Arcturus is extending its cash runway into 2028 by discontinuing its early-stage vaccine candidates.
Arcturus Therapeutics is scaling back work on early-stage candidates and will instead dedicate its resources to its more developed mRNA therapies, the biotech announced Tuesday alongside its first-quarter earnings report.
“It was not an easy decision,” Chief Financial Officer Andrew Sassine told investors during the company’s earnings call. “Due to the current market environment and uncertainty regarding our regulatory process, we have made the decision to focus our research and development expenditures on our [cystic fibrosis (CF)] and [ornithine transcarbamylase (OTC) deficiency] programs exclusively.”
As a result of this move, however, Arcturus will be able to “extend our cash runway until the first quarter of 2028,” Sassine said. At the end of the first quarter, Arcturus had $273.8 million in cash, cash equivalents and restricted cash.
While company executives on Tuesday did not explicitly name specific assets that it would discontinue, Arcturus’ pipeline page lists four investigational vaccines. These include two Phase I influenza vaccines and two preclinical vaccines against undisclosed infectious diseases.
Arcturus also owns a COVID-19 vaccine called Kostaive, approved in the European Union and Japan, though it appears to be unaffected by the pipeline prioritization. CEO Joseph Payne on the call told investors that the biotech continues “to make progress” on expanding the global presence of Kostaive. By the third quarter of this year, Arcturus expects to file for Kostaive’s approval in the U.S.
The slate of therapeutics that are likely being discontinued was being developed in collaboration with CSL Seqirus in a 2022 deal that paid Arcturus $200 million up front. How Arcturus’ decision will affect that deal was not immediately clear.
In CF, Arcturus is advancing an inhalable mRNA therapy, ARCT-032, for which it is running a Phase II trial in patients who cannot be treated with CFTR modulators. Data from the first two cohorts of this study are expected by mid-2025. Arcturus is on track to complete enrollment in the study, dubbed LUNAR-CF, by the end of the year.
On the investor call, Payne noted that 100 enrollees could be a “reasonable” target to pave the path toward a regulatory submission, though he clarified that regulators have not yet signed off on this number.
“It depends on how successful the phase 2 results are,” Payne added. “The more successful they are, the more leverage we have to decrease this number and get this to real subjects commercially as fast as possible.”
Arcturus is also developing its OTC deficiency candidate ARCT-810, which is in Phase II development with data expected in the second quarter.
