Abeona Therapeutics Reports Third Quarter 2022 Financial Results
November 14 2022 - 7:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced financial
results for the third quarter of 2022.
“The positive topline data from the Phase 3
VIITAL study provides strong support for EB-101’s potential and
validation of the Abeona team’s extensive efforts,” said Vish
Seshadri, Chief Executive Officer of Abeona. “This is an exciting
time for Abeona as we are sharply focused on submitting a Biologics
License Application for EB-101 to the U.S. FDA. With the additional
capital raised after quarter-end, we are now well-funded into the
third quarter of 2024, beyond the anticipated timing for potential
BLA approval.”
Third Quarter and Recent Operating
Highlights
EB-101 for the treatment of recessive dystrophic epidermolysis
bullosa (RDEB)
-
On November 3, 2022, Abeona announced positive topline data from
the pivotal Phase 3 VIITAL study of investigational EB-101 in RDEB.
The VIITAL study met its two co-primary efficacy endpoints
demonstrating statistically significant, clinically meaningful
improvements in wound healing and pain reduction in large chronic
RDEB wounds. The Company intends to present more detailed results
from this study at future medical meetings and in a peer-reviewed
journal.
-
Based on the positive VIITAL topline results, the Company plans to
submit a Biologics License Application (BLA) for EB-101 to the U.S.
Food and Drug Administration (FDA) in the second quarter of 2023.
If the BLA is approved, Abeona may be eligible for a Priority
Review Voucher (PRV), which can be used to receive expedited review
by the FDA of a subsequent marketing application for a different
product or sold to another company.
-
Long-term follow up data up to eight years and quality of life data
from a completed Phase 1/2a study of EB-101 in RDEB were published
in Orphanet Journal of Rare Diseases. The data showed that large
chronic RDEB wounds treated with EB-101 had sustained wound healing
with mean 5.9 years of follow-up, and long-term symptomatic relief,
including reduction in pain and itch.
Preclinical programs
- Abeona’s preclinical programs are
investigating the use of novel adeno-associated virus (AAV) capsids
in AAV-based therapies for five undisclosed ophthalmic conditions.
The Company has generated appropriate mouse models, produced
research grade vectors, and started dosing mice in proof-of-concept
studies to support possible pre-Investigational New Drug
Application (IND) meetings with the FDA in early 2023.
Corporate highlights
- On November 3, 2022, the Company
announced a private placement financing with gross proceeds of
$35.0 million. The private placement included participation from
new and existing institutional investors.
Third Quarter Financial
Results
Cash, cash equivalents, restricted cash and
short-term investments totaled $23.5 million as of September 30,
2022. Net cash used in operating activities was $6.8 million for
the third quarter of 2022, compared to $9.0 million in the second
quarter of 2022. Abeona estimates that its current cash and cash
equivalents, restricted cash and short-term investments plus the
net proceeds from the private placement financing on November 3,
2022 are sufficient resources to fund operations into the third
quarter of 2024.
Research and development (R&D) expenses for
the three months ended September 30, 2022 were $5.5 million,
compared to $9.1 million for the same period of 2021. General and
administrative (G&A) expenses were $3.9 million for the three
months ended September 30, 2022, compared to $5.8 million for the
same period of 2021.
Net loss attributable to common shareholders for
the third quarter of 2022 was $9.5 million, or $1.48 loss per
common share as compared to $7.0 million, or $1.80 loss per common
share, in the third quarter of 2021.
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, engineered cell therapy 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 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,” “anticipate,” “expect,”
“plans,” “intend,” 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 timing and outcome of our
Biologics License Application submission to the FDA for EB-101; our
ability to fund operations with current cash and cash equivalents,
restricted cash and short-term investments plus the net proceeds
from our November 2022 private placement; continued interest in our
rare disease portfolio; our ability to enroll patients in clinical
trials; the outcome of any future meetings with the FDA or other
regulatory agencies; 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 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 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
SUBSIDIARIESCondensed Consolidated Statements of
Operations and Comprehensive Loss(Unaudited)(In thousands, except
share and per share amounts)
|
|
For the three months ended September 30, |
|
For the nine months ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
License and other
revenues |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
1,346 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Royalties |
|
|
- |
|
|
|
- |
|
|
|
350 |
|
|
|
- |
|
Research and development |
|
|
5,490 |
|
|
|
9,056 |
|
|
|
22,693 |
|
|
|
25,923 |
|
General and
administrative |
|
|
3,890 |
|
|
|
5,816 |
|
|
|
11,574 |
|
|
|
17,261 |
|
Impairment of licensed
technology |
|
|
- |
|
|
|
- |
|
|
|
1,355 |
|
|
|
- |
|
Impairment of right-of-use
lease asset |
|
|
- |
|
|
|
- |
|
|
|
1,561 |
|
|
|
- |
|
Impairment of
construction-in-progress |
|
|
- |
|
|
|
- |
|
|
|
1,792 |
|
|
|
- |
|
Total expenses |
|
|
9,380 |
|
|
|
14,872 |
|
|
|
39,325 |
|
|
|
43,184 |
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(9,380 |
) |
|
|
(14,872 |
) |
|
|
(37,979 |
) |
|
|
(43,184 |
) |
|
|
|
|
|
|
|
|
|
Gain on settlement with
licensor |
|
|
- |
|
|
|
6,743 |
|
|
|
- |
|
|
|
6,743 |
|
PPP loan payable forgiveness
income |
|
|
- |
|
|
|
1,758 |
|
|
|
- |
|
|
|
1,758 |
|
Interest income |
|
|
72 |
|
|
|
7 |
|
|
|
103 |
|
|
|
35 |
|
Interest expense |
|
|
(157 |
) |
|
|
(683 |
) |
|
|
(558 |
) |
|
|
(3,603 |
) |
Other income (expense) |
|
|
(19 |
) |
|
|
3 |
|
|
|
(136 |
) |
|
|
(2 |
) |
Net loss |
|
$ |
(9,484 |
) |
|
$ |
(7,044 |
) |
|
$ |
(38,570 |
) |
|
$ |
(38,253 |
) |
|
|
|
|
|
|
|
|
|
Deemed dividends related to Series A and Series B |
|
|
|
|
|
|
|
|
Convertible Redeemable Preferred Stock |
|
|
- |
|
|
|
- |
|
|
|
(3,782 |
) |
|
|
- |
|
Net loss attributable to Common Shareholders |
|
$ |
(9,484 |
) |
|
$ |
(7,044 |
) |
|
$ |
(42,352 |
) |
|
$ |
(38,253 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
common share |
|
$ |
(1.48 |
) |
|
$ |
(1.80 |
) |
|
$ |
(7.05 |
) |
|
$ |
(9.93 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
common |
|
|
|
|
|
|
|
|
shares outstanding – basic and
diluted |
|
|
6,421,245 |
|
|
|
3,924,024 |
|
|
|
6,009,902 |
|
|
|
3,853,318 |
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
Change in unrealized gains
(losses) related to available-for-sale debt securities |
|
|
(4 |
) |
|
|
1 |
|
|
|
(11 |
) |
|
|
10 |
|
Foreign currency translation
adjustments |
|
|
(6 |
) |
|
|
(9 |
) |
|
|
(6 |
) |
|
|
(9 |
) |
Comprehensive loss |
|
$ |
(9,494 |
) |
|
$ |
(7,052 |
) |
|
$ |
(42,369 |
) |
|
$ |
(38,252 |
) |
ABEONA THERAPEUTICS INC. AND
SUBSIDIARIESCondensed Consolidated Balance Sheets(In
thousands, except share and per share amounts)
ASSETS |
September 30, 2022 |
|
December 31, 2021 |
|
(Unaudited) |
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
5,733 |
|
|
$ |
32,938 |
|
Short-term investments |
|
12,434 |
|
|
|
12,086 |
|
Restricted cash |
|
5,338 |
|
|
|
5,891 |
|
Accounts receivable |
|
- |
|
|
|
3,000 |
|
Other receivables |
|
1,047 |
|
|
|
- |
|
Prepaid expenses and other
current assets |
|
945 |
|
|
|
2,377 |
|
Total current assets |
|
25,497 |
|
|
|
56,292 |
|
|
|
|
|
Property and equipment,
net |
|
6,606 |
|
|
|
12,339 |
|
Right-of-use lease assets |
|
6,638 |
|
|
|
9,403 |
|
Licensed technology, net |
|
- |
|
|
|
1,384 |
|
Other assets |
|
20 |
|
|
|
168 |
|
Total assets |
$ |
38,761 |
|
|
$ |
79,586 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,748 |
|
|
$ |
4,325 |
|
Accrued expenses |
|
4,121 |
|
|
|
5,585 |
|
Current portion of lease
liability |
|
1,810 |
|
|
|
1,818 |
|
Current portion of payable to
licensor |
|
4,921 |
|
|
|
4,599 |
|
Deferred revenue |
|
- |
|
|
|
296 |
|
Total current liabilities |
|
12,600 |
|
|
|
16,623 |
|
|
|
|
|
Payable to licensor |
|
4,064 |
|
|
|
3,828 |
|
Other long-term
liabilities |
|
200 |
|
|
|
200 |
|
Long-term lease
liabilities |
|
6,484 |
|
|
|
7,560 |
|
Total liabilities |
|
23,348 |
|
|
|
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 September 30, 2022 and |
|
|
|
December 31, 2021,
respectively |
|
- |
|
|
|
- |
|
Common stock - $0.01 par
value; authorized 200,000,000 shares; |
|
|
|
7,671,351 and 5,888,217 shares
issued and outstanding as of |
|
|
|
September 30, 2022 and
December 31, 2021, respectively* |
|
77 |
|
|
|
1,472 |
|
Additional paid-in
capital |
|
709,590 |
|
|
|
705,570 |
|
Accumulated deficit |
|
(694,210 |
) |
|
|
(655,640 |
) |
Accumulated other
comprehensive loss |
|
(44 |
) |
|
|
(27 |
) |
Total stockholders'
equity |
|
15,413 |
|
|
|
51,375 |
|
Total liabilities and
stockholders' equity |
$ |
38,761 |
|
|
$ |
79,586 |
|
* As of November 7, 2022, Abeona had 17,175,799 shares of common
stock outstanding.
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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