Cullinan Therapeutics, Inc.

Cullinan Therapeutics, in collaboration with Taiho Oncology and Taiho Pharmaceutical, announced that its global Phase 3 REZILIENT3 clinical trial met its primary endpoint of progression-free survival (PFS) at a planned interim analysis. The trial evaluated zipalertinib combined with platinum-based chemotherapy for the first-line treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The zipalertinib arm showed statistically significant and clinically meaningful improvement in PFS with manageable safety, leading to a recommendation to unblind the study. The companies plan to seek U.S. regulatory approval for this combination regimen.

Cullinan Therapeutics reported a net loss of $53.7 million for the second quarter of 2026, an improvement from $70.1 million in the same period last year. For the six months ended June 30, 2026, the net loss was $103.4 million. The company maintains $334.5 million in cash, cash equivalents, and short-term investments, which is expected to fund operations for the next twelve months. Cullinan also has an active At-the-Market equity offering program for up to $200 million, though no sales have been made under it as of June 30, 2026.

Cullinan Therapeutics reported its second quarter 2026 financial results, with cash and investments totaling $356.0 million, extending its cash runway into 2029. The company's net loss for the quarter decreased to $53.7 million from $70.1 million in the prior year, driven by reduced R&D expenses. Cullinan also provided significant pipeline updates, including upcoming multi-dose regimen data for CLN-978 and Velinotamig in autoimmune diseases, and the initiation of a potentially registrational Phase 2 study for CLN-049 in relapsed/refractory AML in Q3 2026. Additionally, the NDA for zipalertinib was accepted by the US FDA with a PDUFA date in February 2027.

Cullinan Therapeutics reported its second quarter 2026 financial results and provided an update on its clinical pipeline. The company plans to initiate a potentially registrational Phase 2 study for CLN-049 in relapsed/refractory AML in Q3 2026. Additionally, multi-dose regimen data for CLN-978 in RA and SLE, and for velinotamig in SLE, are expected in Q3 and Q4 2026, respectively, with Phase 2 expansion studies for both programs starting in early 2027. Cullinan ended Q2 2026 with $356 million in cash and investments, providing a runway into 2029, and reported a reduced net loss of $53.7 million for the quarter.

Cullinan Therapeutics, Inc. announced positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 meeting for CLN-049, its FLT3xCD3 T cell engager for acute myeloid leukemia (AML). Based on these discussions, the company plans to initiate a potentially registrational Phase 2 study for CLN-049 in patients with relapsed/refractory AML in the third quarter of 2026, with a study design agreed upon with the FDA. Additionally, Cullinan will begin a Phase 1/2 study evaluating CLN-049 in combination with venetoclax and azacitidine for previously untreated AML.

Cullinan Therapeutics announced updated positive clinical data for CLN-978 in treatment-refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), demonstrating robust efficacy including clinical remission in RA and a favorable safety profile. Initial data for velinotamig in treatment-refractory SLE also showed promising clinical activity, with both treated patients achieving complete renal response and a favorable safety profile. The company plans further clinical development and data readouts for both programs in late 2026 and early 2027, including expansion into new indications.

Cullinan Therapeutics reported positive clinical data for its T cell engagers, CLN-978 (CD19 TCE) and velinotamig (BCMA TCE), in autoimmune diseases. CLN-978 demonstrated potential for immune reset and remissions in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), showing robust efficacy and a favorable safety profile in multi-dose regimens. Initial velinotamig data also showed promising clinical activity, including complete renal responses in lupus nephritis, supporting its potential in plasma cell-driven autoimmune diseases. The company plans further development, including Phase 2a expansion for CLN-978 in early 2027 and a Phase 1/2a trial for velinotamig in autoimmune cytopenias in Q1 2027, with additional data expected in Q3 and Q4 2026.

Cullinan Therapeutics announced initial clinical data from its Phase 1 OUTRACE trials for CLN-978, a CD19xCD3 T cell engager, in patients with treatment-refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The data, presented at EULAR 2026, showed clinical benefit including remissions in both patient groups, deep and dose-dependent B cell depletion, and a favorable safety profile. The company also announced an upcoming Immunology Day to present further data.

Cullinan Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, its novel FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia (AML). This designation underscores the urgent need for new therapies in AML, particularly for patients with TP53-mutated AML who face a poor prognosis. The Orphan Drug Designation provides significant development incentives, including tax credits, exemption from certain FDA user fees, and potential seven years of market exclusivity post-approval. CLN-049 is also currently undergoing Phase 1 studies and has previously received Fast Track designation for R/R AML.

Cullinan Therapeutics announced that initial clinical data from two ongoing Phase 1 studies (OUTRACE RA and OUTRACE SLE) evaluating CLN-978 will be presented at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology from June 3-6, 2026. The abstract reports a favorable safety profile at initial dose levels, robust B cell depletion, and early signals of promising clinical activity in patients with active, treatment-refractory rheumatoid arthritis and moderate to severe systemic lupus erythematosus. Updated data, including additional patients, will be presented at the congress.