Arcturus Therapeutics Holdings (ARCT) Company Report

Arcturus Therapeutics presented at the JP Morgan Healthcare Conference in January 2026, highlighting its next-generation RNA medicines and pipeline candidates.
The company provided an update on ARCT-032 (LUNAR-CF) for Cystic Fibrosis, with interim Phase 2 data showing encouraging mucus plug reduction in 4 out of 6 participants at the 10 mg dose, and a larger 12-week Phase 2 study planned for H1 2026.
For ARCT-810 (LUNAR-OTC) for Ornithine Transcarbamylase Deficiency, interim Phase 2 data demonstrated significant reductions in glutamine levels and stable ammonia levels, with regulatory alignment on pivotal trial strategy expected in H1 2026.
Key objectives for H1 2026 include initiating the ARCT-032 Phase 2 fourth cohort and establishing regulatory clarity for ARCT-810's pivotal trial strategy.

Jan 13, 2026, 1:15 AM

Presentation

Arcturus Therapeutics Outlines 2026 Clinical Milestones for OTC and CF Programs

ARCT

New Projects/Investments

Guidance Update

Layoffs

Arcturus Therapeutics is advancing its Ornithine Transcarbamylase (OTC) deficiency program (ARCT-810), with a key milestone of aligning pivotal trial strategy with regulatory agencies in the first half of 2026. Interim Phase 2 data shows significant glutamine reduction and increased ureogenesis.
The company's Cystic Fibrosis (CF) program (ARCT-032) is preparing to initiate a phase two, 12-week study (fourth cohort) in the first half of 2026. Interim Phase 2 data demonstrated significant mucus plug reductions.
Arcturus has extended its cash runway into 2028 following expense reduction and restructuring, providing financial flexibility to pursue its 2026 clinical milestones.

Jan 13, 2026, 1:15 AM

Transcript

Arcturus Therapeutics Outlines 2026 Clinical Milestones and Extends Cash Runway

ARCT

New Projects/Investments

Guidance Update

Arcturus Therapeutics, an mRNA medicines and therapeutics company, has a COVID vaccine product, Kostaive, approved in over 30 countries, and is partnered with CSL and Meiji for distribution.
For its Ornithine Transcarbamylase (OTC) deficiency program (ARCT-810), Arcturus plans to establish regulatory alignment with the FDA on pivotal trial strategies for pediatric and adult populations in the first half of 2026, following positive Phase 2 interim data.
The company's Cystic Fibrosis (CF) program (ARCT-032) is preparing to initiate a Phase 2, 12-week study in the first half of 2026, building on interim data that showed mucus plug reduction in 4 out of 6 subjects at the 10mg dose level.
Arcturus has extended its cash runway into 2028, providing financial stability to pursue its clinical milestones.

Jan 13, 2026, 1:15 AM

Transcript

Arcturus Therapeutics Provides Update on Pipeline Progress and Financial Stability

ARCT

New Projects/Investments

Guidance Update

Arcturus Therapeutics, an mRNA medicines company, has an approved COVID vaccine, Kostaive, which is distributed in over 30 countries.
For its Ornithine Transcarbamylase (OTC) deficiency program (ARCT-810), the company aims to establish pivotal trial strategy alignment with regulatory agencies in the first half of 2026. Interim Phase II data showed significant and consistent reductions in glutamine levels and increased ureogenesis.
The Cystic Fibrosis (CF) program (ARCT-032) is planning to initiate a Phase II, 12-week study in the first half of 2026. Interim Phase II data demonstrated significant mucus plug reductions in patients at the 10 mg dose level.
The company has extended its cash runway into 2028 due to expense reduction and restructuring, providing financial stability to pursue its clinical milestones.

Jan 13, 2026, 1:15 AM

Transcript

Arcturus Therapeutics Reports Q3 2025 Financials and Provides Pipeline Updates

ARCT

Earnings

Guidance Update

New Projects/Investments

Arcturus Therapeutics reported revenues of $17.2 million for the third quarter of 2025 and a net loss of $13.5 million, or $0.49 per diluted share, for the same period.
As of September 30, 2025, the company held $237.3 million in cash, cash equivalents, and restricted cash, with its cash runway extended into 2028 due to additional planned cost reductions and a delay in the phase three cystic fibrosis clinical trial commencement.
Interim Phase 2 data for ARCT-032 (cystic fibrosis) showed reductions in mucus burden in four of six class one CF participants treated with 10-milligram doses, and a 12-week study is planned to begin in the first half of 2026.
For ARCT-810 (ornithine transcarbamylase deficiency), Arcturus is preparing for meetings with regulatory agencies in the first half of 2026 to discuss pivotal trial strategy for both pediatric and adult populations.
The Costave BLA filing in the United States has been indefinitely delayed due to regulatory changes and uncertain commercial visibility, leading to a decision to reduce additional expenses.

Nov 10, 2025, 9:30 PM

Transcript

Arcturus Therapeutics Announces Q3 2025 Financial Results and Pipeline Updates

ARCT

Earnings

Guidance Update

New Projects/Investments

Arcturus Therapeutics reported revenue of $17.2 million for the third quarter ended September 30, 2025, and a net loss of $13.5 million, or ($0.49) per diluted share.
The company's cash, cash equivalents, and restricted cash totaled $237.3 million as of September 30, 2025, with the cash runway extended into 2028 due to planned cost reductions and a delayed Phase 3 CF clinical trial commencement.
Encouraging interim Phase 2 data for ARCT-032 in cystic fibrosis showed mucus plug reduction, and a 12-week safety and preliminary efficacy study is planned for H1 2026.
The U.S. BLA filing for KOSTAIVE® (COVID-19 vaccine) has been indefinitely delayed due to changes in FDA regulatory requirements, although Meiji Seika Pharma launched an updated version in Japan in August 2025.

Nov 10, 2025, 9:09 PM

8-K

Arcturus Therapeutics Announces Q3 2025 Financial Results and Pipeline Updates

ARCT

Earnings

Guidance Update

Product Launch

Arcturus Therapeutics reported a net loss of $13.5 million, or ($0.49) per diluted share, for the third quarter ended September 30, 2025, with revenues of $17.2 million.
The company's cash, cash equivalents, and restricted cash totaled $237.3 million as of September 30, 2025, and it plans additional cost reductions in Q4 2025 to extend its cash runway into 2028.
Encouraging interim Phase 2 data for ARCT-032 in cystic fibrosis showed mucus plug reduction, with a 12-week safety and preliminary efficacy study planned for the first half of 2026.
The U.S. BLA filing for KOSTAIVE® has been indefinitely delayed due to changes in FDA regulatory requirements, though Meiji Seika Pharma launched the vaccine in Japan in August 2025.

Nov 10, 2025, 9:01 PM

Press Release

Arcturus Therapeutics Shares Decline Following Interim Cystic Fibrosis Trial Results

ARCT

New Projects/Investments

Arcturus Therapeutics' shares plunged between 50% and 61% following interim Phase 2 trial results for its inhaled mRNA therapy ARCT-032, which showed no meaningful improvement in lung function (FEV1) from Day 1 to Day 28 in cystic fibrosis patients.
A post hoc exploratory analysis, however, suggested some lung function improvements at Day 42, with an average absolute increase of 3.8% and a relative increase of 5.1% in percent predicted FEV1, and four of six participants experienced reductions in mucus plugs and volume.
The company is currently recruiting additional patients for higher dose testing and plans a 12-week safety and efficacy study in up to 20 cystic fibrosis patients in the first half of 2026.

Oct 22, 2025, 12:32 PM

Morningstar

Arcturus Therapeutics Reports Interim ARCT-032 Phase 2 Data and KOSTAIVE Regulatory Updates

ARCT

New Projects/Investments

Legal Proceedings

Guidance Update

Arcturus Therapeutics announced interim Phase 2 clinical trial results for its investigational inhaled mRNA therapy, ARCT-032, for cystic fibrosis, indicating it was generally safe and well tolerated.
In the ARCT-032 trial, 4 out of 6 Class I CF participants treated with 10 mg daily over 28 days exhibited encouraging reductions in mucus plug number and volume. A 12-week safety and preliminary efficacy study is planned for the first half of 2026.
On October 14, 2025, the FDA requested additional clinical endpoint efficacy study data for the Biologics License Application (BLA) of KOSTAIVE, the company's COVID-19 vaccine, revising previous guidance and delaying the submission.
CSL Seqirus submitted a Marketing Authorization Application (MAA) for KOSTAIVE to the UK MHRA in June 2025, with approval anticipated in the first quarter of 2026.
Arcturus filed a lawsuit on September 23, 2025, against AbbVie Inc., Capstan Therapeutics, Inc., and others for trade secret misappropriation and breach of contract.

Oct 22, 2025, 11:50 AM

8-K

Arcturus Therapeutics Reports Interim Phase 2 Data for Cystic Fibrosis Program

ARCT

New Projects/Investments

Arcturus Therapeutics announced interim Phase 2 clinical trial results for ARCT-032, an investigational inhaled mRNA therapy for cystic fibrosis.
ARCT-032 was generally safe and well tolerated in the second cohort of six Class I CF adults.
Four out of six Class I CF participants treated with 10 mg of ARCT-032 showed encouraging reductions in mucus plug number and volume after 28 days.
Exploratory analysis also suggested lung function improvements in these four participants, with an average absolute increase of 3.8% and a relative increase of 5.1% in percent predicted FEV1.
A 12-week safety and preliminary efficacy study in up to 20 CF participants is planned to commence in the first half of 2026.