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[8-K] Aprea Therapeutics, Inc. Reports Material Event

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

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.

Aprea Therapeutics (APRE) ha riportato aggiornamenti operativi tramite Form 8-K. L'azienda ha annunciato il dosaggio raccomandato di Fase 2 per ATRN-119, ha sospeso ulteriori arruolamenti sia nei bracci di dosaggio una volta al giorno che due volte al giorno di ABOYA-119, e sta valutando uno sviluppo aggiuntivo di ATRN-119 in terapie di combinazione.

Gli aggiornamenti sono stati comunicati in un comunicato stampa datato 15 ottobre 2025, e accompagnati da una presentazione aziendale aggiornata. Entrambi i materiali sono forniti come exhibits al fascicolo, offrendo maggiori dettagli sui piani di sviluppo attuali e sullo stato del programma clinico.

Aprea Therapeutics (APRE) informó actualizaciones operativas mediante Formulario 8-K. La empresa anunció la dosis recomendada de Fase 2 para ATRN-119, suspendió más reclutamiento tanto en los brazos de dosificación una vez al día como dos veces al día de ABOYA-119, y está considerando desarrollo adicional de ATRN-119 en terapias de combinación.

Las actualizaciones se comunicaron en un comunicado de prensa con fecha del 15 de octubre de 2025, y acompañadas de una presentación corporativa actualizada. Ambos materiales se proporcionan como anexos al expediente, ofreciendo más detalles sobre los planes de desarrollo actuales y el estado del programa clínico.

Aprea Therapeutics (APRE)가 Form 8-K를 통해 운영 업데이트를 보고했습니다. 회사는 ATRN-119의 2상 권고 용량을 발표했으며, ABOYA-119의 일일 1회 및 2회 용량 군의 추가 등록을 중지했고, ATRN-119의 추가 개발을 병용 요법으로 고려하고 있습니다.

업데이트 내용은 2025년 10월 15일자 보도자료로 전달되었고, refreshed된 기업 발표 자료와 함께 제공되었습니다. 두 자료 모두 현재 개발 계획 및 임상 프로그램 상태에 대한 자세한 정보를 제공하는 첨부 자료로 제출됩니다.

Aprea Therapeutics (APRE) a communiqué des mises à jour opérationnelles via le formulaire 8-K. La société a annoncé la posologie recommandée de la phase 2 pour l'ATRN-119, a suspendu le recrutement supplémentaire dans les bras de dosage une fois par jour et deux fois par jour d’ABOYA-119, et envisage un développement supplémentaire d’ATRN-119 en thérapies de combinaison.

Les mises à jour ont été communiquées dans un communiqué de presse daté du 15 octobre 2025, et accompagnées d'une présentation d'entreprise actualisée. Les deux documents sont fournis en tant qu'exhibits au dépôt, offrant plus de détails sur les plans de développement actuels et l'état du programme clinique.

Aprea Therapeutics (APRE) meldete operative Updates über das Formular 8-K. Das Unternehmen gab die empfohlene Phase-2-Dosis für ATRN-119 bekannt, setzte die weitere Rekrutierung sowohl in der Einmal- als auch Zweimal-daily-Dosis-Arm von ABOYA-119 aus und erwägt eine weitere ATRN-119-Entwicklung in Kombinationstherapien.

Die Updates wurden in einer Pressemitteilung vom 15. Oktober 2025 kommuniziert und von einer aktualisierten Unternehmenspräsentation begleitet. Beide Materialien werden als Anhänge zur Einreichung bereitgestellt und bieten weitere Details zu aktuellen Entwicklungsplänen und dem Status des klinischen Programms.

أبريا ثيرابيوتيكس (APRE) أصدرت تحديثات تشغيلية عبر النموذج 8-K. أعلنت الشركة عن الجرعة المقترحة للمرحلة 2 لـ ATRN-119، وأوقفت مزيداً من التوظيف في ذراع الجرعات مرة يومياً ومرة يومياً في ABOYA-119، وتدرس تطويراً إضافياً لـ ATRN-119 في علاجات مركبة.

تم التواصل مع هذه التحديثات في بيان صحفي مؤرخ 15 أكتوبر 2025، ومع عرض تقديمي مؤسسي مجدد. تُقدَّم كلا المواد كمرفقات إلى الملف، وتقدم مزيداً من التفاصيل حول خطط التطوير الحالية وحالة البرنامج السريري.

Aprea Therapeutics (APRE) 通过 Form 8-K 报告了运营更新。 公司宣布 ATRN-119 的二期推荐剂量,暂停 ABOYA-119 在每日一次和每日两次给药臂的进一步招募,并考虑在联合疗法中对 ATRN-119 进行额外开发。

这些更新在2025年10月15日的新闻稿中进行了传达,并附有更新的公司介绍。两份材料均作为备案的展品提供,提供有关当前开发计划和临床项目状态的更多信息。

Positive
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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.

Aprea Therapeutics (APRE) ha riportato aggiornamenti operativi tramite Form 8-K. L'azienda ha annunciato il dosaggio raccomandato di Fase 2 per ATRN-119, ha sospeso ulteriori arruolamenti sia nei bracci di dosaggio una volta al giorno che due volte al giorno di ABOYA-119, e sta valutando uno sviluppo aggiuntivo di ATRN-119 in terapie di combinazione.

Gli aggiornamenti sono stati comunicati in un comunicato stampa datato 15 ottobre 2025, e accompagnati da una presentazione aziendale aggiornata. Entrambi i materiali sono forniti come exhibits al fascicolo, offrendo maggiori dettagli sui piani di sviluppo attuali e sullo stato del programma clinico.

Aprea Therapeutics (APRE) informó actualizaciones operativas mediante Formulario 8-K. La empresa anunció la dosis recomendada de Fase 2 para ATRN-119, suspendió más reclutamiento tanto en los brazos de dosificación una vez al día como dos veces al día de ABOYA-119, y está considerando desarrollo adicional de ATRN-119 en terapias de combinación.

Las actualizaciones se comunicaron en un comunicado de prensa con fecha del 15 de octubre de 2025, y acompañadas de una presentación corporativa actualizada. Ambos materiales se proporcionan como anexos al expediente, ofreciendo más detalles sobre los planes de desarrollo actuales y el estado del programa clínico.

Aprea Therapeutics (APRE)가 Form 8-K를 통해 운영 업데이트를 보고했습니다. 회사는 ATRN-119의 2상 권고 용량을 발표했으며, ABOYA-119의 일일 1회 및 2회 용량 군의 추가 등록을 중지했고, ATRN-119의 추가 개발을 병용 요법으로 고려하고 있습니다.

업데이트 내용은 2025년 10월 15일자 보도자료로 전달되었고, refreshed된 기업 발표 자료와 함께 제공되었습니다. 두 자료 모두 현재 개발 계획 및 임상 프로그램 상태에 대한 자세한 정보를 제공하는 첨부 자료로 제출됩니다.

Aprea Therapeutics (APRE) a communiqué des mises à jour opérationnelles via le formulaire 8-K. La société a annoncé la posologie recommandée de la phase 2 pour l'ATRN-119, a suspendu le recrutement supplémentaire dans les bras de dosage une fois par jour et deux fois par jour d’ABOYA-119, et envisage un développement supplémentaire d’ATRN-119 en thérapies de combinaison.

Les mises à jour ont été communiquées dans un communiqué de presse daté du 15 octobre 2025, et accompagnées d'une présentation d'entreprise actualisée. Les deux documents sont fournis en tant qu'exhibits au dépôt, offrant plus de détails sur les plans de développement actuels et l'état du programme clinique.

Aprea Therapeutics (APRE) meldete operative Updates über das Formular 8-K. Das Unternehmen gab die empfohlene Phase-2-Dosis für ATRN-119 bekannt, setzte die weitere Rekrutierung sowohl in der Einmal- als auch Zweimal-daily-Dosis-Arm von ABOYA-119 aus und erwägt eine weitere ATRN-119-Entwicklung in Kombinationstherapien.

Die Updates wurden in einer Pressemitteilung vom 15. Oktober 2025 kommuniziert und von einer aktualisierten Unternehmenspräsentation begleitet. Beide Materialien werden als Anhänge zur Einreichung bereitgestellt und bieten weitere Details zu aktuellen Entwicklungsplänen und dem Status des klinischen Programms.

0001781983false00017819832025-10-152025-10-15

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.

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