Abeona Therapeutics reports FY2023 results; FDA completes pz-cel PLI with Form 483, PDUFA May 25, 2024

ABEONA THERAPEUTICS INC.

FDA completed Pre-License Inspection of Cleveland manufacturing facility; Form 483 issued for process controls; company submitted response.
Clinical site inspections (Stanford, UMass) for Phase 3 VIITAL study completed with no Form 483 observations.
Net loss $54.2M ($2.53 per share) for FY2023; revenue $3.5M from Taysha license milestone.
Cash and investments $52.6M at Dec 31, 2023; received $20M tranche from $50M Avenue credit facility in Jan 2024.
Cash runway estimated into Q1 2025, excluding potential pz-cel commercial revenue or PRV sale.

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.98

ABEONA THERAPEUTICS INC. reported full year ended December 31, 2023 results: revenue 3.5 million, net income -54.2 million, EPS -2.53.

Period: full year ended December 31, 2023
Revenue: 3.5 million
Net income: -54.2 million
EPS: -2.53
Result: reported results

Exact text from the filing

sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher, if awarded by the FDA. License and other revenues for the year ended December 31, 2023 were $3.5 million, as compared to $1.4 million for the same period of 2022. The revenues in both years primarily represent clinical milestone payments under a licensing agreement with Taysha Gene

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Source: SEC EDGAR

accession 0001493152-24-010206

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