Abeona Reports Third Quarter 2017 Financial Results and Recent Business Highlights
November 15 2017 - 8:25AM
YASTEST
- Investor Conference Call to be
held Monday, November 20th at 10:00 am ET
- Global enrollment continues in
ABO-102 trial for MPS IIIA
- Screening initiated in ABO-101
Phase 1/2 trial for MPS IIIB
- Pivotal Phase 3 planning
underway for EB-101 program in RDEB
NEW YORK and CLEVELAND, Nov. 15,
2017 (GLOBE NEWSWIRE) -- 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 third quarter
and recent business highlights. The Company will provide investors
an update on recent and ongoing business activities and an overview
of its 3Q17 financials on Monday, November 20th, 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).
"The third quarter was marked with achievements
across multiple clinical programs, including initiating enrollments
at our global clinical sites for ABO-102 for MPS IIIA and reporting
additional data that underscored the durability and clinical
benefit of the gene therapy. Our Epidermolysis Bullosa
program achieved FDA Breakthrough Therapy designation, completed
its Phase 1/2 clinical trial and continues to advance as we
finalize the clinical protocol before initiating the pivotal Phase
3 trial next year. We were pleased to have recently initiated
screening in our MPS IIIB program and look forward to commencing
enrollments shortly," stated Timothy J. Miller, Ph.D., President
and CEO. "In addition, work in optimizing our AIM(TM) vector
platform demonstrated exciting progress, including enhanced tissue
tropisms compared to naturally occurring AAV capsids."
3rd Quarter
Summary Financial Results:
- Cash position: Cash and cash equivalents as of
September 30, 2017 were $56.5 million, compared to $58.3 million as
of June 30, 2017. Net cash used in operating activities in the nine
months ended September 30, 2017 was $17.6 million as compared to
$9.6 million in the same period in 2016. Cash and cash equivalents
includes approximately $5 million from exercised warrants in the
third quarter. Subsequent to the end of the third quarter,
the Company closed a public offering of common stock with gross
proceeds of $92 million. Total cash as of October 31, 2017 was
$142.6 million.
- Revenues: Revenues were $219 thousand for the
third quarter of 2017, compared to $184 thousand in the third
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 $0.13 for the
third quarter of 2017, compared to a loss per share of $0.08 in the
comparable period in 2016.
Abeona Recent
Highlights:
- November 9, 2017: Enrolled First Subject at Spain
Clinical Site in Ongoing Phase 1/2 Clinical Trial in MPS IIIA
- October 19, 2017: Announced Closing of $92
Million Underwritten Public Offering and Full Exercise of
Underwriters' Option to Purchase Additional Shares
- October 16, 2017: Announced a Grant of up to
$13.85 Million from Leading Sanfilippo Syndrome Foundations for
Clinical Development of MPS III Gene Therapies
- October 11, 2017: Hosted inaugural R&D day
and announced enrollment of First Two Patients in Global Expansion
of Phase 1/2 Clinical Trial in MPS IIIA
- October 6, 2017: Announced Top-Line One Year Data
from ABO-102 MPS IIIA Trial at ARM's Cell & Gene Meeting on the
Mesa
- Gene therapy demonstrated durable and significant
reduction of underlying disease pathology across multiple clinical
measures in Cohort 1 (n=3) compared to a natural history control
group (n=8-12)
- Systemic biopotency demonstrated time- and
dose-dependent reductions of disease causing Heparan Sulfate in the
Cerebrospinal fluid (CSF) and liver volumes
- Preservation of deep brain architecture observed
after intravenous administration
- Stabilization of neurocognitive assessment scores
at one year post-injection
- October 4, 2017: Announced Dedication of
Commercial Gene Therapy Manufacturing Facility in Cleveland,
Ohio
- September 28, 2017: Announced Collaboration with
Brammer Bio for Commercial Translation of ABO-102
- August 29, 2017: Received FDA Breakthrough
Therapy Designation for EB-101 Autologous Cell Therapy in
Epidermolysis Bullosa
- July 25, 2017: Announced Appointment of Juan
Ruiz, M.D., Ph.D. as Chief Medical Officer
- July 18, 2017: Received Guidance from FDA to
Commence Pivotal Phase 3 for EB-101 Gene Therapy for Patients with
Epidermolysis Bullosa
"We have made great progress in
the quarter towards becoming a key player in the development of
novel breakthrough gene and cell therapies for rare genetic
diseases," stated Steven H. Rouhandeh, Executive Chairman. "The
recent investment from high-quality investors and leading
foundations is another achievement that demonstrates our internal
capabilities and commitment to the advancement of our robust
pipeline and next generation vector platform, including MPS III
gene therapy products. We look forward to further strengthening our
efforts with key hires, advancing clinical capabilities, and
commercial expansion in the coming quarters."
About Abeona:
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical
company developing cell and 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 is developing a proprietary vector platform,
AIM(TM), 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:
Lynn Granito
Berry & Company Public Relations
+1 (212) 253-8881
lgranito@berrypr.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, statements about our ability to
develop our products and technologies; 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 and we plan to initiate a
pivotal Phase III trial early next year; we have recently initiated
screening in our MPS IIIB program and look forward to commencing
enrollments by year-end; our expectation that we will continue to
advance our gene therapy for MPS IIIA patients, our expectation of
accelerating enrollment with our active global sites in Spain and
Australia, and that we remain encouraged by signs of tolerability
and biological effects observed in Cohort 1 post injection.
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,
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
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.
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Abeona Therapeutics Inc via Globenewswire
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