Aytu Biopharma, Inc. · NASDAQ:AYTU
Aytu Biopharma — Investor Day (January 2026)
59 slides from Aytu Biopharma's investor day presentation, Jan 20, 2026
Slide 1: EXXUA Launch: Aytu BioPharma Investor Day
EXXUA™ Launch Aytu BioPharma Investor Day January 20, 2026 Actor portrayals.
Slide 2: Introduction
Introduction Josh Disbrow Co-Founder & Chief Executive Officer
Slide 3: Forward Looking Statements
Forward Looking Statements 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 o
Slide 4: Important Safety Information
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
Slide 5: Select Important Safety Information
Select Important Safety Information CONTRAINDICATIONS EXXUA is contraindicated in patients: ● with known hypersensitivity to gepirone or components of EXXUA. ● with prolonged QTc interval > 450 msec at baseline. ● with congenital long QT syndrome. ● receiving concomitant strong CYP3A4 inhibitors. ●
Slide 6: EXXUA is the First and Only Selective 5-HT1A Agonist Approved for MDD in Adults
EXXUA™ is the First and Only Selective 5-HT1A Agonist Approved for MDD in Adults ● FDA-approved as a once-daily extended-release tablet for treatment of adults with MDD ● Member of the azapirone class, which includes Buspar® (commercially available as generic buspirone)(approved for anxiety, but not
Slide 7: Aytu BioPharma Executive Team
Aytu BioPharma Executive Team Josh Disbrow Ryan Selhorn Greg Pyszczymuka Margaret Cabano Suzane Kennedy Jarrett Disbrow Dr. Gerwin Westfield Chief Executive Officer Chief Financial Officer Chief Commercial Officer Senior VP of Operations Vice President of Regulatory Chief Business Officer Senior VP
Slide 8: Today's Meeting Objectives
Today’s Meeting Objectives ● Discuss the 5-HT1A receptor and its clinical importance in Major Depressive Disorder ● Highlight unmet treatment needs and their implications for antidepressant treatment selection in Major Depressive Disorder ● Share EXXUA clinical trial data including efficacy and safe
Slide 9: Introduction
Introduction Gerwin Westfield, PhD Senior Vice President of Scientific Affairs
Slide 10: The 5-HT1A Receptor and Its Clinical Importance in MDD
The 5-HT1A Receptor and Its Clinical Importance in Major Depressive Disorder (MDD) Stephen M. Stahl, MD, PhD, DSc (Hon), DMedSci (Hon, Cambridge) Adjunct Professor of Psychiatry, University of California San Diego Clinical Professor of Psychiatry and Neuroscience, University of California, Riverside
Slide 11: MDD Pathophysiology
MDD Pathophysiology The monoamine-deficiency theory of depression proposes that depletion of the neurotransmitters serotonin, norepinephrine, and/or dopamine is a key underlying driver of MDD Serotonin • Alterations in these neurotransmitters are believed to affect mood regulation and cognitive func
Slide 12: Defining Major Depressive Disorder
Defining Major Depressive Disorder DSM-5-TR Criteria • Depressed mood* • Reduced interest or pleasure in activities* Symptoms: • Unintentional changes in appetite or weight • Are present almost every day and • Insomnia or hypersomnia represent a change in functioning • Psychomotor agitation or retar
Slide 13: Normal Signaling at a Serotonergic Synapse
Normal Signaling at a Serotonergic Synapse Normal State MDD State Presynaptic neuron Neurotransmitter Synapse (5-HT) Receptor Postsynaptic neuron • Most synapses are “asymmetric,” as In the MDD disease state communication flows from the axon of the first • Presynaptic autoreceptors are upregulated n
Slide 14: Signaling at a Serotonergic Synapse in MDD
Signaling at a Serotonergic Synapse in MDD Presynaptic neuron 5-HT1A autoreceptor In the MDD disease state: • Presynaptic autoreceptors are upregulated • Multiple subtypes of postsynaptic receptors are also upregulated • There is a relative deficiency Synapse of serotonin at the synapse Postsynaptic
Slide 15: Mechanism of Action: SSRIs and SNRIs
Mechanism of Action: SSRIs and SNRIs SSRIs and SNRIs flood the synapse with serotonin, nonselectively binding multiple 5-HT receptor types ● Activation of the 5-HT1A receptor is thought to promote an antidepressant effect ● Activation of the 5-HT2A receptor is associated with sexual dysfunction, ins
Slide 16: Reuptake Inhibitors Can Relieve Symptoms but Sometimes at a Cost
Reuptake Inhibitors Can Relieve Symptoms but Sometimes at a Cost Drugs designed based on reuptake inhibition exhibit some symptom relief but also lead to off-target side effects Reuptake Inhibiting Drugs Clinical Benefits Mechanism-Linked Harms • Improvement in core depressive • Sexual dysfunction s
Slide 17: Presynaptic Effects of EXXUA
Presynaptic Effects of EXXUA™ • EXXUA™ acts as a full agonist at presynaptic 5-HT1A autoreceptors, enhancing 5-HT1A neurotransmission1,2 autoreceptor • 5-HT1A agonism at autoreceptors is thought to facilitate downregulation of inhibitory 5-HT1A autoreceptors, reducing inhibition of serotonergic sign
Slide 18: Postsynaptic Effects of EXXUA
Postsynaptic Effects of EXXUA™1,2 • EXXUA™ acts as a 5-HT1A–specific partial agonist, contributing to its antidepressant action* • EXXUA™ does not have actions at receptors known to be associated with sexual side effects and weight gain 5-HT2A 5-HT1A EXXUA™ Activated receptor 18 *A partial agonist i
Slide 19: Potential Implications for Mood, Anxiety, Cognition, and Stress Circuits
Potential Implications for Mood, Anxiety, Cognition, and Stress Circuits Amygdala2 mPFC1 • Postsynaptic 5-HT1A receptor activation contributes to • Postsynaptic 5-HT1A anxiolytic effects modulates E/I balance • Linked to mood regulation, cognitive control, and the antidepressant response Hippocampus
Slide 20: FDA-Approved Azapirones
FDA-Approved Azapirones1,2 Buspirone EXXUA™ • Azapirone class: 5-HT1A agonist • Azapirone class: 5-HT1A agonist • Broad, low-affinity interactions, • Highly targeted to 5-HT1A receptor including dopamine antagonism • Dosing: once-daily oral ER • Dosing: multiple oral IR tablets tablets daily • Half-
Slide 21: Key Takeaways
Key Takeaways • MDD is thought to be in part caused by depletion of monoamine neurotransmitters across multiple brain regions1 • Nonselective mechanisms of monoamine reuptake–blocking antidepressants frequently cause treatment-emergent adverse events1 • EXXUA™ is a highly targeted 5-HT1A agonist wit
Slide 22: Unmet Treatment Needs in Major Depressive Disorder
Unmet Treatment Needs and Their Implications for Antidepressant Treatment Selection in Major Depressive Disorder Anita H. Clayton, MD Wilford W. Spradlin Professor of Psychiatry and Neurobehavioral Sciences, University of Virginia School of Medicine Professor of Clinical Obstetrics and Gynecology, U
Slide 23: Prevalence of MDD: United States
Prevalence of MDD: United States Past-Year Prevalence of MDD Among US Adults (2021) 20 18.6 15 13.9 Percent 10 11.2 10.3 9.3 8.9 8.3 7.9 5 6.2 6.7 4.5 4.8 5.1 0 All Female Male 18-25 26-49 50+ Hispanic White Black/AA Asian AI/AN NH/OPI ≥2 Sex Age Race/Ethnicity • An estimated 21.0 million adults in
Slide 24: Acute and Long-Term STAR*D Outcomes
Acute and Long-Term STAR*D Outcomes 80 70 71.1 60 64.6 % of patients 50 55.3 40 40.1 36.8 30 34.1 30.6 20 25.6 19.5 16.3 10 13.7 13.0 Step 1 Step 2 Step 3 Step 4 (n=3,671) (n=1,439) (n=390) (n=123) Relapse Intolerance Remission Step 1: Patients begin with SSRI therapy Step 2: Nonremitters move to a
Slide 25: Impact of Tolerability Concerns on Adherence, Persistence, and Quality of Life
Impact of Tolerability Concerns on Adherence, Persistence, and Quality of Life After 1 Treatment After 4 Treatments 0% 0% • 50% to 60% of patients fail to achieve remission with first-line 30% SSRIs 33% • Even if they achieve symptom remission, many patients often do Relapse rate Relapse rate not re
Slide 26: Switching and Discontinuation Patterns
Switching and Discontinuation Patterns Rates of Switching Reasons for Switching A study of 56,521 outpatients In an outpatient survey on SSRI use, beginning antidepressant therapy patients reporting “moderately or found that 8.6% switched extremely bothersome” side effects medications within the fir
Slide 27: Common Antidepressant AEs can Exacerbate MDD
Common Antidepressant AEs can Exacerbate MDD Sexual dysfunction and weight gain are significant causes of treatment discontinuation with antidepressants1 Of patients taking antidepressants: ~ 50% Up to 65% experience treatment-emergent experience weight gain sexual dysfunction (TESD)1 with long-term
Slide 28: The Bidirectional Association Between MDD and Common Antidepressant AEs
The Bidirectional Association Between MDD and Common Antidepressant AEs Depression increases the risk of sexual dysfunction by 50% to 70%1 and increases the risk of obesity by 58%2 SEXUAL MAJOR DYSFUNCTION DEPRESSIVE bidirectional association & WEIGHT DISORDER GAIN Sexual dysfunction and obesity inc
Slide 29: Implications for EXXUA Positioning in Clinical Practice
Implications for EXXUA™ Positioning in Clinical Practice1-3 EXXUA™ does not carry No clinically significant a warning about the risk of increase in body weight sexual dysfunction unlike compared with placebo many antidepressants that act on serotonin receptors ● Sexual dysfunction was not ● Mean inc
Slide 30: EXXUA Demonstrates a Neutral Sexual Profile
EXXUA™ Demonstrates a Neutral Sexual Profile Placebo EXXUA™ Domain 1 3.5 3.5 Sexual Cognition/ Men Women Fantasy Change in DISF-SR domains score 3 3 Domain 2 2.5 2.5 Sexual Arousal/ 2 2 Excitement 1.5 1.5 Domain 3 Sexual Behavior/ 1 1 Activity 0.5 0.5 Domain 4 0 0 Orgasm/Ability to Reach Orgasm -0.5
Slide 31: Key Takeaways
Key Takeaways • 21.0 million adults in the US live with MDD1 • Many patients discontinue or switch treatments due to bothersome side effects2 • The safety and tolerability of EXXUA™ have been established in over 1,900 patients3 • EXXUA™ provides antidepressant efficacy without causing sexual dysfunc
Slide 32: EXXUA Clinical Trial Data: Efficacy and Safety
EXXUA™ Clinical Trial Data: Efficacy and Safety Christoph Correll, MD Professor of Psychiatric Neuroscience, Institute of Behavioral Science, Feinstein Institutes for Medical Research Professor, Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Prof
Slide 33: Primary and Secondary Endpoints
Primary and Secondary Endpoints Study 11 and Study 22 were 8-week, randomized, double-blind, placebo-controlled, flexible-dose, Phase 3 studies in adults with MDD Treatment schedule: Initial dosage of 18.2 mg once daily was titrated to 36.3 mg once daily on Day 4. Dosage could be increased to 54.5 m
Slide 34: Baseline Characteristics
Baseline Characteristics Study 1 (N=202)1 Study 2 (N=238)2 Mean age 39 38 Female 61% 68% Race Caucasian 73% 65% Black 9% 23% Other 18% 12% Course of illness First episode 33% 23% Chronic 15% 8% Recurrent after partial recovery 19% 10% Recurrent after full recovery 33% 59% 34 1. Data on file. Clinica
Slide 35: Significant Symptom Improvement Compared With Placebo (1 of 4)
EXXUA™ Demonstrates Significant Symptom Improvement Compared With Placebo (1 of 4)1,2 In Study 1 and 2 ● EXXUA™ demonstrated statistically significant improvement from baseline in the HAM-D17 total score at Week 8 vs placebo (P=0.018 and P=0.032, respectively) Change from baseline in the HAM-D17 tot
Slide 36: Significant Symptom Improvement Compared With Placebo (2 of 4)
EXXUA™ Demonstrates Significant Symptom Improvement Compared With Placebo (2 of 4)1,2 Mean Change From Baseline in HAM-D17 Total Score by Treatment Week1 Statistically significant separation from placebo as early as 3 weeks *Percentage of patients at each final dose strength: 72.6 mg (66%), 54.5 mg
Slide 37: Significant Symptom Improvement Compared With Placebo (3 of 4)
EXXUA™ Demonstrates Significant Symptom Improvement Compared With Placebo (3 of 4) Mean MADRS Total Score by Treatment Week 35 30 Mean ± SE MADRS Score 25 20 *** 15 *** ** 10 5 Baseline 2 4 6 8 **P<0.01; ***P<0.005. 37 SE, standard error. Bielski RJ, et al. J Clin Psychiatry. 2008;69(4):571-577.
Slide 38: Significant Symptom Improvement Compared With Placebo (4 of 4)
EXXUA™ Demonstrates Significant Symptom Improvement Compared With Placebo (4 of 4) EXXUA™ (N=116), Placebo (N=122), Variable P valuea mean±SE mean±SE Baseline 23.9±0.3 24.2±0.3 HAM-D17 Mean change −10.2±0.8 −8.0±0.7 0.032 Baseline 30.3±0.3 30.8±0.3 MADRS Mean change −13.7±1.0 −9.9±1.0b 0.008 Baselin
Slide 39: Reduction in HAM-D17 Measures With EXXUA
Reduction in HAM-D17 Measures With EXXUA™ Proportion of Patients With MDD Treated With EXXUA™ (N=116) or Placebo (N=122), as Assessed by the HAM-D17 Responders Remitters 50 50 * Placebo ** Placebo Percentage of patients EXXUA™ EXXUA™ Percentage of patients 40 40 ** * 30 30 * 20 20 * 10 10 * 0 0 2 3
Slide 40: No Treatment-Emergent Sexual Dysfunction
No Treatment-Emergent Sexual Dysfunction DISF-SR scores showed no signal of TESD among EXXUA™-treated subjects who completed assessments 12 Placebo EXXUA™ • Higher DISF-SR scores indicate Change in DISF-SR score* 10 improved sexual functioning 8 • Similar patterns favoring EXXUA™ were observed acros
Slide 41: No Clinically Significant Increase in Body Weight Compared With Placebo
No Clinically Significant Increase in Body Weight Compared With Placebo Treatment Mean weight ≥7% weight Overall signal group change gain EXXUA™ Small, clinically (n=101) +1.0 kg insignificant mean (18.2 to 72.6 Rare, no Study 11 difference increase mg/day) between groups No meaningful weight Placeb
Slide 42: Safety Considerations With 5-HT1A–Selective Agents: Overview
Safety Considerations With 5-HT1A– Selective Agents: Overview Safety and tolerability of EXXUA™ were evaluated in 1,976 adult patients with MDD in Phase 2 and 3 clinical studies1 Most common adverse reactions were dizziness, nausea, insomnia, abdominal pain, and dyspepsia1 • ≥5% and twice the incide
Slide 43: Full Profile of AEs From Clinical Trial Data
Full Profile of AEs From Clinical Trial Data Placebo EXXUA™ 18.2 to 76.2 mg Adverse reaction (n=230) (%) (n=226) (%) Dizziness* 10 49 Nausea 13 35 Headache* 20 31 Feeling sleepy or tired* 14 15 Insomnia* 5 14 Diarrhea 9 10 Upper respiratory tract infection 7 8 Dry mouth 5 8 Vomiting 4 7 Abdominal pa
Slide 44: Full Profile of AEs From Clinical Trial Data
Full Profile of AEs From Clinical Trial Data Placebo EXXUA™ 18.2 to 76.2 mg Adverse reaction (n=230) (%) (n=226) (%) Increased appetite 3 5 Constipation 3 4 Nasopharyngitis 3 4 Nasal congestion 2 4 Paresthesia 1 4 Hyperhidrosis 0 4 Palpitations 0 4 Weight increased 1 3 Agitation 0 3 Feeling jittery
Slide 45: QTc Warning and Mitigation Strategies
QTc Warning and Mitigation Strategies EXXUA™ prolongs the QTc interval ● The largest mean increase in QTc interval was 18.4 msec at 2-fold the exposure of the maximum recommended dose (100 mg) with an immediate-release formulation, which was discontinued ● No reported cases of QT prolongation as an
Slide 46: Key Takeaways
Key Takeaways1-3 • Study 1 and Study 2 were 8-week, randomized, double-blind, placebo- controlled, flexible-dose, Phase 3 studies in adults with MDD • In these studies, EXXUA™ demonstrated significant improvement from baseline in MADRS total score by Week 4 • Statistically significant remission in s
Slide 47: Q&A
Soxx ud (gepirone) extended-release tablets 182. 36. mg, 545 mg, 72mg Q&A 47
Slide 48: Financial Overview
Financial Overview Ryan Selhorn Chief Financial Officer 48
Slide 49: EXXUA Key Deal Terms
EXXUA Key Deal Terms • Fixed Payments: • $3M paid at execution • Additional $3M paid within forty-five (45) days of 1st anniversary of Commercial Launch • Second upfront payment increases to $5M if Net Sales for the first 12 months > $35M • Royalties (% of Net Sales): • 28% ‘base’ royalty • 3% cap o
Slide 50: Financial Highlights
Financial Highlights • $32.6 million in cash as of 9/30/25 • No additional cash requirement expected through profitability • TTM Adjusted EBITDA of $6.7M • TTM operating cash burn of $1.4M • Original EXXUA launch investment budget of $10M reduced to $6-8M due to efficiencies & cost management • EXXU
Slide 51: Commercial Launch Plan
Commercial Launch Plan Josh Disbrow Co-Founder & Chief Executive Officer
Slide 52: EXXUA: A Clear Position in the MDD Market
EXXUA: A Clear Position in the MDD Market EXXUA has a unique profile due to its MOA, which helps explain the lack of impact on sexual function or weight – key issues for many MDD patients Novel Mechanism No Impact of Once Daily Brand Weight Neutral of Action Sexual Function Dosing EXXUA™ SSRIs SNRIs
Slide 53: Commercial Launch Plan
Commercial Launch Plan Greg Pyszczymuka Chief Commercial Officer
Slide 54: EXXUA Promotional Mix & Commercial Priorities
EXXUA Promotional Mix & Commercial Priorities Sales force promotion EXXUA Launch Focus • Efficient, multi-faceted launch with emphasis on sales force promotion and metrics-based performance management • Targeted virtual promotion and pull-through to support broad Strategic payor Targeted virtual ass
Slide 55: Focused on Psychiatric Practices
Focused on Psychiatric Practices Aligned to psychiatry with existing Aytu relationships to maximize initial launch: High EXXUA Potential High • Annual MDD Market Opportunity: antidepressant Rx volume • Aligned Territories: 140.0 million TRx1 • Target HCPs: 18.5 million TRx1 • ~5,500 Target HCPs at i
Slide 56: Commercial Infrastructure
Commercial Infrastructure Efficient, experienced, and leverageable commercial infrastructure for Rx Portfolio through initial 40 territories allows for rapid scalable promotional expansion opportunities ● Lean, direct sales force covers core branded MDD prescribers in our current sales footprint ● S
Slide 57: Aytu RxConnect Patient Access Program
Aytu RxConnect Patient Access Program Aytu RxConnect is a proprietary, best-in-class patient access program, supported by an efficient commercial infrastructure, to support patient access to Aytu Rx products. ● Developed in-house to drive patient adherence and increased script pull- through of Aytu’
Slide 58: Q&A
Soxx ud (gepirone) extended-release tablets 182. 36. mg, 545 mg, 72mg Q&A 58
Slide 59: Thank you!
Thank you! EXXUATM is a trademark of Fabre-Kramer Pharmaceuticals, Inc. © 2025 Aytu BioPharma, Inc. All rights reserved.