Cullinan Therapeutics, Inc. filings document formal disclosures for a clinical-stage biopharmaceutical company developing therapies for autoimmune diseases and cancer. Recent Form 8-K reports furnish operating results and financial-condition updates, Regulation FD materials, and clinical disclosures tied to programs including CLN-978, CLN-049 and zipalertinib.
The filing record also covers corporate and governance matters, including definitive proxy disclosures on executive and director compensation, equity awards and shareholder voting matters. Material-event filings document portfolio and contractual actions, including the termination of an exclusive patent license related to CLN-617 through Cullinan Amber Corp.
Cullinan Therapeutics, Inc. (CGEM) initiated a New Drug Application submission to the FDA for zipalertinib with platinum-based chemotherapy in previously untreated, locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. The submission is proceeding under the FDA’s Real-Time Oncology Review program; completion is expected by year-end 2026.
The application is based on Phase 3 REZILIENT3, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival versus chemotherapy alone. A separate NDA for zipalertinib monotherapy in patients previously treated with platinum-based chemotherapy remains under FDA review, with a February 27, 2027 PDUFA target action date. Cullinan is eligible for a $30.0 million payment from Taiho upon U.S. approval for that previously treated indication and up to $100.0 million upon U.S. approval for first-line treatment of adult patients.
Cullinan Therapeutics, Inc. plans to share fourth-quarter 2026 clinical updates across its immunology and oncology pipeline. For CLN-978, it plans to report multi-dose and single target dose regimen data from ongoing Phase 1 trials in treatment-refractory moderate to severe systemic lupus erythematosus, difficult-to-treat rheumatoid arthritis, and treatment-refractory moderate to severe Sjögren’s disease in December.
For velinotamig, Cullinan plans to share multi-dose data from a Phase 1 SLE study conducted in China by Chongqing Genrix Biopharmaceutical at ACR Convergence 2026 in November. It also plans updated Phase 1 dose-escalation data for CLN-049 in relapsed/refractory acute myeloid leukemia in December. CEO Nadim Ahmed said the company plans to initiate a potentially registrational Phase 2 study of CLN-049 following a recent meeting with the FDA.
Cullinan Therapeutics, Inc. (CGEM) reported detailed Phase 3 REZILIENT3 results for investigational EGFR inhibitor zipalertinib in first-line treatment of EGFR exon 20 insertion mutation-positive non-small cell lung cancer, in collaboration with Taiho Oncology and Taiho Pharmaceutical.
In 279 previously untreated advanced NSCLC patients with EGFR ex20ins, zipalertinib 100 mg twice daily plus platinum-based chemotherapy (n=140) produced a median progression-free survival of 14.5 months vs. 8.5 months with chemotherapy alone (hazard ratio 0.50; 95% CI 0.34–0.73; P=0.00015). The PFS benefit was consistent across subgroups, including those with brain metastases (hazard ratio 0.38). Objective response rate was 65.0% vs. 40.3% with chemotherapy alone, with median duration of response of 14.2 vs. 9.9 months.
At an interim overall survival analysis with 30% maturity, the hazard ratio for death was 0.72 (95% CI 0.42–1.23), with follow-up ongoing. Grade ≥3 adverse events occurred more often with the combination (87.1% vs. 54.4%), largely manageable hematologic events (58.6% vs. 28.7%); Grade ≥3 EGFR-related toxicities such as rash (10.7%) and diarrhea (1.4%) were infrequent, and no new safety signals were observed.
Cullinan Therapeutics, Inc. (CGEM) reported that Chief Scientific Officer Jennifer Michaelson exercised stock options and sold shares on September 8, 2026. She exercised options to acquire 4,000 shares of common stock at an exercise price of $4.30 per share, leaving 78,987 shares underlying options outstanding. On the same date she sold 8,000 shares of common stock at a weighted average price of $21.57 per share in multiple trades between $21.31 and $21.83, under a Rule 10b5-1 trading plan adopted on August 7, 2025.
Cullinan Therapeutics, Inc. (CGEM) officer Jennifer Michaelson has notified of a planned sale of 8,000 shares of common stock through Morgan Stanley Smith Barney, with an aggregate market value of $176,720.00 based on a per-share price of $64.354694 as of September 8, 2026.
The shares relate to equity awards and purchases, including stock options, restricted stock units, and employee stock purchase plan shares, and follow prior sales in recent months under a Rule 10b5-1 trading arrangement.
Cullinan Therapeutics Chief Scientific Officer Jennifer Michaelson exercised 30,000 stock options for Common Stock at an exercise price of $4.30 per share, then sold 30,000 Common Shares at a weighted average price of $20.26 per share pursuant to a Rule 10b5-1 trading plan adopted on August 7, 2025. The options exercised were from a grant that vested 25% on July 4, 2020, with the remainder vesting in 36 monthly installments, and she continues to hold 82,987 stock options of this series directly, expiring on October 28, 2030.
Biotechnology Value Fund and affiliated entities report significant ownership of Cullinan Therapeutics, Inc. common stock. As of June 30, 2026, the group, including a managed account, beneficially owns 6,491,123 shares of common stock, representing approximately 9.99% of the outstanding shares.
The position includes 204,209 shares of Series A convertible preferred stock, which are convertible into 2,042,090 common shares at a 10:1 ratio. A 9.99% “Conversion Blocker” currently limits conversion to 740,440 of these underlying shares. Individual vehicles BVF and BVF2 hold approximately 5.7% and 3.5% of the class, respectively, with shared voting and dispositive power allocated among the BVF entities and Mark N. Lampert as described.
T. Rowe Price Associates, Inc., organized in Maryland, reports beneficial ownership of 3,825,950 shares of Cullinan Therapeutics Inc common stock. This position represents 6.2% of the class as of the reporting date. The firm reports sole voting power and sole dispositive power over all 3,825,950 shares, with no shared voting or dispositive power. T. Rowe Price Associates states that this report should not be construed as an admission that it is the beneficial owner of these securities, and it expressly denies such beneficial ownership.
A shareholder of the company with symbol CGEM has indicated an intent to sell 30,000 shares of common stock through Morgan Stanley Smith Barney LLC Executive Financial Services on August 13, 2026 on NASDAQ, in connection with a cash exercise of stock options. The disclosure also lists prior 10b5-1 sales for Jennifer Michaelson of 8,000 shares of common stock on July 6, 2026 for $142,586.
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.