Aytu Biopharma (NasdaqCM:AYTU) 2026 Investor Day Transcript

Aytu Biopharma Investor Day Summary Company Overview - Company: Aytu Biopharma (NasdaqCM:AYTU) - Event: 2026 Investor Day held on January 20, 2026 - Product Launch: Official launch of Exxua, the first and only 5-HT1A agonist for major depressive disorder (MDD) [1][2] Key Points on Exxua - Mechanism of Action: Exxua (Gepirone) is a selective 5-HT1A agonist approved for MDD in adults, functioning as a once-daily extended-release tablet [3][5] - Unique Features: Unlike SSRIs and SNRIs, Exxua does not inhibit re-uptake but activates the 5-HT1A receptor both presynaptically and postsynaptically, enhancing neurotransmission of serotonin and dopamine [3][28] - Safety Profile: Exxua has a favorable safety profile, with no significant increase in sexual dysfunction or weight gain compared to placebo [42][63] Clinical Data and Efficacy - Clinical Trials: Two eight-week randomized, double-blind, placebo-controlled trials demonstrated statistically significant improvement in depression scores [48][51] - Primary Efficacy Measures: Utilized the Hamilton Depression Rating Scale (HAM-D) and Montgomery-Åsberg Depression Rating Scale [48] - Results: - Statistically significant improvement observed as early as week two, with about 50% of patients showing improvement [52][54] - Approximately one-third of patients achieved remission by week eight [56] Unmet Treatment Needs - Prevalence of MDD: In 2021, approximately 21 million Americans (8.3%) experienced major depression, with higher rates in women and younger populations [33][34] - Treatment Challenges: Many patients switch medications due to intolerable side effects, with 50% failing to achieve remission after multiple treatments [36][38] - Importance of Early Intervention: Early use of Exxua is recommended to avoid treatment-resistant depression and improve patient outcomes [68][69] Side Effects and Tolerability - Common Side Effects: Mild to moderate side effects include dizziness, nausea, and insomnia, but these did not lead to significant discontinuation rates [59][63] - Weight and Sexual Function: Exxua does not cause significant weight gain or sexual dysfunction, addressing major concerns associated with traditional antidepressants [42][63] Expert Insights - Ideal Patient Profile: Exxua is suitable for patients who prioritize avoiding sexual dysfunction and weight gain, and should be considered early in treatment [67][68] - Combination Therapy Potential: There is potential for Exxua to be used in combination with other therapies, but it can also serve effectively as a monotherapy [70] Conclusion - Aytu Biopharma's Exxua represents a significant advancement in the treatment of major depressive disorder, with a unique mechanism of action, favorable safety profile, and potential to address unmet needs in the patient population [1][28][42]