Climate Change Data

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• History of losses and may incur additional losses in the future.
• Need for additional funding.
• Difficulty in raising capital for cancer diagnostics and therapeutics businesses.
• Difficulty in obtaining and maintaining intellectual property protection.
• Potential legal proceedings alleging intellectual property infringement.
• Uncertainty in replicating initial results for CchekÔ and CAR-T technology.
• Obstacles to commercial acceptance of CchekÔ.
• Intense competition in the clinical diagnostics industry.
• Dependence on a few key personnel.
• Uncertainty in the market value of patented technologies.

Mitigation Strategies

• Raised nearly $12 million through multiple financing arrangements.
• Intellectual property strategy.
• Contracted with Moffitt to perform studies for IND application.
• Continued efforts to improve CchekÔ protocols and NN software.
• Seeking regulatory approval (CLIA, FDA, or both).
• Developing alternative sourcing strategies for patient samples.

Supply Chain Management

Climate-Related Risks & Opportunities

Sustainable Products & Innovation

• CchekÔ cancer detection platform
• CAR-T ovarian cancer therapeutics

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• History of losses and may incur additional losses in the future.
• Need for additional funding.
• Putative shareholder derivative complaint.
• Limited ability to use net operating loss carryforwards.
• Potential for employee misconduct.
• Pre-revenue, early-stage biotechnology company.
• Difficulty raising capital.
• Potential for intellectual property infringement.
• Difficulty licensing technologies.
• Uncertain results for Cchek™ technology.
• Need for regulatory approvals.
• Dependence on third parties.
• Intense competition.
• Dependence on key personnel.
• Highly speculative biopharmaceutical product development.
• Challenges in CAR-T cell therapy development.
• Potential for adverse events in clinical trials.
• High costs of clinical trials.
• Intense competition in biopharmaceutical industry.
• Dependence on Wistar license for CAR-T technology.
• Potential for litigation related to legacy patent licensing.
• Fluctuations in quarterly operating results.
• Volatility in biotechnology stock prices.
• Potential delisting from NASDAQ.
• Dilution from equity compensation plans.
• Thinly traded common stock.
• Adverse effects of U.S. federal income tax reform.
• No cash dividends anticipated.

Mitigation Strategies

• At-the-market equity offering to raise capital.
• Seeking additional funding through equity or debt.
• Defending against the shareholder derivative complaint.
• Utilizing existing cash, cash equivalents, and short-term investments.
• Code of conduct for employees.
• Strategic collaborations with commercial partners.
• Patent protection, copyrights, trademarks, trade secrets, and regulatory approvals.
• Negotiating licenses to use third-party technologies.
• Conducting further clinical studies to validate Cchek™.
• Seeking CLIA certification or FDA approval.
• Contracting with third-party laboratories.
• Establishing agreements with hospitals and medical practices for patient samples.
• Developing and commercializing products without infringing on third-party intellectual property.
• Developing and implementing strategies to compete effectively.
• Retaining key personnel.
• Successfully completing clinical trials and obtaining regulatory approvals.
• Developing consistent and reliable manufacturing processes.
• Educating medical personnel on CAR-T therapies.
• Establishing sales and marketing capabilities.
• Securing additional licenses as needed.
• Managing potential growth effectively.
• Retaining all earnings for business operations.

Supply Chain Management

Climate-Related Risks & Opportunities

Sustainable Products & Innovation

• Cchek™ cancer detection platform
• CAR-T therapeutics