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Approval Sought in Japan for New SARS-CoV-2 Vaccine
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The vaccine developer's partner in Japan is already working on getting a manufacturing facility built there, noted an H.C. Wainwright & Co. 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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Important Disclosures:

  1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
  2. The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
  3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

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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.

This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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