Duyuru • May 29
Lysogene Announces to Delist from Euronext Lysogene S.A. announced that the Commercial Court of Nanterre has decided to convert the reorganization proceedings of the company, opened by judgment on January 24, 2023, into liquidation proceedings. As a result, trading of Lysogene’s shares will not resume and a delisting will be requested from Euronext soon. Duyuru • Feb 04
Lysogene Appoints Côme de La Tour du Pin as Chief Financial Officer Lysogene announced the appointment of Côme de La Tour du Pin, currently VP Finance/Chief Financial Officer ad interim, as Chief Financial Officer. He will replace Stéphane Durant des Aulnois who has decided to leave the Company to pursue other opportunities. Mr. de La Tour du Pin joined the Company in 2020 as Vice President Finance before becoming CFO ad interim in November 2022, and has been involved in the fundraising, investor relations and FP&A activities. Prior to joining Lysogene, he gained extensive experience within the investor relations teams at Ipsen and at Groupe Casino. Before that, he acquired a solid background in investment banking at BNP Paribas and in audit at PwC. Côme graduated from EM Lyon Business School. Price Target Changed • Nov 16
Price target increased to €11.00 Up from €2.10, the current price target is provided by 1 analyst. New target price is 2,196% above last closing price of €0.48. Stock is down 76% over the past year. The company posted a net loss per share of €0.81 last year. Reported Earnings • Sep 24
First half 2022 earnings released: EPS: €0.04 (vs €0.33 loss in 1H 2021) First half 2022 results: EPS: €0.04 (up from €0.33 loss in 1H 2021). Revenue: €10.0m (up 138% from 1H 2021). Net income: €703.0k (up €6.23m from 1H 2021). Profit margin: 7.0% (up from net loss in 1H 2021). The move to profitability was primarily driven by higher revenue. Over the last 3 years on average, earnings per share has fallen by 30% per year whereas the company’s share price has fallen by 31% per year. Price Target Changed • Apr 27
Price target increased to €11.00 Up from €2.10, the current price target is provided by 1 analyst. New target price is 1,359% above last closing price of €0.75. Stock is down 73% over the past year. The company posted a net loss per share of €0.81 last year. Reported Earnings • Apr 01
Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2021 results: €0.81 loss per share (down from €0.32 loss in FY 2020). Revenue: €7.22m (down 56% from FY 2020). Net loss: €13.6m (loss widened 167% from FY 2020). Revenue exceeded analyst estimates by 127%. Earnings per share (EPS) missed analyst estimates by 75%. Over the last 3 years on average, earnings per share has fallen by 5% per year but the company’s share price has fallen by 29% per year, which means it is performing significantly worse than earnings. Reported Earnings • Sep 26
First half 2021 earnings released: €0.33 loss per share (vs €0.015 profit in 1H 2020) The company reported a poor first half result with weaker earnings, revenues and control over costs. First half 2021 results: Revenue: €4.23m (down 60% from 1H 2020). Net loss: €5.53m (down €5.76m from profit in 1H 2020). Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth. Reported Earnings • Apr 19
Full year 2020 earnings released: €0.32 loss per share (vs €0.32 loss in FY 2019) The company reported a poor full year result with increased losses and weaker control over costs, although revenues were flat. Full year 2020 results: Revenue: €16.4m (flat on FY 2019). Net loss: €5.09m (loss widened 19% from FY 2019). Products in clinical trials Phase I: 1 Phase II: 1 Over the last 3 years on average, earnings per share has increased by 70% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth. Duyuru • Feb 16
Lysogene Reports LYS-SAF302 Biomarker Data Presented at the WORLDSymposium 2021 Lysogene reports biomarker data from the ongoing AAVance clinical trial with LYS-SAF302 for the treatment of MPS IIIA (NCT03612869) presented at the WORLDSymposium™ 2021 by Dr. Michaël Hocquemiller, Head of Non-Clinical Development, during the Late-Breaking Science session held on February 12, 2021. Concentration of heparan sulfate (HS) in the cerebrospinal fluid (CSF) has been analyzed in 9 patients so far, with samples at baseline (n=9), 6 months (n=8) and 12 months (n=5) after LYS-SAF302 administration. The concentration of abnormally elevated HS-derived oligosaccharides in the CSF was reduced from baseline by 27% and 30% at 6 and 12 months, respectively (p<0.005 and p<0.05 by paired t-test vs baseline, respectively). In contrast, changes in HS concentrations in serum samples from the same patients were not statistically significant, confirming that the reduction of HS in CSF after LYS-SAF302 treatment is linked to a reduction of HS entering the CSF from the brain parenchyma and not an indirect consequence of a reduction of HS entering the CSF from extra-parenchymal sources, such as choroid plexus or blood. Additionally, changes in dermatan sulfate (DS) and keratan sulfate (KS), which do not accumulate in MPS IIIA, were not statistically significant in serum and CSF, confirming the specificity of HS accumulation in the CSF. Duyuru • Feb 12
Lysogene S.A. Receives FDA Clearance of Investigational New Drug Application to Initiate the Gene Therapy Clinical Trial in the US with Lys-Gm101 for the Treatment of Gm1 Gangliosidosis Lysogene S.A. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LYS-GM101, the company’s gene therapy candidate for the treatment of GM1 gangliosidosis, a serious, pediatric, life threatening disease. LYS-GM101 builds on Lysogene’s extensive experience in direct to CNS adeno-associated viral vector (AAV)-based gene therapy clinical development. The IND clearance follows the recent clinical trial authorization granted by the MHRA in the United Kingdom. Lysogene intends to initiate its global, multi-center, single-arm, two-stage, adaptive-design clinical trial of LYS-GM101 in patients with a diagnosis of early or late infantile GM1 gangliosidosis. The clinical trial will include a safety phase and a confirmatory efficacy phase. The company intends to dose a total of 16 patients, with dosage of the first patient expected in the first half of 2021. Is New 90 Day High Low • Feb 08
New 90-day high: €3.26 The company is up 65% from its price of €1.97 on 10 November 2020. The French market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 53% over the same period. Duyuru • Jan 12
Lysogene Receives MHRA and Research Ethics Committee Approvals to Initiate the Gene Therapy Clinical Trial in the UK with LYS-GM101 for the Treatment of GM1 Gangliosidosis Lysogene announced that it has received MHRA and Research Ethics Committee approvals to initiate the gene therapy clinical trial in the United Kingdom with LYS-GM101 for the treatment of GM1 gangliosidosis, a serious, pediatric, life threatening disease. LYS-GM101 builds on Lysogene’s extensive experience in direct to CNS adeno-associated viral vector (AAV)-based gene therapy clinical development. This is the first regulatory authorization to initiate this global, multi-center, single-arm, two-stage, adaptive-design clinical trial of LYS-GM101 in patients with a diagnosis of early or late infantile GM1 gangliosidosis. The company expects to dose the first patient in the first half of 2021. LYS-GM101 (‘adeno-associated viral vector serotype rh.10 expressing beta-galactosidase’) received orphan drug designation for the treatment of GM1 gangliosidosis in the European Union and in the US in 2017, as well as the Rare Pediatric Disease designation in the US in 2016. Leading international gene therapy and Lysosomal Storage Disease centers plan to participate in the clinical trial (NCT04273269). Lysogene is also funding a GM1 gangliosidosis natural history study being conducted by Casimir Trials to collect prospective and/or retrospective videos of children doing certain everyday tasks and behaviors in infantile and juvenile GM1 gangliosidosis (NCT04310163). Is New 90 Day High Low • Dec 28
New 90-day high: €2.65 The company is up 25% from its price of €2.12 on 29 September 2020. The French market is up 14% over the last 90 days, indicating the company outperformed over that time. However, it underperformed the Biotechs industry, which is up 31% over the same period. Duyuru • Dec 28
Lysogene Reports Positive Biomarker Data With LYS-SAF302 Lysogene reported positive biomarker data from the ongoing AAVance clinical trial with LYS-SAF302 for the treatment of MPS IIIA (NCT03612869). Changes in heparan sulfate (HS) concentration in cerebrospinal fluid (CSF) are being monitored in patients treated with LYS-SAF302 to provide evidence of in vivo biological activity of the drug and demonstrate proof of concept. First results show reductions in the concentration of HS in the CSF of all nine patients analyzed so far, at 6 and 12 months after treatment with LYS-SAF302, relative to pre-treatment values. Average reductions were highly statistically significant. In contrast, there were no statistically significant changes in serum HS concentrations following treatment with LYS-SAF302. These results are consistent with the hypothesis that LYS-SAF302 leads to a reduction of HS entering the CSF from the brain parenchyma, with little or no effect on HS-derived oligosaccharides entering the CSF from extra-parenchymal sources, such as choroid plexus or blood. Furthermore, statistically significant reductions in the secondary storage products GM2 and GM3 ganglioside, which are thought to be possible contributors to neuronal damage in lysosomal storage diseases, were observed in the CSF of treated patients, relative to pre-treatment values. Is New 90 Day High Low • Oct 21
New 90-day low: €2.06 The company is down 20% from its price of €2.57 on 23 July 2020. The French market is flat over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 7.0% over the same period. Duyuru • Oct 15
Lysogene Provides Update on the AAVance Clinical Trial Evaluating Lys-Saf302 in Patients with MPS IIIA Lysogene announced that a patient has passed away in the AAVance clinical trial (NCT03612869), a global Phase 2/3 gene therapy trial for the treatment of Mucopolysaccharidosis Type IIIA (MPS IIIA, also known as Sanfilippo syndrome type A). MPS IIIA is a serious, life-threatening, inherited neurodegenerative lysosomal storage disorder characterized by intractable behavioral problems and developmental regression resulting in early death. The immediate cause of death is currently unknown and additional information is being collected. At this time, there is no evidence that the event is linked to the study drug administration. Lysogene is diligently following per study protocol the 18 patients who have been treated in the clinical trial. Lysogene is profoundly saddened by the passing of this child and extends its deepest sympathies to the family. The company remains committed to the LYS-SAF302 development program and the Sanfilippo patient community. The company plans to provide further information on the LYS-SAF302 program based on both ongoing data collection and future regulatory status updates. Is New 90 Day High Low • Sep 30
New 90-day low: €2.07 The company is down 26% from its price of €2.78 on 02 July 2020. The French market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period. Reported Earnings • Sep 27
First half earnings released Over the last 12 months the company has reported total losses of €2.15m, with losses narrowing by 61% from the prior year. Total revenue was €18.9m over the last 12 months, up 45% from the prior year. 