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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act
of 1934
Date of Report (Date of earliest
event reported): August 7, 2023
ARCTURUS THERAPEUTICS HOLDINGS
INC.
(Exact name of registrant as
specified in its charter)
Delaware |
|
001-38942 |
|
32-0595345 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
10628 Science Center Drive, Suite
250
San Diego, California 92121
(Address
of principal executive offices)
Registrant’s telephone
number, including area code: (858) 900-2660
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of
the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
Common stock, par value $0.001 per share |
|
ARCT |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Conditions.
On August 7, 2023, Arcturus Therapeutics Holdings Inc.
(the “Company” or “Arcturus”) issued a press release, a copy of which is furnished herewith as Exhibit 99.1, announcing
the Company’s financial results for the quarter ended June 30, 2023 and providing a corporate update (the “Press Release”).
The information contained in Item 2.02 of this Current
Report on Form 8-K, including the Press Release, shall not be deemed “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended, or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities
Act of 1933, as amended (the “Securities Act”). In addition, this information shall not be deemed incorporated by reference
into any of the Company’s filings with the Securities and Exchange Commission (the “SEC”), except as shall be expressly
set forth by specific reference in any such filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K and the Press Release
contain 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 Current Report on
Form 8-K or the 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 program
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.
Item 8.01 Other Events.
On December 23, 2022, the Company entered
into the Controlled Equity Offering℠ Sales Agreement (the “Sales Agreement”) with
Cantor Fitzgerald & Co. and Wells Fargo Securities, LLC, as sales agents (each an “Agent”
and together the “Agents”), to sell shares of the Company’s common stock, par value $0.001, having an aggregate offering
price of up to $200,000,000, from time to time, through an “at the market offering” as defined in Rule 415 under the Securities
Act.
On August 7, 2023, the Company entered
into Amendment No. 1 (the “Amendment”) to the Sales Agreement, pursuant to which William Blair & Company, L.L.C.
was added as an additional Agent under the Sales Agreement. The material terms and conditions of the Sales Agreement otherwise remain
unchanged.
The foregoing description of the terms of the Amendment does not purport
to be complete and is subject to, and qualified in its entirety by reference to, the Amendment, which is filed herewith as Exhibit 1.1
and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
Arcturus Therapeutics Holdings Inc. |
Date: August 7, 2023 |
|
|
By: |
/s/ Joseph E. Payne |
|
Name: |
Joseph E. Payne |
|
Title: |
Chief Executive Officer |
ARCTURUS THERAPEUTICS HOLDINGS INC.
AMENDMENT NO. 1 TO
Controlled
Equity OfferingSM Sales Agreement
August 7, 2023
CANTOR FITZGERALD & CO.
499 Park Avenue
New York, NY 10022
WELLS FARGO SECURITIES, LLC
30 Hudson Yards
New York, New York 10001
William Blair &
Company, L.L.C.
150 N. Riverside Plaza
Chicago, Illinois 60606
Ladies and Gentlemen:
Reference is made to the Controlled Equity
OfferingSM Sales Agreement, dated December 23, 2022 (the “Sales Agreement”), by and among Arcturus
Therapeutics Holdings Inc., a Delaware corporation (the “Company”), Cantor Fitzgerald & Co. (“Cantor”)
and Wells Fargo Securities, LLC (“Wells Fargo” and together with Cantor, the “Existing
Agents”), pursuant to which the Company agreed, in its sole discretion, to issue and sell, from time to time, through the
Existing Agents, up to $200,000,000 of shares of common stock, par value $0.001 per share, of the Company. All capitalized terms used
in this Amendment No. 1 to the Sales Agreement (this “Amendment”) and not otherwise defined herein shall
have the respective meanings assigned to such terms in the Sales Agreement. The Company and the Existing Agents hereby agree as follows:
A.
Amendments to the Sales Agreement. The Sales Agreement is amended as follows:
1. The
definitions of the terms “Agent” and “Agents” in the first sentence of the Sales Agreement are hereby amended
to read as follows: “Cantor Fitzgerald & Co., Wells Fargo Securities, LLC and William Blair & Company, L.L.C. (each an “Agent”
and collectively, the “Agents”)”.
2. Section
9(g) of the Sales Agreement is hereby amended and restated as follows:
(g) Agents’
Counsel Legal Opinion. The Agents shall have received from Paul Hastings LLP, counsel for the Agents, such opinion or opinions, on
or before the date on which the delivery of the Company Counsel legal opinion is required pursuant to Section 7(m), with respect
to such matters as the Agents may reasonably require, and the Company shall have furnished to such counsel such documents as they may
request to enable them to pass upon such matters.
3. Section
13 of the Sales Agreement is hereby amended to include the following subsection following Wells Fargo’s relevant information in
such section:
“And
William Blair & Company, L.L.C.
150 N. Riverside Plaza
Chicago, Illinois 60606
Attention: [●]
Email: [●]
And
with a copy (which shall not
constitute notice) to:
Paul Hastings LLP
MetLife Building
200 Park Avenue
New York, New York 10166
Attention: Siavosh Salimi
Email: seosalimi@paulhastings.com”
4. Schedule
1 of the Sales Agreement is hereby amended to read as follows:
FORM OF PLACEMENT NOTICE
“From: |
[ ] |
|
[ ] |
|
Arcturus Therapeutics Holdings Inc. |
Cc: |
[ ] |
To: |
[Cantor Fitzgerald & Co.] [Wells Fargo Securities, LLC] [William Blair & Company, L.L.C.] |
Subject: |
[Cantor Fitzgerald] [Wells Fargo Securities] [William Blair
& Company, L.L.C.]
—At the Market Offering—Placement
|
Ladies and Gentlemen:
Pursuant to the terms and subject to the conditions contained
in the Controlled Equity OfferingSM Sales Agreement, dated December 23, 2022, as amended by Amendment No. 1 to the Controlled
Equity OfferingSM Sales Agreement, dated August 7, 2023 (as amended, the “Agreement”), by and
among Arcturus Therapeutics Holdings Inc., a Delaware corporation (the “Company”), Cantor Fitzgerald & Co.,
Wells Fargo Securities, LLC, and William Blair & Company, L.L.C., I hereby request on behalf of the Company that the Designated Agent
(as defined in the Agreement) sell up to [● ] shares of common stock, $0.001 par value per share, of the Company (the “Shares”),
at a minimum market price of $[●] per share[; provided that no more than [●] Shares shall be sold in any
one Trading Day (as such term is defined in Section 3 of the Agreement)]. Sales should begin [on the date of this Placement
Notice] and end on [DATE] [until all Shares that are the subject of this Placement Notice are sold].”
5. Schedule
2 of the Sales Agreement is hereby amended to include the following subsections following Wells Fargo’s relevant information in
such section:
“William Blair & Company,
L.L.C.
[●]”
B. Obligations Binding upon William
Blair & Company, L.L.C. William Blair & Company, L.L.C. hereby agrees to be bound by the terms of the Sales Agreement.
William Blair & Company, L.L.C. shall be considered to be an Agent under the Sales Agreement to the same extent as if it were a party
to the Sales Agreement on the date of the execution thereof.
C. Prospectus Supplement. The
Company shall file a Prospectus Supplement pursuant to Rule 424(b) of the Securities Act reflecting the terms of this Amendment within
two business days of the date hereof.
D. No Other Amendments; References
to Agreement. Except as set forth in Part A above, all the terms and provisions of the Sales Agreement shall continue
in full force and effect. All references to the Sales Agreement in the Sales Agreement or in any other document executed or delivered
in connection therewith shall, from the date hereof, be deemed a reference to the Sales Agreement as amended by this Amendment.
E. Counterparts. This Amendment
may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one
and the same instrument. Delivery of an executed counterpart by one party to the other may be made by facsimile or email transmission
F. Governing Law. This Amendment
shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the principles of
conflicts of laws.
[signature page follows]
If the foregoing correctly sets forth
the understanding among the Company and each of the Agents, please so indicate in the space provided below for that purpose, whereupon
this Amendment No. 1 to Sales Agreement and your acceptance shall constitute a binding agreement among the Company and each of the Agents.
|
Very truly yours, |
|
|
|
|
ARCTURUS THERAPEUTICS HOLDINGS, INC. |
|
|
|
|
By: |
/s/ Joseph E. Payne |
|
Name: |
Joseph E. Payne |
|
Title: |
Chief Executive Officer |
CANTOR FITZGERALD & CO. |
|
|
|
|
By: |
/s/ Sameer Vasudev |
|
Name: |
Sameer Vasudev |
|
Title: |
Managing Director |
|
|
|
|
|
|
|
WELLS FARGO SECURITIES, LLC |
|
|
|
By: |
/s/ David Bohn |
|
Name: |
David Bohn |
|
Title: |
Managing Director |
|
|
|
|
|
|
|
WILLIAM BLAIR & COMPANY, L.L.C. |
|
|
|
|
By: |
/s/ Steve Maletzky |
|
Name: |
Steve Maletzky |
|
Title: |
Head of Capital Markets |
|
Arcturus
Therapeutics Announces Second Quarter 2023 Financial Update and Pipeline Progress
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
SAN DIEGO--(BUSINESS WIRE)--Aug. 7, 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 second quarter and six months ended June 30, 2023 and provided corporate updates.
“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
| · | The primary endpoint was achieved in the ARCT-154 Phase 3 booster vaccine study, demonstrating non-inferiority
of immune response against SARS-CoV-2 ancestral strain compared to Comirnaty. Superiority of ARCT-154 in neutralizing antibody response
against SARS-CoV-2 Omicron BA.4/5 variant was also demonstrated as a key secondary endpoint. |
| o | The study compared immune responses between ARCT-154 and Comirnaty
booster doses (original strain) in Japanese adults (N = 828 and randomized 1:1 to ARCT-154 and Comirnaty) that were previously immunized
with two doses of mRNA COVID-19 vaccine then a third booster dose of Comirnaty at least 3 months prior to enrollment. |
| o | ARCT-154, a self-amplifying mRNA vaccine, was administered at 5 mcg,
a significantly lower dose relative to Comirnaty (30 mcg). |
| o | Initial study results have been published in MedRxiv. The data suggests
increased immunogenicity associated with ARCT-154 at Day 29 with 1.43-fold higher geometric mean titers of neutralizing antibodies against
the vaccine strain versus Comirnaty. |
| o | At the time of interim data cut, ARCT-154 was considered safe and
tolerable with no safety concerns identified. |
| o | Meiji Seika Pharma and the Japanese government provided funding for
the ARCT-154 Phase 3 booster study. |
| o | Meiji Seika Pharma is responsible for obtaining regulatory approval,
distribution, sales and marketing of ARCT-154 in Japan. |
| o | Meiji Seika Pharma announced a collaboration with ARCALIS Co., Ltd. to establish integrated cGMP mRNA
vaccine manufacturing capabilities, from drug substance to drug product, in Japan. ARCALIS recently announced that construction has been
completed for their state-of-the-art manufacturing facility in Japan. |
| · | A Phase 1/2 clinical trial demonstrated one-year durability of immune response following ARCT-154 booster
vaccine administration using validated microneutralization (MNT) assays. The geometric mean fold rise (GMFR) in neutralizing antibodies
remained greater than 10-fold above baseline for one year across a panel of variants (ref: Figure), including Omicron BA.1. |
| · | The LUNAR-FLU program continues to progress with funding and operational support from CSL Seqirus. LUNAR-FLU
utilizes Arcturus’ validated next generation STARR® mRNA platform. |
| · | In June, the Company announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track
Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency. The Company has
also recently received Rare Pediatric Disease Designation from the FDA for ARCT-810, which is designed to recognize serious or life-threatening
manifestations primarily affecting patients under 18 years of age. Due to such designation, if ARCT-810 achieves approval for a pediatric
indication in the original rare pediatric disease product application, Arcturus will receive a voucher for priority review of a subsequent
marketing application for a different product. |
| o | ARCT-810 Phase 1b single ascending dose study in the U.S. has completed
enrollment and dosing of all cohorts (N = 16 patients). |
| o | ARCT-810 Phase 2 study in UK and Europe will enroll up to 24 adolescents
and adults with OTC deficiency. The ongoing study is evaluating two dose levels and includes up to six (6) bi-weekly administrations
for each participant. The Company expects to share interim data on biological activity from a subset of patients in the coming months. |
| · | ARCT-032, the Company’s inhaled mRNA therapeutic for cystic fibrosis, has completed dosing in a
Phase 1 study in New Zealand, including 32 subjects across four (4) ascending single-dose cohorts. The Company received regulatory approval
of a protocol amendment to allow the transition to a Phase 1b clinical study of ARCT-032 in up to 8 adult cystic fibrosis patients. |
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
| • | Domestic: 1-877-407-0784 |
| • | International: 1-201-689-8560 |
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 | ) |
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
v3.23.2
Cover
|
Aug. 07, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Aug. 07, 2023
|
Entity File Number |
001-38942
|
Entity Registrant Name |
ARCTURUS THERAPEUTICS HOLDINGS
INC.
|
Entity Central Index Key |
0001768224
|
Entity Tax Identification Number |
32-0595345
|
Entity Incorporation, State or Country Code |
DE
|
Entity Address, Address Line One |
10628 Science Center Drive
|
Entity Address, Address Line Two |
Suite
250
|
Entity Address, Address Line Three |
|
Entity Address, City or Town |
San Diego
|
Entity Address, State or Province |
CA
|
Entity Address, Postal Zip Code |
92121
|
City Area Code |
(858)
|
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900-2660
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common stock, par value $0.001 per share
|
Trading Symbol |
ARCT
|
Security Exchange Name |
NASDAQ
|
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Grafico Azioni Arcturus Therapeutics (NASDAQ:ARCT)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Arcturus Therapeutics (NASDAQ:ARCT)
Storico
Da Set 2023 a Set 2024