Loans

Lysogene Enters into a Loan Agreement of €15 million with the European Investment Bank (EIB)

Paris–(work wire) – Regulatory news:

Lysogene (FR0013233475 – LYS), a phase III gene therapy platform targeting central nervous system (CNS) diseases, announced today that it has entered into a €15 million loan agreement with the European Investment Bank to accelerate the development of its gene therapy platform. .

The funding will support the clinical development of the company’s major product candidates, and in particular the Phase 1/2 clinical trial with LYS-GM101 for the treatment of GM1 bacteriuria and the initiation of preclinical studies with LYS-FXS01 in Fragile X syndrome.

Lysogene will receive the EIB loan in three tranches including the first tranche of €3 million that can be drawn down without conditions and two further tranches of €5 million and €7 million respectively available upon completion of pre-determined phases.

Since its inception, Lysogene has aimed to develop genetic therapies for rare and incurable diseases affecting the central nervous system. Starting with diseases for which there is no appropriate treatment despite the clear medical need. The operation is subject to the EGF Venture Debt Program loan, a product secured under the Pan-European Guarantee Fund, designed to support companies whose business has been negatively affected by the COVID-19 outbreak, or who are developing products that can support the fight against the pandemic.

Stéphane Durant des Aulnois, Chief Financial Officer, Lysogene comment: “We are very grateful for the support and trust shown by the European Investment Bank, which demonstrates the validity of Lysogene’s long-term strategy to be a technology platform that advances gene therapy assets from early research to the clinical stage. It was announced in November, bringing total funding agreements to nearly 20 million Euro”.

Ambroise Fayol, Vice President of the European Investment Bank, explain: “We are pleased to support Lysogene, which has gained real expertise in the field of gene therapy over the past 10 years and is at a turning point in its history to become a recognized gene therapy platform. With a rich and diversified pipeline, Lysogene has a very promising future. Besides, this is in line with this Funding entirely with the mandate set by the EIB shareholders – EU member states – for the EIB to support innovation across Europe.”

This loan will carry a decreasing fixed interest rate according to the tranche and the specific maturity date associated with it. For example, the first tranche will have a commissioned interest rate of 8% with a maturity of five years. The loan is supplemented by an agreement to issue guarantee notes to the European Investment Bank, the number of which varies according to the tranche and the Lysogene share price. Each order will grant the right to subscribe to one regular lot of Lysogene at the subscription price of €0.01 and at the exercise price calculated on the basis of volume-weighted average for 30 trading days prior to pricing, at a discount of 5.0%1. The guarantees will have a maturity of 20 years and can be exercised 5 years after the first tranche is drawn down or when certain events occur, thus avoiding dilution for existing shareholders in the near term. The Agreement includes an Equivalency of Practice Amendment clause which may be applied under certain circumstances. When the first tranche matures or when a specific event occurs, the EIB will be given the option to sell its promissory notes to Lysogene for their intrinsic value, as an alternative to exercising its warrants.

Kepler Cheuvreux acted as an exclusive advisor to the company.

About the European Investment Bank (EIB)

The European Investment Bank is a long-term financing institution of the European Union, and its shareholders are the 27 member states of the European Union. Its mission is to contribute to the integration, balanced development and economic and social cohesion of the member states of the European Union. It borrows large amounts of money from the capital markets and lends it on very favorable terms to support projects that contribute to the achievement of EU objectives. The European Investment Bank is putting the European Union at the forefront of the next wave of innovation, particularly in the health sector. In response to the Covid-19 health crisis, the European Investment Bank has earmarked 6 billion euros for investments in the health sector to support medical infrastructure, additional research activities or other financing related to vaccines and treatments. As a European climate-friendly bank, the European Investment Bank is one of the main providers of funds in the green transition towards a sustainable, low-carbon growth model.

About Lysogen

Lysogene is a gene therapy company focused on treating orphan diseases of the central nervous system (CNS). The company has built a unique capacity to enable delivery of gene therapies into the central nervous system to treat lysosomal diseases and other genetic disorders of the central nervous system. A Phase 2/3 clinical trial is now underway in MPS IIIA in partnership with Sarepta Therapeutics, Inc. An adaptive clinical trial in GM1 is still ongoing. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc. , will own Sarepta Therapeutics, Inc. Exclusive commercial rights of LYS-SAF302 in the US and markets outside Europe; Lysogene will retain commercial exclusivity for LYS-SAF302 in Europe. Lysogene has also entered into an exclusive global licensing agreement with SATT Conectus for a gene therapy candidate to treat fragile X syndrome, a genetic disease related to autism. www.lysogene.com.

forward-looking statement

This press release may contain certain forward-looking statements, particularly regarding the company’s progress in clinical trials and the cash runway. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical facts contained in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, and (iii) the results of Clinical trials, (4) increased manufacturing costs, (5) potential claims on its products, and (6) modified the terms of its agreements with Sarepta Therapeutics. These statements may include, but are not limited to, any statements that are preceded or followed by or include words such as “aim,” “believe,” “expect,” “intend,” “intend,” “may,” “expect,” “estimate.” , ‘plan’, ‘objective’, ‘project’, ‘will’, ‘could be’, ‘potential’, ‘should’, ‘will’, ‘could’ and other words and terms with equivalent or negative meaning Forward-looking statements are subject to inherent risks and uncertainties that are outside the Company’s control and that could cause the Company’s actual results, performance or achievements to differ materially from the expected results, performance or achievements expressed or implied by such forward-looking statements. A list and additional description of these risks, uncertainties and other risks can be found in the company’s regulatory filings with the French Autorité des Marchés Financiers, including the 2020 Global Registration Document, registered with the French market authorities on April 12, 2021, under No. D.21-0296, and future files and reports by the Company.Furthermore, these forward-looking statements are made only as of the date of this press release. You should not place excessive reliance on these forward-looking statements. Except as required by law, the Company has no obligation to publicly update these forward-looking statements, or to update the reasons why actual results may differ materially from those projected in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more of the forward-looking statements, it should not be concluded that it will or will not make additional updates with respect to those or other forward-looking statements.

This press release has been prepared in French and English. If there are any differences between the two texts, the French version shall replace them.


1The final terms and conditions of the notes are still under discussion and will be finalized before the first tranche is withdrawn

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