Abeona Therapeutics Reports Second Quarter 2019 Financial Results and Business Updates
August 09 2019 - 4:15PM
Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader
in gene and cell therapy, today announced second quarter 2019
financial results and business updates, which will be discussed on
a conference call scheduled for Monday, August 12 at 10:00 a.m. ET.
Interested parties are invited to participate in the call by
dialing 844-369-8770 (toll-free domestic) or 862-298-0840
(international) or via webcast
at https://www.investornetwork.com/event/presentation/51859.
“The second quarter was highlighted by progress
made in both of our MPS III programs,” said João Siffert, M.D.,
Chief Executive Officer. “Data from our Transpher A study showed
that children with MPS IIIA who were treated early with ABO-102
preserved neurocognitive development within the normative range
12-18 months post treatment. Our MPS IIIB program has also
progressed, with enrollment of additional patients in cohort 2 of
the Transpher B study. Our team remains highly focused on our lead
programs, including the start of our VIITAL Phase 3 clinical trial
in recessive dystrophic epidermolysis bullosa, continued enrollment
in the MPS III programs, and preparations to start the clinical
trial in CLN1 disease.”
Second Quarter Financial
Results:Cash, cash equivalents and marketable securities
as of June 30, 2019, were $62.5 million compared to $68.3 million
as of March 31, 2019. The decrease in cash was driven primarily by
the net cash used in operating activities of $15.2 million.
Research and development expenses for the second
quarter ended June 30, 2019 were $16.3 million compared to $7.9
million in the same period of 2018. The increase in R&D expense
was primarily attributable to increased in-house manufacturing
activities and related headcount costs.
General and administrative expenses for the
second quarter ended June 30, 2019 were $5.6 million compared to
$4.6 million in the same period of 2018. The increase in G&A
expenses was primarily due to increased headcount and related
facility costs.
Net loss was $0.49 per share for the second
quarter of 2019 compared to $0.26 per share in the same period of
2018.
Second Quarter and Recent
Highlights:
- July 25, 2019: Announced positive interim data from the Phase
1/2 AAV9 gene therapy clinical trial in MPS IIIA showing
preservation of neurocognitive function for the three youngest
patients treated with ABO-102, as well as robust and sustained
improvements in biomarkers of the disease. No product-related
serious adverse events were reported to date.
- June 26, 2019: Appointed Dr. Victor Paulus as Senior Vice
President of Regulatory Affairs and Jodie Gillon as Vice President
of Patient Advocacy and Clinical Affairs
- June 18, 2019: Received FDA Fast Track Designation for ABO-202
AAV9 gene therapy in CLN1 disease
- May 21, 2019: Announced FDA clearance of Investigational New
Drug application for ABO-202 AAV9 gene therapy in CLN1 disease
- May 14, 2019: Announced treatment of first patient in second
cohort of Phase 1/2 clinical trial for ABO-101 AAV9 gene therapy in
MPS IIIB
- May 1, 2019: Reported preclinical data demonstrating broad
therapeutic potential of AIM™ gene therapy in retinal diseases at
Association for Research in Vision and Ophthalmology Annual
Meeting
- April 30, 2019: Reported preclinical data demonstrating
therapeutic potential of ABO-401 for treatment of cystic fibrosis
at American Society of Gene and Cell Therapy annual meeting
- April 4, 2019: Received FDA Fast Track Designation for ABO-101
AAV9 gene therapy for MPS IIIB
Steven H. Rouhandeh, Abeona’s Executive
Chairman, said, “Abeona has continued the development of its
breakthrough gene and cell therapies for rare genetic diseases
through 2019 with important regulatory and clinical achievements
secured. We look forward to progressing our MPS programs, and to
starting of our Phase 3 VIITAL trial in EB before year end.”
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 numerous
regulatory designations from the FDA and EMA for its pipeline
candidates and is the only company with Regenerative Medicine
Advanced Therapy designation for two candidates (EB-101 and
ABO-102). For more information, visit
www.abeonatherapeutics.com.
Forward-Looking StatementsThis
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 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, litigation 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
WarnerSenior Director, Investor RelationsAbeona Therapeutics+1
(646) 813-4710swarner@abeonatherapeutics.com
Media Contact:Scott
SantiamoDirector, Corporate CommunicationsAbeona Therapeutics+1
(718) 344-5843ssantiamo@abeonatherapeutics.com
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