Climate Change Data

Environmental Metrics

Governance Achievements

• Renewal of Jean Mariani's administrator mandate for three years.

Climate Goals & Targets

Environmental Challenges

• Limited operating history, financial situation, and capital needs.
• Clinical development is a long and expensive process, and regulatory approval may not be obtained.
• Difficulties in recruiting patients or finding and retaining researchers for clinical trials.
• Potential for adverse side effects of drug candidates.
• Dependence on third parties for raw material supply and conducting preclinical studies and clinical trials.
• Significant competition.
• Governmental restrictions on pricing and reimbursement.
• Need to establish sales capabilities.
• Difficulties in attracting and retaining senior management and key scientific personnel.
• Potential product liability lawsuits.
• Current and future collaborations may not be successful.
• Potential for significant disruptions to IT systems or data security breaches.
• Potential for misconduct or inappropriate activities by employees or independent contractors.
• Potential inability to comply with environmental laws and regulations.
• Need to protect intellectual property and proprietary rights.
• Potential inability to resolve disputes concerning infringement or misappropriation of proprietary rights or the proprietary rights of others.
• Ongoing regulatory scrutiny even if regulatory approval is obtained.
• Potential for total or substantial eradication of COVID-19 reducing or eliminating demand for BIO101 (20-hydroxyecdysone).
• Regulatory bodies may change policies and requirements concerning approvals and emergency use authorizations or revoke emergency use authorizations already granted.
• Potential inability to obtain orphan drug designation if sought.
• Impact of health legislation and relationships with researchers, healthcare professionals, consultants, third-party payers, patient advocacy groups, and customers.
• Impact of U.S. and foreign anti-corruption and anti-money laundering laws.
• Potential inability to maintain certain tax benefits applicable to French technology companies.
• Impact of U.S. tax laws on activities.
• Requirements associated with being a U.S. listed company may strain resources.
• Non-compliance with Nasdaq listing requirements, including the minimum equity requirement of $2.5 million, could result in delisting.
• Active market for ADSs may not continue, and the market price of equity securities may be volatile.
• Exposure to foreign exchange risk.
• Large number of outstanding warrants and convertible debt instruments could have a dilutive effect on shareholders, and the price of securities could be affected by future massive sales of securities.
• U.S. investors may have difficulty bringing civil actions against the company, directors, and officers, and experts named in this annual report, and may not have recourse for claims related to the depositary agreement.
• Articles of incorporation and French corporate law may delay or discourage a takeover attempt.
• Ability of ADS holders to exercise voting rights, participate in any future preferential subscription rights, receive dividends, or transfer ADSs.
• Status as a foreign private issuer and an emerging growth company may not attract certain investors.
• Designation as a passive foreign investment company carries risks.
• Potential inability to maintain effective internal control over financial reporting.
• Debt could limit operations and make the company more vulnerable to adverse economic conditions.
• Operations could be significantly affected by pandemics or epidemics, including the ongoing COVID-19 pandemic and its variants, or the emergence of other infectious diseases.
• Dependence on third parties for raw materials and preclinical and clinical supplies.
• Significant competition in a rapidly changing technological and scientific environment.
• Governmental restrictions on pricing and reimbursement.
• Need to establish sales capabilities.
• Potential difficulties in managing growth.
• Dependence on services of senior management.
• Potential product liability lawsuits.
• Existing collaborations and additional collaboration agreements that may be entered into in the future may not be successful.
• Potential for significant disruptions to IT systems or data security breaches.
• Potential for misconduct or inappropriate activities by employees or independent contractors.
• Use of hazardous materials and need to comply with environmental laws and regulations.
• Potential inability to effectively protect proprietary rights.
• Potential infringement of the intellectual property rights of others.
• Ongoing regulatory scrutiny even if regulatory approval is obtained.
• Potential for total or substantial eradication of COVID-19 reducing or eliminating demand for BIO101 (20-hydroxyecdysone).
• Regulatory bodies may change policies and requirements concerning approvals and emergency use authorizations or revoke emergency use authorizations already granted.
• Potential inability to obtain orphan drug designation if sought.
• Large number of outstanding warrants and convertible debt instruments could have a dilutive effect on shareholders, and the price of securities could be affected by future massive sales of securities.
• Articles of incorporation and French corporate law may delay or discourage a takeover attempt.
• Potential loss of foreign private issuer status in the future, which could result in significant additional costs and expenses.

Mitigation Strategies

• Several capital increases implemented to minimize reliance on convertible bonds.
• Seeking partners for Phase 3 trial of SARA program.
• Planning to start Phase 2 OBA program in mid-2024.
• Seeking Scientific Advice from EMA and FDA on COVA program.
• Addressing HAS request for additional data on COVA program.
• Reactivating early access program in Brazil.
• Appealing Nasdaq delisting decision.
• Implementing a remediation plan to regain Nasdaq compliance.
• Implementing an action plan to increase equity level and regain compliance.

Supply Chain Management

Climate-Related Risks & Opportunities

Reporting Standards

Frameworks Used: IFRS