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Arcturus Therapeutics Announces First Quarter 2022 Financial Update and Pipeline Progress ARCT-154 booster data show 54- and 46-fold increases in neutralizing antibody response against Omicron BA.1 and BA.2 Investor conf

Key Takeaway: Therapeutics Announces First Quarter 2022 Financial Update and Pipeline Progress ARCT-154 booster data show 54- and 46-fold increases in neutralizing antibody response against Omicron BA.1 and BA.2 Investor conference call at 4:30 p.m. ET today SAN DIEGO-(BUSINESS WIRE)-May 9

Full Press Release Details

Therapeutics Announces First Quarter 2022 Financial Update and Pipeline Progress
ARCT-154 booster data show 54- and 46-fold increases
in neutralizing antibody response against Omicron BA.1 and BA.2
Investor conference call at 4:30 p.m. ET today
SAN DIEGO-(BUSINESS WIRE)-May 9, 2022 - 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 significant opportunities within liver and respiratory rare diseases, today announced its financial results for the first quarter
ended March 31, 2022, and provided corporate updates.
first quarter of this year has been commemorated by several key achievements for Arcturus. Our self-amplifying mRNA platform has been
the first of its kind to demonstrate meaningful protection against COVID-19 disease in a pivotal primary vaccination trial," said
Joseph Payne, President and CEO of Arcturus Therapeutics. "In addition, ARCT-154 has shown promising booster data against all SARS-CoV-2
variants tested, including Omicron BA.1 and BA.2. We are expanding development activities of ARCT-154 into a global registrational
booster trial and expect to begin dosing soon."
Recent Corporate Highlights
Pseudovirus MNT assay (exploratory assay; Moore Laboratory, National
Institute for Communicable Diseases and University
of the Witwatersrand, South
Africa) showing GMFR levels of neutralizing antibody responses over Day 1 (baseline levels prior to boosting with ARCT-154) calculated
using geometric mean concentrations (with 95% confidence intervals) obtained from participants measured at Days 1 and 29 (n = 12/12).
Financial Results for the First Quarter Ended March 31, 2022
Revenues in conjunction with strategic alliances and collaborations:
Arcturus' primary sources of revenues were from consulting and related technology transfer fees, license fees and collaborative
payments received from research and development arrangements with pharmaceutical and biotechnology partners. Total revenue for the three
months ended March 31, 2022, was $5.2 million, compared with $2.1 million in the three months ended March 31, 2021, and $5.8 million for
the three months ended December 31, 2021. The increase in revenue during the three months ended March 31, 2022, when compared with the
three months ended March 31, 2021, is primarily due to the recognition of revenue from manufacturing technology transfer and clinical
consulting services provided that are related to the Vinbiocare agreement.
Operating expenses: Total operating expenses for the three months
ended March 31, 2022, were $55.6 million compared with $59.8 million for the three months ended March 31, 2021, and $43.4 million for
the three months ended December 31, 2021. The increase in operating expenses of $12.2 million sequentially was primarily due to the increase
in research and development expenses.
Research and development expenses: Research and development
expenses for the three months ended March 31, 2022, were $44.9 million compared with $50.0 million for the three months ended March 31,
2021, and $32.6 million for the three months ended December 31, 2021. The increase in the three months ended March 31, 2022, when compared
with the three months ended December 31, 2021, is primarily attributable manufacturing and quality runs for covid products and an increase
in costs associated with the start-up activities toward initiation of the booster trial. In January 2022, the Company entered into an
agreement with a pharmaceutical company, whereby the pharmaceutical company agreed to fund up to $25 million for a clinical trial for
a LUNAR-COV19 vaccine candidate as a booster.
Net Loss: For the three months ended March 31, 2022, Arcturus
reported a net loss of approximately $51.2 million, or ($1.94) per basic and diluted share, compared with a net loss of $56.3 million,
or ($2.15) per basic and diluted share in the three months ended March 31, 2021, and a net loss of $38.7 million, or ($1.47) per basic
and diluted share in the three months ended December 31, 2021.
Cash Position: Cash and cash equivalents were $319.7 million
as of March 31, 2022, and $370.5 million at December 31, 2021. Based on the current pipeline, the Company's cash position is expected
to be sufficient to support operations into late 2023.
Monday, May 9 @ 4:30 p.m. ET
Domestic: 888-256-1007
International: 323-994-2093
Conference ID: 6122841
Webcast: Link
About Arcturus Therapeutics
and based in San Diego, California, Arcturus Therapeutics
Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines
and vaccines company with enabling technologies: (i) LUNAR lipid-mediated delivery, (ii) STARR mRNA Technology and (iii)
mRNA drug substance along with drug product manufacturing expertise. Arcturus' diverse pipeline of RNA therapeutic and vaccine
candidates includes mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza, and other programs to potentially treat ornithine
transcarbamylase (OTC) deficiency, and cystic fibrosis along with partnered programs including glycogen storage disease type III (GSD
III), hepatitis B virus (HBV), and non-alcoholic steatohepatitis (NASH). Arcturus' versatile RNA therapeutics platforms can be
applied toward multiple types of nucleic acid medicines including messenger RNA, self-amplifying mRNA, small interfering RNA, circular
RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio
(with patents and patent applications issued in the U.S., Europe, Japan, China and
other countries). Arcturus' commitment to the development of novel RNA therapeutics has led to collaborations with Janssen
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson
& Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Duke-NUS Medical School,
and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com.
In addition, please connect with us on Twitter and LinkedIn.
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 expectations for or likelihood of success
of any collaborations, the promise of the company's platform technologies for multiple types of nucleic acid medicines, the likelihood
of success (including safety and efficacy) of the Company's pipeline (including ARCT-154, ARCT-810, ARCT-032 and a STARR mRNA candidate
for influenza), the likelihood that any independent verification by Arcturus, or any regulatory body's assessment of, of data will
be consistent with the information shared by Vinbiocare from the ARCT-154 study in Vietnam, the likelihood that the clinical results
of ARCT-154 studies (including the efficacy, booster durability or other antibody responses), or any other non-clinical or clinical data,
will be predictive of future clinical results or efficacy, predictive of results against existing or future COVID variants, or sufficient
for any regulatory approval, the likelihood of regulatory clearance to proceed with, and the planned timing, design (including number
of participants), screening, enrollment, initiation or completion of, and data readouts of, a booster study of ARCT-154, a Phase 2 study
for ARCT-810, or any other clinical trials, the timing of interim data from the ARCT-810 study or any other data, the likelihood or timing
of an EUA or regulatory approval in Vietnam for ARCT-154 or for
any regulatory approval, the likelihood, and timing for, a filing to proceed with a clinical study of ARCT-032, the likelihood that a
patent will issue from any patent application, its financial projections, 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 otherwise.
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.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
March 31, 2022 December 31, 2021
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 319,678 $ 370,492
Accounts receivable 3,691 3,367
Prepaid expenses and other current assets 3,636 5,102
Total current assets 327,005 378,961
Property and equipment, net 7,530 5,643
Operating lease right-of-use asset, net 5,245 5,618
Equity-method investment 131 515
Non-current restricted cash 2,077 2,077
Total assets $ 341,988 $ 392,814
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 10,014 $ 10,058
Accrued liabilities 19,970 23,523
Current portion of long-term debt 24,260 22,474
Deferred revenue 53,062 43,482
Total current liabilities 107,306 99,537
Deferred revenue, net of current portion 6,641 19,931
Long-term debt, net of current portion 39,235 40,633
Operating lease liability, net of current portion 4,057 4,502
Total liabilities $ 157,239 $ 164,603
Stockholders' equity
Common stock: $0.001 par value; 60,000 shares authorized; 26,407 issued and outstanding at March 31, 2022 and 26,372 issued and outstanding at December 31, 2021 26 26
Additional paid-in capital 583,382 575,675
Accumulated deficit (398,659 ) (347,490 )
Total stockholders' equity 184,749 228,211
Total liabilities and stockholders' equity $ 341,988 $ 392,814
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Last updated: May 9, 2022