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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): August 8, 2024
ABEONA
THERAPEUTICS INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-15771 |
|
83-0221517 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
6555
Carnegie Ave, 4th Floor
Cleveland,
OH 44103
(Address
of principal executive offices) (Zip Code)
(646)
813-4701
(Registrant’s telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 par value |
|
ABEO |
|
Nasdaq
Capital Markets |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of
Certain Officers.
The
Board of Directors (the “Board”) of Abeona Therapeutics Inc. (the “Company”), acting upon the recommendation
of its Nominating and Corporate Governance Committee, appointed Bernhardt G. Zeiher, MD, FCCP, FACP, on August 8, 2024 and Eric Crombez,
MD on August 12, 2024 as members of the Board of the Company. Dr. Zeiher and Dr. Crombez are both considered “independent”
directors under relevant U.S. Securities and Exchange Commission (“SEC”) and Nasdaq rules, and neither has yet been appointed
to serve as a member of any Board committee. Dr. Zeiher will serve as a Class 1 director and Dr. Crombez will serve as a Class 2 director.
Dr.
Zeiher spent more than 10 years at Astellas Pharma, holding multiple roles of increasing responsibility in drug development, leading
up to his role as CMO, where he led early- and late-stage drug development, medical and regulatory affairs, pharmacovigilance, and quality
assurance. Prior to Astellas, Dr. Zeiher held various roles leading drug development at other pharmaceutical companies including Pfizer
and Eli Lilly and Company. He also practiced medicine at a tertiary medical center in Indianapolis. Dr. Zeiher currently serves on multiple
public company boards, including Entrada Therapeutics and Amylyx Pharmaceuticals, Inc. He previously served on the boards of TransCelerate
Biopharma, Biotechnology Innovation Organization and Astellas Global Health Foundation. Dr. Zeiher received a B.S. in biology from the
University of Toledo and an MD from Case Western Reserve University School of Medicine. He completed his internal medicine residency
and chief residency at University Hospitals of Cleveland and then finished his physician training as a Pulmonary and Critical Care Fellow
at University of Iowa Hospitals and Clinics.
Dr.
Crombez joined Ultragenyx following the acquisition of Dimension Therapeutics in November 2017. He is also an appointed industry representative
on the FDA Cellular, Tissue, and Gene Therapies Advisory Committee. At Dimension Therapeutics, Dr. Crombez served as chief medical officer
and led the clinical development efforts for clinical gene therapy programs in hemophilia B, hemophilia A, ornithine transcarbamylase
(OTC) deficiency and glycogen storage disease type Ia (GSDIa). Previously, he worked at Shire in its Human Genetics Therapy business
unit. Before joining industry, Dr. Crombez was assistant professor, Department of Pediatrics, Division of Medical Genetics at the David
Geffen School of Medicine at the University of California, Los Angeles (UCLA). He is a board-certified clinical geneticist and completed
residencies in pediatrics and medical genetics and a fellowship in clinical biochemical genetics at the UCLA School of Medicine. Dr.
Crombez obtained his B.S. degree in biology from the University of Michigan, Ann Arbor, and his M.D. degree from Wayne State University
School of Medicine, Detroit.
There
are no family relationships between Dr. Zeiher or Dr. Crombez and any other director or executive officer of the Company. Nor are there
any transactions between Dr. Zeiher or Dr. Crombez or any member of their respective immediate family and the Company that would be reportable
as a related party transaction under the rules of the SEC. Further, there is no arrangement or understanding between them and any other
persons or entities pursuant to which they were appointed as directors of the Company.
Each
of Dr. Zeiher and Dr. Crombez will receive an annual Board fee of $50,000 in cash and a one-time sign-on equity grant in the amount of
$55,000 worth of Company stock, in the form of restricted stock awards (RSAs) with a one-year vesting period. Both Dr. Zeiher and Dr.
Crombez will be eligible for the Board’s regular 2025 equity grant, which is determined annually by the Board upon recommendation
of the Compensation Committee of the Board, based on the advice of an external compensation consultant.
The
full text of the press release announcing Dr. Zeiher’s or Dr. Crombez’s appointment is attached hereto as Exhibit 99.1.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Abeona
Therapeutics Inc. |
|
(Registrant) |
|
|
|
|
By: |
/s/
Joseph Vazzano |
|
Name:
|
Joseph
Vazzano |
|
Title:
|
Chief
Financial Officer |
|
Date:
August 14, 2024
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/318306/000149315224031862/ex99-1_001.jpg)
Abeona
Therapeutics® Announces Appointment of Bernhardt Zeiher, MD, FCCP, FACP, and Eric Crombez, MD to its Board of Directors
CLEVELAND,
August 14, 2024 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Bernhardt G. Zeiher, MD, FCCP, FACP,
and Eric Crombez, MD as new independent members to its Board of Directors. Dr. Zeiher brings more than 20 years of drug development experience
where, in various roles, he oversaw the approval of 15 new treatments that addressed unmet needs in serious diseases with few to no treatment
options. Dr. Crombez currently serves as Chief Medical Officer of Ultragenyx Pharmaceutical Inc. and brings extensive expertise in the
development and execution of clinical development programs for rare genetic disorders.
Michael
Amoroso, Chairman of Abeona’s Board of Directors, said, “We are delighted to welcome both Bernie Zeiher and Eric Crombez
to our Board during this important period in Abeona’s history. As recognized and dynamic life sciences leaders, they bring a wealth
of diverse drug development expertise to Abeona. We look forward to their valuable insights as we continue to both focus on bringing
pz-cel to patients with recessive dystrophic epidermolysis bullosa and as we seek to advance and expand our pipeline.”
Dr.
Zeiher spent more than 10 years at Astellas Pharma, holding multiple roles of increasing responsibility in drug development, leading
up to his role as CMO, where he led early- and late-stage drug development, medical and regulatory affairs, pharmacovigilance, and quality
assurance. Prior to Astellas, Dr. Zeiher held various roles leading drug development at other pharmaceutical companies including Pfizer
and Eli Lilly and Company. He also practiced medicine at a tertiary medical center in Indianapolis. Dr. Zeiher currently serves on multiple
public company boards, including Entrada Therapeutics and Amylyx Pharmaceuticals, Inc. He previously served on the boards of TransCelerate
Biopharma, Biotechnology Innovation Organization and Astellas Global Health Foundation. Dr. Zeiher received a B.S. in biology from the
University of Toledo and an MD from Case Western Reserve University School of Medicine. He completed his internal medicine residency
and chief residency at University Hospitals of Cleveland and then finished his physician training as a Pulmonary and Critical Care Fellow
at University of Iowa Hospitals and Clinics.
Dr.
Crombez joined Ultragenyx following the acquisition of Dimension Therapeutics in November 2017. He is also an appointed industry representative
on the FDA Cellular, Tissue, and Gene Therapies Advisory Committee. At Dimension Therapeutics, Dr. Crombez served as chief medical officer
and led the clinical development efforts for clinical gene therapy programs in hemophilia B, hemophilia A, ornithine transcarbamylase
(OTC) deficiency and glycogen storage disease type Ia (GSDIa). Previously, he worked at Shire in its Human Genetics Therapy business
unit. Before joining industry, Dr. Crombez was assistant professor, Department of Pediatrics, Division of Medical Genetics at the David
Geffen School of Medicine at the University of California, Los Angeles (UCLA). He is a board-certified clinical geneticist and completed
residencies in pediatrics and medical genetics and a fellowship in clinical biochemical genetics at the UCLA School of Medicine. Dr.
Crombez obtained his B.S. degree in biology from the University of Michigan, Ann Arbor, and his M.D. degree from Wayne State University
School of Medicine, Detroit.
About
Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage
biopharmaceutical company developing cell and gene therapies for serious diseases. Prademagene zamikeracel (pz-cel) is Abeona’s
investigational autologous cell-based gene therapy 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.
Forward-Looking
Statements
This
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 results of ongoing testing and other corrective actions being performed
in response to the FDA’s identified deficiencies, which could delay the Company’s BLA resubmission; the timing and outcome
of the FDA’s review of our resubmission; the FDA’s grant of a Priority Review Voucher upon approval; 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 securities laws.
Investor
and Media Contact:
Greg
Gin
VP,
Investor Relations and Corporate Communications
Abeona
Therapeutics
ir@abeonatherapeutics.com
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