Abeona Therapeutics Reports Third Quarter 2019 Financial Results and Business Updates
November 12 2019 - 3:30PM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in gene and cell therapy, today announced third quarter 2019
financial results and business updates, which will be discussed on
a conference call scheduled for Wednesday, November 13 at 10:00
a.m. ET. Interested parties are invited to participate in the call
by dialing 844-602-0380 (toll-free domestic) or 862-298-0970
(international) or via webcast at
https://www.investornetwork.com/event/presentation/56788.
“Abeona has made progress on our lead clinical
program, EB-101, for the treatment of recessive dystrophic
epidermolysis bullosa,” said João Siffert, M.D., Chief Executive
Officer of Abeona. “We continue to anticipate receiving CMC
clearance for this pivotal trial by year-end following the recent
submission of additional transport stability data for EB-101, in
response to the Clinical Hold Letter received in the quarter, as
well as the submission of updated clinical and comparability
protocols for the VIITALTM Phase 3 study.”
Dr. Siffert continued, “We were also very
pleased with the publication of positive long-term data from our
Phase 1/2a clinical trial, reinforcing the potential of EB-101 to
safely provide durable healing for the most challenging to treat,
large and painful RDEB wounds. Three years post treatment, the
majority of EB-101-treated wounds remained healed and without pain.
We believe that EB-101 is uniquely positioned to address the needs
of the majority of RDEB patients who suffer from these types of
chronic wounds and we remain dedicated to delivering this therapy
to the community.”
Third Quarter Financial
Results: Cash, cash equivalents and marketable securities
as of September 30, 2019, were $47.9 million compared to $62.5
million as of June 30, 2019. The decrease in cash was driven
primarily by the net cash used in operating activities of $18.3
million.
Research and development expenses for the third
quarter ended September 30, 2019 were $10.9 million compared to
$13.2 million in the same period of 2018. The decrease in R&D
expense was primarily attributable to decreased clinical and
development work, partially offset by increased salary and related
costs from the hiring of additional clinical, regulatory,
manufacturing and quality staff.
General and administrative expenses for the
third quarter ended September 30, 2019 were $4.7 million compared
to $5.0 million in the same period of 2018. The decrease in G&A
expenses was primarily due to decreased rental, recruiting,
professional fee and salary related costs.
Net loss was $0.35 per share for the third
quarter of 2019 compared to $0.34 per share in the same period of
2018.
Third Quarter and Recent
Highlights:
- Submitted additional transport
stability data for EB-101 in response to September 17 FDA Clinical
Hold Letter regarding the planned Phase 3 VIITAL™ study.
- Submitted Phase 3 VIITAL™ clinical
trial protocol with updated PRO assessments, and submitted the
retrovirus comparability protocol to FDA.
- Presentation of data from the
Transpher A Study, the Company’s ongoing Phase 1/2 clinical trial
evaluating ABO-102 for the treatment of MPS IIIA, and research
updates from its library of novel AIMTM adeno-associated virus
capsids at the 27th European Society of Gene and Cell Therapy
Congress.
- Publication of positive long-term
safety and efficacy data from the Phase 1/2a clinical trial of
EB-101 in JCI Insight with collaborators from Stanford University
School of Medicine. • Three years after treatment with EB-101,
a majority of RDEB patients had sustained wound healing, with 80%
(16/20) of wounds achieving ≥50% healing, and 70% (14/20) achieving
≥75%• Two years after treatment, only 1 of 6 untreated (17%),
prospectively selected control wounds, had ≥50% healing• 50%
or greater wound healing was associated with no pain (0/16) and no
itch (0/16) at treated sites three years post-treatment, compared
with presence of pain in 53% (20/38) and itch in 61% (23/38) of
wound sites at baseline• EB-101 was associated with long-term
molecular expression of type VII collagen protein, which plays an
important role in anchoring the dermal and epidermal layers of the
skin• No serious treatment-related adverse events were
observed during the three-year observation period
- Retained Jefferies LLC as its
financial advisor to assist with the review of strategic
initiatives focused on advancing the Company’s mission and
maximizing stakeholder value.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical
company developing gene and cell therapies for serious diseases.
The Company’s clinical programs include EB-101, its autologous,
gene-corrected cell therapy for recessive dystrophic epidermolysis
bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene
therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS
IIIB), respectively. The Company’s portfolio of AAV9-based gene
therapies also features ABO-202 and ABO-201 for CLN1 disease and
CLN3 disease, respectively. Its preclinical assets include ABO-401,
which uses the novel AIM™ AAV vector platform to address all
mutations of cystic fibrosis. Abeona has received twenty regulatory
designations from the FDA and EMA for its pipeline candidates. 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. These
statements include statements about the timing for CMC clearance
for the VIITAL™ trial and the Company’s beliefs relating thereto,
the Company’s ability to provide additional transport stability
data points in response to the FDA clinical hold letter and the
timing thereof, the Company’s belief that completion of its CMC
work and the durable safety and efficacy data will ultimately be
critical to support a future Biologics License Application,
the ability of its management team to lead the Company and deliver
on key strategies, the Company’s clinical trials and its products
and product candidates, future regulatory interactions with
regulatory authorities, as well as the Company’s goals and
objectives. 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 continued interest in our rare disease
portfolio, 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 impact of
competition, the ability to secure licenses for any technology that
may be necessary to commercialize our products, the ability to
achieve or obtain necessary regulatory approvals, risk of whether
or when the FDA will lift the clinical hold respecting the
Company’s planned Phase 3 clinical trial for EB-101, the impact of
changes in the financial markets and global economic conditions,
risks associated with data analysis and reporting, and other risks
as may be detailed from time to time in the Company’s Annual
Reports on Form 10-K and quarterly reports on Form 10-Q and other
periodic reports filed by the Company 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
presentation, whether as a result of new information, future
developments or otherwise, except as required by the federal
securities laws.
Investor Contact:Sofia Warner Senior Director,
Investor Relations Abeona Therapeutics +1 (646)
813-4710swarner@abeonatherapeutics.com
Media Contact:Scott Santiamo Director,
Corporate Communications Abeona Therapeutics +1 (718)
344-5843ssantiamo@abeonatherapeutics.com
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