---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-010206"
form_type: "8-K"
ticker: "ABEO"
cik: "0000318306"
company_name: "ABEONA THERAPEUTICS INC."
filed_at: "2024-03-18T23:59:59+00:00"
generated_at: "2026-06-04T16:05:49.421075+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-24-010206
- form_type: 8-K
- ticker: ABEO
- cik: 0000318306
- company_name: ABEONA THERAPEUTICS INC.
- filed_at: 2024-03-18T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/0001493152-24-010206-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-010206
- JSON: https://secwatch.observer/filing/0001493152-24-010206.json
- Plain text: https://secwatch.observer/filing/0001493152-24-010206.txt

## Key facts
- Earnings Releases
  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
  source text: 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
  evidence_url: https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/0001493152-24-010206-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.