Climate Change Data

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• substantial additional funding is needed to complete the development of our product candidates
• the Company has incurred significant losses and may never be profitable
• the occurrence of security breaches, improper access to or disclosure of our data or user data, and other cyber incidents or undesirable cyber activity related to our, or our third-party vendor’s systems and data
• we may not have adequate personnel and may not be able to attract or retain personnel needed to develop our products
• delays in commencement, enrollment, and completion of clinical testing could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates
• our exosome technologies are unproven in their ability to achieve sufficient biological activity or scale in development to date
• product candidates can fail to meet their efficacy endpoints at any time during the clinical development process, which would likely make them ineligible for becoming commercial products
• we may not be able to use our facilities to manufacture CAP-1002 product for commercial purposes
• we may be required to obtain consent from CSMC in order to sell commercial product from our Los Angeles facility
• we may not be able to satisfy clinical and/or regulatory requirements necessary for the approval of our product in the U.S. or Japan
• we may not be able to reach the milestones set forth in our distribution agreements therefore preventing us from receiving the financial benefits of those agreements
• our partners may not perform as expected and therefore deny us the financial benefits of those agreements
• the manufacturing of our product candidates is heavily reliant on supply chain requirements including the availability of donor hearts and other raw materials that are critical for the manufacturing of our product candidates
• we may need to rely upon third-party manufacturers for the expansion of our manufacturing capabilities for later-stage clinical trials and for ultimate commercialization
• we may not have adequate manufacturing facilities required for any scale-up of manufacturing which may be required in the future
• we may not be able to replicate our manufacturing processes
• we may not be able to comply with cGMP regulations
• we may not be able to identify or retain necessary manufacturing personnel
• the FDA may not accept the viability or comparability of our manufacturing processes
• the FDA may not approve our manufacturing facilities for the manufacture of commercial products
• we may not be able to obtain, maintain, protect, and enforce our intellectual property rights
• we may face potential challenges to the validity, enforceability, or scope of our intellectual property
• we may experience claims from third parties that we are infringing their patents or other intellectual property rights
• we may not be able to satisfy our obligations under our licensing agreements
• we depend on our relationships with our licensors, collaborators, and other third parties and there is no guarantee that such relationships will continue
• we will depend on the ability of Nippon Shinyaku to perform according to the terms of the U.S. Distribution and Japan Distribution Agreements and all applicable laws, and to successfully commercialize our lead product CAP-1002 in DMD
• our products will likely face intense competition
• any of our product candidates for which we receive regulatory approval may not achieve broad market acceptance, which could limit the revenue that we will generate from their sales, if any
• our products may expose us to potential product liability
• we expect that our stock price will continue to fluctuate significantly
• we have never paid dividends and we do not anticipate paying dividends in the future

Mitigation Strategies

• We intend to implement numerous risk mitigation measures to comply with such regulations in this complex operating environment
• We intend to defend against and respond to data security incidents
• We continue to build and improve our information systems and infrastructure and believe we have taken appropriate security measures to minimize these risks to our data, information technology systems and computer systems

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Climate Goals & Targets

Supply Chain Management

Climate-Related Risks & Opportunities