Aeglea's latest layoffs, pipeline cull curb spending, but cash crunch still on the cards

Aeglea BioTherapeutics’ cost-cutting drive has had limited effect on its cash runway, with the biotech still barreling toward a fourth-quarter funding showdown despite recent cuts to its pipeline and head count. 

In January, the clinical-stage enzyme therapy specialist revealed a 15% reduction in its head count, which added to the layoffs made last summer, and the halting of preclinical work. Aeglea framed the changes as a way to streamline the organization and maximize the value of its two clinical programs, pegtarviliase and pegzilarginase.

Now, the biotech has shared more details in its fourth-quarter results. Combined R&D and administrative costs fell $4.8 million year on year, in part because of the layoffs, but the cash pile continued to shrink. Aeglea burned through almost $18 million over the final three months of the year, leaving it with $57.3 million in its name. Management expects the money to fund operations into the fourth quarter of 2023.

The cash runway prediction, which is unchanged from the forecast the biotech made in November, gives Aeglea limited opportunity to change investor perceptions of its prospects. A European approval decision on lead drug pegzilarginase for the treatment of arginase 1 deficiency is due late this year. The FDA hit Aeglea with a refuse-to-file letter last summer and asked for further evidence of the efficacy of the drug.

Aeglea has largely languished in penny stock territory since the regulatory setback in the U.S., limiting the company’s ability to raise money to fund operations. The biotech responded with two sets of layoffs and a pullback from preclinical programs. Aeglea ended last year with 69 employees. 

The preclinical pullback affected one publicly known candidate, AGLE-325. Aeglea was developing the prospect as a treatment for cystinuria, a rare genetic disease characterized by recurrent kidney stones. The biotech designed AGLE-325 to cut levels of cystine, an amino acid involved in the formation of kidney stones, but is now seeking “strategic options” for the asset rather than advancing it internally.