BlossomHill Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development (R&D) expenses for Q3 2026 were $21.9 million, an increase of $7.3 million compared to $14.7 million in Q3 2025, driven by higher clinical development costs for BH-30643, increased personnel expenses, and IND-enabling work for BH-501284.
• General and administrative (G&A) expenses for Q3 2026 were $3.6 million, an increase of $1.5 million compared to $2.1 million in Q3 2025, due to higher personnel costs, overhead, outside services, and legal expenses.
• Net loss for Q3 2026 was $24.0 million ($1.29 per basic and diluted share), compared to $16.0 million ($6.54 per basic and diluted share) in Q3 2025; the increase was primarily due to higher operating expenses, partially offset by increased other income.
• Cash and cash equivalents totaled $224.9 million as of September 30, 2026, up from $136.7 million as of December 31, 2025.
• The company completed its IPO in August 2026, selling 10,516,240 shares for gross proceeds of $168.3 million.
• Total operating expenses for the nine months ended September 30, 2026, were $72.3 million compared to $42.3 million for the same period in 2025.
• Net loss for the nine months ended September 30, 2026, was $68.8 million compared to $39.7 million in the same period of 2025.
• Interest income, net, was $1.5 million for Q3 2026 compared to $0.8 million in Q3 2025.

Guidance and Future Outlook:

• BlossomHill believes its cash and cash equivalents as of September 30, 2026, will be sufficient to fund operations into the second quarter of 2028.
• SOLARA-2, the pivotal Phase 2 portion of the SOLARA trial, is expected to dose the first patient in Q1 2027.
• An Investigational New Drug (IND) application for BH-501284 is planned for Q1 2027.
• Updated Phase 1 data for BH-30643, including C797S durability, is expected in the first half of 2027.
• Phase 1 data on TKI-naive durability and initial chemotherapy combination cohort data for BH-30643 are expected in the second half of 2027.
• Updated Phase 1 data on safety and anti-leukemic effects for BH-30236 is expected in the first half of 2027.
• Translational data regarding BH-30236's mechanism of action will be presented at the American Society of Hematology Annual Meeting in December.

Business Segments and Product Lines:

• BH-30643: An OMNI-EGFR inhibitor for EGFR-mutant NSCLC; received Fast Track designation for the C797S resistance population. The FDA aligned on a recommended Phase 2 dose of 50 mg twice daily based on favorable PK, safety, and efficacy data from the Phase 1 SOLARA trial.
• BH-501284: A novel, pseudo-irreversible, Switch-II pan-KRAS inhibitor; preclinical data presented at the AACR Conference demonstrated sustained KRAS pathway suppression and durable antitumor activity across multiple KRAS-mutant tumor models.
• BH-30236: A macrocyclic CLK inhibitor for relapsed or refractory AML and higher-risk MDS; received orphan drug designation from the FDA.
• Foundation Medicine Collaboration: Announced a partnership to develop a companion diagnostic assay for the EGFR C797S resistance mutation.

Market and Competitive Landscape:

• BH-30643 is designed to overcome limitations of currently approved EGFR inhibitors, demonstrating potent activity across classical, on-target resistance (C797S), atypical mutations, and exon 20 insertions while maintaining selectivity over wild-type EGFR.
• BH-501284 utilizes a non-covalent scaffold to achieve "pseudo-irreversible" binding, aiming to overcome limitations of current KRAS-targeted therapies.
• BH-30236 targets aberrant alternative splicing machinery exploited by cancer cells to develop resistance to venetoclax, FLT3 inhibitors, and cytarabine.

Risks and Challenges:

• Forward-looking statements are subject to risks including limited operating history, history of significant losses, and early stage of product development.
• Risks include uncertainties in clinical trial initiation, timing, design, enrollment, and data generation; potential failure to demonstrate safety and efficacy; and regulatory approval outcomes.
• Competition from third parties developing products for similar indications and reliance on third-party contract research and manufacturing organizations.
• Need for additional financing and the risk that regulatory designations (Fast Track, orphan drug) may not result in faster development or approval.

Management Commentary and Tone:

• J. Jean Cui, Ph.D., Founder, President, and CEO, expressed pleasure regarding the FDA alignment on the Phase 2 dose and stated the company is preparing to initiate SOLARA-2.
• Management highlighted confidence in the pipeline, noting the potential of BH-30236 to address significant unmet needs in myeloid malignancies and the unique binding profile of BH-501284.
• The tone reflects strategic progress in advancing the portfolio and aligning with regulatory expectations for accelerated approval pathways.

Other Key Points:

• The company's lead clinical program, BH-30643, is being evaluated in the global Phase 1/2 SOLARA trial, with ongoing Phase 1 dose expansion cohorts in TKI-pretreated and TKI-naive settings.
• BH-30643 has received Fast Track designation specifically for the C797S resistance population after progression on a third-generation EGFR TKI.
• BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human trial for R/R AML and HR-MDS.
• The company is headquartered in San Diego, California.