View Future GrowthThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsLysogene 過去の業績過去 基準チェック /06Lysogeneは32%の年平均成長率で業績を伸ばしているが、Biotechs業界はgrowingで17%毎年増加している。売上は成長しており、年平均27%の割合である。主要情報32.04%収益成長率34.29%EPS成長率Biotechs 業界の成長30.80%収益成長率27.04%株主資本利益率n/aネット・マージン-57.76%前回の決算情報30 Jun 2022最近の業績更新Reported Earnings • Sep 24First 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.Reported Earnings • Apr 01Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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 26First 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 19Full 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.Reported Earnings • Sep 27First half earnings releasedOver 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.すべての更新を表示Recent updatesお知らせ • May 29Lysogene Announces to Delist from EuronextLysogene 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.お知らせ • Feb 04Lysogene Appoints Côme de La Tour du Pin as Chief Financial OfficerLysogene 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 16Price target increased to €11.00Up 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 24First 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 27Price target increased to €11.00Up 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 01Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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 26First 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.分析記事 • May 05Breakeven On The Horizon For Lysogene S.A. (EPA:LYS)With the business potentially at an important milestone, we thought we'd take a closer look at Lysogene S.A.'s...Reported Earnings • Apr 19Full 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.分析記事 • Feb 17Lysogene (EPA:LYS) Shareholders Have Enjoyed A 5.9% Share Price GainIf you want to compound wealth in the stock market, you can do so by buying an index fund. But one can do better than...お知らせ • Feb 16Lysogene Reports LYS-SAF302 Biomarker Data Presented at the WORLDSymposium 2021Lysogene 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.お知らせ • Feb 12Lysogene 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 GangliosidosisLysogene 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 08New 90-day high: €3.26The 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.お知らせ • Jan 25+ 2 more updatesLysogene S.A., Annual General Meeting, Jun 25, 2021Lysogene S.A., Annual General Meeting, Jun 25, 2021.お知らせ • Jan 12Lysogene 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 GangliosidosisLysogene 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 28New 90-day high: €2.65The 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.お知らせ • Dec 28Lysogene Reports Positive Biomarker Data With LYS-SAF302Lysogene 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 21New 90-day low: €2.06The 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.お知らせ • Oct 15Lysogene Provides Update on the AAVance Clinical Trial Evaluating Lys-Saf302 in Patients with MPS IIIALysogene 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 30New 90-day low: €2.07The 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 27First half earnings releasedOver 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.収支内訳Lysogene の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史ENXTPA:LYS 収益、費用、利益 ( )EUR Millions日付収益収益G+A経費研究開発費30 Jun 2213-751531 Mar 2210-1051531 Dec 217-1451630 Sep 219-1251630 Jun 2110-1151631 Mar 2113-851631 Dec 2016-551630 Sep 2018-451630 Jun 2019-251731 Mar 2018-351731 Dec 1917-441830 Sep 1915-551530 Jun 1913-661331 Mar 199-861231 Dec 186-1161130 Sep 184-1451330 Jun 183-1741531 Mar 183-1741531 Dec 173-1851530 Sep 172-1541330 Jun 172-1341131 Mar 172-103831 Dec 161-72630 Sep 161-62530 Jun 161-52431 Mar 161-52431 Dec 150-41331 Dec 141-111質の高い収益: LYSは現在利益が出ていません。利益率の向上: LYSは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: LYSの過去 5 年間の前年比収益成長率がプラスであったかどうかを判断するにはデータが不十分です。成長の加速: LYSの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: LYSは利益が出ていないため、過去 1 年間の収益成長をBiotechs業界 ( 45% ) と比較することは困難です。株主資本利益率高いROE: LYSの負債は資産を上回っているため、自己資本利益率を計算することは困難です。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2023/07/08 06:49終値2023/07/06 00:00収益2022/06/30年間収益2021/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Lysogene S.A. これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。3 アナリスト機関Lea De CabezonGilbert DupontDelphine Le LouetSociete Generale Cross Asset ResearchEric Le BerrigaudStifel, formerly Bryan Garnier
Reported Earnings • Sep 24First 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.
Reported Earnings • Apr 01Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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 26First 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 19Full 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.
Reported Earnings • Sep 27First half earnings releasedOver 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.
お知らせ • May 29Lysogene Announces to Delist from EuronextLysogene 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.
お知らせ • Feb 04Lysogene Appoints Côme de La Tour du Pin as Chief Financial OfficerLysogene 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 16Price target increased to €11.00Up 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 24First 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 27Price target increased to €11.00Up 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 01Full year 2021 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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 26First 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.
分析記事 • May 05Breakeven On The Horizon For Lysogene S.A. (EPA:LYS)With the business potentially at an important milestone, we thought we'd take a closer look at Lysogene S.A.'s...
Reported Earnings • Apr 19Full 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.
分析記事 • Feb 17Lysogene (EPA:LYS) Shareholders Have Enjoyed A 5.9% Share Price GainIf you want to compound wealth in the stock market, you can do so by buying an index fund. But one can do better than...
お知らせ • Feb 16Lysogene Reports LYS-SAF302 Biomarker Data Presented at the WORLDSymposium 2021Lysogene 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.
お知らせ • Feb 12Lysogene 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 GangliosidosisLysogene 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 08New 90-day high: €3.26The 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.
お知らせ • Jan 25+ 2 more updatesLysogene S.A., Annual General Meeting, Jun 25, 2021Lysogene S.A., Annual General Meeting, Jun 25, 2021.
お知らせ • Jan 12Lysogene 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 GangliosidosisLysogene 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 28New 90-day high: €2.65The 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.
お知らせ • Dec 28Lysogene Reports Positive Biomarker Data With LYS-SAF302Lysogene 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 21New 90-day low: €2.06The 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.
お知らせ • Oct 15Lysogene Provides Update on the AAVance Clinical Trial Evaluating Lys-Saf302 in Patients with MPS IIIALysogene 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 30New 90-day low: €2.07The 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 27First half earnings releasedOver 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.