BlossomHill Therapeutics Raises $168.3 Million in IPO and Receives FDA Fast Track Designation
News related to:BlossomHill Therapeutics Inc · 2 min read
SAN DIEGO, Sept. 18, 2026 (GLOBE NEWSWIRE), BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company focused on developing innovative small molecule medicines for cancer treatment, has reported significant progress in its pipeline and financial standing.
The company has successfully completed an upsized initial public offering (IPO) in August 2026, raising approximately $168.3 million. This substantial funding will support the company’s ongoing and upcoming clinical trials and regulatory milestones.
BlossomHill has also received a Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational drug BH-30643, a macrocyclic OMNI-EGFR™ inhibitor, for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR C797S mutations after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). BH-30643 is designed to overcome the limitations of existing EGFR inhibitors by selectively targeting C797S resistance.
At the American Society of Clinical Oncology (ASCO) 2026 annual meeting, preliminary results from the ongoing Phase 1/2 SOLARA trial of BH-30643 were presented. The data showed a 45% objective response rate and an 88% disease control rate in patients with C797S resistance to prior TKIs, with or without concurrent T790M mutations. The company is now looking forward to an end-of-phase 1 meeting with the FDA later this year, which is expected to provide recommendations for a Phase 2 dose selection and potential accelerated approval pathway.
In addition, the company has presented preclinical data from its pseudo-irreversible pan-KRAS inhibitor BH-501284, which utilizes a novel Switch-II chemical scaffold. BH-501284 demonstrated potent inhibitory activity across various EGFR mutation categories, including classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations, and exon 20 insertions, while maintaining marked selectivity over wild-type EGFR.
BlossomHill’s other pipeline candidate, BH-30236, an orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor, has also shown promising results. Initial clinical data from the ongoing first-in-human Phase 1/1b trial in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS) were presented at the European Hematology Association (EHA) 2026 Congress. The data highlighted encouraging safety and early signs of anti-leukemic activity observed with BH-30236, both as a monotherapy and in combination with venetoclax.
Financially, BlossomHill reported R&D expenses of $21.4 million for the second quarter of 2026, up from $12.5 million in the same period in 2025. The increase was primarily due to greater clinical development expenses, including support for the SOLARA trial and expenses related to IND-enabling studies for BH-501284. General and administrative expenses for the quarter were $3.3 million, compared with $1.6 million in the same period in 2025, reflecting higher legal and personnel-related expenses.
The company’s net loss for the second quarter of 2026 was $23.8 million, or $(8.75) per basic and diluted share, compared with a net loss of $13.2 million, or $(5.51) per basic and diluted share for the same period in 2025. As of June 30, 2026, the company’s cash and cash equivalents totaled $95.4 million. With the proceeds from its IPO, BlossomHill believes its financial position will support its operations into the second quarter of 2028.