Full Press Release Details
Arcturus Therapeutics Announces First Quarter
2021 Company Overview and
Financial Results and Provides New Clinical
ARCT-021 Phase 2 interim data showed favorable
safety profile and greater than 90% seroconversion after a single dose; data supports advancement into Phase 3
In negotiations with multiple regulatory authorities
regarding ARCT-021 Phase 3 study program
Continued progress advancing mRNA therapeutic
platform, including liver (ARCT-810) and lung (ARCT-032) targeted programs
Investor conference call at 4:30 p.m. ET
San Diego, Calif, May 10, 2021 -
Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a leading clinical-stage 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, 2021 and provided corporate updates.
"Arcturus has made continued progress advancing
our clinical pipeline, highlighted by our development efforts for ARCT-021, a differentiated mRNA vaccine candidate targeting COVID-19.
Based on promising data from our Phase 1/2 study, and the new interim safety and immunogenicity data from our Phase 2 study, we are looking
forward to initiating ARCT-021 Phase 3 study as well as the continued advancement of our other pipeline programs," said Steve Hughes,
M.D., Chief Medical Officer of Arcturus.
"Our Self-Transcribing and Replicating mRNA
(STARR ) delivered with our LUNAR delivery system potentially has important differences from currently authorized mRNA vaccines
for emergency use. We believe that ARCT-021, as a single shot lyophilized self-amplifying mRNA vaccine, if approved, may represent a preferred
vaccine option. We are very pleased with the recent successes in our mRNA drug product manufacturing efforts, and in the expansion of
our global safety database - and the positive readthrough this provides to the Company's pipeline of mRNA therapeutics. We
eagerly look forward to the next major development milestones for our vaccine, liver, and lung mRNA pipeline programs," said Joseph
Payne, President & CEO of Arcturus.
Recent Corporate Highlights
ARCT-021, STARR mRNA Vaccine Candidate
ARCT-810, mRNA Therapeutic Candidate for Ornithine
Transcarbamylase (OTC) Deficiency
ARCT-032, mRNA Therapeutic Candidate for Cystic
Financial results for the quarter ended March
Revenues in conjunction with strategic alliances
and collaborations: Arcturus' primary sources of revenues were from license fees and collaborative payments received from research
and development arrangements with pharmaceutical and biotechnology partners. For the three months ended March 31, 2021, the Company reported
revenue of $2.1 million, compared with $2.6 million in the three months ended March 31, 2020.
Operating expenses: Total operating expenses
for the three months ended March 31, 2021 were $59.8 million compared with $12.1 million for the three months ended March 31, 2020 and
$33.3 million for the three months ended December 31, 2020.
Research and development expenses increased by
approximately $42.1 year over year and $25.8 million sequentially from the fourth quarter of 2020. The primary driver of the sequential
increase was driven by higher clinical and manufacturing cost of $17.2 million for our ARCT-021 program. The remaining increase was primarily
driven by higher personnel costs and related to the acquisition of an exclusive license from Alexion Pharmaceuticals for certain patent-pending
inventions relating to nucleic acid purification technologies for approximately $5.0 million of Arcturus stock.
Net loss: For the three months ended March
31, 2021 Arcturus reported a net loss of approximately $56.3 million, or ($2.15) per basic and diluted share, compared with a net loss
of $9.8 million, or ($0.67) per basic and diluted share in the three months ended March 31, 2020 and a net loss of $31.1 million, or ($1.25)
per basic and diluted share in the three months ended December 31, 2020.
The Company's cash balance totaled $466.9
million as of March 31, 2021, compared to cash and cash equivalents of $463.0 million at December 31, 2020. Based on our current plans,
the Company's cash position is expected to be sufficient to support operations for more than two years.
May 10th @ 4:30 p.m. ET
| Domestic: | 877-256-4295 | |
| International: | 212-231-2927 | |
| Conference ID: | 21993793 | |
| Webcast: | http://public.viavid.com/index.php?id=144682 |
About Arcturus Therapeutics
Founded in 2013 and based in San Diego, California, Arcturus
Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage 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 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus' versatile
RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA,
replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent
portfolio (209 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, Synthetic Genomics Inc., 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.
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, collaborations, the planned initiation, design or completion of clinical trials,
the likelihood that the Company will obtain clearance from regulatory authorities to proceed with planned clinical trials, the likelihood
that preclinical or clinical data will be predictive of future clinical results, the likelihood that clinical data will be sufficient
for regulatory approval or completed in time to submit an application for regulatory approval within a particular timeframe, the likelihood
of success (including safety and efficacy) of the Company's pipeline, including ARCT-021, ARCT-810 or ARCT-032, the potential administration
regimen or dosage, or ability to administer multiple doses of, any of Company's drug candidates, the ability to enroll subjects
in clinical trials, the Company's efforts to develop a vaccine against COVID-19 and therapeutic potential thereof based on the Company's
mRNA therapeutics, the Company's manufacturing methods and technologies (including purification and lyophilization, and stability
of manufactured product), the ability of the Company to scale up manufacturing of products or substances, the likelihood that a patent
will issue from any patent application, its current cash position and expected cash burn and the impact of general business and economic
conditions. Actual results and performance could differ materially from those projected in any forward-looking statements as a result
of many factors including, without limitation, the ability to enroll subjects in clinical trials as a result of the COVID-19 pandemic,
the impact of commercialization of third-party COVID-19 vaccines on the design, and ability to conduct, clinical trials, the availability
of manufacturing capacity and raw materials, unexpected clinical results, government regulations impacting the regulatory environment
or intellectual property landscape, and general market conditions that may prevent such achievements or performance. 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. Such statements are based on management's
current expectations and involve risks and uncertainties, including those discussed under the heading "Risk Factors" in Arcturus'
Annual Report on Form 10-K for the fiscal year ended December 31, 2020, and in subsequent filings with, or submissions to, the SEC. 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.
IR and Media Contacts
Arcturus Therapeutics
Kendall Investor Relations
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
| March 31, 2021 | December 31, 2020 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 466,839 | $ | 462,895 | ||||
| Accounts receivable | 2,007 | 2,125 | ||||||
| Prepaid expenses and other current assets | 1,150 | 2,769 | ||||||
| Total current assets | 469,996 | 467,789 | ||||||
| Property and equipment, net | 3,427 | 3,378 | ||||||
| Operating lease right-of-use asset, net | 6,690 | 5,182 | ||||||
| Equity-method investment | 1,248 | - | ||||||
| Non-current restricted cash | 107 | 107 | ||||||
| Total assets | $ | 481,468 | $ | 476,456 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,597 | $ | 10,774 | ||||
| Accrued liabilities | 29,800 | 20,639 | ||||||
| Deferred revenue | 17,936 | 18,108 | ||||||
| Total current liabilities | 53,333 | 49,521 | ||||||
| Deferred revenue, net of current portion | 11,313 | 12,512 | ||||||
| Long-term debt, net of current portion | 58,147 | 13,845 | ||||||
| Operating lease liability, net of current portion | 5,710 | 4,025 | ||||||
| Other long-term liabilities | 358 | - | ||||||
| Total liabilities | $ | 128,861 | $ | 79,903 | ||||
| Stockholders' equity | ||||||||
| Common stock: $0.001 par value; 60,000 shares authorized; 26,319 issued and outstanding at March 31, 2021 and 26,192 issued and outstanding at December 31, 2020 | 26 | 26 | ||||||
| Additional paid-in capital | 552,743 | 540,343 | ||||||
| Accumulated deficit | (200,162 | ) | (143,816 | ) | ||||
| Total stockholders' equity | 352,607 | 396,553 | ||||||
| Total liabilities and stockholders' equity | $ | 481,468 | $ | 476,456 |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS