Cullinan Therapeutics Updates on Corporate Matters and Q1 2024 Financial Results

Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical firm based in Cambridge, Massachusetts, reported significant milestones and financial results for the first quarter ending March 31, 2024. The company, which specializes in developing targeted therapies for cancer and autoimmune diseases, made notable advancements in both its portfolio and corporate structure.

In the first quarter of 2024, Cullinan Therapeutics announced a strategic shift into immunology, specifically focusing on autoimmune diseases. The company's CD19xCD3 T cell engager (TCE), CLN-978, will now be developed initially for systemic lupus erythematosus (SLE). This decision followed positive clinical data from a Phase 1 study in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), showcasing CLN-978's efficacy and safety. As a result, Cullinan has discontinued the B-NHL study to concentrate on autoimmune applications. The company plans to submit an Investigational New Drug (IND) application for SLE in the third quarter of 2024, while also exploring additional autoimmune indications for CLN-978.

In oncology, Cullinan continues to advance its clinical-stage pipeline. The company will present initial data on CLN-619, an anti-MICA/MICB monoclonal antibody, for solid tumors and hematological malignancies at the 2024 ASCO Annual Meeting. Furthermore, Cullinan intends to report initial data from disease-specific dose expansion cohorts in early 2025.

Another promising candidate is Zipalertinib, developed in collaboration with Taiho Oncology, targeting EGFR ex20ins non-small cell lung cancer (NSCLC). The pivotal Phase 2b portion of the REZILIENT1 study is expected to complete enrollment by the end of 2024. Additionally, updates are anticipated from ongoing Phase 1 studies of CLN-049 (targeting FLT3xCD3 for acute myeloid leukemia and myelodysplastic syndromes) and CLN-418 (a B7H4x4-1BB bispecific immune activator for solid tumors) in the second half of 2024.

Corporate developments include the appointment of David Meek to the Board of Directors, effective May 15, 2024. Meek, who has held executive roles at Mirati Therapeutics, FerGene, and Ipsen, brings valuable experience in organizational growth and commercialization. Concurrently, Thomas Ebeling will resign from the Board at the end of his term on June 26, 2024.

Financially, Cullinan reported cash, cash equivalents, investments, and interest receivable totaling $434.8 million as of March 31, 2024. This, combined with $280 million from an April private placement, extends the company's cash runway into 2028. Research and development (R&D) expenses decreased to $30.6 million in the first quarter of 2024, compared to $52.1 million in the same period of the previous year, mainly due to a one-time in-licensing fee for CLN-418 in 2023 and reduced manufacturing costs. However, general and administrative (G&A) expenses increased to $12.3 million, up from $10.7 million in the first quarter of 2023, largely driven by higher personnel costs and equity-based compensation.

Net loss for the first quarter of 2024 was $37.3 million, an improvement from $58.1 million in the first quarter of 2023. The decrease in net loss was primarily due to reduced R&D expenses and increased interest income. As of May 8, 2024, Cullinan had 57,634,234 shares of common stock outstanding.

Cullinan Therapeutics is committed to developing innovative therapies that inhibit key disease drivers or harness the immune system to eliminate diseased cells, with a strong focus on both oncology and autoimmune diseases. The company continues to advance its diverse portfolio, aiming to bring transformative therapeutics to patients in need.