Abeona Therapeutics Reports Second Quarter 2023 Financial Results
08 August 2023 - 9:30PM
Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial
results for the second quarter of 2023 and provided an update on
progress toward achieving key corporate objectives.
“Abeona is at a pivotal moment in our history as
we are busy finalizing and planning to soon submit the BLA for
EB-101 for the treatment of recessive dystrophic epidermolysis
bullosa,” said Vish Seshadri, Chief Executive Officer of Abeona.
“The recent capital raise allows us to initiate preparations for
the commercial launch of EB-101 in the U.S., while also extending
our cash runway well beyond the anticipated regulatory approval
time for EB-101.”
Second Quarter and Recent
Progress
Strengthened balance sheet, preparing for commercialization of
EB-101 in the U.S.
-
In July, Abeona raised $25 million in a registered direct offering
priced at-the-market with select existing investors to primarily
fund initiation of the Company’s launch preparations in
anticipation of the EB-101 BLA submission and potential
approval.
EB-101 for recessive dystrophic epidermolysis bullosa (RDEB)
-
Completed the Process Performance Qualification manufacturing runs
for both retroviral vector (RVV) and EB-101 drug product
manufacturing to demonstrate Abeona’s validated process and
readiness for commercial production. This data will be included in
the chemistry, manufacturing, and controls (CMC) module for the
EB-101 BLA submission.
-
Generated the additional data requested by the U.S. Food and Drug
Administration (FDA) that supports comparability between two RVV
sources used in EB-101 clinical studies. This data will be included
in the CMC module for the EB-101 BLA submission.
-
Submitted the briefing package for the pre-BLA meeting with the FDA
in August 2023 for its anticipated BLA submission of EB-101 in the
treatment of RDEB. Abeona anticipates submitting the BLA in the
third quarter of 2023.
-
Additional efficacy and safety data from the pivotal Phase 3 VIITAL
study of investigational EB-101 in RDEB were presented at the
International Societies for Investigative Dermatology (ISID) and
Society for Pediatric Dermatology (SPD) meetings. The positive
top-line data from the VIITAL study were reported in November
2022.
Preclinical programs
- Completed pre-Investigational New
Drug Application (IND) meetings with the FDA regarding the
preclinical development plans and regulatory requirements to
support first-in-human trials for two preclinical gene therapy
product candidates from Abeona’s adeno-associated virus (AAV)
ophthalmology programs. The Company intends to initiate
IND-enabling studies in the second half of 2023.
- Presented new preclinical data at
the 26th Annual Meeting of the American Society of Gene & Cell
Therapy (ASGCT), including data on three internally developed
preclinical gene therapy product candidates from its AAV
ophthalmology programs.
Second Quarter Financial
Results
Cash, cash equivalents, restricted cash and
short-term investments totaled $37.1 million as of June 30, 2023,
prior to the $25 million registered direct offering in July 2023,
as compared to $40.7 million as of March 31, 2023. Abeona estimates
that its cash and cash equivalents, restricted cash and short-term
investments as of June 30, 2023, in addition to the proceeds from
the $25 million registered direct offering in July 2023, are
sufficient resources to fund operations into the fourth quarter of
2024.
License and other revenues in the second quarter
of 2023 were $3.5 million, compared to $1.0 million in the second
quarter of 2022. Research and development expenses for the three
months ended June 30, 2023 were $8.5 million, compared to $6.7
million for the same period of 2022. General and administrative
expenses were $5.0 million for the three months ended June 30,
2023, compared to $3.5 million for the same period of 2022. Net
loss attributable to common shareholders was $16.7 million for the
second quarter of 2023, or $0.92 loss per common share as compared
to a net loss attributable to common shareholders of $7.9 million,
or $1.36 loss per common share, in the second quarter of 2022.
Conference Call Details
Abeona Therapeutics will host a conference call
and webcast today, August 8, 2023, at 8:30 a.m. ET, to discuss its
financial results and business update. To access the call, dial
888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and
Entry Code: 446072 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, 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,”
“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;
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.
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 June 30, |
|
For the six months ended June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
License and other revenues |
|
$ |
3,500 |
|
|
$ |
1,000 |
|
|
$ |
3,500 |
|
|
$ |
1,346 |
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Royalties |
|
|
1,575 |
|
|
|
350 |
|
|
|
1,575 |
|
|
|
350 |
|
Research and development |
|
|
8,523 |
|
|
|
6,658 |
|
|
|
16,564 |
|
|
|
17,203 |
|
General and administrative |
|
|
5,021 |
|
|
|
3,460 |
|
|
|
9,018 |
|
|
|
7,684 |
|
Impairment of licensed technology |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,355 |
|
Loss/(gain) on right-of-use lease assets |
|
|
(1,065 |
) |
|
|
— |
|
|
|
(1,065 |
) |
|
|
1,561 |
|
Impairment of construction-in-progress |
|
|
— |
|
|
|
(1,460 |
) |
|
|
— |
|
|
|
1,792 |
|
Total expenses |
|
|
14,054 |
|
|
|
9,008 |
|
|
|
26,092 |
|
|
|
29,945 |
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
|
(10,554 |
) |
|
|
(8,008 |
) |
|
|
(22,592 |
) |
|
|
(28,599 |
) |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
417 |
|
|
|
31 |
|
|
|
781 |
|
|
|
38 |
|
Interest expense |
|
|
(103 |
) |
|
|
(200 |
) |
|
|
(204 |
) |
|
|
(401 |
) |
Change in fair value of warrant liabilities |
|
|
(8,629 |
) |
|
|
4,198 |
|
|
|
(6,364 |
) |
|
|
2,945 |
|
Other income (expense) |
|
|
2,215 |
|
|
|
(118 |
) |
|
|
2,618 |
|
|
|
(124 |
) |
Net
loss |
|
$ |
(16,654 |
) |
|
$ |
(4,097 |
) |
|
$ |
(25,761 |
) |
|
$ |
(26,141 |
) |
Deemed dividends related to Series A and Series B Convertible
Redeemable Preferred Stock |
|
— |
|
|
|
(3,782 |
) |
|
|
— |
|
|
|
(3,782 |
) |
Net loss
attributable to Common Shareholders |
|
$ |
(16,654 |
) |
|
$ |
(7,879 |
) |
|
$ |
(25,761 |
) |
|
$ |
(29,923 |
) |
|
|
|
|
|
|
|
|
|
Basic
and diluted loss per common share |
|
$ |
(0.92 |
) |
|
$ |
(1.36 |
) |
|
$ |
(1.48 |
) |
|
$ |
(5.16 |
) |
|
|
|
|
|
|
|
|
|
Weighted
average number of common |
|
|
|
|
|
|
|
|
shares outstanding – basic and diluted |
|
|
18,017,874 |
|
|
|
5,806,473 |
|
|
|
17,464,026 |
|
|
|
5,800,822 |
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
Change in unrealized gains (losses) related to available-for-sale
debt securities |
|
(30 |
) |
|
|
(4 |
) |
|
|
34 |
|
|
|
(7 |
) |
Comprehensive loss |
|
$ |
(16,684 |
) |
|
$ |
(7,883 |
) |
|
$ |
(25,727 |
) |
|
$ |
(29,930 |
) |
|
|
|
|
|
|
|
|
|
ABEONA THERAPEUTICS INC. AND SUBSIDIARIES |
Condensed Consolidated Balance Sheets |
(In thousands, except share and per share amounts) |
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
6,225 |
|
|
$ |
14,217 |
|
Short-term investments |
|
30,547 |
|
|
|
37,932 |
|
Restricted cash |
|
338 |
|
|
|
338 |
|
Accounts receivable |
|
3,500 |
|
|
|
— |
|
Other receivables |
|
2,227 |
|
|
|
188 |
|
Prepaid expenses and other current assets |
|
1,201 |
|
|
|
424 |
|
Total current assets |
|
44,038 |
|
|
|
53,099 |
|
Property and equipment,
net |
|
4,489 |
|
|
|
5,741 |
|
Right-of-use lease assets |
|
4,915 |
|
|
|
5,331 |
|
Other assets |
|
108 |
|
|
|
43 |
|
Total assets |
$ |
53,550 |
|
|
$ |
64,214 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,477 |
|
|
$ |
1,811 |
|
Accrued expenses |
|
4,161 |
|
|
|
3,991 |
|
Current portion of lease liability |
|
1,597 |
|
|
|
1,773 |
|
Other current liabilities |
|
205 |
|
|
|
204 |
|
Total current liabilities |
|
9,440 |
|
|
|
7,779 |
|
Payable to licensor |
|
4,367 |
|
|
|
4,163 |
|
Long-term lease
liabilities |
|
4,377 |
|
|
|
5,854 |
|
Warrant liabilities |
|
26,021 |
|
|
|
19,657 |
|
Total liabilities |
|
44,205 |
|
|
|
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 June 30, 2023 and December 31,
2022, respectively |
|
— |
|
|
|
— |
|
Common stock - $0.01 par value; authorized 200,000,000 shares;
21,478,157 and 17,719,720 shares issued and outstanding as of June
30, 2023 and December 31, 2022, respectively |
|
215 |
|
|
|
177 |
|
Additional paid-in capital |
|
730,322 |
|
|
|
722,049 |
|
Accumulated deficit |
|
(721,097 |
) |
|
|
(695,336 |
) |
Accumulated other comprehensive loss |
|
(95 |
) |
|
|
(129 |
) |
Total stockholders' equity |
|
9,345 |
|
|
|
26,761 |
|
Total liabilities and stockholders' equity |
$ |
53,550 |
|
|
$ |
64,214 |
|
|
|
|
|
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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