Aytu BioPharma has successfully raised $16.6 million through an upsized public offering to fund the commercial launch of EXXUA (gepirone), a first-in-class antidepressant that could reshape treatment options for major depressive disorder. The financing was led by healthcare-focused institutional investors, including the company's largest shareholders Nantahala Capital Management and Stonepine Capital Management.
Novel Mechanism Addresses Key Treatment Gap
EXXUA represents a significant advancement in depression treatment as the first FDA-approved selective serotonin 5HT1a receptor agonist for adults with major depressive disorder. Unlike traditional selective serotonin reuptake inhibitors (SSRIs), EXXUA operates through a distinct mechanism with no reuptake inhibition activity. The drug's antidepressant effect is believed to be related to its modulation of serotonin activity through exclusive and strong binding affinity for 5HT1a receptors, which are key regulators of mood and emotion.
Notably, EXXUA is the only antidepressant acting on serotonin receptors that does not carry label warnings about the risk of sexual dysfunction. In clinical trials involving more than 5,000 patients, the incidence of sexual side effects experienced with EXXUA was comparable to placebo, addressing a major limitation that affects patient compliance with current antidepressant therapies.
Comprehensive Safety Profile
The extensive clinical development program demonstrated that EXXUA exhibits no significant adverse effects on weight, blood pressure, heart rate, or liver function. However, the drug does carry important safety considerations, including potential QT prolongation that requires electrocardiogram monitoring and electrolyte level checks before and during treatment.
The FDA approval includes contraindications for patients with prolonged QTc intervals greater than 450 msec, congenital long QT syndrome, severe liver problems, or those taking strong CYP3A4 inhibitors or monoamine oxidase inhibitors.
Market Entry Strategy
Aytu BioPharma is positioning EXXUA to compete in the over $22 billion United States prescription major depressive disorder market. The company anticipates launching the treatment in the fourth quarter of 2025 as a centerpiece of its commercial efforts, with EXXUA expected to serve as a major growth catalyst.
The net proceeds from the offering will support working capital, general corporate purposes, and enable the company to exclusively commercialize EXXUA in the United States. Gepirone, the active ingredient in EXXUA, is classified as a new chemical entity, further emphasizing its novel therapeutic approach.
Clinical Development Foundation
EXXUA has been extensively studied across multiple clinical trials involving over 5,000 patients, demonstrating significant improvement in depression symptoms. The comprehensive clinical program established both the efficacy and safety profile that supported FDA approval for this new class of therapeutics.
The company has scheduled a conference call for June 11, 2025, to discuss the EXXUA opportunity and commercialization plan, indicating confidence in the drug's commercial potential and market positioning strategy.
