LYSOGENE (EGF VD)

The proposed transaction supports the company's research and development (R&D) investments including inter alia the clinical regulatory and manufacturing development costs of the company's portfolio candidates with a focus on the lead gene therapies targeting rare central nervous system (CNS) diseases with 4 programmes (MPS IIIa, GM1 gangliosidosis disease, Gaucher disease and FragileX syndrome).

The proposed transaction supports the company's R&D investments including inter alia the clinical regulatory and manufacturing development costs of all portfolio candidates with a focus on the lead products, i.e. SAF302, GM101 and FXS01. The EIB financing will also contribute to accelerate the screening and early stage pre-clinical development of new products, which are expected to constitute the backbone of the company's growth in the future. The project will be coordinated from the company's headquarters located in Neuilly-sur-Seine near Paris.

The project concerns an operation under the European Guarantee Fund. The purpose of the loan is to provide direct, equity-type financing under EIB's Venture Debt Instrument to support Research, Development and Innovation ("RDI") activities of the innovative company Lysogene, a French SME focused on gene therapy for rare CNS diseases, which has been impacted by the COVID-19 pandemic. The financing of this project addresses the failure in financial markets for RDI, arising from limited access to commensurate financing as a result of factors such as information asymetries, misalignment of incentives, etc.

The Promoter is a dedicated biotech company that develops a innovative, disease-modifying treatments for young patients affected by disabling diseases of the CNS. Hence, the project targets unmet needs with high socio-economic impact. By creating knowledge externalities, the project will provide significant socio-economic benefits, will strengthen French and Europe's leading position in medical technologies, and it will help to retain skilled staff engaged in the Company's RDI activities. EIB's financing would be complementary to European venture capital ("VC") investors and would provide a signaling effect to crowd-in other capital providers, which are necessary for the completion of the clinical development stage and the launch of commercial operations.

Thanks to EIB's involvement, this project will not be significantly delayed due to the crisis.

The project mainly concerns investments in R&D that are expected to be carried out in existing facilities already authorised for the same purpose and would therefore not require an environmental impact assessment (EIA) under the Directive 2014/52/EU amending the EIA Directive 2011/92/EU. Full environmental details will be verified during the appraisal.

The Promoter is a private company not operating in the utilities sector and not having the status of a contracting authority; thus, the project is not covered by the EU Directives on procurement. However, the Promoter's procurement procedures are expected to be in line with EIB guidelines for private sector projects. The Bank's services will verify details during the project due diligence.

Lysogene is a French biotechnology company pioneering gene therapies for rare genetic diseases affecting the central nervous system (CNS) and for which no treatment is available. Since its inception in 2009, Lysogene has brought to clinic two gene therapy products for the treatment of the Sanfilippo syndrome and GM1 gangliosidosis diseases. In addition to these two programmes at clinical stage, Lysogene has two programmes at pre-clinical development stage. The company has regular interactions with patient organisations and is involved in numerous collaborations with reputable academic research groups.