Approval Sought in Japan for New SARS-CoV-2 Vaccine
Research Report

Arcturus Therapeutics Holdings Inc.'s (ARCT:NASDAQ) self-amplifying messenger RNA (mRNA) vaccine candidate ARCT-154 "could enter the Japanese market as a COVID-19 primary vaccine course and as a booster dose in 2023," reported H.C. Wainwright & Co. analyst Ed Arce in a July 3 research note.

Applications for both uses were submitted by Arcturus' Japanese partner, Meiji Seika Pharma, tasked with obtaining regulatory approval, distribution, sales, and marketing of the vaccine in Japan.

"We expect Meiji to begin marketing ARCT-154 shortly after its approval," Arce wrote.

Attractive Gain Potential

H.C. Wainwright reiterated its Buy rating and US$51 per share target price on Arcturus.

Currently, the company is trading at about US$28.68 per share. The difference between these prices implies a significant return for investors of 78%.

Supportive Phase 3 Data

Meiji Seika filed the application, asking for ARCT-154 to be approved as a COVID-19 vaccine booster in adults in Japan, on June 30, 2023. This request was based on recent positive results of the Phase 3 noninferiority immunogenicity vaccine trial in Japan, jRCT2071220080.

In the study, the vaccine met the primary efficacy endpoint of "geometric mean titers and seroconversion rates of neutralizing antibodies against SARS-CoV-2," the Wuhan strain, on day 29 after a booster shot of ARCT-154 or Pfizer's COMIRNATY. Also, ARCT-154 exhibited a favorable safety profile.

NDA Filed Earlier

Previously, in late April, Meiji Seika filed a new drug application in Japan for ARCT-154 as a primary immunization against COVID-19 in adults.

Arcturus' management team expects to receive a decision on both applications this year, Arce wrote.

Manufacturing Being Addressed

In anticipation of and preparation for ARCT-154's approval, Meiji is working with ARCALIS, a joint venture company between Arcturus and Axcelead Inc., the latter a drug discovery services provider in Japan, to establish an mRNA vaccine manufacturing facility in the Japanese city of Minamisoma.

"This facility would enable Meiji to supply ARCT-154 in Japan as soon as possible following its potential approval," wrote Arce.

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Disclosures for H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., July 3, 2023

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Arcturus Therapeutics Holdings Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of June 30, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Arcturus Therapeutics Holdings Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Arcturus Therapeutics Holdings Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from Arcturus Therapeutics Holdings Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Arcturus Therapeutics Holdings Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited.

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