Core Insights - Aytu Biopharma has officially launched Exxua, a first-in-class treatment for major depressive disorder, marking a significant milestone in the company's history [1] - The sales force for Exxua is fully deployed and actively generating prescriptions, indicating strong market enthusiasm and potential for growth [2] Company Developments - The launch of Exxua represents a transformational opportunity for Aytu Biopharma as it introduces the first and only 5-HT1a agonist in the market [1] - The company is currently experiencing positive feedback from the field regarding the new product, suggesting a promising reception among healthcare providers [2]

Core Insights - Aytu BioPharma, Inc. held an Investor Day on January 20, 2026, focusing on its product EXXUA, the first FDA-approved 5HT1a agonist for major depressive disorder (MDD) [1][3][23] Group 1: EXXUA Overview - EXXUA is a novel oral selective serotonin 5-HT1A receptor agonist indicated for the treatment of MDD in adults [73] - The product was launched on December 15, 2025, and the full commercial launch is now underway [25][26] - The U.S. MDD market exceeds $22 billion, with over 345 million prescriptions written annually for antidepressants [24] Group 2: Clinical Insights - An estimated 21 million adults in the U.S. had at least one major depressive episode in 2021, representing 8.3% of all U.S. adults [9] - 50% to 60% of patients fail to achieve remission with first-line SSRIs, and nearly half discontinue their first-line treatment due to side effects [11][12] - EXXUA does not carry a warning about the risk of sexual dysfunction, unlike many antidepressants, and demonstrates a neutral sexual profile in clinical studies [13][26] Group 3: Clinical Trial Data - In pivotal studies, EXXUA demonstrated statistically significant improvement in the Hamilton Depression Rating Scale (HAM-D17) total score at Week 8 compared to placebo [15][19] - The mean increase in body weight with EXXUA was 1 kg compared to 0 kg with placebo in pivotal Study 1, and 0.3 kg compared to 0.1 kg in Study 2 [14] - The most common adverse reactions were dizziness, nausea, insomnia, abdominal pain, and dyspepsia, with a discontinuation rate of 7% for EXXUA due to adverse events [19][22][101] Group 4: Commercialization Strategy - Aytu's commercialization agreement for EXXUA includes a $3 million upfront payment and additional payments based on sales milestones [27][28] - The company has a comprehensive launch strategy focused on prescriber adoption and brand growth, leveraging a virtual sales team and a patient access program [46][62] - Aytu aims to deliver nearly 20,000 customer contacts during the initial launch phase, targeting high-volume prescribers of antidepressants [61][52] Group 5: Financial Highlights - Aytu reported $32.6 million in cash as of September 30, 2025, with no additional cash requirement expected through profitability [35][36] - The expected gross margin for EXXUA is 66-68%, compared to a company-wide gross margin of 67.6% [40][41] - The original launch investment budget for EXXUA was reduced from $10 million to $6-8 million due to efficiencies [39]

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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]

Introduction Josh Disbrow Co-Founder & Chief Executive Officer Forward Looking Statements EXXUA™ Launch Aytu BioPharma Investor Day January 20, 2026 Actor portrayals. This presentation includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended ("Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended ("Exchange Act"). All statements other than statements of historical facts contained in this presentation, are forward-looking s ...

Aytu Biopharma FY Conference Summary Company Overview - **Company**: Aytu Biopharma (NasdaqCM:AYTU) - **Focus**: Launch of Exua, a new antidepressant targeting major depressive disorder (MDD) Key Points Exua Launch and Market Positioning - Exua was discovered at the JPMorgan Healthcare Conference and is positioned as a unique antidepressant that does not fall under the SSRI or SNRI categories, which dominate the market with over 345 million prescriptions annually in the U.S. [3][6] - The drug specifically targets the 5-HT1A serotonin receptors, aiming to reduce common side effects associated with traditional antidepressants, such as sexual dysfunction and weight gain [7][8] - Aytu Biopharma has a sales force of approximately 44 representatives already aligned with psychiatry, facilitating a smooth transition to marketing Exua [9][10] Commercial Strategy - The company has established a focused commercial infrastructure that includes a patient access program called RxConnect, designed to simplify the prescription process for physicians and patients [25][26] - The sales team is fully aligned with high-prescribing psychiatrists, ensuring targeted marketing efforts [11][12] - Aytu aims to position Exua as a second or third-line therapy initially, with potential to move up the treatment hierarchy as familiarity with the drug increases [20][21][22] Financial Performance and Legacy Business - Aytu's legacy business, primarily in ADHD medications, generated approximately $55.5 million over the last 12 months, with stable performance despite a highly genericized market [34][35] - The company also has a smaller pediatric product line generating around $8 million, which is not a focus for resource allocation [36] - Aytu has raised $17 million gross for the Exua launch and ended the last quarter with $32.6 million in cash, indicating no immediate need for additional funding [47][48] Competitive Landscape and Risks - The ADHD market faces generic competition, particularly from Teva, which has launched an authorized generic for Adzenis. However, Aytu's RxConnect program is expected to mitigate the impact of this competition [38][39][40] - The company anticipates that Exua's unique mechanism of action and patient access program will help it capture market share in the antidepressant space, which is significantly larger than the ADHD market [44][46] Future Outlook - Aytu Biopharma is optimistic about Exua's potential to transform the company, with expectations of achieving multiples of its current business revenue [44][46] - The company is focused on maintaining a strong market presence and ensuring that Exua is accessible to patients through its innovative RxConnect program [31][32] Additional Insights - The company emphasizes a strategic focus on psychiatry, avoiding a broad approach to maximize efficiency and effectiveness in marketing [14][15] - Aytu's approach to patient access and cost predictability is designed to alleviate common barriers faced by physicians when prescribing new medications [27][30] This summary encapsulates the key discussions and insights from the Aytu Biopharma FY Conference, highlighting the company's strategic direction, market positioning, and financial outlook.

DENVER, CO / ACCESS Newswire / January 13, 2026 / Aytu BioPharma, Inc. (the "Company" or "Aytu") (Nasdaq:AYTU), a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients, announced today that Josh Disbrow, Chief Executive Officer of Aytu, will participate in a fireside chat moderated by Thomas Flaten, Senior Research Analyst at Lake Street Capital Markets, at the Lytham Partners 2026 Investor Healthcare Summit. ...

Core Insights - Aytu BioPharma, Inc. is hosting an Investor Day on January 20, 2026, at 11:00 a.m. Eastern time in New York City [1] Company Overview - Aytu BioPharma, Inc. focuses on advancing innovative medicines for complex central nervous system diseases [1]

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Financial Performance - Aytu BioPharma reported a quarterly loss of $0.08 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.06, representing an earnings surprise of -33.33% [1] - The company posted revenues of $13.89 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 10.05%, but down from $16.57 million a year ago [2] - Over the last four quarters, Aytu BioPharma has not surpassed consensus EPS estimates and has topped revenue estimates only once [2] Stock Performance - Aytu BioPharma shares have increased by approximately 21.2% since the beginning of the year, outperforming the S&P 500's gain of 16.5% [3] - The stock currently holds a Zacks Rank 5 (Strong Sell), indicating expectations of underperformance in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.24 on revenues of $13.01 million, and for the current fiscal year, it is -$0.45 on revenues of $52.65 million [7] - The trend of estimate revisions for Aytu BioPharma was unfavorable prior to the earnings release, which may impact future stock movements [6] Industry Context - Aytu BioPharma operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the top 35% of over 250 Zacks industries [8] - Research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]