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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Arcturus Therapeutics Announces First Quarter 2024 Financial Update and Pipeline Progress


Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global 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 first quarter ended March 31, 2024, and provided corporate updates.

"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 Japan this year. Finally, our cash runway remains strong for at least three years into the first quarter of fiscal year 2027."

Recent Corporate Highlights

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 $38.0 million compared with $80.3 million for the three months ended March 31, 2023. The decrease was primarily attributable to the CSL agreement as $78.2 million total revenue was recognized during the first quarter of 2023 upon the achievement of a conditional payment and multiple milestones, compared to $32.4 million total revenue related to CSL during the first quarter of 2024, resulting in a decrease of $45.8 million. The total decrease was primarily offset by an increase in revenue of $4.9 million related to the agreement with BARDA.

Operating expenses:

Total operating expenses for the three months ended March 31, 2024, were $68.4 million compared with $65.5 million for the three months ended March 31, 2023.

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 $53.6 million for the three months ended March 31, 2024, compared with $51.8 million in the comparable period last year. The increase in research and development expenses were primarily driven by the CSL and BARDA programs as well as Arcturus' internal OTC and Cystic Fibrosis programs. Additionally, investments increased in early stage and discovery technologies, including the initiation of preclinical research related to its Lyme Disease and Gonorrhea vaccine discovery programs.

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 $14.9 million for the three months ended March 31, 2024, compared with $13.8 million in the comparable period last year. The increase in expenses resulted primarily from increased personnel expenses due to increased salaries, increased travel and consulting expenses as well as escalated rent expense associated with facilities.

Net Loss:

For the three months ended March 31, 2024, Arcturus reported a net loss of approximately $26.8 million, or ($1.00) per diluted share, compared with a net income of $50.8 million, or $1.87 per diluted share in the three months ended March 31, 2023.

Cash Position and Balance Sheet:

Cash, cash equivalents and restricted cash were $345.3 million as of March 31, 2024, and $348.9 million on December 31, 2023. Arcturus achieved a total of approximately $420.1 million in upfront payments and milestones from CSL as of March 31, 2024, and expects to continue to receive future milestone payments from CSL supporting the ongoing development of the COVID and flu programs and three additional vaccine programs by CSL. The expected cash runway extends at least three years based on the current pipeline and programs through the first quarter of fiscal year 2027.

Earnings Call: Wednesday, May 8, 2024 @ 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 mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine (Kostaive®) in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. 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 RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications 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 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 Japan, that preclinical or clinical data will be predictive of future clinical results, the likelihood and timing of clinical study updates (including for ARCT-2138 (LUNAR-FLU), ARCT-032 (LUNAR-CF)), the qualification for commercial milestones under the CSL collaboration, the continuation and expected recruitment in the Phase 3 pivotal study of ARCT-2303 candidate vaccine containing the Omicron XBB.1.5 variant, the ongoing recruitment in the ARCT-2138 (LUNAR-FLU) Phase 1 study, the likelihood or timing of collection of accounts receivables including expected future milestone and other 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

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, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 26,917 at March 31, 2024 and 26,828 at December 31, 2023

 

 

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

 

Unaudited

 

 

 

Three Months Ended

 

 

March 31,

 

December 31,

(in thousands, except per share data)

 

2024

 

2023

 

2023

Revenue:

 

 

 

 

 

 

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:

 

 

 

 

 

 

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

)

 


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