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1301 Harbor Bay
Parkway Alameda, CA 94502 T: 510-521-3390, F: 510-521-3389 www.biotimeinc.com |
Dear Fellow Shareholders,
The past year has been an historic one for BioTime and its subsidiary companies. Most notably, the acquisition of the stem cell assets of Geron Corporation and our approval to initiate clinical trials of Renevia in Europe, highlight the execution of our business strategy; namely:
Based on progress since last years meeting, we believe that BioTime is well poised to be a formidable leader in the field of regenerative medicine. To put all this in perspective, lets begin with a bit of relevant history, delve into some of the specifics on our plans, and highlight some of our recent accomplishments.
Regenerative medicine: a new platform for treating degenerative disease
The field of regenerative medicine began at Geron Corporation in 1995 when I organized the worlds first effort to isolate and characterize human embryonic stem cells. Based on the work we had previously done at Geron in the field of telomeres, telomerase, and cell aging, we believed these cells would have at least two unique properties that would allow them to fuel a new industry in medicine. First, they would be the ultimate stem cell, capable of changing into all the cell types in the human body. This is what is meant by the term pluripotent. Second, based on work with the immortalizing enzyme known as telomerase, we believed that these cells would differ from all the cell types of the body normally cultured in the laboratory, in that they could be replicated and scaled up indefinitely without aging. We believed this was because they would express the enzyme telomerase at high levels and that when body cell types were made from them, telomerase would turn off as it normally does in development, leading to young human cells of all types. Our vision, therefore, was that for the first time in the history of medicine, we could build an industrial scale manufacturing platform to make any of the cellular building blocks of the human body. We obviously saw this as a pretty exciting project.
Not only was the idea a novel and exciting one, the potential markets were extraordinary. Aging is the demographic trend of our time due to the aging post-World War II baby boomers. As President Obama said in his 2013 State of the Union Address, the biggest driver of our long-term debt is the rising cost of health care for an aging population. The reason for this is simply that aging brings on chronic degenerative diseases that are difficult and expensive to treat, and often lead to continual care or rehabilitation over months or even years. Having the source of young cells of all types, and matrices to fashion those cells into novel regenerative therapies, could change those economics dramatically.
Back to the history. I left Geron in 1998 to pursue the possibility of turning any cell in the body into patient-specific embryonic stem cells using nuclear transfer technology. At around that time, Dr. Thomas Okarma joined the Geron team, and subsequently became Gerons CEO, overseeing some of the worlds first commercial development of therapeutic cells from pluripotent stem cells. The first FDA-approved clinical trials were for the product designated OPC1, designed to improve outcomes following serious spinal cord injuries. Toms group also turned the discoveries we had made regarding the widespread and abnormal expression of telomerase in malignant tumors, into two types of cancer vaccines. One called VAC1 was a vaccine designed to train the immune system to specifically attack the telomerase positive tumor cells. The other, called VAC2, was a more advanced version of the vaccine where the cells that carry these instructions to the patients immune system are made from human pluripotent stem cells. VAC1 was also in human clinical trials at Geron. The telomerase vaccine was considered by many to also be very exciting because never in the history of cancer research has a target been identified that is abnormally expressed in over 90% of cancers.
Because of the importance of these clinical trials, as well as the mountain of materials and patents generated at Geron, Tom and I felt a deep sense of duty and opportunity in joining forces to acquire and reassemble the stem cell assets. The BioTime family of companies now hold patents and other stem cell assets of Geron, technology licensed to BioTime from Advanced Cell Technology, and technology developed by Singapore-based ES Cell International, Pte Ltd, making us a leader of this important sector.
Technology integration between BioTimes subsidiaries
In the last few years we have made enormous progress in our research of more than 200 diverse PureStem cell lines. These are scalable populations of cells but differ from those typically used in stem cell research in that, while made from a starting population of human pluripotent stem cells, they are purified lineages intermediate between pluripotent stem cells and the final cell types in the body. We have determined that many of these PureStem lines can be scaled to about 100 million doses of 100 million cells. This scalability combined with their high purity and identity may potentially greatly simplify the development of the cells as therapeutic products. In addition, the highly-defined PureStem cells when combined with our GMP-grade injectable matrix Renevia is a particularly exciting opportunity. Therefore our strategy is to integrate these and other advanced technologies through cross-licensing patents, know how, and cell lines between BioTime and its subsidiaries to build strong disease-focused subsidiaries that can build state-of-the-art products.
A continual focus on near-term commercialization
Since we see our principal duty to be that of building value for our shareholders, we continue to put a significant emphasis on products with a potential for near-term commercialization. A major challenge of biotechnology in general is the relatively long timelines to commercial launch of products compared to other technology sectors. This is due in part to the lengthy process of meeting FDA requirements for product launch.
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To address these issues, our strategy is to aggressively develop and market products arising out of our stem cell platform with significant near-term potential, yet synergistic with the longer-term cellular therapies. Our HyStem® hydrogels like Renevia, are easily seen as such a product. While currently being tested by BioTime for the transfer of fat cells in the body, there is strong scientific support for the potential use of the product to engraft a wide array of other cell types into the body. Our subsidiary LifeMap Sciences has a trio of online databases called GeneCards®, MalaCards, and LifeMap Discovery providing data on genes, diseases, and cells respectively. With over 2,000,000 unique visitors to the LifeMap Sciences databases, we believe there is considerable opportunity to monetize this important resource for the medical research community. Lastly, based on our stem cell expertise, our subsidiary OncoCyte has identified important new markers of cancer that are being developed as a blood test based diagnostic called PanC-Dx.
Salient milestones from the past year
In the past year we announced numerous strategic advances in building the foundation of our company, including the following achievements.
Major Asset Acquisition
Advanced near-term and intermediate-term product development
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Expanded research product offerings
Advanced R&D collaborations and executed licensing agreements
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Expanded and strengthened Board of Directors and management team
Key research publications and presentations
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In summary, we have made strategic strides this year in building the leading biotechnology company in regenerative medicine. Our focus has been specifically on technologies relating to pluripotent stem cells, cells which we believe have the most potential to serve the large markets in age-related degenerative disease. Our future success will now largely depend on advancing our product pipeline through laboratory development and into clinical development.
On a sad note, we lost two of our directors over the past year. Barry Cohen passed away last November and Arnold Burns, who resigned last May for health reasons, passed away very recently. Both provided us with wise counsel and will sorely be missed.
Thank you for supporting our efforts to develop these products and potentially improve the length and quality of life of millions of people around the world. We welcome you to join us again in New York City on October 28, 2013 for our Annual Meeting of Shareholders, and shareholders of record that attend the shareholders meeting will also be invited to attend a later meeting featuring a series of presentations from the principals of each of our subsidiaries.
Sincerely,
Michael D. West, Ph.D. |
Alfred D. Kingsley |
President & CEO | Chairman of the Board |
October 2, 2013 |
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