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.
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
CGEM Reports Positive CLN-049 Phase 1 AML Data and Provides Financial Outlook
CGEM
New Projects/Investments
Guidance Update
- CGEM presented promising Phase 1 clinical data for CLN-049, a FLT3xCD3 bispecific T cell engager, in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) at ASH 2025. At the highest target dose of 12 µg/kg, CLN-049 achieved a 31% CR+CRh rate in heavily pre-treated R/R AML patients, with responses durable beyond 16 weeks. For TP53-mutated AML, the CR+CRh rate was 50% in the 12 µg/kg cohorts.
- CLN-049 has U.S. FDA Fast Track designation in R/R AML, and expansion cohorts are planned to begin in early 2026. The company believes a single-arm Phase 2 study may be sufficient for accelerated approval, targeting a $1B+ commercial opportunity in the R/R AML segment alone.
- As of September 30, 2025, CGEM held $475 million in cash and investments, which is projected to fund operations into 2029.
- The company is also developing CLN-978 for autoimmune diseases, with initial Phase 1 data in SLE and RA anticipated in H1 2026.
Dec 9, 2025, 1:00 AM
Cullinan Therapeutics Highlights Positive CLN-049 Data and Future Milestones
CGEM
New Projects/Investments
- Cullinan Therapeutics received Fast Track designation from the FDA for CLN-049 for the treatment of relapse refractory AML.
- Initial clinical data for CLN-049 showed a composite complete response (CR) rate of 31% at the 12 micrograms dose, with the majority of responses durable beyond 16 weeks.
- The company plans to initiate the expansion phase of the CLN-049 trial in Q1 2026, targeting completion by the end of 2026, with a regulatory pathway for accelerated approval in relapse refractory AML.
- Cullinan Therapeutics anticipates generating multiple value-creating milestones for its CLN-978 program in the first half of 2026, including presenting initial data from RA and lupus studies.
- The company reported 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
Cullinan Therapeutics Presents Positive CLN-049 Clinical Data in AML
CGEM
New Projects/Investments
- Cullinan Therapeutics presented updated Phase 1 clinical data for its novel FLT3xCD3 bispecific T cell engager, CLN-049, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the 67th ASH Annual Meeting on December 8, 2025.
- As of the August 2025 data cutoff, CLN-049 demonstrated promising efficacy in heavily pretreated AML patients, including a 31% complete response (CR)/CRh rate at the highest target dose of 12 µg/kg (n=16). Notably, 50% (4/8) of patients with TP53 -mutated AML treated at this dose achieved a CR/CRh response.
- The study also showed a favorable safety profile across all doses assessed, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%) and infusion-related reaction (33.3%), with nearly all CRS events limited to Grade 1 or 2.
- CLN-049 recently received Fast Track designation from the U.S. FDA for R/R AML, and the company plans to continue dose escalation with expansion cohorts in early 2026.
Dec 8, 2025, 3:31 PM
Cullinan Therapeutics outlines pipeline priorities and cash runway
CGEM
Guidance Update
New Projects/Investments
Product Launch
- Cullinan Therapeutics (CGEM) reported approximately $475 million in cash as of the end of September 2025, extending its cash runway into 2029.
- The company has discontinued two programs, CLN-617 and CLN-619, to reallocate resources to priority programs.
- CLN-978, a CD19 x CD3 T-cell engager for autoimmune diseases, is a key focus, with initial data for SLE and RA expected in H1 2026 and H2 2026, respectively.
- CLN-049 for AML demonstrated a 30% composite complete response rate in an ongoing dose escalation study, with an oral presentation at ASH.
- Partner Taiho is on track to submit the NDA for Zipalertinib by the end of 2025, which could provide $130 million in regulatory milestone payments and a 50/50 profit share in the US.
Nov 12, 2025, 1:00 PM
Cullinan Therapeutics Provides Pipeline and Financial Update at Healthcare Conference
CGEM
New Projects/Investments
Guidance Update
- Cullinan Therapeutics is focusing its pipeline on first-in-class or best-in-class molecules for cancer and autoimmune diseases, including CLN-978 (CD19 x CD3 T-cell engager) and CLN-049 (FLT3 x CD3 T-cell engager), having recently discontinued two programs to optimize resource allocation.
- The company reported $475 million in cash as of the end of September 2025, providing a cash runway into 2029.
- Key upcoming catalysts include the NDA submission for zipalertinib by partner Taiho by the end of 2025, an oral presentation for CLN-049 at ASH, and initial data for CLN-978 in SLE in H1 2026 and RA in H2 2026.
- CLN-049 demonstrated a 30% composite complete response rate in an ongoing dose escalation study for AML, with an oral presentation scheduled at ASH.
Nov 12, 2025, 1:00 PM
Cullinan Therapeutics Provides Pipeline Update, Financial Position, and Upcoming Milestones
CGEM
New Projects/Investments
Guidance Update
- Cullinan Therapeutics (CGEM) reported approximately $475 million in cash as of the end of September 2025, providing a cash runway into 2029 following the discontinuation of two programs, CLN-617 and CLN-619, to reallocate resources.
- The company is advancing CLN-978, a CD19 x CD3 T-cell engager for autoimmune diseases, with initial data from an SLE study expected in the first half of 2026 and an RA study in the second half of 2026.
- For its oncology pipeline, CLN-049, a FLT3 x CD3 T-cell engager for AML, showed promising initial data with a 30% composite complete response rate in an ongoing dose escalation study and will have an oral presentation at ASH.
- Cullinan's partner, Taiho, is on track to initiate the NDA submission for Zipalertinib (for NSCLC) by the end of 2025, which could provide $130 million in regulatory milestone payments and a 50/50 profit share in the US.
Nov 12, 2025, 1:00 PM
Cullinan Therapeutics Reports Q3 2025 Financial Results and Provides Pipeline Update
CGEM
Earnings
Guidance Update
New Projects/Investments
- Cullinan Therapeutics reported $475.5 million in cash, cash equivalents, short- and long-term investments, and interest receivable as of September 30, 2025, with a projected cash runway into 2029.
- For the third quarter ended September 30, 2025, the company recorded a net loss of $50.6 million, with research and development expenses at $42.0 million and general and administrative expenses at $13.6 million.
- The company has discontinued the CLN-619 and CLN-617 programs to strategically focus resources on select clinical-stage programs.
- Key pipeline updates include promising Phase 1 clinical data for CLN-049 in AML, demonstrating a ~30% CRc rate, which will be presented at ASH 2025. Initial data for CLN-978 in autoimmune diseases is expected in the first half of 2026, and partner Taiho plans to initiate a rolling NDA submission for zipalertinib by year-end 2025.
Nov 6, 2025, 12:00 PM
Cullinan Therapeutics to Present Positive CLN-049 Clinical Data at ASH Meeting
CGEM
New Projects/Investments
- Cullinan Therapeutics will present new Phase 1 clinical data for CLN-049, a novel FLT3xCD3 bispecific T cell engager for relapsed/refractory (r/r) AML and MDS, at the 67th ASH Annual Meeting on December 8, 2025.
- The data demonstrated compelling anti-leukemic activity, with a composite complete response (CRc) rate of 30% at target doses ≥6 µg/kg, and a CRc rate of 31% and overall response rate (ORR) of 69% at the highest target dose of 12 µg/kg.
- CLN-049 showed a manageable safety profile and achieved responses regardless of FLT3 mutational status or baseline genetic risk, including in TP53-mutated AML patients.
Nov 3, 2025, 2:11 PM
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