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Abeona Therapeutics® Acquires Phase 3-Ready APT-1011, Now ABO-801, and Enters Into Agreement for $30 Million Private Placement

ABEO
  • Abeona Therapeutics acquired ABO-801 (formerly APT-1011), a once-daily oral therapy candidate for eosinophilic esophagitis (EoE), from Ellodi Pharmaceuticals.
  • The acquisition involves $20 million in equity consideration with no upfront cash payment.
  • Ellodi is eligible for up to $30 million upon FDA approval, up to an additional $30 million upon sales milestones, & tiered royalties on net sales ranging from low to mid teens.
  • ABO-801 received FDA Orphan Drug & Fast Track Designations for the treatment of EoE.
  • Abeona secured $30 million in private placement financing through the sale of 6,400,000 common shares at $3.75 per share & pre-funded warrants for up to 1,600,043 shares at $3.7499 per warrant.
  • The financing includes participation from investors such as Nantahala Capital, Marshall Wace, Monashee Investment Management, Perceptive Advisors, TPG, & healthcare-focused funds.
  • ABO-801 is a fluticasone propionate oral disintegrating tablet designed to deliver topical corticosteroid therapy with very low systemic exposure.
  • The asset has a clinical foundation including Phase 1/2a, Phase 2b, & two completed Phase 3 studies, though the Phase 3 studies did not meet co-primary symptom endpoints but showed significant endoscopic improvements.
  • Abeona anticipates initiating a new Phase 3 study in mid-2027 with potential topline results by the end of 2028.
  • Net proceeds from the private placement will fund pipeline development & support commercialization efforts for ZEVASKYN.
  • Morgan Stanley is acting as the sole placement agent for the private placement.
Company
Abeona Therapeutics Inc.
Keywords
Nasdaq:ABEO, Abeona Therapeutics Inc.