Abeona Therapeutics Reports Second Quarter 2017 Financial Results and Recent Business Highlights
August 15 2017 - 8:25AM
Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical-stage
biopharmaceutical company focused on developing novel gene
therapies for life-threatening rare diseases, announced financial
results for the second quarter and recent business highlights. The
Company will provide investors an update on ongoing business
activities and an overview of its 2Q17 financials on Tuesday,
August 22nd, at 10:00 am (Eastern). Interested parties are invited
to participate in the call by dialing 877-269-7756 (toll free
domestic) or 201-689-7817 (international).
“We made a lot of progress during the second
quarter, and the feedback received from the FDA to accelerate our
EB-101 program to a pivotal Phase 3 trial supports the
potential of this gene therapy program. The strengths of our
clinical programs were also underscored by the achievement of
additional regulatory designations for our gene therapy programs
and the recent appointment of key executives within the Company,”
stated Timothy J. Miller, Ph.D., President and CEO.
2nd Quarter Summary Financial
Results:
Cash position: Cash, cash equivalents and
marketable securities as of June 30, 2017 were $58.3 million,
compared to $63.2 million as of March 31, 2017. Net cash used in
operating activities in the six months ended June 30, 2017 was
$10.8 million as compared to $5.6 million in the same period in
2016.
Revenues: Revenues were $217 thousand for the
second quarter of 2017, compared to $214 thousand in the second
quarter of 2016. Revenues consisted of a combination of royalties
from marketed products, primarily MuGard®, and recognition of
deferred revenues related to upfront payments from early license
agreements.
Loss per share: Loss per share was $0.21 for the
second quarter of 2017, compared to a loss per share of $0.20 in
the comparable period in 2016.
Abeona Recent Highlights: July
25, 2017: Announced appointment of Juan Ruiz, Ph.D., M.D., as Chief
Medical OfficerJuly 18, 2017: Received guidance from FDA to
commence pivotal Phase 3 for EB-101 gene therapy for patients with
Epidermolysis Bullosa (EB)June 29, 2017: Received FDA Orphan Drug
Designation for ABO-201 Juvenile Batten disease gene therapy
programMay 30, 2017: Received Rare Pediatric Disease designation
for EB-101 gene therapy in Epidermolysis BullosaMay 25, 2017:
Received FDA Orphan Drug Designation for EB-101 gene therapy in
Epidermolysis BullosaMay 12, 2017: Announced top-line data for
ABO-102 Phase 1/2 MPS IIIA gene therapy trial at ASGCT --
Positive dose response in central nervous system with 60.7% +/-
8.8% reduction of disease-causing heparan sulfate GAG observed in
Cohort 2 -- Reduction of disease manifestation observed in
decreased liver volume of 14.81% (+/- 1.2%) -- Cohort 1
demonstrated stabilized or improved Leiter Nonverbal IQ scores at
six months
May 9, 2017: Received regulatory approval to
initiate clinical trial in Australia with ABO-102 gene therapy for
patients with MPS IIIA
May 2, 2017: Provided update on EB-101 Phase 1/2
gene therapy for severe form of Epidermolysis Bullosa from the
Society for Investigative Dermatology (SID) Conference --
Demonstrated significant wound healing (defined as greater than 50%
healed) in 100% of treated wounds (36/36) at 3 months; 89% (32/36)
at 6 months, 83% (20/24) at 12 months, 88% (21/24) at 24 months and
100% (6/6) at 36 months post-administration -- Clinical
endpoints supported by Natural History Study data observations from
1,436 wounds in 128 patients with Recessive Dystrophic
Epidermolysis Bullosa (RDEB)
“In the second quarter, we continued making
meaningful progress towards our goal of building a strong
leadership position in the development of novel therapies for rare
diseases," stated Steven H. Rouhandeh, Executive Chairman. "With
the positive biopotency data seen in our ABO-102 Phase 1/2 clinical
trial in Sanfilippo syndrome Type A (MPS IIIA) recently, along with
two-year follow-up data in our completed EB-101 Phase 1/2 study in
EB, we look forward to accelerating each program over the coming
months.”
About Abeona: Abeona
Therapeutics Inc. is a clinical-stage biopharmaceutical company
developing gene therapies for life-threatening rare genetic
diseases. Abeona's lead programs include ABO-102 (AAV-SGSH), an
adeno-associated virus (AAV) based gene therapy for Sanfilippo
syndrome type A (MPS IIIA) and EB-101 (gene-corrected skin grafts)
for recessive dystrophic epidermolysis bullosa (RDEB). Abeona
is also developing ABO-101 (AAV-NAGLU) for Sanfilippo syndrome type
B (MPS IIIB), ABO-201 (AAV-CLN3) gene therapy for juvenile Batten
disease (JNCL), ABO-202 (AAV-CLN1) for treatment of infantile
Batten disease (INCL), EB-201 for epidermolysis bullosa (EB),
ABO-301 (AAV-FANCC) for Fanconi anemia (FA) disorder and ABO-302
using a novel CRISPR/Cas9-based gene editing approach to gene
therapy for rare blood diseases. In addition, Abeona has a
proprietary vector platform, AIM™, for next generation product
candidates. For more information, visit
www.abeonatherapeutics.com.
Investor Contact:Christine Silverstein Vice
President, Investor Relations Abeona Therapeutics Inc. +1
(212)-786-6212 csilverstein@abeonatherapeutics.com
Media Contact:Andrea Lucca Vice President,
Communications & Operations Abeona Therapeutics Inc. +1
(212)-786-6208alucca@abeonatherapeutics.com
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 that involve risks and
uncertainties. These statements include, without limitation, our
plans for continued development and internationalization of our
clinical programs, that patients will continue to be identified,
enrolled, treated and monitored in the EB-101 clinical trial, and
that studies will continue to indicate that EB-101 is
well-tolerated and may offer significant improvements in wound
healing; the addition of two additional global clinical sites will
accelerate our ability to enroll and evaluate ABO-102 as a
potential treatment for patients with Sanfilippo syndrome type A,
or MPS IIIA. Such statements are subject to 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 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; our belief that initial signals of
biopotency and clinical activity, which suggest that ABO-102
successfully reached target tissues throughout the body, including
the central nervous system and the increased reductions in CNS GAG
support our approach for intravenous delivery for subjects with
Sanfilippo syndromes, 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 reports filed by the Company with
the Securities and Exchange Commission. The Company undertakes
no obligations to make any revisions to the forward-looking
statements contained in this release or to update them to reflect
events or circumstances occurring after the date of this release,
whether as a result of new information, future developments or
otherwise.
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