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APRE outlines ATRN-119 Phase 2 dosing; halts ABOYA-119 enrollment

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Aprea Therapeutics (APRE) reported operational updates via Form 8-K. The company announced the recommended Phase 2 dosing for ATRN-119, paused further enrollment in both once-daily and twice-daily dosing arms of ABOYA-119, and is considering additional ATRN-119 development in combination therapies.

The updates were communicated in a press release dated October 15, 2025, and accompanied by a refreshed corporate presentation. Both materials are provided as exhibits to the filing, offering more detail on current development plans and clinical program status.

Positive

  • None.

Negative

  • None.

Insights

Program update: Phase 2 dose set; separate study enrollment paused.

The update identifies a recommended Phase 2 dose for ATRN-119, a standard milestone that helps define next-step study designs. In parallel, enrollment in both dosing arms of ABOYA-119 is paused, which narrows near-term activity in that study while the company evaluates direction.

Management also notes potential exploration of combination therapies for ATRN-119, which can broaden clinical options but typically requires additional study planning. The exhibits include a October 2025 press release and corporate presentation; actual impact will depend on subsequent protocol decisions and data shared in future disclosures.

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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

October 15, 2025

Date of Report (Date of earliest event reported)

Aprea Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

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))

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, 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 8.01Other Events.

On October 15, 2025, Aprea Therapeutics, Inc. (the “Company”) issued a press release announcing the recommended Phase 2 dosing for ATRN-119, the pausing of further enrollment in both once daily and twice daily dosing arms of ABOYA-119 and its consideration of further ATRN-119 development in combination therapies. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference.

On October 15, 2025, the Company also 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.

Exhibit
Number

    

Description

99.1

Press release dated October 15, 2025.

99.2

Corporate Presentation (October 2025).

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.

Aprea Therapeutics, Inc.

Dated: October 15, 2025

By:

/s/ Oren Gilad

Name:

Oren Gilad, Ph.D.

Title:

President and Chief Executive Officer

FAQ

What did Aprea Therapeutics (APRE) announce in its 8-K?

It announced the recommended Phase 2 dosing for ATRN-119, paused enrollment in ABOYA-119’s once-daily and twice-daily arms, and is considering combination therapies.

Which clinical program had enrollment paused by APRE?

The company paused further enrollment in both dosing arms of ABOYA-119.

What is the development stage update for ATRN-119?

Aprea identified the recommended Phase 2 dose for ATRN-119 and is considering development in combination therapies.

Did Aprea provide additional materials with this update?

Yes. A press release (Exhibit 99.1) and an updated corporate presentation (Exhibit 99.2) were included.

When were these updates announced by APRE?

On October 15, 2025.

Where can investors find the detailed information?

In the exhibits to the 8-K filing: the press release (99.1) and the corporate presentation (99.2).
Aprea Therapeutics, Inc.

NASDAQ:APRE

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