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

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8-K
Rhea-AI Filing Summary

Aclaris Therapeutics (Nasdaq: ACRS) has filed a Form 8-K to inform investors that it will host a conference call on 29 Jul 2025 to review top-line data from its Phase 2a study of ATI-2138, an oral covalent ITK/JAK3 inhibitor for moderate-to-severe atopic dermatitis. Two items are furnished: Exhibit 99.1 (investor presentation) and Exhibit 99.2 (press release). Under Reg FD, Items 7.01 and 8.01 are furnished—not filed—so the information is not subject to Exchange Act liability nor automatically incorporated into other SEC reports.

The 8-K contains no numerical efficacy, safety, or financial metrics. Investors must consult the accompanying exhibits or join the conference call for detailed results. No changes to financial statements or previously issued guidance are included.

Aclaris Therapeutics (Nasdaq: ACRS) ha presentato un modulo 8-K per informare gli investitori che terrà una conference call il 29 luglio 2025 per esaminare i dati preliminari del suo studio di Fase 2a su ATI-2138, un inibitore orale covalente ITK/JAK3 per la dermatite atopica da moderata a grave. Sono forniti due documenti: l'Esibizione 99.1 (presentazione per investitori) e l'Esibizione 99.2 (comunicato stampa). In base al Reg FD, gli Elementi 7.01 e 8.01 sono forniti ma non depositati, quindi le informazioni non sono soggette a responsabilità secondo l'Exchange Act né automaticamente incorporate in altri rapporti SEC.

Il modulo 8-K non contiene dati numerici su efficacia, sicurezza o metriche finanziarie. Gli investitori devono consultare gli allegati o partecipare alla conference call per i risultati dettagliati. Non sono incluse modifiche ai bilanci o alle precedenti previsioni.

Aclaris Therapeutics (Nasdaq: ACRS) ha presentado un Formulario 8-K para informar a los inversores que realizará una llamada conferencia el 29 de julio de 2025 para revisar los datos preliminares de su estudio de Fase 2a sobre ATI-2138, un inhibidor oral covalente ITK/JAK3 para dermatitis atópica de moderada a grave. Se proporcionan dos documentos: Anexo 99.1 (presentación para inversores) y Anexo 99.2 (comunicado de prensa). Según el Reg FD, los Ítems 7.01 y 8.01 se proporcionan pero no se presentan formalmente, por lo que la información no está sujeta a responsabilidad bajo la Exchange Act ni se incorpora automáticamente en otros informes de la SEC.

El 8-K no incluye datos numéricos de eficacia, seguridad o métricas financieras. Los inversores deben consultar los anexos o participar en la llamada conferencia para obtener resultados detallados. No se incluyen cambios en los estados financieros ni en las guías previamente emitidas.

Aclaris Therapeutics (나스닥: ACRS)는 2025년 7월 29일에 경구용 공유 결합 ITK/JAK3 억제제인 ATI-2138의 중등도에서 중증 아토피 피부염에 대한 2a상 연구의 주요 결과를 검토하기 위한 컨퍼런스 콜을 개최할 것임을 투자자에게 알리기 위해 Form 8-K를 제출했습니다. 두 가지 자료가 제공됩니다: 전시물 99.1 (투자자 프레젠테이션) 및 전시물 99.2 (보도자료). Reg FD에 따라 항목 7.01과 8.01은 제출된 것이 아니라 제공된 것이므로, 이 정보는 거래법상 책임 대상이 아니며 다른 SEC 보고서에 자동으로 포함되지 않습니다.

8-K에는 수치로 된 효능, 안전성 또는 재무 지표가 포함되어 있지 않습니다. 투자자들은 상세한 결과를 위해 첨부된 자료를 참조하거나 컨퍼런스 콜에 참여해야 합니다. 재무제표 변경이나 이전에 발표된 가이던스 변경은 포함되어 있지 않습니다.

Aclaris Therapeutics (Nasdaq : ACRS) a déposé un formulaire 8-K pour informer les investisseurs qu'elle organisera une conférence téléphonique le 29 juillet 2025 afin de passer en revue les données principales de son étude de phase 2a sur ATI-2138, un inhibiteur oral covalent ITK/JAK3 pour la dermatite atopique modérée à sévère. Deux documents sont fournis : l'annexe 99.1 (présentation aux investisseurs) et l'annexe 99.2 (communiqué de presse). Conformément au règlement FD, les points 7.01 et 8.01 sont fournis mais non déposés, ce qui signifie que ces informations ne sont pas soumises à la responsabilité en vertu de l'Exchange Act et ne sont pas automatiquement intégrées dans d'autres rapports SEC.

Le formulaire 8-K ne contient aucune donnée chiffrée concernant l'efficacité, la sécurité ou les indicateurs financiers. Les investisseurs doivent consulter les annexes ou participer à la conférence téléphonique pour obtenir des résultats détaillés. Aucune modification des états financiers ou des prévisions précédemment émises n'est incluse.

Aclaris Therapeutics (Nasdaq: ACRS) hat ein Formular 8-K eingereicht, um Investoren darüber zu informieren, dass am 29. Juli 2025 eine Telefonkonferenz stattfinden wird, um die vorläufigen Daten der Phase-2a-Studie zu ATI-2138, einem oralen kovalenten ITK/JAK3-Inhibitor für mittelschwere bis schwere atopische Dermatitis, zu besprechen. Zwei Anlagen werden bereitgestellt: Anlage 99.1 (Investorpräsentation) und Anlage 99.2 (Pressemitteilung). Gemäß Reg FD werden die Punkte 7.01 und 8.01 bereitgestellt, jedoch nicht eingereicht, sodass die Informationen nicht der Haftung nach dem Exchange Act unterliegen und nicht automatisch in andere SEC-Berichte aufgenommen werden.

Das 8-K enthält keine numerischen Angaben zu Wirksamkeit, Sicherheit oder finanziellen Kennzahlen. Investoren müssen die beigefügten Anlagen einsehen oder an der Telefonkonferenz teilnehmen, um detaillierte Ergebnisse zu erhalten. Es gibt keine Änderungen an den Finanzberichten oder zuvor veröffentlichten Prognosen.

Positive
  • Announcement of top-line Phase 2a results for ATI-2138 signals ongoing development progress and upcoming clinical visibility.
Negative
  • Filing lacks any efficacy or safety data, leaving investors unable to gauge clinical success or valuation impact.

Insights

TL;DR: Filing announces forthcoming Phase 2a data; impact indeterminate until actual numbers released.

Pipeline progress matters in biotech valuations, and ATI-2138’s emergence from Phase 2a is a gating event. However, the 8-K omits efficacy or safety readouts, preventing assessment of clinical or commercial viability. Investors should withhold judgment until Exhibit 99.2 is reviewed or management comments on response rates, pruritus scores and adverse events.

TL;DR: Procedural 8-K; no immediate valuation catalyst without data.

The filing satisfies Reg FD by alerting the market to an upcoming disclosure. Because the information is furnished, it does not trigger SEC liability or automatic inclusion in future filings. Absent quantitative results, share-price impact is likely muted until the press release or call provides clarity on trial success, timeline to Phase 3 and funding needs.

Aclaris Therapeutics (Nasdaq: ACRS) ha presentato un modulo 8-K per informare gli investitori che terrà una conference call il 29 luglio 2025 per esaminare i dati preliminari del suo studio di Fase 2a su ATI-2138, un inibitore orale covalente ITK/JAK3 per la dermatite atopica da moderata a grave. Sono forniti due documenti: l'Esibizione 99.1 (presentazione per investitori) e l'Esibizione 99.2 (comunicato stampa). In base al Reg FD, gli Elementi 7.01 e 8.01 sono forniti ma non depositati, quindi le informazioni non sono soggette a responsabilità secondo l'Exchange Act né automaticamente incorporate in altri rapporti SEC.

Il modulo 8-K non contiene dati numerici su efficacia, sicurezza o metriche finanziarie. Gli investitori devono consultare gli allegati o partecipare alla conference call per i risultati dettagliati. Non sono incluse modifiche ai bilanci o alle precedenti previsioni.

Aclaris Therapeutics (Nasdaq: ACRS) ha presentado un Formulario 8-K para informar a los inversores que realizará una llamada conferencia el 29 de julio de 2025 para revisar los datos preliminares de su estudio de Fase 2a sobre ATI-2138, un inhibidor oral covalente ITK/JAK3 para dermatitis atópica de moderada a grave. Se proporcionan dos documentos: Anexo 99.1 (presentación para inversores) y Anexo 99.2 (comunicado de prensa). Según el Reg FD, los Ítems 7.01 y 8.01 se proporcionan pero no se presentan formalmente, por lo que la información no está sujeta a responsabilidad bajo la Exchange Act ni se incorpora automáticamente en otros informes de la SEC.

El 8-K no incluye datos numéricos de eficacia, seguridad o métricas financieras. Los inversores deben consultar los anexos o participar en la llamada conferencia para obtener resultados detallados. No se incluyen cambios en los estados financieros ni en las guías previamente emitidas.

Aclaris Therapeutics (나스닥: ACRS)는 2025년 7월 29일에 경구용 공유 결합 ITK/JAK3 억제제인 ATI-2138의 중등도에서 중증 아토피 피부염에 대한 2a상 연구의 주요 결과를 검토하기 위한 컨퍼런스 콜을 개최할 것임을 투자자에게 알리기 위해 Form 8-K를 제출했습니다. 두 가지 자료가 제공됩니다: 전시물 99.1 (투자자 프레젠테이션) 및 전시물 99.2 (보도자료). Reg FD에 따라 항목 7.01과 8.01은 제출된 것이 아니라 제공된 것이므로, 이 정보는 거래법상 책임 대상이 아니며 다른 SEC 보고서에 자동으로 포함되지 않습니다.

8-K에는 수치로 된 효능, 안전성 또는 재무 지표가 포함되어 있지 않습니다. 투자자들은 상세한 결과를 위해 첨부된 자료를 참조하거나 컨퍼런스 콜에 참여해야 합니다. 재무제표 변경이나 이전에 발표된 가이던스 변경은 포함되어 있지 않습니다.

Aclaris Therapeutics (Nasdaq : ACRS) a déposé un formulaire 8-K pour informer les investisseurs qu'elle organisera une conférence téléphonique le 29 juillet 2025 afin de passer en revue les données principales de son étude de phase 2a sur ATI-2138, un inhibiteur oral covalent ITK/JAK3 pour la dermatite atopique modérée à sévère. Deux documents sont fournis : l'annexe 99.1 (présentation aux investisseurs) et l'annexe 99.2 (communiqué de presse). Conformément au règlement FD, les points 7.01 et 8.01 sont fournis mais non déposés, ce qui signifie que ces informations ne sont pas soumises à la responsabilité en vertu de l'Exchange Act et ne sont pas automatiquement intégrées dans d'autres rapports SEC.

Le formulaire 8-K ne contient aucune donnée chiffrée concernant l'efficacité, la sécurité ou les indicateurs financiers. Les investisseurs doivent consulter les annexes ou participer à la conférence téléphonique pour obtenir des résultats détaillés. Aucune modification des états financiers ou des prévisions précédemment émises n'est incluse.

Aclaris Therapeutics (Nasdaq: ACRS) hat ein Formular 8-K eingereicht, um Investoren darüber zu informieren, dass am 29. Juli 2025 eine Telefonkonferenz stattfinden wird, um die vorläufigen Daten der Phase-2a-Studie zu ATI-2138, einem oralen kovalenten ITK/JAK3-Inhibitor für mittelschwere bis schwere atopische Dermatitis, zu besprechen. Zwei Anlagen werden bereitgestellt: Anlage 99.1 (Investorpräsentation) und Anlage 99.2 (Pressemitteilung). Gemäß Reg FD werden die Punkte 7.01 und 8.01 bereitgestellt, jedoch nicht eingereicht, sodass die Informationen nicht der Haftung nach dem Exchange Act unterliegen und nicht automatisch in andere SEC-Berichte aufgenommen werden.

Das 8-K enthält keine numerischen Angaben zu Wirksamkeit, Sicherheit oder finanziellen Kennzahlen. Investoren müssen die beigefügten Anlagen einsehen oder an der Telefonkonferenz teilnehmen, um detaillierte Ergebnisse zu erhalten. Es gibt keine Änderungen an den Finanzberichten oder zuvor veröffentlichten Prognosen.

0001557746false00015577462025-07-292025-07-29

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): July 29, 2025

Aclaris Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-37581

46-0571712

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

701 Lee Road, Suite 103

Wayne, PA 19087

(Address of principal executive offices, including zip code)

(484) 324-7933

(Registrant’s telephone number, including area code)

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, $0.00001 par value

 

ACRS

 

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 7.01 Regulation FD Disclosure.

On July 29, 2025, Aclaris Therapeutics, Inc. (the “Registrant”) will hold a conference call to discuss the top-line results for its Phase 2a clinical trial of ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor, in subjects with moderate to severe atopic dermatitis (the “Top-line Results”). A copy of the presentation that will accompany the conference call is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 8.01 Other Events.

On July 29, 2025, the Registrant issued a press release announcing the Top-line Results. A copy of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

 

Number

Exhibit Description

99.1

Company Presentation.

99.2

Press Release dated July 29, 2025.

104

The cover page from Aclaris Therapeutics, Inc.’s Form 8-K filed on July 29, 2025, formatted in Inline XBRL.

2

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.

ACLARIS THERAPEUTICS, INC.

By:

/s/ Kevin Balthaser

Date: July 29, 2025

Kevin Balthaser

Chief Financial Officer

3

FAQ

What did Aclaris Therapeutics (ACRS) announce in its 8-K?

The company disclosed it will discuss top-line Phase 2a results for ATI-2138 during a 29 Jul 2025 conference call and issued related exhibits.

Is the actual ATI-2138 Phase 2a data included in the filing?

No. The 8-K references a presentation (Ex. 99.1) and press release (Ex. 99.2); the filing itself contains no numerical results.

What is ATI-2138?

ATI-2138 is an investigational oral covalent ITK/JAK3 inhibitor being studied for moderate-to-severe atopic dermatitis.

Are the furnished materials considered "filed" with the SEC?

No. Under Reg FD, Items 7.01 and 8.01 are furnished, not filed, and are not subject to Exchange Act liability.

Will this 8-K affect Aclaris’s financial statements?

The filing contains no financial statements or guidance updates, so existing financials remain unchanged.
Aclaris Therapeutics Inc

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