FUJIFILM : BlueRock Therapeutics, FUJIFILM Cellular Dynamics, and Opsis Therapeutics Enter into a Strategic R&D Alliance to Discover and Develop Cell Therapies for Eye Diseases (Fujifilm)

Cambridge, Mass., and Madison, Wis. [May 17, 2021] - BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, FUJIFILM Cellular Dynamics, Inc. a leading global developer and manufacturer of human induced pluripotent stem (iPS) cell technologies, and Opsis Therapeutics, LLC, a joint venture of FUJIFILM Cellular Dynamics (FCDI) and David Gamm, M.D., Ph.D., co-founder, focusing on developing cell therapies for patients with ocular diseases, today announced that they have entered into a strategic research and development (R&D) alliance.

As part of the alliance, the companies will combine their collective expertise to discover and develop off-the-shelf iPS cell therapies for ocular diseases. Under this agreement, BlueRock Therapeutics will have the option to exclusively license from both parties three (3) retinal cell therapy programs focused on dry age-related macular degeneration (AMD) and inherited retinal diseases (IRDs) containing human retinal pigment epithelial cells and photoreceptor cells, currently in pre-clinical development.

There is a strong strategic fit between BlueRock Therapeutics' mission to create an entirely new generation of cellular therapies, and FUJIFILM Cellular Dynamics and Opsis Therapeutics' shared mission to create best-in-class cell replacement therapies targeting degenerative retinal diseases.

'We believe deeply that authentic cells are the breakthrough approach needed to treat degenerative retinal diseases like AMD and IRDs,' states Emile Nuwaysir, Ph.D., President and CEO, BlueRock Therapeutics. 'This strategic alliance between BlueRock Therapeutics, Opsis Therapeutics, and FUJIFILM Cellular Dynamics will allow each party to do what they do best, and when combined with our deep expertise in ophthalmology at Bayer, we are well positioned to lead in this rapidly advancing field and potentially make a meaningful difference in millions of people's lives.'

'This alliance will leverage FUJIFILM Cellular Dynamics and Opsis Therapeutics' combined expertise in iPS cell technologies and understanding of retinal diseases, with BlueRock Therapeutics' experience in research and development of cell therapies, to provide next-generation ocular treatments,' says Takeshi Yamamoto, Chief Executive Officer, FUJIFILM Cellular Dynamics, Inc. 'We are excited to team with BlueRock Therapeutics to discover and develop cell therapies to reverse the progression of ocular diseases and restore vision for patients impacted by these conditions.'

'Millions of patients around the world today are suffering from permanent vision loss as a result of incurable ocular diseases,' states Nick Manusos, Chief Executive Officer, Opsis Therapeutics. 'Bringing together the expertise of our partners with Opsis Therapeutics' innovation in generating authentic iPS cell-derived human retinal cells, we have the potential to develop life-changing treatments for patients and their families.'

Under the terms of the agreement, FUJIFILM Cellular Dynamics and Opsis Therapeutics will receive an upfront payment of 30 million USD and up to 40 million USD R&D and part of manufacturing funding for the development of the three candidate programs. BlueRock Therapeutics will have the option to license the three programs on a program-by-program basis and will be responsible for development and commercialization of the licensed products. FUJIFILM Cellular Dynamics and BlueRock Therapeutics will share manufacturing responsibilities, with FUJIFILM Cellular Dynamics responsible for clinical supply and Parties sharing responsibility for commercial supply. Per the agreement, FUJIFILM Cellular Dynamics and Opsis Therapeutics will be eligible to receive payments upon achievement of certain development and commercial milestones, as well as tiered high single-digit/low double-digit royalty payments on a per-program basis.