The Question is …, Advanced Cell Technology (ACTC.OB)
Can Advanced Cell Technology (ACTC.OB) continue its existence and access to further capital requirements to move their programs to the clinic? I believe that Bill Caldwell, Bob Lanza and ACTC.OB who have lasted this long through many, many travails … with the right financing and agreements (with past investors and holders of debentures) … could … make it but, the jury is still out.
But, these past financing agreements NEED to be restructured and reversed post ANY potential government funding for clinical trials. However, ACTC.OB received an unqualified opinion from its independent auditor stated 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 ACTC.OB’s ability to continue to operate without additional capital. ACTC.OB is still in full compliance with Section 404 of the Sarbanes-Oxley Act.
FY09 achievements included:
- Strengthened balance sheet through completion of 3 private placement agreements with institutional and accredited investors,
- Relisted on the OTCBB, brought its financial reports current, and relisted its shares on the OTC Bulletin Board,Reached agreements with the holders of debentures, under which the investors agreed to restructure the debt. Over the past six months, ACTC.OB has retired a significant amount of the debentures and expects that all debt will be extinguished prior to the end of FY10,
- 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, ACTC.OB 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 7 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. ACTC.OB also determined hESCs could potentially be used in the treatment of age-related macular degeneration and Stargardt disease,
- Discovered hemangioblasts or 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,
- Appointed Edmund Mickunas as Vice President of Regulatory Affairs.
The increase in revenue during FY09 was due to new licenses being granted as compared to license agreements that were terminated in 2009 or that were recognized in 2009 revenue. During 2009, ACTC.OB recognized approximately $382 K in license fee revenue for licenses that were terminated in 2009. Further, ACTC.OB received $3.6 M in license fees in 2009 and of that recognized an additional $231 K in license fee revenues. R&D consists mainly of facility costs, payroll and payroll related expenses, research supplies and costs incurred in connection with specific research grants, and for scientific research. R&D expenditures declined from $8,635,577 in FY08 to $3,531,540 for FY0909; this decline in R&D expenditures during the 2009 as compared to 2008 is primarily due to the fact of closures in Charlestown, Ma and Alameda, Ca facilities at the end of 5/08 with the layoff of a majority of employees. G&A expenses for FY09 decreased $1,570,333 to $3,439,085 as compared with FY08. This expense decrease was primarily a result of reducing costs and streamlining operations. In FY09, ACTC.OB settled $505,199 in accounts payable through the issuance of 39,380,847 shares of common stock and also recorded a loss on settlement of $4,793,949 for FY09. Still ugly!!
