Current Report Filing (8-k)
May 17 2022 - 8:02AM
Edgar (US Regulatory)
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2022-05-16
2022-05-16
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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): May 16, 2022
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)
813-4701
(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
1.01. |
Entry
into a Material Definitive Agreement. |
On
May 16, 2022, Abeona Therapeutics Inc. (the “Company”) and Ultragenyx Pharmaceutical Inc. (“Ultragenyx”) entered
into an exclusive license agreement (the “License Agreement”) for AAV gene therapy ABO-102 for the treatment of Sanfilippo
syndrome type A (MPS IIIA) (“ABO-102”). Under the License Agreement, Ultragenyx will assume responsibility for the ABO-102
program, with the exclusive right to develop, manufacture, and commercialize ABO-102 worldwide. Also pursuant to the License Agreement,
following regulatory approval, the Company is eligible to receive tiered royalties from mid-single-digit up to 10% on net sales and up
to $30.0 million in commercial milestone payments.
The
License Agreement is effective as of May 16, 2022 and will continue in full force and effect, on a licensed product-by-licensed product
basis until the end of the royalty term for such licensed product. The royalty term for each licensed product will continue from the
first commercial sale of the licensed product until the later of (i) the date that no valid patent claim would be infringed in the absence
of the license granted under the License Agreement by the sale of the licensed product in the first country in which no such valid patent
claim exists, and (ii) the tenth anniversary of the first commercial sale of the licensed product.
The
License Agreement may be terminated by (i) either party upon a material breach by the other party (subject to prior written notice and
a cure period), (ii) either party upon certain insolvency events, including bankruptcy proceedings, (iii) by Ultragenyx for convenience
upon six months’ written notice, or (iv) by Ultragenyx upon written notice in the event Ultragenyx makes a good faith determination
that there is a material safety issue or efficacy concern with respect to the licensed products, with Ultragenyx bearing responsibility
for clinical study wind-down in the case of termination while clinical studies are ongoing. The License Agreement includes standard and
customary provisions regarding, among other things, compliance with laws and regulations, confidentiality, intellectual property, representations
and warranties, liability, indemnification, and insurance.
The
foregoing description of the License Agreement is qualified in its entirety by reference to the complete text of the License Agreement,
which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2022.
Item
7.01 Regulation FD Disclosure.
On
May 17, 2022, the Company and Ultragenyx issued a joint press release announcing the License Agreement. A copy of the press release
is attached hereto as exhibit 99.1.
The
information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “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 deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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/
Brendan M. O’Malley |
|
Name: |
Brendan
M. O’Malley |
|
Title:
|
Senior
Vice President, General Counsel |
Date:
May 17, 2022
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