Climate Change Data

Environmental Metrics

Social Achievements

• Maintains strong relations with employees; offers benefits including medical, dental, vision insurance, and unlimited paid time off.

Climate Goals & Targets

Environmental Challenges

• Limited operating history and no revenue generation (except research grants); significant operating losses; need for substantial additional funding; limited experience in drug discovery and development; challenges in patient enrollment for clinical trials; potential for undesirable side effects; reliance on third parties for preclinical studies, clinical trials, and manufacturing; competition from major pharmaceutical and biotechnology companies; challenges in managing growth; risks related to employee misconduct; business interruptions from various factors; challenges in acquiring, developing, and deploying technology; risks related to intellectual property; challenges in obtaining marketing approvals in foreign jurisdictions; risks related to healthcare reform measures; risks related to pricing and reimbursement; risks related to compliance with environmental, health, and safety laws and regulations; risks related to data security breaches; challenges in acquiring, developing, and marketing additional drug candidates; reliance on third-party manufacturers for clinical supplies and commercial production; potential for manufacturing challenges; risks related to collaborations with third parties; risks related to cash balances exceeding FDIC coverage; risks related to COVID-19 pandemic or other infectious disease outbreaks; challenges in managing growth and expanding vendor relationships; dependence on senior management team; challenges in attracting and retaining highly skilled employees; risks related to employee misconduct; risks related to business interruptions; risks related to technology acquisition and development; risks related to patent term extension; risks related to changes in patent laws; risks related to intellectual property litigation; risks related to off-label promotion; risks related to companion diagnostics; risks related to post-marketing restrictions or withdrawal from the market; risks related to competition; risks related to commercialization; risks related to healthcare reform; risks related to government regulation; risks related to pricing and reimbursement; risks related to third-party payor coverage.

Mitigation Strategies

• Securing clinical trial liability insurance; implementing a Code of Business Conduct; investing in maintaining and upgrading cybersecurity systems; carefully managing relationships with CROs; seeking collaborations and partnerships; pursuing patent coverage; complying with regulatory requirements; developing strategies to address challenges in patient enrollment; implementing strategies to mitigate risks related to third-party manufacturers; developing plans for commercialization; engaging in efforts to comply with healthcare laws and regulations; implementing strategies to manage growth; focusing on attracting and retaining highly skilled employees; implementing strategies to mitigate risks related to business interruptions; implementing strategies to address technology challenges; implementing strategies to mitigate risks related to intellectual property; implementing strategies to address challenges in obtaining marketing approvals in foreign jurisdictions; implementing strategies to address risks related to healthcare reform measures; implementing strategies to address risks related to pricing and reimbursement; implementing strategies to address risks related to compliance with environmental, health, and safety laws and regulations; implementing strategies to address risks related to data security breaches; implementing strategies to address challenges in acquiring, developing, and marketing additional drug candidates; implementing strategies to address risks related to collaborations with third parties; implementing strategies to address risks related to cash balances exceeding FDIC coverage; implementing strategies to address risks related to COVID-19 pandemic or other infectious disease outbreaks; implementing strategies to address challenges in managing growth and expanding vendor relationships; implementing strategies to address dependence on senior management team; implementing strategies to address challenges in attracting and retaining highly skilled employees; implementing strategies to mitigate risks related to employee misconduct; implementing strategies to mitigate risks related to business interruptions; implementing strategies to address technology challenges; implementing strategies to mitigate risks related to intellectual property; implementing strategies to address challenges in obtaining marketing approvals in foreign jurisdictions; implementing strategies to address risks related to healthcare reform measures; implementing strategies to address risks related to pricing and reimbursement; implementing strategies to address risks related to compliance with environmental, health, and safety laws and regulations; implementing strategies to address risks related to data security breaches; implementing strategies to address challenges in acquiring, developing, and marketing additional drug candidates.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Social Achievements

• Maintained strong relations with employees; offered benefits including medical, dental, vision insurance, and unlimited paid time off.

Climate Goals & Targets

Environmental Challenges

• Patient enrollment in the Harmonic™ Study in the U.S. has been challenging.
• Supply chain disruptions
• Healthcare staffing shortages

Mitigation Strategies

• Advancing the Harmonic™ clinical trial towards enrollment in East Asian countries.
• Identifying and qualifying additional manufacturers to provide the active pharmaceutical ingredient and fill-and-finish services prior to seeking regulatory approval.

Supply Chain Management

Climate-Related Risks & Opportunities