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Abeona Therapeutics Announces $50 Million Credit Facility CLEVELAND

Key Takeaway: Abeona Therapeutics announced a $50 million credit facility with Avenue Venture Opportunities Fund to bolster its commercialization plans for pz-cel, an investigational gene therapy. This facility includes an initial $20 million, followed by additional tranches if certain conditions are met. With a PDUFA target action date set for May 25, 2024, for the FDA's review of pz-cel, the company is positioned to potentially launch the product soon. The funds will also allow for general corporate purposes and extend the company's financial reach.

Market Sentiment Analysis

POSITIVE FACTORS

  • Abeona Therapeutics secured a $50 million credit facility to support its commercialization efforts.
  • The company anticipates a potential FDA approval for pz-cel by May 25, 2024.
  • The financing arrangement will allow Abeona to extend its cash runway beyond important milestones.

Full Press Release Details

Therapeutics Announces $50 Million Credit Facility
January 8, 2024 - Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has entered into a $50 million credit facility
with the Avenue Venture Opportunities Fund, L.P. The credit agreement, which has a term of three and a half years, includes a first tranche
of $20 million at closing, a second tranche of $10 million of committed capital, and an additional accordion option to upsize the credit
facility by an additional $20 million upon satisfaction of certain terms and conditions.
from the facility are intended to support the Company's ongoing preparations for launch and commercialization in anticipation of
a potential approval for marketing in the U.S. by the Food and Drug Administration (FDA) of pz-cel (prademagene zamikeracel), Abeona's
investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis
bullosa (RDEB), and for general corporate purposes. The FDA has accepted and granted Priority Review with a PDUFA target action date
of May 25, 2024 for the Biologics License Application for pz-cel.
are excited to enter into this relationship with Avenue Venture Fund and secure additional financial resources to further support our
launch and commercialization efforts for pz-cel," said Joe Vazzano, Chief Financial Officer of Abeona. "We expect the proceeds
from this term loan facility will meaningfully extend Abeona's cash runway even further beyond value creating milestones, including
the potential approval of pz-cel."
Global Partners served as financial advisor and sole lead arranger to the Company on this transaction.
Avenue Venture Opportunities
Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science
companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created
by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group
of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets estimated
to be approximately $12.6 billion as of November 30, 2023, visit www.avenuecapital.com.
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. The U.S.
FDA has accepted and granted Priority Review with a PDUFA target action date of May 25, 2024 for the Biologics License Application for
pz-cel (prademagene zamikeracel), Abeona's investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development
for recessive dystrophic epidermolysis bullosa. The Company's fully integrated cell and gene therapy cGMP manufacturing facility
served as the manufacturing site for pz-cel used in its Phase 3 VIITAL trial, and is capable of supporting commercial production
of pz-cel upon FDA approval. The Company's development portfolio also features AAV-based gene therapies for ophthalmic diseases
with high unmet medical need. Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a
variety of devastating diseases. For more information, visit www.abeonatherapeutics.com.
press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted
to identify forward-looking statements by such terminology as "may," "will," "believe," "anticipate,"
"expect," "intend," "potential," and similar words and expressions (as well as other words or expressions
referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual
results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous
risks and uncertainties, including but not limited to, the timing and outcome of our Biologics License Application submission to the
FDA for pz-cel; the FDA's grant of a Priority Review Voucher; continued interest in our rare disease portfolio; our ability to
enroll patients in clinical trials; the outcome of future meetings with the FDA or other regulatory agencies, including those relating
to preclinical programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial
markets and global economic conditions; risks associated with data analysis and reporting; and other risks disclosed in the Company's
most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities and Exchange Commission. The Company
undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after
the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal
VP, Investor Relations and Corporate Communications

Frequently Asked Questions

What is the value of Abeona Therapeutics' new credit facility?

Abeona Therapeutics has announced a $50 million credit facility.

What will the credit facility be used for?

The funds will support pz-cel's launch preparations and general corporate purposes.

When is the FDA's target action date for pz-cel?

The target action date for pz-cel is May 25, 2024.

Who is the financial advisor for this credit facility?

Global Partners served as the financial advisor and lead arranger.

What type of company is Abeona Therapeutics?

Abeona Therapeutics is a clinical-stage biopharmaceutical company.

Last updated: Jan 8, 2024