Arcturus Therapeutics Holdings Inc. (ARCT) SEC Filings & Earnings Calls

Clinical trial risks; ARCT-810 is still in Phase 2; regulatory approval not guaranteed.

“Forward-looking statements caution about clinical development risks and regulatory approvals.”

Clinical-stage biotech with no approved products; ARCT-810 program still in development with regulatory plan pending.

“Additional data and the regulatory plan for this program is expected to be communicated later this quarter.” · word for word

Dependence on CSL Seqirus termination and future partnerships

“We will need to raise additional debt or equity financing or enter into additional partnerships to fund development.” · word for word

Clinical trial and regulatory risk for ARCT-032 and ARCT-810

“Our ability to transition to profitability is dependent on regulatory approvals and subsequent sales of KOSTAIVE, and identifying and developing other successful mRNA drug and vaccine candidates.” · word for word

Cash burn and going concern risk

“We expect to continue to incur additional losses in the long term, and we will need to raise additional debt or equity financing or enter into additional partnerships to fund development.” · word for word

Pipeline dependency on clinical trial outcomes; no approved products yet.

“ARCT-032 and ARCT-810 are in Phase 2; regulatory and commercial success uncertain.”

Cash burn and runway risk; no revenue from products.

“No revenue disclosed; forward-looking statements mention cash position and expected cash burn.”

Dependence on Thermo Fisher for commercial manufacturing; if unable to supply, Arcturus may only use alternative manufacturer for shortfall quantities.

“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.” · word for word

Pipeline and regulatory risks inherent in biotech; forward-looking statements caution

“Cautionary note regarding forward-looking statements and risk factors”

Dependence on CSL Seqirus collaboration and potential arbitration

“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.” · word for word

Clinical trial and regulatory risk for ARCT-032 and ARCT-810

“Our ability to transition to profitability is dependent on regulatory approvals and subsequent sales of KOSTAIVE, and identifying and developing other successful mRNA drug and vaccine candidates.” · word for word

Cash burn and going concern risk

“We expect to continue to incur additional losses in the long term, and we will need to raise additional debt or equity financing or enter into additional partnerships to fund development.” · word for word

CSL Seqirus write-down and potential separation risk

“CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing decline in the COVID-19 market and more onerous U.S. regulatory requirements.”

KOSTAIVE weak demand in Japan

“To date, demand for KOSTAIVE in Japan has been weak, and future sales may decrease and our partners may decide to cease commercialization.”

No product sales revenue and continued losses

“We have not recognized any revenue from product sales since our inception.”

Dependence on CSL Seqirus collaboration

“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”

Potential CFO vacancy risk

“On December 11, 2025, we and Andy Sassine, our former Chief Financial Officer and former member of the Board of Directors, mutually agreed to end his employment relationship in an amicable manner effective December 31, 2025.”

CSL Seqirus collaboration impairment

“CSL Limited reported an accounting write-down of approximately $430 million attributable to our collaboration agreement with CSL Seqirus, citing decline in the COVID-19 market and more onerous U.S. regulatory requirements.” · word for word

No product sales revenue

“We have not recognized any revenue from product sales since our inception.” · word for word

KOSTAIVE commercial failure risk

“To date, demand for KOSTAIVE in Japan has been weak, and future sales may decrease and our partners may decide to cease commercialization.” · word for word

CFO departure and key person risk

“On December 11, 2025, we and Andy Sassine, our former Chief Financial Officer and former member of the Board of Directors, mutually agreed to end his employment relationship in an amicable manner effective December 31, 2025.” · word for word

Need for additional capital

“We expect that we will need to raise additional capital in the future, which may not be available on acceptable terms, or at all.” · word for word

Clinical trial risk; regulatory alignment needed for ARCT-810.

“Timing for Type C regulatory meetings for ARCT-810 and feedback therefrom.” · word for word

Key management departure; interim CFO may lack public company CFO experience

“CFO departure; interim CFO is Controller with no prior CFO role.”

FDA Regulatory Delay

“On October 14, 2025, the FDA informed the Company that, although the FDA had previously agreed that the Company’s proposed data package could support a single-dose indication, upon further consideration it finds that additional data from a clinical endpoint efficacy study will be needed to align with the current COVID-19 vaccine regulatory framework requirem” · word for word

Revenue Decline

“Revenue decreased by $24.5 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024.” · word for word

Cash Burn

“Net cash used in operating activities was $58.0 million for the nine months ended September 30, 2025.” · word for word

FDA regulatory change for COVID vaccines delays KOSTAIVE U.S. BLA filing indefinitely, impacting commercial prospects.

“The sudden changes in regulatory requirements by the FDA for COVID-19 vaccines have delayed the U.S. BLA filing for KOSTAIVE® indefinitely.” · word for word

Cash runway concern drives additional cost reductions in Q4.

“We have decided to reduce additional expenses to extend the runway for the CF and OTC deficiency programs.” · word for word