CAMBRIDGE, Mass. & PARIS--(BUSINESS WIRE)--Regulatory News:
Lysogene (FR0013233475 – LYS) (Paris:LYS), a pioneering biopharmaceutical company specializing in gene therapy targeting central nervous system (CNS) diseases, today reports its cash position for the second quarter 2018 and provides a business as well as a strategic update.
Cash position as of June 30, 2018
As of June 30, 2018, cash and cash equivalent amounted to €8.16 million, compared to €9.9 million on March 31, 2018. The Company’s cash position allows the Company to cover its anticipated needs until November 2018, based on the company's current operational development plan. Lysogene did not generate revenues during the second quarter 2018.
Update on recent manufacturing and clinical progress with LYS-SAF302, a Phase 2/3 drug candidate for the treatment of MPS IIIA
As planned, Lysogene has made significant progress regarding the preparation of the Phase 2/3 Pivotal study with LYS-SAF302. Most recent progress include the successful production of clinical batches, with batch release activities currently on going.
All plans to activate eight clinical sites in the U.S. and Europe for this trial remain underway, in order to enable maximum patient access to the Company’s novel gene therapy treatment, the first Phase 2/3 MPS IIIA drug candidate worldwide.
Update on Lysogene’s second asset, LYS-GM101, drug candidate for the treatment of GM1 and recent collaboration for Fragile X syndrome
Lysogene’s IND-enabling preclinical study program in GM1 Gangliosidosis is progressing and the Company intends to report long-term results in the second half of 2018.
Scientific Advice/Protocol Assistance meeting with the European Medicines Agency was held on June 11, 2018. The EMA Final Advice Letter provides valuable guidance for Lysogene on preclinical, clinical and manufacturing considerations. Most importantly, the EMA accepted the adaptive design proposal from Lysogene.
Together with the future Pre-IND meeting with the U.S. Food and Drug Administration, these regulatory interactions should enable Lysogene to further define the optimal development plan for this new innovative therapy.
The activities related to the Fragile X Syndrome gene therapy program developed in collaboration with Dr Herve Lemoine progressed.
The implementation of each of these programs will depend on the financial capabilities of the Company.
Given the current cash runway of the Company, the Company has decided to focus its efforts on the conclusion of a strategic partnership or transaction, or potential sale of one or several products. The Company has retained Torreya to serve as its financial advisor in this process.
Lysogene does not have a defined timeline yet for such potential transactions and will disclose future developments, as the case may be, as soon as appropriate.
The Company is also currently working on cost containment measures in order to reduce its cash burn, and will communicate on the progress of the above in more detail in Q3 2018.
Attention of the public is drawn to the risk factors presented in the 2017 registration document (Document de référence), registered with the French Markets Authorities on June 4, 2018, under number R. 18-047, and in particular to the liquidity risk and risk associated to the dependence to a successful development of LYS-SAF 302 as set out in paragraphs 4.2.2 and 4.4.2 of the 2017 registration document (Document de référence).
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 safe and effective delivery of gene therapies to the CNS to treat lysosomal diseases and other genetic disorders of the CNS. A pivotal clinical trial in MPS IIIA and a phase 1-2 clinical trial in GM1 Gangliosidosis are in preparation, while we are currently collaborating with a major partner to define the strategy of development for the treatment of Fragile X syndrome, a genetic disease related to autism. www.lysogene.com
Forward looking statement
This press release may contain certain forward-looking statements. 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 and (iii) the financial capabilities of the Company. 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,” “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 2017 registration document (Document de référence), registered with the French Markets Authorities on June 4, 2018, under number R. 18-047, and future filings and reports by the Company. 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.
This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Lysogene in any country. 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.