BlossomHill Therapeutics, Inc.

What they do

BlossomHill applies a chemistry-based approach to design small molecule medicines for cancer. Its lead candidate BH-30643 is a macrocyclic OMNI-EGFR inhibitor in a Phase 1/2 trial (SOLARA) for EGFR-mutant NSCLC, including C797S-positive resistance. Other programs include BH-30236, a CLK inhibitor in Phase 1/1b for R/R AML and HR-MDS, and BH-501284, a preclinical pan-KRAS inhibitor. The company is headquartered in San Diego and has no approved products.

Revenue drivers

• BH-30643 (OMNI-EGFR inhibitor) — Clinical-stage product candidate in Phase 1/2 SOLARA trial for EGFR-mutant NSCLC; no revenue generated to date. Received FDA Fast Track designation in 2026.
• BH-30236 (CLK inhibitor) — Phase 1/1b candidate for relapsed/refractory AML and higher-risk MDS; no revenue. Presented early safety and anti-leukemic activity data at EHA 2026.
• BH-501284 (pan-KRAS inhibitor) — Preclinical candidate; IND submission targeted for Q1 2027. No revenue, but represents a pipeline expansion opportunity.

Recent performance

As of June 30, 2026, total assets were $124.1 million, total liabilities $42.1 million, and cash and equivalents $95.4 million. Stockholders' equity was negative $174.8 million. For Q2 2026, research and development expenses were $21.4 million, up from $12.5 million in Q2 2025, driven by clinical development for the SOLARA trial. In August 2026, the company completed an upsized initial public offering with gross proceeds of approximately $168.3 million.

Strategy

The company is prioritizing clinical development of BH-30643, with an end-of-Phase 1 meeting with the FDA planned for Q4 2026 to discuss recommended Phase 2 dose and a potential accelerated approval pathway in C797S resistance. It plans to dose the first patient in a pivotal Phase 2 trial in Q1 2027 and report updated Phase 1 data in 1H 2027. For BH-501284, an IND submission is targeted for Q1 2027. The company strengthened its balance sheet with its IPO and expanded its board with two new directors.

Risks

• Clinical trial risk — BH-30643 and other candidates are in early stages; the 45% objective response rate and 88% disease control rate are preliminary and may not be replicated in later trials.
• Regulatory risk — Fast Track designation does not guarantee approval, and the planned end-of-Phase 1 meeting may not support an accelerated pathway.
• Financial risk — The company has no product revenue and a stockholders' deficit of $174.8 million; future losses are expected, and additional financing may be needed despite the IPO proceeds.
• Competitive risk — The oncology space is crowded, and larger companies may develop competing therapies for EGFR-mutant NSCLC and other targets.

Outlook

Management expects an end-of-Phase 1 meeting with the FDA in Q4 2026 for BH-30643, followed by a pivotal Phase 2 trial initiation in Q1 2027. Updated Phase 1 data on C797S durability is expected in 1H 2027, with additional data on TKI-naive patients and chemo combo cohorts in 2H 2027. An IND for BH-501284 is planned for Q1 2027, and updated Phase 1 data for BH-30236 is anticipated in 1H 2027.