Abeona Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
March 18 2019 - 3:45PM
Abeona Therapeutics Reports Fourth Quarter and Full Year 2018
Financial Results
Abeona Therapeutics Inc. (Nasdaq: ABEO), a leading clinical-stage
biopharmaceutical company developing novel cell and gene therapies
for serious diseases, today announced fourth quarter and full year
2018 financial results, and provided business highlights. The
Company will host a conference call on Tuesday, March 19 at 10:00
a.m. ET to discuss fourth quarter and full year results, and to
provide business highlights. 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/44847.
“The diligent work conducted over the past nine
months at our GMP manufacturing facility puts us on track to
initiate the pivotal VITAL™ study evaluating EB-101, our
gene-corrected cell therapy for the treatment of recessive
dystrophic epidermolysis bullosa, in mid-2019. We will produce
EB-101 at our Cleveland facility, which is an important milestone
for Abeona. We are also advancing our manufacturing capabilities to
support our AAV gene therapy programs and expect to be at scale for
GMP production in the second half of this year,” said João Siffert,
M.D., Chief Executive Officer. “On the lysosomal storage disease
programs, we have stepped up efforts to accelerate patient
enrollment in the MPS III programs and recently implemented the
protocols to enroll younger, higher functioning patients.”
“We believe that these important steps have
positioned Abeona for success in 2019 as we focus on advancing our
clinical programs and developing our pipeline utilizing novel AAV
capsids,” added Dr. Siffert.
Fourth Quarter and Full Year
Summary Financial Results:
Cash, cash equivalents and marketable securities
as of December 31, 2018 were $85.0 million, compared to $112.2
million as of September 30, 2018. The decrease in cash of $27.2
million was driven primarily by the net cash used for operating
activities of $17.0 million and cash used for the acquisition of
the REGENXBIO license of $10 million.
Revenues were $0.5 million for the fourth
quarter of 2018 compared with $0.2 million for the fourth quarter
of 2017. The increased quarterly revenues resulted from the
recognition of Foundation grants that were announced during the
fourth quarter of 2017.
Net loss was $0.36 per share for the fourth
quarter of 2018, compared to $0.19 per share in the comparable
period in 2017. For the twelve months ended December 31, 2018, net
loss was $1.19 per share compared to $0.66 per share in the same
period in 2017.
Fourth Quarter and Recent
Highlights:
- December 6, 2018: Provided lead program updates and unveiled
data from AIM™ AAV vector platform in cystic fibrosis and retinal
diseases at R&D Day
- January 8, 2019: Appointed Christine Silverstein as Chief
Financial Officer and Ed Carr as Chief Accounting Officer
- February 5-6, 2019: Presented new supportive data for novel
gene therapies, including new proof-of-concept data for
the AIM™ vector platform at WORLDSymposium
- February 11, 2019: Appointed João Siffert, M.D. as Chief
Executive Officer
“As a fully-integrated organization, Abeona is
on the forefront of cell and gene therapy thanks to in-house
manufacturing facilities, the AIM™ AAV vector platform, and two
programs in the clinic that have exclusive license to the AAV9
vector,” said Steven H. Rouhandeh, Chairman of the Board and
Executive Chairman. “Under João’s leadership, the Company is
focused on maximizing these end-to-end capabilities as it prepares
for important near-term milestones and beyond.”
About Abeona Therapeutics
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 EB-101, its
gene-corrected cell therapy for recessive dystrophic epidermolysis
bullosa, and ABO-102, a novel AAV9 based gene therapy for
Sanfilippo syndrome type A (MPS IIIA). The Company’s portfolio of
AAV9 based gene therapies also features ABO-101 for Sanfilippo
syndrome type B (MPS IIIB), and ABO-201 and ABO-202 for CLN3
disease and CLN1 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 investigational
therapies (EB-101 and ABO-102). For more information, visit
www.abeonatherapeutics.com.
Forward Looking StatementThis
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 including but not limited to statements about
our existing cash and cash equivalents; our belief that we have a
rich pipeline of products and product candidates; our belief in our
ability to continue to develop our novel AAV-vector gene therapy
platform technology; our belief that EB-101 could potentially
benefit patients with recessive dystrophic epidermolysis bullosa
(“RDEB”); our ability to initiate a Phase III clinical trial for
patients with RDEB and complete enrollment of patients into the
trial; our belief that AAV treatment could potentially benefit
patients with MPS IIIA and B; our ability to add clinical sites and
identify additional patients for our Phase I/II clinical trial for
patients with MPS IIIA and B; our ability to continue to secure and
maintain regulatory designations for our product candidates; our
ability to develop manufacturing capability compliant with current
good manufacturing practices for our product candidates; our
ability to manufacture gene therapy products and produce an
adequate product supply to support clinical trials and potentially
future commercialization; our ability to secure timely regulatory
review related to our clinical program; our belief in the adequacy
of the data from clinical trials in EB-101 and expansion cohort of
our Phase I/II clinical trial in ABO-102 (AAV-SGSH) for MPS IIIA,
together with the data generated in the program to date, to support
regulatory approvals; our intellectual property position and our
ability to obtain, maintain and enforce intellectual property
protection and exclusivity for our proprietary assets. We
have attempted to identify forward looking statements by such
terminology as “may,” “will,” “anticipate,” “believe,” “estimate,”
“expect,” “intend,” 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 submit protocols and protocol amendments to
regulatory agencies, our ability to initiate and enroll
patients in clinical trials, the adequacy of manufacturing
capabilities, the impact of competition, the ability to secure
licenses or establish intellectual property rights for any
technology that may be necessary to continue to develop and
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 reports filed by
the Company with the Securities and Exchange Commission. The
Company undertakes no obligation to revise the forward-looking
statements or 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
Director, Investor Relations Abeona Therapeutics +1 (646)
813-4707swarner@abeonatherapeutics.com
Media Contact:Scott Santiamo
Director, Corporate Communications Abeona Therapeutics +1 (718)
344-5843ssantiamo@abeonatherapeutics.com
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