PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
Lysogene (Paris:LYS) (FR0013233475 – LYS), a leading clinical-stage biopharmaceutical company specializing in gene therapy technology applied to central nervous system diseases, today announced its 2016 financial results, as approved by the Board of Directors on April 19, 2017. Audit procedures on the statutory and consolidated financial statements have been performed in accordance with professional standards applicable in France.
Selected financial information at December 31, 2016 (IFRS Consolidated accounts)
|In € million||2016||2015|
|Other operating revenue||1,493||414|
|Administrative, sales and marketing expenses||(2,453)||(1,311)|
|Net income per share (€)||(0.91)||(0.50)|
|Net cash flow related to operating activities||(6,653)||(2,949)|
|Net cash flow related to financing activities||(217)||6,171|
|Cash position variation (excl. forex differences)||(6,616)||3,159|
|Cash and cash equivalents at the end of the period||6,353||13,451|
The “other operating revenue” increase from €0.4 million, in 2015, to €1.5 million, in 2016, due to higher Research Tax Credit in 2016 related to the higher R&D expenditure.
Operating costs doubled from €4.3 million to €8.8 million, reflecting the Company’s rapid development with several senior management recruitments in 2016, the launch of GMP (Good Manufacturing Practices) manufacturing for LYS-SAF302 and the MPS IIIA Natural History study (mucopolysaccharidosis type IIIA or Sanfilippo type A).
The net loss came to €(3.8) million and €(7.5) million for the years ending December 31, 2015 and December 31, 2016, respectively.
EPS (Earnings per Share) was (0.50) euros and (0.91) euros for years ending December 31, 20151 and December 31, 2016.
2016 key operational highlights
- Start of the Natural History study in MPS IIIA, a multi-national observational study including up to 25 patients in Europe and Brazil. The aim of this study is to assess clinical progression in untreated MPS IIIA patients. This study will serve as a control group for the upcoming pivotal gene therapy trial in this indication. Eighteen patients were enrolled as of December 31, 2016.
- Launch of LYS-SAF302 manufacturing, with an industrial partner, compliant with Good Manufacturing Practices (GMP standards), required for the scheduled preclinical studies and clinical trials.
- Pre-IND meeting with the FDA (Food and Drug Administration) to discuss the MPS IIIA pivotal study design and benefit from the US agency’s scientific and protocol advice.
- Initiation, of preclinical activities, including additional IND enabling non-clinical studies to optimize the clinical dose, biodistribution and the assessment of the injection device. The majority of these studies will be undertaken in 2017.
Key operational highlights since January 1, 2017
- February 10, 2017: an important milestone in Lysogene’s development was the successful initial public offering on Euronext Paris, raising nearly €22.6 million.
- February 21, 2017: successful key regulatory milestone achieved for Lysogene’s second product candidate, LYS-GM101 for treating GM1 gangliosidosis. The European Medicines Agency (EMA) granted orphan drug designation to LYS-GM101. The U.S. Food and Drug Administration also granted an orphan drug designation and a rare pediatric disease designation to LYS-GM101 earlier in the year.
- March 28, 2017: Lysogene announced baseline data from the first International Pivotal Observational Study in MPS IIIA (SAMOS).
- April 20, 2017: selection of the MRI Interventions’ SmartFlow™ cannula to be used in Lysogene’s planned Phase II/III clinical trial in MPS IIIA. The clinical study is scheduled to begin in early 2018.
The Company announces that its Chief Medical Officer, Soraya Bekkali is standing down from her position. Her replacement is currently being finalized.
The 2016 Annual Financial Report is now available to the public and on the Company’s website at: www.lysogene.com
Next financial milestones:
- Ordinary shareholders’ meeting on June 22, 2017
- Second quarter 2017 revenue and cash position on July 12, 2017 (after market close)
Lysogene is a leading, clinical stage biotechnology company, specializing in the basic research and clinical development of AAV gene therapy for CNS disorders with a high unmet medical need. Since 2009, Lysogene has established a solid platform and network, with lead products in MPS IIIA and GM1 Gangliosidosis, to become a global leader in orphan CNS diseases. Lysogene has also obtained ODD by the EMA and FDA and rare pediatric designation by the FDA for both its two candidate products LYS-SAF302 and LYS-GM101.
Lysogene is listed on the Euronext regulated market in Paris (ISIN code: FR0013233475)
For more information, please visit www.lysogene.com.
1 Please note that this EPS was calculated after the 10-for-1 division of the nominal decided by the Shareholders’ Meeting of November 23, 2016.