Arcturus Introduces LUNAR 2.0 After ARCT-810 Data

The Tip Desk · November 11, 2026 · 3 min read

The company reported third-quarter revenue of $18.3 million and a net loss of $7.4 million, or $0.26 a share, as it advanced liver and cystic fibrosis programs.

Arcturus Therapeutics Holdings Inc. (ARCT), a messenger RNA medicines company focused on liver and respiratory therapeutics, presented interim Phase 2 data for ARCT-810 in ornithine transcarbamylase deficiency and introduced LUNAR 2.0, a next-generation delivery platform it said showed 38-fold greater potency than the key lipid in ARCT-810 in non-human primates.

The San Diego company reported revenue of $18.3 million for the three months ended September 30, 2026, compared with $17.2 million a year earlier. Collaboration revenue was $16.9 million, versus $14.2 million in the year-ago quarter. Grant revenue fell to $1.4 million from $3.0 million.

The company said the third-quarter revenue increase was driven primarily by a $12.0 million termination payment from CSL Seqirus and remaining deferred revenue recognized when that collaboration ended, partially offset by lower grant revenue. Under the termination and settlement agreement, Arcturus regained global rights to KOSTAIVE and a broader infectious disease vaccine portfolio. Deferred revenue fell to $0.4 million at September 30, 2026 from $8.2 million at December 31, 2025.

Net loss narrowed to $7.4 million, or $0.26 a share, from $13.4 million, or $0.49 a share, a year earlier. Research and development expenses were $17.0 million, down from $23.3 million, which the company attributed to reduced clinical and manufacturing activity, particularly across LUNAR-COVID and BARDA programs, and lower personnel and facilities costs. General and administrative expenses were $10.5 million.

Cash and cash equivalents were $184.8 million at September 30, 2026, down $46.1 million from $230.9 million at year-end 2025. The company said the decrease was primarily driven by cash used in ongoing clinical development, including cystic fibrosis and OTC deficiency programs, partially offset by the $12.0 million CSL Seqirus payment. Chief Financial Officer Dennis Mulroy said the company maintains a cash runway of over two years through year-end 2028.

ARCT-810 at 0.3 mg/kg and 0.5 mg/kg reduced and/or maintained first-morning fasting ammonia within the normal range, including during increased protein intake, and reduced glutamine in all participants. The 0.5 mg/kg dose achieved mean glutamine concentrations within the normal range during treatment. The company said the candidate was generally safe and well tolerated.

ARCT-2601 is the first mRNA therapeutic candidate using LUNAR 2.0. Arcturus plans to begin Phase 2 dosing in the first quarter of 2027, with top-line data expected in the second half of 2027, following FDA feedback from a June 2026 Type C meeting. An amended Phase 2 protocol is expected to incorporate ARCT-2601 into the ongoing ARCT-810 study in participants with OTC deficiency ages 12 and older. Non-human primate data suggested the potential for lower and/or less frequent dosing of ARCT-2601 compared with ARCT-810.

The company expanded its pipeline to include programs targeting PKU and gout on LUNAR 2.0 and said it plans to submit an IND for PKU in the second half of 2027. It also completed the myNEO acquisition, which it said adds AI-driven capabilities in antigen design, mRNA optimization, and target identification.

ARCT-032 Phase 2 Cohort 4, evaluating 10 mg daily inhaled dosing over 12 weeks in up to 20 adults with cystic fibrosis, is expected to complete enrollment by year-end 2026. Full Cohort 4 data are planned for presentation in the second quarter of 2027. A decision to proceed into Phase 3 is expected before that data presentation and would trigger significant contributions from Thermo Fisher Scientific, which is actively and financially supporting the program.

Marketing authorization holders for KOSTAIVE in the EU and UK were transferred from CSL Seqirus to Arcturus in September and October 2026, in preparation for commercial activities in 2027. Meiji Seika Pharma is distributing KOSTAIVE in Japan for the 2026/2027 season.