BlossomHill reports Q2 2026 results, FDA Fast Track for lung cancer drug BH-30643

BlossomHill Therapeutics announced financial results for the second quarter of 2026 on September 18, 2026, highlighting several pipeline updates. The FDA granted Fast Track designation to BH-30643, a macrocyclic OMNI-EGFR inhibitor, for adult patients with advanced or metastatic EGFR C797S-positive non-small cell lung cancer who had prior treatment with a third-generation EGFR TKI.¹

The company also disclosed trial data at several conferences. At ASCO 2026 and later at the IASLC World Conference on Lung Cancer, BlossomHill presented follow-up results from the Phase 1/2 SOLARA trial showing a 45% objective response rate and 88% disease control rate in patients with C797S resistance to prior TKIs, with or without a concurrent T790M mutation.¹ Separately, the company presented initial clinical data from its ongoing Phase 1/1b trial of BH-30236, a CLK inhibitor, in relapsed or refractory AML and higher-risk myelodysplastic syndromes at EHA 2026.¹

Looking ahead, BlossomHill said it expects an end-of-phase 1 meeting with the FDA in the fourth quarter of 2026 regarding recommended Phase 2 dosing and a potential accelerated approval pathway for BH-30643 in the C797S-resistant population, with a first patient expected to be dosed in a pivotal Phase 2 trial in the first quarter of 2027.¹ The company also plans an IND submission for its preclinical pan-KRAS candidate BH-501284 in the first quarter of 2027.

On financials, BlossomHill had $95.4 million in cash and cash equivalents as of June 30, 2026, and subsequently completed its IPO in August 2026, selling 10,516,240 shares for gross proceeds of $168.3 million.¹ The company said its cash position, combined with IPO proceeds, is expected to fund operations into the second quarter of 2028.¹ Net loss for the quarter was $23.8 million, or $(8.75) per basic and diluted share, compared with $13.2 million, or $(5.51) per share, in the same period of 2025.¹