San Diego-based RNA biotech Arcturus is doubling down on mRNA therapeutics and stepping back from earlier-stage vaccine work in an effort to prioritize spending and extend its cash runway.
In a brief line coming from first-quarter financial results published May 12, the biotech’s CEO Joseph Payne said the company “made a strategic decision to streamline resources to focus on our mRNA therapeutics pipeline.”
On a call with analysts Monday evening, Arcturus Chief Financial Officer Andrew Sassine offered some more color about the changes.
"It was not an easy decision ... but, as you know in this environment, I think it was very prudent for us to focus on our two most critical programs," Sassine said.
“And, as a consequence of that,” Sassine continued, “we had to make some tough decisions with respect to cost reductions, including some elimination of early development in R&D programs, as well as consolidation of our facility.”
The biotech did not respond to Fierce Biotech’s questions about possible layoffs associated with the changes.
The prioritized programs are an inhaled cystic fibrosis treatment called ARCT-032, which is expected to post phase 2 data later this year, and ARCT-810, an intravenous mRNA therapeutic currently in midstage testing for ornithine transcarbamylase deficiency.
Analysts at Citi lauded the “smart decision,” noting that the discontinued programs—which include early mRNA vaccine efforts for chlamydia, gonorrhea and Lyme disease—had “low [return on investment] visibility."
The move extends the biotech’s financial runway, specifically until the first quarter of 2028, Sassine explained. The CFO added that “uncertainty regarding our regulatory process” also played a role in prompting the changes.
The decision doesn’t appear to impact Arcturus' mRNA COVID-19 vaccine work, with Sassine saying Arcturus still anticipates filing this year for a potential FDA approval in 2026. The company’s CSL Seqirus-partnered COVID vaccine is already approved in Europe under the name Kostaive.
The biotech has also been working on a self-amplifying mRNA vaccine, dubbed LUNAR-H5N1 or ARCT-2304, as a potential bird flu vaccine for humans that moved into phase 1 testing last December.
The study is fully funded by a Biomedical Advanced Research and Development Authority (BARDA) contract of up to $63 million. The continuance of the federal financing was cast in doubt as the new Trump administration has scaled back in certain research areas, with rumors swirling that Moderna—further along in its bird flu vaccine program—was set to see its substantial financial government support revoked.
Moderna has still not said whether its federal funding has changed or been revoked. Back in March, Arcturus told Fierce Biotech that it was “highly unlikely” it would lose the promised government funding for its bird flu mRNA vaccine trial.
Now, Arcturus has said that the ARCT-2304 program with BARDA is still "very active," according to a May 14 emailed statement to Fierce Biotech.
The company continues to list two undisclosed preclinical programs, both in infectious diseases, on its online pipeline page.
Editor's note: This story was updated at 1 p.m. ET on May 14 to include further comment from Arcturus.