Aytu BioPharma enters exclusive agreement with Fabre-Kramer Pharmaceuticals

Aytu BioPharma (AYTU) announced the signing of an exclusive agreement to commercialize EXXUAextended-release tablets in the United States. Gepirone is a new chemical entity, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the United States Food and Drug Administration for the treatment of MDD in adults. EXXUA has been extensively studied in over 5,000 patients and represents a new class of therapeutics to compete in the over $22B United States prescription MDD market. Importantly, EXXUA is the only antidepressant acting on serotonin receptors that does not carry label warnings about the risk of sexual dysfunction. The mechanism of the antidepressant effect of EXXUA is believed to be related to its modulation of serotonin activity and, specifically, its exclusive and strong binding affinity for 5HT1a receptors, which are key regulators of mood and emotion. EXXUA is not a selective serotonin reuptake inhibitor and has no reuptake inhibition activity. EXXUA also exhibits no significant adverse effects on weight, blood pressure, heart rate or liver function. 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.