0000318306 false 0000318306 2020-09-23 2020-09-23 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): September 23, 2020

 

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.)

 

1330 Avenue of the Americas, 33rd Floor,

New York, NY 10019

(Address of principal executive offices) (Zip Code)

 

(646) 813-4712
(Registrant’s telephone number, including area code)

 

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 Market

 

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.

 

On September 23, 2020, João Siffert, M.D., Chief Executive Officer, Head of Research and Development and Chief Medical Officer, and a member of the Board of Directors (the “Board”) notified the Company of his resignation effective immediately. Dr. Siffert was not a member of any committees of the Board.

 

On September 27, 2020, Brian J.G. Pereira, M.D., Executive Chairman, notified the Company of his resignation effective immediately. Dr. Pereira was not a member of any committees of the Board.

 

Also on September 27, 2020, George Migausky resigned as a member of the Board and Chairman of the Audit Committee of the Board effective immediately. 

 

On September 28, 2020, Shawn Tomasello, Stephen Howell, M.D. and Stefano Buono each resigned as a member of the Board and from their respective positions as members of the several committees of the Board effective immediately. Ms. Tomasello was serving as a member of the Nominating and Corporate Governance Committee (the “Nominating Committee”) at the time of her resignation. Dr. Howell was serving as a member of both the Compensation Committee and the Nominating Committee at the time of his resignation. Mr. Buono was serving as Chairman of the Nominating Committee.

 

None of the foregoing resignations were due to any dispute or disagreement with the Company on any matter relating to the Company’s operations, policies, governance or practices.

 

Item 7.01 Regulation FD.

 

The Company has issued a press release, dated September 28, 2020, announcing the foregoing resignations. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein. The information furnished in Exhibit 99.1 hereto shall not be considered “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended, or under the Exchange Act, unless the Company expressly sets forth in such future filings that such information is to be considered “filed” or incorporated by reference therein.

 

Item 9.01 Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press release, dated September 28, 2020

 

 
 

 

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.

 

September 29, 2020 Abeona Therapeutics Inc.
  (Registrant)
     
  By: /s/ Brendan M. O’Malley
  Name: Brendan M. O’Malley
  Title: Corporate Secretary

 

 

 

 

Exhibit 99.1

 

 

Abeona Therapeutics Announces Leadership and Board Transitions

 

NEW YORK and CLEVELAND, Sep. 28, 2020 – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced changes in its executive leadership and Board of Directors. João Siffert, M.D. resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020. On September 27, 2020, Brian Pereira, M.D., Stefano Buono, Stephen B. Howell, M.D., George Migausky and Shawn Tomasello each announced that they had stepped down from the Board, effective immediately. No director gave any reason for their resignation and no director indicated any disagreements with the Company.

 

The Company is reviewing and exploring all strategic options and alternatives focused on advancing the Company’s mission and maximizing stakeholder value, including the sale of some or all of its assets or sale of the Company. There can be no assurance this strategic review will result in the completion of any particular course of action. There is no defined timeline for completion of the review process.

 

About Abeona Therapeutics

 

Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona’s clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company’s portfolio of AAV-based gene therapies also features ABO-201 for CLN3 disease. Abeona’s novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona’s fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and commercial production of AAV-based gene therapies. 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. These statements include statements about the Company exploring all strategic options, including the sale of some or all of its assets or sale of the Company. We have attempted to identify forward looking statements by such terminology as “may,” “will,” “believe,” “estimate,” “expect,” and similar 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 potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of 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 quarterly reports on Form 10-Q and other 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 presentation, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

 

Investor Contact:

 

Greg Gin

VP, Investor Relations

Abeona Therapeutics

+1 (646) 813-4709

ggin@abeonatherapeutics.com

 

Media Contact:

 

Scott Santiamo

Director, Corporate Communications

Abeona Therapeutics

+1 (718) 344-5843

ssantiamo@abeonatherapeutics.com

 

   

 

v3.20.2
Cover
Sep. 23, 2020
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Sep. 23, 2020
Entity File Number 001-15771
Entity Registrant Name ABEONA THERAPEUTICS INC.
Entity Central Index Key 0000318306
Entity Tax Identification Number 83-0221517
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 1330 Avenue of the Americas
Entity Address, Address Line Two 33rd Floor
Entity Address, City or Town New York
Entity Address, State or Province NY
Entity Address, Postal Zip Code 10019
City Area Code (646)
Local Phone Number 813-4712
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.01 par value
Trading Symbol ABEO
Security Exchange Name NASDAQ
Entity Emerging Growth Company false