Arcturus Therapeutics Files 2023 10-K Report

Ticker: ARCT · Form: 10-K · Filed: Mar 14, 2024 · CIK: 1768224

Arcturus Therapeutics Holdings Inc. 10-K Filing Summary
FieldDetail
CompanyArcturus Therapeutics Holdings Inc. (ARCT)
Form Type10-K
Filed DateMar 14, 2024
Risk Levelmedium
Pages15
Reading Time17 min
Key Dollar Amounts$0.001, $17.5 million
Sentimentneutral

Sentiment: neutral

Topics: 10-K, Arcturus Therapeutics, Pharmaceuticals, Clinical Trials, Financial Report

TL;DR

<b>Arcturus Therapeutics Holdings Inc. has submitted its annual 10-K filing for the fiscal year ended December 31, 2023, detailing its business operations, financial status, and material agreements.</b>

AI Summary

Arcturus Therapeutics Holdings Inc. (ARCT) filed a Annual Report (10-K) with the SEC on March 14, 2024. Arcturus Therapeutics Holdings Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The company's principal business address is 10628 Science Center Drive, Suite 250, San Diego, CA 92121. Arcturus Therapeutics is involved in the Pharmaceutical Preparations industry (SIC code 2834). The filing references various agreements and collaborations, including those with CSL Seqirus, Ultragenyx, and the Cystic Fibrosis Foundation Therapeutics Inc. Key financial dates and events are noted, such as credit agreements and lease amendments.

Why It Matters

For investors and stakeholders tracking Arcturus Therapeutics Holdings Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Arcturus Therapeutics' financial health, operational activities, and strategic partnerships for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information on collaborations, research and development expenses, and financial instruments within the filing is essential for understanding the company's progress in its therapeutic development pipeline and its financial commitments.

Risk Assessment

Risk Level: medium — Arcturus Therapeutics Holdings Inc. shows moderate risk based on this filing. The company operates in the highly competitive and regulated pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products, as indicated by the numerous agreements and R&D expenses detailed in the filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Arcturus Therapeutics' current financial position and the potential risks associated with its drug development programs.

Key Numbers

  • 2023-12-31 — Fiscal Year End (Report period)
  • 2834 — SIC Code (Pharmaceutical Preparations)
  • 001-38942 — SEC File Number (Company's SEC filing number)
  • 2024-03-14 — Filing Date (Date the 10-K was filed)

Key Players & Entities

  • Arcturus Therapeutics Holdings Inc. (company) — Filer name
  • 2023-12-31 (date) — Fiscal year end
  • 2024-03-14 (date) — Filing date
  • San Diego, CA (location) — Business address city and state
  • CSL Seqirus (company) — Collaboration partner
  • Ultragenyx (company) — Collaboration partner
  • Cystic Fibrosis Foundation Therapeutics Inc (company) — Collaboration partner
  • Wells Fargo (company) — Credit agreement provider

FAQ

When did Arcturus Therapeutics Holdings Inc. file this 10-K?

Arcturus Therapeutics Holdings Inc. filed this Annual Report (10-K) with the SEC on March 14, 2024.

What is a 10-K filing?

A 10-K is a comprehensive annual financial report required by the SEC, covering audited financials, business operations, risk factors, and management discussion. This particular 10-K was filed by Arcturus Therapeutics Holdings Inc. (ARCT).

Where can I read the original 10-K filing from Arcturus Therapeutics Holdings Inc.?

You can access the original filing directly on the SEC's EDGAR system. The filing is publicly available and includes all exhibits and attachments submitted by Arcturus Therapeutics Holdings Inc..

What are the key takeaways from Arcturus Therapeutics Holdings Inc.'s 10-K?

Arcturus Therapeutics Holdings Inc. filed this 10-K on March 14, 2024. Key takeaways: Arcturus Therapeutics Holdings Inc. filed its 10-K report for the fiscal year ending December 31, 2023.. The company's principal business address is 10628 Science Center Drive, Suite 250, San Diego, CA 92121.. Arcturus Therapeutics is involved in the Pharmaceutical Preparations industry (SIC code 2834)..

Is Arcturus Therapeutics Holdings Inc. a risky investment based on this filing?

Based on this 10-K, Arcturus Therapeutics Holdings Inc. presents a moderate-risk profile. The company operates in the highly competitive and regulated pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market adoption of its products, as indicated by the numerous agreements and R&D expenses detailed in the filing.

What should investors do after reading Arcturus Therapeutics Holdings Inc.'s 10-K?

Investors should review the detailed financial statements and risk factors in the 10-K to understand Arcturus Therapeutics' current financial position and the potential risks associated with its drug development programs. The overall sentiment from this filing is neutral.

Risk Factors

  • Customer Concentration Risk [medium — market]: The company faces risk due to concentration of sales revenue with its top four customers during the period from January 1, 2021, to December 31, 2021.

Key Dates

  • 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
  • 2024-03-14: Filing Date — Date the 10-K was officially submitted to the SEC.
  • 2023-04-21: Wells Fargo Credit Agreement — Date related to a significant credit agreement.

Filing Stats: 4,370 words · 17 min read · ~15 pages · Grade level 17 · Accepted 2024-03-14 09:09:33

Key Financial Figures

  • $0.001 — ch registered Common Stock, par value $0.001 per share ARCT The Nasdaq Stock Mar
  • $17.5 million — t, pursuant to which CSL Seqirus made a $17.5 million milestone payment related to a developm

Filing Documents

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 45 Item 1B. Unresolved Staff Comments 78 Item 1C. Cybersecurity 78 Item 2.

Properties

Properties 79 Item 3.

Legal Proceedings

Legal Proceedings 79 Item 4. Mine Safety Disclosures 79 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 80 Item 6. Reserved 81 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 82 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 90 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 90 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 90 Item 9A.

Controls and Procedures

Controls and Procedures 90 Item 9B. Other Information 94 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 94 PART III Item 10. Directors, Executive Officers and Corporate Governance 96 Item 11.

Executive Compensation

Executive Compensation 96 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 96 Item 13. Certain Relationships and Related Transactions, and Director Independence 96 Item 14. Principal Accounting Fees and Services 96 PART IV Item 15. Exhibits, Financial Statement Schedules 97 Item 16 Form 10-K Summary 97 i Special Note Regarding Forward-Looking Statements This Annual Report on Form 10-K, or this Annual Report, and the documents incorporated by reference herein may contain "forward-looking statements" within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part I, Item 1.A, "Risk Factors" in this Annual Report. Except as required by law, we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as "may," "will," "expect," "anticipate," "intend," "plan," "believe," "estimate" or other words indicating future results, though not all forward-looking statements necessarily contain these identifying words. Such statements may include, but are not limited to, statements concerning the following: our compliance, and ability to remain in compliance, with the requirements of our collaboration agreements, including our collaboration with Seqirus Inc. ("CSL Seqirus"); the anticipated benefits and success of our collaboration agreement with CSL Seqirus related to the licensure of our STARR mRNA technology and LUNAR lipid-mediated delivery, including our timely receipt of upfront and potential royalty and other payments thereunder; the continued development ac

Business

Item 1. Business Overview We are a global messenger RNA medicines company focused on the development of infectious disease vaccines and therapeutics for liver and respiratory rare diseases. In addition to our messenger RNA ("mRNA") platform, our proprietary lipid nanoparticle ("LNP") delivery system, LUNAR , may enable multiple nucleic acid medicines. Our proprietary self-amplifying mRNA technology (Self-Transcribing and Replicating RNA, or STARR , technology) may provide longer-lasting RNA and sustained protein expression at lower dose levels as compared to conventional mRNA. We are leveraging our proprietary LUNAR platform and our nucleic acid technologies to develop and advance a pipeline of mRNA-based vaccines and therapeutics for infectious diseases and rare genetic disorders with significant unmet medical needs. We continue to expand this platform by adding new innovative delivery solutions that allow us to expand our efforts. Our proprietary LUNAR technology is intended to address the major hurdles in RNA drug development, namely the effective and safe delivery of RNA therapeutics to disease-relevant target tissues. We believe the versatility of our platform to target multiple tissues, its compatibility with various nucleic acid therapeutics, and our expertise in developing scalable manufacturing processes can allow us to deliver on the next generation of nucleic acid medicines. In June 2020, we initiated our first clinical study, a Phase 1 study for our mRNA-based therapeutic candidate for ornithine transcarbamylase ("OTC") deficiency. We launched our COVID-19 vaccine program in March 2020, and in November 2023, our self-amplifying mRNA vaccine against COVID-19, ARCT-154, received marketing approval in Japan. In November 2022, we entered into a Collaboration and License Agreement (the "CSL Collaboration Agreement") with Seqirus, Inc. ("CSL Seqirus"), a part of CSL Limited and one of the world's leading influenza vaccine providers, for the global excl

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