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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 Holdings Inc. (ARCT) reporting person Andy Sassine, who is both a director and the Chief Financial Officer, acquired 1,238 shares of the issuer's common stock on 08/15/2025 through the company's 2020 Employee Stock Purchase Plan (ESPP). The shares were purchased at a price of $16.558 per share, which the filing states equals 85% of the closing price on the purchase date. Following the transaction, the reporting person beneficially owned 221,764 shares. The Form 4/A is an amendment to an earlier filing and is signed by an attorney-in-fact on 08/20/2025. The document contains an explanation that the purchase was effected under the ESPP and the discounted purchase price formula.
Arcturus Therapeutics Holdings Inc. (ARCT) reporting person Andy Sassine, who is identified as both a Director and the Chief Financial Officer, executed a purchase under the companys 2020 Employee Stock Purchase Plan on 08/15/2025. The filing states 1,238 shares were purchased at an effective price of $16.558, which the filer explains was based on 85% of the closing price on that date. Following the reported transaction the filing lists 221,764 shares beneficially owned. The Form 4 is signed by an attorney-in-fact, Ilan Katz, dated 08/19/2025.
Arcturus reported lower collaboration-driven revenue as its COVID-19 vaccine transitioned to commercialization, while advancing clinical programs and recognizing milestone payments.
Total revenue for the quarter was $28.3 million versus $49.9 million a year earlier, driven by $24.4 million of collaboration revenue from CSL Seqirus and $3.8 million of grant revenue from BARDA. Net loss was $9.18 million for the quarter and $23.26 million for the six months. Cash and restricted cash totaled $253.4 million, and the accumulated deficit was $472.1 million.
The company highlighted regulatory and commercial progress for KOSTAIVE (ARCT-154) with approvals in Japan and the EU, receipt of a $200.0 million upfront payment from CSL and approximately $509.7 million of total upfronts and milestones to date, including a $20.0 million development milestone recognized this quarter. Research and development and general and administrative expenses declined year-over-year as programs shifted toward commercialization.
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.
Schedule 13G/A (Amendment 8) filed on 07/30/2025 discloses that ARK Investment Management LLC and its CEO/CIO Catherine D. Wood collectively hold a significant position in Arcturus Therapeutics Holdings Inc. (ARCT).
- Shares beneficially owned: 1,715,040 common shares.
- Ownership percentage: 6.32 % of ARCT’s outstanding stock.
- Voting & dispositive power: ARK has sole voting and dispositive power over the full position; Wood has shared power through her control of ARK.
- Form type of filer: ARK is an investment adviser (IA); Wood is reported as a holding-company/control person (HC, IN).
- Client concentration: The ARK Genomic Revolution ETF is the only ARK client with an interest >5 % of ARCT.
The filing states the shares were acquired and are held in the ordinary course of business and not with the intent to influence control of the issuer.