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.
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