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Abeona to Buy APT-1011 in $20 Million Equity Deal

The commercial-stage biopharmaceutical company is pairing the asset-purchase of a Phase 3-ready eosinophilic esophagitis candidate with a $30 million private placement to fund the pipeline.

Abeona Therapeutics Inc. (ABEO) agreed to acquire APT-1011, now ABO-801, from Ellodi Pharmaceuticals for $20 million of Abeona common stock at closing, with no upfront cash payment. The commercial-stage biopharmaceutical company also entered a securities purchase agreement for a $30 million private placement.

ABO-801 is a once-daily oral disintegrating tablet of fluticasone propionate being developed for eosinophilic esophagitis, a chronic inflammatory disease of the esophagus marked by difficulty swallowing and food impaction. The company said the asset has FDA Orphan Drug and Fast Track designations.

Under the asset purchase, Ellodi is also eligible to receive $30 million upon FDA approval of ABO-801 and up to an additional $30 million on specified sales milestones, plus tiered royalties on net sales ranging from low to mid teen percentages.

Chief Executive Officer Vish Seshadri, Ph.D., said the acquisition “is an important step in building Abeona into a diversified commercial-stage company with multiple opportunities for value inflection, adding an asset with substantial revenue potential in a rapidly growing disease.” The company said the deal and the financing reflect a disciplined approach to capital allocation.

ABO-801 has been evaluated in a 24-patient Phase 1/2a study, a 106-patient Phase 2b dose-ranging study and two completed Phase 3 studies that enrolled a combined 361 patients, with additional longer-term treatment experience through an Expanded Access Program involving 265 cumulative participants. Across the program, the company said ABO-801 demonstrated histologic and endoscopic activity, with encouraging evidence of symptomatic activity and a favorable safety profile. Neither Phase 3 study met its prespecified co-primary patient-reported symptom endpoint; both showed statistically significant improvements in several endoscopic measures, the company said.

Abeona said it anticipates initiating a planned Phase 3 study in the second quarter of 2027 and, subject to the timing of study initiation and enrollment, currently anticipates topline results by the end of 2028. The company said learnings from the two completed Phase 3 studies inform the design of that planned study.

The private placement covers 6,400,000 shares of common stock at $3.75 a share and pre-funded warrants to purchase up to 1,600,043 shares at $3.7499 a warrant, expected to result in $30 million in gross proceeds before fees and expenses. Participants included Nantahala Capital, Marshall Wace, Monashee Investment Management, Perceptive Advisors, TPG, and a group of healthcare-focused funds. Morgan Stanley is the sole placement agent. Abeona intends to use net proceeds for general corporate purposes, including pipeline development and commercialization of ZEVASKYN.

The company’s portfolio also includes ZEVASKYN (prademagene zamikeracel), an autologous cell-based gene therapy for wounds in recessive dystrophic epidermolysis bullosa, and ABO-701, an investigational engineered T-cell therapy targeting PSMA.

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