Abeona Therapeutics Reports First Quarter Financial Results and Business Updates
May 06 2020 - 4:14PM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in gene and cell therapy, today announced first quarter 2020
financial results, which will be discussed on a conference call
scheduled for Thursday, May 7, 2020 at 8:30 a.m. ET. Interested
parties are invited to participate in the call by dialing
844-455-1352 (U.S. toll-free) or 509-844-0155 (international), and
reference conference ID 5352629, or via webcast at
https://investors.abeonatherapeutics.com/ir-calendar.
“During these challenging times, our priority
remains to ensure the safety of our employees and patients, while
supporting continuity of our business and clinical operations,”
said João Siffert, M.D., Chief Executive Officer of Abeona. “We
have made considerable progress in our clinical programs in the
first quarter of 2020, and are working with our investigators to
minimize the impact of the COVID-19 pandemic. It is our intention
to restore full patient access to our clinical programs as soon as
possible. Our gene and cell therapies in development aim at
addressing urgent unmet needs, and have the potential to provide
durable benefit to patients who have no approved treatments.”
First Quarter and Recent
Highlights
- First patient treated in pivotal
Phase 3 VIITAL™ study evaluating EB-101 for recessive
dystrophic epidermolysis bullosa (RDEB). An additional 10 patients
have been prescreened for this study.
- Additional patients treated in dose
cohort 3 of the Transpher A study and the Transpher B study.
- Presented positive interim data
from the Transpher A study of ABO-102 at WORLDSymposium™
demonstrating improved neurocognitive skills 18 months to two years
post-treatment in MPS IIIA patients younger than 30 months,
sustained, dose-related biomarker improvements, and a favorable
safety profile.
- Presented positive interim data
from the Transpher B study of ABO-101 at WORLDSymposium™
demonstrating initial improvement in multiple disease-specific
biomarkers, denoting clear biologic effects, and a favorable safety
profile among MPS IIIB patients.
- Updated interim results from the
Transpher A and Transpher B studies to be presented during the
American Society of Gene & Cell Therapy (ASGCT) 23rd Annual
Meeting, which will take place online May 12-15, 2020.
- Two U.S. patents issued for
adeno-associated virus (AAV) capsids exclusively licensed by Abeona
from the University of North Carolina (“UNC”), generated using
UNC’s AIM™ vector platform.
- Announced key appointments of
industry leaders to its Board of Directors in April. Dr. Brian J.
G. Pereira was appointed as Executive Chairman and Ms. Shawn
Tomasello as an Independent Board Member. Dr. Pereira is a seasoned
biopharmaceutical and healthcare leader with experience in
financing and growing companies, including the clinical development
and commercialization of innovative drug products. Ms. Tomasello
has substantial commercial and strategic experience, including
serving as Chief Commercial Officer at cell therapy pioneer Kite
Pharma, which was acquired by Gilead Sciences.
- Strengthened its leadership team
with the appointments of Gregory Gin as Vice President, Investor
Relations and Dr. Dan Rudin as Vice President, Clinical
Development, focusing on the EB-101 program. Mr. Gin brings more
than 25 years of investor relations, communications, and capital
markets experience with small- and mid-cap biotechnology and
specialty pharmaceutical companies developing novel treatments for
orphan diseases and areas of high unmet medical need. Dr. Rudin has
substantial research and development experience gained in industry
and academia with focus on rare diseases, including lysosomal
storage diseases. He has led several programs through the lifecycle
of clinical development supporting multiple product approvals.
Dr. Siffert continued, “We look forward to
working with our new Executive Chairman, Dr. Brian Pereira and
Independent Board Member, Ms. Shawn Tomasello. Both bring
invaluable experience guiding biotech companies from clinical
development through commercial launch. In addition, with the
appointments of Greg and Dan, we have strengthened our leadership
in investor relations and clinical development, respectively.”
COVID-19 Impact Mitigation
The ongoing COVID-19 pandemic has caused
meaningful disruptions to the global healthcare system, including
the conduct of clinical trials as healthcare institutions shift
their focus and resources to treating COVID-19 patients. In
response to the unprecedented challenges related to the COVID-19
pandemic, Abeona has taken several measures to protect and support
the health of its employees and their families, healthcare partners
and patients participating in its clinical trials. At the same
time, the Company has implemented measures to maintain continuity
of its operations and to preserve financial flexibility for the
future.
First Quarter Financial
Results
Cash, cash equivalents and marketable securities
as of March 31, 2020, were $116 million compared to $129 million as
of December 31, 2019. The decrease in cash of $13 million was
driven by R&D expenses across our programs along with
supporting administrative costs.
The net loss was $0.52 per share for the first
quarter of 2020, compared to $0.39 per share in the comparable
period in 2019. The increase in the net loss per share results
primarily from the non-cash impairment charge on the termination of
the REGENXBIO license of $32.9 million, or $0.36 per share.
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 AAV-based gene
therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS
IIIB), respectively. The Company’s portfolio of AAV-based gene
therapies also features ABO-202 and ABO-201 for CLN1 disease and
CLN3 disease, respectively. Abeona has received numerous regulatory
designations from the FDA and EMA for its pipeline candidates,
including Regenerative Medicine Advanced Therapy designation for
two candidates (EB-101 and ABO-102). 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 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 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
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, 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:Greg GinVP, Investor
RelationsAbeona Therapeutics+1 (646)
813-4709ggin@abeonatherapeutics.com
Media Contact:Scott Santiamo Director,
Corporate Communications Abeona Therapeutics +1 (718) 344-5843
ssantiamo@abeonatherapeutics.com
Abeona Therapeutics (NASDAQ:ABEO)
Historical Stock Chart
From Mar 2024 to Apr 2024
Abeona Therapeutics (NASDAQ:ABEO)
Historical Stock Chart
From Apr 2023 to Apr 2024