PARIS–(COMMERCIAL THREAD) – Regulatory news:
Lysogene (FR0013233475 – LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today announced that it has entered into a € 15 million loan agreement with the European Bank of Investment to accelerate the development of its gene therapy platform.
The funding will support the clinical development of the Company’s flagship product candidates, and in particular the Phase 1/2 clinical trial with LYS-GM101 for the treatment of GM1 gangliosidosis and the launch of preclinical studies with LYS-FXS01 in the syndrome of fragile X.
Lysogene will receive the EIB loan in three tranches, including a first tranche of € 3 million that can be drawn unconditionally and two other tranches of € 5 million and € 7 million respectively available after predefined milestones .
Since its inception, Lysogene has aimed to develop gene therapies for rare and uncurable diseases affecting the central nervous system. Starting with diseases for which there is no suitable remedy despite an obvious medical need. This operation is part of the loan from the EGF Venture Debt program, a product guaranteed under the Pan-European Guarantee Fund, intended to support companies whose activity is negatively impacted by the COVID-19 epidemic, or who 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 trust of the EIB, which demonstrates the merits of Lysogene’s long-term strategy of being a technology platform that develops gene therapy assets from early research to clinical stage. With the 4.3 million euros of non-dilutive BPI announced in November, this brings the total of financing agreements to almost 20 million euros.
Ambroise Fayolle, Vice-President of the EIB, Explain: “We are happy to support Lysogene which has acquired 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 platform for gene therapy. With a rich and diverse pipeline, Lysogene has a very bright future. Furthermore, this funding is fully in line with the mandate given to the EIB by its shareholders – the EU Member States – to support innovation across Europe. “
This loan will bear a declining fixed interest rate according to the tranche and an associated specific maturity. For example, the first tranche will have a capitalized interest rate of 8% with a maturity of five years. The loan is supplemented by an agreement to issue warrants for the benefit of the EIB, the number of which varies according to the tranche and the price of the Lysogene share. 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 on the volume-weighted average of the 30 trading sessions preceding the listing, with a discount of 5 , 0%1. The warrants will have a maturity of 20 years and can be exercised 5 years after the drawdown of the first tranche or upon the occurrence of certain events, thus avoiding dilution for existing shareholders in the short term. The agreement includes an exercise parity adjustment clause that could apply, under certain conditions. At the end of the first tranche or upon the occurrence of certain events, the EIB will be granted an option to sell its BSAs to Lysogene for their intrinsic value, as an alternative to the exercise of its BSAs.
Kepler Cheuvreux acted as exclusive advisor to the Company.
About the European Investment Bank (EIB)
The EIB is the long-term finance institution of the European Union (EU) 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 the EU Member States. It borrows large volumes of funds from the capital markets and lends them on very favorable terms to support projects which contribute to the achievement of EU objectives. The EIB works 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 funding related to vaccines and to treatments. As a European bank in the service of the climate, the EIB is one of the main donors of the green transition towards a more low-carbon and sustainable growth model.
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 the delivery of gene therapy 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 underway. An adaptive clinical trial in GM1 gangliosidosis is underway. In accordance with the agreements signed between Lysogene and Sarepta Therapeutics, Inc., Sarepta Therapeutics, Inc. will hold the exclusive commercial rights for LYS-SAF302 in the United States and in markets outside Europe; and Lysogene will retain the commercial exclusivity of LYS-SAF302 in Europe. Lysogene has also entered into an exclusive worldwide licensing agreement with SATT Conectus for a gene therapy candidate for the treatment of fragile X syndrome, a genetic disorder linked to autism. www.lysogene.com.
This press release may contain certain forward-looking statements, in particular about the Company’s progress in its clinical trials and its cash flow track. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release regarding future events are subject to (i) change without notice, (ii) factors beyond the Company’s control, (iii) results of clinical trials, (iv) increased manufacturing costs, (v) potential claims on its products, and (vi) a change in the terms of its agreements with Sarepta Therapeutics. These statements may include, but are not limited to, statements preceded, followed or including words such as “target”, “believe”, “expect”, “aim”, “intend”, ” power “,” anticipate “,” estimate, “” plan “,” goal “,” project “,” will “,” may have “,” likely “,” should “,” should “,” could “and other words and terms with similar meanings or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the control of the Company that could cause the actual results, performance or achievements of the Company. Company are materially different from the expected results, performances or achievements expressed or implied by these forward-looking statements. A more detailed list and description of these risks, uncertainties and other risks appear in the regulatory documents of the Company with the Autorité des financial markets, including in the documen t 2020 universal registration, registered with the French Markets Authority on April 12, 2021, under number D.21-0296, and future Company filings and reports. In addition, these forward-looking statements speak 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 why 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 whether or not it will make further updates with respect to such or other forward-looking statements.
This press release has been prepared in French and English. In the event of any discrepancy between the two texts, the French language version will prevail.
1the final terms and conditions of the BSA are still under discussion and will be finalized before the first tranche is drawn.