Cullinan reports Q2 2026 results, outlines T cell engager trial timelines
Cullinan says a positive FDA meeting clears the way for a registrational AML study this quarter, with cash runway into 2029.
Cullinan Therapeutics reported second quarter 2026 results and a pipeline update on August 6, 2026. The company said that following a positive End-of-Phase 1 meeting with the U.S. FDA in July, it will initiate a potentially registrational Phase 2 study in patients with relapsed/refractory AML in Q3 20261. That study will begin with a dose-optimization phase with seamless progression to a single-arm expansion cohort at the recommended Phase 2 dose.1 Cullinan also plans a Q4 2026 update from the Phase 1 dose escalation portion in AML or MDS patients, and said in Q4 2026, the Company will initiate a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with previously untreated AML.1
For CLN-978 in rheumatoid arthritis, Cullinan said in Q3 2026, it plans to share additional multi-dose regimen data and also plans to begin Phase 2 expansion in early 2027.1 For CLN-978 in SLE, the company said in Q4 2026 it plans to share initial multi-dose regimen data and also plans to begin Phase 2 expansion in early 2027 in patients with SLE and in patients with lupus nephritis.1 For Sjögren's disease, the company plans to share initial data from the single target dose escalation portion of the study in Q4 2026.1
On velinotamig, additional multi-dose regimen data from the Genrix Bio Phase 1/2 study in China are expected in Q4 2026, and Cullinan plans to initiate a global Phase 1/2 basket study in early 2027 in patients with autoimmune cytopenias, including ITP and AIHA.1
On the partnered oncology asset, the FDA accepted an NDA in April for zipalertinib in EGFR ex20ins NSCLC patients who progressed on platinum-based chemotherapy, with a PDUFA target action date of February 27, 2027.1 Taiho expects top-line results from the REZILIENT3 pivotal study by the end of 2026.1
Financially, cash, cash equivalents, short- and long-term investments, and interest receivable were $356.0 million as of June 30, 2026, and the company expects this to provide runway into 2029 under its current operating plan.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.