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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): November 13, 2023
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
2.02. |
Results
of Operations and Financial Condition. |
On
November 13, 2023, Abeona Therapeutics Inc. issued a press release regarding its results of operations and financial condition for the
third quarter of 2023. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated
herein.
The
information in Item 2.02 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/
Joseph Vazzano |
|
Name:
|
Joseph
Vazzano |
|
Title:
|
Chief
Financial Officer |
Date:
November 13, 2023
Exhibit 99.1
Abeona Therapeutics Reports Third Quarter 2023 Financial
Results and Corporate Developments
Abeona’s first-ever U.S. Biologics License
Application (BLA) submission completed in September 2023
FDA decision on priority review and acceptance
of BLA for pz-cel (prademagene zamikeracel, formerly
known as EB-101) in recessive dystrophic epidermolysis bullosa (RDEB) expected by late-November 2023
Initiated commercial readiness activities for
potential U.S. launch of pz-cel
CLEVELAND, November 13, 2023 – Abeona Therapeutics
Inc. (Nasdaq: ABEO) today reported financial results for the third quarter of 2023 and provided corporate updates.
“In the third quarter, we made substantial progress
in our evolution from a late-stage clinical development company to one with significant commercial opportunity,” said Vish Seshadri,
Chief Executive Officer of Abeona. “With the completion of Abeona’s first-ever U.S. BLA submission, we moved a step closer
toward the potential approval of pz-cel as the first therapy that delivered instantaneous wound coverage and multi-year healing in RDEB
wounds with a one-time application in clinical trials. In addition, we are also establishing Abeona’s capabilities in late-stage
development and manufacturing of autologous engineered cell therapies. Lastly, we have initiated commercial readiness activities for our
potential launch of pz-cel.”
Third Quarter and Recent Progress
Pz-cel for RDEB
● |
The
proposed non-proprietary (generic) name prademagene zamikeracel (referred to as “pz-cel” going forward) was approved
by the World Health Organization as the International Nonproprietary Name for Abeona’s investigational autologous, COL7A1 gene-corrected
epidermal sheets formerly known as EB-101. |
● |
In August, Abeona completed a positive pre-BLA meeting in which it reached alignment with the U.S. Food and Drug Administration (FDA) that the pz-cel clinical efficacy and safety data appear adequate to support a BLA submission. The FDA also agreed that retroviral vector manufactured at Abeona and Indiana University appear comparable based on the data that Abeona provided in its briefing book. |
● |
In September, Abeona submitted a BLA to FDA seeking approval with priority review of pz-cel for RDEB. The FDA’s decision on BLA acceptance is typically made during the 60-day window following submission. If accepted with Priority Review, Abeona expects potential BLA approval in the second quarter of 2024. |
Strengthened balance sheet, initiated U.S. commercial launch preparations
for pz-cel
● |
Abeona
raised $25 million in a registered direct offering priced at-the-market with select existing institutional investors to primarily
fund the Company’s initial commercial preparations in support of the potential U.S. launch of pz-cel. |
● |
Appointed Madhav Vasanthavada, Ph.D., M.B.A. as Chief Commercial Officer and Head of Business Development. Dr. Vasanthavada brings over 20 years of diverse leadership experience in the life sciences industry with recent experience in launching autologous cell therapies at Bristol Myers Squibb (BMS) and Celgene. |
● |
Started
U.S. commercial launch planning activities for pz-cel, including initiating onboarding discussions with EB treatment
sites, payer engagement, and hiring key commercial roles. |
Third Quarter Financial Results
Cash, cash equivalents, restricted cash and short-term
investments totaled $54.1 million as of September 30, 2023, including the net proceeds from the $25 million registered direct offering
in July 2023, as compared to $37.1 million as of June 30, 2023. Abeona estimates that its cash and cash equivalents, restricted cash and
short-term investments as of September 30, 2023 are sufficient resources to fund operations into the fourth quarter of 2024.
Research and development expenses for the three months
ended September 30, 2023 were $7.1 million, compared to $5.5 million for the same period of 2022. General and administrative expenses
were $4.2 million for the three months ended September 30, 2023, compared to $3.9 million for the same period of 2022. Net loss attributable
to common shareholders was $11.8 million for the third quarter of 2023, or $0.48 loss per common share as compared to a net loss attributable
to common shareholders of $6.4 million, or $1.00 loss per common share, in the third quarter of 2022.
Conference Call Details
Abeona Therapeutics will host a conference call and
webcast today, November 13, 2023, at 8:30 a.m. ET, to discuss its financial results and developments. To access the call, dial 888-506-0062
(U.S. toll-free) or 973-528-0011 (international) and Entry Code: 963663 five minutes prior to the start of the call. A live, listen-only
webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com.
The archived webcast replay will be available for 30 days following the call.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage
biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s lead clinical program is pz-cel (prademagene
zamikeracel, formerly known as EB-101), its investigational
autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa. 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. Abeona’s
fully integrated cell and gene therapy cGMP manufacturing facility produced pz-cel for the pivotal Phase 3 VIITAL™ study and is
capable of clinical and potential 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. 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; 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
ABEONA THERAPEUTICS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
| |
For the three months ended September 30, | | |
For the nine months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Revenues: | |
| | | |
| | | |
| | | |
| | |
License and other revenues | |
$ | — | | |
$ | — | | |
$ | 3,500 | | |
$ | 1,346 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Royalties | |
| 30 | | |
| — | | |
| 1,605 | | |
| 350 | |
Research and development | |
| 7,148 | | |
| 5,490 | | |
| 23,712 | | |
| 22,693 | |
General and administrative | |
| 4,156 | | |
| 3,890 | | |
| 13,174 | | |
| 11,574 | |
Impairment of licensed technology | |
| — | | |
| — | | |
| — | | |
| 1,355 | |
Loss/(gain) on right-of-use lease assets | |
| — | | |
| — | | |
| (1,065 | ) | |
| 1,561 | |
Impairment of construction-in-progress | |
| — | | |
| — | | |
| — | | |
| 1,792 | |
Total expenses | |
| 11,334 | | |
| 9,380 | | |
| 37,426 | | |
| 39,325 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (11,334 | ) | |
| (9,380 | ) | |
| (33,926 | ) | |
| (37,979 | ) |
| |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 593 | | |
| 72 | | |
| 1,374 | | |
| 103 | |
Interest expense | |
| (105 | ) | |
| (157 | ) | |
| (309 | ) | |
| (558 | ) |
Change in fair value of warrant liabilities | |
| (1,101 | ) | |
| 3,050 | | |
| (7,465 | ) | |
| 5,995 | |
Other income (expense) | |
| 111 | | |
| (19 | ) | |
| 2,729 | | |
| (136 | ) |
Net loss | |
$ | (11,836 | ) | |
$ | (6,434 | ) | |
$ | (37,597 | ) | |
$ | (32,575 | ) |
Deemed dividends related to Series A and Series B Convertible Redeemable Preferred Stock | |
| — | | |
| — | | |
| — | | |
| (3,782 | ) |
Net loss attributable to Common Shareholders | |
$ | (11,836 | ) | |
$ | (6,434 | ) | |
$ | (37,597 | ) | |
$ | (36,357 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per common share | |
$ | (0.48 | ) | |
$ | (1.00 | ) | |
$ | (1.89 | ) | |
$ | (6.05 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted average number of common shares outstanding – basic and diluted | |
| 24,797,564 | | |
| 6,421,245 | | |
| 19,942,613 | | |
| 6,009,902 | |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Change in unrealized gains (losses) related to available-for-sale debt securities | |
| (33 | ) | |
| (4 | ) | |
| 1 | | |
| (11 | ) |
Foreign currency translation adjustments | |
| 29 | | |
| (6 | ) | |
| 29 | | |
| (6 | ) |
Comprehensive loss | |
$ | (11,840 | ) | |
$ | (6,444 | ) | |
$ | (37,567 | ) | |
$ | (36,374 | ) |
ABEONA THERAPEUTICS INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,712 | | |
$ | 14,217 | |
Short-term investments | |
| 49,042 | | |
| 37,932 | |
Restricted cash | |
| 338 | | |
| 338 | |
Other receivables | |
| 2,209 | | |
| 188 | |
Prepaid expenses and other current assets | |
| 963 | | |
| 424 | |
Total current assets | |
| 57,264 | | |
| 53,099 | |
Property and equipment, net | |
| 3,999 | | |
| 5,741 | |
Right-of-use lease assets | |
| 4,685 | | |
| 5,331 | |
Other assets | |
| 139 | | |
| 43 | |
Total assets | |
$ | 66,087 | | |
$ | 64,214 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,592 | | |
$ | 1,811 | |
Accrued expenses | |
| 3,972 | | |
| 3,991 | |
Current portion of lease liability | |
| 1,649 | | |
| 1,773 | |
Other current liabilities | |
| 199 | | |
| 204 | |
Total current liabilities | |
| 8,412 | | |
| 7,779 | |
Payable to licensor | |
| 4,472 | | |
| 4,163 | |
Long-term lease liabilities | |
| 4,043 | | |
| 5,854 | |
Warrant liabilities | |
| 27,122 | | |
| 19,657 | |
Total liabilities | |
| 44,049 | | |
| 37,453 | |
Commitments and contingencies | |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| — | | |
| — | |
Common stock - $0.01 par value; authorized 200,000,000 shares; 24,713,908 and 17,719,720 shares
issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 247 | | |
| 177 | |
Additional paid-in capital | |
| 754,823 | | |
| 722,049 | |
Accumulated deficit | |
| (732,933 | ) | |
| (695,336 | ) |
Accumulated other comprehensive loss | |
| (99 | ) | |
| (129 | ) |
Total stockholders’ equity | |
| 22,038 | | |
| 26,761 | |
Total liabilities and stockholders’ equity | |
$ | 66,087 | | |
$ | 64,214 | |
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Abeona Therapeutics (NASDAQ:ABEO)
Graphique Historique de l'Action
De Mai 2024 à Juin 2024
Abeona Therapeutics (NASDAQ:ABEO)
Graphique Historique de l'Action
De Juin 2023 à Juin 2024