Full Press Release Details
Therapeutics Announces Fourth Quarter and Fiscal Year 2024 Financial Update and Pipeline Progress
Phase 2 interim data for ARCT-032 (CF) &
ARCT-810 (OTCD) on track for Q2 2025
Meiji Seika Pharma and ARCALIS received MHLW
approval for commercial manufacturing of KOSTAIVE
Meiji Seika Pharma Submitted Application for
Two-Dose Vial of KOSTAIVE
KOSTAIVE U.S. BLA filing anticipated 2025
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--(BUSINESS WIRE)--March 6, 2025-- Arcturus
Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a commercial messenger RNA medicines
company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today
announced its financial results for the fourth quarter ended December 31, 2024, and provided corporate updates.
"We continue to progress our flagship rare
disease programs and look forward to sharing meaningful Phase 2 interim data from our cystic fibrosis (CF) and ornithine transcarbamylase
(OTC) deficiency programs in Q2 2025," said Joseph Payne, President & CEO of Arcturus Therapeutics. "Arcturus continues
to make excellent progress with our STARR sa-mRNA vaccines pipeline and platform. We are very pleased to have recently received European
Commission approval for KOSTAIVE and MHLW approval for Meiji Seika Pharma and ARCALIS to add commercial manufacturing sites in Japan.
Our team continues to work diligently with CSL Seqirus to prepare KOSTAIVE regulatory filings for the United States and the United Kingdom."
Corporate Highlights
| o | First Phase 1 participant was dosed December 2024, and the Company expects interim Phase 1 data in H2 2025. | |
| o | The primary objective of this initial clinical trial is to evaluate safety and immune responses of three different dose levels and two different vaccination schedules of ARCT-2304 vaccine. Immune responses are measured by hemagglutination inhibition (HAI), virus microneutralization (MN) and neuraminidase enzyme-linked lectin assays (ELLA). |
Financial Results for the three months ended December 31, 2024,
and the year ended December 31, 2024
Revenues in conjunction with strategic alliances and collaborations:
Arcturus' primary revenue streams include
license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research and
development arrangements with pharmaceutical and biotechnology partners. For the three months ended December 31, 2024, we reported revenue
of $22.8 million, a decrease of $8.1 million from the $30.9 million reported in the same period in 2023. The decline was attributable
to lower milestone achievements from the CSL agreement during the fourth quarter of 2024.
For the year ended December 31, 2024, we reported
revenue of $152.3 million, a decrease of $14.5 million from the $166.8 million reported for the year ended 2023. The decrease was due
to lower milestone achievements from the CSL agreement, offset by increased BARDA revenue due to progress of the pandemic flu program.
Total operating expenses for the three months
ended December 31, 2024, were $56.2 million compared with $49.1 million for the three months ended December
31, 2023. Total operating expenses for the year ended December 31, 2024, were $248.0 million compared with $245.0
million for the year ended December 31, 2023.
Research and development expenses:
Research and development expenses consist primarily of external manufacturing
costs, in vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants,
personnel-related expenses, facility-related expenses and laboratory supplies related to conducting research and development activities.
Research and development expenses were $43.8 million for the three months ended December 31, 2024, compared with $36.6 million for the
three months ended December 31, 2023. Additionally, research and development expenses were $195.2 million for the year ended December
31, 2024, compared with $192.1 million for the year ended December 31, 2023. The increase in research and development expenses for both
the quarter and the full year was primarily driven by higher clinical trial costs associated with our OTC and CF programs, as well as
the COVID-19 and LUNAR-FLU programs in collaboration with CSL. However, the increase was partially offset by a reduction in manufacturing
expenses related to clinical trials and drug supply agreements as part of the COVID-19 program.
General and Administrative Expenses:
General and administrative expenses primarily
consist of salaries and related benefits for executive, administrative, legal and accounting functions and professional service fees for
legal and accounting services as well as other general and administrative expenses. General and administrative expenses were $12.4
million for the three months ended December 31, 2024, compared with $12.5 million for the three months ended December
31, 2023. Additionally, General and administrative expenses were $52.8 million for the year ended December 31, 2024, compared
with $52.9 million for the year ended December 31, 2023. These expenses remained relatively consistent between the two
periods. We expect general and administrative expenses to decrease slightly during the next twelve months driven by lower share-based
compensation costs and a reduction in general and administrative expenses related to the commercial transition of the COVID program to
For the three months ended December 31, 2024,
Arcturus reported a net loss of approximately $30.0 million, or ($1.11) per diluted share, compared with a net loss of $11.7
million, or ($0.44) per diluted share for the three months ended December 31, 2023. Additionally, for the year ended December
31, 2024, Arcturus reported a net loss of approximately $80.9 million, or ($3.00) per diluted share, compared with a net loss of $29.7
million, or ($1.12) per diluted share for the year ended December 31, 2023.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were
$293.9 million as of December 31, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $473.1 million
in upfront payments and milestones from CSL as of December 31, 2024, and expects to continue to receive future milestone payments from
CSL supporting the ongoing development of the COVID program. During the quarter ended December 31, 2024, CSL reported to Arcturus that
Arcturus' share of gross profit from sales of KOSTAIVE was approximately $28.0 million. This amount will be credited against Arcturus'
share of the COVID-19 program costs paid by CSL. When CSL has recouped Arcturus' share of such costs, Arcturus will begin to receive
shared net profit payments from CSL for sales of KOSTAIVE, consistent with Arcturus' eligibility to receive a 40% share of net profits
from COVID-19 vaccine sales. Based on the current pipeline and programs, the cash runway is expected to extend until the end of Q1 2027.
Arcturus Therapeutics Fourth Quarter and Full Year 2024 Earnings
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR
lipid-mediated delivery, (ii) STARR mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing
expertise. Arcturus developed KOSTAIVE , the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved.
Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS,
focused on the manufacture of mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially
treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2
(COVID-19) and influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines
including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics.
Arcturus' technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China,
and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
Forward Looking Statements
This press release contains 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 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 anticipated timing for providing
interim data from the ARCT-032 Phase 2 CF study and the ARCT-810 Phase 2 OTC deficiency study, the completion of and timing for KOSTAIVE
regulatory filings for the United States and United Kingdom, the expected treatment protocol for the ARCT-032 Phase 2 CF study, the expected
infusions and timing therefor for the ARCT-810 Phase 2 OTC deficiency study, the potential supply of mRNA vaccines by Meiji Seika Pharma
and ARCALIS, the likelihood that CSL Seqirus will recoup the development costs of the COVID-19 program and that Arcturus will receive
net profit payments from CSL Seqirus for sales of KOSTAIVE, the likelihood that preclinical or clinical data will be predictive of future
clinical results, the likelihood or timing of collection of accounts receivables including expected payments from CSL Seqirus, 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.