APRE

EX-99.1

2 apre-20260513xex99d1.htm

EX-99.1

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Exhibit 99.1

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Aprea Therapeutics Reports First Quarter 2026 Financial Results and Provides a Corporate Update

•Oversubscribed $30 million private placement closed, with proceeds expected to support ongoing development of APR-1051

•Two partial responses observed with continued encouraging tolerability in the ongoing Phase 1 dose escalation ACESOT-1051 trial of WEE1 inhibitor APR-1051

•Additional clinical data from ACESOT-1051 to be provided at the ASCO 2026 Annual Meeting on May 30, 2026

•$46.5 million in cash and cash equivalents as of March 31, 2026, with anticipated cash runway into Q1 2028

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DOYLESTOWN, PA, May 13, 2026 (GLOBE NEWSWIRE) – Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.

“We are very encouraged by the progress made across both our clinical and corporate priorities during the first quarter of 2026, including two partial responses observed in the ACESOT-1051 trial evaluating APR-1051. One of these has been confirmed at a second imaging assessment and this patient remains on study,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “These efficacy results, coupled with the encouraging tolerability, support our precision medicine strategy and reinforce the potential of targeted therapies for patients who have limited treatment options. We look forward to presenting an update from ACESOT-1051 at ASCO 2026 and providing additional insight into APR-1051’s emerging clinical profile. The recent $30 million private placement significantly strengthens our balance sheet and enables us to meaningfully expand patient enrollment, generating the clinical data needed to inform the future clinical path for APR-1051. We are grateful for the trust and support of both new and existing investors, whose participation reflects confidence in our development strategy and the potential of our programs.”

Key Business Updates and Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

•APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as monotherapy in uterine serous carcinoma patients regardless of mutation, cyclin E-overexpressing platinum-resistant ovarian cancer, advanced solid tumors harboring CCNE1, CCNE2, PPP2R1A or FBXW7 mutations, colorectal cancer harboring KRAS & TP53 mutations and HPV+ head and neck squamous cell carcinoma. These patient populations are associated with poor prognosis and limited effective treatment options.

•To date, two patients in ACESOT-1051 have achieved partial responses (“PR”). One uterine carcinosarcoma patient with PPP2R1A-mutation treated at the 220 mg dose level achieved a 50% reduction in target lesion size per RECIST v1.1 criteria and a significant reduction in CA-125 levels at the first imaging assessment. At the confirmatory, second imaging assessment, an additional 9.5% reduction in target lesion size was observed, along with a further decline in CA-125 to 40.2 U/mL

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from 362 U/mL at baseline. This patient remains on study with an ongoing PR. There has also been an unconfirmed PR in a second patient with PPP2R1A-mutated uterine serous carcinoma, treated at the 150 mg dose level.

•A total of 28 patients have been treated in ACESOT-1051 to date at doses ranging from 10 mg to 300 mg once daily. Six patients have achieved best overall response of stable disease, including patients with colorectal cancer, HPV+ head and neck squamous cell carcinoma, and endometrial cancer.

•Dose escalation is ongoing with enrollment currently underway in the 300 mg cohort (dose level 9). Additional eligible patients will be backfilled at 220 mg to further characterize safety, tolerability, and clinical activity, once dose level 9 is fully enrolled.

•APR-1051 has been shown to be well tolerated; the two most common adverse events have been Grade 1 or 2 nausea and fatigue. No treatment-related class-limiting toxicities, including severe myelosuppression or severe gastrointestinal toxicity, have been observed to date.

•Supported by the $30 million financing that closed on March 31, 2026, Aprea is expanding enrollment in ACESOT-1051 to include at least 50 patients with uterine serous carcinoma (USC), as well as patients with cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC). The expansion is intended to provide additional safety, tolerability and preliminary efficacy data to inform the future clinical path for APR-1051. Completion of dose escalation is anticipated in the second quarter of 2027.

•Further clinica

Aprea Therapeutics, Inc._March 16, 2026 0001781983false00017819832026-03-162026-03-16 ​ ​

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 March 16, 2026 Date of Report (Date of earliest event reported)

Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter)

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Delaware 001-39069 84-2246769

(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

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3805 Old Easton Road Doylestown, PA (Address of principal executive offices) 18902 (Zip Code)

​ Registrant’s telephone number, including area code: (215) 948-4119 (Former name or former address, if changed since last report): Not applicable

​ 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: ​ ​

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☐ 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))

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

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Title of each class ​ ​ Trading Symbol(s) ​ ​ Name of each exchange on which registered

Common stock, par value $0.001 per share ​

APRE

​ The Nasdaq Stock Market LLC

​ 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 2.02Results of Operations and Financial Condition. On March 16, 2026, Aprea Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and twelve months ended December 31, 2025, and provided an update on the Company’s operations for the same period. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for the 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, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing. ​ Item 8.01Other Events. On March 16, 2026, the Company updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is filed as Exhibit 99.2 hereto and incorporated herein by reference. ​ Item 9.01Financial Statements and Exhibits. ​ (d) Exhibits. ​

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Exhibit Number ​ ​ ​ Description

99.1 ​ Press release issued by Aprea Therapeutics, Inc. dated March 16, 2026.

99.2 ​ Corporate Presentation (March 2026).

104 ​ Cover Page Interactive Data File (embedded within the inline XBRL document).

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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. ​

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​ Aprea Therapeutics, Inc.

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Dated: March 16, 2026 By: /s/ Oren Gilad

​ Name: Oren Gilad, Ph.D.

​ Title: President and Chief Executive Officer

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Aprea Therapeutics, Inc._November 12, 2025 0001781983false00017819832025-11-122025-11-12 ​ ​

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 November 12, 2025 Date of Report (Date of earliest event reported)

Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter)

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​

​

Delaware 001-39069 84-2246769

(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

​

​

3805 Old Easton Road Doylestown, PA (Address of principal executive offices) 18902 (Zip Code)

​ Registrant’s telephone number, including area code: (215) 948-4119 (Former name or former address, if changed since last report): Not applicable

​ 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))

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

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​

​

​

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common stock, par value $0.001 per share ​

APRE

​ The Nasdaq Stock Market LLC

​ 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 2.02Results of Operations and Financial Condition. On November 12, 2025, Aprea Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and nine months ended September 30, 2025, and provided an update on the Company’s operations for the same period. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1. In accordance with General Instruction B.2 of Form 8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for the 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, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing. ​ Item 8.01Other Events. On November 12, 2025, the Company updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is filed as Exhibit 99.2 hereto and incorporated herein by reference. ​ Item 9.01Financial Statements and Exhibits. ​ (d) Exhibits. ​

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Exhibit Number

Description

99.1 ​ Press release issued by Aprea Therapeutics, Inc. dated November 12, 2025.

99.2 ​ Corporate Presentation (November 2025).

104 ​ Cover Page Interactive Data File (embedded within the inline XBRL document).

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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. ​

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​ Aprea Therapeutics, Inc.

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Dated: November 12, 2025 By: /s/ Oren Gilad

​ Name: Oren Gilad, Ph.D.

​ Title: President and Chief Executive Officer

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