Arcturus Therapeutics Announces Fourth Quarter and Fiscal Year 2023 Financial Update and Pipeline Progress
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Insights
The anticipated launch of Kostaive® in Japan could represent a significant milestone for Arcturus Therapeutics, potentially opening up a new market and revenue stream. Japan is known for its rigorous regulatory environment and a successful launch there could enhance the company's reputation and credibility. The extension of the cash runway to Q1 2027 is also noteworthy, as it suggests that the company has secured enough capital to sustain its operations and research for an extended period. This financial stability might be seen positively by investors, as it reduces the immediate risk of dilutive fundraising.
The progression of ARCT-032, ARCT-810 and ARCT-2138 through clinical trials is critical for Arcturus' pipeline. The interim data expected in Q2 for ARCT-032 and ARCT-810 will be pivotal in determining the future of these candidates. Positive data could lead to an increase in stock value due to heightened investor confidence. The initiation of the Phase 1 study for the Quadrivalent LUNAR-FLU vaccine also indicates the company's commitment to expanding its infectious disease portfolio. The new STARR® vaccine discovery programs for Lyme Disease and Gonorrhea show that Arcturus is diversifying its research, which could mitigate risks associated with its current pipeline and offer additional growth avenues.
The global messenger RNA (mRNA) medicines market has gained significant attention, especially in the wake of the COVID-19 pandemic. Arcturus' focus on mRNA vaccines for infectious diseases places it within a competitive and fast-evolving industry. Its strategic initiatives, such as the expansion into vaccines for Lyme Disease and Gonorrhea, are likely to be closely watched by competitors and investors alike. The company's ability to extend its cash runway and progress its clinical programs may be interpreted as signs of operational efficiency and effective strategic planning. However, it's important to remain cautious and consider the high level of competition and the scientific and regulatory challenges inherent in vaccine development.
Kostaive® anticipated to launch in
ARCT-032 remains on track for Phase 1b interim data in Q2
ARCT-810 remains on track for Phase 2 interim data by the end of Q2
ARCT-2138 (Quadrivalent LUNAR-FLU) Phase 1 study for seasonal influenza vaccine initiated
New STARR® vaccine discovery programs initiated for Lyme Disease and Gonorrhea
Cash runway extended to Q1 2027
Investor conference call at 4:30 p.m. ET today
“I am excited about the continued pipeline progress and efforts toward commercialization achieved by Arcturus in 2023,” said Joseph Payne, President & CEO of Arcturus Therapeutics. “Alongside our global vaccine partner CSL Seqirus and their COVID vaccine partner in
Mr. Payne continued: “We are especially pleased to announce the
Andy Sassine, Chief Financial Officer of Arcturus said, “I am pleased to announce the cash runway was extended to the first quarter 2027 due to disciplined cost management and progression of the CSL collaboration. This is the second sequential quarter our runway was extended without including any contributions from Kostaive® revenues or commercial milestones.”
Recent Corporate Highlights
-
In February 2024, the Company announced new COVID-19 sa-mRNA results in collaboration with CSL, demonstrating a longer duration of immunity compared to conventional COVID-19 mRNA vaccine booster. Short communication follows previously published data in The Lancet Infectious Diseases in December 2023. The randomized, double-blind, active-controlled study, conducted at 11 sites in
Japan assessed the immunogenicity of Kostaive® and Comirnaty® at one, three- and six-months post-booster.-
The new analysis extends the time of observation of immune response from 3 months to 6 months post booster dose, demonstrating an advantage in antibody persistence of Kostaive® over Comirnaty against both the original
Wuhan strain and the Omicron BA.4/5 variant. - The superior immune response of Kostaive® in terms of magnitude and duration of antibody persistence was achieved with one sixth the dose of Comirnaty (5 μg vs 30 μg).
-
The new analysis extends the time of observation of immune response from 3 months to 6 months post booster dose, demonstrating an advantage in antibody persistence of Kostaive® over Comirnaty against both the original
-
In November,
Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for Kostaive®, a self-amplifying mRNA COVID-19 vaccine for primary vaccination and booster for adults 18 years and older. This marks the first marketing approval milestone for CSL and Arcturus since signing the Collaboration and License agreement in November 2022.-
The approval is based on positive clinical data from several Kostaive® studies, including a 16,000 subject efficacy study performed in
Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator. The study results have been published in The Lancet Infectious Diseases.
-
The approval is based on positive clinical data from several Kostaive® studies, including a 16,000 subject efficacy study performed in
-
Kostaive® is anticipated to launch in
Japan this year. - In January 2024, the Company, under its collaboration with CSL, initiated a Phase 1 dose-finding study for ARCT-2138 (Quadrivalent LUNAR-FLU) seasonal influenza vaccine in healthy young and older adults.
-
The Company continues to advance the development of ARCT-810, an mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.
-
ARCT-810 Phase 1b single ascending dose study in the
U.S. has completed enrollment and dosing of all cohorts (N = 16 patients). -
ARCT-810 Phase 2 study in
UK andEurope is enrolling 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 Phase 2 interim data by the end of Q2.
-
ARCT-810 Phase 1b single ascending dose study in the
-
In November 2023, Arcturus received Orphan Drug Designation from the
U.S. FDA for ARCT-032, for the treatment of Cystic Fibrosis. - In February 2024, Arcturus was granted Orphan Medicinal Product Designation from the European Commission for ARCT-032. ARCT-032 remains on track for Phase 1b interim data in Q2 2024.
-
Based on the clinical and regulatory validation of LUNAR® and STARR® technologies provided by the approval of Kostaive® in
Japan , the Company has initiated new vaccine discovery programs for Lyme Disease and Gonorrhea.
Financial Results for the Year Ended December 31, 2023
Revenues in conjunction with collaborations and grants:
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 year ended December 31, 2023, we reported revenue of
Operating expenses:
Total operating expenses for the year ended December 31, 2023, were
Research and Development Expenses:
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. Research and development expenses were
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. For the year ended December 31, 2023, general and administrative expenses were
Net Loss:
For the year ended December 31, 2023, we reported a net loss of approximately
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were
Earnings Call: Thursday, March 7, 2024 @ 4:30 pm ET
- Domestic: 1-877-407-0784
- International: 1-201-689-8560
- Conference ID: 13744044
- Webcast: Link
About Arcturus Therapeutics
Founded in 2013 and based in
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 likelihood that preclinical or clinical data will be predictive of future clinical results, including that the results from Kostaive® (or ARCT-154) will be predictive of results for updated versions of the vaccine, the potential commercial launch of Kostaive®, the continued advancement ARCT-032 or its potential as a treatment for any of the CF population, the continued advancement of ARCT-810, the anticipated timing and sharing of clinical data including for the Company’s ARCT810 Phase 2 study and the ARCT-032 Phase 1b study, the continued efforts for our vaccine discovery programs for lyme disease or gonorrhea, the potential of the Company’s platform technology to be meaningfully differentiated from other technologies, the continued progress of the LUNAR-FLU program, the ability to enroll participants in clinical studies including the Company’s ARCT-810 and ARCT-032 programs, the likelihood and timing of commercial activities for the Company’s LUNAR-COVID program, 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, 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 |
||||||||
CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
As of December 31, |
||||||
(in thousands, except par value information) |
|
2023 |
|
|
2022 |
|
||
Assets |
|
(unaudited) |
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
292,005 |
|
|
$ |
391,883 |
|
Restricted cash |
|
|
55,000 |
|
|
|
— |
|
Accounts receivable |
|
|
32,064 |
|
|
|
2,764 |
|
Prepaid expenses and other current assets |
|
|
7,521 |
|
|
|
8,686 |
|
Total current assets |
|
|
386,590 |
|
|
|
403,333 |
|
Property and equipment, net |
|
|
12,427 |
|
|
|
12,415 |
|
Operating lease right-of-use asset, net |
|
|
28,500 |
|
|
|
32,545 |
|
Non-current restricted cash |
|
|
1,885 |
|
|
|
2,094 |
|
Total assets |
|
$ |
429,402 |
|
|
$ |
450,387 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
5,279 |
|
|
$ |
7,449 |
|
Accrued liabilities |
|
|
31,881 |
|
|
|
30,232 |
|
Current portion of long-term debt |
|
|
— |
|
|
|
60,655 |
|
Deferred revenue |
|
|
41,695 |
|
|
|
28,648 |
|
Total current liabilities |
|
|
78,855 |
|
|
|
126,984 |
|
Deferred revenue, net of current portion |
|
|
42,496 |
|
|
|
20,071 |
|
Operating lease liability, net of current portion |
|
|
25,907 |
|
|
|
30,216 |
|
Other non-current liabilities |
|
|
497 |
|
|
|
2,804 |
|
Total liabilities |
|
|
147,755 |
|
|
|
180,075 |
|
Stockholders’ equity: |
|
|
|
|
||||
Common stock: |
|
|
27 |
|
|
|
27 |
|
Additional paid-in capital |
|
|
646,352 |
|
|
|
608,426 |
|
Accumulated deficit |
|
|
(364,732 |
) |
|
|
(338,141 |
) |
Total stockholders’ equity |
|
|
281,647 |
|
|
|
270,312 |
|
Total liabilities and stockholders’ equity |
|
$ |
429,402 |
|
|
$ |
450,387 |
|
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES |
||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) |
||||||||||||
|
|
Year Ended December 31, |
||||||||||
(in thousands, except per share data) |
|
2023 |
|
|
2022 |
|
|
2021 |
|
|||
Revenue: |
|
(unaudited) |
|
|
|
|
||||||
Collaboration revenue |
|
$ |
160,882 |
|
|
$ |
205,755 |
|
|
$ |
12,359 |
|
Grant revenue |
|
|
9,051 |
|
|
|
244 |
|
|
|
— |
|
Total revenue |
|
|
169,933 |
|
|
|
205,999 |
|
|
|
12,359 |
|
Operating expenses: |
|
|
|
|
|
|
||||||
Research and development, net |
|
|
192,133 |
|
|
|
147,751 |
|
|
|
173,760 |
|
General and administrative |
|
|
52,871 |
|
|
|
46,071 |
|
|
|
41,451 |
|
Total operating expenses |
|
|
245,004 |
|
|
|
193,822 |
|
|
|
215,211 |
|
(Loss) income from operations |
|
|
(75,071 |
) |
|
|
12,177 |
|
|
|
(202,852 |
) |
(Loss) gain from equity-method investment |
|
|
— |
|
|
|
(515 |
) |
|
|
515 |
|
(Loss) gain from foreign currency |
|
|
(229 |
) |
|
|
(598 |
) |
|
|
584 |
|
Finance income (expense), net |
|
|
16,591 |
|
|
|
(420 |
) |
|
|
(1,921 |
) |
Gain on debt extinguishment |
|
|
33,953 |
|
|
|
— |
|
|
|
— |
|
Net (loss) income before income taxes |
|
|
(24,756 |
) |
|
|
10,644 |
|
|
|
(203,674 |
) |
Provision for income taxes |
|
|
1,835 |
|
|
|
1,295 |
|
|
|
— |
|
Net (loss) income |
|
$ |
(26,591 |
) |
|
$ |
9,349 |
|
|
$ |
(203,674 |
) |
(Loss) earnings per share: |
|
|
|
|
|
|
||||||
Basic |
|
$ |
(1.00 |
) |
|
$ |
0.35 |
|
|
$ |
(7.74 |
) |
Diluted |
|
$ |
(1.00 |
) |
|
$ |
0.35 |
|
|
$ |
(7.74 |
) |
Weighted-average shares used in calculation of (loss) earnings per share: |
|
|
|
|
|
|
||||||
Basic |
|
|
26,628 |
|
|
|
26,445 |
|
|
|
26,317 |
|
Diluted |
|
|
26,628 |
|
|
|
27,093 |
|
|
|
26,317 |
|
Comprehensive (loss) income: |
|
|
|
|
|
|
||||||
Net (loss) income |
|
$ |
(26,591 |
) |
|
$ |
9,349 |
|
|
$ |
(203,674 |
) |
Comprehensive (loss) income: |
|
$ |
(26,591 |
) |
|
$ |
9,349 |
|
|
$ |
(203,674 |
) |
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES |
||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (UNAUDITED) |
||||||||||||
|
|
Three Months Ended |
||||||||||
|
|
December 31, |
|
September 30, |
||||||||
(in thousands, except per share data) |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|||
Revenue: |
|
|
|
|
|
|
||||||
Collaboration revenue |
|
$ |
28,212 |
|
|
$ |
160,049 |
|
|
$ |
43,376 |
|
Grant revenue |
|
|
5,777 |
|
|
|
244 |
|
|
|
1,764 |
|
Total revenue |
|
|
33,989 |
|
|
|
160,293 |
|
|
|
45,140 |
|
Operating expenses: |
|
|
|
|
|
|
||||||
Research and development, net |
|
|
36,620 |
|
|
|
26,981 |
|
|
|
51,077 |
|
General and administrative |
|
|
12,507 |
|
|
|
11,860 |
|
|
|
13,377 |
|
Total operating expenses |
|
|
49,127 |
|
|
|
38,841 |
|
|
|
64,454 |
|
Income (loss) from operations |
|
|
(15,138 |
) |
|
|
121,452 |
|
|
|
(19,314 |
) |
(Loss) gain from foreign currency |
|
|
(54 |
) |
|
|
(3,835 |
) |
|
|
4 |
|
Finance expense, net |
|
|
6,881 |
|
|
|
1,025 |
|
|
|
3,981 |
|
Net (loss) income before income taxes |
|
|
(8,311 |
) |
|
|
118,642 |
|
|
|
(15,329 |
) |
Provision for income taxes |
|
|
262 |
|
|
|
1,295 |
|
|
|
893 |
|
Net (loss) income |
|
$ |
(8,573 |
) |
|
$ |
117,347 |
|
|
$ |
(16,222 |
) |
(Loss) earnings per share: |
|
|
|
|
|
|
||||||
Basic |
|
$ |
(0.32 |
) |
|
$ |
4.43 |
|
|
$ |
(0.61 |
) |
Diluted |
|
$ |
(0.32 |
) |
|
$ |
4.33 |
|
|
$ |
(0.61 |
) |
Weighted-average shares used in calculation of (loss) earnings per share: |
|
|
|
|
|
|
||||||
Basic |
|
|
26,628 |
|
|
|
26,508 |
|
|
|
26,574 |
|
Diluted |
|
|
26,628 |
|
|
|
27,080 |
|
|
|
26,574 |
|
Comprehensive (loss) income: |
|
|
|
|
|
|
||||||
Net (loss) income |
|
$ |
(8,573 |
) |
|
$ |
117,347 |
|
|
$ |
(16,222 |
) |
Comprehensive (loss) income |
|
$ |
(8,573 |
) |
|
$ |
117,347 |
|
|
$ |
(16,222 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240307376363/en/
IR and Media Contacts
Arcturus Therapeutics
Neda Safarzadeh
VP, Head of IR/PR/Marketing
(858) 900-2682
IR@ArcturusRx.com
Source: Arcturus Therapeutics Holdings Inc.
FAQ
When is Kostaive® anticipated to launch in Japan?
What is the status of ARCT-032 Phase 1b interim data?
When is ARCT-810 Phase 2 interim data expected?
What new vaccine discovery programs have been initiated?
What is the extended cash runway for Arcturus Therapeutics Holdings Inc.?
