Aytu BioPharma Recaps Investor Day Held on January 20, 2026

About this update from Aytu Biopharma, Inc.

DENVER, CO / ACCESS Newswire / January 20, 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, today provided a summary of the Company's Investor Day, held today, Tuesday, January 20, 2026, at 11:00 a.m. Eastern time in New York City. The Investor Day was conducted both in-person and via webcast. A replay of the event can be found on the Investors section of the Company's website at https://investors.aytubio.com under Events & Presentations. The event can also be accessed directly at https://app.webinar.net/Qo7DrDvVzq8 . The Investor Day primarily focused on EXXUA™ (gepirone), extended-release tablets ("EXXUA"), the first and only 5HT1a agonist approved by the United States Food and Drug Administration ("FDA") for the treatment of major depressive disorder ("MDD"), which was initially launched last month. Key Opinion Leaders ("KOLs") in the field of psychiatry and Aytu's senior management team presented on the EXXUA opportunity and led question and answer sessions. KOL Presentation Highlights Stephen M. Stahl, MD, PhD, DSc (Hon) reviewed the 5-HT1a receptor and its clinical importance in MDD. Anita Clayton, MD discussed unmet treatment needs and their implications for antidepressant treatment selection in MDD. Christoph Correll, MD discussed EXXUA's clinical trial data, including efficacy and safety. Aytu Management Team Presentation Highlights Josh Disbrow , Chief Executive Officer, provided an overview of the EXXUA opportunity and commented on early positive signs in the days following initial product availability and full commercial launch. Ryan Selhorn , Chief Financial Officer, provided an overview of the key EXXUA commercialization agreement deal terms along with highlights of the Company's financials. Gerwin Westfield , PhD, Senior Vice President, Scientific Affairs. Greg Pyszczymuka , Chief Commercial Officer, described the Company's approach to the EXXUA commercial launch and provided details on elements of the launch plan. In summary, the launch of EXXUA will be highly focused with a heavy lean towards a well-informed expansion of promotional resources as cash flows allow to support further prescriber growth and brand adoption. With the EXXUA commercial launch now underway, the Company expects to provide periodic updates to investors during quarterly earnings calls and investor events. About Stephen M. Stahl, MD, PhD, DSc (Hon) Dr. Stahl is an internationally renowned physician-scientist, educator, and author with deep expertise in psychiatry, psychopharmacology, and neuroscience. He received his B.S. and M.D. from Northwestern University and his Ph.D. in pharmacology and physiology from the University of Chicago, and completed clinical training in internal medicine, neurology, and psychiatry at top U.S. institutions. Dr. Stahl has held faculty appointments at Stanford University, UCLA, the Institute of Psychiatry London, and currently serves as Distinguished Health Sciences Clinical Professor at the University of California, Riverside, as well as Adjunct Professor of Psychiatry at the University of California, San Diego. He is also an Honorary Visiting Senior Fellow at the University of Cambridge and Senior Academic Advisor for the California Department of State Hospitals. He is a prolific contributor to medical science with hundreds of articles, textbooks, and scientific presentations, most famously Stahl's Essential Psychopharmacology and Stahl's Essential Psychopharmacology Prescriber's Guide, which are widely used in clinical education worldwide. Dr. Stahl has received numerous honors for his contributions to psychiatric education, including the Lundbeck Foundation Award in Education, multiple book awards from the British Medical Association, and the David A. Mrazek Memorial Award, and his alma mater honors top psychiatry students with the Stephen M. Stahl Award. His career blends clinical leadership, academic scholarship, and teaching, and he continues to influence the field through editorial roles (including Editor-in-Chief of CNS Spectrums), global lectures, and contributions to psychiatric nomenclature and education. About Anita H. Clayton, MD Dr. Clayton is a leading American psychiatrist, clinician, and researcher specializing in women's mental health, sexual dysfunction, and mood disorders. She serves as Chair of the Department of Psychiatry and Neurobehavioral Sciences and the David C. Wilson Professor of Psychiatry and Neurobehavioral Sciences at the University of Virginia School of Medicine, with a secondary appointment as Professor of Clinical Obstetrics and Gynecology. Dr. Clayton earned her M.D. from the University of Virginia School of Medicine and completed her psychiatry residency and fellowship at UVA, after which she served as a physician in the U.S. Navy before joining the UVA faculty in 1990. Her research focuses on psychopharmacology, mood disorders associated with reproductive life events, sexual dysfunction related to psychiatric illness and treatment, and female sexual disorders. She has published over 200 peer-reviewed papers, developed validated clinical assessment tools, and co-edited Women's Mental Health: A Comprehensive Textbook. Dr. Clayton has held leadership roles in professional organizations, including past presidency of the International Society for the Study of Women's Sexual Health and leadership positions with the American Society for Clinical Psychopharmacology. She is a Distinguished Fellow of the American Psychiatric Association and a recognized expert on women's mental and sexual health. About Christoph U. Correll, MD Dr. Correll is a highly influential German-born psychiatrist, clinician, and researcher recognized internationally for his work in psychopharmacology, severe mental illness, and child and adolescent psychiatry. He currently serves as Professor of Psychiatry and Molecular Medicine at The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in New York and Professor and Chair of the Department of Child and Adolescent Psychiatry, Psychosomatic Medicine and Psychotherapy at Charité - Universitätsmedizin Berlin, Germany. Dr. Correll completed his medical studies at the Free University of Berlin and Dundee University Medical School in Scotland, followed by residencies and fellowship training in psychiatry and child and adolescent psychiatry in New York. He is board-certified in both general and child/adolescent psychiatry and has worked in academic and clinical settings in both the United States and Germany since 1997. A prolific scholar, Dr. Correll has authored or co-authored hundreds of scientific articles on topics such as schizophrenia, bipolar disorder, mood disorders, and the psychopharmacological management of severe psychiatric conditions. His work spans clinical trials, epidemiology, meta-analyses, and evaluation of psychotropic medications, and he has been listed annually since 2014 as one of the most influential scientific minds and top 1% cited scientists in psychiatry. Dr. Correll's research also addresses the interface of physical health and mental health, comparative effectiveness of psychiatric treatments, and early identification and treatment strategies across the life span. He has received numerous national and international awards for his scientific contributions and is widely regarded as a global expert in psychopharmacology and severe mental illness. About Aytu BioPharma Aytu is a pharmaceutical company focused on advancing innovative medicines for complex central nervous system diseases to improve the quality of life for patients. The Company's prescription products include EXXUA™ (gepirone) extended-release tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of major depressive disorder (MDD), and treatments for attention deficit-hyperactivity disorder (ADHD). Aytu is committed to delivering the Company's medications through best-in-class patient access programs that help to enable optimal patient outcomes. For more information, please visit aytubio.com or follow us on LinkedIn . About EXXUA EXXUA is a novel oral selective serotonin 5-HT1A receptor agonist indicated for the treatment of major depressive disorder (MDD) in adults. IMPORTANT SAFETY INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. EXXUA is not approved for use in pediatric patients. INDICATIONS AND USAGE EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. DOSAGE AND ADMINISTRATION Important Recommendations Prior to Initiating and During Treatment with EXXUA Electrocardiogram and Electrolyte Monitoring Correct electrolyte abnormalities prior to initiating EXXUA. In patients with electrolyte abnormalities, or who are receiving diuretics or glucocorticoids, or who have a history of hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA. Perform an electrocardiogram (ECG) prior to initiating EXXUA, during dosage titration, and periodically during treatment. Do not initiate EXXUA if QTc is > 450 msec at baseline. Monitor ECGs more frequently if EXXUA is used: Do not escalate the EXXUA dosage if the QTcF is > 450 msec. Bipolar Disorder, Mania, and Hypomania Screening Screen patients for a personal or family history of bipolar disorder, mania, or hypomania prior to initiating treatment with EXXUA. Important Administration Instructions Take EXXUA orally with food at approximately the same time each day. Swallow tablets whole. Do not split, crush, or chew EXXUA. Recommended Dosage The recommended starting dosage of EXXUA is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to 36.3 mg orally once daily on Day 4 and further titrated to 54.5 mg orally once daily after Day 7 and to 72.6 mg orally once daily after an additional week. The maximum recommended daily dosage of EXXUA is 72.6 mg once daily. Dosage Recommendations in Geriatric Patients The recommended starting dosage of EXXUA in geriatric patients is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to maximum recommended dosage of 36.3 mg orally once daily after Day 7. Recommended Dosage in Patients with Renal Impairment The recommended starting dosage of EXXUA in patients with creatinine clearance < 50 mL/min is 18.2 mg orally once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. The recommended dosage in patients with creatinine clearance ≥ 50 mL/min is the same as in patients with normal renal function. Recommended Dosage in Patients with Hepatic Impairment The recommended starting dose of EXXUA in patients with moderate (Child-Pugh B) hepatic impairment is 18.2 mg once daily. Based on clinical response and tolerability, the dosage may be increased to the maximum recommended dosage of 36.3 mg orally once daily after Day 7. EXXUA is contraindicated in patients with severe (Child-Pugh C) hepatic impairment. The recommended dosage in patients with mild (Child-Pugh A) hepatic impairment is the same as patients with normal hepatic function. Dosage Modifications for Concomitant Use with CYP3A4 Inhibitors Reduce the EXXUA dose by 50% when used concomitantly with a moderate CYP3A4 inhibitor. EXXUA is contraindicated in patients receiving strong CYP3A4 inhibitors. Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days must elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with EXXUA. Conversely, at least 14 days must be allowed after stopping EXXUA before starting an MAOI antidepressant. CONTRAINDICATIONS EXXUA is contraindicated in patients: WARNINGS AND PRECAUTIONS Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients aged 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied. There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. *EXXUA is not approved for use in pediatric patients. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing EXXUA, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. QT Prolongation EXXUA prolongs the QTc interval. Serotonin Syndrome Concomitant use of EXXUA with SSRIs or tricyclic antidepressants may cause serotonin syndrome, a potentially life-threatening condition with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor. The concomitant use of EXXUA with MAOIs is contraindicated. In addition, do not initiate EXXUA in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking EXXUA discontinue EXXUA before initiating treatment with the MAOI. If concomitant use of EXXUA with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and monitor for symptoms. Discontinue EXXUA and/or concomitant serotonergic drug immediately if the above symptoms occur and initiate supportive symptomatic treatment. Activation of Mania or Hypomania Antidepressant treatment can precipitate a manic, mixed, or hypomanic manic episode. The risk appears to be increased in patients with bipolar disorder or who have risk factors for bipolar disorder. Prior to initiating treatment with EXXUA, screen patients for a history of bipolar disorder and the presence of risk factors for bipolar disorder (e.g., family history of bipolar disorder, suicide, or depression). EXXUA is not approved for use in treating bipolar depression. ADVERSE REACTIONS Most common adverse reactions (incidence of ≥5% and at least twice incidence of placebo) were dizziness, nausea, insomnia, abdominal pain, and dyspepsia. The following adverse reactions are discussed in greater detail in other sections of the labeling: To report SUSPECTED ADVERSE REACTIONS, contact Aytu BioPharma at 1-855-298-8246 or http://www.exxua.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . USE IN SPECIFIC POPULATIONS Pregnancy The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including EXXUA, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/ . Lactation There is no data on the presence of gepirone in human milk, the effects on the breastfed infant, or the effects on milk production. Gepirone is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are reports of breastfed infants exposed to other serotonergic antidepressants experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EXXUA and any adverse effects on the breastfed infant from EXXUA or from the underlying maternal condition. OVERDOSAGE In clinical studies, cases of acute ingestions up to 454 mg (6.25 times the maximum recommended dose) of EXXUA alone or in combination with other drugs, were reported. Signs and symptoms reported with overdose of EXXUA at doses up to 454 mg included vomiting and transient incomplete bundle branch block; an unknown dose of EXXUA produced altered level of consciousness and a 60-second convulsion. No specific antidotes for EXXUA are known. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations. Please see Full Prescribing Information for EXXUA. Footnote 1 Aytu uses the term adjusted EBITDA, which is a term not defined under United States generally accepted accounting principles ("U.S. GAAP"). The Company uses this term because it is a widely accepted financial indicator utilized to analyze and compare companies on the basis of operating performance. The Company believes that presenting adjusted EBITDA by certain categories allows investors to evaluate the various performance of these categories. The Company's method of computation of adjusted EBITDA may or may not be comparable to other similarly titled measures used by other companies. The Company believes that net income is the performance measure calculated and presented in accordance with U.S. GAAP that is most directly comparable to adjusted EBITDA. See below for a reconciliation of net income to adjusted EBITDA. Forward-Looking Statements This press release 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 press release, are forward-looking statements. Forward-looking statements are generally written in the future tense and/or are preceded by words such as "may," "will," "should," "forecast," "could," "expect," "suggest," "believe," "estimate," "continue," "anticipate," "intend," "plan," or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical facts contained in this press release, are forward-looking statements. These statements are predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks are described in "Risk Factors" in Part I, Item 1A of the Company's most recent Annual Report on Form 10 K and in the other reports and documents it files with the United States Securities and Exchange Commission. Contacts for Investors Ryan Selhorn, Chief Financial Officer Aytu BioPharma, Inc. [email protected] Robert Blum Lytham Partners [email protected] SOURCE: Aytu BioPharma, Inc. View the original press release on ACCESS Newswire

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