On September 18, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported financial results for the second quarter 2026 and highlighted recent progress.

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"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 (Free AACR Whitepaper) where we highlighted the sustained target engagement leading to tumor regression at low dose levels. At ASCO (Free ASCO Whitepaper) 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 (Free EHA Whitepaper) 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."

Recent Business Highlights and Corporate Updates:

Strengthened the balance sheet with approximately $168.3 million in gross proceeds from the initial public offering (IPO) in August 2026
Announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BH-30643, a macrocyclic OMNI-EGFR inhibitor, for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
Presented preliminary results of BH-30643 from dose escalation and backfill cohorts in the ongoing Phase 1/2 SOLARA trial in advanced or metastatic EGFR-mutant NSCLC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 annual meeting, and additional follow up data at IASLC 2026 World Conference on Lung Cancer, which highlighted a 45% objective response rate and 88% disease control rate observed in patients with C797S resistance to prior TKIs, with or without concurrent T790M mutation
Presented the first preclinical data from the pseudo-irreversible pan-KRAS inhibitor BH-501284, built on a novel chemical scaffold, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 annual meeting
Presented initial clinical data from the ongoing first-in-human Phase 1/1b trial of BH-30236, an orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor, in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress
Expanded the Company’s Board of Directors with the appointments of Sheila Gujrathi, M.D., and John Schmid

Anticipated Upcoming Milestones:
BH-30643

Q4 2026: End of Phase 1 meeting regarding a recommended Phase 2 dose selection and a potential accelerated approval pathway in C797S resistance
Q1 2027: First patient dosed in anticipated pivotal Phase 2 trial
1H 2027: Updated Phase 1 data, including C797S durability
2H 2027: Updated Phase 1 data on TKI-naive durability and initial chemo combo cohort data
BH-501284

Q1 2027: Investigational New Drug submission

BH-30236

1H 2027: Updated Phase 1 data on safety and anti-leukemic effect

Second Quarter 2026 Financial Results

Research and development (R&D) expenses for the second quarter of 2026 were $21.4 million, compared with $12.5 million for the same period in 2025. The increase was primarily due to greater clinical development expenses driven by the SOLARA trial, expenses to support IND-enabling studies for BH-501284, and greater costs related to personnel, facilities and other overhead.

General and administrative (G&A) expenses for the second quarter of 2026 were $3.3 million, compared with $1.6 million for the same period in 2025. The increase was primarily due to greater legal expenses, personnel-related expenses and overhead.

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. The increase in net loss was primarily attributable to increased operating expenses.

Cash and cash equivalents totaled $95.4 million as of June 30, 2026. BlossomHill subsequently completed its IPO in August 2026 in which it sold 10,516,240 shares of its common stock, including partial exercise of the over-allotment option, for gross proceeds of $168.3 million. BlossomHill believes that its cash and cash equivalents as of June 30, 2026, together with the proceeds from its IPO, will be sufficient to fund its operations into the second quarter of 2028.

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – 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. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine. BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML. For additional information on this trial, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06501196).

About BH-501284
BH-501284 is an investigational, orally bioavailable pan-KRAS inhibitor, which utilizes a novel Switch-II chemical scaffold to achieve prolonged, potent and selective inhibition of KRAS mutations. We believe this molecule, which uses a non-covalent scaffold, is unique in its potential to achieve tight and durable binding, a feature described as "pseudo-irreversible" binding. In preclinical studies, BH-501284 has achieved pseudo-irreversible binding characteristics with high binding affinity, while maintaining high selectivity for KRAS.

(Press release, BlossomHill Therapeutics, SEP 18, 2026, View Source [SID1234670960])