in the second half of 2026. A phase I/II combination study in the frontline setting is planned for Q4 2026. The relapsed/refractory segment for CLN-049 could be a billion-dollar opportunity, with the frontline setting potentially unlocking a multi-billion dollar opportunity.
- Cullinan's partner, Taiho, is completing the rolling NDA submission for zipalertinib (EGFR exon 20 NSCLC) in Q1 2026 and will complete enrollment in the frontline study in the first half of 2026. Cullinan is owed $130 million in regulatory milestones for US approvals and has a 50/50 profit share in the US for zipalertinib.
- As of the end of December 2025, Cullinan Therapeutics reported over $430 million in cash, providing a cash runway into 2029.
Feb 19, 2026, 3:00 PM
Cullinan Therapeutics discusses 2026 pipeline catalysts and financial outlook
CGEM
New Projects/Investments
Guidance Update
Product Launch
- Cullinan Therapeutics anticipates multiple catalysts across its oncology and autoimmune pipelines in 2026, including key updates for CLN-978, CLN-049, and zipalertinib.
- For CLN-049 (AML), dose expansion cohorts are set to begin in Q2 2026, with a dose escalation data update expected in the second half of 2026, and a frontline combination study initiating in Q4 2026. The relapsed/refractory segment alone is projected as a billion-dollar opportunity.
- Partner Taiho is anticipated to complete the rolling NDA submission for zipalertinib (non-small cell lung cancer) in Q1 2026 and finish enrollment in its frontline study in the first half of 2026. This collaboration includes $130 million in regulatory milestones and a 50/50 profit share in the US.
- The company maintains a robust balance sheet, reporting over $430 million in cash as of the end of December 2025, providing a financial runway into 2029.
Feb 19, 2026, 3:00 PM
Cullinan Therapeutics Outlines Key 2026 Catalysts and Program Updates
CGEM
New Projects/Investments
Guidance Update
Product Launch
- Cullinan Therapeutics (CGEM) expects multiple catalysts throughout 2026 for its high-priority T cell engager programs, CLN-978 (autoimmune diseases) and CLN-049 (AML).
- Initial single-dose data for CLN-978 in lupus and RA studies is anticipated in Q2 2026, with initial repeat dosing data expected in Q3 2026.
- CLN-049 received Fast Track designation and demonstrated compelling monotherapy efficacy in AML; the company plans to identify a recommended Phase II dose in 2026 for a pivotal study and initiate a combination study later in the year.
- The company reported over $430 million in cash at the end of 2025, providing a financial runway into 2029.
- Zipalertinib is a strategic asset with $130 million in outstanding regulatory milestones and a 50/50 U.S. profit share, with an NDA submission for relapsed disease expected in Q1 2026.
Feb 12, 2026, 4:00 PM
Cullinan Therapeutics Outlines 2026 Catalysts and Program Updates
CGEM
New Projects/Investments
Guidance Update
- Cullinan Therapeutics anticipates a "super exciting year" in 2026 with catalysts across its portfolio, focusing on CLN-978 for autoimmune diseases and CLN-049 for AML.
- For CLN-978, data readouts from lupus, RA, and Sjögren's disease studies are planned throughout 2026, with the first single-dose data from at least nine lupus patients and seven RA patients expected in Q2 2026, followed by initial repeat dosing data in Q3 2026.
- CLN-049, a first-in-class FLT3 bispecific for AML, demonstrated compelling monotherapy efficacy with 31% CR/CRh rates at the 12 microgram per kilogram dose and received Fast Track designation. The company aims to identify the recommended phase II dose in 2026 and initiate a phase 2 single-arm study in 2027 for potential accelerated approval.
- Cullinan reported over $430 million in cash at the end of 2025, providing a runway into 2029 without immediate capital raising needs.
- The zipalertinib program is anticipated to generate significant near-term, non-dilutive capital, with $130 million in outstanding regulatory milestones and a 50/50 US profit share; an NDA submission for relapsed disease is planned for Q1 2026.
Feb 12, 2026, 4:00 PM
Cullinan Therapeutics Outlines 2026 Catalysts and Program Updates
CGEM
New Projects/Investments
Guidance Update
Product Launch
- Cullinan Therapeutics anticipates a "super exciting year" in 2026 with catalysts across its entire portfolio, focusing on its high-priority T cell engager programs, CLN-978 and CLN-049.
- For CLN-978, a CD19 x CD3 bispecific T cell engager for autoimmune diseases, data readouts are planned throughout 2026, with initial single-dose data from lupus and RA studies expected in Q2 2026.
- CLN-049, a FLT3 x CD3 T cell engager for AML, showed compelling monotherapy efficacy data at ASH and received Fast Track designation. The company plans to identify a recommended Phase II dose for a pivotal study in 2026 and initiate a combination study later this year.
- The company ended 2025 with over $430 million in cash, providing a runway into 2029, which supports program advancement without immediate capital raising.
- Cullinan expects to complete the NDA submission for zipalertinib for relapsed disease in Q1 2026, with $130 million in outstanding regulatory milestones and a 50/50 profit share in the US.
Feb 12, 2026, 4:00 PM
CG Oncology Expedites PIVOT-006 Phase 3 Data Timeline
CGEM
New Projects/Investments
Guidance Update
- CG Oncology has announced an expedited timeline for the topline data readout of its Phase 3 PIVOT-006 clinical trial.
- Topline data for PIVOT-006, which evaluates cretostimogene monotherapy for intermediate-risk non-muscle invasive bladder cancer (IR NMIBC), is now expected in the first half of 2026, nearly one year ahead of schedule.
- This trial is the first randomized registrational trial for an investigational therapy in IR NMIBC, a patient population estimated at over fifty thousand in the US.
- The accelerated timeline is due to rapid study enrollment across more than 90 sites.
Jan 9, 2026, 1:30 PM
Cullinan Therapeutics Presents Promising CLN-049 Clinical Data and Outlines Development Strategy
CGEM
New Projects/Investments
Guidance Update
- Cullinan Therapeutics presented initial results for CLN-049, a FLT3 x CD3 bispecific T-cell engager, at ASH, demonstrating a composite CR rate of 31% in relapsed/refractory AML patients at the 12 mcg/kg dose level, with some responses lasting beyond four months.
- The company secured Fast Track designation from the FDA for CLN-049 in relapsed/refractory AML, with current efficacy data meeting the benchmark for regulatory approval and enabling a clear pathway for accelerated approval via a single-arm study.
- Cullinan plans to initiate initial expansion studies for CLN-049 in Q1 2026 for both all-comer and TP53 mutated AML patients, alongside a pivotal single-arm study for accelerated approval and a Phase I/II combination study in the frontline setting, all planned for 2026.
- The company maintains a robust cash position of approximately $475 million as of the end of September, providing a financial runway into 2029.
Dec 9, 2025, 1:00 AM
CGEM Provides Update on CLN-049 and CLN-978 Clinical Programs
CGEM
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Cullinan Therapeutics (CGEM) announced that its FLT3 x CD3 bispecific T-cell engager, CLN-049, received Fast-Track designation from the FDA for relapse refractory Acute Myeloid Leukemia (AML).
- Initial clinical data for CLN-049 in relapse refractory AML showed a composite CR rate of 31% at the 12 micrograms dose, with most responses durable beyond 16 weeks. The company plans to initiate the expansion phase in Q1 2026.
- The company anticipates generating multiple value-creating milestones in the first half of 2026 for its CD19 x CD3 bispecific T-cell engager, CLN-978, with initial data from RA and lupus studies expected next year.
- CGEM maintains a robust cash position of approximately $475 million as of the end of September 2025, providing a runway into 2029.
Dec 9, 2025, 1:00 AM
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