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[8-K] Arcturus Therapeutics Holdings Inc. Reports Material Event

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Rhea-AI Filing Summary

Arcturus Therapeutics furnished a press release reporting its financial results for the quarter ended June 30, 2025 and provided a corporate update; the press release is furnished as Exhibit 99.1 and the company states the information is furnished (not filed) with customary forward-looking statements.

The filing highlights program and regulatory topics discussed in the press release, including ARCT-032 (Phase 2 cystic fibrosis study), ARCT-810 (Phase 3 design discussions), partnered COVID-19 and seasonal flu programs with CSL Seqirus, a BARDA-supported pandemic flu Phase 1 study, and regulatory filings and potential approvals related to KOSTAIVE with CSL and Meiji Seika Pharma and a planned U.S. BLA filing. The company disclaims any obligation to update forward-looking statements.

Arcturus Therapeutics ha diffuso un comunicato stampa sui risultati finanziari per il trimestre terminato il 30 giugno 2025 e ha fornito un aggiornamento aziendale; il comunicato è incluso come Allegato 99.1 e la società specifica che le informazioni sono fornite (non depositate) e comprendono le consuete affermazioni prospettiche.

Il documento mette in evidenza i programmi e i temi regolatori citati nel comunicato, inclusi ARCT-032 (studio di fase 2 per la fibrosi cistica), ARCT-810 (discussioni sul disegno della fase 3), i programmi in collaborazione per COVID-19 e influenza stagionale con CSL Seqirus, uno studio pandemico di fase 1 per l'influenza sostenuto da BARDA, e le pratiche regolatorie e le potenziali approvazioni relative a KOSTAIVE con CSL e Meiji Seika Pharma nonché una prevista presentazione BLA negli Stati Uniti. La società declina ogni obbligo di aggiornare le dichiarazioni prospettiche.

Arcturus Therapeutics difundió un comunicado de prensa con sus resultados financieros del trimestre cerrado el 30 de junio de 2025 y ofreció una actualización corporativa; el comunicado se adjunta como Anexo 99.1 y la compañía indica que la información se facilita (no se presenta) e incluye las habituales declaraciones prospectivas.

El documento destaca los programas y asuntos regulatorios mencionados en el comunicado, incluidos ARCT-032 (estudio de fase 2 para fibrosis quística), ARCT-810 (discusiones sobre el diseño de la fase 3), los programas en colaboración para COVID-19 e influenza estacional con CSL Seqirus, un estudio de fase 1 sobre influenza pandémica apoyado por BARDA, y las solicitudes regulatorias y posibles aprobaciones relacionadas con KOSTAIVE con CSL y Meiji Seika Pharma, además de la prevista presentación de una BLA en EE. UU. La compañía renuncia a cualquier obligación de actualizar las declaraciones prospectivas.

Arcturus Therapeutics는 2025년 6월 30일로 종료된 분기의 재무 실적을 알리는 보도자료를 제공하고 회사 현황을 업데이트했습니다. 해당 보도자료는 증빙자료 99.1로 제공되었으며, 회사는 이 정보가 제출(filed)이 아닌 제공(furnished)된 것이며 통상적인 미래예측진술을 포함한다고 명시했습니다.

서류는 보도자료에서 언급된 프로그램 및 규제 관련 사안을 강조합니다. 주요 내용으로는 ARCT-032(낭포성 섬유증 임상 2상), ARCT-810(임상 3상 설계 논의), CSL Seqirus와의 코로나19 및 계절성 독감 공동 프로그램, BARDA가 지원하는 팬데믹 독감 임상 1상, CSL 및 Meiji Seika Pharma와 관련한 KOSTAIVE의 규제 제출 및 잠재적 승인 가능성, 그리고 미국 BLA 제출 계획 등이 포함됩니다. 회사는 미래예측진술을 업데이트할 의무가 없음을 부인합니다.

Arcturus Therapeutics a diffusé un communiqué de presse faisant état de ses résultats financiers pour le trimestre clos le 30 juin 2025 et a fourni une mise à jour d'entreprise ; le communiqué est fourni en tant qu'Exhibit 99.1 et la société précise que l'information est fournie (non déposée) et comprend les habituelles déclarations prospectives.

Le dépôt met en lumière les programmes et questions réglementaires abordés dans le communiqué, notamment ARCT-032 (essai de phase 2 pour la mucoviscidose), ARCT-810 (discussions sur la conception de la phase 3), les programmes COVID-19 et grippe saisonnière en partenariat avec CSL Seqirus, un essai de phase 1 sur la grippe pandémique soutenu par la BARDA, ainsi que les dossiers réglementaires et les autorisations potentielles concernant KOSTAIVE avec CSL et Meiji Seika Pharma et un dépôt BLA prévu aux États‑Unis. La société décline toute obligation de mise à jour des déclarations prospectives.

Arcturus Therapeutics veröffentlichte eine Pressemitteilung zu den Finanzergebnissen für das Quartal zum 30. Juni 2025 und gab ein Unternehmensupdate; die Pressemitteilung ist als Anlage 99.1 beigefügt, und das Unternehmen stellt klar, dass die Informationen bereitgestellt (nicht eingereicht) werden und die üblichen zukunftsgerichteten Aussagen enthalten.

Die Einreichung hebt die im Pressetext behandelten Programm- und Zulassungsthemen hervor, darunter ARCT-032 (Phase‑2‑Studie zur Mukoviszidose), ARCT-810 (Diskussionen zum Design der Phase‑3), partnerschaftliche COVID‑19‑ und saisonale Grippeprogramme mit CSL Seqirus, eine von BARDA unterstützte Phase‑1‑Studie zur Pandemiegrippe sowie regulatorische Einreichungen und mögliche Zulassungen in Bezug auf KOSTAIVE mit CSL und Meiji Seika Pharma und eine geplante BLA‑Einreichung in den USA. Das Unternehmen weist jegliche Verpflichtung zur Aktualisierung zukunftsgerichteter Aussagen zurück.

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Insights

TL;DR: Routine 8-K furnishing of quarterly results and pipeline/regulatory updates; limited immediate market impact without financial detail.

The report primarily furnishes a press release containing results for the quarter ended June 30, 2025 and a corporate update. It follows standard disclosure practice by characterizing the release as "furnished" rather than "filed," which limits certain SEC liabilities. The filing lists multiple potential near- and mid-term catalysts (ARCT-032 Phase 2 CF, ARCT-810 Phase 3 discussions, partnered COVID-19/flu programs with CSL Seqirus, BARDA pandemic flu Phase 1, and KOSTAIVE regulatory filings), but provides no financial metrics or outcomes. Investors need the actual press release for numeric results; absent those figures, the 8-K itself is informational rather than catalytic.

TL;DR: Disclosure aligns with SEC practices; forward-looking caution reduces legal exposure while signalling transparency on pipeline and regulatory interactions.

The company appropriately furnishes the press release and includes a comprehensive cautionary note covering forward-looking statements, reducing legal exposure for predictive language. The filing enumerates specific programs and regulatory interactions, which improves transparency about management's focus and potential milestones. However, the absence of underlying data in the 8-K means material assessment requires reviewing the referenced press release and future filings that may contain detailed results or regulatory filings.

Arcturus Therapeutics ha diffuso un comunicato stampa sui risultati finanziari per il trimestre terminato il 30 giugno 2025 e ha fornito un aggiornamento aziendale; il comunicato è incluso come Allegato 99.1 e la società specifica che le informazioni sono fornite (non depositate) e comprendono le consuete affermazioni prospettiche.

Il documento mette in evidenza i programmi e i temi regolatori citati nel comunicato, inclusi ARCT-032 (studio di fase 2 per la fibrosi cistica), ARCT-810 (discussioni sul disegno della fase 3), i programmi in collaborazione per COVID-19 e influenza stagionale con CSL Seqirus, uno studio pandemico di fase 1 per l'influenza sostenuto da BARDA, e le pratiche regolatorie e le potenziali approvazioni relative a KOSTAIVE con CSL e Meiji Seika Pharma nonché una prevista presentazione BLA negli Stati Uniti. La società declina ogni obbligo di aggiornare le dichiarazioni prospettiche.

Arcturus Therapeutics difundió un comunicado de prensa con sus resultados financieros del trimestre cerrado el 30 de junio de 2025 y ofreció una actualización corporativa; el comunicado se adjunta como Anexo 99.1 y la compañía indica que la información se facilita (no se presenta) e incluye las habituales declaraciones prospectivas.

El documento destaca los programas y asuntos regulatorios mencionados en el comunicado, incluidos ARCT-032 (estudio de fase 2 para fibrosis quística), ARCT-810 (discusiones sobre el diseño de la fase 3), los programas en colaboración para COVID-19 e influenza estacional con CSL Seqirus, un estudio de fase 1 sobre influenza pandémica apoyado por BARDA, y las solicitudes regulatorias y posibles aprobaciones relacionadas con KOSTAIVE con CSL y Meiji Seika Pharma, además de la prevista presentación de una BLA en EE. UU. La compañía renuncia a cualquier obligación de actualizar las declaraciones prospectivas.

Arcturus Therapeutics는 2025년 6월 30일로 종료된 분기의 재무 실적을 알리는 보도자료를 제공하고 회사 현황을 업데이트했습니다. 해당 보도자료는 증빙자료 99.1로 제공되었으며, 회사는 이 정보가 제출(filed)이 아닌 제공(furnished)된 것이며 통상적인 미래예측진술을 포함한다고 명시했습니다.

서류는 보도자료에서 언급된 프로그램 및 규제 관련 사안을 강조합니다. 주요 내용으로는 ARCT-032(낭포성 섬유증 임상 2상), ARCT-810(임상 3상 설계 논의), CSL Seqirus와의 코로나19 및 계절성 독감 공동 프로그램, BARDA가 지원하는 팬데믹 독감 임상 1상, CSL 및 Meiji Seika Pharma와 관련한 KOSTAIVE의 규제 제출 및 잠재적 승인 가능성, 그리고 미국 BLA 제출 계획 등이 포함됩니다. 회사는 미래예측진술을 업데이트할 의무가 없음을 부인합니다.

Arcturus Therapeutics a diffusé un communiqué de presse faisant état de ses résultats financiers pour le trimestre clos le 30 juin 2025 et a fourni une mise à jour d'entreprise ; le communiqué est fourni en tant qu'Exhibit 99.1 et la société précise que l'information est fournie (non déposée) et comprend les habituelles déclarations prospectives.

Le dépôt met en lumière les programmes et questions réglementaires abordés dans le communiqué, notamment ARCT-032 (essai de phase 2 pour la mucoviscidose), ARCT-810 (discussions sur la conception de la phase 3), les programmes COVID-19 et grippe saisonnière en partenariat avec CSL Seqirus, un essai de phase 1 sur la grippe pandémique soutenu par la BARDA, ainsi que les dossiers réglementaires et les autorisations potentielles concernant KOSTAIVE avec CSL et Meiji Seika Pharma et un dépôt BLA prévu aux États‑Unis. La société décline toute obligation de mise à jour des déclarations prospectives.

Arcturus Therapeutics veröffentlichte eine Pressemitteilung zu den Finanzergebnissen für das Quartal zum 30. Juni 2025 und gab ein Unternehmensupdate; die Pressemitteilung ist als Anlage 99.1 beigefügt, und das Unternehmen stellt klar, dass die Informationen bereitgestellt (nicht eingereicht) werden und die üblichen zukunftsgerichteten Aussagen enthalten.

Die Einreichung hebt die im Pressetext behandelten Programm- und Zulassungsthemen hervor, darunter ARCT-032 (Phase‑2‑Studie zur Mukoviszidose), ARCT-810 (Diskussionen zum Design der Phase‑3), partnerschaftliche COVID‑19‑ und saisonale Grippeprogramme mit CSL Seqirus, eine von BARDA unterstützte Phase‑1‑Studie zur Pandemiegrippe sowie regulatorische Einreichungen und mögliche Zulassungen in Bezug auf KOSTAIVE mit CSL und Meiji Seika Pharma und eine geplante BLA‑Einreichung in den USA. Das Unternehmen weist jegliche Verpflichtung zur Aktualisierung zukunftsgerichteter Aussagen zurück.

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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): August 11, 2025

 

ARCTURUS THERAPEUTICS HOLDINGS INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38942   32-0595345
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

10628 Science Center Drive, Suite 250

San Diego, California 92121 

(Address of principal executive offices)

 

Registrant’s telephone number, including area code: (858) 900-2660

 

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   ARCT   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 2.02. Results of Operations and Financial Conditions.

 

On August 11, 2025, Arcturus Therapeutics Holdings Inc. (the “Company” or “Arcturus”) issued a press release, a copy of which is furnished herewith as Exhibit 99.1, announcing the Company’s financial results for the quarter ended June 30, 2025 and providing a corporate update (the “Press Release”).

 

The information contained in Item 2.02 of this Current Report on Form 8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, this information shall not be deemed incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission (the “SEC”), except as shall be expressly set forth by specific reference in any such filing.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K and the Press Release contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this Current Report on Form 8-K and the Press Release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success of the Company’s pipeline (including ARCT-032 and ARCT-810) and partnered programs (including the COVID-19 and flu programs partnered with CSL Seqirus), the likelihood of and timing for providing interim data from the ARCT-032 Phase 2 CF study, the likelihood of and timing for completion of enrollment in the ARCT-032 Phase 2 CF study, the likelihood of and timing for Phase 3 trial design alignment with regulatory agencies for ARCT-810, the timing for Phase 1 results from the BARDA pandemic flu Phase 1 study, the likelihood of and timing for meetings with the FDA and other regulatory agencies relating to the CF and OTC programs, the likelihood of and timing for initiation of Phase 3 studies for the CF and OTC programs, the timing for completion of enrollment in the ARCT-032 (CF) Phase 2 study, the likelihood of and timing for approval of the MAA on KOSTAIVE filed by CSL to the UK MHRA, the likelihood and timing for approvals of NDA applications for KOSTAIVE filed by Meiji Seika Pharma with Japan’s PMDA, the planned U.S. BLA filing and expected approval decision for KOSTAIVE, efforts for optimization and testing for seasonal influenza program, the timing for Phase 1 results for the pandemic influenza vaccine candidate, the likelihood that general and administrative expenses will decrease, the likelihood that preclinical or clinical data will be predictive of future clinical results, its current cash position and expected cash burn and runway, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description of Exhibit
     
99.1   Press Release dated August 11, 2025
104   Cover Page to this Current Report on Form 8-K in Inline XBRL

 

 

 

 

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.

 

  Arcturus Therapeutics Holdings Inc.
Date: August 11, 2025  
     
  By: /s/ Joseph E. Payne
  Name: Joseph E. Payne
  Title: Chief Executive Officer

 

 

 

 

 

 

 

FAQ

What did Arcturus (ARCT) disclose in this 8-K?

The company furnished a press release reporting financial results for the quarter ended June 30, 2025 and a corporate update; the press release is furnished as Exhibit 99.1.

Does this 8-K include Arcturus' financial results numbers?

No; the 8-K references a press release for the quarter ended June 30, 2025 but does not present financial figures within the filing itself.

Which pipeline programs and partnerships are mentioned in the filing for ARCT?

The filing references ARCT-032 (Phase 2 CF), ARCT-810 (Phase 3 design discussions), COVID-19 and seasonal flu programs partnered with CSL Seqirus, a BARDA-supported pandemic flu Phase 1 study, and regulatory actions related to KOSTAIVE.

Is the press release in this 8-K considered 'filed' with the SEC?

No; the company explicitly states the information is furnished and therefore is not deemed 'filed' for certain SEC liability provisions.

Does the filing include forward-looking statements and will Arcturus update them?

Yes; the 8-K contains forward-looking statements covering strategy, clinical timelines, approvals, cash position and other items, and the company disclaims any obligation to update them except as required by law.
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