Soon-Shiong is set back again

Patrick Soon-Shiong sold Abraxis Bioscience to Celgene back in 2010, but since then he can’t catch a break. His latest venture, Immunitybio – the rebranded Nantkwest with a reduced focus on NK cell therapies – just fell flat, failing to get the IL-15 superagonist Anktiva approved for BCG-unresponsive non-muscle invasive bladder cancer. The FDA’s complete response letter, citing manufacturing deficiencies and CMC problems, came two days ago, but Immunitybio only slipped the news out today via an SEC filing, causing its stock to plummet 56%. Even after the fall Immunitybio carries a $1.2bn market cap – remarkable considering its dire financial situation. Immunitybio has so far burned through $2.5bn of investor funds, and carries $91m of cash against $717m in debt – $471m falling due in the next year – owed to entities controlled by Soon-Shiong, its chairman and main shareholder. Anktiva’s failure comes amid growing interest in pre-metastatic bladder cancer, where Ferring’s Adstiladrin saw a surprise US approval in December. Recent phase 2 successes include the Sunrise-1 study of Johnson & Johnson’s gemcitabine formulation TAR-200 plus cetrelimab, and the Core-001 trial of CG Oncology’s oncolytic virus cretostimogene grenadenorepvec (CG0070) plus Keytruda. Evaluate Vantage profiled this space in February.