Abeona Therapeutics Reports Second Quarter 2022 Financial Results
August 11 2022 - 7:30AM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in cell and gene therapy, today announced financial results for the
second quarter of 2022. The Company will host a conference call and
webcast today, August 11, 2022, at 8:30 a.m. ET, to discuss its
financial results and business update.
“We have taken decisive action to focus our
resources on our lead asset EB-101, for which we expect pivotal
Phase 3 VIITAL™ topline results in the coming months,” said Vish
Seshadri, Chief Executive Officer of Abeona. “With Ultragenyx
assuming all financial responsibility for the continued development
of ABO-102, we were able to extend our cash runway well beyond the
VIITAL data readout. The additional runway puts us in a strong
position to forge the optimal commercial partnership that fully
appreciates the value of EB-101 post-data readout.”
Second Quarter and Recent Operating
Highlights
-
Ultragenyx Pharmaceutical Inc. and Abeona entered into an exclusive
license agreement for ABO-102 (now UX111) for Sanfilippo syndrome
type A (MPS IIIA), under which Ultragenyx assumes responsibility
for the ABO-102 program and in return Abeona is eligible to receive
tiered royalties and commercial milestone payments following
potential regulatory approval.
-
Topline data from the Phase 3 VIITAL™ study of EB-101 in RDEB is on
track for late third quarter to early fourth quarter of 2022 upon
completion of the last patient monitoring visit, which is expected
by mid-September. Baseline wound characteristics underscore the
large size and severe pain associated with wounds included in
VIITAL™. Treated randomized wounds had mean per patient body
surface area of 156 cm2, the largest reported for pivotal studies
in RDEB. Baseline pain reported for randomized wounds using the
Wong-Baker FACES Pain Rating Scale of 0-10 further highlights the
severity of these wounds, with eight of the 11 patients reporting a
minimum pain score of 6 in at least one randomized wound and four
of the 11 patients reporting a maximum baseline pain score of 10
for certain randomized wounds.
-
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 were presented at the Society of Investigative Dermatology
(SID) Annual Meeting. The data showed EB-101 treatment of large
chronic RDEB wounds resulted in considerable wound healing with
mean 5.9 years of follow-up. In addition, reduced wound burden was
associated with long-term symptomatic relief, including reduction
in pain.
- 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.
- On July 19, 2022, Abeona received
notice from Nasdaq that the Company has regained compliance with
the minimum bid price requirement under Nasdaq Listing Rule
5550(a)(2) for continued listing on the Nasdaq Capital Market.
Second Quarter Financial
Results
Cash, cash equivalents, restricted cash and
short-term investments totaled $26.0 million as of June 30, 2022.
Net cash used in operating activities was $9.0 million for the
second quarter of 2022, compared to $13.7 million in the first
quarter of 2022.
License and other revenues in the second quarter
of 2022 were $1.0 million, compared to nil in the second quarter of
2021. The revenue in the second quarter of 2022 resulted from a
clinical milestone achieved under a sublicense agreement with
Taysha Gene Therapies relating to an investigational AAV-based gene
therapy for Rett syndrome, including certain intellectual property
relating to MECP2 gene constructs and regulation of their
expression.
Research and development (R&D) expenses for
the three months ended June 30, 2022 were $6.7 million, compared to
$8.5 million for the same period of 2021. General and
administrative (G&A) expenses were $3.5 million for the three
months ended June 30, 2022, compared to $5.2 million for the same
period of 2021.
Net loss attributable to common shareholders for
the second quarter of 2022 was $12.1 million, or $2.08 loss per
common share as compared to $15.2 million, or $3.93 loss per common
share, in the second quarter of 2021.
Conference Call Details
Abeona Therapeutics will host a conference call
and webcast today, August 11, 2022, at 8:30 a.m. ET, to discuss its
financial results and business update. To access the call, dial
877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and
Entry Code: 857476 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 is 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, our ability to continue as a going concern; 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; our ability to enroll patients in
clinical trials; the outcome of any future meetings with the U.S.
Food and Drug Administration 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;
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
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 endedJune
30, |
|
|
For the six months endedJune
30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and other revenues |
|
$ |
1,000 |
|
|
$ |
— |
|
|
$ |
1,346 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties |
|
|
350 |
|
|
|
— |
|
|
|
350 |
|
|
|
— |
|
Research and development |
|
|
6,658 |
|
|
|
8,533 |
|
|
|
17,203 |
|
|
|
16,868 |
|
General and administrative |
|
|
3,460 |
|
|
|
5,182 |
|
|
|
7,684 |
|
|
|
11,444 |
|
Impairment of licensed technology |
|
|
— |
|
|
|
— |
|
|
|
1,355 |
|
|
|
— |
|
Impairment of right-of-use lease asset |
|
|
— |
|
|
|
— |
|
|
|
1,561 |
|
|
|
— |
|
Impairment of construction-in-progress |
|
|
(1,460 |
) |
|
|
— |
|
|
|
1,792 |
|
|
|
— |
|
Total expenses |
|
|
9,008 |
|
|
|
13,715 |
|
|
|
29,945 |
|
|
|
28,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(8,008 |
) |
|
|
(13,715 |
) |
|
|
(28,599 |
) |
|
|
(28,312 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
30 |
|
|
|
8 |
|
|
|
31 |
|
|
|
23 |
|
Interest expense |
|
|
(317 |
) |
|
|
(1,500 |
) |
|
|
(518 |
) |
|
|
(2,920 |
) |
Net loss |
|
$ |
(8,295 |
) |
|
$ |
(15,207 |
) |
|
$ |
(29,086 |
) |
|
$ |
(31,209 |
) |
Deemed dividends related to Series A and Series B Convertible
Redeemable Preferred Stock |
|
|
(3,782 |
) |
|
|
— |
|
|
|
(3,782 |
) |
|
|
— |
|
Net loss attributable to
Common Shareholders |
|
$ |
(12,077 |
) |
|
$ |
(15,207 |
) |
|
$ |
(32,868 |
) |
|
$ |
(31,209 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
common share |
|
$ |
(2.08 |
) |
|
$ |
(3.93 |
) |
|
$ |
(5.67 |
) |
|
$ |
(8.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding – basic and diluted |
|
|
5,806,473 |
|
|
|
3,864,791 |
|
|
|
5,800,822 |
|
|
|
3,817,380 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains related to available-for-sale debt
securities |
|
|
(4 |
) |
|
|
(4 |
) |
|
|
(7 |
) |
|
|
9 |
|
Comprehensive losses |
|
$ |
(12,081 |
) |
|
$ |
(15,211 |
) |
|
$ |
(32,875 |
) |
|
$ |
(31,200 |
) |
ABEONA THERAPEUTICS INC. AND
SUBSIDIARIESCondensed Consolidated Balance Sheets(In
thousands, except share and per share amounts)
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,133 |
|
|
$ |
32,938 |
|
Short-term investments |
|
|
13,963 |
|
|
|
12,086 |
|
Restricted cash |
|
|
5,891 |
|
|
|
5,891 |
|
Accounts receivable |
|
|
1,000 |
|
|
|
3,000 |
|
Other receivables |
|
|
1,869 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
1,440 |
|
|
|
2,377 |
|
Total current assets |
|
|
30,296 |
|
|
|
56,292 |
|
Property and equipment,
net |
|
|
7,460 |
|
|
|
12,339 |
|
Right-of-use lease assets |
|
|
6,943 |
|
|
|
9,403 |
|
Licensed technology, net |
|
|
— |
|
|
|
1,384 |
|
Other assets |
|
|
20 |
|
|
|
168 |
|
Total assets |
|
$ |
44,719 |
|
|
$ |
79,586 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,738 |
|
|
$ |
4,325 |
|
Accrued expenses |
|
|
5,331 |
|
|
|
5,585 |
|
Current portion of lease liability |
|
|
1,798 |
|
|
|
1,818 |
|
Current portion of payable to licensor |
|
|
4,818 |
|
|
|
4,599 |
|
Deferred revenue |
|
|
— |
|
|
|
296 |
|
Total current liabilities |
|
|
13,685 |
|
|
|
16,623 |
|
Payable to licensor |
|
|
4,011 |
|
|
|
3,828 |
|
Other long-term
liabilities |
|
|
200 |
|
|
|
200 |
|
Long-term lease
liabilities |
|
|
6,737 |
|
|
|
7,560 |
|
Total liabilities |
|
|
24,633 |
|
|
|
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 June 30, 2022 and December 31,
2021, respectively |
|
|
— |
|
|
|
— |
|
Common stock - $0.01 par value; authorized 200,000,000 shares;
5,870,375 and 5,888,217 shares issued and outstanding as of June
30, 2022 and December 31, 2021, respectively |
|
|
1,467 |
|
|
|
1,472 |
|
Additional paid-in capital |
|
|
703,379 |
|
|
|
705,570 |
|
Accumulated deficit |
|
|
(684,726 |
) |
|
|
(655,640 |
) |
Accumulated other comprehensive loss |
|
|
(34 |
) |
|
|
(27 |
) |
Total stockholders’ equity |
|
|
20,086 |
|
|
|
51,375 |
|
Total liabilities and stockholders’ equity |
|
$ |
44,719 |
|
|
$ |
79,586 |
|
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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