Arcturus reports Q3 2026 results, CF enrollment nears completion, OTC program advances
Arcturus said ARCT-032 Phase 2 enrollment should finish by year-end with data in Q2 2027, while ARCT-2601 Phase 2 dosing is planned for Q1 2027.
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) reported financial results for the quarter ended September 30, 2026 on November 5, 2026, along with pipeline updates.
For ARCT-032 in cystic fibrosis, the company said full Phase 2 data from Cohort 4, which evaluates 10 mg daily inhaled dosing over 12 weeks in up to 20 adults with cystic fibrosis (primarily class I), are planned for presentation in Q2 2027.1 Arcturus said enrollment has accelerated due to increased site activations in Israel and Turkey and is expected to be completed by year-end.1 The program remains actively and financially supported by Thermo Fisher Scientific, with a decision to proceed into Phase 3 triggering significant contributions from Thermo, expected before the planned Phase 2 data presentation.1
On ARCT-810 for OTC deficiency, the company said interim Phase 2 data at 0.3 mg/kg and 0.5 mg/kg showed meaningful biomarker activity, reducing and/or maintaining first-morning fasting ammonia within the normal range, including during increased protein intake, and reducing glutamine levels in all participants, with the 0.5 mg/kg dose achieving mean glutamine concentrations within the normal range during treatment, with generally safe and well tolerated results.1
The company's newer LUNAR 2.0 platform showed 38-fold greater potency than the key lipid in ARCT-810, in a non-human primate study based on human ornithine transcarbamylase (hOTC) expression.1 Arcturus said it plans to initiate ARCT-2601 Phase 2 dosing in Q1 2027, with top-line data expected in H2 2027, following FDA feedback and clarity on the regulatory pathway from a June 2026 Type C meeting.1
The company also said it plans to submit an IND to the FDA for PKU in the second half of 2027.1 Separately, it noted it has successfully completed the myNEO acquisition, integrating AI-driven capabilities in antigen design, mRNA optimization, and target identification.1
On finances, Arcturus reported cash and cash equivalents of $184.8 million as of September 30, 2026, down from $230.9 million at December 31, 2025, a decrease of $46.1 million.1 CFO Dennis Mulroy said the company continues to maintain a strong balance sheet and cash runway of over two years through year end 2028.1
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