Taiho Oncology to present updated zipalertinib data in lung cancer

PRINCETON/CAMBRIDGE - Taiho Oncology and Cullinan Therapeutics (market cap: $443.79M) will present new data from clinical trials of zipalertinib in non-small cell lung cancer (NSCLC) patients at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer in Barcelona this September. According to InvestingPro data, Cullinan maintains a strong financial position with more cash than debt on its balance sheet.

The companies announced Tuesday that two abstracts have been accepted for mini oral presentations at the conference. The first presentation will feature updated efficacy and safety data from the Phase 2b REZILIENT1 trial in patients with NSCLC harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations who were previously treated with amivantamab. With Cullinan’s next earnings report due August 7, InvestingPro reveals that three analysts have recently revised their earnings expectations upward for the upcoming period.

The second presentation will share preliminary results from the Phase 2 REZILIENT2 trial, examining zipalertinib’s effectiveness in patients with advanced or metastatic NSCLC carrying uncommon non-exon 20 insertion EGFR mutations.

"Previously, zipalertinib has demonstrated clinical activity against ex20ins and preclinical activity against uncommon, non-ex20ins EGFR-mutant NSCLC," said Harold Keer, Chief Medical Officer at Taiho Oncology, in the press release statement.

Zipalertinib is an oral small molecule designed to target activating mutations in EGFR while sparing wild-type EGFR. The drug has received Breakthrough Therapy Designation from the FDA and is being jointly developed by Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics.

Both presentations are scheduled for September 9 during the session on common and uncommon EGFR mutations. Complete abstract details will be available on the conference website on August 13.

The investigational therapy has not yet received approval from any health authority. While Cullinan shows strong liquidity with a current ratio of 11.62, InvestingPro analysis suggests the stock may be currently undervalued, presenting potential opportunity for investors interested in the biotech sector.

In other recent news, Cullinan Oncology has maintained its Buy rating from Clear Street with a price target of $22.00, despite the recent FDA approval of a competing drug, sunvozertinib, for specific lung cancer treatments. Clear Street believes this development does not affect its investment thesis for Cullinan. Meanwhile, Cullinan Therapeutics has broadened its focus on autoimmune diseases by acquiring an exclusive license for velinotamig, a T cell engager, from Genrix Bio. This agreement, excluding Greater China, aims to repurpose velinotamig, which has shown promising results in Phase 2 trials for multiple myeloma, for autoimmune conditions. Additionally, Cullinan Therapeutics has initiated a clinical study in the United States for its drug candidate CLN-978, targeting Sjögren’s disease. This study follows FDA clearance and will assess the safety and efficacy of CLN-978 in patients with moderate to severe Sjögren’s disease. The trial will also explore the drug’s impact on related conditions, including systemic lupus erythematosus and rheumatoid arthritis. These developments highlight Cullinan’s ongoing efforts to innovate and expand its therapeutic offerings.

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