Cullinan Therapeutics, Inc. (CGEM)

BDTX and Cullinan advance next-gen EGFR inhibitors, but silevertinib's potential and valuation tilt momentum toward BDTX.

Cullinan Therapeutics, Inc. (NASDAQ:CGEM ) Morgan Stanley 23rd Annual Global Healthcare Conference September 10, 2025 8:30 AM EDT Company Participants Chad Messer Nadim Ahmed - President, CEO & Director Jeffrey Jones - Chief Medical Officer Conference Call Participants Sean Laaman - Morgan Stanley, Research Division Presentation Sean Laaman Head of Healthcare Research & Equity Analyst Good morning, everyone, and welcome to Morgan Stanley's Global Healthcare Conference. I'm Sean Laaman, Head of U.S. Smid-Cap Biotech Equity Research here at the firm.

Updated efficacy and safety data to be presented from the REZILIENT1 trial of zipalertinib from the cohort of patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who were previously treated with amivantamab Preliminary clinical efficacy and safety data to be presented from the cohort of patients with uncommon non-ex20ins EGFR mutations in the REZILIENT2 trial of zipalertinib PRINCETON, N.J. and CAMBRIDGE, Mass.

CAMBRIDGE, Mass., Aug. 21, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its participation in the following upcoming investor conferences:

CLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren's disease

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.

Advances Cullinan's leadership in T cell engager (TCE) development for autoimmune diseases with both a CD19 TCE and BCMA TCE in its pipeline

PRINCETON, N.J. and CAMBRIDGE, Mass.

CAMBRIDGE, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its management team will host a company event at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL and will participate in the Jefferies 2025 Global Healthcare Conference, being held June 3-5, 2025 in New York, NY.

CAMBRIDGE, Mass. and TOKYO, Japan and PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. today announced new positive results from the pivotal Phase 2b cohorts of the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. These data will be presented on Sunday, June 1 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation during the “Lung Cancer – Non-Small Cell Metastatic” session from 9:00 AM-9:12 AM CDT (Abstract #8503).

Company received approval from European Medicines Agency (EMA) for CLN-978; Phase 1 study in active, difficult-to-treat rheumatoid arthritis to initiate in Q2 2025

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.

CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases Sjögren's disease represents the third indication under development for CLN-978, and is a disease with high unmet need and no currently approved therapies CAMBRIDGE, Mass., April 29, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S. The Company previously received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) Application clearance to study the CD19 T cell engager in patients with moderate to severe systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval to study CLN-978 in active, difficult-to-treat rheumatoid arthritis.

Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate

Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025

Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024.