Full Press Release Details
Arcturus Therapeutics Announces
Third Quarter 2021 Financial Update and Pipeline Progress
Phase 1/2/3a and 3b study of ARCT-154 COVID-19
vaccine candidate completed enrollment with over 17,000 participants
Initiated ~2,000 participant ARCT-154 Phase
3c sub-study to compare immunogenicity noninferiority to AstraZeneca COVID-19 vaccine; enrollment to be completed this week
Preparing to file Emergency Use Authorization
(EUA) application for ARCT-154, pending interim study results, with the Vietnam Ministry of Health in December 2021; potential for EUA
Investor conference call at 4:30 p.m. ET today
San Diego, Calif., Nov. 8, 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 third quarter ended September 30, 2021 and provided corporate updates.
"We are extremely pleased to have rapidly
completed full enrollment of the Phase 1/2/3a and 3b cohorts and are looking forward to completing enrollment in the Phase 3c sub-study
of the ARCT-154 pivotal trial this week, in collaboration with Vinbiotech. Assuming favorable data, we look forward to filing for Emergency
Use Authorization as soon as December of this year," said Joseph Payne, President and CEO of Arcturus Therapeutics. "ARCT-154
has an attractive and differentiated profile as a low dose, self-amplifying mRNA vaccine candidate that targets multiple SARS-CoV2 variants
of concern, and we are working diligently with our global manufacturing partners to make it available as soon as possible."
Recent Corporate Highlights
Financial Results for the Quarter Ended September
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 September 30, 2021, the Company
reported revenue of $2.4 million, compared with $2.3 million in the three months ended September 30, 2020 and $2.0 million for the three
months ended June 30, 2021.
Operating expenses: Total operating expenses for
the three months ended September 30, 2021, were $56.3 million compared with $23.3 million for the three months ended September 30, 2020
and $55.7 million for the three months ended June 30, 2021.
Research and development expenses increased to
$45.4 million year over year compared to $17.7 million from the third quarter of 2020. Research and development expenses were relatively
consistent compared to $45.7 million in the second quarter of 2021.
For the three months ended September 30, 2021,
Arcturus reported a net loss of approximately $54.1 million, or ($2.05) per basic and diluted share, compared with a net loss of $21 million,
or ($0.92) per basic and diluted share in the three months ended September 30, 2020 and a net loss of $54.6 million, or ($2.07) per basic
and diluted share in the three months ended June 30, 2021.
The Company's cash balance totaled $413.9
million as of September 30, 2021, compared to a cash balance of $433.6 million at June 30, 2021 and $462.9 million at December 31, 2020.
The cash balance includes $40 million received from Vinbiotech Research and Manufacture Joint Stock Company, of which $30 million was
received during the current quarter ended September 30, 2021. Based on the current pipeline, the Company's cash position is expected
to be sufficient to support operations for two years.
| Monday, Nov. 8 at 4:30 p.m. ET |
| Domestic: 877-407-0784 International: 201-689-8560 Conference ID: 13724305 Webcast: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47084/indexl.html |
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 (with patents and patent applications, issued and filed 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.
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 expectations for or likelihood of
success of any collaborations (including with respect to LUNAR-HBV), the likelihood of success (including safety and efficacy) of the
Company's pipeline (including LUNAR-FLU, ARCT-021, ARCT-032, ARCT-154, ARCT-165 and ARCT-810), anticipated sponsorship and/or funding
of clinical trials of the Company's candidates, the Company's efforts to develop a vaccine against COVID-19 and therapeutic
potential thereof based on the Company's mRNA therapeutics, the planned initiation, design or completion of clinical trials, the
likelihood that the Company will obtain clearance from regulatory authorities to proceed with future planned clinical trials, the likelihood
that preclinical or clinical data will be predictive of future clinical results (including with respect to safety, immunogenicity and
efficacy), the ability to enroll, and timing for enrollment of, subjects in clinical trials, the timing and nature of any study 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 or timing of any regulatory approval, the Company's manufacturing plans or
technologies (including with its partner, Vinbiotech), the likelihood that a patent will issue from any patent application, its current
cash position and adequacy of its capital to support future operations 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.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except par value information)
| September 30, 2021 | June 30, 2021 | December 31, 2020 | ||||||||||
| (unaudited) | (unaudited) | |||||||||||
| Assets | ||||||||||||
| Current assets: | ||||||||||||
| Cash and cash equivalents | $ | 413,880 | $ | 433,574 | $ | 462,895 | ||||||
| Accounts receivable | 2,015 | 2,163 | 2,125 | |||||||||
| Prepaid expenses and other current assets | 5,071 | 2,301 | 2,769 | |||||||||
| Total current assets | 420,966 | 438,038 | 467,789 | |||||||||
| Property and equipment, net | 4,843 | 3,407 | 3,378 | |||||||||
| Operating lease right-of-use asset, net | 5,983 | 6,341 | 5,182 | |||||||||
| Equity-method investment | 670 | 920 | - | |||||||||
| Non-current restricted cash | 2,074 | 107 | 107 | |||||||||
| Total assets | $ | 434,536 | $ | 448,813 | $ | 476,456 | ||||||
| Liabilities and stockholders' equity | ||||||||||||
| Current liabilities: | ||||||||||||
| Accounts payable | $ | 8,265 | $ | 10,084 | $ | 10,774 | ||||||
| Accrued liabilities | 52,358 | 42,614 | 20,639 | |||||||||
| Deferred revenue | 57,616 | 18,071 | 18,108 | |||||||||
| Total current liabilities | 118,239 | 70,769 | 49,521 | |||||||||
| Deferred revenue, net of current portion | 8,497 | 9,850 | 12,512 | |||||||||
| Long-term debt, net of current portion | 42,345 | 56,309 | 13,845 | |||||||||
| Operating lease liability, net of current portion | 4,935 | 5,359 | 4,025 | |||||||||
| Other long-term liabilities | 1,394 | 878 | - | |||||||||
| Total liabilities | $ | 175,410 | $ | 143,165 | $ | 79,903 | ||||||
| Stockholders' equity | ||||||||||||
| Common stock: $0.001 par value; 60,000 shares authorized; 26,349 issued and outstanding at September 30, 2021, 26,327 issued and outstanding at June 30, 2021 and 26,192 issued and outstanding at December 31, 2020 | 26 | 26 | 26 | |||||||||
| Additional paid-in capital | 567,927 | 560,365 | 540,343 | |||||||||
| Accumulated deficit | (308,827 | ) | (254,743 | ) | (143,816 | ) | ||||||
| Total stockholders' equity | 259,126 | 305,648 | 396,553 | |||||||||
| Total liabilities and stockholders' equity | $ | 434,536 | $ | 448,813 | $ | 476,456 |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
except per share data)
| Three Months Ended | ||||||||||||
| September 30, | June 30, | |||||||||||
| 2021 | 2020 | 2021 | ||||||||||
| Collaboration revenue | $ | 2,437 | $ | 2,333 | $ | 2,001 | ||||||
| Operating expenses: | ||||||||||||
| Research and development, net | 45,398 | 17,699 | 45,679 | |||||||||
| General and administrative | 10,860 | 5,572 | 10,042 | |||||||||
| Total operating expenses | 56,258 | 23,271 | 55,721 | |||||||||
| Loss from operations | (53,821 | ) | (20,938 | ) | (53,720 | ) | ||||||
| (Loss) gain from equity-method investment | (250 | ) | - | (328 | ) | |||||||
| (Loss) gain from foreign currency | 506 | - | (13 | ) | ||||||||
| Finance expense, net | (519 | ) | (66 | ) | (520 | ) | ||||||
| Net loss | $ | (54,084 | ) | $ | (21,004 | ) | $ | (54,581 | ) | |||
| Net loss per share, basic and diluted | $ | (2.05 | ) | $ | (0.92 | ) | $ | (2.07 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 26,338 | 22,938 | 26,323 | |||||||||
| Comprehensive loss: | ||||||||||||
| Net loss | $ | (54,084 | ) | $ | (21,004 | ) | $ | (54,581 | ) | |||
| Comprehensive loss | $ | (54,084 | ) | $ | (21,004 | ) | $ | (54,581 | ) |
IR and Media Contacts
Arcturus Therapeutics
Deepankar Roy, Ph.D.
Kendall Investor Relations