Arcturus 2026 nine-month revenue falls 69% to $23.3M
Ending the CSL collaboration returned vaccine-portfolio control to Arcturus, while Meiji's Japan arrangements for KOSTAIVE continue through the 2026–2027 season.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Arcturus Therapeutics Holdings Inc. (ARCT) reported third-quarter 2026 revenue of $18.3 million, versus $17.2 million a year earlier, and net loss of $7.4 million versus $13.4 million. For the nine months ended September 30, 2026, revenue was $23.3 million versus $74.8 million and net loss was $58.2 million versus $36.7 million. Cash and cash equivalents were $184.8 million as of September 30, 2026; operating cash use for the nine-month period was $46.3 million, versus $58.0 million.
After ending the CSL Seqirus collaboration on August 3, 2026, Arcturus received $12.0 million and was released from approximately $16.0 million in R&D-credit and repayment obligations, while regaining strategic control of its vaccine portfolio. Meiji arrangements for KOSTAIVE in Japan continue through the Northern Hemisphere 2026–2027 season, expected to end on or around June 30, 2027; future commercialization of certain vaccines carries single-digit royalties and revenue sharing to CSL Seqirus. Arcturus completed its myNEO acquisition on October 15, 2026, for approximately $5.0 million cash and 361,355 shares, with contingent payments up to $20.0 million.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointThird-quarter revenue rose 7% to $18.3 million.
- Moderate pointThird-quarter net loss narrowed to $7.4 million from $13.4 million.
- Moderate pointOperating cash use was $46.3 million, versus $58.0 million.
Negative
- Moderate pointNine-month revenue fell 69% to $23.3 million.
- Moderate pointNine-month net loss widened to $58.2 million from $36.7 million.
Filing Explained
After CSL’s termination, Arcturus bears sole responsibility for vaccine development, manufacturing and commercialization, with no further CSL milestone, research-funding or profit-sharing payments. Thermo Fisher agreed to provide up to
Key Figures
Key Terms
self-amplifying mRNA medical
open-label medical
anti-dilutive financial
performance obligations financial
contract development and manufacturing organization technical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were ARCT's third-quarter 2026 revenue and net loss?
How much cash did ARCT have at September 30, 2026?
What is the ARCT-032 Phase 2 fourth cohort testing?
When does ARCT plan to begin ARCT-2601 dosing?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 3, 2026, the registrant had
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
TABLE OF CONTENTS
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Page |
PART I. |
FINANCIAL INFORMATION |
1 |
Item 1. |
Financial Statements (unaudited) |
1 |
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Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2026 and 2025 |
2 |
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Condensed Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2026 and 2025 |
3 |
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Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 |
4 |
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Notes to Condensed Consolidated Financial Statements |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
14 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
21 |
Item 4. |
Controls and Procedures |
21 |
PART II. |
OTHER INFORMATION |
22 |
Item 1. |
Legal Proceedings |
22 |
Item 1A. |
Risk Factors |
22 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
23 |
Item 3. |
Defaults Upon Senior Securities |
23 |
Item 4. |
Mine Safety Disclosures |
23 |
Item 5. |
Other Information |
23 |
Item 6. |
Exhibits |
24 |
Signatures |
28 |
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i
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q (this “Quarterly Report”), including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and the documents incorporated by reference herein may contain express or implied “forward-looking statements” within the meaning of the federal securities laws, Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth below under Part II, Item 1A, “Risk Factors” in this Quarterly Report. Except as required by law, Arcturus assumes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise. These statements, which represent our current expectations or beliefs concerning various future events, may contain words such as “may,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate” or other words indicating future results, though not all forward-looking statements necessarily contain these identifying words. Such statements may include, but are not limited to, statements concerning the following:
ii
These and other forward-looking statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. In addition, historic results of scientific research, preclinical and clinical trials do not guarantee that future research or trials will suggest the same conclusions, nor that historic results referred to herein will be interpreted in the same manner due to additional research, preclinical and clinical trial results or otherwise. The forward-looking statements contained in this Quarterly Report are subject to risks and uncertainties, including those discussed in our other filings with the United States Securities and Exchange Commission (the “Commission”). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof unless specifically stated otherwise. Although Arcturus currently believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance, or achievements.
iii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
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September 30, |
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December 31, |
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(in thousands, except par value information) |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets, net |
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Non-current restricted cash |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Deferred revenue |
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Total current liabilities |
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Operating lease liabilities, net of current portion |
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Total liabilities |
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Stockholders’ equity |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
1
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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(in thousands, except per share data) |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue: |
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Collaboration revenue |
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$ |
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$ |
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$ |
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$ |
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Grant revenue |
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Total revenue |
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Operating expenses: |
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Research and development, net |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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Finance income, net |
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Other expense |
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( |
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( |
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( |
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( |
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Loss before income taxes |
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( |
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( |
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( |
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( |
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Provision for income taxes |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted-average shares outstanding, basic and diluted |
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Comprehensive loss: |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Comprehensive loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
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Additional |
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Total |
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Common Stock |
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Paid-In |
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Accumulated |
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Stockholders’ |
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(in thousands) |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance – December 31, 2025 |
|
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$ |
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$ |
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$ |
( |
) |
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$ |
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||||
Net loss |
|
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— |
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— |
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— |
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( |
) |
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( |
) |
Share-based compensation expense |
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— |
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— |
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— |
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Issuance of common stock upon exercise of stock options |
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— |
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— |
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Balance – March 31, 2026 |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Net loss |
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— |
|
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— |
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— |
|
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( |
) |
|
|
( |
) |
Share-based compensation expense |
|
|
— |
|
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— |
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|
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|
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— |
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||
Balance – June 30, 2026 |
|
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|
$ |
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$ |
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$ |
( |
) |
|
$ |
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||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
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||
Issuance of common stock upon exercise of stock options |
|
|
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— |
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— |
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|||
Issuance of common stock under equity plans |
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— |
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— |
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|||
Balance – September 30, 2026 |
|
|
|
|
$ |
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$ |
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$ |
( |
) |
|
$ |
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||||
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Additional |
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Total |
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|||||
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Common Stock |
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Paid-In |
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Accumulated |
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Stockholders’ |
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(in thousands) |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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|||||
Balance – December 31, 2024 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
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|
||
Issuance of common stock upon exercise of stock options |
|
|
|
|
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— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Balance – March 31, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Balance – June 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Share-based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
|
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|
||
Issuance of common stock upon exercise of stock options |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
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|
|||
Issuance of common stock under equity plans |
|
|
|
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
|||
Balance – September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
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Nine Months Ended September 30, |
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|||||
(in thousands) |
|
2026 |
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2025 |
|
||
Operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Share-based compensation expense |
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Gain on sale of equipment |
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( |
) |
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Foreign currency transaction (gain) loss |
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( |
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Loss on disposal of property and equipment |
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Changes in assets and liabilities: |
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Accounts receivable |
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( |
) |
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Prepaid expense and other assets |
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Right-of-use assets |
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Accounts payable |
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( |
) |
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Accrued liabilities |
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( |
) |
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( |
) |
Deferred revenue |
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( |
) |
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( |
) |
Lease liabilities |
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( |
) |
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( |
) |
Net cash used in operating activities |
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( |
) |
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( |
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Investing activities |
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Acquisition of property and equipment |
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( |
) |
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( |
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Proceeds from sale of equipment |
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Net cash used in investing activities |
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( |
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Financing activities |
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Proceeds from exercise of stock options |
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Proceeds from the issuance of common stock under equity plans |
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Proceeds from debt |
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Payments on debt obligations |
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( |
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Net cash provided by financing activities |
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Net decrease in cash, cash equivalents and restricted cash |
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( |
) |
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( |
) |
Cash, cash equivalents and restricted cash at beginning of the period |
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Cash, cash equivalents and restricted cash at end of the period |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ARCTURUS THERAPEUTICS HOLDINGS INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1. Description of Business, Basis of Presentation and Summary of Significant Accounting Policies
Description of Business
Arcturus Therapeutics Holdings Inc. (the “Company” or "Arcturus") is a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics. Arcturus became a clinical stage company in 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-COVID were approved by applicable health authorities. In 2023, our COVID-19 vaccine, ARCT-154 (also referred to as KOSTAIVE®), received marketing authorization approval in Japan for
Basis of Presentation
The accompanying condensed consolidated financial statements include the accounts of Arcturus and its subsidiaries and are unaudited. All intercompany accounts and transactions have been eliminated in consolidation. These condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results for the interim periods presented.
Interim financial results are not necessarily indicative of results anticipated for the full year. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
These condensed consolidated financial statements are prepared in accordance with GAAP, which requires management to make estimates and assumptions regarding the valuation of equity instruments, share-based compensation, accruals for liabilities, income taxes, revenue and deferred revenue, leases, 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 periods. Although these estimates are based on management’s knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions.
There were no significant changes to our significant accounting policies as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
Recently Issued Accounting Standards Not Yet Adopted
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“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 condensed consolidated financial statements and disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement–Reporting Comprehensive Income–Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public entities to disclose specified information about certain costs and expenses on an interim and annual basis. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that adoption of ASU 2024-03 will have on the financial statement disclosures.
5
Note 2. 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, product revenue and government grant 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, technology transfer milestones or success-based 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 during the nine months ended September 30, 2026 in the balances of contract assets and liabilities as compared to what was disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.
(in thousands) |
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December 31, 2025 |
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Additions |
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Deductions |
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September 30, 2026 |
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Contract Assets: |
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Accounts receivable |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Contract Liabilities: |
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Deferred revenue |
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$ |
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$ |
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$ |
( |
) |
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$ |
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The following table summarizes the Company’s revenues for the periods indicated.
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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(in thousands) |
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2026 |
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2025 |
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2026 |
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2025 |
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Collaboration Revenue: |
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CSL Seqirus |
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$ |
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$ |
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$ |
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$ |
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Other collaboration revenue |
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Total collaboration revenue |
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$ |
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$ |
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$ |
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$ |
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Grant revenue: |
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BARDA |
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$ |
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$ |
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$ |
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$ |
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Gates Foundation |
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Total grant revenue |
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$ |
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$ |
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$ |
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$ |
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The following paragraphs provide information regarding the nature and purpose of the Company’s most significant collaboration and grant arrangements.
6
CSL Seqirus
On November 1, 2022, the Company entered into a Collaboration and License Agreement (as amended, the “CSL Collaboration Agreement”) with Seqirus, Inc., a part of CSL Limited (“CSL Seqirus”). Under the CSL Collaboration Agreement, the Company granted CSL Seqirus an exclusive global license to its mRNA technology (including STARR®) and LUNAR® lipid-mediated delivery, along with mRNA drug substance and drug product manufacturing processes. The Company received a $
Termination Agreement
On August 3, 2026, the Company entered into a Termination and Settlement Agreement (the "Termination Agreement") with CSL Seqirus, under which the parties mutually terminated the CSL Collaboration Agreement, effective as of that date, except for certain provisions that continue to apply solely to the commercialization of KOSTAIVE® in Japan by Meiji through the Northern Hemisphere 2026–2027 season. Under the Termination Agreement, the Company received a one-time cash payment of $
Upon termination, the Company was released from its remaining obligation to perform research and development services funded through the R&D credit. As a result, the Company had no remaining performance obligations under the CSL Collaboration Agreement. Transition activities under the Termination Agreement are mutual and administrative in nature and do not represent promised goods or services to CSL Seqirus. Accordingly, during the three months ended September 30, 2026, the Company recognized the remaining deferred revenue balance of $
The $
Total revenue recognized under the CSL Collaboration Agreement was $
As a result of the termination, the Company regained strategic control of its vaccine portfolio. This includes KOSTAIVE® and its vaccine programs for seasonal influenza, pandemic influenza, respiratory syncytial virus ("RSV"), and Epstein-Barr virus ("EBV"). This control is subject to ongoing arrangements with Meiji Seika Pharma ("Meiji") for the Northern Hemisphere 2026–2027 season, which is expected to end on or around June 30, 2027. Beginning with the Northern Hemisphere 2027–2028 season, the Company expects to work directly with Meiji for KOSTAIVE® activities in Japan.
Under the Termination Agreement, certain provisions of the CSL Collaboration Agreement survive solely to allow CSL Seqirus to continue to supply and commercialize KOSTAIVE® in Japan through Meiji for the Northern Hemisphere 2026–2027 season, after which the CSL Collaboration Agreement will terminate in its entirety. CSL Seqirus retained its existing economic rights with respect to KOSTAIVE® sales for that season. In addition, under the Termination Agreement, the Company is obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement, and on successor products, where certain CSL Seqirus intellectual property is incorporated into those products. These payments are subject to agreed terms and conditions and applicable time limitations. For certain of the vaccine products, the Company is also obligated to pay CSL Seqirus a percentage of upfront payments received from future licensees, up to pre-agreed amounts.
BARDA
In August 2022, the Company entered into a cost reimbursement contract (the “BARDA 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 $
7
The Company determined that the BARDA Contract 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 condensed consolidated statements of operations and comprehensive loss.
As of September 30, 2026, the remaining available funding net of revenue earned was $
Gates Foundation
The Company recognized grant revenue related to cost reimbursement under two grants awarded by the Gates Foundation.
The grants support development of (i) a therapeutic HPV vaccine candidate and (ii) durability assessments of self-amplifying mRNA COVID-19 vaccine platforms. Grant funding is conditional upon achievement of defined milestones and submission of periodic progress and financial reports. Revenue is recognized when qualifying costs, including employee full-time equivalent (“FTE”) labor and related expenses, are incurred in accordance with the terms of each agreement.
Amounts received in advance are recorded as deferred revenue until the related qualifying costs are incurred. As of September 30, 2026, deferred grant revenue related to these agreements totaled $
Note 3. 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.
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 and accrued liabilities approximate their respective fair values due to their relatively short maturities.
Note 4. Other Balance Sheet Details
Property and equipment, net balances consisted of the following:
(in thousands) |
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September 30, 2026 |
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December 31, 2025 |
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Research equipment |
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$ |
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$ |
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Computers and software |
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Office equipment and furniture |
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Leasehold improvements |
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Total |
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Less accumulated depreciation and amortization |
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( |
) |
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( |
) |
Property and equipment, net |
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$ |
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$ |
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Depreciation and amortization expense was $
8
Accrued liabilities consisted of the following:
(in thousands) |
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September 30, 2026 |
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December 31, 2025 |
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Accrued compensation |
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$ |
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$ |
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Cystic Fibrosis Foundation liability |
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Current portion of |
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Accrued facilities costs |
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Clinical trial accruals |
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Legal accrual |
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Other accrued research and development expenses |
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Total |
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$ |
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$ |
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The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the unaudited condensed consolidated balance sheets that sum to the total of the same such amounts shown in the unaudited condensed consolidated statement of cash flows:
(in thousands) |
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September 30, 2026 |
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September 30, 2025 |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash |
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Non-current restricted cash |
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Total cash, cash equivalents and restricted cash |
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$ |
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$ |
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Restricted cash includes cash required to be set aside as security for lease payments and to maintain a letter of credit for the benefit of the landlord of the Company’s offices. As of September 30, 2026 and 2025, the Company had restricted cash of $
Note 5. Stockholders’ Equity
Net Loss per Share
Potentially dilutive securities that were not included in the calculation of diluted net loss per share as they were anti-dilutive totaled
Sales Agreement
On December 23, 2022, the Company entered into a Controlled Equity Offering℠ Sales Agreement, which was amended on August 7, 2023 (as amended, the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”), Wells Fargo Securities, LLC (“Wells Fargo Securities”), and William Blair & Company, L.L.C. (“William Blair”) relating to shares of the Company's common stock. In accordance with the terms of the Sales Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $
During the three months ended December 31, 2025, the Company sold
9
Note 6. Share-Based Compensation Expense
In June 2024 at the Company’s 2024 Annual Meeting of Stockholders (the "2024 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, increased the aggregate number of shares authorized for use in making awards to eligible persons under the 2019 Plan by
In October 2021, the Company adopted the 2021 Inducement Equity Incentive Plan which covers the award of up to
Share-Based Compensation
Share-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive loss was as follows:
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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(in thousands) |
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2026 |
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2025 |
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2026 |
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2025 |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Total |
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$ |
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$ |
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$ |
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$ |
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Note 7. Income Taxes
The Company is subject to taxation in the United States and various states. The Company computes its quarterly income tax provision by using a forecasted annual effective tax rate and adjusts for any discrete items arising during the quarter. The primary difference between the effective tax rate and the federal statutory rate is due to federal and state income tax expense offset by a valuation allowance on the Company’s deferred tax assets.
The Company recorded negligible income tax expense for the three and nine months ended September 30, 2026 and 2025. No tax benefit was recorded for losses incurred in the United States, as such losses are offset by a full valuation allowance.
Note 8. Commitments and Contingencies
Cystic Fibrosis Foundation Agreement
On September 25, 2023, the Company amended its Development Program Letter Agreement, dated May 16, 2017 and as amended July 13, 2018 and August 1, 2019, with the Cystic Fibrosis Foundation (“CFF”). Pursuant to the amendment, (i) CFF increased the amount it will award to advance LUNAR-CF to $
Thermo Fisher Agreement
In June 2026, the Company entered into a series of agreements with Thermo Fisher Scientific Inc. (“Thermo Fisher”) and certain of Thermo Fisher’s affiliates to establish a strategic collaboration for the provision of contract development and manufacturing organization (“CDMO”) and contract research organization (“CRO”) services in connection with the development of ARCT-032, the Company's investigational mRNA therapeutic for cystic fibrosis (“CF”). Under the agreement, Thermo Fisher has agreed to provide qualifying clinical manufacturing services with an aggregate value of up to $
10
ARCT-032 into Phase 3 clinical development, the Company has agreed to engage Thermo Fisher's affiliate, PPD, Inc. (“PPD”), to perform qualifying CRO services for an aggregate value of up to $
The agreement also contemplates that, following regulatory approval of ARCT-032 and subject to execution of a future commercial supply agreement and Thermo Fisher's continued ability to manufacture ARCT-032 in compliance with applicable regulatory requirements, Thermo Fisher would receive certain exclusive commercial manufacturing rights. As of September 30, 2026,
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 extended for approximately
In December 2025, the Company vacated this office space with no intention of operating out of the location in the future. The Company remains obligated to make the remaining lease payments through March 2027. An impairment loss of $
In September 2021, the Company entered into a non-cancellable lease agreement for office, research and development, engineering and laboratory space near its prior headquarters, and such lease term commenced during the second quarter of 2022. The initial term of this lease extends
Operating lease right-of-use assets and liabilities 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 assets and liabilities. 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 September 30, 2026, the remaining payments of the operating lease liabilities were as follows:
(in thousands) |
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Remaining Lease Payments |
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2026 (remainder of year) |
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2027 |
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2028 |
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2029 |
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2030 |
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Thereafter |
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Total remaining lease payments |
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Less: imputed interest |
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( |
) |
Total operating lease liabilities |
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$ |
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Weighted-average remaining lease term |
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Weighted-average discount rate |
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% |
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Operating lease costs consist of the fixed lease payments included in operating lease liabilities and are recorded on a straight-line basis over the lease terms. Operating lease costs were $
11
Note 9. Segment Information
The Company operates in
The following table presents information about reported segment revenues, segment loss, and significant segment expenses:
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For the Three Months Ended September 30, |
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For the Nine Months Ended September 30, |
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(in thousands) |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenues |
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$ |
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$ |
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$ |
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$ |
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Less: |
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Research and development: |
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LUNAR-COVID |
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LUNAR-OTC |
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BARDA |
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LUNAR-CF, net |
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Early-stage programs |
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Discovery technologies |
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Payroll and benefits |
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Facilities and equipment |
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Total research and development |
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General and administrative |
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Other (1) |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
) |
(1)
Note 10. Related Party Transactions
Equity-method Investment - ARCALIS, Inc.
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 the Company's joint venture in ARCALIS, Inc. with Axcelead, Inc. 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 loss. As of September 30, 2026, the carrying value of the equity-method investment in ARCALIS remained at
Note 11. Subsequent Events
Acquisition of myNEO
On October 15, 2026, the Company, through its wholly owned subsidiary, Arcturus Therapeutics Europe B.V., completed the acquisition of all of the outstanding securities of myNeo BV (“myNEO”), a Belgium-based biotechnology company, including its proprietary artificial intelligence-based computational discovery platform and related intellectual property and technology. The Company acquired myNEO to strengthen its artificial intelligence infrastructure, improve mRNA design quality and enhance target identification capabilities.
At closing, the Company paid approximately $
As the acquisition was completed subsequent to September 30, 2026, the Company is in the process of assessing the accounting treatment of the acquisition as a business combination versus an asset acquisition and evaluating the significance of the acquisition under applicable SEC rules. The Company will provide additional disclosures regarding the acquisition, including the acquisition-date fair value of the consideration transferred, the amounts recognized for the major classes of assets acquired and liabilities assumed,
12
goodwill, if any, the total amount of acquisition-related costs, and, if required, supplemental pro forma revenue and earnings information, in the Company's Annual Report on Form 10-K for the year ending December 31, 2026.
13
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following is a discussion of the financial condition and results of operations of Arcturus Therapeutics Holdings Inc. for the three and nine months ended September 30, 2026. Unless otherwise specified herein, references to the “Company,” “Arcturus,” “we,” “our” and “us” mean Arcturus Therapeutics Holdings Inc. and its consolidated subsidiaries. You should read the following discussion and analysis together with the interim condensed consolidated financial statements and related notes included elsewhere herein. For additional information relating to our management’s discussion and analysis of financial conditions and results of operations, please see our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”), which was filed with the U.S. Securities and Exchange Commission (the “Commission”) on March 3, 2026. Unless otherwise defined herein, capitalized words and expressions used herein shall have the same meanings ascribed to them in the 2025 Annual Report.
This report includes forward-looking statements which, although based on assumptions that we consider reasonable, are subject to risks and uncertainties which could cause actual events or conditions to differ materially from those currently anticipated and expressed or implied by such forward-looking statements. This report also includes certain statements based solely on information, reports and studies provided by or conducted by Seqirus, Inc. and Meiji Seika Pharma Co., Ltd. or their respective affiliates.
You should read this report and the documents that we reference in this report and have filed as exhibits to this report completely and with the understanding that our actual future results may be materially different from what we expect. You should also review the factors and risks we describe in the reports we will file or submit from time to time with the Commission after the date of this report.
Overview
We are a messenger RNA medicines company focused on the development of liver and respiratory therapeutics. We have ongoing Phase 2 clinical studies for our RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF).
We developed the world’s first approved self-amplifying messenger RNA (sa-mRNA) vaccine, KOSTAIVE® (“KOSTAIVE”). KOSTAIVE has achieved approval in Japan, the European Union and the United Kingdom as a vaccine against COVID-19, and sales of KOSTAIVE began in Japan in October 2024.
We have several key platform technologies that we leverage to develop and advance a pipeline of mRNA-based therapeutics for rare genetic disorders with significant unmet medical needs and vaccines for infectious diseases. Current mRNA medicines have two critical components: the messenger RNA (“mRNA”) constructs and the lipid nanoparticles (“LNP”) which help deliver the mRNA to disease-relevant target tissues. We have extensive expertise in the design and optimization of mRNA constructs, including with respect to a type of mRNA technology known as self-amplifying mRNA (sa-mRNA). Our proprietary self-amplifying mRNA technology platform, or STARR® (“STARR”), has been demonstrated to induce a robust, longer-lasting and broader humoral immune response at lower dose levels than conventional mRNA-based vaccines. Our proprietary LNP delivery system, LUNAR® (“LUNAR”), is intended to address the major hurdle in RNA drug development, namely the effective and safe delivery of RNA to disease-relevant target tissues. LUNAR may enable multiple nucleic acid medicines. We also have significant expertise and valuable know-how in the development and scalability of complex and robust manufacturing processes required to deliver the next generation of nucleic acid medicines.
Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, following termination of the CSL Collaboration Agreement, we regained strategic control of KOSTAIVE® and our broader vaccine portfolio, subject to ongoing arrangements with Meiji in Japan for the Northern Hemisphere 2026-2027 season.
Business Updates
Key Updates on Arcturus-Owned mRNA Therapeutic Development Candidates
14
The ongoing Phase 2 clinical trial (NCT06747858) is an open-label, multiple ascending dose study to assess safety and efficacy of ARCT-032 in CF adults who do not benefit from current CFTR modulators, including those with Class I null mutations. The study initiated dosing in the U.S. in December 2024 and enrollment and dosing have completed for the initial three cohorts. Each participant received daily inhaled treatments of ARCT-032 at doses of 5 mg, 10 mg, or 15 mg for 28 days.
The treatment was generally safe and well tolerated. Bronchospasm was not reported in these participants, either with or without pretreatment with a bronchodilator. Treatment-related AEs that were identified in the single-dose Phase 1 study were also observed in some participants for the first few doses but ceased with continued dosing. Two subjects experienced SAEs after the dosing period that were unrelated to ARCT-032, and the safety review committee approved the study to proceed. After amending the protocol, a fourth cohort of up to 20 subjects began enrolling in March 2026 and continues to advance with active screening and enrollment in the United States, Israel and Turkey. Enrollment has accelerated due to increased site activations in Israel and Turkey and is expected to be completed by year-end 2026. The fourth cohort was initiated with 10 mg administered once daily via inhalation over a 12-week period to better assess longer term safety, tolerability, and early evidence of clinical efficacy.
We have completed enrollment in the open-label multiple ascending dose Phase 2 study of ARCT-810 and all enrolled participants have completed study drug dosing. The study evaluates safety and pharmacodynamics in adults and adolescents requiring clinical management for OTC deficiency. In September 2026, we presented interim results from the U.S. Phase 2 study, in which eight participants were enrolled across the 0.3 mg/kg and 0.5 mg/kg dose cohorts.
In the Phase 2 study to date, ARCT-810 has generally been safe and well tolerated, with no serious adverse events reported. Most treatment-emergent adverse events were mild to moderate in severity; two participants experienced Grade 3 non-serious asymptomatic transaminitis events, which resolved after stopping study drug, and one participant discontinued after a single dose due to a non-serious adverse event. Study results demonstrated reductions in and/or maintenance of first-morning fasting ammonia levels within the normal range, including during periods of increased dietary protein intake. Treatment with ARCT-810 also reduced glutamine levels, with participants receiving the 0.5 mg/kg dose achieving mean glutamine concentrations within the normal range during treatment. In addition, weight gain was observed in all participants. These results are interim and based on a small number of participants in an open-label study and may not be predictive of final results.
ARCT-2601 is our next-generation investigational mRNA therapeutic candidate for the treatment of OTC deficiency. To date, ARCT-2601 has demonstrated a safety profile similar to ARCT-810 in non-GLP preclinical studies. Following a Type C meeting with the FDA in June 2026, we received feedback regarding the regulatory pathway for ARCT-2601. Based on available data and FDA feedback, we plan to initiate dosing of ARCT-2601 in participants with OTC deficiency aged 12 years and older in Q1 2027 under an amended Phase 2 protocol that is expected to incorporate ARCT-2601 into the ongoing ARCT-810 Phase 2 study. Based on non-human primate data, ARCT-2601 may offer the potential for lower and/or less frequent dosing compared to ARCT-810.
LUNAR 2.0™
In September 2026, we announced LUNAR 2.0™, the Company’s next-generation mRNA delivery technology that incorporates improved lipids and an enhanced formulation process specific to these lipids. In non-human primates (NHPs), LUNAR 2.0™ demonstrated a 40-fold improvement compared to LUNAR 1.0 in expressing human erythropoietin (hEPO). In a separate NHP study, LUNAR 2.0™ exhibited 38-fold more potency than ATX-95, the key lipid in ARCT-810, in expressing human ornithine transcarbamylase (hOTC). We have expanded our mRNA therapeutics pipeline to include programs targeting phenylketonuria (PKU) and gout using the LUNAR 2.0™ platform. These preclinical results may not be replicated in humans. ARCT-2601 uses the LUNAR 2.0™ platform and modification to the mRNA chemistry. In a preclinical model of OTC deficiency in mice, ARCT-2601 achieved 100% survival through Day 45 across all evaluated dosing regimens (weekly, bi-weekly, monthly) compared with approximately 33% survival for ARCT-810 at the same dose weekly (only regimen evaluated for ARCT-810).
myNEO Agreement
On September 21, 2026, we entered into a definitive agreement to acquire myNeo BV (“myNEO”), a Belgium-based artificial intelligence discovery company with which we have collaborated since 2024. The transaction closed on October 15, 2026. Through the acquisition, we obtained myNEO’s computational engine and related proprietary intellectual property, which we intend to use to enhance our mRNA design and target identification capabilities in antigen design, mRNA optimization and target identification, including to support pipeline development and expand strategic opportunities in oncology. The consideration consists of a base
15
purchase price of $10.0 million, subject to customary adjustments, payable in a combination of cash and an aggregate of 361,355 unregistered shares of our common stock with a number of shares and an amount of cash held in escrow, plus contingent milestone and collaboration payments of up to an aggregate of $20.0 million, a portion of which may be paid in shares of our common stock at our election. See Note 11 to our condensed consolidated financial statements for additional information.
Termination of Vaccine Collaboration with CSL Seqirus
On August 3, 2026, the Company entered into the Termination Agreement with CSL Seqirus pursuant to which the Company and CSL Seqirus mutually terminated the CSL Collaboration Agreement, effective as of such date. Under the Termination Agreement, the Company received a one-time cash payment of $12.0 million from CSL Seqirus. In addition, the Company was released from an R&D credit and from repayment of unspent development payments with an aggregate value of approximately $16.0 million.
As a result of the termination, the Company regained strategic control of its vaccine portfolio, including KOSTAIVE® and its vaccine programs for seasonal influenza, pandemic influenza, respiratory syncytial virus (“RSV”) and Epstein-Barr virus (“EBV”), subject to ongoing arrangements with Meiji Seika Pharma (“Meiji”) for the Northern Hemisphere 2026-2027 season, which is expected to end on or around June 30, 2027. Beginning with the Northern Hemisphere 2027–2028 season, the Company expects to work directly with Meiji for KOSTAIVE® activities in Japan.
We are obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on our future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement and successor products, where certain CSL Seqirus intellectual property is incorporated into such products, subject to agreed terms and conditions and applicable time limitations. With respect to certain of the vaccine products, we are obligated to pay a percentage of upfront payments received from future licensees up to pre-agreed amounts.
As a result of the termination, we recognized revenue of approximately $16.8 million during the third quarter of 2026.
KOSTAIVE®
Meiji launched in Japan the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC in August 2025. In June 2026, Meiji filed a Partial Change Application for KOSTAIVE updated for the NB.1.8.1 variant in a two-dose vial with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to support commercialization for the 2026-2027 season in Japan. The application was approved on August 25, 2026, and commercial sales of KOSTAIVE in Japan are ongoing for the 2026-2027 season.
In the EU and UK, the Marketing Authorization Holders (MAHs) for KOSTAIVE were successfully transferred from CSL Seqirus to Arcturus in September and October 2026, respectively, in preparation for KOSTAIVE commercial activities in 2027.
Publications
In September 2026, we published the manuscript 'Extended dosing intervals enhance the durability of a self-amplifying mRNA vaccine against pandemic H5N1 influenza: a randomized, observer-blind, dose-finding Phase I study' in Nature Communications (https://doi.org/10.1038/s41467-026-78031-9). The manuscript summarizes results from a Phase 1 study (NCT06602531) of ARCT-2304, a bicistronic self-amplifying mRNA vaccine against H5N1 influenza, in 212 healthy adults. Participants received two doses of 1.5 µg, 5 µg or 12 µg, given either four or eight weeks apart. The study concluded that the longer dosing interval enhanced the durability of the immune response, and the results support a potential role for self-amplifying mRNA platforms in protecting against pandemic influenza.
Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Report and our audited financial statements and related notes for the year ended December 31, 2025. Our historical results of operations and the year-to-year comparisons of our results of operations that follow are not necessarily indicative of future results.
16
Revenue
We enter into arrangements with pharmaceutical and biotechnology partners and government agencies that may contain upfront payments, license fees for research and development arrangements, research and development funding, milestone payments, option exercise and exclusivity fees and royalties on future sales. The following table summarizes our total revenues for the periods indicated:
|
|
Three Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
||||
Collaboration revenue |
|
$ |
16,852 |
|
|
$ |
14,153 |
|
|
$ |
2,699 |
|
|
|
19 |
% |
Grant revenue |
|
|
1,445 |
|
|
|
2,998 |
|
|
|
(1,553 |
) |
|
|
-52 |
% |
Total |
|
$ |
18,297 |
|
|
$ |
17,151 |
|
|
$ |
1,146 |
|
|
|
7 |
% |
Revenue increased by $1.1 million during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. Collaboration revenue increased $2.7 million, primarily driven by the termination of the CSL Collaboration Agreement on August 3, 2026, upon which we recognized the $12.0 million termination payment and the remaining deferred revenue under the agreement, resulting in total CSL revenue of $16.8 million for the three months ended September 30, 2026. The increase was partially offset by a $1.6 million decrease in grant revenue, primarily related to our agreements with BARDA and the Gates Foundation.
|
|
Nine Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
||||
Collaboration revenue |
|
$ |
18,342 |
|
|
$ |
64,140 |
|
|
$ |
(45,798 |
) |
|
|
-71 |
% |
Grant revenue |
|
|
4,975 |
|
|
|
10,695 |
|
|
|
(5,720 |
) |
|
|
-53 |
% |
Total |
|
$ |
23,317 |
|
|
$ |
74,835 |
|
|
$ |
(51,518 |
) |
|
|
-69 |
% |
Revenue decreased by $51.5 million during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. Collaboration revenue decreased $45.8 million, primarily due to lower revenue recognized under the CSL Collaboration Agreement prior to its termination, partially offset by the recognition of the $12.0 million termination payment and the remaining deferred revenue upon termination of the CSL Collaboration Agreement on August 3, 2026. Grant revenue decreased $5.7 million, primarily related to our agreement with BARDA, partially offset by increased grant revenue from the Gates Foundation.
Operating Expenses
Our operating expenses consist of research and development and general and administrative expenses.
|
|
Three Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
|
Nine Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
||||||||||||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development, net |
|
$ |
16,998 |
|
|
$ |
23,265 |
|
|
$ |
(6,267 |
) |
|
|
-27 |
% |
|
$ |
56,040 |
|
|
$ |
87,736 |
|
|
$ |
(31,696 |
) |
|
|
-36 |
% |
General and administrative |
|
|
10,484 |
|
|
|
10,398 |
|
|
|
86 |
|
|
|
1 |
% |
|
|
30,938 |
|
|
|
32,052 |
|
|
|
(1,114 |
) |
|
|
-3 |
% |
Total |
|
$ |
27,482 |
|
|
$ |
33,663 |
|
|
$ |
(6,181 |
) |
|
|
-18 |
% |
|
$ |
86,978 |
|
|
$ |
119,788 |
|
|
$ |
(32,810 |
) |
|
|
-27 |
% |
Research and Development Expenses, net
17
The following table presents our total research and development expenses by category:
|
|
Three Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
|
Nine Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
||||||||||||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
||||||||
LUNAR-COVID |
|
$ |
1,115 |
|
|
$ |
3,890 |
|
|
$ |
(2,775 |
) |
|
|
-71 |
% |
|
$ |
2,108 |
|
|
$ |
13,530 |
|
|
$ |
(11,422 |
) |
|
|
-84 |
% |
LUNAR-OTC |
|
|
3,073 |
|
|
|
780 |
|
|
|
2,293 |
|
|
* |
|
|
|
7,661 |
|
|
|
5,257 |
|
|
|
2,404 |
|
|
|
46 |
% |
|
BARDA |
|
|
- |
|
|
|
1,043 |
|
|
|
(1,043 |
) |
|
|
-100 |
% |
|
|
966 |
|
|
|
5,983 |
|
|
|
(5,017 |
) |
|
|
-84 |
% |
LUNAR-CF, net |
|
|
2,042 |
|
|
|
3,210 |
|
|
|
(1,168 |
) |
|
|
-36 |
% |
|
|
11,166 |
|
|
|
14,987 |
|
|
|
(3,821 |
) |
|
|
-25 |
% |
Early-stage programs |
|
|
- |
|
|
|
370 |
|
|
|
(370 |
) |
|
|
-100 |
% |
|
|
335 |
|
|
|
536 |
|
|
|
(201 |
) |
|
|
-38 |
% |
Discovery technologies |
|
|
1,747 |
|
|
|
1,720 |
|
|
|
27 |
|
|
|
2 |
% |
|
|
4,842 |
|
|
|
6,346 |
|
|
|
(1,504 |
) |
|
|
-24 |
% |
Payroll and benefits |
|
|
7,345 |
|
|
|
9,693 |
|
|
|
(2,348 |
) |
|
|
-24 |
% |
|
|
23,695 |
|
|
|
33,347 |
|
|
|
(9,652 |
) |
|
|
-29 |
% |
Facilities and equipment |
|
|
1,676 |
|
|
|
2,559 |
|
|
|
(883 |
) |
|
|
-35 |
% |
|
|
5,267 |
|
|
|
7,750 |
|
|
|
(2,483 |
) |
|
|
-32 |
% |
Total research and development expenses, net |
|
$ |
16,998 |
|
|
$ |
23,265 |
|
|
$ |
(6,267 |
) |
|
|
-27 |
% |
|
$ |
56,040 |
|
|
$ |
87,736 |
|
|
$ |
(31,696 |
) |
|
|
-36 |
% |
* Greater than 100%
Research and development expenses were $17.0 million for the three months ended September 30, 2026, compared with $23.3 million for the three months ended September 30, 2025, and $56.0 million for the nine months ended September 30, 2026, compared with $87.7 million for the nine months ended September 30, 2025. The decreases for both periods were primarily driven by lower clinical trial expenses associated with the LUNAR-COVID and BARDA programs and lower manufacturing costs related to the LUNAR-COVID program. Additional decreases for both periods were attributable to lower payroll and benefits costs associated with a reduction in headcount and lower share-based compensation expense, as well as lower facilities costs.
Early-stage programs represent programs that are in the preclinical or Phase 1 clinical stage and may be partnered or unpartnered. Early-stage programs include our Phase 1 clinical stage LUNAR-FLU program which was formerly partnered with CSL Seqirus. Discovery technologies represent our efforts to expand our product pipeline and are primarily related to pre-partnered studies and new capabilities. The related expenses were partially offset with funds that have been reimbursed or awarded to us and consist of external manufacturing costs, lab supplies, equipment, and consulting and professional fees. Expenses for both early-stage programs and discovery technologies are expected to increase slightly over the next twelve months as we continue to advance both our early- and later-stage programs.
General and Administrative Expenses
General and administrative expenses were $10.5 million for the three months ended September 30, 2026, compared with $10.4 million for the three months ended September 30, 2025. The slight increase was related to legal and professional fees offset by reduced share-based compensation. General and administrative expenses were $30.9 million for the nine months ended September 30, 2026, compared with $32.1 million for the nine months ended September 30, 2025. The decrease was primarily due to lower payroll and benefit costs and lower share-based compensation expense, both resulting from reduced headcount, partially offset by an increase in legal and professional fees.
Finance income, net
|
|
Three Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
|
Nine Months Ended September 30, |
|
|
Change 2026 vs 2025 |
|
||||||||||||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
|
2026 |
|
|
2025 |
|
|
$ change |
|
|
% change |
|
||||||||
Interest income |
|
$ |
1,773 |
|
|
$ |
3,234 |
|
|
$ |
(1,461 |
) |
|
|
-45 |
% |
|
$ |
5,524 |
|
|
$ |
8,572 |
|
|
$ |
(3,048 |
) |
|
|
-36 |
% |
Interest income is generated by the Company’s cash and cash equivalents. The decrease in interest income for the three and nine months ended September 30, 2026, compared to the same periods in 2025, was primarily due to lower interest rates and a reduced cash balance.
Liquidity and Capital Resources
From the Company’s inception through the quarter ended September 30, 2026, the Company has funded its operations principally with the proceeds from revenues earned through collaboration agreements and government contracts, the sale of capital stock and long-term debt. Through the termination of the CSL Collaboration Agreement, we received a total of approximately $514.3 million in upfront payments and milestones from CSL Seqirus, in addition to the $12.0 million payment received under the Termination Agreement. As of September 30, 2026, the Company’s balance of cash and cash equivalents was $184.8 million.
18
CSL Seqirus, Inc. Collaboration and License Agreement
In November 2022, we entered into the CSL Collaboration Agreement with CSL Seqirus, a part of CSL Limited, one of the world’s leading influenza vaccine providers, for global exclusive rights to research, develop, manufacture and commercialize mRNA vaccines. On August 3, 2026, we entered into the Termination Agreement with CSL Seqirus, pursuant to which we mutually terminated the CSL Collaboration Agreement effective as of such date.
Under the Termination Agreement, we received a one-time cash payment of $12.0 million from CSL Seqirus. In addition, we were released from an R&D credit and from repayment of unspent development payments with an aggregate value of approximately $16.0 million. We also regained strategic control of our vaccine portfolio, including KOSTAIVE® and our vaccine programs for seasonal influenza, pandemic influenza, RSV and EBV, subject to ongoing arrangements with Meiji for the Northern Hemisphere 2026-2027 season.
We are obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on our future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement and successor products, where certain CSL Seqirus intellectual property is incorporated into such products, subject to agreed terms and conditions and applicable time limitations. With respect to certain of the vaccine products, we are obligated to pay a percentage of upfront payments received from future licensees up to pre-agreed amounts.
In connection with the termination, the parties agreed to dismiss the arbitration and exchanged mutual releases of claims.
As a result of the termination, we recognized revenue of approximately $16.8 million during the third quarter of 2026.
Thermo Fisher Agreement
On June 26, 2026, we entered into a series of agreements with Thermo Fisher in support of the clinical development of ARCT-032. Under the agreement, Thermo Fisher has agreed to provide up to $40.0 million of qualifying clinical manufacturing services. We believe the agreement may reduce our future cash requirements associated with the clinical development of ARCT-032 by funding a portion of those development activities, subject to the terms of the agreement. See Note 8 to the condensed consolidated financial statements for additional information regarding the agreement.
Grant from the Biomedical Advanced Research and Development Authority
On August 31, 2022, we entered into a cost reimbursement contract (the “BARDA 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”) to support the development of a low-dose pandemic influenza candidate based on our proprietary self-amplifying messenger RNA-based vaccine platform. The BARDA Contract is to support our non-clinical and pre-clinical development, early-stage clinical development through Phase 1, and associated drug product manufacturing, regulatory and quality-assurance activities over a period of three years. It provides for reimbursement by BARDA of our permitted costs up to $63.2 million. As of September 30, 2026, the remaining available funding net of revenue earned was $23.8 million.
General Financial Resources
A portion of our current cash balance is expected to be utilized during the next twelve months to fund (i) advances to our LUNAR-CF program in clinical trials, (ii) the continued Phase 2 trial of ARCT-810, our LUNAR-OTC candidate, and the planned integration of ARCT-2601 into that trial, (iii) expenses incurred prior to customer payments under the BARDA agreement and any transition or settlement-related activities following termination of the CSL Collaboration Agreement, (iv) the cash portion of the consideration for our acquisition of myNEO, which closed on October 15, 2026, and (v) continued exploratory activities related to our platform, including LUNAR 2.0™, the integration of myNEO, and other general administrative activities.
Our future capital requirements are difficult to forecast and will depend on many factors that are out of our control. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected. There can be no assurance that we will be able to obtain additional needed financing on acceptable terms or at all. Additionally, equity or debt financings may have a dilutive effect on the holdings of our existing shareholders.
We expect to continue to incur additional losses in the long term, and we will need to raise additional debt or equity financing or enter into additional partnerships to fund development. Our ability to transition to profitability is dependent on regulatory approvals of our product candidates and subsequent sales of KOSTAIVE and any approved products, and identifying and developing other successful mRNA drug and vaccine candidates. If we are not able to achieve planned milestones or incur costs in excess of our forecasts, we will need to reduce discretionary spending, discontinue the development of some or all of our programs, which will delay part of our development programs, all of which will have a material adverse effect on our ability to achieve our intended business objectives.
19
Cash Flows
The following table shows a summary of our cash flows:
|
|
Nine Months Ended September 30, |
|
|||||
(in thousands) |
|
2026 |
|
|
2025 |
|
||
Cash provided by (used in): |
|
|
|
|
|
|
||
Operating activities |
|
$ |
(46,256 |
) |
|
$ |
(58,044 |
) |
Investing activities |
|
|
— |
|
|
|
(318 |
) |
Financing activities |
|
|
307 |
|
|
|
1,694 |
|
Net decrease in cash, cash equivalents and restricted cash |
|
$ |
(45,949 |
) |
|
$ |
(56,668 |
) |
Operating Activities
Net cash used in operating activities was $46.3 million for the nine months ended September 30, 2026, compared to $58.0 million for the nine months ended September 30, 2025. The decrease in net cash used in operating activities was primarily driven by the $12.0 million payment received under the Termination Agreement and lower cash outflows related to accrued liabilities and deferred revenue, partially offset by a higher net loss and lower share-based compensation expense.
Investing Activities
Net cash used in investing activities was nominal for the nine months ended September 30, 2026, compared to $0.3 million for the nine months ended September 30, 2025. The decrease in cash outflows was primarily driven by a decrease in purchases of property and equipment during the current-year period.
Financing Activities
Net cash provided by financing activities was $0.3 million for the nine months ended September 30, 2026, compared to $1.7 million for the nine months ended September 30, 2025. The decrease in cash provided by financing activities was primarily driven by lower proceeds from employee stock option exercises.
Funding Requirements
We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin commercialization of our products. As a result, we will require additional capital to fund our operations in order to support our long-term plans. We believe that our current cash position will be sufficient to meet our anticipated cash requirements through at least the next twelve months, assuming, among other things, no significant unforeseen expenses and continued funding under existing agreements at anticipated levels. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements with partners or through other sources of financing when and as needed. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate our assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.
Our future funding requirements are difficult to forecast and will depend on many factors, including the following:
20
Critical Accounting Policies and Estimates
We prepare our condensed consolidated financial statements in conformity with GAAP. As such, we make certain estimates, judgments and assumptions that we believe are reasonable, based upon information available to us. These judgments involve making estimates about the effect of matters that are inherently uncertain and may significantly impact our reported results of operations and financial condition. We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements for the year ended December 31, 2025 included in the 2025 Annual Report.
There have been no material changes to our critical accounting policies and estimates from the information provided in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in the 2025 Annual Report, except as related to the myNEO acquisition discussed in Note 11 to the condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of interest rates in the United States. Due to the nature of our cash and cash equivalents, we believe that we are not subject to any material market risk exposure. We maintain an immaterial amount of foreign currency, which we do not consider to pose a material risk. We do not use derivative financial instruments.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) and Rule 15d-15(b) of the Exchange Act, our management, including our principal executive officer, and our principal financial and accounting officer, conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, management has concluded that as of September 30, 2026, our disclosure controls and procedures were effective at the reasonable assurance level for the period covered by this report.
The Company’s disclosure controls and procedures have been designed to ensure that: (i) information required to be disclosed by us in reports that we file or submit to the SEC under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in applicable rules and forms and (ii) material information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to management, including the CEO and the CFO, as appropriate, to allow for accurate and timely decisions regarding required disclosure.
Management does not expect that our disclosure controls and procedures will prevent all error and all fraud. The effectiveness of our system, or any system, of disclosure controls and procedures, however well designed and operated, can provide only reasonable assurance that the objectives of the system will be met and is subject to certain limitations, including the exercise of judgment in designing, implementing, and evaluating controls and procedures and the assumptions used in identifying the likelihood of future events.
Changes in Internal Control over Financial Reporting
As required by Rule 13a-15(d) and Rule 15d-15(d) of the Exchange Act, our management, including our principal executive officer and our principal financial and accounting officer, conducted an evaluation of the internal control over financial reporting to determine whether any other changes occurred during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Based on that evaluation, our principal executive officer and our principal financial and accounting officer concluded that there were no changes in our internal controls over financial reporting during the periods covered by this Quarterly Report on Form 10-Q that materially affected, or were reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business, and the results of litigation and claims are inherently unpredictable and uncertain. Other than as set forth below, we are not currently a party to any material legal proceedings.
On September 23, 2025, we filed a lawsuit against AbbVie Inc., Capstan Therapeutics, Inc. and other defendants in the United States District Court for the Southern District of California, asserting claims for trade secret misappropriation and breach of contract. We filed an Amended Complaint on April 13, 2026, against the same defendants and asserting the same claims. Defendants answered the Amended Complaint on May 11, 2026. On the same date, Capstan Therapeutics asserted counterclaims for trade secret misappropriation against us and two of our employees, and for breach of contract against the two employees. We and the two employees answered the counterclaims on June 12, 2026. The parties are presently engaged in motion practice regarding identification of trade secret claims and have served discovery upon one another. The Court has not yet set a trial date.
On August 3, 2026, we entered into a Termination and Settlement Agreement with CSL Seqirus, pursuant to which the parties agreed to dismiss the arbitration with CSL Seqirus that was before the International Chamber of Commerce (the “ICC”), seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE® in the European Union (“EU Milestone Payment”), and exchanged mutual releases of claims, including those related to the EU Milestone Payment. On August 5, 2026, we informed the ICC that we were dismissing the arbitration because of the resolution reached with CSL Seqirus. That same day, the arbitral tribunal acknowledged dismissal of the arbitration.
Item 1A. Risk Factors.
Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which we strongly encourage you to review. Except as disclosed below, there have been no material changes from the risk factors described in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Commission on March 3, 2026.
The termination of our collaboration with CSL Seqirus requires us to advance, fund, and seek partners for our vaccine programs, and subjects us to additional risks and uncertainties.
On August 3, 2026, we entered into a Termination and Settlement Agreement with CSL Seqirus pursuant to which we mutually terminated the CSL Collaboration Agreement, effective as of such date (the “Termination Agreement”). The CSL Collaboration Agreement provided CSL Seqirus with exclusive global rights to research, develop, manufacture, and commercialize mRNA vaccines against COVID-19, influenza, and other infectious diseases using our STARR® and LUNAR® platform technologies. Under the CSL Collaboration Agreement, CSL Seqirus was responsible for leading development and commercialization of vaccines in the licensed fields, and collaboration revenue has historically been a significant component of our total revenue. We now bear sole responsibility for all decisions regarding the development, manufacturing, and commercialization of these vaccine products. We have limited experience commercializing vaccine products independently, and we may need to build internal commercial capabilities, enter into new partnerships, or engage distributors in order to maximize value of the assets, and there can be no assurance that we will be able to do so on favorable terms or at all. Several of the vaccine programs are in early-stage development, which will require substantial additional capital and resources to advance. We do not expect to receive any further milestone payments, research funding, or profit-sharing payments under the CSL Collaboration Agreement. Under the Termination Agreement, we are also obligated to pay CSL Seqirus royalties and revenue-sharing on our future commercialization of these vaccine products and successor products if such products are covered by CSL Seqirus royalty-bearing intellectual property, which could reduce the profitability of our vaccine programs and make such programs less attractive to potential partners.
During the Northern Hemisphere 2026-2027 season (expected to end June 30, 2027), CSL Seqirus and Meiji Seika Pharma (“Meiji”) will continue to be responsible for commercializing KOSTAIVE® in Japan, and for future seasons, we will need to establish direct or indirect commercial arrangements with Meiji or another distributor for the Japanese market, and any other markets. Any disruption in the transition of activities, supply, or regulatory responsibilities could adversely affect sales of KOSTAIVE® in Japan and damage our relationships with key counterparties and regulators. We have entered into a transition plan with CSL Seqirus for the orderly transfer of clinical trials, regulatory filings, intellectual property, and other materials, but there can be no assurance that such transition will be completed without delays or disruptions. We intend to evaluate strategic opportunities to maximize the value of the vaccine portfolio, including development, commercialization, and partnering opportunities, but there can be no assurance that we will identify suitable partners or enter into collaboration arrangements on favorable terms. The pursuit of multiple early-stage vaccine programs in parallel could strain our financial and operational resources and divert management attention from our rare disease therapeutic programs, which are our primary area of focus, and could have a material adverse impact on our business and results of operations.
22
We may not realize the anticipated benefits of our acquisition of myNEO, and the acquisition and integration of myNEO may disrupt our business.
On October 15, 2026, we completed our acquisition of myNEO, an artificial intelligence discovery company based in Belgium. The success of the acquisition will depend on our ability to integrate myNEO’s personnel, technology and operations, retain key myNEO personnel, several of whom have transitioned to consulting arrangements with us, and successfully apply myNEO’s computational engine to our mRNA design and target identification efforts. myNEO’s technology has not been validated in the development of an approved product, and there can be no assurance that it will improve the quality, speed or success of our research and development programs. The integration of myNEO may require significant management attention and resources, may involve unanticipated costs, liabilities or delays, and may expose us to risks associated with operating in a foreign jurisdiction, including compliance with data privacy, employment and tax laws. In addition, we issued unregistered shares of our common stock as part of the closing consideration and may issue additional shares in satisfaction of contingent milestone payments, which would result in dilution to our existing stockholders, and the sale of such shares into the public market following any applicable holding period could adversely affect the market price of our common stock. If we are unable to integrate myNEO successfully or realize the anticipated benefits of the acquisition, our business, financial condition and results of operations could be adversely affected.
Geopolitical risks associated with ongoing wars and armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.
Geopolitical developments related to ongoing global conflicts and tensions are sources of uncertainty and risk, and may cause disruptions to global or regional markets, supply chains or operations in applicable regions, including those related to conflicts in the Middle East. We have and may continue to evaluate and engage in activities, including engagement of clinical sites, in the Middle East. Conflicts in the Middle East could disrupt operations of companies doing business in the region, including in Israel. Any significant changes in the political, economic, financial, competitive, legal and regulatory or reimbursement conditions where we conduct, or plan to expand, our international operations may have a material impact on our business, financial condition or results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
During the three months ended September 30, 2026, none of our directors or officers, as defined in Rule 16a-1(f) of the Exchange Act,
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Item 6. Exhibits.
Exhibit Index
Exhibit Number |
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Description |
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1.1 |
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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. 333-269003). |
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1.2 |
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Amendment No. 1 to Controlled Equity Offering℠ Sales Agreement by and between Cantor Fitzgerald & Co., Wells Fargo Securities, LLC, William Blair & Company, L.L.C., and Arcturus Therapeutics Holdings Inc. Incorporated by reference to Exhibit 1.1 to Form 8-K filed on August 7, 2023. |
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3.1 |
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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). |
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3.2 |
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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). |
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3.3 |
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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). |
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4.1 |
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Description of Registrant’s Securities. Incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed on February 28, 2022 (File No. 001-38942). |
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10.1† |
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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). |
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10.2† |
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Amended and Restated 2019 Omnibus Equity Incentive Plan. Incorporated by reference to Exhibit 4.3 to the Registration Statement on Form S-8 filed on August 5, 2020 (File No. 333-240397). |
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10.3† |
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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). |
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10.4*** |
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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). |
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10.5*** |
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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). |
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10.6*** |
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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. |
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10.7*** |
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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). |
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10.8*** |
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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). |
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10.9*** |
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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). |
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10.10*** |
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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). |
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10.11*** |
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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). |
24
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10.12*** |
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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). |
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10.13† |
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2020 Employee Stock Purchase Plan. Incorporated by reference to Exhibit 4.3 to Form S-8 filed on August 5, 2020 (File No. 333-240392). |
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10.14 |
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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, 2021 (File No. 001-38942). |
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10.15 |
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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, 2021 (File No. 001-38942). |
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10.16† |
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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). |
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10.17† |
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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) |
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10.18† |
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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). |
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10.19† |
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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). |
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10.20† |
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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). |
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10.21 |
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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). |
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10.22 |
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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). |
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10.23 |
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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). |
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10.24† |
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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 14, 2024 (File No. 001-38942). |
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10.25*** |
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Study Support Agreement effective October 31, 2022, by and between Arcturus Therapeutics, Inc. and Vinbiocare Research and Manufacture 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). |
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10.26*** |
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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). |
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10.27*** |
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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). |
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10.28*** |
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Manufacturing Support Agreement Termination Letter, dated March 23, 2023, by and between Arcturus Therapeutics, Inc. and the Economic Development of Singapore. Incorporated by reference to Exhibit 10.41 to Annual Report on Form 10-K filed on March 29, 2023 (File No. 001-38942). |
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10.29*** |
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Credit Agreement dated April 21, 2023, by and between Arcturus Therapeutics, Inc. and Wells Fargo Bank, National Association. Incorporated by reference to Exhibit 10.28 to Quarterly Report on Form 10-Q filed on May 9, 2023 (File No. 001-38942). |
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25
10.30*** |
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Security Agreement dated April 21, 2023, by and between Arcturus Therapeutics, Inc. and Wells Fargo Bank, National Association. Incorporated by reference to Exhibit 10.29 to Quarterly Report on Form 10-Q filed on May 9, 2023 (File No. 001-38942). |
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10.31*** |
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Revolving Line of Credit Note dated April 21, 2023, by and between Arcturus Therapeutics, Inc. and Wells Fargo Bank, National Association. Incorporated by reference to Exhibit 10.30 to Quarterly Report on Form 10-Q filed on May 9, 2023 (File No. 001-38942). |
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10.32*** |
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Amendment Number One to Collaboration and License Agreement, dated August 3, 2023, by and between Arcturus Therapeutics, Inc. and Seqirus Inc. Incorporated by reference to Exhibit 10.31 to Quarterly Report on Form 10-Q filed on November 14, 2023 (File No. 001-38942). |
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10.33*** |
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Amendment No. 4 to Letter Agreement, dated September 25, 2023, by and between Arcturus Therapeutics, Inc. and the Cystic Fibrosis Foundation. Incorporated by reference to Exhibit 10.32 to Quarterly Report on Form 10-Q filed on November 14, 2023 (File No. 001-38942). |
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10.34*** |
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First Amendment to Credit Agreement and First Amendment to Revolving Line of Credit, dated June 26, 2024, by and between Arcturus Therapeutics, Inc. and Wells Fargo Bank, National Association. Incorporated by reference to Exhibit 10.35 to Quarterly Report on Form 10-Q filed on August 5, 2024 (File No. 001-38942). |
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10.35 |
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Fifth Amendment to Lease, by and between Arcturus Therapeutics, Inc. and ARE-SD Region No. 44, LLC, dated July 12, 2024. Incorporated by reference to Exhibit 10.36 to Quarterly Report on Form 10-Q filed on November 7, 2024 (File No. 001-38942). |
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10.36†
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Separation Agreement and General Release between Arcturus Therapeutics Holdings Inc. and Andy Sassine dated December 11, 2025. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on December 15, 2025 (File No. 001-38942). |
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10.37†
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Employment Agreement between Arcturus Therapeutics Holdings Inc. and Joe Roberts dated July 3, 2018. Incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed on December 15, 2025 (File No. 001-38942). |
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10.38†
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Employment Agreement between Arcturus Therapeutics Holdings Inc. and Dennis Mulroy dated April 27, 2026. Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on May 7, 2026 (File No. 001-38942). |
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10.39*** |
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Master Services Agreement between Arcturus Therapeutics, Inc. and Thermo Fisher Scientific Inc., dated June 26, 2026. Incorporated by reference to Exhibit 10.39 to Quarterly Report on Form 10-Q filed on August 6, 2026 (File No. 001-38942). |
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10.40*** |
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Project Addendum for Development Services between Arcturus Therapeutics, Inc. and Patheon UK Limited, dated June 26, 2026. Incorporated by reference to Exhibit 10.40 to Quarterly Report on Form 10-Q filed on August 6, 2026 (File No. 001-38942). |
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10.41* *** |
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Termination and Settlement Agreement, dated August 3, 2026, by and between Arcturus Therapeutics, Inc. and Seqirus Inc. |
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31.1* |
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Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended. |
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31.2* |
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Certification by Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended. |
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32.1** |
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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. |
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32.2** |
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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. |
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101* |
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The following financial statements and footnotes from the Registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2026 formatted in Inline Extensible Business Reporting Language (Inline XBRL): |
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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 |
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101.SCH Inline XBRL Taxonomy Extension Schema |
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101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase |
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101.DEF Inline XBRL Taxonomy Extension Definition Linkbase |
26
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101.LAB Inline XBRL Taxonomy Extension Label Linkbase |
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101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Filed herewith.
** The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report are not deemed filed with the SEC and are not to be incorporated by reference into any filing of Arcturus Therapeutics Holdings Inc. under the Securities Act of 1933 or the Securities Exchange Act of 1934, whether made before or after the date of this Quarterly Report, irrespective of any general incorporation language contained in such filing
*** Certain confidential portions of this exhibit have been omitted because such portions are both (i) not material and (ii) the type of information that the registrant treats as private or confidential.
† Management compensatory plan, contract or arrangement.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ARCTURUS THERAPEUTICS HOLDINGS INC. |
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Date: November 5, 2026 |
By: |
/s/ Dennis Mulroy |
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Dennis Mulroy |
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Chief Financial Officer Principal Financial Officer |
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