Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ARCT | |
Entity Registrant Name | ARCTURUS THERAPEUTICS HOLDINGS INC. | |
Entity Central Index Key | 0001768224 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-38942 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 32-0595345 | |
Entity Address, Address Line One | 10628 Science Center Drive | |
Entity Address, Address Line Two | Suite 250 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92121 | |
City Area Code | 858 | |
Local Phone Number | 900-2660 | |
Entity Common Stock, Shares Outstanding | 26,723,332 | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 311,918 | $ 391,883 |
Restricted cash | 35,000 | |
Accounts receivable | 38,220 | 2,764 |
Prepaid expenses and other current assets | 8,130 | 8,686 |
Total current assets | 393,268 | 403,333 |
Property and equipment, net | 12,715 | 12,415 |
Operating lease right-of-use asset, net | 29,534 | 32,545 |
Non-current restricted cash | 22,133 | 2,094 |
Total assets | 457,650 | 450,387 |
Current liabilities: | ||
Accounts payable | 18,362 | 7,449 |
Accrued liabilities | 28,553 | 30,232 |
Current portion of long-term debt | 60,655 | |
Deferred revenue | 40,768 | 28,648 |
Total current liabilities | 87,683 | 126,984 |
Deferred revenue, net of current portion | 41,911 | 20,071 |
Long-term debt | 20,000 | |
Operating lease liability, net of current portion | 27,018 | 30,216 |
Other non-current liabilities | 976 | 2,804 |
Total liabilities | 177,588 | 180,075 |
Stockholders’ equity | ||
Common stock, $0.001 par value; 60,000 shares authorized; issued and outstanding shares were 26,723 at September 30, 2023 and 26,555 at December 31, 2022 | 27 | 27 |
Additional paid-in capital | 636,194 | 608,426 |
Accumulated deficit | (356,159) | (338,141) |
Total stockholders’ equity | 280,062 | 270,312 |
Total liabilities and stockholders’ equity | $ 457,650 | $ 450,387 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 60,000,000 | 60,000,000 |
Common stock, shares issued | 26,723,000 | 26,555,000 |
Common stock, shares outstanding | 26,723,000 | 26,555,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 45,140 | $ 13,369 | $ 135,944 | $ 45,706 |
Operating expenses: | ||||
Research and development, net | 51,077 | 37,688 | 155,513 | 120,770 |
General and administrative | 13,377 | 12,488 | 40,364 | 34,211 |
Total operating expenses | 64,454 | 50,176 | 195,877 | 154,981 |
Loss from operations | (19,314) | (36,807) | (59,933) | (109,275) |
Loss from equity-method investment | (515) | |||
Gain (loss) from foreign currency | 4 | 1,862 | (175) | 3,237 |
Gain on debt extinguishment | 33,953 | |||
Finance income (expense), net | 3,981 | (321) | 9,710 | (1,445) |
Net loss before income taxes | (15,329) | (35,266) | (16,445) | (107,998) |
Provision for income taxes | 893 | 1,573 | ||
Net loss | $ (16,222) | $ (35,266) | $ (18,018) | $ (107,998) |
Net loss per share: | ||||
Basic | $ (0.61) | $ (1.33) | $ (0.68) | $ (4.09) |
Diluted | $ (0.61) | $ (1.33) | $ (0.68) | $ (4.09) |
Weighted-average shares outstanding: | ||||
Basic | 26,574 | 26,467 | 26,559 | 26,423 |
Diluted | 26,574 | 26,467 | 26,559 | 26,423 |
Comprehensive loss: | ||||
Net loss | $ (16,222) | $ (35,266) | $ (18,018) | $ (107,998) |
Comprehensive loss | (16,222) | (35,266) | (18,018) | (107,998) |
Collaboration Revenue [Member] | ||||
Revenue: | ||||
Total revenue | 43,376 | $ 13,369 | 132,670 | $ 45,706 |
Grant Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 1,764 | $ 3,274 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2021 | $ 228,211 | $ 26 | $ 575,675 | $ (347,490) |
Balance (in shares) at Dec. 31, 2021 | 26,372 | |||
Net income (loss) | (51,169) | (51,169) | ||
Share-based compensation expense | 7,371 | 7,371 | ||
Issuance of common stock upon exercise of stock options | 336 | 336 | ||
Issuance of common stock upon exercise of stock options (in shares) | 35 | |||
Balance at Mar. 31, 2022 | 184,749 | $ 26 | 583,382 | (398,659) |
Balance (in shares) at Mar. 31, 2022 | 26,407 | |||
Balance at Dec. 31, 2021 | 228,211 | $ 26 | 575,675 | (347,490) |
Balance (in shares) at Dec. 31, 2021 | 26,372 | |||
Net income (loss) | (107,998) | |||
Balance at Sep. 30, 2022 | 145,667 | $ 26 | 601,129 | (455,488) |
Balance (in shares) at Sep. 30, 2022 | 26,492 | |||
Balance at Mar. 31, 2022 | 184,749 | $ 26 | 583,382 | (398,659) |
Balance (in shares) at Mar. 31, 2022 | 26,407 | |||
Net income (loss) | (21,563) | (21,563) | ||
Share-based compensation expense | 7,274 | 7,274 | ||
Issuance of common stock upon exercise of stock options | 257 | 257 | ||
Issuance of common stock upon exercise of stock options (in shares) | 27 | |||
Balance at Jun. 30, 2022 | 170,717 | $ 26 | 590,913 | (420,222) |
Balance (in shares) at Jun. 30, 2022 | 26,434 | |||
Net income (loss) | (35,266) | (35,266) | ||
Share-based compensation expense | 9,436 | 9,436 | ||
Issuance of common stock upon exercise of stock options | 369 | 369 | ||
Issuance of common stock upon exercise of stock options (in shares) | 36 | |||
Issuance of common stock under equity plans | 411 | 411 | ||
Issuance of common stock under equity plans (in shares) | 22 | |||
Balance at Sep. 30, 2022 | 145,667 | $ 26 | 601,129 | (455,488) |
Balance (in shares) at Sep. 30, 2022 | 26,492 | |||
Balance at Dec. 31, 2022 | 270,312 | $ 27 | 608,426 | (338,141) |
Balance (in shares) at Dec. 31, 2022 | 26,555 | |||
Net income (loss) | 50,754 | 50,754 | ||
Share-based compensation expense | 8,182 | 8,182 | ||
Balance at Mar. 31, 2023 | 329,248 | $ 27 | 616,608 | (287,387) |
Balance (in shares) at Mar. 31, 2023 | 26,555 | |||
Balance at Dec. 31, 2022 | 270,312 | $ 27 | 608,426 | (338,141) |
Balance (in shares) at Dec. 31, 2022 | 26,555 | |||
Net income (loss) | (18,018) | |||
Balance at Sep. 30, 2023 | 280,062 | $ 27 | 636,194 | (356,159) |
Balance (in shares) at Sep. 30, 2023 | 26,723 | |||
Balance at Mar. 31, 2023 | 329,248 | $ 27 | 616,608 | (287,387) |
Balance (in shares) at Mar. 31, 2023 | 26,555 | |||
Net income (loss) | (52,550) | (52,550) | ||
Share-based compensation expense | 8,383 | 8,383 | ||
Issuance of common stock upon exercise of stock options | 94 | 94 | ||
Issuance of common stock upon exercise of stock options (in shares) | 19 | |||
Balance at Jun. 30, 2023 | 285,175 | $ 27 | 625,085 | (339,937) |
Balance (in shares) at Jun. 30, 2023 | 26,574 | |||
Net income (loss) | (16,222) | (16,222) | ||
Share-based compensation expense | 9,269 | 9,269 | ||
Issuance of common stock upon exercise of stock options | 1,231 | 1,231 | ||
Issuance of common stock upon exercise of stock options (in shares) | 114 | |||
Issuance of common stock under equity plans | 609 | 609 | ||
Issuance of common stock under equity plans (in shares) | 35 | |||
Balance at Sep. 30, 2023 | $ 280,062 | $ 27 | $ 636,194 | $ (356,159) |
Balance (in shares) at Sep. 30, 2023 | 26,723 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating Activities | ||
Net loss | $ (18,018) | $ (107,998) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation and amortization | 2,142 | 976 |
Share-based compensation expense | 25,834 | 24,081 |
Loss from equity-method investment | 515 | |
Foreign currency translation loss (gain) | 90 | (2,976) |
Gain on debt extinguishment | (33,953) | |
Other non-cash expenses | 502 | 5,084 |
Changes in assets and liabilities | ||
Accounts receivable | (35,456) | 1,323 |
Prepaid expense and other assets | 556 | (1,858) |
Right-of-use assets | 3,011 | 2,290 |
Accounts payable | 10,497 | 5,335 |
Accrued liabilities | (3,437) | 2,015 |
Deferred revenue | 33,960 | (53,578) |
Lease liabilities | (3,198) | (3,475) |
Net cash provided by (used in) operating activities | (17,470) | (128,266) |
Investing activities: | ||
Acquisition of property and equipment | (2,026) | (3,919) |
Net cash used in investing activities | (2,026) | (3,919) |
Financing activities: | ||
Proceeds from debt | 20,000 | |
Proceeds from exercise of stock options | 1,325 | 962 |
Proceeds from the issuance of common stock under equity plans | 609 | 411 |
Payments on debt obligations | (27,364) | (2,000) |
Net cash (used in) provided by financing activities | (5,430) | (627) |
Net decrease in cash, cash equivalents and restricted cash | (24,926) | (132,812) |
Cash, cash equivalents and restricted cash at beginning of the period | 393,977 | 372,569 |
Cash, cash equivalents and restricted cash at end of the period | 369,051 | 239,757 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 2,102 | 585 |
Non-cash investing activities | ||
Right-of-use assets acquired through operating leases | 30,191 | |
Purchase of property and equipment in accounts payable and accrued expenses | $ 416 | $ 2,761 |
Description of Business, Basis
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies | 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 global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases. The Company became a clinical stage company during 2020 when it announced that its Investigational New Drug (“IND”) application for ornithine transcarbamylase (“OTC”) deficiency and its Clinical Trial Application (“CTA”) for candidate LUNAR-COV19 were approved by applicable health authorities. 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, 2022. These condensed consolidated financial statements are prepared in accordance with GAAP, which requires management to make estimates and assumptions regarding the valuation of debt instruments, the equity-method investment, share-based compensation expense, 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. Joint Ventures, Equity Method Investments and Variable Interest Entities Investments for which the Company exercises significant influence, but does not have control are accounted for under the equity method. Equity method investment activity is related to the Companay's joint venture in ARCALIS, Inc. with Axcelead, Inc. As of September 30, 2023, the Company's ownership in ARCALIS was 45.8 %. ARCALIS has received financial grants of $ 165 million to date from the Japanese government, which are subject to certain terms and conditions that have not yet been met, that may increase the value of ARCALIS in the future. The Company’s share of the investees’ results is presented as either income or loss from equity method investees in the accompanying condensed consolidated statements of operations and comprehensive loss. Liquidity The Company has incurred significant operating losses since its inception. As of September 30, 2023 and December 31, 2022, the Company had an accumulated deficit of $ 356.2 million and $ 338.1 million, respectively. The Company’s activities since inception have consisted principally of research and development activities, general and administrative activities, and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations. From the Company’s inception through September 30, 2023, the Company has funded its operations principally with the proceeds from the sale of capital stock, revenues earned through collaboration agreements, expense reimbursements from government contracts and proceeds from long-term debt. At September 30, 2023, the Company’s balance of cash and cash equivalents, including restricted cash and non-current restricted cash, was $ 369.1 million. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these condensed consolidated financial statements were available to be issued. There can be no assurance that the Company will be successful in securing additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. Segment Information In making decisions regarding resource allocation and assessing performance, the chief operating decision-maker identifies operating segments as components of an enterprise for which separate discrete financial information is available for evaluation. The Company and its chief operating decision-maker view the Company’s operations and manage its business in one operating segment, which is the research and development of medical applications for the Company’s nucleic acid-focused technology. Revenue Recognition At contract inception, the Company analyzes executed arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration reflect a vendor-customer relationship and are therefore within the scope of ASC 606. The Company determines revenue recognition for arrangements within the scope of Topic 606 by performing the following five steps: (i) identify the contract; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies a performance obligation. The terms of the Company’s revenue agreements include license fees, upfront payments, milestone payments, reimbursement for research and development activities, option exercise fees, consulting and related technology transfer fees and royalties on sales of commercialized products. Arrangements that include upfront payments are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. The event-based milestone payments represent variable consideration, and the Company uses the most likely amount method to estimate this variable consideration because the Company will either receive the milestone payment or will not, which makes the potential milestone payment a binary event. The most likely amount method requires the Company to determine the likelihood of earning the milestone payment. Given the high degree of uncertainty around achievement of these milestones, the Company determines the milestone amounts to be fully constrained and does not recognize revenue until the uncertainty associated with these payments is resolved. The Company will recognize revenue from sales-based royalty payments when or as the sales occur. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved and other changes in circumstances occur. A performance obligation is a promise in a contract to transfer a distinct good or service to the collaborative partner and is the unit of account in Topic 606. A contract’s transaction price is allocated to each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the performance obligation is satisfied. For performance obligations that are recognized over time, the Company measures the progress using an input method. The input methods used are based on the effort expended or costs incurred toward the satisfaction of the performance obligation. The Company estimates the amount of effort expended, including the time estimated it will take to complete the activities, or costs incurred in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This approach requires the Company to make estimates and use judgment. If estimates or judgments change over the course of the collaboration, a cumulative catch up of revenue is recognized in the period such changes are identified. See “Note 2, Revenue” for specific details surrounding the Company’s arrangements. Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For the Company's operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. The Company's incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. See “Note 9, Commitments and Contingencies” for specific details surrounding the Company’s leases. Research and Development Costs, Net All research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, employee benefits, costs associated with preclinical studies and clinical trials (including amounts paid to clinical research organizations and other professional services), in process research and development expenses and license agreement expenses, net of any grants and prelaunch inventory. Payments made prior to the performance of research and development services are capitalized until the services are performed. The Company records accruals for estimated research and development costs, comprising payments for work performed by third party contractors, laboratories, participating clinical trial sites, and others. Some of these contractors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. For the latter, the Company accrues the expenses as goods or services are used or rendered. Clinical trial activities performed by third parties are accrued and expensed based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with Clinical Research Organizations ("CROs") and clinical trial sites. Estimates are determined by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Pre-Launch Inventory Prior to obtaining initial regulatory approval for an investigational product candidate, the Company expenses costs relating to production of inventory as research and development expense in its condensed consolidated statements of operations and comprehensive loss, in the period incurred. When the Company believes regulatory approval and subsequent commercialization of an investigational product candidate is probable, and the Company also expects future economic benefit from the sales of the investigational product candidate to be realized, it will then capitalize the costs of production as inventory. Restricted Cash The Company includes the restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheet to the total of the same such amounts shown in the condensed consolidated statement of cash flows: (in thousands) September 30, 2023 September 30, 2022 Cash and cash equivalents $ 311,918 $ 237,676 Restricted cash 35,000 — Non-current restricted cash 22,133 2,081 Total cash, cash equivalents and restricted $ 369,051 $ 239,757 Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock method. No dividends were declared or paid during the reported periods. Recently Issued Accounting Standards Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, 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. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | 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 and product revenue agreements. Under these arrangements, the Company is entitled to receive license fees, consulting fees, product fees, technological transfer fees, upfront payments, milestone payments if and when certain research and development milestones or technology transfer milestones are achieved, royalties on approved product sales and reimbursement for research and development activities. The Company’s costs of performing these services are included within research and development expenses. The Company’s milestone payments are typically defined by achievement of certain preclinical, clinical, and commercial success criteria. Preclinical milestones may include in vivo proof of concept in disease animal models, lead candidate identification, and completion of IND-enabling toxicology studies. Clinical milestones may, for example, include successful enrollment of the first patient in or completion of Phase 1, 2 and 3 clinical trials, and commercial milestones are often tiered based on net or aggregate sale amounts. The Company cannot guarantee the achievement of these milestones due to risks associated with preclinical and clinical activities required for development of nucleic acid medicine-based therapeutics and vaccines. The following table presents changes during the nine months ended September 30, 2023 in the balances of contract assets and liabilities as compared to what was disclosed in the Company’s Annual Report. (in thousands) December 31, 2022 Additions Deductions September 30, 2023 Contract Assets: Accounts receivable $ 2,764 $ 170,244 $ ( 134,788 ) $ 38,220 Contract Liabilities: Deferred revenue $ 48,719 $ 169,904 $ ( 135,944 ) $ 82,679 The following table summarizes the Company’s revenues for the periods indicated. For the Three Months For the Nine Months (in thousands) 2023 2022 2023 2022 Collaboration Revenue: CSL Seqirus $ 43,433 $ — $ 129,257 $ — Vinbiocare — 11,237 — 26,815 Janssen — 934 660 2,593 Other collaboration revenue ( 57 ) 1,198 2,753 3,798 Total collaboration revenue $ 43,376 $ 13,369 $ 132,670 $ 45,706 Grant revenue: BARDA $ 1,764 $ — $ 3,274 $ — Total grant revenue $ 1,764 $ — $ 3,274 $ — The following paragraphs provide information regarding the nature and purpose of the Company’s most significant collaboration and grant arrangements. 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”), for the global exclusive rights to research, develop, manufacture, and commercialize vaccines. Under the terms of the CSL Collaboration Agreement, the Company provides CSL Seqirus with an exclusive global license to its mRNA technology (including STARR ® ) LUNAR ® lipid-mediated delivery, along with mRNA drug substance and drug product manufacturing process. CSL Seqirus will lead development and commercialization of vaccines under the collaboration. The collaboration plans to advance vaccines against SARS-CoV-2 (COVID-19), influenza, pandemic preparedness as well as three other respiratory infectious diseases. The Company received a $ 200.0 million upfront payment and is eligible to receive over $ 1.3 billion in development milestones if all products are registered in the licensed fields, and entitled to potentially receive up to $ 3.0 billion in commercial milestones based on net sales of vaccines in the various fields. In addition, the Company is eligible to receive a 40 % net profit share for COVID-19 vaccine products and up to low double-digit royalties for vaccines against flu, pandemic preparedness and three other respiratory pathogens. In March 2023, the Company achieved development milestones, including milestones associated with nominating next generation vaccine candidates, resulting in $ 90.0 million received from CSL Seqirus during the second quarter of 2023. In April 2023 the Company also received an advance payment of $ 23.6 million for the manufacturing and supply of ARCT-154 drug product. The advance payment was for specified manufacturing runs of ARCT-154 which include the drug substance utilized, as well as the reservation fees and related manufacturing requirements. The Company concluded that the promise to manufacture and supply ARCT-154 drug product is a customer option as part of the CSL Collaboration Agreement and is accounted for as a separate contract. The advance payment of $ 23.6 million is included in deferred revenue as of September 30, 2023. In September 2023, the Company achieved a development milestone related to the completion of the first GMP batch manufacture of drug product in a multi-dose vial for clinical studies in the SARS-CoV-2 field. The Company invoiced CSL Seqirus and added $ 35.0 million to the transaction price during the three months ended September 30, 2023. The Company anticipates that it will receive this payment from CSL Seqirus during the fourth quarter of 2023. In evaluating the CSL Collaboration Agreement in accordance with Accounting Standards Codification (“ASC”) Topic 606, the Company concluded that CSL Seqirus is a customer. The Company identified all promised goods/services within the CSL Collaboration Agreement, and when combining certain promised goods/services, the Company concluded that there are five distinct performance obligations. The nature of the performance obligations consists of delivery of the vaccine license, research and development services for COVID and non-COVID vaccines and regulatory activities for COVID vaccines. For each performance obligation, the Company estimated the standalone selling price based on 1) in the case of the license, the fair value using costs to recreate plus margin method and 2) in the case of research and development services and regulatory activities, cost plus margin for estimated full-time equivalent (“FTE”) costs, direct costs including laboratory supplies, contractors, and other out-of-pocket expenses for research and development services and regulatory activities. As of September 30, 2023, the transaction price consisted of upfront consideration received and milestones achieved in March 2023 and September 2023. Additional variable consideration was not included in the transaction price at September 30, 2023 because the Company could not conclude that it is probable that including the variable consideration will not result in a significant revenue reversal. The Company allocated the transaction price to the performance obligations in proportion to their standalone selling price. The vaccine license was recognized at the point in time when it was transferred and any additional consideration allocated to the license is recognized at the point that the consideration becomes probable of non-reversal as the performance obligation has been delivered. The research and development and regulatory activities performance obligations are recognized over a period of time based on the percentage of services rendered using the input method, meaning actual costs incurred divided by total costs budgeted to satisfy the performance obligation. Any consideration related to sales-based royalties will be recognized when the amounts are probable of non-reversal, provided that the reported sales are reliably measurable and the Company has no remaining promised goods/services, as they are constrained and therefore have also been excluded from the transaction price. The revenue recognized during the quarter ended September 30, 2023 relates to the license delivered, milestones achieved and services performed. Total deferred revenue as of September 30, 2023 and December 31, 2022 was $ 82.5 million and $ 45.6 million, respectively. In August 2023, the Company entered into an amendment to the CSL Collaboration Agreement, pursuant to which the Company agreed to sponsor and conduct a Phase I clinical study in the influenza field. As part of the amendment, the Company and CSL Seqirus agreed to a $ 17.5 million milestone payment which was met during the third quarter of 2023 upon the execution of a Phase I study start-up agreement. The amendment also provides for up to $ 1.5 million in additional payments which are achievable upon meeting certain clinical milestones relating to the Phase I clinical study in the influenza field. The Company previously concluded that the expansion of research and development support services under the CSL Collaboration Agreement represented an option that was not a material right. Therefore the Company concluded the promise to sponsor and conduct the Phase I clinical study is a separate contract and the sole performance obligation under the new arrangement. During the third quarter of 2023, the Company recognized $ 1.2 million related to the performance obligation and recorded the remaining amount of $ 16.3 million to deferred revenue. Vinbiocare During 2021 the Company entered into certain agreements (collectively, the “Vinbiocare License & Supply Agreements”) with Vinbiocare Biotechnology Joint Stock Company (“Vinbiocare”), a member of Vingroup Joint Stock Company, whereby the Company would provide technical expertise and support services to Vinbiocare to assist in the build out of a mRNA drug product manufacturing facility in Vietnam. The Company received an upfront payment in aggregate of $ 40.0 million as part of the Vinbiocare License & Supply Agreements. In October 2022, the Company and Vinbiocare executed a letter of agreement terminating the License & Supply Agreements. The Company incurred no financial penalties in connection with the termination of the License & Supply Agreements and has no further financial obligations to Vinbiocare under these terminated agreements. In October 2022, in association with the termination of the License & Supply Agreements, the Company signed the Study Support Agreement with Vinbiocare which provides that Vinbiocare shall continue to serve as the regulatory and financial sponsor of clinical studies conducted in Vietnam of ARCT-154 pursuant to the Company’s arrangements with Vinbiocare (the “Study Support Agreement”). To support the continuing activities of these studies, the Study Support Agreement further provides for the Company to conduct certain services and to compensate Vinbiocare to help achieve the objectives of these studies. In February 2023, the Company agreed to provide additional financial support in the amount of approximately $ 2.1 million to allow Vinbiocare to provide additional study support duties related to the ARCT-154 clinical study. As a result, the Company reserved $ 11.8 million of the original upfront payment to be paid to Vinbiocare over the future periods pursuant to the Study Support Agreement by reclassifying a portion of the upfront payment received from Vinbiocare pursuant to the License & Supply Agreements, from deferred revenue to short-term and long-term liabilities, based on the anticipated timing of the payments to Vinbiocare, and removed that portion of the upfront payment from the transaction price of the modified arrangement. The transaction price was not adjusted for payments that are contingent upon the occurrence of future regulatory or sales-related events based on the information currently available to the Company. The Company has concluded that it has no remaining performance obligations under its prior arrangements with Vinbiocare as summarized above as of September 30, 2023. As of September 30, 2023 , the Company has accrued liabilities related to this arrangement of $ 3.5 million in current liabilities and $ 1.0 million in non-current liabilities that will be paid upon the occurrence of specified events through the first quarter of 2025. Vinbiocare is also eligible to receive a single digit percentage of amounts from net sales, if any, of ARCT-154 (or next-generation COVID vaccine) up to a capped amount of low single digit millions. The Company has no remaining deferred revenue as of September 30, 2023 and December 31, 2022. BARDA Grant In August 2022, the Company entered into a cost reimbursement contract with the Biomedical Advanced Research and Development Authority ("BARDA"), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) for an award of up to $ 63.2 million for the development of a pandemic influenza vaccine using the Company's STARR ® self-amplifying mRNA vaccine platform technology. The Company earns grant revenue for performing tasks under the agreement. The Company determined that the agreement with BARDA is not in the scope of ASC 808 or ASC 606. Applying International Accounting Standards No. 20 ("IAS 20"), Accounting for Government Grants and Disclosure of Government Assistance, by analogy, the Company recognizes grant revenue from the reimbursement of direct out-of-pocket expenses, overhead allocations and fringe benefits for research costs associated with the grant. The costs associated with these reimbursements are reflected as a component of research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss. The Company recognized $ 1.8 million and $ 3.3 million of revenue during the three and nine months ended September 30, 2023, respectively. As of September 30, 2023 , the remaining available funding net of revenue earned was $ 59.6 million. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 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, accrued liabilities and the Singapore Loan (as defined below) approximate their respective fair values due to their relative short maturities. Prior to payoff and forgiveness of long-term debt in the first quarter of 2023, the carrying amounts of long-term debt for the amount drawn on the Company’s debt facility approximated fair value as the interest rate was variable and reflected current market rates. As of September 30, 2023 and December 31, 2022 , all assets measured at fair value on a recurring basis consisted of cash equivalents and money market funds, which were classified within Level 1 of the fair value hierarchy. The fair value of these financial instruments was measured based on quoted prices. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Details | Note 4. Balance Sheet Details Property and equipment, net balances consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Research equipment $ 15,764 $ 10,251 Computers and software 1,370 1,154 Office equipment and furniture 958 958 Leasehold improvements 2,548 2,491 Construction in progress — 3,344 Total 20,640 18,198 Less accumulated depreciation and amortization ( 7,925 ) ( 5,783 ) Property and equipment, net $ 12,715 $ 12,415 Depreciation and amortization expense was $ 0.8 million and $ 2.1 million for the three and nine months ended September 30, 2023 , respectively, and $ 0.4 million and $ 1.0 million for the three and nine months ended September 30, 2022, respectively. Construction in progress at December 31, 2022 primarily includes research equipment that was placed into service during 2023. Accrued liabilities consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Accrued compensation $ 10,200 $ 4,038 Income tax payable 482 1,295 Current portion of operating lease liability 4,200 3,884 Clinical accruals 3,180 4,531 Contractual liabilities 3,492 7,468 Other accrued research and development expenses 6,999 9,016 Total $ 28,553 $ 30,232 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Note 5. Debt Wells Fargo Credit Agreement On April 21, 2023, the Company’s wholly-owned subsidiary, Arcturus Therapeutics, Inc. entered into a credit agreement with Wells Fargo Bank, National Association (“Wells Fargo”) whereby Wells Fargo will make a $ 50.0 million revolving credit line available to the Company (the “Loan”) and each Loan evidenced by a revolving line of credit note (the “Note”). Borrowings under the agreement will bear interest at a rate of 1.00 % above either the Daily Simple SOFR or Term SOFR (as such terms are defined in the Note), with “SOFR” being the rate per annum equal to the secured overnight financing rate as administered by the Federal Reserve Bank of New York. If an Event of Default (as defined in the agreement) occurs, then all Loans shall bear interest at a rate equal to 2.00 % above the interest rate applicable immediately prior to the occurrence of the Event of Default. The term of the agreement is two years , with an option for one-year renewals subject to Wells Fargo approval and the Company furnishing to Wells Fargo a non-refundable commitment fee equal to 0.25 % of the Loan amount for each such renewal. There is no penalty for terminating the facility prior to the maturity date of the Note. As collateral, the Company has agreed to pledge $ 55.0 million in cash to be held at the Company’s securities accounts with Wells Fargo Securities, LLC, an affiliate of Wells Fargo, pursuant to a security agreement. In September 2023, the Company drew down $ 20.0 million from the Loan. Manufacturing Support Agreement On November 7, 2020, the Company’s wholly-owned subsidiary, Arcturus Therapeutics, Inc., entered into a Manufacturing Support Agreement (the “Support Agreement”) with the Economic Development Board of the Republic of Singapore (the “EDB”). Pursuant to the Support Agreement, the EDB agreed to make a term loan (the “Singapore Loan”) of S$ 62.1 million to the Company, subject to the satisfaction of customary deliveries, to support the manufacture of the LUNAR-COV19 vaccine candidate (ARCT-021). The Singapore Loan accrued interest at a rate of 4.5 % per annum calculated on a daily basis. The Company elected to borrow the full amount available under the Support Agreement of S$ 62.1 million ($ 46.6 million) on January 29, 2021. During the first quarter of 2023, the EDB agreed to an extension of the reconciliation period to March 22, 2023, with unused funds not utilized for the manufacture of ARCT-021 as of such date returned to the EDB. As of December 31, 2022, the outstanding balance of the Singapore Loan, which includes accrued interest, was $ 50.4 million of which the Company paid S$ 22.8 million ($ 17.1 million) in March 2023. During the first quarter of 2023, the remaining principal portion of the Singapore Loan plus accrued interest, totaling $ 34.0 million, was forgiven and recorded as a gain on debt extinguishment in the condensed consolidated statement of operations and comprehensive loss. For the three months ended September 30, 2023, the Company recorded no interest expense, compared to interest expense of $ 0.5 million for the same period in 2022. For the nine months ended September 30, 2023, the Company recorded interest expense of $ 0.5 million, compared to interest expense o f $ 1.6 million fo r the same period in 2022. Termination of Agreement with Western Alliance Bank On March 14, 2023, the Loan and Security Agreement, dated as of October 12, 2018 (as amended and supplemented, the “Western Alliance Agreement”) with Western Alliance Bank, an Arizona corporation (“Western Alliance”), was terminated (the “Termination”) upon the receipt by Western Alliance of a payoff amount of approximately $ 7.4 million from the Company. The Western Alliance Agreement provided for a collateralized term loan in the aggregate principal amount of up to $ 15.0 million, with interest at a floating rate ranging from 1.25 % to 2.75 % above the prime rate and a maturity date of October 30, 2023 . The payoff amount was made by the Company to Western Alliance from available cash on hand, pursuant to a payoff letter, and included payment of (i) approximately $ 7.0 million in principal and interest, (ii) $ 0.3 million fee payable upon prepayment as a result of prior FDA approval of an IND and (iii) de minimis amounts in prepayment charges and various operational fees. The Company was released from all liens under the Western Alliance Agreement. For the three months ended September 30, 2023, the Company recorded no interest expense, compared to interest expense of $ 0.7 million for the same period in 2022. For the nine months ended September 30, 2023 and 2022, the Company recorded interest expense of $ 0.3 million and $ 2.1 million, respectively. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Note 6. Stockholders’ Equity Net Loss per Share Potentially dilutive securities that were not included in the calculation of diluted net loss per share for the three and nine months ended September 30, 2023 as they were anti-dilutive totaled 1.2 million and 0.8 million, respectively, and 0.5 million and 0.7 million for the three and nine months ended September 30, 2022, respectively. |
Share-Based Compensation Expens
Share-Based Compensation Expense | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation Expense | Note 7. Share-Based Compensation Expense In June 2022 at the Company’s 2022 Annual Meeting of Stockholders (the "2022 Annual Meeting"), the stockholders of the Company approved an amendment to the Company’s 2019 Omnibus Equity Incentive Plan (as amended, the “2019 Plan”) which, among other things, increased the aggregate number of shares authorized for use in making awards to eligible persons under the 2019 Plan by 3,750,000 shares, for a total of up to 8,750,000 shares available for issuance. As of September 30, 2023, a total of 1,523,452 shares remain available for future issuance under the 2019 Plan, subject to the terms of the 2019 Plan. In October 2021, the Company adopted the 2021 Inducement Equity Incentive Plan which covers the award of up to 1,000,000 shares of common stock (the “2021 Plan”) effective as of October 15, 2021. Approval of the Company’s stockholders is not required as a condition to the effectiveness of the 2021 Plan for so long as the plan is in compliance with applicable Nasdaq inducement plan rules. In April 2022, the compensation committee of the Company’s board of directors approved a proposal to reduce the total number of shares available for future issuance under the 2021 Plan to 130,000 . As of September 30, 2023, a total of 100,725 shares remain available for future issuance under the 2021 Plan, subject to the terms of the 2021 Plan. Stock Options Share-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022 was as follows: For the Three Months For the Nine Months (in thousands) 2023 2022 2023 2022 Research and development $ 3,863 $ 3,996 $ 11,112 $ 10,811 General and administrative 5,406 5,440 14,722 13,270 Total $ 9,269 $ 9,436 $ 25,834 $ 24,081 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 8. 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 tax rate is due to federal and state income tax expense offset by valuation allowance on the Company's deferred tax assets. For the three and nine months ended September 30, 2023, the Company recorded $ 0.9 million and $ 1.6 million of income tax expense, respectively. No tax benefit was provided for losses incurred in United States because those losses are offset by a full valuation allowance. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 9. 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 $ 24.6 million from approximately $ 15.6 million, (ii) the Company agreed to incur at least $ 15.0 million toward activities under the research plan. Subsequent to September 30, 2023, the Company received the full payment from CFF related to the amendment. The funds received from CFF will be recognized as contra research and development expense beginning in the three months ended September 30, 2023. Total contra expense of $ 1.8 million was recognized during the three and nine months ended September 30, 2023. For the three and nine months ended September 30, 2022, the Company recognized contra expense of $ 0.5 million and $ 3.2 million, respectively, which related to the August 2019 amendment. As of September 30, 2023 and December 31, 2022, no amounts were included in accrued liabilities. Leases In October 2017, the Company entered into a non-cancellable operating lease agreement for office space adjacent to its previously occupied headquarters. The commencement of the lease began in March 2018 and the lease extends for approximately 84 months from the commencement date with a remaining lease term through March 2025. Monthly rental payments are due under the lease and there are escalating rent payments during the term of the lease. The Company is also responsible for its proportional share of operating expenses of the building and common areas. In conjunction with the new lease, the Company received free rent for four months and received a tenant improvement allowance of $ 0.1 million. The lease may be extended for one five-year period at the then current market rate with annual escalations ; however, the Company deemed the extension option not reasonably certain to be exercised and therefore excluded the option from the lease terms. The Company entered into an irrevocable standby letter of credit with the landlord for a security deposit of $ 0.1 million upon executing the lease which is included (along with additional funds required to secure the letter of credit) in the balance of non-current restricted cash. In February 2020, the Company entered into a second non-cancellable operating lease agreement for office space near its current headquarters. The lease extended for 13 months from the commencement date and included a right to extend the lease for one twelve-month period. In February 2021, the Company opted to extend the lease through March 2025 to coincide with the lease term of the Company’s headquarters . In September 2021, the Company entered into a third non-cancellable lease agreement for office, research and development, engineering and laboratory space near its current headquarters and lease term commenced during the second quarter of 2022. The initial term of the lease extends ten years and eight months from the date of possession, and the Company has the right to extend the term of the lease for an additional five-year period . When the lease term was determined for the operating lease right-of-use assets and lease liabilities, the extension option for the lease was not included. The lease has a monthly base rent ranging from $ 0.3 million to $ 0.4 million which escalates over the lease term. The Company received a free rent period of four months and also pays for various operating costs, including utilities and real property taxes. The Company entered into an irrevocable standby letter of credit with the landlord for a security deposit of $ 2.0 million upon executing the lease which is included (along with additional funds required to secure the letter of credit) in the balance of non-current restricted cash. Operating lease right-of-use asset and liability on the condensed consolidated balance sheets represent the present value of remaining lease payments over the remaining lease terms. The Company does not allocate lease payments to non-lease components; therefore, payments for common-area-maintenance and administrative services are not included in the operating lease right-of-use asset and liability. The Company uses its incremental borrowing rate to calculate the present value of the lease payments, as the implicit rate in the lease is not readily determinable. As of September 30, 2023, the remaining payments of the operating lease liability were as follows: (in thousands) Remaining Lease Payments 2023 $ 1,378 2024 5,646 2025 4,019 2026 3,603 Thereafter 23,283 Total remaining lease payments 37,929 Less: imputed interest ( 6,711 ) Total operating lease liabilities $ 31,218 Weighted-average remaining lease term 8.3 Weighted-average discount rate 4.9 % Operating lease costs consist of the fixed le ase payments included in operating lease liability and are recorded on a straight-line basis over the lease terms. Operating lease costs were $ 1.4 million and $ 4.2 million for the three and nine months ended September 30, 2023 , respectively, and $ 1.4 million and $ 3.3 million for the three and nine months ended September 30, 2022, respectively. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 10. Related Party Transactions 28,125 shares in GRI Bio, or approximately 1 %. Upon the closing of the merger, the Company determined that it did not have the ability to exercise significant influence over operating and financial policies of GRI Bio. As such, the Company discontinued equity method of accounting for its investment in GRI Bio. See “Note 1, Joint Ventures, Equity Method Investments and Variable Interest Entities” for specific details surrounding the Company’s agreement with Axcelead to form the joint venture entity, ARCALIS, Inc. |
Description of Business, Basi_2
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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, 2022. These condensed consolidated financial statements are prepared in accordance with GAAP, which requires management to make estimates and assumptions regarding the valuation of debt instruments, the equity-method investment, share-based compensation expense, 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. |
Joint Ventures, Equity Method Investments and Variable Interest Entities | Joint Ventures, Equity Method Investments and Variable Interest Entities Investments for which the Company exercises significant influence, but does not have control are accounted for under the equity method. Equity method investment activity is related to the Companay's joint venture in ARCALIS, Inc. with Axcelead, Inc. As of September 30, 2023, the Company's ownership in ARCALIS was 45.8 %. ARCALIS has received financial grants of $ 165 million to date from the Japanese government, which are subject to certain terms and conditions that have not yet been met, that may increase the value of ARCALIS in the future. The Company’s share of the investees’ results is presented as either income or loss from equity method investees in the accompanying condensed consolidated statements of operations and comprehensive loss. |
Liquidity | Liquidity The Company has incurred significant operating losses since its inception. As of September 30, 2023 and December 31, 2022, the Company had an accumulated deficit of $ 356.2 million and $ 338.1 million, respectively. The Company’s activities since inception have consisted principally of research and development activities, general and administrative activities, and raising capital. The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before the Company achieves sustainable revenues and profit from operations. From the Company’s inception through September 30, 2023, the Company has funded its operations principally with the proceeds from the sale of capital stock, revenues earned through collaboration agreements, expense reimbursements from government contracts and proceeds from long-term debt. At September 30, 2023, the Company’s balance of cash and cash equivalents, including restricted cash and non-current restricted cash, was $ 369.1 million. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date these condensed consolidated financial statements were available to be issued. There can be no assurance that the Company will be successful in securing additional funding, that the Company’s projections of its future working capital needs will prove accurate, or that any additional funding would be sufficient to continue operations in future years. |
Segment Information | Segment Information In making decisions regarding resource allocation and assessing performance, the chief operating decision-maker identifies operating segments as components of an enterprise for which separate discrete financial information is available for evaluation. The Company and its chief operating decision-maker view the Company’s operations and manage its business in one operating segment, which is the research and development of medical applications for the Company’s nucleic acid-focused technology. |
Revenue Recognition | Revenue Recognition At contract inception, the Company analyzes executed arrangements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808). For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration reflect a vendor-customer relationship and are therefore within the scope of ASC 606. The Company determines revenue recognition for arrangements within the scope of Topic 606 by performing the following five steps: (i) identify the contract; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies a performance obligation. The terms of the Company’s revenue agreements include license fees, upfront payments, milestone payments, reimbursement for research and development activities, option exercise fees, consulting and related technology transfer fees and royalties on sales of commercialized products. Arrangements that include upfront payments are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. The event-based milestone payments represent variable consideration, and the Company uses the most likely amount method to estimate this variable consideration because the Company will either receive the milestone payment or will not, which makes the potential milestone payment a binary event. The most likely amount method requires the Company to determine the likelihood of earning the milestone payment. Given the high degree of uncertainty around achievement of these milestones, the Company determines the milestone amounts to be fully constrained and does not recognize revenue until the uncertainty associated with these payments is resolved. The Company will recognize revenue from sales-based royalty payments when or as the sales occur. The Company will re-evaluate the transaction price in each reporting period as uncertain events are resolved and other changes in circumstances occur. A performance obligation is a promise in a contract to transfer a distinct good or service to the collaborative partner and is the unit of account in Topic 606. A contract’s transaction price is allocated to each distinct performance obligation based on relative standalone selling price and recognized as revenue when, or as, the performance obligation is satisfied. For performance obligations that are recognized over time, the Company measures the progress using an input method. The input methods used are based on the effort expended or costs incurred toward the satisfaction of the performance obligation. The Company estimates the amount of effort expended, including the time estimated it will take to complete the activities, or costs incurred in a given period, relative to the estimated total effort or costs to satisfy the performance obligation. This approach requires the Company to make estimates and use judgment. If estimates or judgments change over the course of the collaboration, a cumulative catch up of revenue is recognized in the period such changes are identified. See “Note 2, Revenue” for specific details surrounding the Company’s arrangements. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For the Company's operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. The Company's incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. See “Note 9, Commitments and Contingencies” for specific details surrounding the Company’s leases. |
Research and Development Costs, Net | Research and Development Costs, Net All research and development costs are expensed as incurred. Research and development costs consist primarily of salaries, employee benefits, costs associated with preclinical studies and clinical trials (including amounts paid to clinical research organizations and other professional services), in process research and development expenses and license agreement expenses, net of any grants and prelaunch inventory. Payments made prior to the performance of research and development services are capitalized until the services are performed. The Company records accruals for estimated research and development costs, comprising payments for work performed by third party contractors, laboratories, participating clinical trial sites, and others. Some of these contractors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. For the latter, the Company accrues the expenses as goods or services are used or rendered. Clinical trial activities performed by third parties are accrued and expensed based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with Clinical Research Organizations ("CROs") and clinical trial sites. Estimates are determined by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Pre-Launch Inventory | Pre-Launch Inventory Prior to obtaining initial regulatory approval for an investigational product candidate, the Company expenses costs relating to production of inventory as research and development expense in its condensed consolidated statements of operations and comprehensive loss, in the period incurred. When the Company believes regulatory approval and subsequent commercialization of an investigational product candidate is probable, and the Company also expects future economic benefit from the sales of the investigational product candidate to be realized, it will then capitalize the costs of production as inventory. |
Restricted Cash | Restricted Cash The Company includes the restricted cash balance in the cash, cash equivalents and restricted cash reconciliation of operating, investing and financing activities in the condensed consolidated statements of cash flows. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheet to the total of the same such amounts shown in the condensed consolidated statement of cash flows: (in thousands) September 30, 2023 September 30, 2022 Cash and cash equivalents $ 311,918 $ 237,676 Restricted cash 35,000 — Non-current restricted cash 22,133 2,081 Total cash, cash equivalents and restricted $ 369,051 $ 239,757 |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock and dilutive common stock equivalents outstanding for the period determined using the treasury-stock method. No dividends were declared or paid during the reported periods. |
Recently Issued Accounting Standards Not Yet Adopted | Recently Issued Accounting Standards Not Yet Adopted From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, 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. |
Description of Business, Basi_3
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash and cash equivalents and restricted cash reported within the condensed consolidated balance sheet to the total of the same such amounts shown in the condensed consolidated statement of cash flows: (in thousands) September 30, 2023 September 30, 2022 Cash and cash equivalents $ 311,918 $ 237,676 Restricted cash 35,000 — Non-current restricted cash 22,133 2,081 Total cash, cash equivalents and restricted $ 369,051 $ 239,757 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Changes in Balances of Receivables and Contract Liability | The following table presents changes during the nine months ended September 30, 2023 in the balances of contract assets and liabilities as compared to what was disclosed in the Company’s Annual Report. (in thousands) December 31, 2022 Additions Deductions September 30, 2023 Contract Assets: Accounts receivable $ 2,764 $ 170,244 $ ( 134,788 ) $ 38,220 Contract Liabilities: Deferred revenue $ 48,719 $ 169,904 $ ( 135,944 ) $ 82,679 |
Schedule of Revenue | The following table summarizes the Company’s revenues for the periods indicated. For the Three Months For the Nine Months (in thousands) 2023 2022 2023 2022 Collaboration Revenue: CSL Seqirus $ 43,433 $ — $ 129,257 $ — Vinbiocare — 11,237 — 26,815 Janssen — 934 660 2,593 Other collaboration revenue ( 57 ) 1,198 2,753 3,798 Total collaboration revenue $ 43,376 $ 13,369 $ 132,670 $ 45,706 Grant revenue: BARDA $ 1,764 $ — $ 3,274 $ — Total grant revenue $ 1,764 $ — $ 3,274 $ — |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Components of Property and Equipment, Net | Property and equipment, net balances consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Research equipment $ 15,764 $ 10,251 Computers and software 1,370 1,154 Office equipment and furniture 958 958 Leasehold improvements 2,548 2,491 Construction in progress — 3,344 Total 20,640 18,198 Less accumulated depreciation and amortization ( 7,925 ) ( 5,783 ) Property and equipment, net $ 12,715 $ 12,415 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: (in thousands) September 30, 2023 December 31, 2022 Accrued compensation $ 10,200 $ 4,038 Income tax payable 482 1,295 Current portion of operating lease liability 4,200 3,884 Clinical accruals 3,180 4,531 Contractual liabilities 3,492 7,468 Other accrued research and development expenses 6,999 9,016 Total $ 28,553 $ 30,232 |
Share-Based Compensation Expe_2
Share-Based Compensation Expense (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-based Compensation Expenses | Share-based compensation expense included in the Company’s condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022 was as follows: For the Three Months For the Nine Months (in thousands) 2023 2022 2023 2022 Research and development $ 3,863 $ 3,996 $ 11,112 $ 10,811 General and administrative 5,406 5,440 14,722 13,270 Total $ 9,269 $ 9,436 $ 25,834 $ 24,081 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Remaining Payments of Operating Lease Liability | As of September 30, 2023, the remaining payments of the operating lease liability were as follows: (in thousands) Remaining Lease Payments 2023 $ 1,378 2024 5,646 2025 4,019 2026 3,603 Thereafter 23,283 Total remaining lease payments 37,929 Less: imputed interest ( 6,711 ) Total operating lease liabilities $ 31,218 Weighted-average remaining lease term 8.3 Weighted-average discount rate 4.9 % |
Description of Business, Basi_4
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies (Details Textual) $ in Millions | 9 Months Ended | ||||
Sep. 30, 2023 USD ($) Segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Nov. 07, 2020 SGD ($) | |
Summary Of Significant Accounting Policy [Line Items] | |||||
Accumulated deficit | $ 356,159,000 | $ 338,141,000 | |||
Cash and cash equivalents, including restricted cash and non-current restricted cash | $ 369,051,000 | $ 239,757,000 | $ 393,977,000 | $ 372,569,000 | |
Number of operating segment for research and development | Segment | 1 | ||||
Dividends declared or paid | $ 0 | $ 0 | |||
Singapore Economic Development Board [Member] | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
Term loan | $ 62.1 | ||||
Arcalis, Inc [Member] | |||||
Summary Of Significant Accounting Policy [Line Items] | |||||
Equity method ownership percentage | 45.80% | ||||
Financial grants received from the Japanese government | $ 165,000,000 |
Description of Business, Basi_5
Description of Business, Basis of Presentation and Summary of Significant Accounting Policies - Schedule of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 311,918 | $ 391,883 | $ 237,676 | |
Restricted cash | 35,000 | |||
Non-current restricted cash | 22,133 | 2,094 | 2,081 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 369,051 | $ 393,977 | $ 239,757 | $ 372,569 |
Revenue - Summary of Changes in
Revenue - Summary of Changes in Balances of Receivables and Contract Liability (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Revenue from Contract with Customer [Abstract] | |
Accounts receivable, Balance | $ 2,764 |
Additions | 170,244 |
Deductions | (134,788) |
Accounts receivable, Balance | 38,220 |
Deferred revenue, Balance | 48,719 |
Additions | 169,904 |
Deductions | (135,944) |
Deferred revenue, Balance | $ 82,679 |
Revenue - Summary of Revenues (
Revenue - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 45,140 | $ 13,369 | $ 135,944 | $ 45,706 |
Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 43,376 | 13,369 | 132,670 | 45,706 |
Grant Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 1,764 | 3,274 | ||
CSL Seqirus [Member] | Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 43,433 | 129,257 | ||
Vinbiocare [Member] | Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 11,237 | 26,815 | ||
Janssen [Member] | Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | 934 | 660 | 2,593 | |
Other Collaboration Revenue [Member] | Collaboration Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | (57) | $ 1,198 | 2,753 | $ 3,798 |
BARDA [Member] | Grant Revenue [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Total revenue | $ 1,764 | $ 3,274 |
Revenue (Details Textual)
Revenue (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Nov. 01, 2022 | Aug. 31, 2023 | Feb. 28, 2023 | Aug. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2021 | Apr. 30, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Revenue [Line Items] | ||||||||||
Deferred revenue | $ 82,679,000 | $ 82,679,000 | $ 48,719,000 | |||||||
Deductions | (135,944,000) | |||||||||
BARDA [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Deductions | 1,800,000 | 3,300,000 | ||||||||
Grant revenue | $ 63,200,000 | |||||||||
Grant revenue outstanding | 59,600,000 | |||||||||
ASC 606 [Member] | Vinbiocare [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Deferred revenue | 0 | 0 | 0 | |||||||
Performance obligation | 0 | 0 | ||||||||
Study Support Agreement | Current | ASC 606 [Member] | Vinbiocare [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Accrued liabilities paid upon occurrence of specified events | 3,500,000 | |||||||||
Study Support Agreement | Non-current | ASC 606 [Member] | Vinbiocare [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Accrued liabilities paid upon occurrence of specified events | 1,000,000 | |||||||||
Vinbiocare Agreement [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Upfront payment received | $ 40,000,000 | |||||||||
Reserved upfront payment | $ 11,800,000 | |||||||||
Additional financial support | $ 2,100,000 | |||||||||
Research Collaboration And License Agreement [Member] | Seqirus, Inc [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Upfront payment received | $ 200,000,000 | |||||||||
Development milestones received | $ 90,000,000 | |||||||||
Development milestones received advance payment | $ 23,600,000 | |||||||||
Development milestones advance payment included in deferred revenue | 23,600,000 | 23,600,000 | ||||||||
Amount added to transaction price for achieving development milestone | 35,000,000 | |||||||||
Research Collaboration And License Agreement [Member] | Maximum [Member] | Seqirus, Inc [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Eligible to receive development milestone payment | 1,300,000,000 | |||||||||
Eligible to receive commercial milestone payment | $ 3,000,000,000 | |||||||||
Research Collaboration And License Agreement [Member] | COVID-19 Vaccine [Member] | Seqirus, Inc [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Net profits percentage | 40% | |||||||||
CSL Collaboration Agreement [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Deferred revenue | 82,500,000 | 82,500,000 | $ 45,600,000 | |||||||
CSL Collaboration Agreement [Member] | Phase I Clinical Study [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Milestone payments | 17,500,000 | |||||||||
Deferred revenue | 16,300,000 | 16,300,000 | ||||||||
Performance obligation | $ 1,200,000 | $ 1,200,000 | ||||||||
CSL Collaboration Agreement [Member] | Phase I Clinical Study [Member] | Maximum [Member] | ||||||||||
Revenue [Line Items] | ||||||||||
Additional payments upon meeting certain clinical milestones | $ 1,500,000 |
Balance Sheet Details - Summary
Balance Sheet Details - Summary of Components of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 20,640 | $ 18,198 |
Less accumulated depreciation and amortization | (7,925) | (5,783) |
Property and equipment, net | 12,715 | 12,415 |
Research equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 15,764 | 10,251 |
Computer and software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,370 | 1,154 |
Office equipment and furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 958 | 958 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,548 | 2,491 |
Construction in progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 3,344 |
Balance Sheet Details (Details
Balance Sheet Details (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation and amortization | $ 800 | $ 400 | $ 2,142 | $ 976 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued compensation | $ 10,200 | $ 4,038 |
Income tax payable | 482 | 1,295 |
Current portion of operating lease liability | 4,200 | 3,884 |
Clinical accruals | 3,180 | 4,531 |
Contractual liabilities | 3,492 | 7,468 |
Other accrued research and development expenses | 6,999 | 9,016 |
Total | $ 28,553 | $ 30,232 |
Debt (Details Textual)
Debt (Details Textual) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||
Apr. 21, 2023 USD ($) | Mar. 31, 2023 USD ($) | Mar. 14, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 SGD ($) | Jan. 29, 2021 USD ($) | Jan. 29, 2021 SGD ($) | Nov. 07, 2020 SGD ($) | |
Western Alliance Bank [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest expense related to long-term debt | $ 0 | $ 700,000 | $ 300,000 | $ 2,100,000 | |||||||||
Loan and Security Agreement [Member] | Western Alliance Bank [Member] | Long-term Debt [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Term loan | $ 15,000,000 | ||||||||||||
Repayment of term loan | 7,400,000 | ||||||||||||
Repyament of principal and interest on collateralized term loan | 7,000,000 | ||||||||||||
Fee payable | $ 300,000 | ||||||||||||
Loan maturity date | Oct. 30, 2023 | ||||||||||||
Loan and Security Agreement [Member] | Western Alliance Bank [Member] | Long-term Debt [Member] | Minimum [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest of the prime rate plus | 1.25% | ||||||||||||
Loan and Security Agreement [Member] | Western Alliance Bank [Member] | Long-term Debt [Member] | Maximum [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest of the prime rate plus | 2.75% | ||||||||||||
Wells Fargo Credit Agreement [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Revolving credit line available | $ 50,000,000 | ||||||||||||
Loans interest rate, percentage | 2% | ||||||||||||
Term of agreement | 2 years | ||||||||||||
Option for renewal term | 1 year | ||||||||||||
Non-refundable commitment fee, percentage | 0.25% | ||||||||||||
Debt instrument, collateral amount | $ 55,000,000 | ||||||||||||
Amount drawn from Loan | $ 20,000,000 | ||||||||||||
Wells Fargo Credit Agreement [Member] | SOFR [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Loan accrued interest rate per annum, percentage | 1% | ||||||||||||
Singapore Economic Development Board [Member] | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Term loan | $ 62.1 | ||||||||||||
Term loan draw down | $ 46,600,000 | $ 62.1 | |||||||||||
Loan accrued interest rate per annum, percentage | 4.50% | ||||||||||||
Remaining loan including accrued interest forgiveable | $ 34,000,000 | ||||||||||||
Repayment of term loan | $ 17,100,000 | $ 22.8 | |||||||||||
Long-term debt | $ 50,400,000 | ||||||||||||
Interest expense related to long-term debt | $ 0 | $ 500,000 | $ 500,000 | $ 1,600,000 |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - shares shares in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Class Of Stock [Line Items] | ||||
Antidilutive securities excluded from computation of earnings per share | 1.2 | 0.5 | 0.8 | 0.7 |
Share-Based Compensation Expe_3
Share-Based Compensation Expense (Details Textual) - shares | Sep. 30, 2023 | Jun. 30, 2022 | Apr. 30, 2022 | Oct. 15, 2021 |
2019 Omnibus Equity Incentive Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation number of shares authorized | 3,750,000 | |||
2019 Omnibus Equity Incentive Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation number of shares authorized | 8,750,000 | |||
2019 Omnibus Equity Incentive Plan [Member] | Stock Option [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for future issuance | 1,523,452 | |||
2021 Inducement Equity Incentive Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Reduction in number of common stock shares available for future issuance | 130,000 | |||
2021 Inducement Equity Incentive Plan [Member] | Maximum [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares available | 1,000,000 | |||
2021 Inducement Equity Incentive Plan [Member] | Stock Option [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common stock reserved for future issuance | 100,725 |
Share-Based Compensation Expe_4
Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expenses | $ 9,269 | $ 9,436 | $ 25,834 | $ 24,081 |
Research and Development [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expenses | 3,863 | 3,996 | 11,112 | 10,811 |
General and Administrative [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Share-based compensation expenses | $ 5,406 | $ 5,440 | $ 14,722 | $ 13,270 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ 893 | $ 1,573 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Textual) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 50 Months Ended | ||||||
Aug. 01, 2019 | Sep. 30, 2021 | Oct. 31, 2017 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 25, 2023 | Dec. 31, 2022 | Feb. 29, 2020 | |
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease costs | $ 1,400,000 | $ 1,400,000 | $ 4,200,000 | $ 3,300,000 | ||||||
Accrued liabilities | 28,553,000 | $ 28,553,000 | $ 30,232,000 | |||||||
October 2017 Lease Amendment [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease extended additional term | 84 months | |||||||||
Lessee, operating lease, term of contract | 4 months | |||||||||
Tenant improvement allowance | $ 100,000 | |||||||||
Lessee, operating leases, option to extend | The lease may be extended for one five-year period at the then current market rate with annual escalations | |||||||||
Security deposit | $ 100,000 | |||||||||
February 2020 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease extended additional term | 13 months | |||||||||
Lessee, operating leases, option to extend | the lease for one twelve-month period. In February 2021, the Company opted to extend the lease through March 2025 to coincide with the lease term of the Company’s headquarters | |||||||||
September 2021 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease extended additional term | 10 years 8 months | |||||||||
Lessee, operating leases, option to extend | the Company has the right to extend the term of the lease for an additional five-year period | |||||||||
Security deposit | $ 2,000,000 | |||||||||
Underlying Agreement [Member] | Cystic Fibrosis Foundation [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Minimum amount agreed to incur under research plan | $ 15,000,000 | |||||||||
Contra expense included in research and development expense | 1,800,000 | $ 500,000 | $ 1,800,000 | $ 3,200,000 | ||||||
Accrued liabilities | $ 0 | $ 0 | $ 0 | |||||||
Underlying Agreement [Member] | LUNAR-CF [Member] | Cystic Fibrosis Foundation [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Payments for advance | $ 15,600,000 | $ 24,600,000 | ||||||||
Maximum [Member] | September 2021 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Monthly base rent | 400,000 | |||||||||
Minimum [Member] | September 2021 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Monthly base rent | $ 300,000 |
Commitments and Contingencies -
Commitments and Contingencies - Remaining Payments of Operating Lease Liability (Details) $ in Thousands | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
2023 | $ 1,378 |
2024 | 5,646 |
2025 | 4,019 |
2026 | 3,603 |
Thereafter | 23,283 |
Total remaining lease payments | 37,929 |
Less: imputed interest | (6,711) |
Total operating lease liabilities | $ 31,218 |
Weighted-average remaining lease term | 8 years 3 months 18 days |
Weighted-average discount rate | 4.90% |
Related Party Transactions - Eq
Related Party Transactions - Equity-Method Investment (Details Textual) - GRI Bio [Member] | Apr. 30, 2023 shares |
Related Party Transaction [Line Items] | |
Number of shares owned | 28,125 |
Percentage of owned shares | 1% |