Cullinan Therapeutics: A Biopharmaceutical Company with a Modality-Agnostic Approach to Drug Development

Cullinan Therapeutics, a biopharmaceutical company, uses a modality-agnostic approach to drug development by targeting biological mechanisms in oncology and autoimmune conditions. They select the most effective modality for each therapeutic target, allowing for a flexible strategy and partnerships. The company is awaiting a new drug application catalyst for its lead asset, Zipalertinib.

Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company, employs a unique modality-agnostic approach to drug development. This strategy involves targeting biological mechanisms in oncology and autoimmune conditions by selecting the most effective modality for each therapeutic target. This flexible approach, combined with partnerships and in-licensing strategies, has enabled Cullinan Therapeutics to build a diversified pipeline [1].

The company's late-stage candidate, Zipalertinib, has the potential to be submitted for a New Drug Application (NDA) in the second half of 2025. Zipalertinib is intended for treating non-small cell lung cancer (NSCLC) with a genetic mutation known as EGFR exon 20 insertion. The drug is designed to selectively inhibit these mutations while minimizing activity against the normal EGFR found in healthy cells, potentially reducing side effects [1].

Cullinan Therapeutics' balance sheet is well capitalized, with a healthy runway into 2028. This should be sufficient to see Zipalertinib's potential approval materialize. The company's recent Q1 2025 report shows $76.7 million in cash and $486.6 million in investments, totaling $563.3 million in available resources [1].

In addition to Zipalertinib, Cullinan Therapeutics has other clinical-stage candidates in its pipeline. CLN-619, a monoclonal antibody for pan-cancer applications, has first-in-class potential and is currently in Phase 1 expansion cohorts. Other earlier-stage programs include CLN-049, a bispecific T-cell engager for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), and CLN-617, a fusion protein therapy for solid tumors [1].

Cullinan Therapeutics has also licensed its exclusive global rights outside Greater China to develop and commercialize Velinotamig, an IP originally from Genrix Bio for the treatment of autoimmune diseases. The company will pay an upfront license fee of $20 million to Genrix in exchange for Velinotamig for BCMA, which can address a broader range of autoimmune conditions [1].

The FDA has been actively involved in Cullinan Therapeutics' drug development process. In June 2025, Taiho Oncology, a partner of Cullinan Therapeutics, began the Phase 3 REZILIENT3 trial for Zipalertinib. The trial aims to test Zipalertinib for NSCLC with EGFR mutations in a larger confirmatory study [1].

Cullinan Therapeutics' valuation is currently at a $464.5 million market cap. The company's book value reached $551.8 million in Q1 2025, indicating a cheap P/B of 0.8 compared to the sector's median P/B of 2.4. This suggests that Cullinan Therapeutics may be undervalued after a recent 74% decline since May 2024 [1].

Cullinan Therapeutics remains a speculative bet in oncology, but its long runway and uniquely differentiated oncology approach are significant positives. The company's progress across its pipeline and the potential for Zipalertinib's NDA submission in 2025 warrant a speculative "Buy" rating at these levels, especially after such a massive pullback from its 2024 highs [1].

References:
[1] https://seekingalpha.com/article/4801488-cullinan-therapeutics-biotech-stock-betting-on-zipalertinib-nda-catalyst
[2] https://www.marketbeat.com/stocks/NASDAQ/CGEM/fda-events/