What is Cell Cure Neurosciences?
Cell Cure Neurosciences was founded in 2005 as a subsidiary of ES Cell International Pte Ltd., a subsidiary of BioTime, Inc. Cell Cure Neurosciences is located in Jerusalem, Israel on the campus of Hadassah University Hospital. Cell Cure Neurosciences’ mission is to become a leading supplier of human cell-based therapies for the treatment of retinal and neural degenerative diseases. Its technology platform is based on the manufacture of diverse cell products sourced from clinical grade (GMP) human embryonic stem cells. Its current programs include developing cells for the treatment of macular degeneration, Parkinson’s disease, and cells potentially useful in treating multiple sclerosis.
What is our focus?
Cell Cure Neurosciences is focused on the development of cell therapies for retinal and neural degenerative diseases. Its therapeutic cells include retinal pigmented epithelial (RPE) cells and neural progenitor cells. These cells are derived from human embryonic stem cells (hESCs), the recently isolated cells capable of morphing into all of the cell types in the human body.
What are our products?
Cell Cure Neurosciences is developing two products at present:
- OpRegen® is a cell therapy for the treatment of age-related macular degeneration (dry-AMD).
- We are also developing types of nerve cells designed to treat neural diseases such as Parkinson’s disease or multiple sclerosis.
Who are our investors?
Cell Cure Neurosciences’ shareholders include ES Cell International Pte Ltd. (ESI), BioTime, Inc., Hadasit Bio-Holdings Ltd., and Teva Pharmaceutical Industries.
What is age-related macular degeneration?
Age-related macular degeneration (AMD) is the leading cause of blindness in the aging population. The US Centers for Disease Control and Prevention estimate that about 1.8 million people in the United States have advanced stage AMD and another 7.3 million have an earlier stage and are at risk of vision impairment from the disease. Most people are afflicted with the dry form of the disease, for which there is currently no effective treatment.
AMD destroys sharp, central vision, which is needed to see objects clearly and do common daily tasks such as read and drive. It affects the macula, the part of the eye that allows people to see fine detail. AMD causes no pain.
Do we own any patents?
ES Cell International has exclusively licensed to Cell Cure Neurosciences all of its IP related to neurodegenerative diseases, which includes three important patent families covering methods and cells related to the derivation of neural cells from hESCs, as well as their transplantation. The company is also developing its own IP, as well as in-licensing IP from Hadasit Ltd.
What is Cell Cure Neurosciences’ relation to Biotime, Inc.?
BioTime, Inc. and its subsidiary, ES Cell International Ltd. (ESI), are the majority shareholders in Cell Cure Neurosciences. Cell Cure Neurosciences is BioTime’s neurological arm for advancing human embryonic stem cell-based therapies.
How do we fit into Biotime’s product development strategy?
BioTime’s product development strategy is to pursue subsidiaries that focus on specific organ systems and their related diseases, for which there is a high, unmet need. This allows the management team of each subsidiary to focus on a narrow therapeutic window.
Cell Cure Neurosciences fits that description in retinal and neural degenerative diseases. Cell Cure Neurosciences is BioTime’s neurological arm for advancing human embryonic stem cell-based therapies. BioTime believes that building subsidiaries in particular disease applications facilitates the optimization of science and commercial collaborations. This will improve the probabilities of BioTime becoming an industry leader.
7.1 Million Dollar Investment
Cell Cure Neurosciences announced a $7.1 million equity investment from its existing shareholders BioTime, Inc., Teva Pharmaceutical Industries Ltd., and Hadasit Bio-Holdings. The equity investment will enable Cell Cure Neurosciences to continue development of OpRegen® for the treatment of AMD and the development of human embryonic stem cell-based therapies for neural degenerative disorders, such as Parkinson’s disease and multiple sclerosis.
From what other sources do we receive funding?
Cell Cure Neurosciences enjoys non-dilutive financial support from the Office of the Chief Scientist in Israel’s Ministry of Industry, Trade and Labor, which funds up to 60% of approved annual R&D programs.
License Option Agreement with Teva Pharmaceuticals
Cell Cure Neurosciences and Hadasit Bio Holdings have entered into an exclusive license option agreement with Teva Pharmaceutical Industries to develop and commercialize Cell Cure Neurosciences’ OpRegen® product for the treatment of AMD.
Teva Pharmaceutical Industries will also have the option to license OpRegen-Plus®. If Teva Pharmaceutical Industries exercises its option to license OpRegen-Plus®, Teva Pharmaceutical Industries and Cell Cure Neurosciences would enter into an additional license agreement on substantially the same terms as the OpRegen® license.
What are the terms of the agreement?
Subject to the terms of the agreement, if Teva Pharmaceutical Industries exercises its option to obtain an exclusive worldwide license to use certain patents and technology, to complete the clinical development of, and to manufacture, distribute, and sell OpRegen®, Teva Pharmaceutical Industries will pay Cell Cure Neurosciences $1M. Teva Pharmaceutical Industries will then have the responsibility of funding clinical trials, obtaining regulatory approvals, and marketing the product from that point on.
What payments will Cell Cure receive?
If Teva Pharmaceutical Industries exercises its option, it will pay Cell Cure Neurosciences $1M and make milestone payments to Cell Cure Neurosciences as the clinical development and commercialization of OpRegen® progresses. If the milestones are met, Cell Cure Neurosciences will receive a total of $28.5M in milestone payments, in addition to the $1M option payment, for the first approved medical indication of OpRegen®. In addition, Teva Pharmaceutical Industries will pay Cell Cure Neurosciences royalties on the sale of the product, at rates ranging from 6% to 10% of the net sale price of OpRegen, depending upon the total amount of annual sales.
Who will benefit financially from the LOA?
As investors in Cell Cure Neurosciences, ES Cell International and Hadasit Medical Research Services and Development, a HBL affiliate and technology transfer arm of the Hadassah Medical Organization, will share a portion of the milestone payments and royalties received by Cell Cure Neurosciences.
Sec Form 8-K
On October 12, 2010, BioTime filed a Form 8-K with the Securities and Exchange Commission.
What did Biotime report?
On October 7, 2010, BioTime entered into a share purchase agreement with Cell Cure Neurosciences, Ltd. BioTime agreed to purchase 104,027 shares of Cell Cure Neurosciences, Ltd. BioTime also reported the financial terms of the license option agreement between Cell Cure Neurosciences and Teva Pharmaceutical Industries.
How much did Biotime invest in Cell Cure?
BioTime invested $4.1M, which included $3,847,392 in cash and converted a $250,000 loan previously made to Cell Cure Neurosciences into SRES.
Did other companies invest?
Yes, two of Cell Cure Neurosciences’ existing shareholders also made an investment.
- Hadasit Bio-Holdings, Ltd. agreed to purchase 25,625 shares by paying $896,962 in cash and by converting a $100,000 loan previously made to Cell Cure Neurosciences into shares.
- Teva Pharmaceutical Industries agreed to purchase 49,975 shares for $2M.
What is each investor’s ownership position?
BioTime, Inc. (directly and through ES Cell International Pte Ltd., a wholly-owned subsidiary): 53.6%
Hadasit Bio-Holdings Ltd.: 26.3%
Teva Pharmaceutical Industries Ltd.: 19.9%
Will the board of directors change?
Cell Cure’s board of directors will be set at seven. BioTime will be entitled to elect four directors; HBL will be entitled to elect two directors; and Teva Pharmaceutical Industries will be entitled to elect one director.