Climate Change Data

Environmental Metrics

ESG Focus Areas

• Environment
• Social
• Governance

Social Achievements

• The company's CSR information considers employment-related and environmental consequences of the business and social commitments in favor of sustainable development, preventing discrimination and promoting diversity.

Governance Achievements

• Implemented internal control policy and procedures, reviewed and evaluated by statutory auditors.

Climate Goals & Targets

Environmental Challenges

• Financial risks linked to the effects of climate change (low carbon strategy).

Mitigation Strategies

• The Company’s environmental responsibility is further described in section 8.2.2 of this Document. Given the nature of its activities, GenSight Biologics is not exposed to any environment-specific risk.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• We have never generated revenue from product sales and have incurred significant operating losses since our inception. We expect to continue to incur significant losses for the foreseeable future and may never achieve profitability.
• We may need to raise additional capital in the future, which may not be available on acceptable terms, or at all, and failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.
• Our product candidates are based on novel technologies, including gene therapy, which may implicate ethical, social and legal concerns about genetic testing and genetic research in general, and such novel technologies make it difficult to predict the timing and costs of development of new and unforeseen regulatory requirements and of subsequently obtaining regulatory approval.
• The regulatory approval process of the FDA, the EMA and other regulatory authorities and the clinical trials that our product candidates will need to undergo, are time-consuming and expensive, the outcomes of which are unpredictable, and for which there is a high risk of failure.
• We have not completed the evaluation of our lead product candidate, GS010, in clinical trials, and we are currently conducting a Phase I/II clinical trial for our second most advanced product candidate, GS030.
• Our product candidates and the process for administering our product candidates using AAV vectors may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
• Success in preclinical studies or early clinical trials may not be indicative of results obtained in later trials.
• We have entered, and may in the future enter, into collaborations with third parties for the development and commercialization of our product candidates. If we are unable to enter into such collaborations on acceptable terms, or if these collaborations are not successful, our business could be adversely affected.
• Gene therapies are novel, complex and difficult to manufacture. We have limited manufacturing experience and could experience production problems that result in delays in our development or commercialization programs.
• We may not be successful in our efforts to identify or discover additional product candidates and may fail to capitalize on programs or product candidates that may be a greater commercial opportunity or for which there is a greater likelihood of success.
• We do not own any issued patents and our rights to develop and commercialize our product candidates are subject to the terms and conditions of intellectual property licenses granted to us by others.

Mitigation Strategies

• The procedures implemented by the Company as part of its internal control are reviewed and evaluated by the statutory auditors during their annual reviews of half-year and annual consolidated financial statements. The findings of these tasks are shared with the Company’s financial management, allowing it to take corrective measures and improve the Company’s internal control. These findings are also shared with the Audit Committee.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

Climate Goals & Targets

Environmental Challenges

• Liquidity Risk: Insufficient net working capital to meet obligations for the next 12 months.
• Significant operating losses since inception and expectation of continued losses.
• Need to raise additional capital, which may not be available on acceptable terms.
• Potential loss of access to research tax credits.
• Shareholder dilution due to issuance of warrants and shares.
• Risks related to the discovery and development of and obtaining regulatory approval for product candidates.
• Risks related to manufacturing and commercialization of product candidates.
• Risks related to business operations, including employee retention and conflicts of interest.
• Risks related to intellectual property, including patent protection and license compliance.
• Risks of product liability lawsuits.

Mitigation Strategies

• Exploring additional financing options through debt or equity.
• Modifying operating plans by delaying or limiting research and development programs.
• Implementing expense-control measures.
• Outsourcing manufacturing to specialized CMOs.
• Implementing internal control and risk management procedures.
• Maintaining insurance coverage for clinical trials and operations.

Supply Chain Management

Climate-Related Risks & Opportunities

Environmental Metrics

ESG Focus Areas

• Not disclosed

Environmental Achievements

• Applied environmentally responsible paper management practices such as the use of an electronic document management system, setting all printers to default to double-sided printing, and purchasing only reams of paper of “ecological quality” (EU Ecolabel or PEFC).

Social Achievements

• Not disclosed

Governance Achievements

• Not disclosed

Climate Goals & Targets

Environmental Challenges

• Liquidity Risk
• Risks related to the discovery and development of and obtaining regulatory approval for our product candidates
• Risks related to manufacturing and commercialization of our product candidates
• Risks related to our business operations
• Legal risks and risks related to our intellectual property
• Risks related to the impacts of the Covid-19

Mitigation Strategies

• Issued 4,477,612 new ordinary shares for a total gross proceeds of approximately €30 million.
• Implemented measures to protect its staff against Covid-19 by encouraging remote working for all employees.
• Contracts with Brammer Bio to manufacture clinical and commercial supplies of our product candidates.
• Implemented a policy to cover the main insurable risks with coverage amounts that we deem compatible with the nature of our operations.
• Implemented an internal control policy and a certain number of procedures.
• outsourced manufacturing to specialized contract manufacturing organizations

Supply Chain Management

Supplier Audits: Not disclosed

Responsible Procurement

• Not disclosed

Climate-Related Risks & Opportunities

Physical Risks

• Not disclosed

Transition Risks

• Not disclosed

Opportunities

• Not disclosed

Reporting Standards

Frameworks Used: IFRS

Certifications: Null

Third-party Assurance: Deloitte & Associés and Becouze

UN Sustainable Development Goals

• Not disclosed

Not disclosed

Sustainable Products & Innovation

• Not disclosed

Awards & Recognition

• Not disclosed

Environmental Metrics

ESG Focus Areas

• Not disclosed

Environmental Achievements

• Not disclosed

Social Achievements

• Not disclosed

Governance Achievements

• Not disclosed

Climate Goals & Targets

Environmental Challenges

• Liquidity Risk: Insufficient working capital to meet obligations for at least the next 12 months.
• Significant operating losses since inception and expectation of continued losses.
• Need to raise additional capital in the future, which may not be available on acceptable terms or at all.
• Potential loss of access to research tax credits.
• Shareholder dilution due to issuance of equity instruments.
• Realization of security interests attached to bond financing could adversely impact operations.
• Risks related to the foreign investment screening procedure.
• Regulatory approval process is time-consuming, expensive, and unpredictable.
• Product candidates are based on novel technologies with ethical, social, and legal concerns.
• Potential delays in clinical trials.
• Undesirable side effects or properties of product candidates.
• Uncertainty regarding regulatory approval timing and indication.
• Manufacturing complexities and reliance on third-party manufacturers.
• Reliance on third parties for preclinical studies and clinical trials.
• Uncertainty regarding future insurance coverage and reimbursement.
• Inability to establish sales, marketing, and distribution capabilities.
• Commercial success depends on market acceptance.
• Risks related to the impacts of the Covid-19 pandemic.
• Dependence on key employees and potential conflicts of interest.
• Potential failure to identify or discover additional product candidates.
• Potential product liability lawsuits.
• Lack of issued patents and reliance on intellectual property licenses.
• Inability to obtain and maintain adequate patent protection.
• Failure to comply with obligations under intellectual property licenses.
• Inability to protect intellectual property rights worldwide.
• Potential legal proceedings alleging intellectual property infringement.

Mitigation Strategies

• Considering various financing sources, including debt or equity instruments.
• Modifying operating plans if additional funding is not secured.
• Implementing internal control and risk management procedures.
• Outsourcing manufacturing to specialized CMOs.
• Implementing measures to protect staff against Covid-19.
• Developing sales and marketing capabilities.
• Seeking strategic partnerships for commercialization.
• Maintaining insurance coverage for clinical trials.
• Regularly reviewing and updating internal controls and procedures.
• Engaging with regulatory authorities.
• Implementing targeted corrections around enhanced process control and more rigorous supervision inside the manufacturing suites.

Supply Chain Management

Supplier Audits: Not disclosed

Responsible Procurement

• Not disclosed

Climate-Related Risks & Opportunities

Physical Risks

• Not disclosed

Transition Risks

• Not disclosed

Opportunities

• Not disclosed

Reporting Standards

Frameworks Used: IFRS

Certifications: Null

Third-party Assurance: Deloitte & Associés and Becouze

UN Sustainable Development Goals

• Not disclosed

Not disclosed

Sustainable Products & Innovation

• Not disclosed

Awards & Recognition

• Not disclosed

Environmental Metrics

ESG Focus Areas

• Not disclosed

Environmental Achievements

• Not disclosed

Social Achievements

• Not disclosed

Governance Achievements

• Not disclosed

Climate Goals & Targets

Environmental Challenges

• Insufficient working capital to meet obligations beyond June 2023.
• Significant operating losses since inception and expectation of continued losses.
• Need to raise additional capital, which may not be available on acceptable terms.
• Risks related to the foreign investment screening procedure.
• Time-consuming and expensive regulatory approval process for gene therapies.
• Novel technologies making it difficult to predict development timing and costs.
• Potential for substantial delays in clinical trials.
• Undesirable side effects or properties of product candidates.
• Uncertainty regarding regulatory approval timing and indication.
• Complex and difficult manufacturing process for gene therapies.
• Reliance on third-party manufacturers and CROs.
• Uncertainty regarding future insurance coverage and reimbursement.
• Need to establish sales, marketing, and distribution capabilities.
• Dependence on market acceptance of product candidates.
• Dependence on key employees and potential conflicts of interest.
• Difficulty in identifying and discovering additional product candidates.
• Potential for product liability lawsuits.
• Reliance on intellectual property licenses and potential loss of license rights.
• Inability to protect intellectual property rights worldwide.
• Potential for third-party infringement claims.
• Potential inadequacy of insurance coverage.

Mitigation Strategies

• Implementing cash preservation measures to reduce operating cash burn.
• Actively discussing financing and strategic options, including M&A opportunities.
• Discussing options with existing shareholders and financial partners.
• Intending to seek additional funding.
• Exploring a combination of equity or debt financings and non-dilutive financings.
• Working with manufacturing partner to implement targeted corrections and enhance process control.
• Jointly involving MSAT team and GenSight experts in validation campaign.
• Withdrawing EMA application for LUMEVOQ® to address remaining objections and resubmit.
• Engaging with FDA on the design of an additional placebo-controlled trial for LUMEVOQ®.
• Developing sales, marketing, and distribution capabilities internally and through partnerships.
• Implementing a policy to cover main insurable risks.

Supply Chain Management

Supplier Audits: Not disclosed

Responsible Procurement

• Not disclosed

Climate-Related Risks & Opportunities

Physical Risks

• Not disclosed

Transition Risks

• Not disclosed

Opportunities

• Not disclosed

Reporting Standards

Frameworks Used: IFRS

Certifications: Null

Third-party Assurance: Deloitte & Associés and Becouze

UN Sustainable Development Goals

• Not disclosed

Not disclosed

Sustainable Products & Innovation

• Not disclosed

Awards & Recognition

• Not disclosed