Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may
80
become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
As of December 31, 2022, our management, with the participation of our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to management, including our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2022.
Management’s Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Exchange Act Rules 13a-15(f) and 15(d) -15(f) as a process designed by, or under the supervision of, our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles.
Because of inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions or that the degree of compliance with the policies or procedures may deteriorate.
As of December 31, 2022, our management assessed the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013). In adopting the 2013 Framework, management assessed the applicability of the principles within each component of internal control and determined whether or not they have been adequately addressed within the current system of internal control and adequately documented. Based on this assessment, management, under the supervision and with the participation of our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer, concluded that, as of December 31, 2022, our internal control over financial reporting was effective based on those criteria.
Changes in Internal Control Over Financial Reporting.
An evaluation was also performed under the supervision and with the participation of our management, including our Chief Executive Officer, Chief Financial Officer and Principal Accounting Officer of any changes in our internal control over financial reporting that occurred during our last fiscal quarter and that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during the quarter ended December 31, 2022 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None.
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Not Applicable.
81
PART III
Item 10. Directors, Executive Off icers and Corporate Governance
Information required by this item will be contained in our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2022. Such information is incorporated herein by reference.
Item 11. Executiv e Compensation
Information required by this item will be contained in our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2022. Such information is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters
Information required by this item will be contained in our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2022. Such information is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Information required by this item will be contained in our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2022. Such information is incorporated herein by reference.
Item 14. Principal Accoun ting Fees and Services
Information required by this item will be contained in our Definitive Proxy Statement for our 2023 Annual Meeting of Stockholders, to be filed pursuant to Regulation 14A with the Securities and Exchange Commission within 120 days of December 31, 2022. Such information is incorporated herein by reference.
82
PART IV
Item 15. Exhibits, Financ ial Statement Schedules
(a)
(1) The information required by this item is included in Item 8 of Part II of this Annual Report.;
(2) Financial statement schedules not listed above have been omitted because information required to be set forth therein is not applicable, not required, or the information required by such schedules is shown in the consolidated financial statements or the notes thereto.
(3) See the exhibit index preceding the signature pages to this Annual Report, which is incorporated by reference herein.
(b) See the exhibit index preceding the signature pages to this Annual Report, which is incorporated by reference herein.
(c) Not applicable.
Item 16. Form 10-K Summary
None.
83
Exhibit Index
Exhibit
Number
Description
1.1
Controlled Equity Offering℠ Sales Agreement, dated as of December 23, 2022 by and between Cantor Fitzgerald & Co, Wells Fargo Securities, LLC and Arcturus Therapeutics Holdings Inc. Incorporated by reference to Exhibit 1.2 to Registration Statement on Form S-3 filed on December 23, 2022 (File No. 333269003).
3.1
Certificate of Incorporation. Incorporated by reference to Annex B to the proxy statement/prospectus which forms part of the Registration Statement on Form S-4 filed on March 18, 2019 (File No. 333-230353).
3.2
Certificate of Amendment, dated November 25, 2020. Incorporated by reference to Exhibit 3.1 to Form 8-K filed on November 25, 2020 (File No. 001-38942).
3.3
Bylaws of Arcturus Therapeutics Holdings Inc. Incorporated by reference to Exhibit 3.2 to the Company’s Registration Statement on Form S-3, filed with the SEC on May 8, 2020 (File No. 333-238139).
4.1*
Description of Registrant’s Securities.
10.1
Form of Indemnification Agreement. Incorporated by reference to Exhibit 10.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 16, 2020 (File No. 001-38942).
10.2
Amended and Restated 2019 Omnibus Equity Incentive Plan. Incorporated by reference Exhibit 4.3 to the Registration Statement on Form S-8 filed on August 5, 2020 (File No. 001-38942).
10.3
Arcturus Therapeutics Ltd. Amended and Restated Compensation Policy for Company Office Holders. Incorporated by reference to Exhibit 99.2 to the Company’s Report of Foreign Private Issuer on Form 6-K filed on July 27, 2018 (File No. 001-35932).
10.4**
Loan and Security Agreement, dated October 12, 2018, by and between Western Alliance Bank and Arcturus Therapeutics, Inc. Incorporated by reference to Exhibit 10.1 to the Company’s Report of Foreign Private Issuer on Form 6-K filed on October 15, 2018 (File No. 001-35932).
10.5**
Amended and Restated Amendment to Development and Option Agreement, dated as of September 28, 2018, by and between CureVac AG and Arcturus Therapeutics Inc. Incorporated by reference to Exhibit 99.2 to the Company’s Report of Foreign Private Issuer on Form 6-K filed on October 1, 2018 (File No. 001-35932).
10.6**
Research Collaboration and License Agreement, by and between Arcturus Therapeutics, Inc. and Janssen Pharmaceuticals, Inc., dated October 18, 2017. Incorporated by reference to Exhibit 4.7 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.7**
Research and Exclusive License Agreement, by and between Arcturus Therapeutics, Inc. and Synthetic Genomics, Inc., effective October 24, 2017. Incorporated by reference to Exhibit 4.8 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.8**
Research Collaboration and License Agreement, by and between Arcturus Therapeutics, Inc. and Ultragenyx Pharmaceutical Inc., entered into as of October 26, 2015, as amended October 17, 2017 and April 20, 2018. Incorporated by reference to Exhibit 4.10 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.9**
Third Amendment to Research Collaboration and License Agreement, by and between Arcturus Therapeutics, Inc. and Ultragenyx Pharmaceutical Inc., effective June 18, 2019. Incorporated by reference to Exhibit 10.2 to Form 8-K filed on June 20, 2019 (File No. 001- 38942).
84
Exhibit
Number
Description
10.10**
Letter Agreement, by and between Arcturus Therapeutics, Inc. and the Cystic Fibrosis Foundation, dated May 16, 2017. Incorporated by reference to Exhibit 4.11 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.11**
Amendment No. 2 to Letter Agreement, by and between Arcturus Therapeutics, Inc. and the Cystic Fibrosis Foundation, dated August 1, 2019. Incorporated by reference to Exhibit 10.16 to Form 10-Q filed on August 14, 2019.
10.12**
Development and Option Agreement, by and between Arcturus Therapeutics, Inc. and CureVac AG, dated January 1, 2018, as amended May 3, 2018. Incorporated by reference to Exhibit 4.12 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.13**
Third Amendment to Development and Option Agreement, by and between Arcturus Therapeutics, Inc. and CureVac AG, dated July 26, 2019. Incorporated by reference to Exhibit 10.20 to Form 10-Q filed on August 14, 2019 (File No. 001-38942).
10.14**
License Agreement, by and between Arcturus Therapeutics, Inc., as successor-in-interest to Marina Biotech, Inc., and Protiva Biotherapeutics Inc., dated as of November 28, 2012. Incorporated by reference to Exhibit 4.14 to Form 20-F/A filed on July 10, 2018 (File No. 001-35932).
10.15**
Patent Assignment and License Agreement, by and between Arcturus Therapeutics, Inc. and Marina Biotech, Inc., dated as of August 9, 2013. Incorporated by reference to Exhibit 4.15 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.16
Share Exchange Agreement, dated as of February 11, 2019, by and between Arcturus Therapeutics Ltd. and Arcturus Therapeutics Holdings Inc. Incorporated by reference to Exhibit 10.13 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on March 18, 2019 (File No. 001-35932).
10.17**
Amended and Restated Joint Venture, Research Collaboration and License Agreement, dated as of July 14, 2018 by and between Arcturus Therapeutics, Inc. and Providence Therapeutics, Inc. Incorporated by reference to Exhibit 10.14 to the Company’s Amendment No. 1 to Annual Report on Form 10-K for the year ended December 31, 2018 filed on April 10, 2019 (File No. 001-35932).
10.18
Lease Agreement, by and between Arcturus Therapeutics, Inc. and ARE-SD Region No. 44, LLC, dated October 4, 2017. Incorporated by reference to Exhibit 4.6 to Form 20-F filed on May 14, 2018 (File No. 001-35932).
10.19
First Amendment to Lease Agreement, by and between Arcturus Therapeutics Holdings Inc. and ARE-SD Region No. 44, LLC dated February 1, 2020. Incorporated by reference to Exhibit 10.23 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 16, 2020 (File No. 001-38942).
10.20**
Acceptance Letter, dated March 4, 2020, by and between Arcturus Therapeutics Holdings Inc. and the Economic Development Board of Singapore. Incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 filed on March 16, 2020 (File No. 001-38942).
10.21**
Manufacturing Support Agreement, dated November 7, 2020, by and between Arcturus Therapeutics Holdings Inc. and the Economic Development Board of Singapore. Incorporated by reference to Exhibit 10.33 to Quarterly Report on Form 10-Q filed on November 9, 2020 (File No. 001-38942).
10.22
Fourth Amendment to Loan and Security Agreement, dated December 1, 2020, by and between Arcturus Therapeutics, Inc. and Western Alliance Bank. Incorporated by reference to Exhibit 10.1 to Form 8-K filed on December 7, 2020 (File No. 001-38942).
10.23
2020 Employee Stock Purchase Plan. Incorporated by reference to Exhibit 4.3 to Form S-8 filed on August 5, 2020 (File No. 001-38942).
85
Exhibit
Number
Description
10.24
Second Amendment to Lease, by and between Arcturus Therapeutics, Inc. and ARE-SD Region No. 44, LLC, dated November 13, 2020. Incorporated by reference to Exhibit 10.29 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 1, 2020 (File No. 001-38942).
10.25
Third Amendment to Lease, by and between Arcturus Therapeutics, Inc. and ARE-SD Region No. 44, LLC, dated February 25, 2021. Incorporated by reference to Exhibit 10.30 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 1, 2020 (File No. 001-38942).
10.26
Arcturus Therapeutics Holdings Inc. Severance Policy for Executives. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on April 26, 2021 (File No. 001-38942).
10.27
Employment Agreement, dated as of June 13, 2019, between the Company and Joseph Payne. Incorporated by reference to Exhibit 10.1 to Form 8-K12B filed on June 14, 2019 (File No. 001-38942)
10.28
Employment Agreement, dated as of June 13, 2019, between the Company and Andy Sassine. Incorporated by reference to Exhibit 10.2 to Form 8-K12B filed on June 14, 2019 (File No. 001-38942)
10.29
Employment Agreement, dated as of June 13, 2019, between the Company and Dr. Padmanabh Chivukula. Incorporated by reference to Exhibit 10.3 to Form 8-K12B filed on June 14, 2019 (File No. 001-38942)
10.30
2021 Inducement Equity Incentive Plan. Incorporated by reference to Exhibit 4.1 to Form S-8 filed on October 20, 2021 (File No. 333-260391).
10.31
Fifth Amendment to Loan and Security Agreement, dated October 27, 2021, by and between Arcturus Therapeutics, Inc. and Western Alliance Bank. Incorporated by reference to Exhibit 10.34 to Form 10-Q filed on November 9, 2021 (File No. 001-38942).
10.32
Lease, by and between Arcturus Therapeutics, Inc. and TPSC IX, LLC, dated September 29, 2021. Incorporated by reference to Exhibit 10.35 to Form 10-Q filed on November 9, 2021 (File No. 001-38942).
10.33
Third Amendment to Lease, by and between Arcturus Therapeutics, Inc. and ARE-SD Region No. 44, LLC, dated February 25, 2021. Incorporated by reference to Exhibit 10.30 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed on March 1, 2020 (File No. 001-38942).
10.34
Technology License and Technical Support Agreement, signed July 29, 2021 and effective July 30, 2021, by and between Arcturus Therapeutics, Inc. and Vinbiotech Research and Manufacture Joint Stock Company. Incorporated by reference to Exhibit 10.32 to Quarterly Report on Form 10-Q filed on August 10, 2021 (File No. 001-38942).
10.35
Framework Drug Substance Supply Agreement, signed July 29, 2021 and effective July 30, 2021, by and between Arcturus Therapeutics, Inc. and Vinbiotech Research and Manufacture Joint Stock Company. Incorporated by reference to Exhibit 10.33 to Quarterly Report on Form 10-Q filed on August 10, 2021 (File No. 001-38942).
10.36
Sixth Amendment to Loan and Security Agreement, dated April 19, 2022, by and between Arcturus Therapeutics, Inc. and Western Alliance Bank. Incorporated by reference to Exhibit 10.36 to Quarterly Report on Form 10-Q filed on May 9, 2022 (File No. 001-38942).
10.37
Amended and Restated 2019 Omnibus Equity Incentive Plan, as amended. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on June 24, 2022 (File No. 001-38942).
86
Exhibit
Number
Description
10.38**
Study Support Agreement effective October 31, 2022 by and between Arcturus Therapeutics, Inc. and Vinbiocare Biotechnology Joint Stock Company. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on November 4, 2022 (File No. 001-38942).
10.39**
Cost Reimbursement Contract dated August 31, 2022, by and between Arcturus Therapeutics Holdings Inc. and Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services. Incorporated by reference to Exhibit 10.36 to Quarterly Report on Form 10-Q filed on November 9, 2022 (File No. 001-38942).
10.40**
Collaboration and License Agreement, dated November 1, 2022, by and between Arcturus Therapeutics Holdings Inc. and CSL Limited. Incorporated by reference to Exhibit 10.38 to Quarterly Report on Form 10-Q filed on November 9, 2022 (File No. 001-38942).
10.41* **
Manufacturing Support Agreement Termination Letter, dated March 23, 2023, by and between Arcturus Therapeutics, Inc. and the Economic Development of Singapore.
23.1*
Consent of Independent Registered Public Accounting Firm
24.1*
Power of Attorney (included on the signature page of this Annual Report).
31.1*
Certification by Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.2*
Certification by Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.3*
Certification by Principal Accounting Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended.
32.1*
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.3*
Certification of Principal Accounting Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*
The following financial statements and footnotes from the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 formatted in Inline Extensible Business Reporting Language (Inline XBRL):
101.INS Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
101.SCH Inline XBRL Taxonomy Extension Schema
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase
101.LAB Inline XBRL Taxonomy Extension Label Linkbase
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed herewith.
**
Certain confidential portions of this exhibit have been redacted from the publicly filed document because such portions are (i) not material and (ii) would be competitively harmful if publicly disclosed.
Management compensatory plan, contract or arrangement.
87
SIGNAT URES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .
ARCTURUS THERAPEUTICS HOLDINGS INC.
Date: March 28, 2023
By:
/s/ Joseph E. Payne
Name: Joseph E. Payne
Title: President, Chief Executive Officer and Director
The undersigned officers and directors of Arcturus Therapeutics Holdings Inc., hereby severally constitute and appoint Joseph E. Payne and Dr. Padmanabh Chivukula, and each of them individually, with full power of substitution and resubstitution, as their true and lawful attorneys and agents, to do any and all acts and things in their name and behalf in their capacities as directors and officers and to execute any and all instruments for them and in their names in the capacities indicated below, which said attorneys and agents, may deem necessary or advisable to enable said corporation to comply with the Securities Exchange Act of 1934, as amended, and any rules, regulations and requirements of the Securities and Exchange Commission, in connection with this Annual Report on Form 10-K, including specifically but without limitation, power and authority to sign for them or any of them in their names in the capacities indicated below, any and all amendments hereto, and they do hereby ratify and confirm all that said attorneys and agents, or either of them, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Name
Title
Date
/s/ Joseph E. Payne
President, Chief Executive Officer and Director
March 28, 2023
Joseph E. Payne
(principal executive officer)
/s/ Dr. Peter Farrell
Chairman of the Board
March 28, 2023
Dr. Peter Farrell
/s/ Andrew Sassine
Director and Chief Financial Officer
March 28, 2023
Andrew Sassine
(principal financial officer)
/s/ Dr. Magda Marquet
Director
March 28, 2023
Dr. Magda Marquet
/s/ James Barlow
Director
March 28, 2023
James Barlow
/s/ Edward Holmes
Director
March 28, 2023
Edward Holmes
/s/ Jing Marantz
Director
March 28, 2023
Jing Marantz
/s/ Dr. John Markels
Director
March 28, 2023
Dr. John Markels
/s/ Keith C. Kummerfeld
Vice President of Finance and Corporate Controller
March 28, 2023
Keith C. Kummerfeld
(principal accounting officer)
88
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
F- 1
Consolidated Balance Sheets as of December 31, 2022 and 202 1
F- 4
Consolidated Statements of Operations and Comprehensive Income (Loss) for the Years ended December 31, 2022 and 2021
F- 5
Consolidated Statements of Changes in Stockholders’ Equity for the Years ended December 31, 2022 and 2021
F- 6
Consolidated Statements of Cash Flows for the Years ended December 31, 2022 and 2021
F- 7
Notes to Consolidated Financial Statements
F- 8
F- 1
Report of Independent Regist ered Public Accounting Firm
To the Stockholders and the Board of Directors of Arcturus Therapeutics Holdings Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Arcturus Therapeutics Holdings Inc. and its Subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations and comprehensive income (loss), changes in stockholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal controls over financial reporting. As part of our audits, we are required to obtain an understanding of internal controls over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal controls over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F- 2
Accrued research and development expenses
Description of the Matter
At December 31, 2022, the Company incurred $147.8 million for research and development expenses and accrued $4.5 million for clinical trial expenses. As described in Note 2 to the consolidated financial statements, the Company records accruals for estimated costs of research and development activities, including for third party contractors, laboratories, participating clinical trial sites and others. Clinical trial activities performed by third parties are accrued and expensed based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with Clinical Research Organizations ("CROs") and clinical trial sites. Estimates are determined by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
Auditing management’s accounting for accrued research and development expenses, was especially challenging as evaluating the progress or stage of completion of the activities under the Company’s research and development agreements is dependent upon information from internal clinical personnel and third party service providers and involves a high volume of data which is tracked in spreadsheets and other end user computing programs.
How We Addressed the Matter in Our Audit
To test the Company’s accrued research and development expenses, we obtained supporting evidence of the research and development activities performed for significant clinical trials. To assess the appropriate measurement of accrued research and development costs, our audit procedures included, among others, obtaining and inspecting significant agreements and agreement amendments, evaluating the Company’s documentation of trial timelines, confirming amounts incurred to-date with third-party service providers, and testing a sample of transactions and comparing the costs against related invoices and contracts. We also tested a sample of subsequent payments to evaluate the completeness of the accrued expenses and compared the results to the current year accrual.
/s/ Ernst & Young, LLP
We have served as the Company’s auditor since 2018.
San Diego, California
March 28, 2023
F- 3
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONSOLIDATED BA LANCE SHEETS
As of December 31,
(in thousands, except par value information)
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
391,883
$
370,492
Accounts receivable
2,764
3,367
Prepaid expenses and other current assets
8,686
5,102
Total current assets
403,333
378,961
Property and equipment, net
12,415
5,643
Operating lease right-of-use asset, net
32,545
5,618
Equity-method investment
—
515
Non-current restricted cash
2,094
2,077
Total assets
$
450,387
$
392,814
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
7,449
$
10,058
Accrued liabilities
30,232
23,523
Current portion of long-term debt
60,655
22,474
Deferred revenue
28,648
43,482
Total current liabilities
126,984
99,537
Deferred revenue, net of current portion
20,071
19,931
Long-term debt, net of current portion
—
40,633
Operating lease liability, net of current portion
30,216
4,502
Other non-current liabilities
2,804
—
Total liabilities
180,075
164,603
Stockholders’ equity:
Common stock: $ 0.001 par value; 60,000 shares authorized; issued and outstanding shares were 26,555 at December 31, 2022 and 26,372 at December 31, 2021
27
26
Additional paid-in capital
608,426
575,675
Accumulated deficit
( 338,141
)
( 347,490
)
Total stockholders’ equity
270,312
228,211
Total liabilities and stockholders’ equity
$
450,387
$
392,814
The accompanying notes are an integral part of these consolidated financial statements.
F- 4
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
C ONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
Year Ended December 31,
(in thousands, except per share data)
2022
2021
Revenue:
Collaboration revenue
$
205,755
$
12,359
Grant revenue
244
—
Total revenue
205,999
12,359
Operating expenses:
Research and development, net
147,751
173,760
General and administrative
46,071
41,451
Total operating expenses
193,822
215,211
Income (loss) from operations
12,177
( 202,852
)
(Loss) gain from equity-method investment
( 515
)
515
(Loss) gain from foreign currency
( 598
)
584
Finance expense, net
( 420
)
( 1,921
)
Net income (loss) before income taxes
10,644
( 203,674
)
Provision for income taxes
1,295
-
Net income (loss)
$
9,349
$
( 203,674
)
Earnings (loss) per share:
Basic
$
0.35
$
( 7.74
)
Diluted
$
0.35
$
( 7.74
)
Weighted-average shares used in calculation of earnings (loss) per share:
Basic
26,445
26,317
Diluted
27,093
26,317
Comprehensive income (loss):
Net income (loss)
$
9,349
$
( 203,674
)
Comprehensive income (loss)
$
9,349
$
( 203,674
)
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
(in thousands)
Shares
Amount
Capital
Deficit
Equity
Balance at December 31, 2020
26,192
$
26
$
540,343
$
( 143,816
)
$
396,553
Share-based compensation
—
—
28,915
—
28,915
Issuance of common stock related to acquired in-process research and development
75
—
5,000
—
5,000
Issuance of common stock upon exercise of stock options
92
—
902
—
902
Issuance of common stock under equity plans
13
—
515
—
515
Net loss
—
—
—
( 203,674
)
( 203,674
)
Balance at December 31, 2021
26,372
$
26
$
575,675
$
( 347,490
)
$
228,211
Share-based compensation
—
—
30,611
—
30,611
Issuance of common stock upon exercise of stock options
161
1
1,729
—
1,730
Issuance of common stock under equity plans
22
—
411
—
411
Net income
—
—
—
9,349
9,349
Balance at December 31, 2022
26,555
$
27
$
608,426
$
( 338,141
)
$
270,312
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEM ENTS OF CASH FLOWS
Year Ended December 31,
(in thousands)
2022
2021
Operating activities
Net income (loss)
$
9,349
$
( 203,674
)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization
1,527
1,193
Share-based compensation expense
30,611
28,915
Acquired in-process research and development expense
—
5,000
Loss (gain) from equity-method investment
515
( 515
)
Foreign currency transaction loss (gain)
375
( 577
)
Other non-cash expenses
2,173
1,990
Changes in assets and liabilities:
Accounts receivable
603
( 1,242
)
Prepaid expenses and other current assets
( 3,584
)
( 2,333
)
Right-of-use assets
3,264
1,392
Accounts payable
( 3,112
)
( 769
)
Accrued liabilities
9,443
4,134
Deferred revenue
( 14,694
)
32,794
Lease liabilities
( 4,477
)
( 1,351
)
Net cash provided by (used in) operating activities
31,993
( 135,043
)
Investing activities
Acquisition of property and equipment
( 7,726
)
( 3,406
)
Net cash used in investing activities
( 7,726
)
( 3,406
)
Financing activities
Proceeds from long-term debt, net of lender fees
—
46,599
Proceeds from exercise of stock options
1,730
902
Proceeds from issuance of common stock under equity plans
411
515
Principal payments on debt
( 5,000
)
—
Net cash (used in) provided by financing activities
( 2,859
)
48,016
Net increase (decrease) in cash, cash equivalents and restricted cash
21,408
( 90,433
)
Cash, cash equivalents and restricted cash, beginning of year
372,569
463,002
Cash, cash equivalents and restricted cash, end of year
$
393,977
$
372,569
Year Ended December 31,
2022
2021
Supplemental disclosure of cash flow information
Cash paid for interest
$
813
$
684
Non-cash investing activities
Right-of-use assets acquired through operating leases
$
30,191
$
1,828
Acquisition of in-process research and development through issuance of common stock
$
—
$
5,000
Purchase of property and equipment in accounts payable and accrued expenses
$
573
$
53
The accompanying notes are an integral part of these consolidated financial statements.
F- 7
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization
Description of Business
Arcturus Therapeutics Holdings Inc. (the “Company” or "Arcturus") is a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases. The Company became a clinical stage company during 2020 when it announced that its Investigational New Drug (“IND”) application for ornithine transcarbamylase (“OTC”) deficiency and its Clinical Trial Application (“CTA”) for candidate LUNAR-COV19 were approved by applicable health authorities.
Recent Developments
See “Note 3 Revenue – CSL Seqirus” for further information on the agreement with Seqirus, Inc. ("CSL Seqirus"), whereby CSL Seqirus and the Company will collaborate on research and development, manufacturing and global commercialization of vaccines.
Liquidity
The Company has incurred significant operating losses since its inception. As of December 31, 2022 and 2021, the Company had an accumulated deficit of $ 338.1 million and $ 347.5 million, respectively.
The Company’s activities since inception have consisted principally of research and development activities, general and administrative activities, and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations. From the Company’s inception through the year ended December 31, 2022 , the Company has funded its operations principally with the proceeds from the sale of capital stock, revenues earned through collaboration agreements and proceeds from long-term debt. During fiscal year 2022, the Company received an upfront payment of $ 200.0 million as part of its collaboration agreement with CSL Seqirus for the research, manufacture and global commercialization of self-amplifying mRNA vaccines against COVID-19, influenza and three other respiratory infectious diseases. At December 31, 2022, the Company’s balance of cash and cash equivalents, including restricted cash, was $ 394.0 million.
Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these consolidated financial statements were available to be issued. There can be no assurance that the Company will be successful in acquiring additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years.
F- 8
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Note 2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Arcturus Therapeutics Holdings Inc. and its subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. These consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (U.S. GAAP), which requires management to make estimates and assumptions regarding the valuation of certain debt and equity instruments, the equity method investment, share-based compensation, accruals for liabilities, income taxes, revenue and deferred revenue, leases, expense accruals, and other matters that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Although these estimates are based on management’s knowledge of current events and actions the Company may undertake in the future, actual results could materially differ from those estimates.
Segment Information
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company and its chief operating decision-maker view the Company’s operations and manage its business in one operating segment which is the research and development of medical applications for the Company’s nucleic acid-focused technology.
Cash and Cash Equivalents
Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at the date of purchase.
Restricted cash
Restricted cash represents cash required to be set aside as security for lease payments and to maintain a letter of credit for the benefit of the landlord for the Company’s offices. At December 31, 2022 and 2021, the Company had restricted cash of $ 2.1 million and $ 2.1 million in conjunction with property leases in San Diego, California, and such restriction is expected to be removed at the end of the lease term.
Fair Value Measurements
Fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. A hierarchy has been established for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available.
Observable inputs are inputs that market participants would use in valuing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available under the circumstances. The hierarchy consists of three levels. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and inputs (other than quoted prices) that are observable for the asset or liability, either directly or indirectly. Level 3 inputs are unobservable inputs for the asset or liability. Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
Accounts Receivable
Accounts receivable are recorded at the net invoice value and are non-interest bearing. The Company considers receivables past due based on the contractual payment terms. The Company reserves for specific receivables if collectability is no longer reasonably assured. Estimates for allowances for doubtful accounts are determined based on existing contractual obligations, historical payment patterns, and individual customer circumstances. The Company reevaluates such reserves on a regular basis and adjusts its reserves as needed. Once a
F- 9
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
receivable is deemed to be uncollectible, such balance is charged against the reserve. No reserves have been recorded as of December 31, 2022 or 2021 .
Concentration of Credit Risk and Significant Customers
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist of cash and cash equivalents. The Company limits its exposure to credit loss by placing its cash and cash equivalents with high credit quality financial institutions in instruments with short maturities.
There were two customers that comprised 100 % of the total accounts receivable balance at December 31, 2022 and two customers that comprised 100 % of the total accounts receivable balance at December 31, 2021.
For the year ended December 31, 2022, the Company’s top five customers collectively represented 99 % of the Company’s total revenue. For the year ended December 31, 2021, there were four customers that collectively represented 99 % of the Company’s total revenue.
Joint Ventures, Equity Method Investments and Variable Interest Entities
Investments for which the Company exercises significant influence but does not have control are accounted for under the equity method. Equity method investment activity is related to a 49 % joint venture with Axcelead, Inc. (see the following paragraph for further details) and a 6 % ownership in Vallon Pharmaceuticals, Inc. (see “ Note 12, Related Party Transactions” for further details). The Company’s share of the investees results is presented as either income or loss from equity method investees in the accompanying consolidated statements of operations and comprehensive income (loss).
In April 2021, Arcturus and Axcelead, Inc., a company existing under the laws of Japan (“Axcelead”), formed a joint venture entity, named Arcalis, Inc. (“JV Entity”), which operates as a corporation under the laws of Japan. Axcelead is an integrated drug discovery solutions provider to the pharmaceutical industry in Japan. On July 1, 2017, Axcelead became the successor to a portion of the drug discovery research department of Takeda Pharmaceutical Company Limited. The goal of the JV Entity is to be a contract development and manufacturing organization focused on mRNA manufacturing that would provide manufacturing services to the Company and also to third parties. The joint venture includes a shareholders agreement setting forth initial funding of the JV Entity and rights of the shareholders, including certain approval rights of Arcturus. As part of the joint venture, the Company entered into a License and Technology Transfer Agreement with the JV Entity, pursuant to which Arcturus grants to JV Entity a nonexclusive license to certain intellectual property for use at the JV Entity’s facilities, and obligates Arcturus to conduct certain technology transfer activities.
The Company consolidates variable interest entities (“VIEs”) where it has been determined that the Company is the primary beneficiary of those entities’ operations. Management believes that power is shared between Arcturus and Axcelead, as unrelated parties. The consent of each of the parties is substantive and is required to make the decisions about the JV Entity’s significant activities. Management does not believe that Arcturus has the power to direct the activities of the JV Entity that most significantly impact the JV Entity’s economic performance. Therefore, the Company concluded it is not required to consolidate the JV Entity under the VIE model.
The equity method of accounting is applicable for the JV Entity as the Company does not own more than 50 % of voting power, but has influence over the operation and financial policies of the investee. The Company accounts for its investment in the JV Entity using the equity method of accounting as specified in ASC 323, Investments — Equity Method and Joint Ventures . Under ASC 323, equity method investments are recorded initially at cost. The Company’s initial investment in the JV Entity totaled $ 9.2 million. However, the JV Entity paid the Company back the initial investment of $ 9.2 million as an upfront fee/consideration for the License and Technology Transfer Agreement. In substance, there was no cash consideration paid by the Company for its 49 % equity interest in the JV Entity.
F- 10
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Property and Equipment, net
Property and equipment are stated at cost, net of accumulated depreciation and amortization. The cost of property and equipment is depreciated or amortized using the straight-line method over the respective useful lives of the assets, ranging from three to five years . Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the lease term. Long-lived assets, including property and equipment are reviewed for impairment whenever events or circumstances indicate that the carrying amount of these assets may not be recoverable. The determinants used for this evaluation include management’s estimate of an asset’s ability to generate positive income from operations and positive cash flow in future periods, as well as the strategic significance of the assets to the Company’s business objectives. The Company did no t recognize any impairment losses for the years ended December 31, 2022 and 2021 .
Comprehensive Income/Loss
Comprehensive income/loss is defined as the change in stockholders’ equity during a period from transactions and other events and circumstances from non-owner sources. There was no other comprehensive loss in the years ended December 31, 2022 or 2021 . There was no income tax effect related to unrealized losses for the years ended December 31, 2022, or 2021 .
Revenue Recognition
At contract inception, the Company analyzes the collaboration arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration reflect a vendor-customer relationship and are therefore within the scope of ASC 606.
The Company determines revenue recognition for arrangements within the scope of Topic 606 by performing the following five steps: (i) identify the contract; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the company satisfies a performance obligation.
The terms of the Company’s revenue agreements include license fees, upfront payments, milestone payments, reimbursement for research and development activities, option exercise fees, consulting and related technology transfer fees and royalties on sales of commercialized products. Arrangements that include upfront payments are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. The event-based milestone payments represent variable consideration, and the Company uses the most likely amount method to estimate this variable consideration because the Company will either receive the milestone payment or will not, which makes the potential milestone payment a binary event. The most likely amount method requires the Company to determine the likelihood of earning the milestone payment. Given the high degree of uncertainty around achievement of these milestones, the Company determines the milestone amounts to be fully constrained and does not recognize revenue until the uncertainty associated with these payments is resolved. The Company will recognize revenue from sales-based royalty payments when or as the sales occur. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved and other changes in circumstances occur.
A performance obligation is a promise in a contract to transfer a distinct good or service to the collaborative partner and is the unit of account in Topic 606. A contract’s transaction price is allocated to each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the performance obligation is satisfied.
For performance obligations that are recognized over time, the Company measures the progress using an input method. The input methods used are based on the effort expended or costs incurred toward the satisfaction of the performance obligation. The Company estimates the amount of effort expended, including the time estimated it will take to complete the activities, or costs incurred in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This approach requires the Company to make numerous estimates and use significant judgement. If estimates or judgements change over the course of the collaboration, a cumulative catch up of revenue is recognized in the period such changes are identified.
F- 11
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
See “Note 3, Revenue” for specific details surrounding the Company’s arrangements.
Leases
The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For the Company's operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. The Company's incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components.
See “Note 11, Commitments and Contingences” for specific details surrounding the Company’s leases.
Research and Development Costs, net
All research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, employee benefits, costs associated with preclinical studies and clinical trials (including amounts paid to clinical research organizations and other professional services), in process research and development expenses and license agreement expenses, net of any grants and prelaunch inventory. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.
The Company records accruals for estimated research and development costs, comprising payments for work performed by third party contractors, laboratories, participating clinical trial sites, and others. Some of these contractors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. For the latter, the Company accrues the expenses as goods or services are used or rendered.
Clinical trial activities performed by third parties are accrued and expensed based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with Clinical Research Organizations ("CROs") and clinical trial sites. Estimates are determined by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services.
F- 12
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Share-Based Compensation
The Company recognizes share-based compensation for equity awards granted to employees, consultants, officers and directors as an expense on the statements of operations and comprehensive income (loss). Share-based compensation is recognized over the requisite service period of the individual awards using the straight-line attribution method, which generally equals the vesting period. Employees and officers’ stock options have a ten-year life and generally vest 25 % on the first anniversary of the grant and in 1/36 th equal installments on each monthly anniversary thereafter, such that options are fully vested on the four-year anniversary of the date of grant. The exercisability and vesting periods of options granted to consultants and directors vary.
The fair value of stock options is estimated using a Black-Scholes valuation model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected volatility of stock options is based upon the historical volatility of a peer group of publicly traded companies. The Company has not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the implied yield currently available in United States Treasury securities at maturity with a term equivalent to the expected term of the stock options. The effect of forfeited awards is recorded when the forfeiture occurs.
Pre-Launch Inventory
Prior to obtaining initial regulatory approval for an investigational product candidate, the Company expenses costs relating to production of inventory as research and development expense in its consolidated statements of operations and comprehensive income (loss), in the period incurred. When the Company believes regulatory approval and subsequent commercialization of an investigational product candidate is probable, and the Company also expects future economic benefit from the sales of the investigational product candidate to be realized, it will then capitalize the costs of production as inventory.
Statement of Cash Flows
The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the consolidated balance sheets to the total of such amounts shown in the consolidated statement of cash flows:
As of December 31,
(in thousands)
2022
2021
Cash and cash equivalents
$
391,883
$
370,492
Non-current Restricted cash
2,094
2,077
Total cash, cash equivalents and restricted cash
shown in the statement of cash flows
$
393,977
$
372,569
Income Tax Expense
Income taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting basis and the tax basis of the Company’s assets and liabilities at the applicable tax rates, along with net operating loss and tax credit carryovers. The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. Management has considered estimated taxable income and ongoing prudent and feasible tax planning strategies in assessing the amount of the valuation allowance. Based upon the weight of available evidence, which includes the Company’s historical operating performance and limited potential to utilize tax credit carryforwards, the Company has determined that total deferred tax assets should be fully offset by a valuation allowance. When the Company establishes or reduces the valuation allowance against its deferred tax assets, its provision for income taxes will increase or decrease, respectively, in the period such determination is made.
The Company is required to file federal and state income tax returns in the United States and various other state jurisdictions. The Company also files income tax returns in the foreign countries in which it operates. The
F- 13
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
preparation of these income tax returns requires the Company to interpret the applicable tax laws and regulations in effect in such jurisdictions, which could affect the amount of tax paid by the Company.
Additionally, the Company follows an accounting standard addressing the accounting for uncertainty in income taxes that prescribes rules for recognition, measurement, and classification in the consolidated financial statements of tax positions taken or expected to be taken in a tax return.
In December 2019, the FASB issued an ASU 2019-12 that simplifies the accounting for income taxes by eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. This ASU is effective for annual periods and interim periods for those annual periods beginning after December 15, 2020, with early adoption permitted. The Company adopted this standard effective January 1, 2021 . The adoption of this standard did no t have an impact on the Company’s Consolidated Financial Statements.
Net Income (Loss) per Share
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. Diluted net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive shares of common stock for the years ended December 31, 2022 and 2021 are comprised of stock options.
No dividends were declared or paid during the reporting periods.
Recently Issued Accounting Standards Not Yet Adopted
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the consolidated financial statements and disclosures.
NOTE 3. Revenue
The Company has entered into license agreements and collaborative research and development arrangements with pharmaceutical and biotechnology companies, as well as consulting, related technology transfer and product revenue agreements. Under these arrangements, the Company is entitled to receive license fees, consulting fees, product fees, technological transfer fees, upfront payments, milestone payments if and when certain research and development milestones or technology transfer milestones are achieved, royalties on approved product sales and reimbursement for research and development activities. The Company’s costs of performing these services are included within research and development expenses. The Company’s milestone payments are typically defined by achievement of certain preclinical, clinical, and commercial success criteria. Preclinical milestones may include in vivo proof of concept in disease animal models, lead candidate identification, and completion of IND-enabling toxicology studies. Clinical milestones may, for example, include successful enrollment of the first patient in or completion of Phase 1, 2 and 3 clinical trials, and commercial milestones are often tiered based on net or aggregate sale amounts. The Company cannot guarantee the achievement of these milestones due to risks associated with preclinical and clinical activities required for development of nucleic acid medicine-based therapeutics and vaccines.
The following table presents changes in the balances of receivables and contract liabilities related to strategic collaboration agreements during the year ended December 31, 2022:
(in thousands)
December 31, 2021
Additions
Deductions
December 31, 2022
Contract Assets:
Accounts receivable
$
3,367
$
203,077
$
( 203,680
)
$
2,764
Contract Liabilities:
Deferred revenue
$
63,413
$
203,077
$
( 217,771
)
$
48,719
F- 14
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
The following table summarizes the Company’s revenue for the periods indicated. Approximately $ 192.7 million and $ 5.0 million of total revenue represents revenue derived from foreign countries for the years ended December 31, 2022 and 2021, respectively.
For the Year Ended December 31,
(in thousands)
2022
2021
Collaboration revenue:
CSL Seqirus
$
154,425
$
—
Vinbiocare
24,571
4,364
Janssen
9,201
3,129
Ultragenyx
3,739
3,700
CureVac
900
1,019
Israel Ministry of Health
12,500
—
Other
419
147
Total collaboration revenue
$
205,755
$
12,359
Grant revenue:
BARDA
$
244
$
—
Total grant revenue
$
244
$
—
The following paragraphs provide information regarding the nature and purpose of the Company’s most significant revenue arrangements.
CSL Seqirus
On November 1, 2022, the Company entered into a Collaboration and License Agreement (the “CSL Collaboration Agreement”) with Seqirus, Inc. (“CSL Seqirus”), for the global exclusive rights to research, develop, manufacture, and commercialize vaccines. Under the terms of the CSL Collaboration Agreement, the Company will provide CSL Seqirus with an exclusive global license to its STARR self-amplifying mRNA technology, LUNAR ® lipid-mediated delivery, along with mRNA drug substance and drug product manufacturing process. CSL Seqirus will lead development and commercialization of vaccines under the collaboration. The collaboration plans to advance vaccines against SARS-CoV-2 (COVID-19), influenza, pandemic preparedness as well as three other respiratory infectious diseases.
The Company received a $ 200.0 million upfront payment and is eligible to receive over $ 1.3 billion in development milestones if all products are registered in the licensed fields and entitled to potentially receive up to $ 3.0 billion in commercial milestones based on “net sale” of vaccines in the various fields. In addition, the Company is eligible to receive a 40 % net profit share for COVID-19 vaccine products and up to low double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens.
In March 2023, Arcturus achieved development milestones, including milestones associated with nominating next generation vaccine candidates, resulting in $ 90.0 million due from CSL Seqirus.
In evaluating the CSL Collaboration Agreement in accordance with Accounting Standards Codification (“ASC”) Topic 606, the Company concluded that CSL Seqirus is a customer. The Company identified all promised goods/services within the CSL Collaboration Agreement, and when combining certain promised goods/services, the Company concluded that there are five distinct performance obligations. The nature of the performance obligations consists of delivery of the vaccine license, research and development services for COVID and non-COVID vaccines and regulatory activities for COVID vaccines. For each performance obligation, the Company estimated the standalone selling price based on 1) in the case of the license, the fair value using costs to recreate plus margin method and 2) in the case of research and development services and regulatory activities, cost plus margin for estimated full-time equivalent (“FTE”) costs, direct costs including laboratory supplies, contractors, and other out-of-pocket expenses for research and development services and regulatory activities.
As of December 31, 2022, the transaction price consisted of upfront consideration received. Additional variable consideration, including the milestones achieved in March 2023, was not included in the transaction price at December 31, 2022 because the Company could not conclude that it is probable that including the variable consideration will not result in a significant revenue reversal.
F- 15
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
The Company allocated the transaction price to the performance obligations in proportion to their standalone selling price. The vaccine license is recognized at the point in time when it is transferred. The research and development and regulatory activities performance obligations are recognized over a period of time based on the percentage of services rendered using the input method, meaning actual costs incurred divided by total costs budgeted to satisfy the performance obligation. Any consideration related to sales-based royalties will be recognized when the amounts are probable of non-reversal, provided that the reported sales are reliably measurable and the Company has no remaining promised goods/services, as they are constrained and therefore have also been excluded from the transaction price. The revenue recognized in 2022 relates to the license delivered and services performed through December 31, 2022.
Total deferred revenue as of December 31, 2022 for the CSL Collaboration Agreement was $ 45.6 million.
Vinbiocare
During 2021 the Company entered into certain agreements with Vinbiocare, a member of Vingroup Joint Stock Company, whereby the Company would provide technical expertise and support services to Vinbiocare to assist in the build out of a mRNA drug product manufacturing facility in Vietnam. The Company received an upfront payment in aggregate of $ 40.0 million as part of the Vinbiocare Agreement. In October 2022, the Company and Vinbiocare executed a letter agreement terminating the Technology License and Technical Support Agreement and the Framework Drug Substance Supply Agreement (collectively, the “License & Supply Agreements”). The Company incurred no financial penalties in connection with the termination of the License & Supply Agreements and has no further financial obligations to Vinbiocare under these terminated agreements.
In association with the termination of the License & Supply Agreements, the Company signed in October 2022 the Study Support Agreement with Vinbiocare which provides for Vinbiocare to continue serving as the regulatory and financial sponsor of clinical studies conducted in Vietnam of ARCT-154. To support the continuing activities of these studies, the Study Support Agreement further provides for the Company to conduct certain services and to compensate Vinbiocare to help achieve the objectives of these studies. As of December 31, 2022, the Company reserved $ 11.8 million of the original upfront payment to be paid to Vinbiocare over the future periods pursuant to the Study Support Agreement by reclassifying a portion of the upfront payment received from Vinbiocare pursuant to the License & Supply Agreements, from deferred revenue to short-term and long-term liabilities, based on the anticipated timing of the payments to Vinbiocare, and removed that portion of the upfront payment from the transaction price of the modified arrangement. The transaction price was not adjusted for payments that are contingent upon the occurrence of future regulatory or sales related events based on the information currently available to the Company.
In February of 2023, the Company agreed to provide additional financial support in the amount of approximately $ 2.2 million to allow Vinbiocare to provide additional study support duties related to the ARCT-154 clinical study. As a result, the Company adjusted the transaction price which resulted in a reversal of revenue of $ 2.2 million during the year ended December 31, 2022.
The Company has concluded that is has no remaining performance obligations as of December 31, 2022, and therefore has recognized the remaining transaction price as revenue during the year ended December 31, 2022. As of December 31, 2022, the Company has accrued liabilities related to this arrangement of $ 7.5 million in current liabilities and $ 2.8 million in non-current liabilities that will be paid upon the occurrence of specified events through the first quarter of 2025. Vinbiocare is also eligible to receive a single digit percentage of amounts from net sales, if any, of ARCT-154 (or next-generation COVID vaccine) up to a capped amount of low single digit millions. The
F- 16
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Company had no remaining deferred revenue as of December 31, 2022. As of December 31, 2021, the deferred revenue balance was $ 37.2 million.
Janssen
In October 2017, the Company entered into a research collaboration and license agreement with Janssen (the “2017 Agreement”) to collaborate on developing candidates for treating HBV with RNA therapeutics. The 2017 Agreement allocated discovery, development, funding obligations, and ownership of related intellectual property among the Company and Janssen. The Company received an upfront payment of $ 7.7 million and was reimbursed for research costs as incurred.
On October 31, 2022, Arcturus received notice of termination from Janssen Pharmaceuticals, Inc. of the 2017 Agreement, and the termination was effective as of December 30, 2022. The Company will not incur any penalties as a result of this termination. As of December 31, 2022, the licenses granted to Janssen have terminated and the Company recognized approximately $ 6.0 million of upfront consideration received and a development milestone achieved in October of 2021. T he remaining transaction price is expected to be recognized using an input method over the remaining research period of approximately three months during the wind down period.
Total deferred revenue as of December 31, 2022 and 2021 for Janssen was $ 0.4 million and $ 6.3 million, respectively.
Ultragenyx
In October 2015 the Company entered into a research collaboration and license agreement with Ultragenyx (the “Ultragenyx Agreement”), whereby Arcturus granted to Ultragenyx a co-exclusive license to certain Arcturus technology, which is in effect only during the reserve target exclusivity term as discussed in the following paragraphs. This collaboration agreement was amended in 2017, 2018 and during the second quarter of 2019. During the initial phase of the collaboration, the Company will design and optimize therapeutics for certain rare disease targets. Ultragenyx has the option under the Ultragenyx Agreement to add additional rare disease targets during the collaborative development period.
The current potential development, regulatory and commercial milestone payments for the existing development targets as of December 31, 2022 are $ 138.0 million. Ultragenyx will pay royalties as a single-digit percentage of net sales on a product-by-product and country-by-country basis during the applicable royalty term.
As of December 31, 2022, the transaction price included the upfront consideration received, option payments, exclusivity extension payments and additional consideration received pursuant to Amendment 3. The Company recognizes the reimbursement of labor and expenses as costs are incurred and none of the development and commercialization milestones were included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that the consideration is outside the control of the Company and contingent upon success in future clinical trials, approval from the FDA and the collaborator’s efforts. Any consideration related to sales-based royalties will be recognized when the related sales occur as they are constrained, provided that the reported sales are reliably measurable and the Company has no remaining promised goods/services, as such sales were determined to relate predominantly to the license granted to Ultragenyx and therefore have also been excluded from the transaction price.
The transaction price is recognized to revenue on a straight-line basis using an input method over the 4 -year reserve target exclusivity period. The reserve target exclusivity period represents the timing over which promised goods/services will be provided. Total deferred revenue at December 31, 2022 and December 31, 2021 from Ultragenyx was $ 1.8 million and $ 5.5 million, respectively.
CureVac
In January 2018 , the Company entered into a Development and Option Agreement (the “Development and Option Agreement”) with CureVac. Under the terms of the Development and Option Agreement, the parties agreed to conduct joint preclinical development programs once CureVac makes a payment to pull down a target on the basis of which CureVac is granted options for taking a license on pre-agreed license terms to develop and commercialize certain products incorporating the Company’s patents and know-how related to LUNAR ® delivery technology (the “Arcturus Delivery Technology”), and CureVac patents and know-how related to mRNA technology.
F- 17
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
As of December 31, 2022 , the transaction price included the upfront consideration received. The Company recognizes the reimbursement of labor and expenses as costs are incurred and none of the development and commercialization milestones were included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the collaborator’s efforts. Any consideration related to sales-based royalties will be recognized when the related sales occur as they are constrained, provided that the reported sales are reliably measurable and the Company has no remaining promised goods/services, as such sales were determined to relate predominantly to the license granted to CureVac and therefore have also been excluded from the transaction price. As of December 31, 2022 , no adjustments were made to the transaction price.
The upfront consideration of $ 5.0 million was recorded as deferred revenue in the Company’s balance sheet upon receipt and is currently being recognized as revenue on a straight-line basis using an input method over the remaining seven-month contractual term as of December 31, 2022. Total deferred revenue as of December 31, 2022 and December 31, 2021 for CureVac was $ 0.5 million and $ 1.4 million, respectively.
Israeli Ministry of Health
On August 17, 2020, the Company entered into an agreement with the Israeli Ministry of Health (the “MOH”) to supply the Company’s COVID-19 vaccine candidate to Israel (the “Israel Supply Agreement”) subject to certain conditions, including applicable regulatory approvals. In October 2020, and in association with the Israel Supply Agreement, the Company received a non-refundable payment of $ 12.5 million from the MOH. This payment was associated with a specified clinical trial milestone and served as an initial reserve payment for a specified number of doses of the LUNAR-COV19 vaccine candidate pursuant to the Israel Supply Agreement. As a result of making this payment, the MOH became bound to purchase an initial quantity of 500,000 reserved vaccine doses, as set forth in and subject to the terms and conditions of the Israel Supply Agreement. Furthermore, the Israel Supply Agreement permitted termination by the MOH immediately upon written notice to Arcturus if the Company did not obtain certain regulatory approvals by December 31, 2021. On April 14, 2022, Arcturus received notice from the MOH to terminate the Israel Supply Agreement. Therefore, the Company recognized the payment as revenue during the second quarter of 2022 as there were no remaining performance obligations under the agreement. No termination penalties were incurred by the Company connection therewith.
BARDA Grant
In August 2022, the Company entered into a cost reimbursement contract with the Biomedical Advanced Research and Development Authority ("BARDA"), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) for an award of up to $ 63.2 million for the development of a pandemic influenza vaccine using the Company's STARR self-amplifying mRNA vaccine platform technology. The Company earns grant revenue for performing tasks under the agreement.
The Company determined that the agreement with BARDA is not in the scope of ASC 808 or ASC 606. Applying International Accounting Standards No. 20 ("IAS 20"), Accounting for Government Grants and Disclosure of Government Assistance, by analogy, the Company recognizes grant revenue from the reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with the grant. The costs associated with these reimbursements are reflected as a component of research and development expense in the Company’s consolidated statements of operations and comprehensive income (loss).
The Company recognized $ 0.2 million of revenue during the year ended December 31, 2022, which is included in revenue on the Company's consolidated statements of operations. As of December 31, 2022, the remaining available funding net of revenue earned was $ 63.0 million.
NOTE 4. Fair Value Measurements
The Company establishes the fair value of its assets and liabilities using the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company established a fair value hierarchy based on the inputs used to measure fair value.
The three levels of the fair value hierarchy are as follows:
Level 1: Quoted prices in active markets for identical assets or liabilities.
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly.
F- 18
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Level 3: Unobservable inputs in which little or no market data exists and are therefore determined using estimates and assumptions developed by the Company, which reflect those that a market participant would use.
The carrying value of cash, restricted cash, accounts receivable, accounts payable, accrued liabilities and the Singapore loan approximate their respective fair values due to their relative short maturities. The carrying amounts of long-term debt for the amount drawn on the Company’s debt facility approximates fair value as the interest rate is variable and reflects current market rates.
As of December 31, 2022 and 2021 , all assets measured at fair value on a recurring basis consisted of cash equivalents, money market funds, which were classified within Level 1 of the fair value hierarchy. The fair value of these financial instruments was measured based on quoted prices .
NOTE 5. Balance Sheet Details
Accrued liabilities consisted of the following:
December 31,
(in thousands)
2022
2021
Accrued compensation
$
4,038
$
3,578
Cystic Fibrosis Foundation liability
—
2,777
Income tax payable
1,295
—
Current portion of operating lease liability
3,884
1,537
Clinical accruals
4,531
8,675
Vinbiocare contractual liabilities
7,468
—
Other accrued research and development expenses
9,016
6,956
Total
$
30,232
$
23,523
NOTE 6. Property and Equipment, Net
Property and equipment, net consisted of the following:
December 31,
(in thousands)
2022
2021
Research equipment
$
10,251
$
6,735
Computers and software
1,154
488
Office equipment and furniture
958
574
Leasehold improvements
2,491
44
Construction in progress
3,344
2,058
Total
$
18,198
$
9,899
Less accumulated depreciation and amortization
( 5,783
)
( 4,256
)
Property and equipment, net
$
12,415
$
5,643
Depreciation and amortization expense was $ 1.5 million and $ 1.2 million for the years ended December 31, 2022 and 2021, respectively. Construction in progress is primarily comprised of research equipment not yet placed in service.
NOTE 7. Debt
Manufacturing Supply Agreement
On November 7, 2020, the Company’s wholly-owned subsidiary, Arcturus Therapeutics, Inc., entered into a Manufacturing Support Agreement (the “Support Agreement”) with the Economic Development Board of the Republic of Singapore (the “EDB”). Pursuant to the Support Agreement, the EDB agreed to make a term loan (the “Singapore Loan”) of S$ 62.1 million to the Company, subject to the satisfaction of customary deliveries, to support the manufacture of the LUNAR-COV19 vaccine candidate (ARCT-021). The Singapore Loan accrues interest at a rate of 4.5 % per annum calculated on a daily basis. The Company elected to borrow the full amount available under the Support Agreement of S$ 62.1 million ($ 46.6 million) on January 29, 2021. Subsequent to year end, on March 23, 2023, the EDB agreed to an extension of the reconciliation period to March 22, 2023, with unused funds not
F- 19
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
utilized for the manufacture of ARCT-021 as of such date returned to the EDB. On March 27, 2023 the Company paid in full S$ 22.8 million ($ 17.1 million) of the outstanding balance at December 31, 2022 of $ 50.4 million. During March 2023, the Company was forgiven the remaining portion of the Singapore Loan including accrued interest which was approximately $ 33.3 million.
The Singapore Loan was initially recorded as long-term debt at $ 46.6 million, the amount of cash proceeds at the time the Company received the funding. As of December 31, 2022 and 2021, the debt balance including all accrued interest was adjusted to reflect the current exchange rate resulting in debt balances of $ 50.4 and $ 47.9 million, respectively. The Company recorded a net foreign currency translation loss of $ 0.5 million for the year ended December 31, 2022 and a net foreign currency translation gain of $ 0.6 million for the year ended December 31, 2021. The Company also recorded interest expense of $ 2.1 million and $ 1.9 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the Company was in compliance with all covenants under the Singapore Loan and related commitments.
As noted above, the Company no longer has debt or interest related to this agreement as of March 27, 2023.
Debt with Western Alliance Bank
On October 12, 2018, Arcturus Therapeutics, Inc. entered into the Loan with the Bank, whereby it received $ 10.0 million.
The Loan is collateralized by all of the assets of Arcturus Therapeutics, Inc., excluding intellectual property, which is subject to a negative pledge. The Loan contains customary conditions of borrowing, events of default and covenants, including covenants that restrict Arcturus Therapeutics, Inc.’s ability to dispose of assets, merge with or acquire other entities, incur indebtedness and make distributions to holders of its capital stock. In addition, Arcturus Therapeutics, Inc. is required to maintain at least 100 % of its consolidated, unrestricted cash, or $ 15.0 million, whichever is lower, with the Bank.
On October 30, 2019, Arcturus Therapeutics, Inc. and the Bank entered into a Third Amendment (the “Third Amendment”) to the Loan (as amended, the “Loan Agreement”).
Pursuant to the amendment, the Bank agreed to make a term loan to Arcturus Therapeutics, Inc. on October 30, 2019, in the amount of $ 15.0 million (the “Term Loan”). The resulting net increase in the indebtedness of Arcturus Therapeutics, Inc. was $ 5.0 million. The Term Loan bears interest at a floating rate ranging from 1.25 % to 2.75 % above the prime rate. The amendment further provides that the Term Loan has a maturity date of October 30, 2023 . The Loan Agreement was amended such that Arcturus Therapeutics, Inc. made monthly payments of interest only until August 1, 2022.
Upon maturity or prepayment, Arcturus Therapeutics, Inc. will be required to pay a 2 % fee as a result of the FDA’s approval to proceed with the Company’s LUNAR-OTC program based on its IND submission. Such fee is accreted to the long-term debt balance using the effective interest method over the term of the Loan Agreement.
Should an event of default occur, including the occurrence of a material adverse effect, the Company could be liable for immediate repayment of all obligations under the Loan Agreement. As of December 31, 2022, the Company was in compliance with all covenants under the Loan Agreement.
Arcturus Therapeutics, Inc. made principal payments related to the Term Loan of $ 5.0 million during the year ended December 31, 2022. During March 2023, the Loan was terminated and the Company paid in full the remaining principal and interest, including a $ 0.3 million fee payable upon prepayment as a result of prior FDA approval of an IND. See “ Note 13 Subsequent Events ” for further information.
The Company recognized interest expense related to its long-term debt with Western Alliance Bank of $ 0.9 million and $ 0.8 million during the years ended December 31, 2022 and 2021.
NOTE 8. Stockholders’ Equity
Alexion Pharmaceuticals License Agreement
On February 17, 2021, the Company entered into an exclusive license agreement with Alexion Pharmaceuticals, Inc. (“ Alexion ”) pursuant to which Alexion granted to the Company an exclusive, worldwide license to exploit certain specified Alexion patent applications. In accordance with the terms of the license agreement, and in exchange for the license, the Company issued 74,713 shares of its common stock to Alexion on February 19, 2021 valued at approximately $ 5.0 million. The number of shares issued under the agreement was calculated by dividing (i) five million dollars ($5.0 million) by (ii) the volume-weighted average price per share of the Company’s common stock on the Nasdaq Global Market for the thirty (30) trading days immediately preceding the Effective Date (rounded to the nearest whole share). The Company recorded the transaction as an asset purchase
F- 20
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
as management concluded that all of the value received was related to a single identifiable asset. Further, the Company concluded that there was no alternative future use for the asset and recorded a charge at the closing of the transaction for the full $ 5.0 million value assigned to the shares issued in connection with the license agreement. This non-cash charge was recorded as acquired in-process research and development expense in the statements of operations and comprehensive income (loss).
Earnings Per Share
Potentially dilutive securities that were not included in the calculation of diluted earnings per share for the year ended December 31, 2022 as they were anti-dilutive totaled 3.7 million. Potentially dilutive securities that were not included in the calculation of diluted net loss per share for the year ended December 31, 2021 as they were anti-dilutive totaled 1.3 million.
NOTE 9. Share-Based Compensation
In June 2022 at the Company’s 2022 Annual Meeting of Stockholders (the "2022 Annual Meeting"), the stockholders of the Company approved an amendment to the Company’s 2019 Omnibus Equity Incentive Plan (as amended, the “2019 Plan”) which, among other things, increases the aggregate number of shares authorized for use in making awards to eligible persons under the 2019 Plan by 3,750,000 shares, for a total of up to 8,750,000 shares available for issuance. As of December 31, 2022, a total of 1,806,659 shares remain available for future issuance under the 2019 Plan, subject to the terms of the 2019 Plan.
In October 2021, the Company adopted the 2021 Inducement Equity Incentive Plan which covers the award of up to 1,000,000 shares of common stock (the “2021 Plan”) effective as of October 15, 2021. Approval of the Company’s stockholders will not be required as a condition to the effectiveness of the 2021 Plan for so long as the plan is in compliance with Nasdaq inducement plan rules. In April 2022, the compensation committee of the Company’s board of directors approved a proposal to reduce the total number of shares available for future issuance under the 2021 Plan to 130,000 . As of December 31, 2022, a total of 93,142 shares remain available for future issuance under the 2021 Plan, subject to the terms of the 2021 Plan.
Share Options
The following table presents the weighted-average assumptions used in the Black-Scholes valuation model by the Company in calculating the fair value of stock options granted:
For the Year Ended December 31,
2022
2021
Expected life (in years)
6.05
6.03
Expected volatility
82.1
%
73.7
%
Expected dividend yield
—
%
—
%
Risk-free interest rate
2.93
%
1.13
%
Grant date weighted average fair value
$
15.56
$
26.71
The following table summarizes the Company’s stock option activity for the year ended December 31, 2022:
Number of
Shares
Weighted-
Average
Exercise Price
Weighted-
Average
Remaining
Contractual
Term (Years)
Aggregate
Intrinsic Value
(in thousands)
Outstanding – December 31, 2021
4,653,567
$
44.62
8.1 years
$
47,111
Granted
2,980,676
$
22.26
Exercised
( 161,266
)
$
10.72
Forfeited/cancelled
( 850,237
)
$
49.34
Outstanding – December 31, 2022
6,622,740
$
34.78
8.2 years
$
10,721
Exercisable – December 31, 2022
2,573,258
$
36.39
7.1 years
$
9,741
Exercisable and expected to vest –
December 31, 2022
6,622,740
$
34.78
8.2 years
$
10,721
F- 21
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
At December 31, 2022 , the total unrecognized compensation cost of $ 81.8 million will be recognized over the weighted-average remaining service period of approximately 3.0 years. The fair value of the options vested during the years ended December 31, 2022 and 2021 was $ 39.2 million and $ 28.4 million, respectively. The total intrinsic value of options exercised during the years ended December 31, 2022 and 2021 was $ 1.6 million and $ 3.6 million, respectively.
Share-based compensation expenses included in the Company’s statements of operations and comprehensive income (loss) for the years ended December 31, 2022 and 2021 were:
For the Year Ended December 31,
(in thousands)
2022
2021
Research and development
$
14,081
$
14,101
General and administrative
16,530
14,814
Total
$
30,611
$
28,915
NOTE 10. Income Taxes
A reconciliation of income (loss) before income taxes for domestic and foreign locations is as follows:
For the Year Ended December 31,
(In thousands)
2022
2021
United States
$
10,644
$
( 203,674
)
Foreign
—
—
Total income (loss) before income taxes
$
10,644
$
( 203,674
)
A reconciliation of income tax expense for the years ended December 31, 2022 and 2021 is as follows:
For the Year Ended December 31,
2022
2021
Current:
Federal
$
1,121
$
—
State
174
-
Foreign
—
—
Total current income tax expense
$
1,295
$
—
Deferred:
Federal
$
—
$
—
State
—
—
Foreign
—
—
Total deferred income tax expense
—
—
Total income tax expense
$
1,295
$
—
F- 22
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
A reconciliation of the federal statutory income tax rate to the Company’s effective income tax rate is as follows:
For the Year Ended December 31,
2022
2021
Federal statutory income tax rate
21.0
%
21.0
%
State income taxes, net of federal benefit
7.2
%
6.2
%
Stock-based compensation
16.1
%
( 0.4
%)
Officers compensation
21.8
%
( 1.1
%)
Research and development credits
( 40.3
%)
2.9
%
Uncertain tax positions
9.0
%
( 0.4
%)
Change in tax rate
( 12.6
%)
( 1.7
%)
Change in valuation allowance
( 9.4
%)
( 26.7
%)
Other
( 1.0
%)
0.2
%
Permanent differences
0.4
%
—
%
Provision for income taxes
12.2
%
—
%
The significant components of deferred income taxes are as follows:
December 31,
(in thousands)
2022
2021
Deferred tax assets:
Net operating loss
$
47,866
$
69,761
Tax credits
10,460
11,020
Accrued liabilities
1,420
910
Deferred revenue
611
5,098
Inventory
9,016
5,850
Basis difference in equity investments
2,212
1,957
Depreciation and amortization
—
960
Capitalized R&D
19,938
—
Right-of-use lease liability
8,200
1,360
Share-based compensation
7,201
3,971
Total gross deferred tax assets
106,924
100,887
Deferred tax liabilities:
Depreciation and amortization
( 475
)
—
Right-of-use asset
( 7,826
)
( 1,265
)
Total gross deferred tax liabilities
( 8,301
)
( 1,265
)
Valuation allowance
( 98,623
)
( 99,622
)
Net deferred tax asset
$
—
$
—
In assessing the realization of the deferred tax assets, the Company considers whether it is more likely than not that some portion of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences representing net future deductible amounts become deductible. Due to lack of available sources of taxable income, the Company recorded a full valuation allowance against its net deferred tax assets as sufficient uncertainty exists regarding the future realization of these assets. As of December 31, 2022 and 2021, the Company recorded a valuation allowance of $ 98.6 million and $ 99.6 million, respectively. The valuation allowance (decreased)/increased by ($ 1.0 ) million and $ 54.3 million for the years ended December 31, 2022 and 2021, respectively.
At December 31, 2022, the Company has federal and state net operating losses, or NOL, carryforwards of approximately $ 157.1 million and $ 216.5 million, respectively. The federal net operating loss carryover includes $ 156.3 million of net operating losses generated in 2018 and after which can be carried for indefinitely. The Company has $ 0.6 million of state net operating losses that do not expire and the remaining start to expire 2038 .
At December 31, 2022, the Company has federal and state research and development credit carryforwards of approximately $ 6.1 million and $ 5.8 million, respectively. The federal credit carryforwards begin to expire in 2033 ,
F- 23
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
and the state credits carry forward indefinitely. Additionally, the Company has an Orphan Drug Credit of $ 2.3 million as of December 31, 2022 which will begin to expire in 2040 unless previously utilized.
Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the Company’s federal and California net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50 % occurs within a three-year period. The Company has completed an IRC Section 382 analysis through December 31, 2022 regarding the limitation of net operating loss carryforwards and other tax attributes. The Company experienced ownership changes in 2018 and 2020; however, the Company estimates that all tax attributes can be utilized. There is a risk that additional ownership changes may occur in the future. If a change in ownership occurs, the NOL carryforwards and other tax attributes could be limited or restricted.
The company accounts for income taxes in accordance with ASC 740-10, Accounting for Uncertainty in Income Taxes . The impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain tax position will not be recognized if it has less than 50 % likelihood of being sustained.
A reconciliation of unrecognized tax benefits is as follows (in millions):
December 31,
2022
2021
Beginning balance of unrecognized tax benefits
$
2.4
$
1.5
Settlement of prior period tax positions
—
—
Decrease for prior period tax positions
( 0.5
)
( 0.1
)
Increase for current period tax positions
1.0
1.0
Ending balance of unrecognized tax benefits
$
2.9
$
2.4
Amounts in the summary rollforward would no t impact the effective tax rate as the Company maintains a full valuation on its net deferred tax assets. The Company is subject to taxation and files income tax returns in the United States, various U.S. states and foreign jurisdictions. The Company’s tax years from 2014 to date are subject to examination by the U.S., and state taxing authorities due to the carryforward of unutilized net operating losses and research and development credits. The Company’s policy is to recognize interest expense and penalties related to income tax matters as income tax expense. There was no tax related interest or penalties recognized for the years ended December 31, 2022 and 2021.
The Company does not anticipate any material changes to its unrecognized tax benefits within the next twelve months.
NOTE 11. Commitments and Contingencies
Cystic Fibrosis Foundation Therapeutics Funding agreement
On August 1, 2019, the Company amended its Development Program Letter Agreement, dated May 16, 2017 and as amended July 13, 2018, with the Cystic Fibrosis Foundation (“CFF”). Pursuant to the amendment, (i) CFF increased the amount it will award to advance LUNAR-CF to $ 15.0 million from approximately $ 3.2 million, (ii) the Company will provide $ 5.0 million in matching funds for remaining budgeted costs, (iii) the related disbursement schedule from CFF to Arcturus will be modified such that (a) $ 4.0 million will be disbursed upon execution of the CFF Amendment, (b) $ 2.0 million will be disbursed within 30 days of the first day of each of January, April, July and October 2020 upon Arcturus invoicing CFF to meet project goals, and (c) the last payment of $ 3.0 million less the prior award previously paid out, equaling approximately $ 2.1 million. In the first quarter of 2023, the last payment of $ 2.1 million was disbursed upon the Company invoicing CFF to meet good manufacturing practices and opening an Investigational New Drug (“IND”) application. The funds received from CFF are recognized as contra research and development expense. For the years ended December 31, 2022 and 2021, the Company recognized contra expense of $ 5.2 million and $ 3.8 million, respectively. As of December 31, 2022, no accrued liability balance was held by the Company. As of December 31, 2021, $ 2.8 million remained in accrued liabilities.
F- 24
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Leases
In October 2017, the Company entered into a non-cancellable operating lease agreement for office space adjacent to its previously occupied headquarters. The commencement of the lease began in March 2018 and the lease extends for approximately 84 months from the commencement date with a remaining lease term through March 2025. Monthly rental payments are due under the lease and there are escalating rent payments during the term of the lease. The Company is also responsible for its proportional share of operating expenses of the building and common areas. In conjunction with the new lease, the Company received free rent for four months and received a tenant improvement allowance of $ 74,000 . The lease may be extended for one five-year period at the then current market rate with annual escalations ; however, the Company deemed the extension option not reasonably certain to be exercised and therefore excluded the option from the lease terms. The Company entered into an irrevocable standby letter of credit with the landlord for a security deposit of $ 96,000 upon executing the lease which is included (along with additional funds required to secure the letter of credit) in the balance of non-current restricted cash.
In February 2020, the Company entered into a second non-cancellable operating lease agreement for office space near its current headquarters. The lease extended for 13 months from the commencement date and included a right to extend the lease for one twelve-month period. In February 2021, the Company opted to extend the lease through March 2025 to coincide with the lease term of the Company’s headquarters.
In February 2021, the Company entered into a third non-cancellable operating lease agreement for office space near its current headquarters. The lease extends for 12 months from the commencement date with monthly base rent of approximately $ 11,000 . During the third quarter of 2021, the Company opted to extend the lease for an additional 12 months . The lease will expire during the first quarter of 2023 and the Company does not plan to extend the lease.
In September 2021, the Company entered into a fourth non-cancellable lease agreement for office, research and development, engineering and laboratory space near its current headquarters and lease term commenced during the second quarter of 2022. The initial term of the lease will extend ten years and eight months from the date of possession, and the Company will have the right to extend the term of the lease for an additional five-year period . When the lease term was determined for the operating lease right-of-use assets and lease liabilities, the extension option for the lease was not included. The lease has a monthly base rent ranging from $ 268,000 to $ 360,000 which escalates over the lease term. The Company received a free rent period of four months and also pays for various operating costs, including utilities and real property taxes. The Company entered into an irrevocable standby letter of credit with the landlord for a security deposit of $ 2.0 million upon executing the lease which is included (along with additional funds required to secure the letter of credit) in the balance of non-current restricted cash.
Operating lease right-of-use asset and liability on the consolidated balance sheets represent the present value of remaining lease payments over the remaining lease terms. The Company does not allocate lease payments to non-lease components; therefore, payments for common-area-maintenance and administrative services are not included in the operating lease right-of-use asset and liability. The Company uses its incremental borrowing rate to calculate the present value of the lease payments, as the implicit rate in the lease is not readily determinable.
As of December 31, 2022, the payments of the operating lease liability were as follows:
(in thousands)
Remaining Lease
Payments
2023
5,482
2024
5,646
2025
4,019
2026
3,603
Thereafter
23,283
Total remaining lease payments
42,033
Less: imputed interest
( 7,933
)
Total operating lease liabilities
$
34,100
Weighted-average remaining lease term
8.8 years
Weighted-average discount rate
5.0
%
F- 25
Arcturus Therapeutics Holdings Inc. and its Subsidiaries
Notes to Consolidated Financial Statements — Continued
Operating lease costs consist of the fixed lease payments included in operating lease liability and are recorded on a straight-line basis over the lease terms. Operating lease costs were $ 4.7 million and $ 1.9 million for the years ended December 31, 2022 and 2021 , respectively.
Note 12. Related Party Transactions
Equity-Method Investment
In June 2018, the Company completed the sale of its intangible asset related to the ADAIR technology. Pursuant to the asset purchase agreement for ADAIR, the Company received a 30 % ownership interest in the common stock of Vallon Pharmaceuticals, Inc. (“Vallon”) in consideration for the sale of the ADAIR technology. The Company has no requirement to invest further in Vallon. Vallon completed an initial public offering and began trading on The Nasdaq Stock Market under the ticker “VLON” in February 2021. Additionally, Vallon executed the sale of 3,700,000 shares of common stock through a private placement in May 2022 as well as an exercise of warrants for 2,960,000 shares of common stock in August and December 2022. As a result, Arcturus owns 843,750 shares of Vallon, or approximately 6 %. Based on the Company’s ownership and the Vallon board of directors seat held by an executive of Arcturus, the Company has the ability to exercise significant influence over the operating and financial policies of Vallon; therefore, the Company accounts for this investment as an equity-method investment. The Company accounts for its share of the earnings or losses of the investee with a reporting lag of three months, as the financial statements of the investee are not completed on a basis that is sufficient for the Company to apply the equity method on a current basis. Exercise of the aforementioned warrants in August and December of 2022 was at a share price of $ 0.94 , greater than the initial investment of $ 0.70 , resulted in the Company recording a gain in its equity-method investment. As of December 31, 2022, the gain has been fully offset by losses incurred by Vallon.
On December 13, 2022, Vallon entered into an agreement with GRI Bio pursuant to which GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction. Following the closing of the merger, the combined company is expected to operate under the name “GRI Bio, Inc.” and will focus on the development of GRI Bio’s pipeline and trade on the Nasdaq under the ticker symbol “GRI”. The transaction is expected to close in the first quarter of 2023.
See “Note 2, Joint Ventures, Equity Method Investments and Variable Interest Entities” for specific details surrounding the Company’s agreement with Axcelead to form the joint venture entity, Arcalis, Inc.
Note 13. Subsequent Events
Termination of Agreement with Western Alliance Bank
On March 14, 2023, the Loan and Security Agreement, dated as of October 12, 2018 (as amended and supplemented, the “Western Alliance Agreement”) with Western Alliance Bank, an Arizona corporation (“Western Alliance”), was terminated (the “Termination”) upon the receipt by Western Alliance of a payoff amount of approximately $ 7.36 million from the Company. The Western Alliance Agreement provided for a collateralized term loan in the aggregate principal amount of up to $ 15.0 million, with interest at a floating rate ranging from 1.25 % to 2.75 % above the prime rate and a maturity date of October 30, 2023 . The payoff amount was made by the Company to Western Alliance from available cash on hand, pursuant to a payoff letter, and included payment of (i) approximately $ 7.02 million in principal and interest, (ii) $ 300,000 fee payable upon prepayment as a result of prior FDA approval of an IND, (iii) $ 35,000 in prepayment charges and (iv) de minimis amounts for various operational fees. The Company was released from all liens under the Western Alliance Agreement.
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