Abeona Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Developments
November 13 2023 - 7:30AM
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.
ABEONA THERAPEUTICS INC. AND
SUBSIDIARIESCondensed 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 |
|
|
|
110 |
|
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 |
|
|
|
(143 |
) |
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 |
|
|
|
|
|
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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