Advanced Cell Technology Announces Year-End Results
Company Receives Unqualified Audit Opinion Reflecting Strengthened Balance Sheet
WORCESTER, Mass., March 17, 2010 -- Advanced Cell Technology, Inc. (OTCBB: ACTC – News) announced today that it has filed its Annual Report with the Securities and Exchange Commission for the period ended December 31, 2009 on Form 10-K. Some of the fiscal 2009 and recent highlights include:
* Unqualified Audit Opinion. The Company received an unqualified opinion from its indendent auditor that it has sufficient capital to fund its clinical development and other operating activities. In previous years, the auditors had issued a going concern opinion,” reflecting their concern about the Company's ability to continue to operate without additional capital. The Company was also in full compliance with Section 404 of the Sarbanes-Oxley Act, making it one of the smallest public companies to achieve compliance.
* Strengthened balance sheet through completion of three private placement agreements with institutional and accredited investors.
* Relisted on the OTCBB. During 2009, the Company brought its financial reports current, and relisted its shares on the Over-the-Counter Bulletin Board.
* Debt Restructuring. The Company reached agreements with the holders of debentures, under which the investors agreed to restructure the debt. Over the past six months, the Company has retired a significant amount of the debentures and expects that all debt will be extinguished prior to the end of the current year.
* New Drug Application. The Company filed an Investigational New Drug (IND) Application with the Food and Drug Administration (FDA) to initiate the first human clinical trial using embryonic retinal pigment epithelial (RPE) stem cells to treat Stargardt's Macular Dystrophy (Stargardt disease), an untreatable form of eye disease that leads to early-onset blindness. Recently, this program was granted Orphan Drug Status by the FDA. As a result, the company is eligible to receive a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval, and allowance for marketing exclusivity for a period of as long as seven years after drug approval.
* Determined the long-term safety and efficacy of human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells produced under manufacturing conditions suitable for human clinical trials. The Company also determined hESCs could potentially be used in the treatment of age-related macular degeneration and Stargardt disease.
* New discoveries. Discovered hemangioblasts (human progenitor cells) have the potential for both endothelial cell (EC) and vascular smooth muscle cell (SMC) lineage differentiation, a critical factor for the effective treatment of human vascular disease through human stem cell-based therapies.
* Added key personnel. Appointed Edmund Mickunas as Vice President of Regulatory Affairs.
"During 2009, the Company transformed itself, as evidenced by the restructuring of its indebtedness, the strengthening of its balance sheet, and relisting on the Over-the-Counter Bulletin Board,” said William M. Caldwell, IV, Advanced Cell Technology's Chairman and Chief Executive Officer. "For the first time in many years, the Company is in a position to invest in its science, reflected by the November 2009 filing of an IND to initiate the first-ever human clinical trial using embryonic retinal stem cells to treat Stargardt disease, as well as the publication of important stem cell-related research in peer-reviewed scientific journals. Today, we believe Advanced Cell has the scientific platform, expertise, personnel, and capital to move our programs to the clinic, making the use of stem cells to treat unmet medical needs a reality.”
.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 http://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 our 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, 2009.
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.
CEOcast, Inc. for Advanced Cell
Dan Schustack, 212-732-4300
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Bill Douglass, 646-450-3615