As
filed with the Securities and Exchange Commission on May 15, 2024.
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-8
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
Abeona
Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
83-0221517 |
| (State or other jurisdiction
of incorporation or organization) |
|
(I.R.S. Employer Identification
No.) |
| 6555
Carnegie Ave, 4th Floor, Cleveland, OH 44103 |
(Address
of Principal Executive Offices)
(Zip
Code) |
Amended
and Restated Abeona Therapeutics Inc.
2023
Equity Incentive Plan
(Full
title of the plan)
Joseph
Vazzano
Chief
Financial Officer
Abeona
Therapeutics Inc.
6555
Carnegie Ave, 4th Floor
Cleveland,
OH 44103
(646)
813-4701
(Name,
address, and telephone number, including area code, of agent for service)
Copies
of Correspondence to:
Sean
M. Ewen, Esq.
Jared N. Fertman, Esq.
Willkie Farr & Gallagher LLP
787
Seventh Avenue
New York, NY 10019-6099
(212)
728-8000
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer |
☐ |
Accelerated filer |
☐ |
| Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
| |
|
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 7(a)(2)(B) of the Securities Act. ☐
EXPLANATORY
NOTE
This
Registration Statement on Form S-8 (this “Registration Statement”) is filed by Abeona Therapeutics Inc. (the “Registrant”)
to register an additional 1,500,000 shares of the Registrant’s common stock, par value $0.01 per share (the “Common Stock”),
issuable under the Amended and Restated Abeona Therapeutics Inc. 2023 Equity Incentive Plan (the “Plan”), which was amended
and restated on March 15, 2024 to increase the number of shares of Common Stock reserved for issuance thereunder, which amendment and
restatement has been approved by the Registrant’s shareholders.
Pursuant
to the Registration Statement on Form S-8 (Registration No. 333-272103) filed by the Registrant on May 19, 2023 (the “Prior Registration
Statement”), the Registrant previously registered an aggregate of 1,700,000 shares of Common Stock. The additional shares of Common
Stock being registered by this Registration Statement are of the same class as those securities registered on the Prior Registration
Statement and represent an increase in the total shares available for issuance under the Plan by 1,500,000. Pursuant to General Instruction
E to Form S-8, the Registrant incorporates by reference into this Registration Statement the contents of the Prior Registration Statement,
including all exhibits filed therewith or incorporated therein by reference, except as expressly modified herein.
Part
II
INFORMATION
REQUIRED IN THE REGISTRATION STATEMENT
Item
3. Incorporation of Documents by Reference.
The
following documents previously filed by the Abeona Therapeutics Inc. (the “Company” or “Registrant”) with the
Securities and Exchange Commission (the “Commission”) are hereby incorporated by reference into this Registration Statement:
| (i) | The
Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (filed
with the Commission on March 18, 2024); |
| (ii) | The
Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024
(filed with the Commission on May 15, 2024); |
| (iv) | The
description of our common stock, par value $0.01 per share contained in our Registration
Statement on Form
8-A, dated and filed with the SEC on November 4, 2014, as updated by Exhibit 4.4 to our
Form 10-K for the fiscal year ended December 31, 2019, and including any amendments or reports
filed with the SEC for the purpose of updating such description. |
To
the extent that any information contained in any Current Report on Form 8-K, or any exhibit thereto, was furnished to, rather than filed
with, the Commission, such information or exhibit is specifically not incorporated by reference.
All
reports and other documents that the Company subsequently files with the Commission pursuant to Sections 13(a), 13(c), 14, or 15(d) of
the Securities Exchange Act of 1934, as amended, after the date of this Registration Statement and prior to the filing of a post-effective
amendment that indicates that the Company has sold all of the securities offered under this Registration Statement or deregisters the
distribution of all such securities then remaining unsold shall be deemed to be incorporated by reference in this Registration Statement
and to be a part hereof from the date that the Company files such report or document.
Any
statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded
for purposes of this Registration Statement to the extent that a statement contained herein or in any other subsequently filed document
that also is, or is deemed to be, incorporated by reference herein modifies or supersedes such statement. Any such statement so modified
or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.
Item
8. Exhibits.
A
list of exhibits filed herewith is contained in the Exhibit Index below, which is incorporated herein by reference.
EXHIBIT
INDEX
SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by
the undersigned, thereunto duly authorized, in the City of Morristown, in the state of New Jersey, on the 15th day of May, 2024.
| ABEONA THERAPEUTICS INC. |
|
| |
|
|
| By: |
/s/
Joseph Vazzano |
|
| |
Joseph Vazzano |
|
| |
Chief Financial Officer (Principal Financial Officer
and Principal Accounting Officer) |
|
POWER OF ATTORNEY
Each person whose signature appears
below hereby appoints Vishwas Seshadri and Joseph Vazzano and each of them, severally, as his or her true and lawful attorney or attorneys-in-fact
and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all
capacities, to sign any and all amendments to this Registration Statement (including all pre-effective and post-effective amendments and
registration statements filed pursuant to Rule 462 under the Securities Act of 1933, as amended), and to file the same with all exhibits
thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact
and agent full power and authority to do and perform each act and thing requisite and necessary to be done, as fully to all intents and
purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or his or
her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of
the Securities Act of 1933, as amended, this Registration Statement has been signed below by the following persons in the capacities and
dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/ Vishwas Seshadri |
|
President, Chief Executive Officer and Director (Principal Executive Officer) |
|
May 15, 2024 |
| Vishwas Seshadri |
|
|
|
|
| |
|
|
|
|
| /s/ Joseph Vazzano |
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
|
May 15, 2024 |
| Joseph Vazzano |
|
|
|
|
| |
|
|
|
|
| /s/ Leila Alland |
|
Director |
|
May 15, 2024 |
| Leila Alland |
|
|
|
|
| |
|
|
|
|
| /s/ Mark Alvino |
|
Director |
|
May 15, 2024 |
| Mark Alvino |
|
|
|
|
| |
|
|
|
|
| /s/ Michael Amoroso |
|
Director |
|
May 15, 2024 |
| Michael Amoroso |
|
|
|
|
| |
|
|
|
|
| /s/ Faith Charles |
|
Director |
|
May 15, 2024 |
| Faith Charles |
|
|
|
|
| |
|
|
|
|
| /s/ Christine Silverstein |
|
Director |
|
May 15, 2024 |
| Christine Silverstein |
|
|
|
|
| |
|
|
|
|
| /s/ Donald Wuchterl |
|
Director |
|
May 15, 2024 |
| Donald Wuchterl |
|
|
|
|
Exhibit
5.1
 |
787
Seventh Avenue
New York, NY 10019-6099
Tel: 212 728 8000
Fax: 212 728 8111
|
May 15, 2024
Abeona
Therapeutics Inc.
6555
Carnegie Ave., 4th Floor
Cleveland,
OH 44103
Ladies
and Gentlemen:
We
have acted as counsel to Abeona Therapeutics Inc. (the “Company”), a corporation organized under the laws of the state
of Delaware, with respect to the Company’s Registration Statement on Form S-8 (the “Registration Statement”)
to be filed by the Company with the Securities and Exchange Commission (the “Commission”) on or about the date hereof,
in connection with the registration under the Securities Act of 1933, as amended (the “Act”), by the Company of an
additional 1,500,000 shares of the Company’s common stock, par value $0.01 per share, of the Company (the “Shares”)
issuable in connection with the award of stock-based incentives (the “Awards”) under the Amended and Restated Abeona
Therapeutics Inc. 2023 Equity Incentive Plan (the “Plan”).
We
have examined, among other things, originals and/or copies (certified or otherwise identified to our satisfaction) of such documents,
papers, statutes and authorities as we have deemed necessary to form a basis for the opinion hereinafter expressed. In our examination,
we have assumed the genuineness of all signatures and the conformity to original documents of all copies submitted to us. As to various
questions of fact material to our opinion, we have relied without independent check or verification upon statements, certificates and
comparable documents of officers and representatives of the Company.
Based
on the foregoing, we are of the opinion that the Shares issuable in connection with Awards under the Plan, when duly issued and delivered
pursuant to the terms of the Awards and the Plan, will be validly issued, fully paid and non-assessable.
This
opinion is limited to the General Corporation Law of the State of Delaware, and we express no opinion with respect to the laws of any
other jurisdiction or any other laws of the State of Delaware. This opinion speaks only as of the date hereof and is limited to present
statutes, regulations and administrative and judicial interpretations. We undertake no responsibility to update or supplement this letter
after the date hereof.
We
hereby consent to the filing of this opinion as an exhibit to the Registration Statement. In giving such consent, we do not thereby admit
that we are in the category of persons whose consent is required under Section 7 of the Act.
Very
truly yours,
/s/
Willkie Farr & Gallagher LLP
Brussels
Chicago Frankfurt Houston London Los Angeles Milan
Munich New York Palo Alto Paris Rome San Francisco Washington
Exhibit
23.1
CONSENT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We
consent to the incorporation by reference in this Registration Statement on Form S-8 of Abeona Therapeutics Inc. of our report dated
March 29, 2023, relating to the consolidated financial statements appearing in the Annual Report on Form 10-K of Abeona Therapeutics
Inc. for the year ended December 31, 2023.
/s/
Whitley Penn LLP
Plano,
Texas
May
15, 2024
Exhibit
23.2
CONSENT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We consent to
the incorporation by reference in this Registration Statement on Form S-8 of our report dated March 15, 2024 relating to the financial
statements of Abeona Therapeutics Inc., appearing in the Annual Report on Form 10-K of Abeona Therapeutics Inc. for the year ended December
31, 2023.
/s/
Deloitte & Touche LLP
Morristown,
New Jersey
May 15,
2024
Exhibit
107
Calculation
of Filing Fee Table
Form
S-8
(Form
Type)
ABEONA
THERAPEUTICS INC.
(Exact
Name of Registrant as Specified in its Charter)
Table
1: Newly Registered Securities.
| Security Type | |
Security Class Title | |
Fee Calculation Rule | |
Amount
Registered (1) | |
Proposed Maximum Offering Price Per Share (2) | | |
Maximum Aggregate Offering Price (2) | | |
Fee Rate | | |
Amount of Registration Fee | |
| Equity | |
Common stock, par value $0.01 per share | |
Rule 457(c) and 457(h) | |
1,500,000 (3) | |
$ | 4.30 | | |
$ | 6,450,000 | | |
| 0.00014760 | | |
$ | 952.02 | |
| Total Offering Amounts | |
| | | |
$ | 6,450,000 | | |
| | | |
$ | 952.02 | |
| Total Fee Offsets | |
| | | |
| | | |
| | | |
$ | 0.00 | |
| Net Fees Due | |
| | | |
| | | |
| | | |
$ | 952.02 | |
| |
(1) |
Pursuant
to Rule 416(a) under the Securities Act of 1933, as amended (the “Securities Act”), the Registration Statement on Form
S-8 to which this exhibit relates shall be deemed to cover an indeterminate amount of additional shares of the registrant’s
common stock, par value $0.01 per share (the “Common Stock”), that may be offered and issued pursuant to the registrant’s
Amended and Restated Abeona Therapeutics Inc. 2023 Equity Incentive Plan (the “Plan”) as a result of any share split,
share dividend, recapitalization or similar transactions affecting the Common Stock. |
| |
|
|
| |
(2) |
Calculated
pursuant to Rules 457(c) and 457(h) under the Securities Act solely for the purpose of calculating the registration fee. The registration
fee is calculated based on a price of $4.30 per share, which is the average of the high and low prices of the Common Stock as reported
on the Nasdaq Capital Market on May 10, 2024. |
| |
|
|
| |
(3) |
Represents
the additional 1,500,000 shares of Common Stock reserved and available for issuance under the Plan on April 24, 2024. |
Table
2: Fee Offset Claims and Sources
Not
applicable.
Abeona Therapeutics (NASDAQ:ABEO)
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