Abeona Therapeutics Reports First Quarter 2022 Financial Results
May 13 2022 - 7:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in cell and gene therapy, today announced financial results for the
first quarter of 2022. The Company will host a conference call and
webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its
financial results and business update.
“During the quarter, we took significant steps
to preserve our capital with the goal to fund operations over the
next 12 months with existing cash resources,” said Vish Seshadri,
Chief Executive Officer of Abeona. “First, we began off-loading our
MPS assets to reduce cash burn. Second, having completed accrual
for the EB-101 pivotal Phase 3 VIITAL™ study, we are now focusing
R&D resources on generating topline results in the third
quarter of 2022, while aggressively exploring partnerships for
commercialization of EB-101. Furthermore, we have initiated steps
toward regaining compliance with Nasdaq listing requirements.”
First Quarter and Recent
Highlights
-
Completed patient enrollment in pivotal Phase 3 VIITAL™ study
evaluating EB-101 for recessive dystrophic epidermolysis bullosa
(RDEB), and anticipate topline data readout in the third quarter of
2022.
-
Additional long-term follow up data up to eight years and quality
of life data from a completed Phase 1/2 study evaluating EB-101 for
RDEB will be presented at the Society of Investigative Dermatology
(SID) Annual Meeting, which will be held on May 18-21, 2022 in
Portland, OR. The data will be featured in an oral presentation
entitled “Long-term efficacy and safety of investigational
autologous gene-corrected skin sheets (EB-101) for recessive
dystrophic epidermolysis bullosa (RDEB).”
- Reported non-human primate data for AAV204, a novel
adeno-associated virus (AAV) capsid from Abeona's AIM™ capsid
library, highlighting its ability to produce more robust
transduction in the macula area of the eye following para-retinal
administration, which unlike subretinal administration does not
create a retinal detachment. The data was featured at the
Association for Research and Vision in Ophthalmology (ARVO) 2022
Annual Meeting.
-
Appointed Joseph Vazzano as Chief Financial Officer, who brings
valuable experience while serving as the Chief Financial Officer at
Avenue Therapeutics, Inc. where he secured multiple equity
financings.
Nasdaq Compliance Plan
-
Requested a 180-calendar day extension to regain compliance with
the Nasdaq Capital Market’s minimum closing bid price requirement
of $1.00 per share.
-
As part of the Company’s strategy to regain compliance, Abeona
intends to seek approval of a reverse stock split of the
outstanding shares of common stock at a Special Meeting of
stockholders at 10:00 am ET on June 14, 2022. Stockholders as of
May 3, 2022, the record date, are entitled to attend the online
Special Meeting, view the proxy statement and vote at:
www.virtualshareholdermeeting.com/ABEO2022SM.
-
On May 2, 2022, Abeona completed a $25 million private placement
offering of convertible redeemable preferred stock. Holders of the
preferred stock will vote together with the Company's common
stockholders on a proposal to effect a reverse stock split of the
Company's common stock at the Special Meeting.
First Quarter Financial
Results
The unaudited interim condensed consolidated
financial statements for the quarter ended March 31, 2022, which
were filed on Form 10-Q on May 13, 2022, have been prepared on the
going concern basis, which assumes the Company will have sufficient
cash to pay its operating expenses, as and when they become
payable, for a period of at least 12 months from the date the
financial report is issued.
Cash, cash equivalents, restricted cash and
short-term investments totaled $37.2 million as of March 31, 2022.
Net cash used in operating activities was $13.7 million for the
three months ended March 31, 2022.
License and other revenues in the first quarter
of 2022 were $0.3 million, compared to nil in the first quarter of
2021. The revenue in the first quarter of 2022 consisted mainly of
the recognition of deferred revenue related to grants for the
ABO-102 and ABO-101 development programs.
Research and development (R&D) expenses for
the three months ended March 31, 2022 were $10.5 million, compared
to $8.3 million for the same period of 2021. General and
administrative (G&A) expenses were $4.2 million for the three
months ended March 31, 2022, compared to $6.3 million for the same
period of 2021.
Net loss was $20.8 million for the first quarter
of 2022, or $0.14 loss per common share as compared to a net loss
of $16.0 million, or $0.17 loss per common share, in the first
quarter of 2021. The net loss in the first quarter of 2022 includes
$6.2 million in non-cash impairment charges resulting from the
disposition of the ABO-102 and ABO-101 development programs as the
Company focuses resources on its EB-101 pivotal program and
preclinical eye gene therapy programs. The impairment charges have
no impact on the Company's cash position or cash flow from
operating activities and do not have an impact on future
operations.
Conference Call Details
Abeona Therapeutics will host a conference call
and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss
its financial results and business update. To access the call, dial
877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and
Entry Code: 221025 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 EB-101, its investigational
autologous, gene-corrected cell therapy for recessive dystrophic
epidermolysis bullosa in Phase 3 development. 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
produces EB-101 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,” “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 potentially
commercialize our EB-101 product candidate; obtaining a strategic
partnership to take over development activities for ABO-102 and the
successful discontinuation of development activities for our
ABO-101 program; 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 potentially commercialize our
product candidates; 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; reducing our operating expenses and
extending our cash runway; our ability to execute our operating
plan and achieve important anticipated milestones; and other risks
disclosed in the Company’s most recent Annual Report on Form 10-K
and other periodic reports subsequently 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.
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 March 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
License and other
revenues |
|
$ |
346 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
Research and development |
|
|
10,545 |
|
|
|
8,317 |
|
|
General and
administrative |
|
|
4,224 |
|
|
|
6,280 |
|
|
Licensed technology impairment
charge |
|
|
1,355 |
|
|
|
- |
|
|
Lease impairment charge |
|
|
1,561 |
|
|
|
- |
|
|
Construction-in-progress
impairment charge |
|
|
3,252 |
|
|
|
- |
|
|
Total expenses |
|
|
20,937 |
|
|
|
14,597 |
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(20,591 |
) |
|
|
(14,597 |
) |
|
|
|
|
|
|
|
Interest and miscellaneous
income |
|
|
1 |
|
|
|
15 |
|
|
Interest expense |
|
|
(201 |
) |
|
|
(1,420 |
) |
|
Net loss |
|
$ |
(20,791 |
) |
|
$ |
(16,002 |
) |
|
|
|
|
|
|
|
Basic and diluted loss per
common share |
|
$ |
(0.14 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
|
|
Weighted average number of
common |
|
|
|
|
|
shares outstanding – basic and diluted |
|
|
144,877,693 |
|
|
|
94,234,653 |
|
|
|
|
|
|
|
|
Other comprehensive
income: |
|
|
|
|
|
Change in unrealized gains related to available-for-sale debt
securities |
|
|
3 |
|
|
|
13 |
|
|
Comprehensive loss |
|
$ |
(20,788 |
) |
|
$ |
(15,989 |
) |
|
|
|
|
|
|
|
Abeona Therapeutics Inc. and Subsidiaries |
|
|
|
Condensed Consolidated Balance Sheets($ in
thousands, except share and per share amounts) |
|
|
|
(unaudited) |
|
|
|
ASSETS |
March 31, 2022 |
|
December 31, 2021 |
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
20,326 |
|
|
$ |
32,938 |
|
Short-term investments |
|
10,989 |
|
|
|
12,086 |
|
Restricted cash |
|
5,891 |
|
|
|
5,891 |
|
Accounts receivable |
|
- |
|
|
|
3,000 |
|
Prepaid expenses and other current assets |
|
1,998 |
|
|
|
2,377 |
|
Total current assets |
|
39,204 |
|
|
|
56,292 |
|
|
|
|
|
Property and
equipment, net |
|
8,408 |
|
|
|
12,339 |
|
Right-of-use lease
assets |
|
7,540 |
|
|
|
9,403 |
|
Licensed
technology, net |
|
- |
|
|
|
1,384 |
|
Other assets |
|
20 |
|
|
|
168 |
|
Total assets |
$ |
55,172 |
|
|
$ |
79,586 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
1,601 |
|
|
$ |
4,325 |
|
Accrued expenses |
|
4,206 |
|
|
|
5,585 |
|
Current portion of lease liability |
|
1,822 |
|
|
|
1,818 |
|
Current portion of payable to licensor |
|
4,708 |
|
|
|
4,599 |
|
Deferred revenue |
|
- |
|
|
|
296 |
|
Total current liabilities |
|
12,337 |
|
|
|
16,623 |
|
|
|
|
|
Payable to
licensor |
|
3,919 |
|
|
|
3,828 |
|
Other long-term
liabilities |
|
200 |
|
|
|
200 |
|
Long-term lease
liabilities |
|
7,273 |
|
|
|
7,560 |
|
Total liabilities |
|
23,729 |
|
|
|
28,211 |
|
|
|
|
|
Commitments and
contingencies |
|
- |
|
|
|
- |
|
Stockholders'
equity: |
|
|
|
Preferred stock - $0.01 par value; authorized 2,000,000
shares; |
|
|
|
No shares issued and outstanding as of March 31, 2022 and |
|
|
|
December 31, 2021, respectively |
|
- |
|
|
|
- |
|
Common stock - $0.01 par value; authorized 200,000,000 shares; |
|
|
|
147,079,899 and 147,205,422 shares issued and outstanding as |
|
|
|
of March 31, 2022 and December 31, 2021, respectively |
|
1,471 |
|
|
|
1,472 |
|
Additional paid-in capital |
|
706,433 |
|
|
|
705,570 |
|
Accumulated deficit |
|
(676,431 |
) |
|
|
(655,640 |
) |
Accumulated other comprehensive loss |
|
(30 |
) |
|
|
(27 |
) |
Total stockholders' equity |
|
31,443 |
|
|
|
51,375 |
|
Total liabilities and stockholders' equity |
$ |
55,172 |
|
|
$ |
79,586 |
|
|
|
|
|
|
|
|
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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