Cullinan Therapeutics (NASDAQ:CGEM) expects 2026 to be a catalyst-heavy year across its pipeline, led by two “high-priority” T-cell engager programs in autoimmune disease and acute myeloid leukemia (AML), according to comments from CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones during a Guggenheim fireside chat.
Ahmed said the company laid out milestones “starting from Q2,” with planned updates in every quarter. He also highlighted Cullinan’s balance sheet, noting that the company ended 2025 with “over $430 million in cash,” which he said provides runway “into 2029” and supports advancing its lead programs without a near-term capital raise.
CLN-978: Q2 single-dose data in lupus and rheumatoid arthritis
On timelines, management said the first readout is expected in the second quarter from single-dose escalation in lupus and RA. Jones said the company had completed the first two dose cohorts (10 micrograms and 20 micrograms) in both studies and was enrolling the 30 microgram cohort. Based on that, management expects Q2 results to include at least three dose cohorts, representing “at least nine patients” in lupus and “at least seven patients” in RA, with the possibility of entering a fourth 45 microgram cohort depending on recruitment.
Jones also compared the autoimmune dosing strategy to prior oncology experience, noting that a first-in-human oncology study started at 30 micrograms weekly given subcutaneously and included “a complete response in one of three patients” at that starting dose. Despite observing no more than Grade 1 cytokine release syndrome (CRS) at that dose, he said Cullinan started autoimmune development two dose levels lower to prioritize safety while still aiming for physiologic activity.
What management wants to see: B-cell depletion and early dose-response
For the upcoming Q2 update, Jones emphasized that the key objective is to show a dose-response relationship for B-cell depletion with an acceptable therapeutic index. In lupus, Cullinan plans to evaluate peripheral blood B-cell depletion. In RA, Jones said the dataset is “enriched with tissue-level B-cell depletion” from paired biopsies of affected joint linings and lymph nodes.
Management positioned Q2 as a setup for more meaningful efficacy evaluation later in the year. The company has guided to initial repeat-dosing data in the third quarter, and Jones said this is where Cullinan expects to be able to demonstrate “more robust efficacy,” referencing an exposure-response relationship seen in academic reports of T-cell engagers in autoimmune disease.
Safety and outpatient feasibility: focus on low-grade CRS and no ICANS
As Cullinan looks toward later-stage dosing and broader adoption, Jones said physician feedback suggests that meaningful treatment-free remissions paired with manageable safety could support use in the community setting. He described a target profile that would include no higher than Grade 1 CRS in the majority of patients, “single-digit rates of Grade 2 CRS,” and “no ICANS,” adding that Grade 3 CRS would be “out of the question.” He also noted rheumatologists are less familiar with ICANS and would prefer not to manage it.
Jones framed “treatment-free remission” as time when patients can avoid ongoing infusions or daily medications, including maintenance therapy. He pointed to external academic series suggesting some patients have gone “six months, and ongoing” without medication following CD19-directed T-cell engager treatment, describing the potential as transformative compared with chronic immunosuppression.
BCMA program: expanding reach beyond CD19-driven disease biology
Ahmed also addressed Cullinan’s in-licensed BCMA T-cell engager and how it fits alongside CLN-978. He said the company views CD19 and BCMA as complementary, allowing Cullinan to reach more autoimmune diseases and patients than either target alone. Ahmed described CLN-978 as a fit for rheumatologic indications driven by B-cell dysfunction, while BCMA-directed therapy may be more appropriate for diseases where pathogenic antibodies are produced by long-lived plasma cells, citing examples such as myasthenia gravis and certain immune-driven hematologic and thyroid-related indications.
Ahmed added that the acquisition made Cullinan “the only company with both a clinical stage CD19 and a clinical stage BCMA agent.”
CLN-049 in AML: ASH data, Fast Track, and dose expansion plans
In oncology, Cullinan is advancing CLN-049, a FLT3xCD3 T-cell engager for AML. Ahmed said the company presented “compelling monotherapy efficacy data” at the American Society of Hematology (ASH) meeting and received FDA Fast Track designation about a week beforehand. Jones said the key measure in AML is achieving complete remission, and reported that once dosing reached 6 micrograms/kg in Phase I escalation, the company began seeing deep responses that increased as dosing rose to 12 micrograms/kg (the highest dose explored at the time of the ASH presentation).
Jones said composite complete remission rates were “31%” at 12 micrograms/kg and noted some responses were durable beyond 16 weeks, including “at least one patient” with an ongoing complete response out to six months on therapy. He also highlighted responses in difficult-to-treat genetic subgroups, including TP53-mutated disease and complex karyotype.
Looking ahead, Ahmed said Cullinan plans dose expansion at two doses in an all-comer population to support dose optimization under Project Optimus, with the goal of selecting a recommended Phase II dose by year-end. He also described a cohort focused on TP53-mutated patients spanning relapsed/refractory and previously untreated settings. Management said it hopes to initiate a single-arm Phase II study in 2027 that could support an accelerated approval pathway in the U.S. The company has also announced plans to begin a Phase 1b/2 combination study with azacitidine (AZA) in previously untreated patients before the end of 2026.
Separately, Ahmed said Cullinan is also approaching a milestone with zipalertinib, an EGFR exon 20 insertion TKI partnered with Taiho. He said Taiho is now leading development, guiding to completion of enrollment in the frontline study in the first half of 2026 and an NDA submission for relapsed disease “this quarter.” Ahmed added that the program could provide non-dilutive capital, citing “$130 million in regulatory milestones still outstanding” tied to U.S. frontline and second-line approvals and a “50/50 profit share” in the U.S.
About Cullinan Therapeutics (NASDAQ:CGEM)
Cullinan Therapeutics, Inc, a biopharmaceutical company, focuses on developing oncology therapies for cancer patients in the United States. The company's lead program comprises CLN-619, a monoclonal antibody that is in Phase I clinical trial for the treatment of solid tumors. Its development portfolio also includes CLN-049, a humanized bispecific antibody that is in Phase I clinical trial for the treatment of acute myeloid leukemia or myelodysplastic syndrome; CLN-418, a human bispecific immune activator that is in Phase 1 clinical trial for the treatment of multiple solid tumors; and Zipalertinib, a bioavailable small-molecule for treating patients with non-small cell lung cancer.
