Aytu BioPharma Announces Strategic Shift, Indefinite Suspension of Clinical Development Programs

Aytu BioPharma Inc AYTU announced a shift in the company's strategy to accelerate its commercial business growth and achieve profitability.
As a result, the company is announcing the indefinite suspension of its clinical development programs, including AR101/enzastaurin, for treating Vascular Ehlers-Danlos Syndrome (VEDS).
The company initiated a Phase 3 trial for VEDS indication in July. The trial was expected to enroll approximately 260 subjects in this trial and dosing of the first patient by early 2023.
The suspension is expected to save the company over $20 million in projected future study costs and enable the company to achieve quarterly positive Adjusted EBITDA in the first half of calendar 2023.
The company's commercial operations include its prescription and consumer health segments which generated net revenue of $96.7 million in the most recent fiscal year.
Excluding R&D expenses related to its suspended pipeline, the company had a slightly negative Adjusted EBITDA of $(961,000) from its commercial operations, including the first-ever profitable quarter for its prescription segment.
In May, Aytu BioPharma announced to divest or discontinue non-core, unprofitable products, including Cefaclor, Flexichamber, Tuzistra XR, generic Tussionex, and Zolpimist.
Price Action: AYTU shares are down 2.88% at $0.17 on the last check Thursday.