Full Press Release Details
Arcturus Therapeutics Announces First Quarter
2023 Financial Update and Pipeline Progress
New Drug Application (NDA) for ARCT-154,
a next generation COVID-19 vaccine, was submitted in Japan, leading to potential approval in 2023
$23.6 Million advanced for the
manufacturing and supply of ARCT-154
ARCT-032 Phase 1 enrollment and administration
completed successfully; trial expansion to include Cystic Fibrosis patients planned in third quarter
Investor conference call at 4:30 p.m. ET today
SAN DIEGO--May 9, 2023-- Arcturus Therapeutics
Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global late-stage clinical 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 first quarter ended March 31, 2023, and provided corporate updates.
pleased to announce the first NDA submission for the COVID-19 vaccine, ARCT-154, in Japan by Meiji Seika Pharma Co., Ltd., leading to
potential approval later this year. ARCT-154 has the potential to offer effective and longer-lasting protection against COVID-19. We believe
this meaningful milestone is indicative of the broader platform opportunity for our mRNA medicine technologies to result in novel vaccines
and therapeutics over the coming years," said Joseph Payne, President & CEO of Arcturus Therapeutics. "We have also made
meaningful operational and pipeline progress across several clinical and pre-clinical mRNA therapeutic programs with the completion of
enrollment of a Phase 3 study evaluating the safety and immunogenicity of ARCT-154 as a booster against COVID-19 conducted by Meiji Seika
Pharma in Japan, with interim results expected later this quarter."
In April 2023 we received an advance
payment of $23.6 million for the manufacturing and supply of ARCT-154 from CSL Seqirus. The advance payment was for specified manufacturing
runs of ARCT-154 which includes the drug substance utilized, as well as the reservation fees and related manufacturing requirements.
"As we mentioned on the year end conference
call last month, we took a number of positive steps to improve our balance sheet this quarter with the elimination of $34 million in principal
and accrued interest on the Singapore Loan," stated Andrew Sassine, Chief Financial Officer of Arcturus Therapeutics. "On
March 31, 2023, we have no long-term debt on our balance sheet and current assets increased by $21 million sequentially due to $90 million
in accounts receivable from CSL Seqirus which is expected to be collected during the second quarter of 2023. Consequently, I am happy
to report that our cash runway continues to extend into the beginning of 2026 assuming no changes to our clinical programs and expected
development milestones and do not include any expectations of commercial milestones or revenues."
Recent Corporate Highlights
Financial Results for the First Quarter Ended March 31, 2023
Revenues in conjunction with strategic alliances
Arcturus' primary sources of revenues were
from license fees, consulting and related technology transfer fees, reservation fees and collaborative payments received from research
and development arrangements with pharmaceutical and biotechnology partners. Total revenue for the three months ended March 31, 2023,
was $80.3 million, compared with $5.2 million for the three months ended March 31, 2022. The increase in revenue is primarily attributable
to an increase in revenue of $78.2 million related to the agreement with CSL Seqirus and the associated milestones achieved in the first
Total operating expenses for the three months
ended March 31, 2023, were $65.5 million compared with $55.6 million for the three months ended March 31, 2022.
Research and development expenses:
Research and development expense was $51.8 million
for the three months ended March 31, 2023, compared with $44.9 million in the comparable period last year, primarily reflecting increased
manufacturing costs of $5.7 million, an increase of $2.3 million in personnel related expenses, an increase of travel and consulting expenses
of $0.9 million, and increase in facility expenses of $0.7 million. The increases were offset by a decrease in clinical-related expenses
of $4.4 million. We expect that our research and development efforts and associated costs will increase and continue to be substantial
over the next several years as our pipeline progresses. Facilities and equipment expenses continue to increase as we expand. The
three months ended March 31, 2023, includes increased rent and associated costs related to a new facility we took possession of in April
2022. Facilities and equipment expenses are expected to increase in the near term due to increased rent expenses related to our three
General and Administrative Expenses:
General and administrative expenses were $13.8
million for the three months ended March 31, 2023, compared with $10.7 million in the comparable period last year. The increase resulted
primarily from personnel expenses due to increased headcount and salaries, increased travel and consulting expenses as well as increased
rent expense associated with the new facility.
Net Income and other income and expense:
For the three months ended March 31, 2023, Arcturus
reported net income of approximately $50.8 million, or $1.87 per diluted share, compared with a net loss of $51.2 million, or ($1.94)
per diluted share in the three months ended March 31, 2022, and net income of $117.3 million, or $4.33 per diluted share in the three
months ended December 31, 2022. We recorded a gain on debt extinguishment related to the Singapore Loan of $34.0 million during the three
months ended March 31, 2023. Additionally, we reported net interest income of $2.5 million for the three months ended March 31, 2023.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were
$330.1 million as of March 31, 2023, $394.0 million on December 31, 2022, and $321.8 million on March 31, 2022. Additionally, we expect
to collect $90.0 million in the second quarter of 2023, associated with the CSL Seqirus milestones which are in accounts receivable on
March 31, 2023. In April we received $23.6 million related to the manufacturing and supply of ARCT-154 from CSL Seqirus. The cash
runway remains extended through the beginning of 2026 based on the current pipeline and programs.
Tuesday, May 9, 2023 @ 4:30 p.m. ET
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 potential of ARCT-154 to offer
effective or long-lasting protection against COVID-19 disease, the potential for the Company's platform to result in novel vaccines
or therapeutics, the anticipated timing and sharing of Phase 3 pivotal ARCT-154 results and data, the planned production of ARCT-154 doses,
the likelihood and timing of regulatory approvals or orders for, or commercialization of, ARCT-154 in Japan or anywhere else, the planned
submissions to regulatory authorities relating to ARCT-154 including interim data, the anticipated enrollment of the ARCT-810 Phase 2
study, the anticipated sharing of interim Phase 2 data for ARCT-810, the anticipated expansion of the ARCT-032 study to allow the dosing
of patients with CF and its anticipated enrollment, the potential of the LUNAR-HBV program, the likelihood of success of the collaboration
with CSL Seqirus or any collaborations including the achievement of any milestones or other payments, the initiation or completion of
any clinical trial, the likelihood that preclinical or clinical data will be predictive of future clinical results, the timing and nature
of any study results, the likelihood that a patent will issue from any patent application, the likelihood or timing of collection of accounts
receivables including expected payments from CSL Seqirus, its current cash position and expected cash burn 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. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or
Trademark Acknowledgements
The Arcturus logo and other trademarks of Arcturus appearing in this
announcement, including LUNAR and STARR , are the property of Arcturus. All other trademarks, services marks, and trade names
in this announcement are the property of their respective owners.
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