Aytu BioPharma announces exclusive commercialization agreement for Exxua

Aytu BioPharma (AYTU) announced the signing of an exclusive agreement to commercialize Exxua extended-release tablets in the United States. Gepirone is a new chemical entity, and Exxua is the selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of MDD in adults. Under the terms of the agreement, upon closing Aytu paid Fabre-Kramer Pharmaceuticals an upfront payment and will pay an additional fixed payment at the one-year anniversary of the Exxua launch date. In addition, Aytu will pay royalties on net revenue as defined in the definitive agreement, along with a product transfer price. Aytu will also make variable, performance-based milestone payments to Fabre-Kramer Pharmaceuticals upon the achievement of various net revenue thresholds over the term of the agreement. The Exxua transaction is being funded by cash on hand along with a financing led by long-term, healthcare-focused institutional investors, including Aytu’s largest shareholder Nantahala Capital Management, Stonepine Capital Management, Aytu management, and new institutional shareholders. Aytu is actively preparing to launch Exxua in the United States as soon as possible and currently anticipates pharmacy and patient availability in the fourth calendar quarter of 2025.