Aytu BioPharma Recaps Investor Day Held on January 20, 2026 (Form 8-K)

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Selective Serotonin Reuptake Inhibitors ("SSRIs") and Serotonin-Norepinephrine Reuptake Inhibitors ("SNRIs"), collectively Reuptake Inhibitors, 'flood the synapse' with serotonin, non-selectively binding multiple 5-HT receptor types.

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Specific activation of the 5HT1a receptor, the primary mechanism of action of EXXUA, is thought to promote an antidepressant effect.

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Activation of the 5HT2a receptor, an effect of both SSRIs and SNRIs, is associated with sexual dysfunction, insomnia, and anxiety.

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SSRIs and SNRIs may affect thirteen other receptor subtypes, and multiple 5-HT receptor subtypes may affect appetite regulation.

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Reuptake Inhibitors can relieve MDD symptoms, but sometimes at a cost.

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Drugs designed based on re-uptake inhibition exhibit some symptom relief but also lead to off-target side effects.

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EXXUA acts as a full agonist at presynaptic 5HT1a autoreceptors, enhancing neurotransmission.

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5HT1a agonism at autoreceptors is thought to facilitate downregulation of inhibitory 5HT1a autoreceptors, reducing inhibition of serotonergic signaling, improving antidepressant efficacy.

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EXXUA acts as a 5-HT1a-specific partial agonist postsynaptically, contributing to its antidepressant action.

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EXXUA does not have actions at receptors known to be associated with sexual side effects and weight gain.

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EXXUA mechanism of action has potential implications for mood, anxiety, cognition, and stress circuits through potential actions in the medial prefrontal cortex, amygdala, hippocampus, dorsal raphe nucleus, and the ventral tegmental area.

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An estimated 21.0 million adults in the US had at least 1 major depressive episode in 2021, representing 8.3% of all US adults.

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Of those, 14.5 million also experience severe impairment, representing 5.7% of all US adults.

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50% to 60% of patients fail to achieve remission with first-line SSRIs.

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Even if they achieve symptom remission, many patients often do not reach full functional recovery (e.g., cognitive function, workplace productivity, etc.).

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Nearly half of all patients with MDD have been shown to discontinue their first-line treatment.

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Sexual dysfunction and weight gain are significant causes of treatment discontinuation with antidepressants. Of patients taking antidepressants, approximately 50% experience treatment-emergent sexual dysfunction. Additionally, up to 65% experience weight gain with long-term use.

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Implications for EXXUA positioning in clinical practice include the following factors:

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EXXUA does not carry a warning about the risk of sexual dysfunction, unlike many antidepressants that act on serotonin receptors.

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Sexual dysfunction was not reported as an adverse event with an incidence >2% and greater than placebo in pooled MDD studies. EXXUA demonstrates a neutral sexual profile in clinical studies.

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EXXUA demonstrates no clinically significant increase in body weight compared with placebo.

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Mean increase of 1 kg with EXXUA vs. 0 kg with placebo in pivotal Study 1 and 0.3 kg with EXXUA vs. 0.1 kg with placebo in pivotal Study 2.

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Pivotal Study 1 and Study 2 were 8-week, randomized, double-blind, placebo-controlled, flexible-dose, Phase 3 studies in adults with MDD.

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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 mg once daily after Day 7 and 72.6 mg once daily after an additional 7 days.

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Primary efficacy measure: Change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score at Week 8

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Secondary endpoints: Included change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression-Severity (CGI-S) at Week 8

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In Pivotal Study 1 and Pivotal Study 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).

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Change from baseline in the HAM-D 17 total score at Week 8:

Treatment group

Mean baseline

score

LS mean change

from baseline

Placebo-
subtracted

difference
(95% CI)

Study 1

EXXUA (n=101)
(18.2 to 72.6 mg/day)

−2.47
(−4.41, -0.53)

Placebo (n=103)

Study 2

EXXUA (n=116)
(18.2 to 72.6 mg/day)

−2.45

(−4.47, −0.43)

Placebo (n=122)

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In Study 1, the final dose of EXXUA was 72.6, 54.5, and 36.3 mg/day in 64%, 20%, and 17% of patients, respectively.

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In Study 2, the final dose of EXXUA was 72.6, 54.5, 36.3, and 18.2 mg/day in 66%, 22%, 10%, and 2% of patients, respectively.

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Statistically significant remission in symptoms was achieved over placebo as early as week 3.

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Safety and tolerability of EXXUA were evaluated in 1,976 adult patients with MDD in Phase 2 and 3 clinical studies.

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Most common adverse reactions were dizziness, nausea, insomnia, abdominal pain, and dyspepsia (≥5% and twice the incidence of placebo).

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Dizziness was mild to moderate and transient.

Incidence dropped from 33.9% at Week 1 to 19.0% by Week 2 and 2.9% by Week 6 in Study 2.

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Discontinuation due to adverse events was 3% for placebo and 7% for EXXUA.

No treatment-related serious adverse events led to discontinuation, and no deaths occurred in the study.

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Adverse events reported with EXXUA were predominantly early in onset and time limited, with rapid attenuation over the first several weeks of treatment.

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Aytu views EXXUA as a truly unique opportunity, as it represents a novel way of treating major depressive disorder in adults as the first and only 5HT1a agonist indicated for the treatment of major depressive disorder.

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The United States MDD market is over $22 billion, with over 345 million prescriptions written annually for antidepressants.

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EXXUA has a novel product profile and fills a meaningful and very large unmet need.

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The early signs post launch are very positive since initial commercial availability on December 15, 2025, and the final elements of sales force training were completed on January 16, 2026. The full commercial launch of EXXUA is now underway.

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All distributors and wholesalers nationwide are now fully stocked with EXXUA, physicians are engaging, and initial prescriptions have been generated.

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The positioning of EXXUA in the MDD market is unique with respect to its mechanism of action and receptor specificity for 5HT1a.

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EXXUA, as the first and only 5HT1a agonist indicated for the treatment of MDD in adults, is truly novel.

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EXXUA demonstrates no negative impact on sexual function and no clinically or statistically significant weight changes.

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Aytu believes it has a markedly different product that can fill an important gap in treatment, and the early prescriber reactions and traction are providing early evidence of a successful launch.

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The key terms of the EXXUA commercialization agreement with Fabre-Kramer Pharmaceuticals include:

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Fixed Payments:

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$3 million upfront payment; paid at execution in June 2025.

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An additional $3 million payment will be made within forty-five days of the first anniversary of EXXUA Commercial Launch (as defined), such payment to be made in early calendar year 2027.

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The additional payment increases to $5 million if Net Sales (as defined) of EXXUA for the first twelve months of commercialization meet or exceed $35 million.

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Royalties (% of Net Sales):

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28% 'base' royalty.

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Additional 3% (capped) on cost of goods sold.

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Increased royalty rate if annual Net Sales are greater than $300 million.

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Upon a royalty trigger or loss of exclusivity ("LOE"), royalty rates reduce.

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Milestones payments beginning at $100 million in annual Net Sales.

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First milestone of $5 million paid upon Net Sales reaching $100 million.

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Aytu Financial Highlights:

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$32.6 million in cash as of 9/30/25.

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No additional cash requirement expected through profitability.

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Trailing twelve months ("TTM") ending 9/30/25 adjusted EBITDA¹ of $6.7 million.

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TTM operating cash burn of $1.4 million.

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Original EXXUA launch investment budget of $10 million reduced to $6-8 million due to efficiencies and cost management.

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EXXUA expected gross margin of 66-68%.

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Compares to TTM companywide GM of 67.6%.

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Term loan outstanding of $12.5 million as of 9/30/25.

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Reduced high interest liabilities by $7.4 million in TTM.

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Fully diluted shares outstanding of 23.6 million as of 9/30/25.

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Three institutional investors hold 52.3% of fully diluted shares outstanding.

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Dr. Westfield introduced the Investor Day key opinion leaders, who have a combined 40+ years of experience with EXXUA through the FDA review and approval process.

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Launch Overview:

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The EXXUA commercial effort, while efficient in relative spend, will be comprehensive and focused on prescriber adoption and brand growth.

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Heavy emphasis on sales force promotion and metrics-based performance management.

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In addition to the Company's internal sales team, the Company is investing in efficient and rapidly scalable initiatives such as its virtual sales team to significantly broaden Aytu's customer reach.

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Additionally, the Company is leveraging a rolling Contract Sales Organization model which will enable Aytu to scale its in-person promotion based on product performance and cash flows.

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From a non-personal standpoint, a very targeted, media-based compliant consumer promotion approach will be employed.

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The Company is leveraging Aytu's best-in-class patient access program, Aytu RxConnect®, along with full retail distribution for EXXUA through national wholesalers to ensure broad-based product availability at pharmacies throughout the United States.

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Aytu will continue to reinforce with customers that Aytu is committed to an ideal patient access experience and the lowest possible patient out-of-pocket costs when receiving their prescription from an Aytu RxConnect® pharmacy.

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However, if physicians or patients inquire about EXXUA in an area Aytu does not have direct network coverage or a patient simply has a preference for a non-network pharmacy, everyone will have an option to fill their EXXUA prescription.

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Through Aytu's Medical & Scientific Affairs team, the Company is rapidly building out a KOL network and has a strong publication and meeting plan in place.

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Physician Targeting:

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EXXUA physician targeting has been characterized by focus, efficiency, and familiarity in Aytu's approach to launch. The Aytu sales team is initially focusing on a subset of high value psychiatry practices.

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High volume prescribers of antidepressants - specifically SSRI's and SNRI's.

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Prescribers with high potential in the MDD therapeutic class and high levels of active patient switching.

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Psychiatry practices with a higher propensity to prescribe brands.

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Psychiatric practices with familiarity with Aytu - or those psychiatry practices actively prescribing Aytu's attention deficit hyperactivity disorder ("ADHD") products and familiar with the Aytu RxConnect® platform.

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Sales Force Deployment:

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Aytu has deployed the Company's 40 plus person sales force and has positioned them well across a large cross section of the United States with high MDD potential and strong Aytu RxConnect® coverage.

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Annual MDD Market Opportunity:

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Aligned Territories: 140.0 million total prescriptions ("TRxs").

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Target healthcare practitioners ("HCPs") within Aligned Territories: 18.5 million TRxs.

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~5,500 Target HCPs at initial launch.

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100% of Target HCPs are aligned Aytu RxConnect® pharmacies.

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>50% of branded product TRxs volume written by psychiatrists.

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Aytu's sales footprint has also been developed with eye toward expansion as EXXUA performance and Aytu cash flows dictate.

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Virtual sales team will be tasked with building broader prescriber awareness for EXXUA beyond Aytu's in-person promotional efforts.

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Expected to deliver nearly 20,000 customer contacts during the initial launch phase.

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Integration into Aytu RxConnect® & Payor Considerations:

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Aytu RxConnect® is a proprietary, best-in-class patient access program that will play an important role with the launch of EXXUA and the ongoing support for all Aytu medicines.

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Aytu RxConnect® offers unique elements to remove the friction prescribers and patients often face when prescribing and filling branded prescriptions.

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Offers predictable coverage to patients and prescribers by guaranteeing 100% coverage for commercially insured patients regardless of individual plans.

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Creates a low-hassle experience for patients and prescribers by removing common obstacles that occur for branded medications at retail pharmacies by ensuring product availability so patients can initiate therapy without delay.

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Provides affordable access to commercially insured patients by guaranteeing capped out-of-pocket copay maximums.

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For EXXUA, patients with valid prescriptions will pay a maximum of $50 for prescriptions regardless of individual plan coverage.

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Numerous enhancements and improvements to the Aytu RxConnect® program have been implemented since inception.

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Improvements have been made based on insights gained from the over one million prescriptions filled by the Aytu RxConnect® network.

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Realtime data guides the approach with EXXUA contracting for the approximately 60% of commercially insured MDD patients.

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Approximately 40% of the remaining MDD patients are Medicaid and Medicare for which Aytu expects early favorable coverage depending on the geography.

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Aytu is not initially pursuing first-line use for EXXUA and the Company's contracting approach is aligned accordingly.

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Aytu's EXXUA launch coverage expectations for all payers align with recent branded product launches for the treatment of MDD.

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concomitantly with drugs known to prolong the QT interval

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in patients who develop QTc ≥ 450 msec during treatment

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in patients with a significant risk of developing torsade de pointes

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with known hypersensitivity to gepirone or components of EXXUA.

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with prolonged QTc interval > 450 msec at baseline.

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with congenital long QT syndrome.

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receiving concomitant strong CYP3A4 inhibitors.

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with severe hepatic impairment.

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taking, or within 14 days of stopping, MAOIs due to the risk of serious and possibly fatal drug interactions, including hypertensive crisis and serotonin syndrome. Starting EXXUA in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated.

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EXXUA is contraindicated in patients with congenital long QT syndrome and in patients with severe hepatic impairment or in patients receiving concomitant strong CYP3A4 inhibitors as they increase EXXUA plasma concentrations.

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Do not initiate EXXUA if QTc is > 450 msec at baseline.

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Correct electrolyte abnormalities prior to EXXUA initiation. In patients with electrolyte abnormalities, who are receiving diuretics or glucocorticoids, or have a history or hypokalemia or hypomagnesemia, also monitor electrolytes during dose titration and periodically during treatment with EXXUA.

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Perform an ECG prior to EXXUA initiation, during dosage titration, and periodically during treatment. Monitor patients with ECGs more frequently:

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If EXXUA is used concomitantly with drugs known to prolong the QT interval.

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In patients who develop QTc ≥ 450 msec during treatment with EXXUA. Do not escalate the EXXUA dosage if QTcF is > 450 msec.

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In patients with a significant risk of developing torsade de pointes, including those with uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, uncontrolled hypertension, high degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.

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Reduce the EXXUA dosage when used concomitantly with moderate CYP3A4 inhibitors, as they may increase EXXUA concentrations.

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Suicidal Thoughts and Behaviors in Adolescents and Young Adults

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QT Prolongation

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Serotonin Syndrome

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Activation of Mania or Hypomania