PARIS--(BUSINESS WIRE)--Regulatory News:
Lysogene (FR0013233475 – LYS), a phase 3 gene therapy platform Company 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 financing will support the clinical development of the company’s lead product candidates, and in particular the phase 1/2 clinical trial with LYS-GM101 for the treatment of GM1 gangliosidosis and the initiation of the preclinical studies with LYS-FXS01 in the Fragile X syndrome.
Lysogene will receive the EIB loan in three tranches including a first tranche of €3 million that can be unconditionally drawn down and two other tranches of respectively €5 million and €7 million available upon completion of pre-defined milestones.
Since its inception, Lysogene’s objective is to develop gene therapies for rare and non-curable diseases affecting the central nervous system. Starting with diseases for which there is no suitable cure despite a clear medical need. This operation is under the EGF Venture Debt programme loan, a product guaranteed under the Pan-European Guarantee Fund, designed to support companies whose activity is negatively impacted by the COVID-19 outbreak, or are developing products that could support the fight against the pandemic.
Stéphane Durant des Aulnois, Chief Financial Officer of Lysogene commented: "We are very grateful for the support and confidence shown by the EIB, which demonstrates the validity of Lysogene's long-term strategy to be a technological platform that develops gene therapy assets from early research to clinical stage. With the €4.3 million BPI non-dilutive announced in November, this brings total funding agreements to nearly €20 million.”
Ambroise Fayolle, Vice-President of the EIB, explains: “We are pleased to support Lysogene, which has acquired real expertise in the field of gene therapy over the past 10 years and is at an inflection point in its history to become a recognised gene therapy platform. With a rich and diversified pipeline, Lysogene has a very promising future. Besides, this financing is fully in line with the mandate set for the EIB by its shareholders - the EU Member States - to support innovation across Europe."
This loan will carry a decreasing fixed interest rate according to the tranche and a specific associated maturity. For instance, the first tranche will have a capitalized interest rate of 8% with a five-year maturity. The loan is supplemented by an agreement to issue warrants to the EIB, whose number varies according to the tranche and Lysogene’s share price. Each warrant will give the right to subscribe to one ordinary share of Lysogene at the subscription price of €0.01 and at the exercise price calculated based on the volume-weighted average of the 30 trading days preceding the pricing, with a discount of 5.0%1. The warrants will have a maturity of 20 years and be exercisable 5 years after the drawdown of the first tranche or upon the occurrence of certain events, thus avoiding dilution for existing shareholders in the near term. The agreement includes an exercise parity adjustment clause which could apply, under certain conditions. At the maturity of the first tranche or upon the occurrence of certain event, the EIB will be granted an option to sale its warrants to Lysogene for their intrinsic value, as an alternative to the exercise of its warrants.
Kepler Cheuvreux acted as exclusive Advisor to the Company.
About the European Investment Bank (EIB)
The EIB is the European Union (EU) long-term financing institution, and its shareholders are the 27 EU Member States. Its mission is to contribute to the integration, balanced development, and economic and social cohesion of EU Member States. It borrows large volumes of funds from the capital markets and lends them with very favourable terms to support projects which contribute to the achievement of EU objectives. The EIB is working to put the EU at the forefront of the next wave of innovation, especially in the health sector. In response to the Covid-19 health crisis, the EIB has released € 6 billion for investments in the health sector to support medical infrastructure, additional research activities or other financing related to vaccines and treatments. As a European bank supporting the climate, the EIB is one of the main fund providers in the green transition towards a more low-carbon and sustainable growth model.
About Lysogene
Lysogene is a gene therapy Company focused on the treatment of orphan diseases of the central nervous system (CNS). The Company has built a unique capability to enable a delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA in partnership with Sarepta Therapeutics, Inc. is ongoing. An adaptive clinical trial in GM1 gangliosidosis is ongoing. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold exclusive commercial rights to LYS-SAF302 in the United States and markets outside Europe; and Lysogene will maintain commercial exclusivity of LYS-SAF302 in Europe. Lysogene has also entered into an exclusive worldwide license agreement with SATT Conectus for a gene therapy candidate for the treatment of the Fragile X syndrome, a genetic disease related to autism. www.lysogene.com.
Forward Looking Statement
This press release may contain certain forward-looking statements, especially on the Company’s progress of its clinical trials and cash runway. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, (iii) clinical trial results, (iv) increased manufacturing costs, (v) potential claims on its products, and (vi) a modification of the terms of its agreements with Sarepta Therapeutics. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “objective”, “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. A further list and 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 in the 2020 universal registration document, registered with the French Markets Authorities on April 12, 2021, under number D.21-0296, and future filings and reports by the Company. Furthermore, these forward-looking statements are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. If the Company updates one or more forward-looking statements, no inference should be drawn 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 both French and English. In the event of any differences between the two texts, the French language version shall supersede.
1the definitive terms and conditions of the warrants are still being discussed and will be finalized prior to the drawing of the first tranche