Advanced Cell Technology Announces 2013 First Quarter Results
MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT" or the "Company"; OTCBB: ACTC) a leader in the field of regenerative medicine, announced today its first quarter financial results for the period ended March 31, 2013. The Company reported a loss from operations of $(5.8) million compared to a loss from operations of $(5.4) million in the 2012 first quarter, primarily as a result of higher clinical trial expenses. ACT reported a net loss of $(6.4) million or $(0.00) per share, compared to a loss in the same period in 2012 of $(5.7) million or $(0.00) per share.
Net cash used in operations for the 2013 first quarter was $8.3 million, compared to net cash used in operations of $4.8 million during the same period in 2012. The Company ended the 2013 first quarter with cash and cash equivalents of $4.1 million, compared to $7.2 million as of December 31, 2012, primarily due to higher operating expenses. Cash utilization increased significantly as a result of $2.3 million used to settle litigation related to previously issued debentures. The Company expects cash utilization to return to previous levels in the subsequent quarter.
Highlights from the first quarter of 2013 included:
Reached the midway point in all three clinical trials in the U.S. and Europe to investigate hESC-derived RPE cells for the treatment of dry AMD and SMD, both forms of macular degeneration. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or SMD at 12 months, the study's primary endpoint. With the addition of the new cohort 2a patients, each of the U.S. trials will now enroll a total of 16 patients across the ascending dosage format of 50,000 to 200,000 RPE cells.
Received Data and Safety Monitoring Board (DSMB) approval to initiate treatment of the third patient cohort in the Company's three ongoing stem cell clinical trials in the U.S. and Europe. Per each trial's protocol, the first patient of "cohort 3" was injected in April with 150,000 human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. This represents a fifty percent increase in the dose of RPE cells as compared to the previously treated cohort of patients. The first patients treated at this escalated dose will be evaluated, with interim DSMB review after six weeks.
Received DSMB approval to treat additional cohorts of patients with better vision.
Observed the persistence of visual acuity gains and engraftment of transplanted cells in clinical trial patients with no safety issues reported.
ACTC announced a settlement agreement resolving litigation associated with previously issued debentures.
ACT Chief Scientific Officer Dr. Robert Lanza, voted among the top 4 "Most Influential People on Stem Cells."
"I am pleased by the progress we are making in our clinical trials. The clearance to treat patients with higher doses of RPE cells and to treat patients with greater visual acuity represents significant milestones in our clinical trials," said Chairman and CEO Gary Rabin. "Treating patients with better vision significantly improves the likelihood that these patients will show a meaningful benefit when we report data later this year."
The Company will hold a conference call today at 4:30 pm eastern time to discuss the results. Interested parties may access the call live by dialing (888) 264-3177 and using conference ID 14875304. This event is also being streamed via webcast. The webcast is available at http://us.meeting-stream.com/advancedcelltechnology050913. A replay of the call will also be available via the same link. 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.
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 ACT'S results and other risks and uncertainties are detailed from time to time in the Company's periodic reports, including the report on Form 10-K for the year ended December 31, 2012. 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.
James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
David Schull, 858-717-231
KEYWORDS: United States North America Massachusetts
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