BlossomHill Therapeutics, Inc.

EX-99.1 d266261dex991.htm EX-99.1 EX-99.1 Exhibit 99.1

Announced FDA Fast Track designation for BH-30643 for the treatment of advanced

EGFR C797S-positive NSCLC

“We’ve achieved meaningful progress across our pipeline, as well as our significant corporate milestones, since the beginning of the second quarter,” said Jean Cui, Ph.D., Founder, President and Chief Executive Officer of BlossomHill Therapeutics. “In April, we presented our first preclinical data from our pseudo-irreversible pan-KRAS inhibitor BH-501284, built on a novel chemical scaffold, at AACR where we highlighted the sustained target engagement leading to tumor regression at low dose levels. At ASCO in early June we presented the preliminary safety, PK and antitumor activities of BH-30643 in Phase 1 dose escalation of the SOLARA trial, along with the initial efficacy data in C797S-positive NSCLC. More recently we announced that BH-30643 received Fast Track designation, an important regulatory milestone that reflects the FDA’s recognition of the potential for this molecule. We also presented encouraging safety data and early signs of anti-leukemic activity observed with BH-30236, our novel macrocyclic CLK inhibitor, both as a monotherapy and in combination with venetoclax, at EHA in the middle of June. We are now looking forward to our end-of-phase 1 meeting with the FDA later this year. With a strong balance sheet following our successful initial public offering in August, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing our intentionally designed medicines that address significant unmet medical needs in cancer treatment.”