Every 8-K that Cullinan Oncology Inc (CGEM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow CGEM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full CGEM filings page.
Cullinan Therapeutics reported that the global Phase 3 REZILIENT3 trial in previously untreated, locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations met its primary endpoint of progression-free survival at a planned interim analysis. The combination of zipalertinib plus platinum-based chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy alone, with manageable observed safety, leading the Independent Data Monitoring Committee to recommend unblinding. The study, which enrolled 285 adults, will continue to monitor efficacy and safety, with full results to be presented at a future medical conference. Based on these topline results, Cullinan and its partner Taiho plan, after discussions with the U.S. Food and Drug Administration, to pursue U.S. regulatory approval for zipalertinib plus chemotherapy as a first-line treatment option for this genetically defined subset of NSCLC.
Cullinan Therapeutics reported second‑quarter 2026 results and outlined multiple near‑term clinical catalysts. For CLN‑978 in SLE and RA, additional multi‑dose data are planned in Q4 and Q3 2026, with Phase 2 expansion studies targeted for early 2027, including lupus nephritis and difficult‑to‑treat RA.
Velinotamig showed early complete renal responses in two SLE nephritis patients in a China study, with more data expected Q4 2026 and a global Phase 1/2 basket trial in autoimmune cytopenias planned for early 2027. Following a positive End‑of‑Phase 1 FDA meeting, a potentially registrational Phase 2 CLN‑049 study in relapsed/refractory AML is expected to start in Q3 2026, alongside a planned AML combination trial in Q4 2026. Zipalertinib’s NDA for EGFR ex20ins NSCLC has a PDUFA date of February 27, 2027, with Cullinan eligible for up to $130 million in U.S. approval milestones and a 50/50 U.S. profit share.
Financially, cash and investments were $356 million as of June 30, 2026, which management expects to fund operations into 2029. Q2 2026 research and development expenses were $44.4 million and general and administrative expenses were $12.8 million, leading to a net loss of $53.7 million, compared with $70.1 million a year earlier.
Cullinan Therapeutics, Inc. reported the results of its Annual Meeting of Stockholders held on June 16, 2026. Stockholders elected two Class III directors to three-year terms. Nadim Ahmed received 37,519,241 votes for and 12,116,759 votes withheld, while Stephen Webster received 36,963,086 votes for and 12,672,914 votes withheld.
Stockholders also ratified KPMG LLP as the independent registered accounting firm for the fiscal year ending December 31, 2026, with 53,722,477 votes for, 36,815 against, and 3,138 abstentions. In an advisory vote, stockholders approved compensation for the named executive officers, with 48,536,734 votes for, 1,092,209 against, 7,057 abstentions, and 4,126,430 broker non-votes.
Cullinan Therapeutics reported new early-stage clinical data for its T cell engager programs CLN-978 and velinotamig in autoimmune diseases. In Phase 1 OUTRACE RA, two heavily pre-treated rheumatoid arthritis patients showed robust responses, including one DAS28-ESR remission with a disease score falling from 4.0 to 2.2 by week eight. Initial multi-dose data in systemic lupus erythematosus show a favorable safety profile and support a planned Phase 2a expansion in lupus nephritis, expected to start in early 2027.
For velinotamig, the first two refractory SLE patients treated in a Phase 1b/2a study in China experienced rapid drops in SLEDAI-2K scores (from 16 and 14 to 0 and 2 at week eight) and achieved complete renal response, with no CRS or ICANS observed. Cullinan plans further CLN-978 data in RA in Q3 2026 and SLE in Q4 2026, additional velinotamig data in Q4 2026, and a Phase 1/2a trial in autoimmune cytopenias beginning in Q1 2027.
Cullinan Therapeutics reported initial Phase 1 data for CLN‑978, a CD19xCD3 T cell engager, in treatment‑refractory systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) from its OUTRACE trials. As of May 15, 2026, 29 patients had been evaluated across multiple step‑up and multi‑dose cohorts.
In SLE, among 14 patients with at least four weeks of follow‑up, 10 (71%) achieved a ≥4‑point hSLEDAI reduction and 5 reached DORIS remission. Peripheral B cells fell by more than 80% in 14 of 17 patients, with half of those at target doses ≥20 µg reaching depletion below the limit of quantification.
In RA, 5 of 7 patients (71%) showed improved disease activity, including one DAS28‑ESR remission at a 30 µg target dose. Deep, dose‑dependent B cell depletion was observed in blood, lymph node and synovial tissue, while autoantibody levels declined without affecting protective vaccine titers.
Across 10, 20 and 30 µg target doses, CLN‑978 was described as well tolerated. Cytokine release syndrome occurred in 11 of 29 patients, mostly Grade 1 after the initial 10 µg dose; one Grade 3 case followed a 45 µg dose, leading to discontinuation of that cohort. No ICANS events were reported. Cullinan will also discuss these data, first RA multi‑dose results, and initial velinotamig data at an Immunology Day on June 10.
Cullinan Therapeutics reported initial data from its Phase 1 OUTRACE Program testing CLN-978 in treatment‑refractory rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). As of a January 14, 2026 cutoff, 14 patients were dosed across RA (5 patients) and SLE (9 patients) cohorts.
Single subcutaneous step‑up and target doses of 10, 20, or 30 micrograms produced robust B cell depletion. After 10 micrograms, 9 of 11 patients showed more than 75% B cell reduction versus baseline; after 20 micrograms, three of six fell below quantification, with the others showing reductions of 98.5%, 77%, and 64%.
Among patients with at least four weeks of follow‑up, four of five RA patients had lower DAS28‑ESR scores, including four of four improving from high disease activity to moderate activity or remission. Five of six SLE patients had SLEDAI score reductions greater than four points. CLN‑978 was described as well tolerated with a favorable safety profile, and dose escalation is ongoing. Updated data will be presented at the EULAR Congress in June 2026.
Cullinan Therapeutics reported first quarter 2026 results and highlighted key pipeline milestones in autoimmune disease and oncology. Cash, cash equivalents, investments and interest receivable were $393.3 million as of March 31, 2026, which the company expects will fund operations into 2029 under its current plan.
The company booked a net loss of $49.7 million, with research and development expenses of $42.1 million and general and administrative expenses of $11.6 million for the quarter. Cullinan’s partner-led NDA for zipalertinib in EGFR ex20ins NSCLC was accepted by the U.S. FDA, with a PDUFA target action date of February 27, 2027.
Cullinan Therapeutics reported a full-year 2025 net loss attributable to the company of $219.9 million, compared with $167.4 million in 2024, driven mainly by higher research and development spending. Cash, equivalents, investments and interest receivable totaled $439.0 million as of December 31, 2025, which the company expects will fund operations into 2029.
The company highlighted multiple 2026 milestones, including initial clinical data for CLN-978 in systemic lupus erythematosus and rheumatoid arthritis in Q2 2026 and repeat dosing data in Q3 2026. Partner Taiho completed a rolling NDA submission and enrollment of the REZILIENT3 frontline study for zipalertinib, while Cullinan plans to advance CLN-049 toward registrational development in acute myeloid leukemia.
Cullinan Therapeutics reported preliminary cash, cash equivalents, short- and long-term investments, and interest receivable of $439.0 million as of December 31, 2025, and expects this cash runway to last into 2029 based on its current operating plan. The company emphasized that these figures are unaudited and may change once year-end financial closing procedures are complete.
Cullinan also outlined key 2026 milestones across its pipeline. For CLN-978 in multiple autoimmune diseases, it plans initial Phase 1 data readouts across rheumatoid arthritis, systemic lupus erythematosus, and Sjögren's disease between the second and fourth quarters of 2026. Velinotamig entered a Phase 1 study in China in December 2025, with initial data expected in the fourth quarter of 2026 to support global development.
In oncology, CLN-049 received Fast Track designation for relapsed/refractory AML, with further dose escalation updates and expansion cohorts planned through 2026, including preparation for an expected pivotal trial. For zipalertinib, co-developed with Taiho, a rolling NDA for relapsed EGFR ex20ins NSCLC is underway, with NDA completion targeted for the first quarter of 2026 and Cullinan eligible for up to $130.0 million in U.S. regulatory milestones plus 50% of any future pre-tax U.S. profits.
Cullinan Therapeutics, Inc. presented updated Phase 1 data for its bispecific antibody CLN-049 in patients with relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) at the ASH Annual Meeting. As of the August 2025 cutoff, 45 patients were enrolled across dose levels from 1.5 to 12 μg/kg, with 41 evaluable for efficacy. At the highest dose of 12 μg/kg (16 patients), the complete response/complete remission with partial hematologic recovery (CR/CRh) rate was 31% (5 of 16), and the composite complete response (CRc) rate was also 31%.
Across doses at or above 6 μg/kg (32 patients), the CR/CRh rate was 25% (8 of 32) and the CRc rate was 28% (9 of 32), with promising durability: 63% (5 of 8) of CR/CRh responders had responses lasting more than 16 weeks, and some proceeded to stem cell transplant. Among patients with bone marrow blasts under 5% at these doses, 30% were MRD negative, including one ongoing response beyond 36 weeks. In eight patients with high‑risk TP53‑mutated AML at 12 μg/kg, 50% achieved CR/CRh, with most responses lasting over 16 weeks. Safety data showed a favorable profile, with cytokine release syndrome mostly Grade 1–2, no Grade 3 CRS with two step‑up doses, and no CRS‑related treatment discontinuations. CLN-049 development will proceed under U.S. FDA Fast Track designation, with dose escalation ongoing and expansion cohorts planned in early 2026.
Cullinan Therapeutics, through its subsidiary Cullinan Amber Corp., is ending development of its CLN-617 cancer immunotherapy program. On November 18, 2025, the company notified the Massachusetts Institute of Technology that it is terminating their Exclusive Patent License Agreement covering the technology behind CLN-617, with the termination effective February 18, 2026. Under that agreement, MIT had granted Cullinan exclusive worldwide rights to develop the CLN-617 technology, which will now be returned to MIT. This move confirms CLN-617 will no longer be advanced within Cullinan’s pipeline.
Cullinan Therapeutics (CGEM) reported quarterly results and disclosed liquidity details. As of September 30, 2025, cash, cash equivalents, short- and long-term investments, and interest receivable totaled $475.5 million. The company stated its cash resources are expected to provide runway into 2029 under its new operating plan.
The press release with results was furnished as Exhibit 99.1. The disclosure was provided as supplemental information and designated as furnished, not filed, under the Exchange Act.
Cullinan Therapeutics reported new Phase 1 data for CLN-049 in relapsed/refractory AML and MDS, to be presented at the ASH Annual Meeting in December. As of the June 2025 cutoff, 40 patients were enrolled and 29 AML patients were efficacy evaluable.
In AML at target doses ≥6 μg/kg (n=23), CLN-049 showed a CRc rate of 30% and an ORR of 57%. At 12 μg/kg (n=13), the CRc rate was 31% and ORR was 69%. Among nine patients achieving bone marrow blasts <5%, three were MRD negative by flow cytometry; relapse was not observed in MRD-negative patients, and one patient has remained on study for >6 months. Responses were observed regardless of baseline genetic risk, including four responses (2 CRh, 2 MLFS) among five TP53‑mutated AML patients treated at 12 μg/kg.
Safety findings indicate a manageable profile in 40 patients: the most common TEAEs were CRS (40%) and infusion-related reaction (35%). All CRS events were Grade 1–2, with one Grade 1 ICANS; none led to discontinuation. Grade ≥3 TEAEs >10% included febrile neutropenia and white blood cell count decrease (17.5% each), and pneumonia (12.5%). Dose escalation is ongoing.
Cullinan Therapeutics, Inc. reported that it has refreshed its corporate presentation, which it uses in meetings with third parties and posts on its website, and has furnished the updated materials as an exhibit. The company also revised the anticipated timing for announcing initial clinical data from its CLN-978 program in systemic lupus erythematosus, now expecting this readout in the first half of 2026. The expected timelines for clinical data announcements from all of its other programs remain the same.