Arcturus Therapeutics Announces First Quarter 2024 Financial Update and Pipeline Progress
Arcturus Therapeutics announces a positive first-quarter financial update and pipeline progress. The commercial manufacture of Kostaive is on track for the delivery of 4 million doses in Q3. The European Marketing Authorization decision is expected in Q3. Multiple Phase 3 trials demonstrate the breadth of the STARR vaccine platform. Important Phase 1 data for ARCT-2138 is anticipated in Q3. JP Morgan will monetize the company's investment in ARCALIS JV in Japan. Financially, revenues decreased due to the CSL agreement, while operating expenses increased. The net loss was $26.8 million, but the cash position remains strong, with a cash runway of at least three years.
Commercial manufacture of Kostaive on track for delivery of initial 4 million doses in Q3.
Multiple Kostaive Phase 3 trials demonstrate breadth and durability of STARR vaccine platform.
Anticipated topline immunogenicity and safety data for ARCT-2138 in Q3.
JP Morgan engaged to monetize investment in ARCALIS JV in Japan.
Cash, cash equivalents, and restricted cash were $345.3 million as of March 31, 2024.
Expected cash runway extends at least three years into the first quarter of fiscal year 2027.
Revenues decreased to $38.0 million primarily due to the CSL agreement.
Total operating expenses increased to $68.4 million.
Net loss reported of approximately $26.8 million for the first quarter.
Insights
Reviewing Arcturus Therapeutics' financial performance, a significant year-over-year revenue decline is observed, with
From a medical research perspective, the successful achievement of primary endpoints in Phase 3 clinical trials for ARCT-2301, the bivalent COVID-19 vaccine candidate, can be seen as a robust advancement in Arcturus' pipeline. The tolerability of ARCT-810, targeting OTC deficiency, in early-phase trials and the future potential of ARCT-032 for cystic fibrosis also present optimism for the company's strategic direction in mRNA therapeutics. However, the true test will come with later phase trials and subsequent regulatory approvals, which carry inherent risk.
Engaging JP Morgan for the monetization of Arcturus' stake in ARCALIS suggests a strategic move to improve financial flexibility and could signal intention to reallocate resources more efficiently within its core operations. Furthermore, the progression toward commercial milestones and partnerships, for instance with CSL, showcases Arcturus' capability to move from R&D to potential market delivery. The market will be closely monitoring the EMA's decision on Kostaive® which could catalyze European market penetration and positive investor sentiment.
Commercial manufacture of Kostaive® on track for delivery of initial 4 million doses in Q3
Kostaive® European Marketing Authorization Application approval decision expected Q3
Multiple Kostaive® Phase 3 trials further demonstrate breadth and durability of STARR® vaccine platform
ARCT-2138 (LUNAR-FLU) Phase 1 topline immunogenicity and safety data, anticipated in Q3
ARCT-810 (LUNAR-OTC) Phase 2 and ARCT-032 (LUNAR-CF) Phase 1b interim data and update to be provided on July 1st
JP Morgan engaged to monetize investment in ARCALIS JV in
Investor conference call at 4:30 p.m. ET today
“Arcturus continues to make encouraging progress in both our vaccine and therapeutics pipeline,” said Joseph Payne, President & CEO of Arcturus. “In collaboration with our global vaccine partner CSL and their partner Meiji Seika Pharma, we are excited to begin the commercialization of Kostaive this year.”
Mr. Payne continued, “We also look forward to providing meaningful clinical study data updates July 1st, for each of our flagship mRNA therapeutic programs, ARCT-810 (OTC deficiency) and ARCT-032 (CF).”
“I am pleased to announce that we have engaged JP Morgan to monetize our stake in ARCALIS, our JV manufacturing operation in Japan,” stated Andrew Sassine, Chief Financial Officer of Arcturus Therapeutics. “Additionally, I am pleased to announce we will begin to qualify for commercial milestones under our CSL collaboration upon commencement of Kostaive revenues in
Recent Corporate Highlights
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In March, Meiji Seika Pharma announced plans to supply
Japan with 4 million doses of Kostaive for fall/winter season of 2024. To support this effort, Arcturus along with CDMO partners are on track to deliver the initial 4 million commercial doses of Kostaive in Q3. -
In March, the Company, along with partners CSL and Meiji, announced that the Company’s bivalent COVID-19 Vaccine candidate, ARCT-2301 (
Wuhan strain and Omicron BA.4/5), met the primary endpoint (non-inferiority) in a Phase 3 clinical study inJapan . The study enrolled 930 healthy adults and individuals with comorbidities, who previously received three to five doses of mRNA COVID-19 vaccines, including the last booster at least three months prior to recruitment.-
Both the geometric mean titer (GMT) ratio and seroresponse rate (SRR) difference of neutralizing antibodies against SARS-CoV-2 (Omicron BA.4/5) and
Wuhan strains met pre-specified non-inferiority and superiority criteria versus a licensed mRNA vaccine comparator. There were no causally-associated serious adverse events with ARCT-2301.
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Both the geometric mean titer (GMT) ratio and seroresponse rate (SRR) difference of neutralizing antibodies against SARS-CoV-2 (Omicron BA.4/5) and
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In March, Arcturus and CSL initiated a Phase 3 pivotal study with the ARCT-2303 candidate vaccine containing the Omicron XBB.1.5 variant.
-
The purpose of this study is to generate additional immunogenicity and safety data to support product licensure in the
U.S. - The study will also assess the co-administration of ARCT-2303 with the age-appropriate seasonal influenza vaccines.
- Approximately 1,680 young and older adults are planned to be recruited in the southern hemisphere.
-
The purpose of this study is to generate additional immunogenicity and safety data to support product licensure in the
- The Company has filed a Marketing Authorization Application (MAA) for Kostaive to the European Medicines Agency (EMA), with the European Commission (EC) expected to provide an approval decision in Q3.
- ARCT-2138 (LUNAR-FLU, Quadrivalent Seasonal Influenza), is progressing well through Arcturus’ partner CSL. As of May 1, 2024, 84 healthy young adults were recruited in a Phase 1 dose-finding and immunogenicity study and received one of four dose levels of the study vaccine or a licensed influenza vaccine. The recruitment of older adults is ongoing.
-
In April, the Company presented Phase 1 single ascending dose (SAD) studies for ARCT-810, an mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency, at the Society for Inherited Metabolic Diseases (SIMD) annual conference.
- ARCT-810-01 was a Phase 1 SAD study that enrolled 30 healthy adults, randomized 2:1 to receive ARCT-810 (0.1, 0.2, 0.3 or 0.4 mg/kg) or placebo as an intravenous infusion. ARCT-810-02 is a recently completed Phase 1b SAD study that enrolled 16 adults with mild OTC deficiency, randomized 3:1 to receive single doses of ARCT-810 (0.2, 0.3, 0.4, or 0.5 mg/kg) or placebo as an intravenous infusion.
- The results showed that ARCT-810 was generally well tolerated with no serious or severe adverse events in both studies.
-
The results from ARCT-810-01 and ARCT-810-02 studies facilitated the initiation of a Phase 2 multiple ascending dose study of ARCT-810 (ARCT-810-03) in OTC deficiency adolescents and adults which is ongoing in the
UK and EU. Subjects are randomized to receive 6 doses of ARCT-810 or placebo (randomized 3:1) administered every 14 days. - The Company will share a progress update on the Phase 2 study on July 1, 2024.
- Arcturus is advancing ARCT-032, an inhaled mRNA therapeutic for cystic fibrosis. The Company remains on track to share Phase 1b interim data on July 1, 2024. Each CF patient in this trial receives two inhaled administrations of ARCT-032.
Financial Results for the three months ended March 31, 2024
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 March 31, 2024, revenues were
Operating expenses:
Total operating expenses for the three months ended March 31, 2024, 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 related to conducting research and development activities. Research and development expenses were
General and Administrative Expenses:
General and administrative expenses primarily consist of salaries and related benefits for 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
Net Loss:
For the three months ended March 31, 2024, Arcturus reported a net loss of approximately
Cash Position and Balance Sheet:
Cash, cash equivalents and restricted cash were
Earnings Call: Wednesday, May 8, 2024 @ 4:30 pm ET
- Domestic: 1-888-886-7786
- International: 1-416-764-8658
- Conference ID: 96934019
- 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 and continued advancement 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 of delivery of doses of Kostaive (including timing and volume thereof), the anticipated commercialization of Kostaive and the timing thereof, the likelihood and timing of a European Marketing Authorization application approval decision for Kostaive, the monetization of Arcturus’ interests in ARCALIS JV in
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 |
||||||||
|
|
March 31, 2024 |
|
December 31, 2023 |
||||
(in thousands, except par value information) |
|
(unaudited) |
|
|
||||
Assets |
|
|
|
|
||||
Current assets: |
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
288,396 |
|
|
$ |
292,005 |
|
Restricted cash |
|
|
55,000 |
|
|
|
55,000 |
|
Accounts receivable |
|
|
27,057 |
|
|
|
32,064 |
|
Prepaid expenses and other current assets |
|
|
5,335 |
|
|
|
7,521 |
|
Total current assets |
|
|
375,788 |
|
|
|
386,590 |
|
Property and equipment, net |
|
|
11,763 |
|
|
|
12,427 |
|
Operating lease right-of-use asset, net |
|
|
29,413 |
|
|
|
28,500 |
|
Non-current restricted cash |
|
|
1,885 |
|
|
|
1,885 |
|
Total assets |
|
$ |
418,849 |
|
|
$ |
429,402 |
|
Liabilities and stockholders’ equity |
|
|
|
|
||||
Current liabilities: |
|
|
|
|
||||
Accounts payable |
|
$ |
9,144 |
|
|
$ |
5,279 |
|
Accrued liabilities |
|
|
34,770 |
|
|
|
31,881 |
|
Deferred revenue |
|
|
71,516 |
|
|
|
44,829 |
|
Total current liabilities |
|
|
115,430 |
|
|
|
81,989 |
|
Deferred revenue, net of current portion |
|
|
11,795 |
|
|
|
42,496 |
|
Operating lease liability, net of current portion |
|
|
27,652 |
|
|
|
25,907 |
|
Other non-current liabilities |
|
|
— |
|
|
|
497 |
|
Total liabilities |
|
|
154,877 |
|
|
|
150,889 |
|
Stockholders’ equity |
|
|
|
|
||||
Common stock, |
|
|
27 |
|
|
|
27 |
|
Additional paid-in capital |
|
|
658,628 |
|
|
|
646,352 |
|
Accumulated deficit |
|
|
(394,683 |
) |
|
|
(367,866 |
) |
Total stockholders’ equity |
|
|
263,972 |
|
|
|
278,513 |
|
Total liabilities and stockholders’ equity |
|
$ |
418,849 |
|
|
$ |
429,402 |
|
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME |
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Unaudited |
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Three Months Ended |
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|
|
March 31, |
|
December 31, |
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(in thousands, except per share data) |
|
2024 |
|
2023 |
|
2023 |
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Revenue: |
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|
|
|
|
|
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Collaboration revenue |
|
$ |
32,598 |
|
|
$ |
79,729 |
|
|
$ |
25,078 |
|
Grant revenue |
|
|
5,414 |
|
|
|
556 |
|
|
|
5,777 |
|
Total revenue |
|
|
38,012 |
|
|
|
80,285 |
|
|
|
30,855 |
|
Operating expenses: |
|
|
|
|
|
|
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Research and development, net |
|
|
53,573 |
|
|
|
51,768 |
|
|
|
36,620 |
|
General and administrative |
|
|
14,851 |
|
|
|
13,762 |
|
|
|
12,507 |
|
Total operating expenses |
|
|
68,424 |
|
|
|
65,530 |
|
|
|
49,127 |
|
(Loss) income from operations |
|
|
(30,412 |
) |
|
|
14,755 |
|
|
|
(18,272 |
) |
Loss from foreign currency |
|
|
(53 |
) |
|
|
(328 |
) |
|
|
(54 |
) |
Gain on debt extinguishment |
|
|
— |
|
|
|
33,953 |
|
|
|
— |
|
Finance income, net |
|
|
4,016 |
|
|
|
2,477 |
|
|
|
6,881 |
|
Net (loss) income before income taxes |
|
|
(26,449 |
) |
|
|
50,857 |
|
|
|
(11,445 |
) |
Provision for income taxes |
|
|
368 |
|
|
|
103 |
|
|
|
262 |
|
Net (loss) income |
|
$ |
(26,817 |
) |
|
$ |
50,754 |
|
|
$ |
(11,707 |
) |
(Loss) earnings per share |
|
|
|
|
|
|
||||||
Basic |
|
$ |
(1.00 |
) |
|
$ |
1.91 |
|
|
$ |
(0.44 |
) |
Diluted |
|
$ |
(1.00 |
) |
|
$ |
1.87 |
|
|
$ |
(0.44 |
) |
Weighted-average shares used in calculation of (loss) earnings per share: |
|
|
|
|
|
|
||||||
Basic |
|
|
26,879 |
|
|
|
26,555 |
|
|
|
26,628 |
|
Diluted |
|
|
26,879 |
|
|
|
27,149 |
|
|
|
26,628 |
|
Comprehensive (loss) income: |
|
|
|
|
|
|
||||||
Net (loss) income |
|
$ |
(26,817 |
) |
|
$ |
50,754 |
|
|
$ |
(11,707 |
) |
Comprehensive (loss) income |
|
$ |
(26,817 |
) |
|
$ |
50,754 |
|
|
$ |
(11,707 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508223032/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
What is the status of Kostaive manufacturing?
What financial institution will monetize the investment in ARCALIS JV in Japan?
What was the net loss reported for the first quarter of 2024?
What is the cash position as of March 31, 2024?