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Geron Annual Report 2008

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Geron Annual Report 2008 GERON ANNUAL REPORT 2008 Dear Stockholders, The two principal goals for Geron Corporation in 2008 were to initiate the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy and to demonstrate utility of GRN163L, our telomerase inhibitor drug, in cancer patients. In last year’s annual report, we stated that accomplishing these two goals would complete our transition into a fully integrated clinical development company. I am pleased to report success on both fronts as detailed in the enclosed letters. Each product in clinical development is a proprietary, first-in-class therapy with substantial economic potential. We expect a very exciting 2009 as we advance our programs toward the demonstration of safety and clinical utility in patients. As always, we are grateful for your support. REGENERATIVE MEDICINE “ FDA clearance of our GRNOPC1 Investigational New Drug (IND) application is one of Geron’s most significant accomplishments to date. This marks the beginning of what is potentially a new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.” REGENERATIVE MEDICINE GRNOPC1 – Glial Cells fOR SPINAL CORD INJURY Geron Receives FDA Clearance to Begin World’s First Human Clinical Trial of Embryonic Stem Cell-Based Therapy In January of 2009, we received clearance from the U.S. Food and Drug Administration (FDA) to begin a clinical trial of GRNOCP1, our hESC-derived cell therapy for acute spinal cord injury. GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have demonstrated remyelinating and nerve growth stimulating properties leading to restoration of function in animal models of acute spinal cord injury (Journal of Neuroscience, Vol. 25, 2005). This clearance enables us to move forward with the world’s first human trial of a hESC-based therapy. FDA clearance of our GRNOPC1 Investigational New Drug (IND) application is one of Geron’s most significant accomplishments to date. This marks the beginning of what is potentially a new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s spinal cord. Geron has selected up to seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study. We are now in the process of executing the necessary steps at our clinical trial sites to enable patient enrollment. These steps include protocol review, institutional review board (IRB) approval, training of radiologists, spine surgeons and site personnel on product storage, administration and follow-up assessments of safety and efficacy. Patients eligible for the Phase I trial must have documented evidence of functionally complete (ASIA grade A) spinal cord lesions resulting in a neurological level of T3 to T10 and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury. Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established, and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate. Please visit our website, www.geron.com for a full description of the product and the clinical trial program. PROGRESS ON OTHER hESC PROGRAMS Corning Collaboration Since 2006, we have been collaborating with Corning Life Sciences to develop synthetic surfaces to support the scalable manufacturing of hESCs and differentiated cell types derived from them. Our teams have developed a synthetic surface that can be manufactured into multiple culture vessel formats. The surface contains a synthetic peptide that supports the growth and differentiation of hESCs without the use of matrigel or feeder cells. We have demonstrated both hESC growth and differentiation directly on this surface, which potentially will enable the transfer of our cell product production methodology to large bioreactor vessels, a critical step in scaling up product manufacturing and reducing lot to lot variability. Other hESC-Derived Cell Types We continue to make significant progress on other hESC-derived differentiated cells. We have improved the purity and yield of our process to make hESC-derived cardiomyocytes (GRNCM1) for both drug screening and therapeutic use. We have confirmed normal ion channel function in these cells which enables their use in cardiac drug toxicity screens. We are in large animal studies testing their safety and utility in the post myocardial infarction setting to restore cardiac contractility and prevent the onset of heart failure. We have demonstrated that, like GRNOPC1, GRNCM1 evades direct attack by the human immune system in vitro. These are significant steps required to enable us to begin IND-enabling studies to document the safety and utility of these cells for the treatment of patients with heart failure. We have also made progress on improving the function, purity and yields of hESC-derived islet cells (GRNIC1) for diabetes. Our collaborators published studies showing that our hESC-derived islets when transplanted into diabetic animals, engraft, produce insulin and extend the survival of the animals. We have succeeded in growing GRNIC1 in a unique encapsulation device which could serve to prevent the immune recognition of these cells in Type I Diabetic patients. Our U.K. subsidiary, Geron Bio-Med, in collaboration with scientists at the University of Edinburgh, has advanced the chondrocyte, hepatocyte and osteoblast programs. Supported by a £3.6 million grant from the U.K. government, these groups have shown dramatic and stable repair of a surgically induced cartilage defect in rodents treated with hESC-derived chondrocytes. The hepatocyte team has shown survival of transplanted hESC-derived hepatocytes in mice, supporting their possible use in treating liver failure and the bone team has shown that hESC-derived osteoblasts are capable of repairing bone defects in the skulls of rats. Intellectual Property Early in 2008, the U.S. Patent Office upheld the validity of all three fundamental hESC patents covering human embryonic stem cells assigned to the Wisconsin Alumni Research Foundation. Geron holds an exclusive license under this patent estate for developing and commercializing therapies based on hESC-derived neural cells, cardiomyocytes and pancreatic islet cells, and a non-exclusive license for other hESC-derived cell types for both therapeutic and non-therapeutic uses. The re-examination process was detailed and comprehensive, and the positive outcomes have strengthened the patent estate. Two key hESC patents were issued to us in the U.S. in 2008. The first, issued in February, covers a widely used method for producing endoderm from hESCs, a critical step in generating islet cells for the treatment of diabetes. This is Geron’s second fundamental issued U.S. patent covering hESC-derived islet cells. The second, issued in September, provides broad composition of matter claims for hESC-derived cardiomyocytes for cell therapy and drug screening applications. These patents add to Geron’s portfolio of owned and in-licensed patents relating to pluripotent stem cells that includes over 35 patents issued in the U.S., more than 70 issued in other countries and over 200 applications pending worldwide. Thomas B. Okarma, Ph.D., M.D. President and Chief Executive Officer REGENERATIVE MEDICINE MILESTONES 02 05 U.S. Patent 7,326,572 was issued to Geron with claims covering a widely used method for producing endoderm cells from human embryonic stem cells (hESCs). The production of endoderm cells is a critical step in generating pancreatic islet cells from hESCs; Geron is developing the islet cells for potential use in treating diabetes. 02 28 U.S. Patent Office upheld the validity of three patents for human embryonic stem cells that were challenged earlier in reexamination proceedings. All three patents are assigned to the Wisconsin Alumni Research Foundation (WARF) and licensed exclusively to Geron for the development and commercialization of therapies based on three types of cells derived from hESCs: neural cells, cardiomyocytes and pancreatic islet cells. 05 06 The U.K. Stem Cell Foundation, with funding from the Medical Research Council and Scottish Enterprise, awarded two grants to Geron’s collaborator, the University of Edinburgh, to conduct preclinical safety and efficacy studies of hESC-derived hepatocytes for the treatment of liver failure and for use in cell-based assays and hESC-derived osteoblasts and chondrocytes for the treatment of musculoskeletal disorders such as osteoporosis, bone fractures and osteoarthritis. 06 12 Four presentations related to Geron’s hESC programs were given at the International Society of Stem Cell Research (ISSCR) annual meeting. The new data indicate that GRNCM1, the company’s hESC-based therapeutic for the treatment of heart failure, evades direct attack by the human immune system in vitro. Three additional presentations documented continued progress in the development of hESC-based therapeutics for liver disease and orthopedic indications. 09 16 U.S. Patent No. 7,425,448 was issued to Geron with broad claims to cardiomyocytes derived from hESCs. The patent runs until April 2025 (subject to any patent term extension that may be available).
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