Every 8-K that Arcturus Therapeutics Holdings Inc. (ARCT) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ARCT and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ARCT filings page.
Arcturus Therapeutics Holdings Inc. (ARCT) reported interim results from its ongoing Phase 2 ARCT-810 study in OTC deficiency: treatment was generally safe and well tolerated, first morning fasting ammonia was reduced and/or maintained within the normal range, and glutamine was reduced. Participants at the 0.5 mg/kg dose level achieved mean glutamine values within the normal range; weight gain was observed in all participants.
LUNAR 2.0 showed a 40-fold improvement over LUNAR 1.0 in hEPO expression in one non-human-primate study and 38-fold greater potency than ATX-95 in hOTC expression in a separate study. Arcturus plans to initiate ARCT-2601 dosing near year-end in participants aged 12 years and older under an amended protocol integrating it into the current Phase 2 study, following favorable FDA feedback and regulatory-path clarity after a June Type C meeting.
Arcturus entered a definitive agreement to acquire AI discovery company myNEO, subject to customary closing conditions; closing is expected in October. Arcturus said the acquisition is intended to support mRNA design quality and target identification.
Arcturus Therapeutics Holdings Inc. (ARCT) reports that on August 25, 2026 it will present a scientific poster titled “Impact of ARCT-810 mRNA Therapy on Dietary Intake and Biochemical Data in Adolescents and Adults with Ornithine Transcarbamylase Deficiency” at the 2026 Annual Symposium of the Society for the Study of Inborn Errors of Metabolism in Helsinki, Finland. The company states that additional data and the regulatory plan for the ARCT-810 program are expected to be communicated later this quarter. The ARCT-810 presentation is provided as Exhibit 99.1 and is described as furnished, not deemed filed or incorporated by reference into other securities law reports.
Arcturus Therapeutics Holdings Inc. reported Q2 2026 results with total revenue of $3.0 million, down from $28.3 million a year earlier, mainly reflecting reduced collaboration revenue as it moves toward terminating the CSL Seqirus agreement and regaining rights to KOSTAIVE and its infectious disease vaccine portfolio.
The company recorded a net loss of $23.8 million, or $0.84 per share, compared with a $9.2 million loss and $0.34 per share in Q2 2025. Cash and cash equivalents were $191.5 million as of June 30, 2026, versus $230.9 million at December 31, 2025, and management cites a cash runway of over two and a half years through year end 2028.
R&D expenses declined to $17.5 million from $29.6 million as spending was focused on highest-priority programs. ARCT-032 cystic fibrosis Phase 2 enrollment remains on schedule with a Phase 3 proceed decision expected in Q4 2026, while ARCT-810 Phase 2 enrollment and dosing have completed, with data and a regulatory plan to be communicated in Q3 2026.
Arcturus Therapeutics Holdings Inc. entered a strategic collaboration with Thermo Fisher Scientific to support the development of ARCT-032, its investigational mRNA therapy for cystic fibrosis. The relationship is governed by a Master Services Agreement and a detailed Project Addendum.
Under the Master Services Agreement, Thermo Fisher will contribute up to $40 million of clinical manufacturing services for ARCT-032, and Arcturus will engage Thermo Fisher’s PPD business for up to $40 million in contract research organization services. If ARCT-032 receives regulatory approval, Thermo Fisher would gain exclusive commercial manufacturing rights for a specified period, to be finalized in a separate supply agreement.
The initial term of the Master Services Agreement is five years, with automatic one-year renewals unless either party gives at least 90 days’ notice. The Project Agreement covers key activities such as technical transfer, engineering and clinical batches, fill-finish, product release, and stability studies, supporting ARCT-032 through late-stage clinical development and potential commercialization.
Arcturus Therapeutics Holdings Inc. reported the results of its 2026 annual meeting of stockholders. A quorum was present, with 21,435,189 shares represented out of 28,423,069 shares entitled to vote. Stockholders elected eight directors, each receiving more than 15.5 million votes in favor and remaining in office until the 2027 annual meeting. They also approved, on a non-binding advisory basis, the company’s named executive officer compensation, with 15,254,240 votes for and 327,647 against. In addition, stockholders ratified the appointment of Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 21,378,017 votes for and minimal opposition.
Arcturus Therapeutics reported first quarter 2026 revenue of $2.1 million, down sharply from $29.4 million a year earlier, as it pivots from infectious disease vaccines toward rare disease programs. Total operating expenses fell to $31.0 million from $46.2 million, reflecting lower COVID-related manufacturing and trial costs.
The company posted a net loss of about $27.0 million, or ($0.95) per share, compared to a $14.1 million loss, or ($0.52) per share, in the prior-year quarter. Cash, cash equivalents and restricted cash were $213.4 million as of March 31, 2026, supporting a stated cash runway beyond the second quarter of 2028.
Arcturus initiated enrollment earlier than expected in a 12‑week open-label Phase 2 cystic fibrosis study and obtained FDA direction on the pediatric path for its ornithine transcarbamylase deficiency program ahead of an End of Phase 2 meeting in the second half of 2026. The company also appointed Dennis Mulroy as Chief Financial Officer, with a $520,000 base salary, up to 40% bonus eligibility, and options for 100,000 shares vesting over four years, plus severance and change‑in‑control protections.
Arcturus Therapeutics reported weaker revenue but narrower losses for the fourth quarter and full year 2025, while advancing its mRNA rare disease pipeline and extending its cash runway. Full-year revenue fell to $82.0 million from $152.3 million, mainly due to lower collaboration revenue as CSL-related COVID-19 work shifted from development to commercialization.
Operating expenses dropped sharply to $158.3 million from $248.0 million, driven by lower LUNAR-COVID, LUNAR-FLU and LUNAR-CF program costs and an operational restructuring. Net loss improved to $65.8 million (basic and diluted loss of $2.40 per share) from $80.9 million (loss of $3.00 per share) a year earlier.
Quarterly revenue for Q4 2025 was $7.2 million, down from $22.8 million, while net loss was $29.1 million versus $30.0 million. Cash, cash equivalents and restricted cash totaled $232.8 million at December 31, 2025, and the company now expects its cash runway to extend into the second quarter of 2028, supported by a strategic refocus on core rare disease programs. Clinically, ARCT-032 showed generally safe and well tolerated results in a Phase 2 third cohort, and regulators have permitted a 12-week Phase 2 cystic fibrosis study to begin dosing in the first half of 2026.
Arcturus Therapeutics Holdings Inc. reported that Chief Financial Officer and director Andy Sassine will leave the company under a mutual, amicable separation, with his employment ending on December 31, 2025 and his Board service ending on December 11, 2025. He indicated that his departure is not due to any disagreement regarding the company’s operations, policies, or practices, and the Board reduced its size from nine to eight members.
Under a Separation Agreement, Sassine is entitled to a lump-sum severance equal to 12 months of base salary, bonus eligibility if and when paid to the Chief Executive Officer, reimbursement of certain attorney’s fees, up to 18 months of COBRA premiums, and accelerated vesting plus a 24‑month post‑termination exercise period for his stock options beginning December 31, 2025, after a seven‑day revocation period. On December 12, 2025, Controller Joe Roberts, age 43, was appointed interim principal financial officer and interim principal accounting officer, under an existing Employment Agreement that provides a base salary of $219,580, bonus eligibility up to 20% of base salary, and participation in the company’s benefit and equity plans.
Arcturus Therapeutics Holdings Inc. furnished a press release announcing its financial results for the quarter ended September 30, 2025 and providing a corporate update.
Under Item 2.02, the information is furnished, not filed, and includes forward-looking statements covering programs such as ARCT-032, ARCT-810, and partnered COVID-19 and flu vaccine efforts with CSL Seqirus. The press release is attached as Exhibit 99.1.
Arcturus Therapeutics Holdings Inc. announced on September 26, 2025 the launch of a new presentation of KOSTAIVE®, its self‑amplifying mRNA vaccine candidate against COVID‑19. The company said the product is formulated as a two‑dose vial, one vial per carton. In non‑clinical studies it induced neutralizing antibodies against the Omicron sublineage JN.1 and variant XEC, and showed cross‑neutralization versus LP.8.1, XFG and NB.1.8.1. Arcturus also disclosed a distribution and sales agreement with CSL Seqirus for Japan. The filing includes a press release dated September 26, 2025 and a company signature by Joseph E. Payne, Chief Executive Officer. The Item 7.01 disclosure is labeled as Regulation FD information and is not incorporated by reference into other filings unless specifically stated.
Arcturus Therapeutics disclosed that Japanese authorities granted manufacturing and marketing approval for a new presentation of KOSTAIVE® (ARCT-2301), its self-amplifying mRNA COVID-19 vaccine targeting the SARS-CoV-2 Omicron sublineage JN.1 variant XEC. The filing notes non-clinical studies showing induction of neutralizing antibodies not only against JN.1 and XEC but also against LP.8.1 and currently circulating variants XFG and NB.1.8.1. The approved formulation is supplied as a two-dose vial with one vial per carton. The company named CSL Seqirus as the partner for distribution and sales in Japan. The disclosure is reported as Regulation FD information in this 8-K.
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.