- Full data analysis of AAVance Phase 2/3 Gene Therapy Clinical Trial with LYS-SAF302 in MPS IIIA expected early Q4 2022
- Completion of Phase 1 adaptive clinical trial evaluating safety of LYS-GM101 in 5 patients with GM1 gangliosidosis
- Cash position of €7.7m at the end of June 2022, providing financial visibility to the end of January 2023
Paris, France — 23 September 2022 at 7:00 pm CET — Lysogene (FR0013233475 – LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, today reports its first half 2022 financial results, approved by the Board of Directors on 23 September 2022. The financial statements were subject to a limited review by the Company’s statutory auditors. The full interim financial report is available on the Company’s website in the Investors’ section.
Karen Aiach, Founder, Chairman and Chief Executive Officer of Lysogene, said: “We are finally reaching the most exciting time in Lysogene’s journey as results of our lead gene therapy candidate, LYS-SAF302, are expected in the next few weeks. The data set is currently being analyzed by independent data providers and we look forward to having a comprehensive view of the efficacy of our drug candidate to hopefully confirm the preliminary positive efficacy signal observed so far. With these results, we will be able to discuss the next steps with the regulatory authorities.” Karen Aiach added: “We also continue to work on strategic options to extend the Company’s cash runway to fund the development of our extensive pipeline of preclinical programs targeting high prevalence diseases”.
Complete version of the press release is available in pdf version here.
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 delivery of gene therapies to the CNS to treat lysosomal diseases and other disorders of the CNS. A phase 2/3 clinical trial in MPS IIIA is ongoing. An adaptive clinical trial in GM1 gangliosidosis is also ongoing. Lysogene is also developing an innovative AAV gene therapy approach for the treatment of Fragile X syndrome, a genetic disease related to autism. The Company also entered into an exclusive worldwide license agreement with Yeda, the commercial arm of the Weizmann Institute of Science, for a novel gene therapy candidate for neuronopathic Gaucher disease and Parkinson disease with GBA1 mutations. 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. 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 2021 universal registration document, registered with the French Markets Authorities on April 19, 2022, 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.
Stéphane Durant des Aulnois
Chief Financial Officer
+ 33 1 41 43 03 99