Advanced Cell Technology Announces 2013 Third Quarter Results
November 12 2013 - 4:00PM
Business Wire
Thirty Patients Treated to date; Phase II Plan Under
Development
Company Expects to Release “Top Line” Interim Data by Year
End
Advanced Cell Technology, Inc. (“ACT”; OTC:ACTC or the
“Company”), a leader in the field of regenerative medicine,
announced today third quarter financial results for the period
ended September 30, 2013 and provided an update on their clinical
and pre-clinical programs.
Highlights from the third quarter include:
- Received Data Safety Monitoring Board
(“DSMB”) Approval to complete the third cohort, which entails
finishing the enrollment and treatment of the remaining two
patients, in each of the Company’s three ongoing clinical trials
with the higher dosage of retinal pigment epithelial (“RPE”) cells
derived from human embryonic stem cells (hESCs). Patients in the
third cohort were injected with 150,000 hESC-derived RPE cells,
consistent with the trial protocols for the treatment of dry Age
related Macular Degeneration (“AMD”) and Stargardt’s Macular
Dystrophy (“SMD”). This positive evaluation by the DSMB signifies
that this dosage level, which is 50% greater than that of the
previous cohort, was found to lack significant adverse events.
- Filed an Investigational New Animal
Drug (“INAD”) application with the Food and Drug Administration
(“FDA”) to tests its proprietary “off-the-shelf” pluripotent stem
cell-derived mesenchymal stem cells (“MSC”) in a range of different
disease indications. The Company believes these studies are
synergistic with its pre-clinical programs which are targeting
therapies in humans and also provide the Company with an
opportunity to evaluate whether there is a development path in the
veterinary therapeutics market.
2013 Third Quarter Financial Results
ACT recognized revenue of approximately $39,000 for the three
months ended September 30, 2013 compared with approximately $68,000
in the period a year earlier. The revenue relates to license fees
and royalties collected in prior years, which are being amortized
over the period of the license granted. Research and Development
(“R&D”) expenses for the three months ended September 30, 2013
were approximately $2.9 million, compared to approximately $2.4
million for the same period in 2012. R&D expenses increased
compared to the previous year’s third quarter due primarily to
higher personnel costs associated with the Company’s pre-clinical
and ongoing clinical trial activities. General and Administrative
(“G&A”) expenses for the three months ended September 30, 2013
were approximately $3.2 million, compared to approximately $2.7
million for the same period in 2012. The increase was primarily due
to an increase in legal fees incurred as the Company works to
resolve its non-routine legal issues. Also contributing to the
increase in G&A spending was an increase in employee costs as
the Company expanded its workforce in 2013, as compared to
2012.
The Company reported a loss from operations of approximately
$(6.1) million for the three months ended September 30, 2013,
compared to a loss from operations of approximately $(5.0) million
in the 2012 third quarter. ACT reported a net loss of approximately
$(5.7) million or $(0.00) loss per share in the 2013 third quarter,
compared to a net loss of approximately $(8.5) million or $(0.00)
loss per share in the same period a year ago.
Net cash used in operating activities for the three months ended
September 30, 2013 was $4.9 million, compared to net cash used in
operations of $3.8 million for the same period in 2012. The
increase in net cash used in operations was a result of higher
operating losses, as explained above. The Company ended the 2013
third quarter with cash and cash-equivalents of approximately $5.5
million, compared to $7.2 million at December 31, 2012.
“We are pleased with the progress that we made this quarter on
all fronts of the business. Most notably, we continued to advance
our AMD and SMD trials. We’ve now treated 30 patients and we
continue to be encouraged by the safety profile of our novel cell
therapy,” said Gary Rabin, Chief Executive Officer. “ACT is in the
fortunate position of working with many of the leading retinal
specialists in the world. To have their support, and access to
their expertise, as we progress through Phase I, with an eye toward
Phase II design, is an invaluable asset for our Company. We believe
our Phase I data is very instructive for designing our Phase II
studies. We remain steadfastly committed to the clinical
development of this potentially curative treatment for AMD and SMD
and the millions of patients who suffer from these degenerative
diseases.”
Conference Call and Webcast:
The Company will hold a conference call at 4:30 EST today,
November 12, during which it will discuss third quarter 2013
results and provide a corporate update. Interested parties may dial
(888) 264-3177 and using conference ID 14878582. The call will be
available live and for replay by webcast at:
http://us.meeting-stream.com/advancedcelltechnology111213.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company
applying cellular technology in the field of regenerative medicine.
For more information, visit www.advancedcell.com.
Forward-Looking Statements
Statements in this news release regarding future financial and
operating results, future growth in research and development
programs, potential applications of our technology, opportunities
for the company and any other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Any
statements that are not statements of historical fact (including
statements containing the words “will,” “believes,” “plans,”
“anticipates,” “expects,” “estimates,” and similar expressions)
should also be considered to be forward-looking statements. There
are a number of important factors that could cause actual results
or events to differ materially from those indicated by such
forward-looking statements, including: limited operating history,
need for future capital, risks inherent in the development and
commercialization of potential products, protection of our
intellectual property, and economic conditions generally.
Additional information on potential factors that could affect our
results and other risks and uncertainties are detailed from time to
time in the company’s periodic reports, including the Annual Report
on Form 10-K for the year ended December 31, 2012 and its most
recent Quarterly Report on Form 10-Q. Forward-looking statements
are based on the beliefs, opinions, and expectations of the
company’s management at the time they are made, and the company
does not assume any obligation to update its forward-looking
statements if those beliefs, opinions, expectations, or other
circumstances should change. Forward-looking statements are based
on the beliefs, opinions, and expectations of the company’s
management at the time they are made, and the company does not
assume any obligation to update its forward-looking statements if
those beliefs, opinions, expectations, or other circumstances
should change. There can be no assurance that the Company’s
clinical trials will be successful.
Investors:CEOcast, Inc.Bob Woods, 212-732-4300orPress:Russo
PartnersDavid Schull, 858-717-2310