BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage oncology company developing targeted therapies for drug-resistant EGFR-mutant lung cancer and other genetically defined cancers, filed a Form S-1 registration statement with the US Securities and Exchange Commission for an initial public offering. The filing did not disclose the number of shares to be offered or the expected price range, indicating the company has yet to finalize the terms of the IPO. If approved, BlossomHill will list on the Nasdaq Global Select Market under the symbol "BLSM".
Founded by J. Jean Cui, BlossomHill is developing BH-30643, a non-covalent EGFR inhibitor designed to overcome C797S-mediated resistance in non-small cell lung cancer. Cui was the lead inventor of three FDA-approved cancer therapies: crizotinib (Xalkori), lorlatinib (Lorbrena), and repotrectinib (Augtyro). Repotrectinib was the lead program at Turning Point Therapeutics, which Cui co-founded and which Bristol Myers Squibb acquired in 2022. Meanwhile, BlossomHill's Chief Medical Officer, Geoffrey R. Oxnard, co-authored the first published description of the EGFR C797S resistance mutation that the company's lead candidate is designed to address, and previously led thoracic oncology development at Eli Lilly.
BlossomHill has raised more than USD 257 million in private capital since its founding in 2020, according to the filing, with Cormorant Asset Management, OrbiMed, Vivo Capital and Janus Henderson Investors named as holders of 5% or more of the company's stock.
The company's pipeline consists of two clinical-stage programs and one preclinical candidate. BH-30643, a non-covalent, macrocyclic OMNI-EGFR inhibitor, is being evaluated in the Phase I/II SOLARA trial in patients with EGFR-mutant non-small cell lung cancer, including those with the C797S resistance mutation for which no approved oral targeted therapy currently exists. BH-30236, a CDC-like kinase (CLK) inhibitor, is in a Phase I trial in relapsed or refractory acute myeloid leukemia and higher-risk myelodysplastic syndromes, tested as monotherapy and alongside venetoclax. BH-501284, a preclinical pan-KRAS inhibitor designed to spare HRAS and NRAS, is in IND-enabling studies, with an IND submission planned for the first quarter of 2027.
BlossomHill plans to seek an end-of-Phase I meeting with the FDA in the fourth quarter of 2026 regarding a potential accelerated approval pathway for BH-30643 in C797S-positive EGFR-mutant NSCLC, and expects to dose the first patient in a planned pivotal Phase II trial in the first quarter of 2027. The company said it expects to report updated safety and efficacy data from the BH-30236 Phase I trial in the first half of 2027.