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ARCT 10-K & 10-Q changes, risk factors and insider trading

Arcturus Therapeutics Holdings Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1768224 · All filings on SEC.gov

Everything below is quoted or computed from Arcturus Therapeutics Holdings Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

17 / 23risk-factor paragraphs added / removed in latest 10-K
9new risk-factor headings
0Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-03 (period ending 2025-12-31) with 10-K filed 2025-03-06 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

17new paragraphs
23removed paragraphs
19reworded paragraphs
21,446 → 21,261words in section

New heading “CSL Limited’s recent financial report included a significant write-down related to our licensed assets; a potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.”

New heading “We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.”

New heading “A potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.”

New heading “Our rare disease candidates, even if approved, might not have a profitable commercial market.”

New heading “Current regulatory authorities in the United States may change or institute policies that increase challenges for clinical development, regulatory approval and commercialization of our vaccine and other programs”

New heading “A potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.”

New heading “We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.”

New heading “Our use of artificial intelligence technologies may expose us to operational, cybersecurity, legal and reputational risks.”

New heading “A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.”

Removed heading “We are exposed to interest rate risk, including under our loan agreements.”

Removed heading “Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.”

Removed heading “We have identified a material weakness in our internal control over financial reporting, and determined that our disclosure controls and procedures were not effective. If our remediations of this material weakness is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, we may not be able to accurately and timely report our financial results, in which case our business may be harmed, investors may lose confidence in the accuracy and completeness of our financial reports, and the price of our common stock may decline.”

Removed heading “We are exposed to interest rate risk, including under our loan agreements.”

Removed heading “Our indebtedness could materially and adversely affect our business, financial condition and results of operations.”

Removed heading “Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

Removed text topics: material weakness, investigation, penalt, covenant
“If we are unable to successfully remediate our existing material weakness or any future material weakness or other deficiencies in our internal control over financial reporting: the accuracy and timing of our financial reporting may be adversely affected; our liquidity, our access to capital markets and the perceptions of our creditworthiness; we may be unable to maintain compliance with applicable securities laws, Nasdaq listing requirements, and the covenants under our debt instruments regarding the timely filing of periodic reports; …”
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New text topics: litigation, sanction, cybersecurity incident, artificial intelligence
“We permit the use of certain artificial intelligence (“AI”) tools, including large language models and AI agents hosted in data centers located in the United States. We have adopted certain enterprise AI platforms, which our employees may access following internal review and approval processes. We also utilize data exfiltration detection technologies designed to monitor AI usage and alert our security team to potential unauthorized or unsanctioned use. …”
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Removed text topics: default, breach
“Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.”
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Removed text topics: default, breach
“Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.”
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New text topics: litigation, lawsuit, breach, labor
“On September 23, 2025, we filed a lawsuit in the United States District Court for the Southern District of California against AbbVie Inc., Capstan Therapeutics, Inc., and other defendants asserting claims for trade secret misappropriation and breach of contract. The defendants filed a motion to discuss the complaint in December 2025, and we filed an opposition to that motion in January 2026. The Court has not set a case schedule. Litigation is inherently uncertain, time-consuming, and costly. …”
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New text topics: bankruptcy, litigation, liquidity
“On October 1, 2025, the federal government of the United States began a shutdown at 12:01 a.m. EDT as a result of congressional failure to pass appropriations legislation for the 2026 fiscal year, which began that day, and lasted for 43 days. Subsequent partial federal government shutdowns occurred in January and February of 2026. A continued and prolonged shutdown could materially and adversely affect our business, operations, financial condition, and legal matters. …”
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Full comparison: every changed paragraph (59)

Green = added, red = removed. Unchanged paragraphs, 2 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Removed

We are exposed to interest rate risk, including under our loan agreements.

Removed

Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.

Reworded

We are highly dependent upon our relationship with CSL Seqirus to further research, manufacture and commercialize self-amplifying mRNA vaccines against COVID-19, influenza and three other infectious diseases.diseases; CSL Seqirus has announced a significant write-down of the licensed collaboration programs.

Reworded

If any of our product candidates cause undesirable side effects or have other properties impacting safety, theirfurther clinical trials may be denied or delayed and regulatory approval could be prevented, delayed or limited.

Added

CSL Limited’s recent financial report included a significant write-down related to our licensed assets; a potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.

Added

We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.

Removed

We have identified a material weakness in our internal control over financial reporting, and determined that our disclosure controls and procedures were not effective. If our remediations of this material weakness is not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, we may not be able to accurately and timely report our financial results, in which case our business may be harmed, investors may lose confidence in the accuracy and completeness of our financial reports, and the price of our common stock may decline.

Reworded

We are a global messenger RNA medicines company with a limited operating history. Since inception, our operations have been primarily limited to acquiring and licensing intellectual property rights, developing our product platform, undertaking research, partnering assets and running clinical product development programs. We only have one product that, through our partners CSL Seqirus and Meiji, is being commercialized, and it is currently only commercialized in Japan. Consequently, any predictions about our future success or viability, or any evaluation of our business and prospects, is difficult and may not be accurate. In 20242025 we recognized a significant portion of our revenue from non-recurring milestone payments and license revenue under our collaboration agreement with CSL Seqirus. OurWe may not receive any future milestone payments from CSL Seqirus are dependent on our ability to execute by meeting key product development and other milestones within the contract.Seqirus. We have not recognized any revenue from product sales since our inception.

Reworded

Developing pharmaceutical products, including conducting studies and clinical trials, is extremely expensive. We expect our research and development expenses to substantially increase in connection with our ongoing activities, particularly as we advance our product candidates towards and through clinical trials. We expect that we will need to raise additional capital to support our operations and such funding may not be available to us on acceptable terms, or at all. As of December 31, 2024,2025, we had unrestricted cash and cash equivalents of $237.0$230.9 million, which we expect should be sufficient to fund currently planned operations for the near future.future, at least the next 12 months. But if our plans change or we face unexpected circumstances, our capital resources may be depleted more rapidly than we currently anticipate. For example, our clinical trials may encounter technical, regulatory or other difficulties. Any of these events would increase our development costs more than we expect. In order to support our long-term plans, we will need to raise additional capital or otherwise obtain funding through additional strategic alliances if we choose to initiate preclinical or clinical trials for product candidates that are not currently subject to a collaboration. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, future product candidates. Even if the results of clinical studies of our product candidates are positive, the stock market might not react favorably, which would weaken our ability to raise additional capital.

Added

A portion of our current cash balance is expected to be utilized during fiscal year 2026 to fund (i) advances to our LUNAR-CF program in clinical trials, (ii) the continued Phase 2 trial of ARCT-810, our LUNAR-OTC candidate, (iii) expenses incurred prior to customer payments under the CSL Collaboration Agreement and BARDA agreement and (iv) continued exploratory activities related to our platform and other general administrative activities.

Removed

A portion of our current cash balance is expected to be utilized during 2024 to fund our continued preclinical and clinical development activities for our pipeline, including manufacturing activities to support such development activities.

Reworded

adverse decisions by a collaboration partner regarding the amount and timing of resource expenditures for the development, commercialization, distribution, and sale of our drug products;

Removed

We are exposed to interest rate risk, including under our loan agreements.

Removed

We are exposed to market risk from changes in interest rates. Exposure to interest rate risk results from our debt obligations, including the credit agreement entered into on April 21, 2023 and amended on June 26, 2024 by our wholly-owned subsidiary, Arcturus Therapeutics, Inc., and Wells Fargo Bank, National Association (as amended, the “Credit Agreement”), providing for a revolving credit line evidenced by a revolving line of credit note (the “Note”). Borrowings under the Credit 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. All Loans shall bear interest during an Event of Default (as defined in the Credit Agreement) at a rate equal to 2.00% above the interest rate applicable immediately prior to the occurrence of the Event of Default (as defined in the Credit Agreement). As of December 31, 2024, we had no outstanding balance under the Credit Agreement.

Removed

Our indebtedness could materially and adversely affect our business, financial condition and results of operations.

Removed

Agreements with our lenders, including with Wells Fargo Bank, National Association, create several limitations on us, including but not limited to:

Removed

limiting our flexibility in planning for, or reacting to, changes in our business and our industry;

Removed

placing us at a competitive disadvantage compared to our competitors who may have less debt or comparable debt at more favorable interest rates or less strict covenants and other limitations or requirements;

Removed

limiting our ability to incur specified types of additional indebtedness which may be desired for working capital, capital expenditures, research and development efforts, acquisitions, debt service requirements, execution of our business strategy or other purposes; and resulting in an acceleration of our obligations upon the occurrence of an event of default.

Removed

Our ability to comply with these covenants in future periods will depend on our financial and operating performance, which in turn will be subject to economic conditions and to financial, market and competitive factors, many of which are beyond our control. Any of these factors or others described in the Credit Agreement could materially and adversely affect our business, financial condition and results of operations.

Removed

Our debt contains customary default clauses, a breach of which may result in acceleration of the repayment of some or all of this debt.

Removed

The Credit Agreement contains customary default clauses. In the event we were to default on our obligations under our debt and were unable to cure or obtain a waiver of such default, the repayment of our debt may be accelerated. If such acceleration were to occur, we would be required to promptly secure alternative sources of equity or debt financing to be able to repay the debt. Alternative financing may not be available on terms satisfactory to us, or at all. New debt financing may require the cooperation and agreement of our existing lenders. If acceptable alternative financing were unavailable, we would have to consider alternatives to fund the repayment of the debt, which could materially and adversely affect our business, financial condition and results of operations.

Reworded

Under the Tax Cuts and Jobs Act, as modified by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, U.S. federal net operating losses (“NOLs”) incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal NOLs is limited. It is uncertain if and to what extent various states will conform to the Tax Cuts and Jobs Act. To the extent that we continue to generate taxable losses for United States federal income tax purposes, unused NOLs will carry forward to offset future taxable income (subject to any applicable limitations), if any. Under Sections 382 and 383 of the Internal Revenue Code, as amended, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be significantly limited. We believe we may have triggered an “ownership change” limitation; however, we have not completed a study in accordance with Sections 382 and 383 of the Code to determine whether this ownership change has occurred or what the possible effects of an ownership change would be on our ability to use NOLs. We may also experience ownership changes in the future as a result of subsequent shifts in our share ownership. As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset U.S. federal or state taxable income may be subject to limitations, which could potentially result in increased future tax liability to us. Similar provisions of U.S. state tax law may also apply to limit our use of accumulated state tax attributes, including our state NOLs. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. As a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and other tax attributes, which could negatively impact our future cash flows.

Reworded

We are highly dependent upon our relationship with CSL Seqirus to further research, manufacture and commercialize self-amplifying mRNA vaccines against COVID-19, influenza and three other infectious diseases.diseases; CSL Seqirus has announced a significant write-down of the licensed collaboration programs.

Reworded

In November 2022, we entered into the CSL Collaboration Agreement with CSL Seqirus, for the research, manufacture and global commercialization of self-amplifying mRNA vaccines against COVID-19, influenza and three other infectious diseases. If such relationship is unsuccessful, or if CSL Seqirus terminates its collaboration agreement with us, or if we determine it wouldis in our best interests to terminate the agreement, it could negatively impact our ability to conduct our business and generate net product revenue. Failure by CSL Seqirus to perform its duties under its collaboration agreement with us may negatively affect us. TheIn potentialCSL financialLimited’s returnshalf-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to us under our collaboration agreementsagreement with CSL SeqirusSeqirus, dependsciting decline in largethe partCOVID-19 onmarket and more onerous U.S. regulatory requirements. Such action and CSL’s statements indicate that CSL Seqirus no longer believes that the achievementcollaboration assets will generate sufficiently probable, risk-adjusted economic benefits. The development of milestonesthe licensed assets and generationeven ofcommercialization productactivity sales.may be significantly impacted. If CSL Seqirus failsceases, to performsuspends or satisfymaterially its obligations under the collaboration agreement or if we otherwise encounter disagreement with CSL Seqirus regarding the satisfaction of milestones, thereduces development and commercialization activities of our technology under the licensedCSL programs could be delayed, hindered or may not occur andCollaboration, our business and prospects could be materially and adversely affected. TheAny fulfillmentdisagreement with CSL Seqirus regarding the satisfaction of ourmilestones, or of CSL Seqirus’ obligations undertoward development or commercialization of the CSLlicensed Collaborationprograms, Agreementcould result in a dispute that could result in termination of a program, and possibly costly litigation or arbitration which may requiredivert significantmanagement deployment of our resources, which could disrupt or delay our ability to pursue other programs, including our platform developmentattention and development of other product candidates.resources.

Added

A potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.

Added

Reports that CSL Limited intends to separate or spin off its vaccine business, including its subsidiary CSL Seqirus, could disrupt or adversely affect our collaboration with CSL Seqirus and materially harm our business. We cannot predict the timing, terms, structure, or ultimate consummation of any potential separation, and even the announcement or pendency of such a transaction may create uncertainty and execution risk that could adversely affect CSL Seqirus’s performance under our agreements and, as a result, our programs, timelines and costs. For example, a separation could lead to shifting strategic priorities, changes in management focus, or reduced access to corporate resources, capital, manufacturing networks or commercial infrastructure previously available to CSL Seqirus as part of the CSL group. In addition, any stand‑alone entity may have a different risk profile, capital structure, credit quality, or appetite for development and commercial investment, which could impair its ability or willingness to satisfy funding, diligence, supply, or commercialization obligations or to continue programs that were prioritized prior to the separation.

Reworded

If the prevalence of COVID-19 and public concern about the virus continues to decline, the potential market opportunity will shrink for KOSTAIVE under our collaboration with CSL Seqirus. AsFurther, furtheras additional COVID-19 vaccines are approved,approved and production of existing COVID-19 vaccines improves and the COVID-19 impact transitions from pandemic to endemic stage,improves, there may be downward pressure on prices. Therefore, even if we and CSL Seqirus can get through the extremely costly, long and risky process of developing and obtaining regulatory approval to market a vaccine globally, it may not be commercially successful. This failure could be due to reduced demand for COVID-19 vaccines, increased regulatory hurdles, lower prices, distribution problems, competitors’ products or many other reasons. Our manufacturing process for KOSTAIVE includes a step for lyophilization to enhance the stability of the vaccine product. The additional step of lyophilization adds time and costs to the overall production output, which could adversely impact the production volumes and profitability of our COVID-19 vaccines if approval to market a vaccine is achieved. Any changes to our manufacturing processes or our product format could take a long time, be expensive and be unsuccessful. It is also still unclear if the vaccines will enable adequate long-term protection, as (i) many vaccinated individuals have become ill due to “breakthrough infections” and have transmitted the virus to many others, (ii) there are millions of individuals who refuse to be vaccinated or who cannot be vaccinated due to pre-existing conditions, (iii) it is unclear how long the vaccine protection will last, and (iv) genetic mutations or variants of the virus already have had, and are expected to continue to have, an adverse impact on the efficacy of available vaccines. If we cannot, with and through our partner, develop and commercialize a vaccine that adequately addresses some of these shortcomings of vaccines currently on the market, we cannot expect to have commercial success.

Reworded

We are relying on our partner, CSL Seqirus, and CSL Seqirus’ partner, Meiji Seika Pharma (Meiji), to conduct further development and commercialization of KOSTAIVE in Japan. Even if KOSTAIVE continues to be commercialized in Japan, there might not be meaningful sales, due to competition, pricing, product profileprofile, vaccine uptake by the public or other factors. JapaneseTo regulatorydate, agenciesdemand for KOSTAIVE in Japan has been weak, and purchasersfuture mightsales requiremay involvement of Japanese companies in the domestic production of our COVID-19 vaccine,decrease and our Japanese partners andmay contract manufacturers might not be abledecide to scalecease up to commercial quantities. If any such Japanese companies do not participate or fail in such activities, then our and our partners’ ability to commercialize our COVID-19 vaccine will be materially harmed.commercialization. Although KOSTAIVE has received approval in Europe, KOSTAIVE has not, and might never, achieve commercialization in Europe, due to a numbers of factors, such as the competitiveness of different product presentations and formats and the wide market penetration of existing COVID-19 vaccine makers.

Reworded

Even with the partnering of our COVID-19 program and initial commercialization in Japan, we are already at a significant competitive disadvantage to those companies with vaccines on the market, as well as many other competitors pursuing vaccine candidates. Many other competitors have significantly greater product candidate development, manufacturing and marketing resources than we do. Larger pharmaceutical and biotechnology companies have extensive experience in clinical testing and obtaining regulatory approval for their products, and may have the resources to heavily invest to accelerate discovery and development of their vaccine candidates. Our business could be further materially and adversely affected by our competitors’ commercialization of their vaccines before our vaccine candidate is approved in various countries. If the COVID-19 vaccines of our competitors are shown to be are safer, more effective against multiple variants, have fewer or less severe side effects, have broader market acceptance, are more convenient or are less expensive than any vaccine candidate than KOSTAIVE, then KOSTAIVE may not achieve any commercial success even where approved. Furthermore, if any competitors are successful in producing a more efficacious vaccine or other treatment for COVID-19, or if any competitors are able to manufacture and distribute any such vaccines or treatments with greater efficiency, there may be a diversion of potential governmental and other funding away from us and toward such other parties.

Reworded

The biotechnology and pharmaceutical industries are intensely competitive. We have competitors both in the United States and internationally, including major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions. Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing, regulatory and manufacturing organizations. Additional mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. Our competitors may succeed in developing, acquiring or licensing on an exclusive basis, drug products that are more effective, safer or less costly than any product candidate that we may develop. Our existing competitors and new market entrants may respond more quickly to or integrate new or emerging technologies such as artificial intelligence and machine learning, undertake more extensive marketing campaigns, have greater access to clinical information to support ongoing product position in the market, have greater financial, marketing and other resources or be more successful in attracting potential customers, employees and strategic partners. There can be no assurance that any products now in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval or gain market acceptance. If we are unable to develop and launch new products, our ability to maintain or expand our market position in the markets in which we participate may be negatively impacted. Our competitors may achieve patent protection, regulatory approval, or product commercialization that would limit our ability to compete with them. These and other competitive pressures could have a material adverse effect on our business.

Reworded

If any of our product candidates cause undesirable side effects or have other properties impacting safety, theirapprovals to proceed with further clinical trials may be denied or delayed and regulatory approval could be prevented, delayed or limited.

Reworded

Undesirable side effects caused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trialstrials, or to deny or delay approvals to proceed with further clinical trials, and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. It is likely that there will be side effects associated with use of our product candidates. If results of our trials reveal a high and unacceptable severity and prevalence of side effects, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of, or deny approval of, our product candidates for any or all targeted indications. Such side effects could also affect patient recruitment, the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may materially and adversely affect our reputation and financial condition.

Added

Our rare disease candidates, even if approved, might not have a profitable commercial market.

Added

Rare diseases, by definition, have a relatively small population of patients, thereby limiting the potential market size and increasing pressure on the pricing of drug products in order to have a profitable market opportunity. Further, our rare disease therapeutic candidates require dosing of drug substance in far greater quantities than in our vaccine candidates, which significantly increases the costs of manufacture. Such factors, along with political and societal pressure to minimize pricing, could impact the ability of our products to have sustainable and profitable commercial markets. Therefore, even if we can get through the extremely costly, long and risky process of developing and obtaining regulatory approval to market a drug candidate, it may not be commercially successful.

Added

Current regulatory authorities in the United States may change or institute policies that increase challenges for clinical development, regulatory approval and commercialization of our vaccine and other programs

Added

Leadership and policy priorities at the HHS and the FDA have changed and may continue to evolve, which could result in modifications to regulatory requirements, approval standards or development pathways applicable to vaccines and therapeutic products. Although certain regulatory initiatives may be intended to streamline development, recent FDA guidance has adversely affected the timing and expected costs of our programs. On September 5, 2025, the week prior to our planned submission of a Biologics License Application for KOSTAIVE, the FDA requested that we delay our submission and in October 2025 informed us that, although the FDA had previously agreed that our proposed data package could support a single-dose indication, upon further consideration it found that additional data from a clinical endpoint efficacy will be needed based on a revised COVID-19 vaccine regulatory framework. In addition, changes in governmental policies, funding priorities, or staffing levels, including reductions in force or work stoppages affecting federal agencies, could delay regulatory review processes or otherwise negatively impact the development, approval or commercialization of our product candidates. Any such developments could materially adversely affect our business, financial condition and results of operations.

Removed

In addition, the new 2025 U.S. presidential administration has implemented or threatened reductions in force and work stoppages across several U.S. federal agencies. Any such reductions or stoppages at the FDA or other federal agencies could delay the approval or review processes for any of our products and product candidates, which could negatively impact our business and results of operations. In addition, the new presidential administration may institute policies, communications or programs that could negatively impact the biotechnology industry, vaccine products and our ability to raise additional financing.

Reworded

KOSTAIVE has received marketing approval in Japan and Europe,Europe and we intend to make efforts tomay expand into other countries outside of the United States for such product and for future potential products. As a result, we are and expect that we will be subject to additional risks related to entering into international business relationships, including:

Removed

In addition, we cannot be certain if and when we will obtain formulary approval to allow us to sell any products into our target markets. Obtaining formulary approval from hospitals and from pharmacy benefits payors can be an expensive and time-consuming process. Failure to obtain timely formulary approval will limit our commercial success.

Removed

There have been a number of legislative and regulatory proposals to change the healthcare system in the United States and in some foreign jurisdictions that could affect our ability to sell products profitably. These legislative and/or regulatory changes may negatively impact the reimbursement for drug products, following approval. The availability of numerous generic treatments may also substantially reduce the likelihood of reimbursement for our future products. We expect to experience pricing pressures in connection with the sale of any products that we develop, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, and prescription drugs in particular, has and is expected to continue to increase in the future. For instance, government and private payors who reimburse patients or healthcare providers are increasingly seeking greater upfront discounts, additional rebates and other concessions to reduce prices for pharmaceutical products. If we fail to successfully secure and maintain sufficient reimbursement coverage for our future products or are significantly delayed in doing so, we will have difficulty achieving market acceptance of our future products and our business will be harmed.

Removed

In addition, in some non-U.S. jurisdictions, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product, or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. If any country that has price controls or reimbursement limitations for pharmaceutical products does not allow favorable reimbursement and pricing arrangements for any of our products, our sales and profits from that product could be severely limited. Historically, products launched in the EU do not follow price structures of the U.S. and generally tend to be priced significantly lower.

Added

A potential separation of CSL Seqirus could disrupt our collaboration and materially harm our business.

Added

Reports that CSL Limited intends to separate or spin off its vaccine business, including its subsidiary CSL Seqirus, could disrupt or adversely affect our collaboration and materially harm our business. We are party to a strategic collaboration with CSL Seqirus for the development and commercialization of mRNA vaccines for COVID-19, influenza and certain other infectious diseases. We cannot predict the timing, terms, structure, or ultimate consummation of any potential separation, and even the announcement or pendency of such a transaction may create uncertainty and execution risk that could adversely affect CSL Seqirus’s performance under our agreements and, as a result, our programs, timelines and costs. For example, a separation could lead to shifting strategic priorities, changes in management focus, or reduced access to corporate resources, capital, manufacturing networks or commercial infrastructure previously available to CSL Seqirus as part of the CSL group. In addition, any stand‑alone entity may have a different risk profile, capital structure, credit quality, or appetite for development and commercial investment, which could impair its ability or willingness to satisfy funding, diligence, supply, or commercialization obligations or to continue programs that were prioritized prior to the separation.

Added

We have filed a lawsuit alleging trade secret misappropriation and breach of contract, and any unfavorable outcome or related proceedings could materially and adversely affect our business, financial condition, results of operations, and reputation.

Added

On September 23, 2025, we filed a lawsuit in the United States District Court for the Southern District of California against AbbVie Inc., Capstan Therapeutics, Inc., and other defendants asserting claims for trade secret misappropriation and breach of contract. The defendants filed a motion to discuss the complaint in December 2025, and we filed an opposition to that motion in January 2026. The Court has not set a case schedule. Litigation is inherently uncertain, time-consuming, and costly. We may not prevail on our claims, and the defendants may assert counterclaims against us, including challenges to our intellectual property or allegations of our own misconduct, any of which could result in adverse rulings, monetary judgments, fee or cost awards, or other relief that may be material. Even if we are successful in whole or in part, the litigation could result in substantial expense, divert management’s attention and operational resources, disrupt relationships with partners, collaborators, or customers, and require the disclosure of sensitive information in discovery that could diminish the value of our trade secrets or other confidential information. The court could deny our requested relief, limit the scope of our asserted rights, or otherwise issue rulings that adversely affect our ability to protect, use, or commercialize our intellectual property and technology. In addition, associated proceedings, including motions practice, discovery disputes, and potential appeals, could be protracted and unpredictable, particularly given that the court has not yet established a case schedule. Any of these outcomes could negatively impact our competitive position, delay or impede our research, development, manufacturing, or commercialization activities, and result in increased legal and compliance costs. As a result, this litigation and any related proceedings could materially and adversely affect our business, financial condition, cash flows, and results of operations.

Reworded

In addition, the EU has established its own data security and privacy legal framework, including but not limited to Directive 95/46/EC (the “Data Protection Directive”). The European General Data Protection Regulation (“GDPR”) took effect on May 25, 2018, which contains new provisions specifically directed at the processing of health information, higher sanctions and extra-territoriality measures intended to bring non-Enon-EU companies under the regulation. We anticipate that over time we may expand our business operations to include additional operations in the EU, including potentially conducting preclinical and clinical trials. With such expansion, we would be subject to increased governmental regulation in the EU countries in which we might operate, including regulation due to the GDPR.

Added

Our use of artificial intelligence technologies may expose us to operational, cybersecurity, legal and reputational risks.

Added

We permit the use of certain artificial intelligence (“AI”) tools, including large language models and AI agents hosted in data centers located in the United States. We have adopted certain enterprise AI platforms, which our employees may access following internal review and approval processes. We also utilize data exfiltration detection technologies designed to monitor AI usage and alert our security team to potential unauthorized or unsanctioned use. AI systems may generate inaccurate, incomplete or misleading outputs, which could result in operational errors, flawed decision-making or the dissemination of incorrect information. In addition, employees may inadvertently input confidential, proprietary or sensitive information into AI tools, which could result in unauthorized disclosure, cybersecurity incidents, regulatory scrutiny, litigation or reputational harm. Our reliance on third-party AI providers also subjects us to risks relating to service disruptions, security vulnerabilities, or changes in provider policies or pricing. The legal and regulatory framework governing AI is rapidly evolving, and new laws or regulations could restrict our use of AI technologies or increase compliance costs. If we fail to effectively manage risks associated with AI use, our business, financial condition and results of operations could be adversely affected.

Added

A prolonged U.S. federal government shutdown could materially and adversely affect our business, operations, and legal proceedings.

Added

On October 1, 2025, the federal government of the United States began a shutdown at 12:01 a.m. EDT as a result of congressional failure to pass appropriations legislation for the 2026 fiscal year, which began that day, and lasted for 43 days. Subsequent partial federal government shutdowns occurred in January and February of 2026. A continued and prolonged shutdown could materially and adversely affect our business, operations, financial condition, and legal matters. A federal government shutdown may result in the furlough of federal employees, reduced availability of government services, and suspension or delay of activities by key agencies that regulate, fund, or interact with our business, including the SEC, the FDA, the HHS, and the U.S. Patent and Trademark Office. During such periods, review and approval of our filings, applications, and submissions could be delayed, and we may be unable to access or rely upon certain government data or systems. In addition, the Administrative Office of the U.S. Courts and federal judiciary operations rely on appropriated funds and fee-based reserves that may be exhausted in the event of an extended shutdown. If federal court funding lapses or is limited to “essential” functions only, civil litigation, bankruptcy proceedings, and regulatory enforcement actions involving us or our affiliates could be postponed or suspended. Any such delay could impede our ability to resolve disputes, enforce contractual rights, or obtain timely judicial relief, which may have a material adverse effect on our financial position or prospects. Such conditions could negatively impact our access to financing, timing of capital-raising transactions, and the liquidity or trading volume of our securities. Accordingly, the current federal government shutdown, or uncertainty regarding the continuity of government operations could have a material adverse effect on our business, results of operations, and stock price.

Removed

We have identified a material weakness in our internal control over financial reporting, and determined that our disclosure controls were not effective as of December 31, 2023 and December 31, 2024. If our remediations of this material weakness are not effective, or if we experience additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, we may not be able to accurately and timely report our financial results, in which case our business may be harmed, investors may lose confidence in the accuracy and completeness of our financial reports, and the price of our common stock may decline.

Removed

Our management is responsible for establishing and maintaining adequate internal control over financial reporting and for evaluating and reporting on the effectiveness of our system of internal control. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external reporting purposes in accordance with generally accepted accounting principles (“GAAP”). We are required to furnish annually a report by management of its assessment of the effectiveness of our internal control over financial reporting as of the end of our most recent fiscal year. In addition, our independent registered public accounting firm is required to provide a related attestation report on our internal control over financial reporting.

Removed

As previously reported, as part of our assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023, management identified a material weakness related to information technology general controls (“ITGCs”) for information systems and applications that are relevant to the preparation of the consolidated financial statements. Specifically, it was determined we did not design and maintain: (i) sufficient user access controls to ensure appropriate segregation of duties and adequately restrict user and privileged access to financial applications, programs and data to the appropriate personnel; (ii) program change management controls to ensure that information technology (“IT”) program and data changes affecting financial IT applications and underlying accounting records are identified, tested, authorized and implemented appropriately; and (iii) computer operations controls to ensure that critical batch and interfaced jobs are monitored, privileges are appropriately granted, and data backups are authorized and monitored. Business process controls (automated and manual) that are dependent on the ineffective ITGCs, or that rely on data produced from systems impacted by the ineffective ITGCs, are also deemed ineffective. Management also identified a material weakness related to revenue recognition. Certain control activities within the area of revenue did not operate effectively, specifically controls over the review of costs incurred in satisfaction of our performance obligations under collaboration arrangements. Although we remediated the material weakness related to revenue recognition, management does not believe the corrective measures adopted in response to the ITGC-related material weakness have been fully implemented or operating for a sufficient period of time to enable management to conclude these internal controls over financial reporting are operating effectively and sufficiently to remediate this material weakness. As such, we concluded that our disclosure controls and procedures were not effective as of December 31, 2024.

Removed

If we are unable to successfully remediate our existing material weakness or any future material weakness or other deficiencies in our internal control over financial reporting: the accuracy and timing of our financial reporting may be adversely affected; our liquidity, our access to capital markets and the perceptions of our creditworthiness; we may be unable to maintain compliance with applicable securities laws, Nasdaq listing requirements, and the covenants under our debt instruments regarding the timely filing of periodic reports; we may be subject to regulatory investigations and penalties; and investors may lose confidence in our financial reporting. If any such event or circumstance were to occur, our stock price could decline and our business, financial condition and results of operations could be materially adversely affected.

Removed

Notwithstanding the identified material weakness, management does not believe that the deficiencies had an adverse effect on our reported operating results or financial condition, and management has determined that the financial statements and other information included in this report and other periodic filings present fairly in all material respects our financial condition and results of operations at and for the periods presented. The effectiveness of our internal control over financial reporting as of December 31, 2024 has been audited by Deloitte & Touche LLP, an independent registered public accounting firm, as stated in their report which is included elsewhere herein. For further discussion of the material weakness identified and our remedial efforts, see Item 9A. Controls and Procedures.

Reworded

The trading price of our common stock has been and is likely to continue to be volatile. For example, during the year ended December 31, 2025, our Common Stock closed at a high price of $23.16 on October 21, 2025 and closed at a low price of $5.90 on November 20, 2025. Our share price could be subject to wide fluctuations in response to a variety of factors, including but not limited to the following factors:

Reworded

If our existing shareholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline significantly. In particular, the former shareholders, warrant holders and noteholdersAs of ArcturusDecember Therapeutics,31, Inc.2025, received2,048,139 an aggregate of 6,631,712shares of our common stock pursuant to the merger with Alcobra Ltd. in an unregistered transaction, which shares may be sold pursuant to Rule 144 under the Securities Act of 1933, as amended (the “Securities Act”). Those shareholders are eligible to sell those shares in the public market without restriction, except for shareholders who are deemed our “affiliates” under Rule 144 under the Securities Act. In addition, common stock that is either subject to outstanding options or reserved for future issuance under our employee benefit plans, may become eligible for sale in the public market to the extent permitted by vesting schedules and Rule 144 under the Securities Act. If common stock is sold, or if it is perceived that it will be sold, in the public market, that could cause the trading price to decline.

Reworded

On December 23, 2022, we entered into a Controlled Equity Offering℠ Sales Agreement (as amended, the “Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) and Wells Fargo Securities, LLC (“Wells Fargo”), relating to shares of our common stock. On August 7, 2023, we entered into Amendment No. 1 to the Sales Agreement with Cantor, Wells Fargo and William Blair & Company (“William Blair”). In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $200,000,000 from time to time through Cantor, Wells Fargo, or William Blair, each acting as our sales agent. As of the date hereof, we have not offered or sold anyan aggregate of 1,179,201 shares of our common stock pursuantunder tothe Sales Agreement for aggregate gross proceeds of approximately $12 million, leaving an aggregate of approximately $188 million of shares of our common stock remaining for future sale under the Sales Agreement.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

14new paragraphs
12removed paragraphs
19reworded paragraphs
5,587 → 5,774words in section

Removed heading “Vinbiocare Agreement”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: breach, labor
“Either party may terminate the CSL Collaboration Agreement on a field-by-field basis for material breach by the other party, following notice and opportunity to cure. CSL Seqirus may also terminate the collaboration agreement in its entirety or on a field-by-field basis for any reason or no reason whatsoever, with certain limitations. The CSL Collaboration Agreement may also be terminated by CSL Seqirus for safety reasons, clinical data nonviability, commercial nonviability and other specified reasons.”
see in full comparison
Reworded topics: write-down, labor

Paragraph as it now reads, with added and removed wording marked:

Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, we have partnered with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited andSeqirus, one of the world’s leading influenza vaccine providers, on the development and commercialization of mRNA vaccines for COVID-19, influenza and certainthree other infectious diseases. In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.
see in full comparison
New text topics: european commission, labor
“On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE®in the European Union.”
see in full comparison
New text topics: write-down, labor
“In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.”
see in full comparison
New text topics: pandemic, labor
“We received an up-front payment of $200.0 million, with the potential to receive development milestones totaling more than $1.3 billion if all products are registered in the licensed fields. We also are entitled to potentially receive up to $3.0 billion in commercial milestones based on “net sales” of vaccines in the various fields. In addition, we are entitled to receive a 40% share of net profits from COVID-19 vaccine sales and up to low double-digit royalties of annual net sales for vaccines against influenza, pandemic preparedness and three additional infectious diseases. …”
see in full comparison
Reworded topics: antitrust, labor

Paragraph as it now reads, with added and removed wording marked:

In November 2022, we entered into the CSL Collaboration Agreement with CSL Seqirus, a part of CSL Limited, one of the world’s leading influenza vaccine providers,Seqirus for the global exclusive rights to research, develop, manufacture and commercialize self-amplifying mRNA vaccines. The CSL Collaboration Agreement became effective on December 8, 2022, following clearance under the Hart-Scott-Rodino Antitrust Improvements Act.
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Full comparison: every changed paragraph (45)

Green = added, red = removed. Unchanged paragraphs, 6 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Added

We are a messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics. We have ongoing Phase 2 clinical studies for our RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF).

Reworded

We are a messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases. We developed the world’s first approved self-amplifying messenger RNA (sa-mRNA) vaccine, KOSTAIVE® (“KOSTAIVE”)., which we have partnered with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited. KOSTAIVE has achieved approval in JapanJapan, inthe 2023European Union and the United Kingdom as a vaccine against COVID-19.COVID-19, Salesand sales of KOSTAIVE began in Japan in October 2024, marking our transition to a commercial stage company.2024.

Reworded

We have several key platform technologies that we leverage to develop and advance a pipeline of mRNA-based vaccines and therapeutics for infectious diseases and for rare genetic disorders with significant unmet medical needs.needs and vaccines for infectious diseases. Current mRNA medicines have two critical components: the messenger RNA (“mRNA”) constructs and the lipid nanoparticles (“LNP”) which help deliver the mRNA to disease-relevant target tissues. We believe we are among the world leaders in both areas. We have extensive expertise in the design and optimization of mRNA constructs, including with respect to a type of mRNA technology known as self-amplifying mRNA (sa-mRNA). Our proprietary self-amplifying mRNA technology platform, or STARR® (“STARR”), has been demonstrated to induce a robust, longer-lasting and broader humoral immune response at lower dose levels than conventional mRNA-based vaccines. Our proprietary LNP delivery system, LUNAR® (“LUNAR”), is intended to address the major hurdle in RNA drug development, namely the effective and safe delivery of RNA therapeutics to disease-relevant target tissues. LUNAR may enable multiple nucleic acid medicines. TheWe approval of KOSTAIVE in Japan was a significant milestone which validates our LUNAR and STARR platforms, as well as sa-mRNA more generally as a meaningful modality. Finally, wealso have significant expertise and valuable know-how in the development and scalability of complex and robust manufacturing processes required to deliver the next generation of nucleic acid medicines.

Reworded

Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, we have partnered with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited andSeqirus, one of the world’s leading influenza vaccine providers, on the development and commercialization of mRNA vaccines for COVID-19, influenza and certainthree other infectious diseases. In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.

Added

In our CF program, we enrolled and completed dosing in the three initially planned cohorts of our Phase 2 multiple ascending dose study of ARCT-032, confirming the safety and tolerability of ARCT-032 dosed daily for four weeks. This study was initiated in December 2024 and was designed to identify a safe and effective dose regimen in those with Class I (null) CFTR mutations and people with CF who do not benefit from CFTR modulators. In the study, six CF adults with Class I CFTR mutations inhaled 10 mg doses of ARCT-032 daily over 28 days. Interim results released in October 2025 demonstrated that the treatment was generally safe and well tolerated. Treatment-related adverse events (AEs) that were identified in the single-dose Phase 1 study were also observed in some participants for the first few doses but ceased with continued dosing. Bronchospasm has not been reported in this study thus far, neither with nor without albuterol pretreatment. One serious adverse event (SAE) occurred in a participant after the end of the dosing period. The safety review committee found no convincing evidence that the SAE is related to ARCT-032 and approved the study to proceed. We intend to initiate a 12-week safety and preliminary efficacy study in up to 20 CF participants in the first half of 2026, after the third cohort completes treatment. ARCT-032 has received Orphan Drug Designation by the U.S. Food and Drug Administration (the “FDA”) and Orphan Medicinal Product Designation by the European Medicines Agency (the “EMA”) for the treatment of CF, and Rare Pediatric Disease Designation from the FDA.

Removed

We made significant progress in 2024. Commercial sales of KOSTAIVE began in October 2024 in Japan by Meiji Seika Pharma (“Meiji”), CSL Seqirus’ exclusive partner in Japan, marking the first commercial sales of an Arcturus-developed product. In February 2025, we received approval of KOSTAIVE from the European Commission (EC), which provided further validation of our platform by another significant regulatory authority.

Removed

We initiated dosing in a Phase 1 clinical trial of a novel seasonal influenza sa-mRNA vaccine candidate under our collaboration with CSL Seqirus in January 2024. In December 2024, we initiated dosing of an sa-mRNA vaccine candidate against pandemic avian influenza (bird flu) in a Phase 1 trial funded by the Biomedical Advanced Research and Development Authority (“BARDA”).

Reworded

In our OTC program, we completedhave dosingcontinued ofto eight subjects in August 2024 inconduct a Phase 2 double-blind multiple-dose study of ARCT-810. InFive patients with OTC deficiency have now completed dosing, and a sixth patient has initiated dosing. A type C meeting with the secondFDA quarterto discuss our plans for a proposed future pediatric study under the RDEP (Rare Disease Evidence Principles) is scheduled for the first half of 2024, we expanded the Phase 2 clinical program of ARCT-810 with an open-label, multiple-dose study which initiated dosing in December 2024.2026. ARCT-810 has received Orphan Drug Designation from the FDA and Orphan Medicinal Product Designation from the European Medicines Agency (the “EMA”) for treatment of OTC deficiency, as well as Fast Track Designation and Rare Pediatric Disease Designation from the FDA.

Added

Commercial sales of KOSTAIVE began in October 2024 in Japan by Meiji Seika Pharma, Ltd. (“Meiji”), CSL Seqirus’ exclusive partner in Japan, marking the first commercial sales of an Arcturus-developed product. In September 2025, Meiji launched a new presentation of KOSTAIVE in Japan. The product is a 2-dose vial lyophilized presentation incorporating the updated XEC variant strain. Approval for offshore manufacturing of the 2-dose vial lyophilized presentation was granted by Japan in August 2025, followed by approval for onshore manufacturing in January 2026. KOSTAIVE was approved by the European Commission (EC) in February 2025 and by the United Kingdom in January 2026, providing further validation of our platform by additional significant regulatory authorities.

Added

In December 2024, we initiated dosing of an sa-mRNA vaccine candidate against pandemic avian influenza (bird flu) in a Phase 1 trial funded by the Biomedical Advanced Research and Development Authority (“BARDA”). The study results were received in the second half of 2025, indicating a favorable tolerability and safety profile and the ability to induce a robust and durable humoral immune response in young and older adults.

Removed

In our CF program, we initiated dosing in December 2024 in a Phase 2 multiple ascending dose study of ARCT-032 designed to identify a safe and effective dose in people with Class I (null) CFTR mutations and other CF patients who do not benefit from CFTR modulators. In July 2024, we completed dosing and follow-up visits for seven participants in a safety and tolerability Phase 1b clinical study in New Zealand of ARCT-032 in adults with CF. ARCT-032 has received Orphan Drug Designation by the FDA and Orphan Medicinal Product Designation by the EMA for the treatment of CF, and Rare Pediatric Disease Designation from the FDA.

Reworded

We also improved our platform technologies and advanced our early-stage research activities and manufacturing process development and operations. We conducted exploratory platform development activities, including the evaluation of genome editing, and new targeting approaches, where our LUNAR and STARR platforms could potentially be useful for identification and development of additional products for our portfolio. Also, with our sourcing partners, we manufactured cGMP (current good manufacturing practices) batches yielding significant quantities of clinical trial materials for global studies of our candidates, and with our collaborator, CSL Seqirus, we have established commercial production processes for the COVID-19 vaccine program.

Reworded

From the Company’s inception through the year ended December 31, 2024,2025, the Company has funded its operations principally with the proceeds from revenues earned through collaboration agreements and government contracts, the sale of capital stock and long-term debt. During fiscal year 2024,2025, we received milestone payments totaling $96.0$39.1 million from CSL Seqirus. We expect to receive future payments from CSL Seqirus primarily by meeting future milestones related to the CSL Collaboration Agreement. At December 31, 2024,2025, the Company’s balance of cash and cash equivalents, including restricted cash, was $293.9$232.8 million.

Reworded

In November 2022, we entered into the CSL Collaboration Agreement with CSL Seqirus, a part of CSL Limited, one of the world’s leading influenza vaccine providers,Seqirus for the global exclusive rights to research, develop, manufacture and commercialize self-amplifying mRNA vaccines. The CSL Collaboration Agreement became effective on December 8, 2022, following clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

Added

Under the CSL Collaboration Agreement, CSL Seqirus receives global exclusive rights to our technology for vaccines against SARS-CoV-2 (COVID-19), influenza and three other infectious diseases. Specifically, the collaboration agreement grants CSL Seqirus a license to our STARR mRNA technology and LUNAR lipid-mediated delivery, as well as mRNA drug substance and drug product manufacturing expertise. CSL has also been granted global non-exclusive rights in the field of pandemic preparedness (i.e., pathogens identified as priority diseases by the WHO), with the right to convert to an exclusive license.

Removed

CSL Seqirus received exclusive global rights to our technology for vaccines against SARS-CoV-2 (COVID-19), influenza and three other infectious diseases with non-exclusive rights to pandemic pathogens. We received an up-front payment of $200.0 million during the fourth quarter of 2022. We will be eligible to receive development milestones totaling more than $1.3 billion if all products are registered in the licensed fields. We will also be entitled to receive up to $3.0 billion in commercial milestones based on “net sales” of vaccines in the various fields.

Removed

In addition, we are entitled to receive a 40% share of net profits from COVID-19 vaccine sales and up to low double-digit royalties of annual net sales for vaccines against influenza and the other three specified infectious disease pathogens, as well as royalties on revenues from vaccines that may be developed for pandemic preparedness.

Reworded

The CSL Collaboration Agreement sets forth how CSLthe Seqirusparties and we shallwill collaborate to research and develop vaccine candidates. In the COVID-19 field, we will leadundertake activities for certain regulatory filings for ARCT-154our leading self-amplifying mRNA vaccine candidate in COVID-19, ARCT-154, in the USUnited States and Europe and for research and development activities of a next-generation COVID vaccine candidate. CSL Seqirus will leadleads and beis responsible for all other research and development in COVID-19, influenza and the other fields.

Added

We received an up-front payment of $200.0 million, with the potential to receive development milestones totaling more than $1.3 billion if all products are registered in the licensed fields. We also are entitled to potentially receive up to $3.0 billion in commercial milestones based on “net sales” of vaccines in the various fields. In addition, we are entitled to receive a 40% share of net profits from COVID-19 vaccine sales and up to low double-digit royalties of annual net sales for vaccines against influenza, pandemic preparedness and three additional infectious diseases. Entitlement to all such payments is subject to the strict conditions, requirements, royalty reduction provisions and other limitations set forth in the CSL Collaboration Agreement.

Added

Either party may terminate the CSL Collaboration Agreement on a field-by-field basis for material breach by the other party, following notice and opportunity to cure. CSL Seqirus may also terminate the collaboration agreement in its entirety or on a field-by-field basis for any reason or no reason whatsoever, with certain limitations. The CSL Collaboration Agreement may also be terminated by CSL Seqirus for safety reasons, clinical data nonviability, commercial nonviability and other specified reasons.

Added

In March 2024, we entered into Amendment Number Two to the CSL Collaboration Agreement to reflect updates to the development program and other adjustments consistent with our prior disclosures regarding the Collaboration and License Agreement (“Amendment Number Two”). Amendment Number Two, among other things, adjusts (i) the development plans for certain product candidates, (ii) various development milestones related to such product candidates, (iii) provisions of the CSL Collaboration Agreement related to specific royalty payments, (iii) provisions of the CSL Collaboration Agreement related to distributors, and (iv) proprietary payment calculations related to the foregoing.

Added

On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE®in the European Union.

Added

In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.

Reworded

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 agreed to make a $50.0 million revolving credit line available to the Company (as amended, the “Wells Fargo Loan”) with each Wells Fargo Loan evidenced by a revolving line of credit note (each, a “Note”). On June 26, 2024, the parties entered into Amendment No. 1 to the Wells Fargo Loan, whereby the term was extended by one year to April 2026. As of December 31, 2024, no borrowings were made against the Wells Fargo Loan.

Reworded

Borrowings under the agreement will bearbore interest at a rate of 1.00% above either the Daily Simple SOFR or Term SOFR (as such terms are defined in the Wells Fargo Loan), 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 credit agreement) occurs,had occurred, then all Wells Fargo Loans shallwould bear interest at a rate equal to 2.00% above the interest rate applicable immediately prior to the occurrence of the Event of Default.

Reworded

The original term of the agreement iswas 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 Wells Fargo Loan amount for each such renewal. There iswas no penalty for terminating the agreement.agreement There isand no penalty for terminating the facility prior to the maturity date of the Wells Fargo Loan. As collateral, the Company hashad 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.

Added

In December 2025, the Company terminated the credit agreement and related security agreement, and the $55.0 million of cash previously pledged as collateral was released and is no longer classified as restricted cash.

Removed

Vinbiocare Agreement

Removed

During 2021, we entered into a technology license and technical support agreement and the framework drug substance supply agreement with Vinbiocare, a member of Vingroup Joint Stock Company (collectively, the “Vinbiocare License & Supply Agreements”), whereby we would provide technical expertise and support services to Vinbiocare to assist in the build out of an mRNA drug product manufacturing facility in Vietnam. We received an upfront payment in aggregate of $40.0 million as part of the Vinbiocare License and Supply Agreements. In October 2022, in association with the termination of the Vinbiocare License and Supply Agreements, we signed the Vinbiocare Support Agreement with Vinbiocare which continues Vinbiocare’s clinical obligations and reserved a portion of the original $40.0 million upfront payment received from the License and Supply Agreements to be paid over the future periods.

Removed

The Vinbiocare Support Agreement requires us to pay to Vinbiocare certain limited payments, including upon the occurrence of specified events through the first quarter of 2025. Vinbiocare is also eligible to receive a single digit percentage of amounts received by Arcturus on net sales, if any, of ARCT-154 (or next-generation COVID vaccine) up to a capped amount.

Reworded

A portion of our current cash balance is expected to be utilized during fiscal year 20252026 to fund (i) advances to our LUNAR-CF program in clinical trials, (ii) the continued Phase 2 trial of ARCT-810, our LUNAR-OTC candidate, (ii) advances to our LUNAR-CF program in clinical trials, (iii) expenses incurred prior to customer payments under the CSL Collaboration Agreement and BARDA agreement and (iv) continued exploratory activities related to our platform and other general administrative activities.

Reworded

We expect to continue to incur additional losses in the long term, and we will need to execute on milestones within the CSL Collaboration Agreement, raise additional debt or equity financing or enter into additional partnerships to fund development. Our ability to transition to profitability is dependent on regulatory approvals and subsequent sales of KOSTAIVE, executing on milestones within the CSL Collaboration Agreement and identifying and developing other successful mRNA drug and vaccine candidates. If we are not able to achieve planned milestones or incur costs in excess of our forecasts, we will need to reduce discretionary spending, discontinue the development of some or all of our programs, which will delay part of our development programs, all of which will have a material adverse effect on our ability to achieve our intended business objectives.

Reworded

the development of our LUNAR-COV19cystic fibrosis and LUNAR-FLUOTC vaccinedeficiency therapeutic candidates;

Added

Net cash used in operating activities was $74.3 million for the year ended December 31, 2025, compared to $59.7 million for the year ended December 31, 2024. The $14.5 million increase was primarily due to a $29.7 million increase in accounts receivable and a $21.2 million decrease in accrued liabilities, reflecting the timing of billings, collections, and payments, as well as a $12.6 million decrease in share-based compensation due to reduced headcount and a lower stock price. These changes were partially offset by a $31.3 million smaller decrease in deferred revenue compared to the prior year, a $15.2 million reduction in net loss, a $7.5 million increase in cash provided by prepaid expenses and other assets, and the net impact of other working capital and non-cash items, which together reduced the overall increase in cash used in operating activities.

Removed

Net cash used in operating activities was $59.7 million for the year ended December 31, 2024, compared to $18.1 million for the year ended December 31, 2023. The $41.6 million increase in cash used was primarily driven by a $93.8 million year-over-year impact from deferred revenue, as 2023 benefited from a $38.6 million deferred revenue inflow, while 2024 saw a $55.2 million outflow due to revenue recognition exceeding new milestone payments under the CSL collaboration agreement. Additionally, the increase in cash outflows was due to a higher net loss and the absence of a $34.0 million debt extinguishment gain recognized in 2023. These impacts were partially offset by a $57.4 million improvement in accounts receivable, as payments from CSL and BARDA were received in 2024 and a $6.5 million increase in accrued liabilities, primarily due to the timing of bonus accruals.

Reworded

Net cash provided by financing activities was $5.4$13.4 million for the year ended December 31, 2024,2025, compared to a net cash outflow of $24.1$5.4 million in 2023 ,representing a $29.5 million increase.2024. The primary drivers of this increase were the repaymentsdriver of the Singaporeincrease Loanwas andan $11.7 million increase in proceeds from the Loanissuance andof Securitycommon stock under our Sales Agreement withfor Westernat‑the‑market Allianceequity Bankofferings, duringpartially 2023,offset withby noa similar$3.6 debtmillion repayments occurringdecrease in 2024.proceeds from the exercise of stock options.

Reworded

Revenue decreased by $14.5$70.3 million during the year ended December 31, 20242025 as compared to the year ended December 31, 2023.2024. The decrease during 20242025 primarily relates to a $15.9$72.2 million decrease in revenue related to the CSL collaboration agreement, primarily due to ana $82.0$33.1 million decrease in milestone achievements during 20242025 as compared to 2023,2024, offset byand a $23.4$15.8 million increasedecrease in revenue related to CSL commercial supply agreementsagreements, andalong increasedwith decreased revenue recognition from amortization dueduring to2025 theas progressa result of the CSLreduced development programs during 2024. The remaining decrease is primarily due to a decrease of $1.8 million related to the completion of the amortization of the upfront payment during 2023 from the 2015 Research Collaboration and License Agreement with Ultragenyx Pharmaceuticals, Inc., as well as $0.7 million less revenue in 2024 due the termination of the 2017 Research Collaboration and License Agreement with Janssen Pharmaceuticals, Inc.activities. The decrease was primarilypartially offset by an increase in thegrant revenue of $4.8$0.9 million related to the increase in reimbursable research and development expenses for the grant agreementagreements with BARDA.BARDA and the Gates Foundation.

Added

Our research and development expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel related expenses, facility related expenses and laboratory supplies related to conducting research and development activities.

Added

Research and development expenses were $112.2 million for the year ended December 31, 2025, compared with $195.2 million for the year ended December 31, 2024. The decrease was primarily driven by lower manufacturing and clinical costs related to the LUNAR‑COVID program, reflecting the program’s transition from a development program to the commercial phase. Additional decreases were attributable to lower manufacturing costs for the LUNAR‑CF and LUNAR‑FLU programs, as well as lower clinical costs associated with the LUNAR‑OTC program. These reductions were partially offset by higher clinical costs for Phase 2 of the LUNAR‑CF program. Payroll and benefits expenses also decreased, primarily due to lower stock‑based compensation expense and a reduction in headcount.

Removed

Our research and development expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel related expenses, facility related expenses and laboratory supplies related to conducting research and development activities. Research and development expenses were $195.2 million for the year ended December 31, 2024, compared with $192.1 million for the year ended December 31, 2023, primarily reflecting increased payroll and benefits costs due to share-based compensation expense, progress within our BARDA, LUNAR-CF, and LUNAR-FLU programs, and clinical trial costs for the LUNAR-COVID program. The overall increase was offset by decreased manufacturing-related expenses due to lower costs associated with drug product supply agreements related to the LUNAR-COVID program during the year ended December 31, 2024. We expect that our research and development efforts and associated costs will continue to be substantial over the next several years as our pipeline progresses.

Removed

Payroll and benefits primarily consists of employee salaries and benefits, share-based compensation and consultant costs. Although such expenses increased during 2024 as compared to 2023, we expect that they will not increase over the next twelve months due to reduced share-based compensation.

Reworded

Payroll and benefits primarily consists of employee salaries and benefits, share-based compensation and consultant costs. We expect that payroll and benefits costs will not increase over the next twelve months Facilities and equipment expenses include rent, common area maintenance (“CAM”) costs, depreciation, shipping costs and various other costs related to the operation of our two office and laboratory locations. These costs decreasedincreased duringprimarily 2024 as compareddue to 2023a aslease‑related weimpairment downsizedrecognized from three to two facilities. Facilities and equipment expenses are not expected to increase duringin the nextfourth twelvequarter months.after the Company vacated an office location with no further operational use.

Reworded

General and administrative expenses were $52.8$46.1 million and $52.9$52.8 million for the years ended December 31, 20242025 and 2023,2024, respectively. We expect that general and administrative expenses willThe decrease slightlywas during the next twelve monthsprimarily due to reduced share-based compensation fromexpense fullyas vestedwell stockas options.reduced payroll and benefits associated with reductions in headcount.

Removed

Interest expense decreased during the year ended 2024 as compared to the year ended 2023 as no interest expense has been incurred since to the first quarter of 2023. This was a result of the extinguishment of the Loan and Security Agreement dated October 12, 2018 with Western Alliance Bank, and forgiveness of the term loan from Economic Development Board of the Republic of Singapore pursuant to the Manufacturing Support Agreement dated November 7, 2020.

Reworded

Research and development costs consist of salaries and benefits, including share-based compensation, laboratory supplies and facility costs, as well as fees paid to other entities that conduct certain research and development activities on our behalf, such as clinical research organizations, or CROs, and contract manufacturing organizations, or CDMOs.CMOs. Research and development costs are expensed as incurred.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-06 (period ending 2026-06-30) with 10-Q filed 2026-05-07 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

3new paragraphs
2removed paragraphs
0reworded paragraphs
218 → 583words in section

New heading “The termination of our collaboration with CSL Seqirus requires us to advance, fund, and seek partners for our vaccine programs, and subjects us to additional risks and uncertainties.”

Removed heading “Geopolitical risks associated with ongoing wars and armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: labor
“The termination of our collaboration with CSL Seqirus requires us to advance, fund, and seek partners for our vaccine programs, and subjects us to additional risks and uncertainties.”
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Removed text topics: israel, middle east, supply chain
“Geopolitical developments related to ongoing global conflicts and tensions are sources of uncertainty and risk, and may cause disruptions to global or regional markets, supply chains or operations in applicable regions, including those related to conflicts in the Middle East. We have and may continue to evaluate and engage in activities, including engagement of clinical sites, in the Middle East. Conflicts in the Middle East could disrupt operations of companies doing business in the region, including in Israel. …”
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Removed text
“Geopolitical risks associated with ongoing wars and armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.”
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New text topics: labor
“On August 3, 2026, we entered into a Termination and Settlement Agreement with CSL Seqirus pursuant to which we mutually terminated the CSL Collaboration Agreement, effective as of such date (the “Termination Agreement”). The CSL Collaboration Agreement provided CSL Seqirus with exclusive global rights to research, develop, manufacture, and commercialize mRNA vaccines against COVID-19, influenza, and other infectious diseases using our STARR® and LUNAR® platform technologies. …”
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New text topics: labor
“During the Northern Hemisphere 2026-2027 season (expected to end June 30, 2027), CSL Seqirus and Meiji Seika Pharma (“Meiji”) will continue to be responsible for commercializing KOSTAIVE® in Japan, and for future seasons, we will need to establish direct or indirect commercial arrangements with Meiji or another distributor for the Japanese market, and any other markets. Any disruption in the transition of activities, supply, or regulatory responsibilities could adversely affect sales of KOSTAIVE® in Japan and damage our relationships with key counterparties and regulators. …”
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Full comparison: every changed paragraph (5)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Added

The termination of our collaboration with CSL Seqirus requires us to advance, fund, and seek partners for our vaccine programs, and subjects us to additional risks and uncertainties.

Added

On August 3, 2026, we entered into a Termination and Settlement Agreement with CSL Seqirus pursuant to which we mutually terminated the CSL Collaboration Agreement, effective as of such date (the “Termination Agreement”). The CSL Collaboration Agreement provided CSL Seqirus with exclusive global rights to research, develop, manufacture, and commercialize mRNA vaccines against COVID-19, influenza, and other infectious diseases using our STARR® and LUNAR® platform technologies. Under the CSL Collaboration Agreement, CSL Seqirus was responsible for leading development and commercialization of vaccines in the licensed fields, and collaboration revenue has historically been a significant component of our total revenue. We now bear sole responsibility for all decisions regarding the development, manufacturing, and commercialization of these vaccine products. We have limited experience commercializing vaccine products independently, and we may need to build internal commercial capabilities, enter into new partnerships, or engage distributors in order to maximize value of the assets, and there can be no assurance that we will be able to do so on favorable terms or at all. Several of the vaccine programs are in early-stage development, which will require substantial additional capital and resources to advance. We do not expect to receive any further milestone payments, research funding, or profit-sharing payments under the CSL Collaboration Agreement. Under the Termination Agreement, we are also obligated to pay CSL Seqirus royalties and revenue-sharing on our future commercialization of these vaccine products and successor products if such products are covered by CSL Seqirus royalty-bearing intellectual property, which could reduce the profitability of our vaccine programs and make such programs less attractive to potential partners.

Added

During the Northern Hemisphere 2026-2027 season (expected to end June 30, 2027), CSL Seqirus and Meiji Seika Pharma (“Meiji”) will continue to be responsible for commercializing KOSTAIVE® in Japan, and for future seasons, we will need to establish direct or indirect commercial arrangements with Meiji or another distributor for the Japanese market, and any other markets. Any disruption in the transition of activities, supply, or regulatory responsibilities could adversely affect sales of KOSTAIVE® in Japan and damage our relationships with key counterparties and regulators. We have entered into a transition plan with CSL Seqirus for the orderly transfer of clinical trials, regulatory filings, intellectual property, and other materials, but there can be no assurance that such transition will be completed without delays or disruptions. We intend to evaluate strategic opportunities to maximize the value of the vaccine portfolio, including development, commercialization, and partnering opportunities, but there can be no assurance that we will identify suitable partners or enter into collaboration arrangements on favorable terms. The pursuit of multiple early-stage vaccine programs in parallel could strain our financial and operational resources and divert management attention from our rare disease therapeutic programs, which are our primary area of focus, and could have a material adverse impact on our business and results of operations.

Removed

Geopolitical risks associated with ongoing wars and armed conflicts could have an adverse impact on our business, financial condition and results of operations, including our clinical trials.

Removed

Geopolitical developments related to ongoing global conflicts and tensions are sources of uncertainty and risk, and may cause disruptions to global or regional markets, supply chains or operations in applicable regions, including those related to conflicts in the Middle East. We have and may continue to evaluate and engage in activities, including engagement of clinical sites, in the Middle East. Conflicts in the Middle East could disrupt operations of companies doing business in the region, including in Israel. Any significant changes in the political, economic, financial, competitive, legal and regulatory or reimbursement conditions where we conduct, or plan to expand, our international operations may have a material impact on our business, financial condition or results of operations.

Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

21new paragraphs
18removed paragraphs
23reworded paragraphs
3,627 → 4,184words in section

New heading “Thermo Fisher Agreement”

New heading “Master Services Agreement”

New heading “Project Agreement”

New heading “KOSTAIVE® for Japan”

New heading “Thermo Fisher Agreement”

Removed heading “Marketing Authorization Application filing of KOSTAIVE in United Kingdom”

Removed heading “Wells Fargo Credit Agreement”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: investigation, labor
“On June 26, 2026, we entered into a series of agreements with Thermo Fisher Scientific Inc. (“Thermo Fisher”) and certain of Thermo Fisher’s affiliates to establish a strategic collaboration for the provision of contract development and manufacturing organization (“CDMO”) and contract research organization (“CRO”) services in connection with the development of ARCT-032, our investigational mRNA therapeutic for cystic fibrosis (“CF”). …”
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Removed text topics: write-down, labor
“Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, we have partnered with CSL Seqirus, one of the world’s leading influenza vaccine providers, on the development and commercialization of mRNA vaccines for COVID-19, influenza and other infectious diseases. …”
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Removed text topics: european commission, labor
“On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE®in the European Union.”
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Removed text topics: write-down, labor
“In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.”
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Removed text
“Marketing Authorization Application filing of KOSTAIVE in United Kingdom”
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Removed text topics: pandemic, labor
“In November 2022, we entered into a Collaboration and License Agreement (as amended, the “CSL Collaboration Agreement”) with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited, and one of the world’s leading influenza vaccine providers, for global exclusive rights to research, develop, manufacture and commercialize self-amplifying mRNA vaccines against COVID-19, influenza and other infectious diseases and global non-exclusive rights to pandemic pathogens.”
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Full comparison: every changed paragraph (62)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

The following is a discussion of the financial condition and results of operations of Arcturus Therapeutics Holdings Inc. for the three-monththree periodand six months ended MarchJune 31,30, 2026. Unless otherwise specified herein, references to the “Company,” “Arcturus,” “we,” “our” and “us” mean Arcturus Therapeutics Holdings Inc. and its consolidated subsidiaries. You should read the following discussion and analysis together with the interim condensed consolidated financial statements and related notes included elsewhere herein. For additional information relating to our management’s discussion and analysis of financial conditions and results of operations, please see our Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Annual Report”), which was filed with the U.S. Securities and Exchange Commission (the “Commission”) on March 3, 2026. Unless otherwise defined herein, capitalized words and expressions used herein shall have the same meanings ascribed to them in the 2025 Annual Report.

Reworded

We developed the world’s first approved self-amplifying messenger RNA (sa-mRNA) vaccine, KOSTAIVE® (“KOSTAIVE”), which we have partnered with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited.. KOSTAIVE has achieved approval in Japan, the European Union and the United Kingdom as a vaccine against COVID-19, and sales of KOSTAIVE began in Japan in October 2024.

Added

Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, following termination of the CSL Collaboration Agreement, we regained strategic control of KOSTAIVE® and our broader vaccine portfolio, subject to ongoing arrangements with Meiji in Japan for the Northern Hemisphere 2026-2027 season.

Removed

Our internal pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), both rare diseases. In our vaccine program, we have partnered with CSL Seqirus, one of the world’s leading influenza vaccine providers, on the development and commercialization of mRNA vaccines for COVID-19, influenza and other infectious diseases. In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.

Reworded

The treatment was generally safe and well tolerated. Bronchospasm was not reported in these participants, either with or without pretreatment with a bronchodilator. Treatment-related AEs that were identified in the single-dose Phase 1 study were also observed in some participants for the first few doses but ceased with continued dosing. Two subjects experienced SAEs after the dosing period that were unrelated to ARCT-032, and the safety review committee approved the study to proceed. After amending the protocol, a fourth cohort of up to 20 subjects began enrolling in March 2026.2026 and continues to advance with active screening and enrollment in the United States and Israel. The fourth cohort willwas monitorinitiated with 10 mg administered once daily dosingvia inhalation over 12a weeks12-week forperiod safetyto better assess longer term safety, tolerability and early evidence of early clinical benefits.efficacy.

Reworded

We continuehave tocompleted enroll participantsenrollment in the open-label multiple ascending dose Phase 2 study of ARCT-810.ARCT-810 and all enrolled subjects have completed study drug dosing. The study evaluates safety and pharmacodynamics in adult and adolescent patients requiring clinical management for OTC-deficiency.OTC deficiency. We continue to evaluate supplementary data to inform regulatory discussions and preparation for an End-of-Phase 2 meeting regarding the potential path forward across adult and pediatric development.

Added

Thermo Fisher Agreement

Added

On June 26, 2026, we entered into a series of agreements with Thermo Fisher Scientific Inc. (“Thermo Fisher”) and certain of Thermo Fisher’s affiliates to establish a strategic collaboration for the provision of contract development and manufacturing organization (“CDMO”) and contract research organization (“CRO”) services in connection with the development of ARCT-032, our investigational mRNA therapeutic for cystic fibrosis (“CF”). The collaboration is structured through (i) a Master Services Agreement (the “Thermo Fisher MSA”) between Thermo Fisher and Arcturus and (ii) a Project Addendum for Development Services between Patheon UK Limited, a Thermo Fisher affiliate (“Patheon”), and Arcturus (the “Project Agreement”).

Added

Master Services Agreement

Added

The Thermo Fisher MSA establishes the framework under which Thermo Fisher and its affiliates will provide CRO and CDMO services to Arcturus from time to time pursuant to the Project Agreement and any additional individual project addendums. CRO services will be provided through PPD, Inc., Thermo Fisher’s affiliated contract research organization (“PPD”), and CDMO services will be provided through Thermo Fisher’s Pharma Services division. Under the Thermo Fisher MSA, Thermo Fisher will contribute up to $40 million of clinical manufacturing services for ARCT-032, and Arcturus will engage PPD for up to $40 million in CRO services. Upon regulatory approval of ARCT-032, Thermo Fisher would receive exclusive commercial manufacturing rights for the product for a specified duration, on terms to be set forth in a definitive commercial supply agreement to be negotiated in good faith by the parties. Arcturus may engage an alternative manufacturer only if Thermo Fisher is unable to supply, limited solely to the quantities and duration necessary to address the supply shortfall. The Thermo Fisher MSA has an initial term of five years from the effective date and automatically renews for successive one-year periods unless either party provides at least 90 days’ prior written notice of non-renewal.

Added

Project Agreement

Added

Under the Project Agreement, the services to be provided include technical transfer, engineering batches, manufacture of clinical trial materials, manufacture of process performance qualification batches, open-label extension batches, drug product fill and finish, product release, and stability studies. The Project Agreement remains in effect from its effective date until the completion of all services or earlier termination under the Thermo Fisher MSA.

Removed

In March 2026, we held a type C meeting with the FDA to discuss our plans for a proposed future pediatric study. The FDA provided a path forward toward a pivotal pediatric study that would require us to collect additional exploratory data to establish the optimal dose and therapeutic effect. The FDA also advised scheduling an End-of-Phase 2 (EOP2) meeting to discuss the pivotal study design, including the use of biomarkers.

Reworded

Termination of Vaccine Collaboration with CSL Seqirus

Added

On August 3, 2026, the Company entered into the Termination Agreement with CSL Seqirus pursuant to which the Company and CSL Seqirus mutually terminated the CSL Collaboration Agreement, effective as of such date. Under the Termination Agreement, the Company received a one-time cash payment of $12.0 million from CSL Seqirus. In addition, the Company was released from a liability and from repayment of an R&D credit with an aggregate value of approximately $16.0 million.

Added

As a result of the termination, the Company regained strategic control of its vaccine portfolio, including KOSTAIVE® and its vaccine programs for seasonal influenza, pandemic influenza, respiratory syncytial virus (“RSV”) and Epstein-Barr virus (“EBV”), subject to ongoing arrangements with Meiji Seika Pharma (“Meiji”) for the Northern Hemisphere 2026-2027 season, which is expected to end on or around June 30, 2027. Beginning with the Northern Hemisphere 2027–2028 season, the Company expects to work directly with Meiji for KOSTAIVE® activities in Japan.

Added

We are obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on our future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement and successor products, where certain CSL Seqirus intellectual property is incorporated into such products, subject to agreed terms and conditions and applicable time limitations. With respect to certain of the vaccine products, we are obligated to pay a percentage of upfront payments received from future licensees up to pre-agreed amounts.

Added

As a result of the termination, we expect deferred revenue from CSL Seqirus of approximately $5.2 million associated with remaining performance obligations under the CSL Collaboration Agreement to be recognized during the third quarter of 2026.

Added

KOSTAIVE® for Japan

Removed

In November 2022, we entered into a Collaboration and License Agreement (as amended, the “CSL Collaboration Agreement”) with Seqirus, Inc. (“CSL Seqirus”), a part of CSL Limited, and one of the world’s leading influenza vaccine providers, for global exclusive rights to research, develop, manufacture and commercialize self-amplifying mRNA vaccines against COVID-19, influenza and other infectious diseases and global non-exclusive rights to pandemic pathogens.

Reworded

Meiji has launched in Japan the two-dose vial of KOSTAIVE updated for the JN.1 variant XEC in August 2025,2025. followingIn approvalJune from2026, Meiji filed a Partial Change Application for KOSTAIVE updated for the NB.1.8.1 variant in a two-dose vial with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). to support commercialization for the 2026-2027 season in Japan.

Removed

Marketing Authorization Application filing of KOSTAIVE in United Kingdom

Removed

In January 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the International Recognition Procedure (IRP) granted marketing authorization for KOSTAIVE for individuals 18 years and older.

Removed

In CSL Limited’s half-year results presented on February 11, 2026, CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing declining COVID-19 disease burden and more onerous U.S. regulatory requirements.

Reworded

Revenue decreased by $27.3$25.3 million during the three months ended MarchJune 31,30, 2026, as compared to the three months ended MarchJune 31,30, 2025. The decline was primarily driven by lower revenue recognized under the CSL collaboration, reflecting reduced supply agreement revenue and decreased amortization of deferred revenue as KOSTAIVE transitions from development to the commercial phase. RevenueGrant revenue also decreased due to lower grant revenue, primarily related to our agreement with BARDA, partially offset by increased grant revenue from the Gates Foundation.

Added

Revenue decreased by $52.7 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decline was primarily driven by lower revenue recognized under the CSL collaboration, reflecting reduced supply agreement revenue and decreased amortization of deferred revenue as KOSTAIVE transitions from development to the commercial phase. Grant revenue also decreased primarily related to our agreement with BARDA, partially offset by increased grant revenue from the Gates Foundation.

Removed

Our research and development expenses consist primarily of external manufacturing costs, in-vivo research studies and clinical trials performed by contract research organizations, clinical and regulatory consultants, personnel related expenses, facility related expenses and laboratory supplies related to conducting research and development activities.

Reworded

Research and development expenses were $21.5$17.5 million for the three months ended MarchJune 31,30, 2026, compared with $34.9$29.6 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily driven by lower manufacturing costs expenses related to LUNAR-COVID and BARDA, as well as reduced clinical trial expenses associated with the BARDA, LUNAR-CF, and LUNAR-OTC programs, as well as reduced manufacturing costs related to the LUNAR-COVID program.and LUNAR-OTC programs. Additional decreases were attributable to lower payroll and benefits costs associated with lower stock‑basedshare-based compensation expense and a reduction in headcount. These reductions were partially offset by higher manufacturing costs related to LUNAR-OTC.

Added

Research and development expenses were $39.0 million for the six months ended June 30, 2026, compared with $64.5 million for the six months ended June 30, 2025. The decrease was primarily driven by lower manufacturing costs related to the LUNAR-COVID and LUNAR-CF programs, as well as reduced clinical trial expenses associated with the LUNAR-COVID, BARDA, and LUNAR-CF programs. Additional decreases were attributable to lower payroll and benefits costs associated with lower share-based compensation expense and a reduction in headcount, as well as lower facilities costs.

Removed

Early-stage programs represent programs that are in the pre-clinical or Phase 1 clinical stage and may be partnered or unpartnered, and primarily includes the LUNAR-FLU program which is partnered with CSL Seqirus. Discovery technologies represent our efforts to expand our product pipeline and are primarily related to pre-partnered studies and new capabilities assessment.

Reworded

AEarly-stage fewprograms ofrepresent programs that are in the preclinical or Phase 1 clinical stage and may be partnered or unpartnered. Early-stage programs include our programsPhase 1 clinical stage LUNAR-FLU program which was formerly partnered with CSL Seqirus. Discovery technologies represent our efforts to expand our product pipeline and are partprimarily ofrelated ourto collaborativepre-partnered relationships.studies and new capabilities. The related expenses may be partially offset with funds that have been reimbursed or awarded to us and consist of external manufacturing costs, lab supplies, equipment, and consulting and professional fees. Expenses for both early-stage programs and discovery technologies are expected to decreaseincrease slightly over the next twelve months as we shiftcontinue to advance both our focusearly- toand later-stage programs.

Removed

Payroll and benefits primarily consists of employee salaries and benefits, share-based compensation and consultant costs. We expect that payroll and benefits costs will not increase over the next twelve months.

Removed

Facilities and equipment expenses include rent, common area maintenance (“CAM”) costs, depreciation, shipping costs and various other costs related to the operation of our two office and laboratory locations. We expect that facilities and equipment expenses will not increase over the next twelve months.

Removed

General and administrative expenses consist primarily of salaries and related benefits for our executive, administrative and accounting functions and professional service fees for legal and accounting services as well as other general and administrative expenses.

Reworded

General and administrative expenses were $9.5$11.0 million for the three months ended MarchJune 31,30, 2026, compared with $11.3$10.3 million for the three months ended MarchJune 31,30, 2025. The slight increase was related to legal and professional fees offset by reduced share-based compensation. General and administrative expenses were $20.5 million for the six months ended June 30, 2026, compared with $21.7 million for the six months ended June 30, 2025. The decrease was primarily due to reducedlower share-based compensation expense as well asexpense, reduced payroll and benefits associatedcosts withresulting reductionsfrom inlower headcount.headcount, and lower facilities costs.

Reworded

Interest income is generated onby the Company’s cash and cash equivalents. The decrease in interest income for the three and six months ended MarchJune 31,30, 2026, compared to the same period in 2025, was primarily due to lower interest rates and a reduced cash balance.

Reworded

Through MarchJune 31,30, 2026, we have not entered into and did not have any relationships with unconsolidated entities or financial collaborations, such as entities often referred to as structured finance or special purpose entities, established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

Reworded

From the Company’s inception through the quarter ended MarchJune 31,30, 2026, the Company has funded its operations principally with the proceeds from revenues earned through collaboration agreements and government contracts, the sale of capital stock and long-term debt. Through the firstsecond quarter of 2026, we have achievedreceived a total of approximately $514.1$514.3 million in upfront payments and milestones from CSL Seqirus. As of MarchJune 31,30, 2026, the Company’s balance of cash and cash equivalents, including restricted cash,equivalents was $213.4$191.5 million.

Reworded

In November 2022, we entered into the CSL Collaboration Agreement with CSL Seqirus, a part of CSL Limited, one of the world’s leading influenza vaccine providers, for the global exclusive rights to research, develop, manufacture and commercialize mRNA vaccines. Following the end of the second quarter of 2026, we entered into the Termination Agreement with CSL Seqirus, pursuant to which we mutually terminated the CSL Collaboration Agreement effective as of August 3, 2026.

Added

Under the Termination Agreement, we received a one-time cash payment of $12.0 million from CSL Seqirus. In addition, we were released from a liability and from repayment of an R&D credit with an aggregate value of approximately $16.0 million. We also regained strategic control of our vaccine portfolio, including KOSTAIVE® and our vaccine programs for seasonal influenza, pandemic influenza, RSV and EBV, subject to ongoing arrangements with Meiji for the Northern Hemisphere 2026-2027 season.

Added

We are obligated to pay CSL Seqirus single-digit royalties and revenue-sharing payments on our future commercialization of vaccine products formerly licensed under the CSL Collaboration Agreement and successor products, where certain CSL Seqirus intellectual property is incorporated into such products, subject to agreed terms and conditions and applicable time limitations. With respect to certain of the vaccine products, we are obligated to pay a percentage of upfront payments received from future licensees up to pre-agreed amounts.

Added

In connection with the termination, the parties agreed to dismiss the arbitration and exchanged mutual releases of claims.

Added

As a result of the termination, we expect deferred revenue from CSL Seqirus of approximately $5.2 million associated with remaining performance obligations under the CSL Collaboration Agreement to be recognized during the third quarter of 2026.

Added

Thermo Fisher Agreement

Added

On June 26, 2026, we entered into a series of agreements with Thermo Fisher in support of the clinical development of ARCT-032. Under the agreement, Thermo Fisher has agreed to provide up to $40.0 million of qualifying clinical manufacturing services. We believe the agreement may reduce our future cash requirements associated with the clinical development of ARCT-032 by funding a portion of those development activities, subject to the terms of the agreement. See Note 8 to the condensed consolidated financial statements for additional information regarding the agreement.

Removed

CSL Seqirus received exclusive global rights to our technology for vaccines against SARS-CoV-2 (COVID-19), influenza and other infectious diseases with non-exclusive rights to pandemic pathogens. We received an up-front payment of $200.0 million during the fourth quarter of 2022. We will be eligible to receive development milestones totaling more than $1.3 billion if all products are registered in the licensed fields. We will also be entitled to receive up to $3.0 billion in commercial milestones based on “net sales” of vaccines in the various fields.

Removed

In addition, we are entitled to receive a 40% share of net profits from COVID-19 vaccine sales and up to low double-digit royalties of annual net sales for vaccines against influenza and the other three specified infectious disease pathogens, as well as royalties on revenues from vaccines that may be developed for pandemic preparedness.

Removed

The CSL Collaboration Agreement sets forth how CSL Seqirus and we shall collaborate to research and develop vaccine candidates. In the COVID-19 field, we will lead activities for certain regulatory filings for ARCT-154 in the US and Europe and for research and development activities of a next-generation COVID vaccine candidate. CSL Seqirus will lead and be responsible for all other research and development in COVID-19, influenza and the other fields.

Removed

On May 30, 2025, we initiated an arbitration against CSL Seqirus before the International Chamber of Commerce, seeking payment of a milestone under the CSL Collaboration Agreement based on the European Commission’s grant of marketing authorization for a presentation of KOSTAIVE®in the European Union.

Reworded

On August 31, 2022, we entered into a cost reimbursement contract (the “BARDA Contract”) with the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) within the U.S. Department of Health and Human Services (“HHS”) to support the development of a low-dose pandemic influenza candidate based on our proprietary self-amplifying messenger RNA-based vaccine platform. The BARDA Contract is to support our non-clinical and pre-clinical development, early-stage clinical development through Phase 1, and associated drug product manufacturing, regulatory and quality-assurance activities over a period of three years. It provides for reimbursement by BARDA of our permitted costs up to $63.2 million. As of MarchJune 31,30, 2026, the remaining available funding net of revenue earned was $25.8$24.6 million.

Removed

Wells Fargo Credit Agreement

Removed

In December 2025, the Company terminated its revolving credit agreement with Wells Fargo. No amounts were outstanding at termination. Accordingly, the Company had no debt outstanding as of March 31, 2026, and cash previously pledged as collateral is no longer classified as restricted cash.

Reworded

A portion of our current cash balance is expected to be utilized during fiscal year 2026 to fund (i) advances to our LUNAR-CF program in clinical trials, (ii) the continued Phase 2 trial of ARCT-810, our LUNAR-OTC candidate, (iii) expenses incurred prior to customer payments under the BARDA agreement and any transition or settlement-related activities following termination of the CSL Collaboration Agreement and BARDA agreement and (iv) continued exploratory activities related to our platform and other general administrative activities.

Reworded

Net cash used in operating activities was $19.4$39.4 million for the threesix months ended MarchJune 31,30, 2026, compared to $35.1$40.9 million for the threesix months ended MarchJune 31,30, 2025. The decrease in cash outflows was primarily driven by improved collections in accounts receivable.receivable It was also impacted byand more favorable changes in accrued liabilities and deferred revenue. These factors were partially offset by aless higherfavorable netchanges lossin accounts payable and aprepaid reduction in non-cash stock-based compensation.expenses.

Reworded

Net cash provided by investing activities was nominal$0.1 million for the threesix months ended MarchJune 31,30, 2026, compared with net cash used of $0.1 million for the threesix months ended MarchJune 31,30, 2025. ActivityThe increase in bothcash periodsprovided by investing activities was primarily reflecteddriven by the purchase and saleabsence of property and equipment.equipment purchases during the current year period.

Reworded

Net cash provided by financing activities was nominal for the threesix months ended MarchJune 31,30, 2026, compared to $15.2$0.5 million for the threesix months ended MarchJune 31,30, 2025. The decrease in cash inflowsprovided by financing activities was primarily driven by borrowingslower underproceeds thefrom Company’semployee linestock ofoption credit in the prior year period, with no comparable activity in the current year period.exercises.

Reworded

We anticipate that we will continue to generate losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, and begin commercialization of our products. As a result, we will require additional capital to fund our operations in order to support our long-term plans. We believe that our current cash position will be sufficient to meet our anticipated cash requirements through at least the next twelve months, assuming, among other things, no significant unforeseen expenses and continued funding fromunder partnersexisting agreements at anticipated levels. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements with partners or through other sources of financing when and as needed. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, liquidate our assets, file for bankruptcy, reorganize, merge with another entity, or cease operations.

Reworded

the development of our LUNAR-COV19cystic fibrosis and LUNAR-FLUOTC vaccinedeficiency therapeutic candidates;

Removed

the achievement of milestones under our strategic alliance agreements;

Reworded

the terms and timing of any other strategic alliance, licensing and other arrangements that we may establish, including thosetransition arrangements with CSL SeqirusSeqirus, arrangements with Meiji and CSLany Seqirus’new arrangementcollaboration with Meiji,arrangements, and any related payments thereunder, including payments related to completion of milestones under our arrangements with any of these partiesthereunder;

Showing the first 60 of 62 changed paragraphs. The complete comparison will be part of Pro (coming soon). Meanwhile you can read the full text in the original filing.

ARCT insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

No Form 4 stock transactions in this period.

Well-known investors holding ARCT (13F)

InvestorQuarterSharesReported value% of their 13FChange vs prior quarter
ARK Investment Management (Cathie Wood) Common Stock2026-06-302,901,635$19.5M0.13%Added 5%
Two Sigma Investments COM2026-06-301,091,137$7.3M0.01%Added 1%
AQR Capital Management (Cliff Asness) COM2026-06-30675,014$4.5M0.0%Added 319%
D. E. Shaw & Co. COM2026-06-30392,358$2.6M0.0%Added 56%
Millennium Management (Israel Englander) COM2026-06-30336,996$2.3M0.0%Reduced 30%
Point72 Asset Management (Steve Cohen) COM2026-06-30231,582$1.6M0.0%Added 263%
Citadel Advisors (Ken Griffin) COM2026-06-3040,946$275.2K0.0%Added 18%
Renaissance Technologies COM2026-06-3021,400$143.8K0.0%Reduced 88%

13F reports are filed up to 45 days after quarter end and show long U.S. equity positions only; options positions are omitted here.

Coming soon: email alerts when ARCT files, watchlists and downloadable comparisons.