Cullinan Therapeutics is rated a Buy, driven by a robust T-cell engager pipeline, savvy management, and a strong $430M+ cash position. CLN-049 (FLT3xCD3) shows ~30% CR rates in AML, with broad applicability, favorable safety, and a clear accelerated approval path via single-arm study. A clear path to market for CLN-049 and regulatory precedent set by predecessors in AML increase the attractiveness of this setup, along with long-lived IP.
Cullinan Therapeutics, Inc. (CGEM) Presents at Citi's 2026 Virtual Oncology Leadership Summit Transcript
Cullinan Therapeutics is a cash-rich clinical-stage biotech with great autoimmune and AML T-cell research, which has promising catalysts for 2026. CGEM also partnered for zipalertinib, which is nearing NDA completion in Q1 2026. I believe this program alone could quickly unlock considerable shareholder value. Additionally, CGEM's CLN-978 (CD19xCD3) will enter Phase 1 and is progressing well as a potential long-term core value driver post-zipalertinib.
Cullinan Therapeutics, Inc. (CGEM) Discusses Initial CLN-049 Results and Development Strategy for AML Applications Transcript
Cullinan Therapeutics is down some 70% since May 2024, mainly due to lack of data from its autoimmune candidate CLN-978. CLN-978, an off-the-shelf CD19xCD3 T-cell engager, targets autoimmune diseases like SLE, with initial data expected in late 2025. Zipalertinib, Cullinan's lead asset for NSCLC, faces stiff competition and limited market potential despite ongoing pivotal trials and a planned NDA in 2H25.
CGEM has an interesting “modality‑agnostic” approach that focuses on targets first, then models yield the most promising candidates. This way, CGEM has built a relatively well-diversified oncology and autoimmune pipeline. However, their crown jewel right now is the late‑stage Zipalertinib. In my view, Zipalertinib is easily CGEM's main value driver for now. Its NDA filing is expected as early as 2H2025.
The mean of analysts' price targets for Cullinan Therapeutics (CGEM) points to a 292.5% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Cullinan Therapeutics focuses on unaddressed or unmet needs in oncology and autoimmune conditions. In particular, Zipalertinib and CLN-978 stand out as its most promising product candidates. Zipalertinib targets a tiny niche in the large NSCLC market. Management expects to report its Phase 2b results by mid-2025. Similarly, CLN-978 is a first-in-class T-cell engager targeting SLE and RA. It can also potentially be expanded into other B-cell-mediated indications eventually.
Cullinan Therapeutics is a multifocal biotech with promising programs in precision medicine and immunotherapy, despite recent market sentiment declines. Zipalertinib shows potential in treating exon 20 insertion mutation-positive NSCLC, with a 40% objective response rate in early phase trials. CGEM has a strong financial position with cash reserves projected to fund operations into 2028, reducing the need for immediate equity raises.