Aytu BioPharma launches EXXUA for MDD; reports $32.6M cash, reduced launch budget to $6-8M

AYTU BIOPHARMA, INC

EXXUA (gepirone) is first FDA-approved 5HT1a agonist for MDD; full commercial launch underway after Dec 15, 2025 initial availability.
Cash $32.6M as of 9/30/25; TTM adjusted EBITDA $6.7M; launch budget reduced from $10M to $6-8M.
Commercialization deal with Fabre-Kramer: $3M upfront, 28% base royalty plus 3% on COGS, milestones starting at $100M net sales.
Pivotal trials showed significant HAM-D17 improvement vs placebo (P=0.018 and P=0.032); no sexual dysfunction or weight gain warning.
Targeting 5,500 high-value psychiatry prescribers; 40+ person sales force; virtual team to deliver 20,000 contacts in launch phase.

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