Form 8-K

8-K — BlossomHill Therapeutics, Inc.

Accession: 0001193125-26-395031

Filed: 2026-09-18

Period: 2026-09-18

CIK: 0001839970

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 18, 2026

BlossomHill Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-43435

85-1578711

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

10255 Science Center Drive

Suite 200

San Diego, California 92121

(Address of principal executive offices)

Registrant’s telephone number, including area code: (858) 732-3880

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share

BLSM

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02

Results of Operations and Financial Condition.

On September 18, 2026, BlossomHill Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated September 18, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

BlossomHill Therapeutics, Inc.

Dated: September 18, 2026

By:

/s/ J. Jean Cui, Ph.D.

J. Jean Cui, Ph.D.

President and Chief Executive Officer

EX-99.1

Filename: d266261dex991.htm · Sequence: 2

EX-99.1

Exhibit 99.1

BlossomHill Therapeutics Reports Second Quarter 2026 Financial Results

Strengthened balance sheet with successful completion of upsized $168.3 million initial public offering

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

EGFR C797S-positive NSCLC

SAN DIEGO,

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, today announced financial results for the second quarter 2026 and highlighted recent progress.

“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.”

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) 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) 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) 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.

About BlossomHill Therapeutics

BlossomHill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative

small molecule medicines that address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development – including three FDA-approved drugs – BlossomHill Therapeutics applies cutting-edge science with a goal to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers. The company’s lead clinical program is BH-30643, an investigational, non-covalent,

macrocyclic, brain active, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutant non-small cell lung cancer (NSCLC), which has received

Fast Track designation for the C797S resistance population after 3rd generation EGFR TKI treatment. The company is also conducting clinical development of BH-30236, an investigational macrocyclic CDC-like kinase (CLK) inhibitor initially being studied in a clinical trial for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS). The company’s pipeline also includes BH-501284, a preclinical, non-covalent, selective,

pan-KRAS Switch-II inhibitor for potential future development in diverse KRAS-mutant tumors.

BlossomHill Therapeutics is headquartered in San Diego, California. For more information,

visit bhtherapeutics.com and follow us on LinkedIn and X.

Cautionary Note Regarding Forward-Looking

Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as

amended, and other federal securities laws, including, without limitation, statements regarding: the therapeutic potential, clinical benefits, safety and potential competitive differentiation of the company’s product candidates, including BH-30643, BH-30236 and BH-501284; the anticipated benefits of regulatory designations received, or that may be received, by the

company’s product candidates; the design, enrollment, timing, progress and results of the company’s clinical trials and preclinical studies; the company’s planned regulatory interactions and submissions; anticipated program

milestones, including the timing of program and data updates; the period over which the company estimates its existing cash and cash equivalents, together with the net proceeds from its initial public offering, will be sufficient to fund its current

operating plan; statements by the company’s management; and the company’s development plans and continued advancement of its pipeline. The words “anticipate,” “believe,” “could,”

“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “upcoming,”

“will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks,

uncertainties and important factors that may cause actual events or results to differ materially, including, without limitation: the company’s limited operating history, history of significant losses and the early stage of development of its

product candidates; the risk that preliminary and interim clinical data are subject to further analysis and may not be predictive of, may be inconsistent with, or may be more favorable than, data generated as clinical trials continue or data from

future clinical trials; uncertainties inherent in the initiation, timing, design and enrollment of clinical trials, and the availability and timing of data from ongoing and future trials; the company’s ability to successfully demonstrate the

safety and efficacy of its product candidates and to obtain and maintain regulatory approvals; the timing and outcome of planned interactions with, and submissions to, the FDA and other regulatory authorities, including whether an accelerated

approval pathway will be available to the company; the risk that regulatory designations, including Fast Track and orphan drug designation, may not result in a faster development, review or approval process, may not increase the likelihood of

regulatory approval, and may be withdrawn; competition from third parties that are developing products for similar indications; the prior success of the company’s management team may not be indicative of future success; the company’s

reliance on third parties, including contract research organizations and contract manufacturing organizations; the company’s ability to obtain, maintain and protect its intellectual property; and the company’s need for additional

financing and its estimates regarding operating expenses and capital requirements. These and other risks are described in greater detail under the heading “Risk Factors” in the company’s filings with the Securities and Exchange

Commission (the “SEC”), its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which will be filed with the SEC later today, as well as in the company’s subsequent

filings with the SEC. Any forward-looking statements represent the company’s views only as of the date of this press release, and the company expressly disclaims any obligation to update any forward-looking statements, except as required by

law.

Company Contact:

Michael Moore, BlossomHill Therapeutics

michael.moore@bhtherapeutics.com

Media:

Ashlea Kosikowski, 1AB

ashlea@1abmedia.com

BLOSSOMHILL THERAPEUTICS, INC.

UNAUDITED CONDENSED BALANCE SHEETS

(in thousands, except share and par value data)

June 30, 2026

December 31,

2025

(unaudited)

Assets

Current Assets:

Cash and cash equivalents

95,376

136,682

Prepaid expenses and other current assets

5,592

2,144

Total current assets

100,968

138,826

Property and equipment, net

1,489

1,726

Operating lease

right-of-use assets

19,197

19,921

Other assets

2,477

2,495

Total assets

124,131

162,968

Liabilities, convertible preferred stock and stockholders’ deficit

Current liabilities:

Accounts payable

3,930

2,314

Accrued expenses

9,194

8,431

Accrued compensation

3,539

4,730

Other current liabilities

809

—

Operating lease liability, current

1,149

Total current liabilities

18,621

15,480

Operating lease liability, non-current

22,222

22,393

Other long-term liabilities

1,245

—

Total liabilities

42,088

37,873

Convertible preferred stock, $0.0001 par value; 85,552,612 shares authorized at June 30, 2026

and December 31, 2025; 18,258,960 shares issued and outstanding at June 30, 2026 and December 31, 2025; $257,153 aggregate liquidation preference at June 30, 2026 and December 31, 2025

256,823

Stockholders’ deficit:

Common stock, $0.0001 par value; 110,000,000 shares authorized at June 30, 2026 and

December 31, 2025; 2,767,848 and 2,548,659 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

5,014

3,300

Accumulated deficit

(179,795

)

(135,029

)

Total stockholders’ deficit

(174,780

)

(131,728

)

Total liabilities, convertible preferred stock and stockholders’ deficit

124,131

162,968

BLOSSOMHILL THERAPEUTICS, INC.

UNAUDITED CONDENSED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

Three Months Ended June 30,

Six Months Ended June 30,

2026

2025

2026

2025

Operating expenses:

Research and development

21,355

12,530

41,256

22,102

General and administrative

3,315

1,573

5,521

3,455

Total operating expenses

24,670

14,103

46,777

25,557

Loss from operations

(24,670

)

(14,103

)

(46,777

)

(25,557

)

Other income (expense), net:

Interest income, net

915

859

2,017

1,835

Other expense, net

)

—

)

—

Total other income, net

912

859

2,011

1,835

Net loss

(23,758

)

(13,244

)

(44,766

)

(23,722

)

Net loss per share, basic and diluted

(8.75

)

(5.51

)

(16.91

)

(9.90

)

Weighted average common shares outstanding, basic and diluted

2,713,696

2,405,140

2,646,721

2,395,789

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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