We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Arcturus Therapeutics Holdings Inc | NASDAQ:ARCT | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.41 | 1.88% | 22.18 | 22.03 | 22.11 | 22.22 | 21.74 | 22.00 | 142,446 | 17:49:00 |
ARCT-154 Phase 3 COVID-19 booster trial achieved primary endpoint demonstrating strong immune response and favorable safety profile
Meiji Seika Pharma submitted ARCT-154 New Drug Application in Japan
New ARCT-154 booster clinical data demonstrate one-year durability across a panel of variants
Received FDA Fast Track Designation and Rare Pediatric Disease Designation for ARCT-810 for OTC deficiency
Received regulatory approval of ARCT-032 to proceed into a Phase 1b clinical study in CF patients
Investor conference call at 4:30 p.m. ET today
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 second quarter and six months ended June 30, 2023 and provided corporate updates.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230807532754/en/
Geometric mean fold rise (GMFR) of neutralizing antibodies against SARS-CoV-2 variants (versus pre-booster levels) after ARCT-154 booster vaccination measured by validated pseudoviral microneutralization assays (N=12). Error bars represent the 95% CI. GMFR values are included in white. Participants who received any COVID-19 vaccines or had laboratory-confirmed SARS-CoV-2 infection during the follow-up period were excluded from immunogenicity analysis at sampling times after the event. (Graphic: Arcturus Therapeutics)
“Arcturus has continued to achieve significant operational progress alongside our exclusive global vaccines partner CSL Seqirus, highlighted by the NDA submission of ARCT-154, for the COVID-19 primary series vaccine and booster, in Japan by CSL Seqirus’ partner Meiji Seika Pharma,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “As demonstrated by the recently published ARCT-154 Phase 3 head-to-head booster data versus Comirnaty®, we believe that our next generation STARR® mRNA platform is meaningfully differentiated. In addition to ARCT-154, we have also made significant progress with other clinical and pre-clinical mRNA therapeutic programs, and we look forward to sharing clinical data from our ARCT-810 and ARCT-032 programs later this year.”
Recent Corporate Highlights
Financial Results for the Three and Six Months Ended June 30, 2023
Revenues in conjunction with strategic alliances and collaborations:
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. For the three months ended June 30, 2023, we reported revenue of $10.5 million compared with $27.1 million for the three months ended June 30, 2022. Revenue decreased by $16.6 million during the three months ended June 30, 2023 as compared to the prior year period. The decrease was primarily attributable to a decrease in revenue of $12.7 million related to the termination of the agreement with Vinbiocare and a decrease in revenue of $12.5 million related to the agreement with the Israeli Ministry of Health. The decrease was primarily offset by an increase in revenue of $8.6 million related to the collaboration agreement with CSL Seqirus and the grant agreement with BARDA which were both executed in the second half of 2022. Revenue increased by $58.5 million during the six months ended June 30, 2023 as compared to the six months ended June 30, 2022. The increase was attributable to an increase in revenue of $87.6 million primarily related to the collaboration agreement with CSL Seqirus and the grant agreement with BARDA which were both executed in the second half of 2022.
Operating expenses:
Total operating expenses for the three months ended June 30, 2023 were $65.9 million compared with $49.2 million for the three months ended June 30, 2022. Total operating expenses for the six months ended June 30, 2023 were $131.4 million compared with $104.8 million for the six months ended June 30, 2022.
Research and development expenses:
Our 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 $52.7 million for the three months ended June 30, 2023, compared with $38.2 million in the comparable period last year, primarily reflecting increased clinical research and manufacturing costs of $11.4 million and an increase of $2.9 million in personnel related costs. Research and development expenses were $104.4 million for the six months ended June 30, 2023, compared with $83.1 million in the comparable period last year, primarily reflecting increased manufacturing costs of $11.1 million, an increase of $5.9 million in personnel related costs, an increase in consulting expenses of $1.8 million, an increase of $1.3 million in facilities expense and a decrease of contra research and development expenses recognized of $2.7 million. The increase was primarily offset by a decrease of clinical-related expenses of $1.2 million.
General and Administrative Expenses:
General and administrative expenses primarily consist of salaries and related benefits for our 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 $13.2 million and $27.0 million for the three and six months ended June 30, 2023, respectively, compared with $11.0 million and $21.7 million in the comparable periods last year. The increases 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 Loss:
For the three months ended June 30, 2023, Arcturus reported a net loss of approximately $52.6 million, or ($1.98) per diluted share, compared with a net loss of $21.6 million, or ($0.82) per diluted share in the three months ended June 30, 2022. For the six months ended June 30, 2023, Arcturus reported a net loss of approximately $1.8 million, or ($0.07) per diluted share, compared with a net loss of $72.7 million, or ($2.75) per diluted share in the six months ended June 30, 2022.
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were $380.6 million as of June 30, 2023 and $394.0 million on December 31, 2022. We have collected approximately $300.0 million in upfront payments and milestones from CSL Seqirus as of June 30, 2023. Additionally, we received $23.6 million under the manufacturing and supply of ARCT-154 from CSL Seqirus during the quarter ended June 30, 2023. We expect to continue to receive future milestone payments from CSL Seqirus that will support the ongoing development of the covid and flu programs. The cash runway remains extended through the beginning of 2026 based on the current pipeline and programs.
Earnings Call: Monday, August 7, 2023 @ 4:30 pm ET
About Arcturus Therapeutics
Founded in 2013 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 (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, 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 mRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued 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 potential of the Company’s platform technology to be meaningfully differentiated from other technologies, the anticipated timing and sharing of clinical data including from the Company’s ARCT-810 and ARCT-032 programs, the continued progress of the LUNAR-FLU program, the likelihood and timing of regulatory approvals of any products including ARCT-154 in Japan or anywhere else, the anticipated conduct of the ARCT-032 study in New Zealand, the likelihood that preclinical or clinical data will be predictive of future clinical results, the likelihood that the interim study results of the ARCT-154 Phase 3 booster vaccine study will be predictive of, or consistent with, the complete 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 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. 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 SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2023
December 31, 2022
(in thousands, except par value information)
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
323,471
$
391,883
Restricted cash
55,000
—
Accounts receivable
2,799
2,764
Prepaid expenses and other current assets
3,974
8,686
Total current assets
385,244
403,333
Property and equipment, net
12,722
12,415
Operating lease right-of-use asset, net
30,553
32,545
Non-current restricted cash
2,127
2,094
Total assets
$
430,646
$
450,387
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$
13,619
$
7,449
Accrued liabilities
28,763
30,232
Current portion of long-term debt
—
60,655
Deferred revenue
47,963
28,648
Total current liabilities
90,345
126,984
Deferred revenue, net of current portion
25,725
20,071
Operating lease liability, net of current portion
28,111
30,216
Other non-current liabilities
1,290
2,804
Total liabilities
145,471
180,075
Stockholders’ equity
Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 26,574 at June 30, 2023 and 26,555 at December 31, 2022
27
27
Additional paid-in capital
625,085
608,426
Accumulated deficit
(339,937
)
(338,141
)
Total stockholders’ equity
285,175
270,312
Total liabilities and stockholders’ equity
$
430,646
$
450,387
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
Three Months Ended
Six Months Ended
June 30,
June 30,
(in thousands, except per share data)
2023
2022
2023
2022
Revenue:
Collaboration revenue
$
9,565
$
27,093
$
89,294
$
32,337
Grant revenue
954
—
1,510
—
Total revenue
10,519
27,093
90,804
32,337
Operating expenses:
Research and development, net
52,668
38,189
104,436
83,082
General and administrative
13,225
10,993
26,987
21,723
Total operating expenses
65,893
49,182
131,423
104,805
Loss from operations
(55,374
)
(22,089
)
(40,619
)
(72,468
)
Loss from equity-method investment
—
(131
)
—
(515
)
Gain (loss) from foreign currency
149
1,217
(179
)
1,375
Gain on debt extinguishment
—
—
33,953
—
Finance income (expense), net
3,252
(560
)
5,729
(1,124
)
Net loss before income taxes
(51,973
)
(21,563
)
(1,116
)
(72,732
)
Provision for income taxes
577
-
680
Net loss
$
(52,550
)
$
(21,563
)
$
(1,796
)
$
(72,732
)
Net loss per share, basic and diluted
$
(1.98
)
$
(0.82
)
$
(0.07
)
$
(2.75
)
Weighted-average shares outstanding, basic and diluted
26,563
26,425
26,557
26,401
Comprehensive loss:
Net loss
$
(52,550
)
$
(21,563
)
$
(1,796
)
$
(72,732
)
Comprehensive loss
$
(52,550
)
$
(21,563
)
$
(1,796
)
$
(72,732
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20230807532754/en/
IR and Media Contacts Arcturus Therapeutics Neda Safarzadeh VP, Head of IR/PR/Marketing (858) 900-2682 IR@ArcturusRx.com
Kendall Investor Relations Carlo Tanzi, Ph.D. (617) 914-0008 ctanzi@kendallir.com
1 Year Arcturus Therapeutics Chart |
1 Month Arcturus Therapeutics Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions