Breakeven Date Change • Jul 09
Forecast to breakeven in 2028 The analyst covering GenSight Biologics expects the company to break even for the first time. New forecast suggests the company will make a profit of €8.50m in 2028. Average annual earnings growth of 89% is required to achieve expected profit on schedule. Major Estimate Revision • Jul 05
Consensus EPS estimates upgraded to €0.44 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -€0.83 to -€0.437 per share. Revenue forecast unchanged from €5.50m at last update. Biotechs industry in France expected to see average net income growth of 6.0% next year. Consensus price target of €0.30 unchanged from last update. Share price rose 3.4% to €0.083 over the past week. Ankündigung • Apr 14
GenSight Biologics S.A., Annual General Meeting, May 19, 2026 GenSight Biologics S.A., Annual General Meeting, May 19, 2026. Location: 74 rue du faubourg saint antoine, paris France New Risk • Mar 29
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: €652k (US$751k) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€25m). Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Revenue is less than US$1m (€652k revenue, or US$751k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€8.9m net loss in 3 years). Share price has been volatile over the past 3 months (10.0% average weekly change). Market cap is less than US$100m (€18.9m market cap, or US$21.7m). Ankündigung • Mar 27
Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025 GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2025. For the year, the company expected revenues of EUR 1,000; total operating income of EUR 652,000; Operating loss of EUR 11,054,000; Net loss of EUR 12,036,000; Basic and diluted loss per share of EUR 0.08; and Total comprehensive loss of EUR 11,631,000. Ankündigung • Mar 10
GenSight Biologics S.A. Provides Updates About GS010/LUMEVOQ Early Access Programs And The Ongoing REVISE Study GenSight Biologics S.A. provided updates on the GS010/LUMEVOQ early access programs currently underway and the ongoing dose-ranging study REVISE. GS010/LUMEVOQ is the Company’s candidate gene therapy in clinical development as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene. Following the authorization of the AAC program by the national medicines safety agency ANSM in December 2025, individual applications that were submitted in February were approved. The Company is completing the administrative steps to finalize delivery of the product to the 15-20 National Hospital, where the treatments have been scheduled for mid- and late March. The dose-ranging study REVISE is progressing on schedule, with the first patient treated in February and the second patient expected to be enrolled over the next few weeks. A second patient in Israel was approved for treatment under the Paid Named Patient Program by the Israeli Ministry of Health. The Company is supporting the logistical activities to ship and administer the treatment by next quarter. A second US patient will be treated as part of the GS010/LUMEVOQ expanded access program after the FDA cleared the single patient IND for the patient in January 2026. The agency’s decision follows the treatment last year of the patient whose individual patient IND was cleared in October 2025. First payments for the treatments in France are expected to be received before the end of March. Although the Company is unable to predict the precise timing of the treatments and payments in the various early access programs in the coming year, the expected revenues in the aggregate, are expected to be sufficient to, at a minimum, ensure the Company’s operational continuity beyond the February 2026 cash horizon indicated in the January 8th press release and, in the ordinary course of business, through 2026. Beyond this baseline, the Company will continue its funding operations, on a dilutive and non-dilutive basis, to further extend the cash runway and in particular to finance the RECOVER Phase III trial. Ankündigung • Feb 18
Gensight Biologics Announces Executive Changes GenSight Biologics announced the strategic expansion of its Regulatory Affairs & Quality department with two senior appointments following recent regulatory milestones. The company named Fang Li, Ph.D., RAC, as Chief Regulatory Affairs & Quality Officer, and Sabrina Chekroun, Pharm.D., as Senior Vice President, Regulatory Affairs and Quality. Sabrina Chekroun will report to Fang Li. Fang Li is based in the U.S., and Sabrina Chekroun is based in France
Fang Li brings more than 30 years of experience in drug development, including over 25 years in Regulatory Affairs, with extensive expertise in global product development and approvals across the United States and other regions. She held senior regulatory leadership roles across various pharmaceutical and biotechnology companies, including Opthea Ltd, Oculis SA, Graybug Vision, and Iveric Bio, as well as regulatory positions at organizations such as Novartis, Alcon, Bausch + Lomb, and Warner Chilcott. Her experience in regulatory strategy spans the areas of small molecules, biologics, gene therapies, and medical devices. Dr. Li holds a Ph.D. in Medicinal Chemistry from China Pharmaceutical University, a Master’s degree in Organic Chemistry from Wuhan University, and a Bachelor’s degree in Organic Chemistry from Xiamen University. She is RAC (US) certified. Sabrina Chekroun brings more than 23 years of experience in international Regulatory Affairs, with positions in leading pharmaceutical companies such as Sanofi-Genzyme and AstraZeneca, as well as biotechnology companies such as Abivax and Advicenne, where she held senior leadership positions in Global Regulatory Affairs. She has extensive experience in defining and leading global regulatory strategies across Europe, the United States, and other regions, from early development through post-marketing authorization, with a strong focus on orphan drugs and rare diseases. Ms. Chekroun holds a Doctor of Pharmacy degree from the University of Algiers, a Master’s degree in Industrial Pharmaceutics from the University of Tours, and a Master’s degree in Health Law and Management from the University of Paris XI. Ankündigung • Feb 10
The 15-20 National Hospital and Gensight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ Revise Study The 15-20 National Hospital (l'Hopital national des 15-20) in Paris and GenSight Biologics announced the treatment of the first patient enrolled in the REVISE dose-ranging study. The open-label, single center study aims to enroll 14 patients in France. With REVISE now underway, the hospital is currently the only institution in Europe with a clinical study involving GS010/LUMEVOQ, GenSight Biologics' candidate gene therapy being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene1. The named patient requests, each of which resulted from a multidisciplinary consultation, will be individually evaluated by the agency. Enrollment into REVISE is prioritized for patients eligible for both programs. LHON is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells, which results in precipitous and usually irreversible vision loss and typically leads to legal blindness. The ND4 mitochondrial mutation is the most common of the mutations that cause LHON and is associated with the worst prognosis among the leading mutations. A hospital with national standing and university teaching, the 15-20 National Hospital brings together the best medical and care teams and provides dedicated care for visual diseases. In 2018, the hospital founded, with the Institut de la vision, the University Hospital Institute (IHU) FOReSIGHT, whose mission is to promote fundamental research to develop tomorrow's ophthalmology care and provide access to therapeutic innovations through international partnerships and the development of companies involved in preventing and treating eye diseases. Ankündigung • Jan 08
GenSight Biologics S.A. announced that it has received funding GenSight Biologics S.A. announced a private placement of Pre-Funded Warrants giving the right to subscribe to 6,571,428 additional ordinary shares of the company, on January 7, 2026. Ankündigung • Dec 03
GenSight Biologics Announces Regulatory Approval for GS010/LUMEVOQ REVISE Dose-Ranging Study in France GenSight Biologics announced that the French medicines safety agency ANSM (Agence nationale de securite du medicament et des produits de sante) has authorized the dose-ranging study REVISE, which will investigate the efficacy and safety of two dose levels of the Company's candidate gene therapy GS010/LUMEVOQ. Two (2) clinical doses will be investigated in the trial, with patients distributed equally over the two doses. Efficacy, as measured by the change in Best Corrected Visual Acuity (BCVA), 1.5 years post-treatment versus baseline, is the primary endpoint in REVISE. The study is expected to begin in January 2026. While the AAC application is under review, GenSight Biologics is moving forward according to target timelines with the final stages of the technology transfer to its new manufacturing partner and with the preparations to finalize the protocol for the Phase III study. In parallel, the Company is pursuing opportunities to out-license GS010 in markets outside the USA and Europe, while exploring paid Early Access Programs worldwide. LHON is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells, which results in precipitous and usually irreversible vision loss and typically leads to legal blindness. The ND4 mitochondrial mutation is the most common of the mutations that cause LHON and is associated with the worst prognosis among the leading mutations. Ankündigung • Oct 30
GenSight Biologics Announces Regulatory Authorizations for Individual Patient Expanded Access Treatment with GS010/LUMEVOQ in the US GenSight Biologics announced that the Company's gene therapy GS010/LUMEVOQ has been granted regulatory authorizations for an Individual Patient Expanded Access in the United States. The authorizations mark the first set of regulatory green lights for the candidate product since the Company's withdrawal of its European marketing authorization application in 2023. FDA authorization was granted for expanded access treatment of one eligible patient, based on an application by a physician at the University of Pittsburgh School of Medicine (UPMC) to the agency. The required approval of the school's Institutional Review Board (IRB) was also granted. The patient is scheduled to be treated in November 2025. GS010/LUMEVoQ is in Phase III of its clinical development as a treatment for the rare blinding disease Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene and has not received marketing authorization in any country. The Company is currently completing the technology transfer to its new manufacturing partner, Catalent, which is expected to be finalized by year-end 2025. The transition will enable the production of new batches in 2026 to address the full scope of projected clinical and early access needs. GenSight Biologics is preparing for the launch in H2 2026 of the pivotal Phase III study RECOVER for GS010/LUMEV OQ, while engaging with the French medicines agency ANSM regarding a dose-ranging study the agency requested in connection with an Early Access Program (AAC) in France. Reported Earnings • Oct 05
First half 2025 earnings released: €0.054 loss per share (vs €0.071 loss in 1H 2024) First half 2025 results: €0.054 loss per share. Net loss: €6.97m (loss widened 19% from 1H 2024). Revenue is forecast to grow 97% p.a. on average during the next 3 years, compared to a 25% growth forecast for the Biotechs industry in France. Ankündigung • Jul 24
GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million. GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 2,941,176
Price\Range: €0.17
Transaction Features: Reserved Share Offering Major Estimate Revision • Jul 10
Consensus EPS estimates upgraded to €0.22 loss, revenue downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from €7.25m to €6.95m. 2025 losses expected to reduce from -€0.385 to -€0.22 per share. Biotechs industry in France expected to see average net income growth of 9.1% next year. Consensus price target up from €0.36 to €0.46. Share price fell 13% to €0.13 over the past week. Ankündigung • Jul 04
GenSight Biologics S.A. announced that it has received funding GenSight Biologics S.A. announced a private placement of 1,850,000 pre-funded warrants giving the right to subscribe to 1,850,000 additional ordinary shares on July 3, 2025. New Risk • Jul 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 47% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-€27m). Earnings are forecast to decline by an average of 67% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (47% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€66m net loss in 2 years). Revenue is less than US$5m (€2.6m revenue, or US$3.1m). Market cap is less than US$100m (€25.3m market cap, or US$29.7m). Ankündigung • Jun 26
GenSight Biologics Announces Significant Milestone in New Manufacturing Partnership with Catalent GenSight Biologics announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ®?, the Company's gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent Inc. New Risk • Apr 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (12% average weekly change). Negative equity (-€27m). Earnings are forecast to decline by an average of 67% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (67% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€66m net loss in 2 years). Revenue is less than US$5m (€2.6m revenue, or US$3.0m). Market cap is less than US$100m (€32.5m market cap, or US$37.0m). Reported Earnings • Apr 08
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: €0.15 loss per share (improved from €0.54 loss in FY 2023). Revenue: €2.63m (down 11% from FY 2023). Net loss: €14.0m (loss narrowed 47% from FY 2023). Revenue missed analyst estimates by 52%. Earnings per share (EPS) exceeded analyst estimates by 72%. Revenue is forecast to grow 37% p.a. on average during the next 2 years, compared to a 25% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 32% per year but the company’s share price has fallen by 54% per year, which means it is significantly lagging earnings. Ankündigung • Apr 08
GenSight Biologics S.A., Annual General Meeting, May 13, 2025 GenSight Biologics S.A., Annual General Meeting, May 13, 2025. Location: 74 rue du faubourg saint antoine, paris France Ankündigung • Mar 07
GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million. GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 3,829,355
Price\Range: €0.2248
Security Features: Attached Warrants
Transaction Features: Subsequent Direct Listing Ankündigung • Mar 01
GenSight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2024 GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2024. For the year, the company expected revenues of EUR 1,500,000; total operating income of EUR 2,625,000; Operating loss of EUR 15,813,000; Net loss of EUR 14,001,000; Basic and diluted loss per share of EUR 0.15; and Total comprehensive loss of EUR 14,172,000. Ankündigung • Jan 15
GenSight Biologics Announces Publication of 5-Year Outcomes for Patients Treated Unilaterally with LUMEVOQ Gene Therapy GenSight Biologics announced the publication of outcomes data from five years’ follow-up of patients treated unilaterally with LUMEVOQ, the company’s investigational gene therapy for Leber Hereditary Optic Neuropathy due to a mutated ND4 mitochondrial gene. The patients had all participated in the Phase III trials RESCUE and REVERSE and accepted enrolling into the long-term study RESTORE at the end of the RESCUE and REVERSE studies. The paper, published online by the leading journal JAMA Ophthalmology in December 2024, found that patients “demonstrated a sustained bilateral improvement in BCVA [Best-Corrected Visual Acuity] and a good safety profile over 5 years after treatment”. The “persistent benefit” continues the durable effect observed at earlier time points and represents a significant addition to the body of evidence on the benefit-risk ratio of LUMEVOQ gene therapy in ND4 LHON patients. When RESTORE participants enrolled in the study, 2 years after the one-time injection, they had already experienced clinically meaningful improvement relative to the lowest point of their Best-Corrected Visual Acuity: +20 ETDRS letters equivalent in their LUMEVOQ®-treated eyes and +17 ETDRS letters equivalent in their sham-treated eyes. Five years after treatment, the bilateral improvement from nadir was sustained, with LUMEVOQ®-treated eyes achieving a mean improvement against nadir of +22 letters equivalent and sham-treated eyes demonstrating a mean improvement of +20 letters equivalent. Responder analyses at Year 5 indicate that improved BCVA was a benefit for a substantial proportion of the study participants. 66.1% of RESTORE participants achieved clinically meaningful (at least +3 lines’ improvement) from nadir in at least one eye, and the proportion rises to 71.0% if the criterion used is Clinically Relevant Recovery against nadir. At the end of the five-year follow-up period, 80.6% of participants had on-chart vision (BCVA = 1.6 LogMAR) in at least one eye. The impact of such results on patients is demonstrated by increases in the self-reported quality of life scores at Year 5 vs. baseline. Clinically significant improvement from baseline was observed in 7 of 10 subscale scores of the NEI VFQ-25 questionnaire used to assess quality of life. The composite score showed a clinically meaningful gain of 7 points from baseline. Safety findings at 5 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ is well-tolerated. The systemic safety was excellent and most ocular events were mild, none were severe or serious, and none led to study discontinuation. RESTORE is one of the larger long-term follow-up studies for a rare disease treatment, with 62 participants accepting the invitation to enroll. All participants were treated with a single intravitreal injection of LUMEVOQ in one eye and with sham injection in the other. New Risk • Nov 22
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€16m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€16m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€25m). Earnings are forecast to decline by an average of 49% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (150% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€51m net loss in 2 years). Revenue is less than US$5m (€2.0m revenue, or US$2.1m). Market cap is less than US$100m (€36.7m market cap, or US$38.2m). Ankündigung • Nov 13
GenSight Biologics Announces Submission of LUMEVOQ Dossier to ANSM to Prepare for Restart of Early Access Program in France GenSight Biologics S.A. announced the submission of the updated regulatory file for LUMEVOQ gene therapy to the French medicines safety agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to prepare for the restart of the early access (AAC) program in France. The submission documents the successful manufacture of LUMEVOQ, including the blending of two GMP drug substance batches to optimize the number of vials available for clinical use and the passing of all required quality control tests. LUMEVOQ is being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene, a rare mitochondrial genetic disease that causes acute and usually irreversible loss of vision. The updated regulatory file will support the ANSM’s assessment of individual applications for compassionate use, which can now be submitted by healthcare professionals under the rules of the AAC program. GenSight Biologics anticipates a review period for these applications and will work closely with the ANSM to optimize the assessment timeline. GenSight Biologics is preparing to initiate the supply of the drug to the designated treatment center, the Quinze-Vingts hospital in Paris, in mid-December. In parallel, the Company is working with the hospital’s administrative and medical teams to enable the first injections to be administered by the end of December. Reported Earnings • Sep 30
First half 2024 earnings released: €0.071 loss per share (vs €0.26 loss in 1H 2023) First half 2024 results: €0.071 loss per share (improved from €0.26 loss in 1H 2023). Net loss: €5.85m (loss narrowed 51% from 1H 2023). Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 34% growth forecast for the Biotechs industry in France. New Risk • Sep 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€16m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-€16m free cash flow). Negative equity (-€25m). Earnings are forecast to decline by an average of 49% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (129% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€51m net loss in 2 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Revenue is less than US$5m (€2.0m revenue, or US$2.2m). Market cap is less than US$100m (€36.4m market cap, or US$40.7m). New Risk • Aug 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 9.8% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.8% average weekly change). Negative equity (-€31m). Earnings are forecast to decline by an average of 34% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (124% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€66m net loss in 3 years). Revenue is less than US$5m (€3.0m revenue, or US$3.3m). Market cap is less than US$100m (€39.4m market cap, or US$43.7m). Ankündigung • Jul 23
GenSight Biologics S.A. Provides Business Update GenSight Biologics S.A. announced that the manufacture of LUMEVOQ drug product, which required an additional blending step to optimize the number of vials available for the early access program, was successfully performed in July as scheduled. Vials from the batch are now being tested for conformity to the required quality control standards. After accounting for testing requirements, over 100 vials could be available for patients. The full set of quality control results are expected in early September. If the quality control criteria are met, the Company expects to be ready to resumption the AAC program in late September 2024. In parallel, the Company has been engaging with the French medicines safety agency ANSM (Agence Nationale de Securite du Medicament et des produits de sante) and working with the Quinze-Vingts Hospital in Paris, France, to prepare for the resumption of the AAC program, as long anticipated by patients. New Risk • Apr 24
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 69% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€31m). Earnings are forecast to decline by an average of 10.0% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (69% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€36m net loss in 3 years). Revenue is less than US$5m (€3.0m revenue, or US$3.2m). Market cap is less than US$100m (€31.8m market cap, or US$34.0m). Reported Earnings • Apr 22
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: €0.54 loss per share (improved from €0.60 loss in FY 2022). Revenue: €2.96m (down 39% from FY 2022). Net loss: €26.2m (loss narrowed 5.1% from FY 2022). Products in clinical trials Phase I: 1 Phase III: 1 Post-clinical trial products Pre-registration: 1 Revenue exceeded analyst estimates by 36%. Earnings per share (EPS) also surpassed analyst estimates by 6.9%. Revenue is forecast to grow 24% p.a. on average during the next 3 years, compared to a 35% growth forecast for the Biotechs industry in France. Ankündigung • Apr 05
GenSight Biologics S.A. to Report First Half, 2024 Final Results on Sep 23, 2024 GenSight Biologics S.A. announced that they will report first half, 2024 final results on Sep 23, 2024 New Risk • Mar 12
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€27m). Earnings are forecast to decline by an average of 5.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (69% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€31m net loss in 3 years). Revenue is less than US$5m (€3.3m revenue, or US$3.6m). Market cap is less than US$100m (€38.9m market cap, or US$42.5m). Ankündigung • Mar 12
GenSight Biologics Announces Initial Results from New Meta-Analyses on Visual Outcomes with LUMEVOQ® Gene Therapy at NANOS 2024 GenSight Biologics announced initial results of new meta-analyses in Leber Hereditary Optic Neuropathy (LHON), which show those treated with LUMEVOQ® (GS010; lenadogene nolparvovec) gene therapy experienced a rate of visual recovery greater than that of idebenone-treated patients and untreated (natural history) patients. The meta-analyses are the first to focus solely on patients with the m.11778G>A ND4 mutation, which is the most common mutation and one with a poor visual prognosis. The meta-analyses depict a gradient of efficacy of visual recovery with LUMEVOQ® intravitreal gene therapy resulting in greater recovery rates than that of idebenone treatment, and both greater than that in the natural history of the disease. This gradient of recovery, based on the CRR measure of visual improvement, is observed at both eye level and patient level(response in one or both eyes). There is no overlap in confidence intervals when LUMEVOQ® is compared to idebenone and to natural history, indicating a positive difference in visual outcomes. Ankündigung • Mar 06
GenSight Biologics Announces Update on Real-World Data from Early Access Programs of LUMEVOQ® Gene Therapy at NANOS 2024 GenSight Biologics has unveiled promising findings from recent real-world data gathered through early access programs (EAP). These data reinforce the efficacy and safety of LUMEVOQ® in patients with Leber Hereditary Optic Neuropathy (LHON) stemming from the ND4 mutation (ND4-LHON), corroborating outcomes observed in clinical trials. Notably, patients who received bilateral injections exhibited a remarkable average gain of +23 ETDRS letters in best-corrected visual acuity (BCVA) from nadir, surpassing the gains seen in patients with unilateral injections. These results, presented at the 2024 annual meeting of the North American Neuro-Ophthalmology Society (NANOS), indicate significant visual improvement among a majority of treated patients. Dr. Chiara La Morgia, MD, PhD, emphasized the consistency and robustness of these findings, underlining their relevance for patients grappling with severe vision impairment. With a more comprehensive dataset compared to earlier releases, these analyses offer a definitive perspective on the sustained upward trajectory of mean visual acuity post-treatment, further supporting the viability of lenadogene nolparvovec as a therapeutic option. Additionally, safety assessments aligned with previous clinical studies, affirming the favorable safety profile of LUMEVOQ® with comparable rates of intraocular inflammation events. These promising outcomes herald a new chapter in the treatment landscape for LHON patients, promising hope and tangible benefits for those afflicted with this debilitating condition. New Risk • Feb 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 69% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€27m). Shareholders have been substantially diluted in the past year (69% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€26m net loss in 2 years). Share price has been volatile over the past 3 months (7.6% average weekly change). Revenue is less than US$5m (€3.3m revenue, or US$3.6m). Market cap is less than US$100m (€30.9m market cap, or US$33.3m). Ankündigung • Feb 08
GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million. GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 13,061,651
Price\Range: €0.3828
Transaction Features: Subsequent Direct Listing Ankündigung • Jan 26
Gensight Biologics S.A. Announces CFO Changes GenSight Biologics S.A. announced that Thomas Gidoin, Chief Financial Officer since 2015, has resigned, effective January 26, 2024. An interim CFO was appointed until a permanent replacement is recruited. New Risk • Jan 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 21% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-€27m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€26m net loss in 2 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (€3.3m revenue, or US$3.6m). Market cap is less than US$100m (€23.9m market cap, or US$26.0m). Ankündigung • Jan 17
GenSight Biologics Announces Board Changes The Board of Directors of GenSight Biologics acknowledged the resignation of Mr. Bernard Gilly from his position as director. The Board of Directors of the Company also announced its decision, after consultation of the Nomination Committee, to co-opt Mrs. Laurence Rodriguez as director for the remainder of Bernard Gilly’s term of office (expiring at the end of the annual shareholders meeting to be held in 2024 to approve the financial statements for the financial year ending December 31, 2023). The co-optation of Laurence Rodriguez will be subject to ratification by the next shareholders’ meeting of the Company. Laurence Rodriguez appointment as Chief Executive Officer became effective on December 21, 2023. She has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ®'s commercialization and created strong relationships with the stakeholders. Ankündigung • Dec 22
GenSight Biologics S.A. Announces CEO Changes GenSight Biologics announced the appointment of Mrs. Laurence Rodriguez, as new Chief Executive Officer. Laurence Rodriguez has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ's commercialization and created strong and trustworthy relationships with the various stakeholders. Laurence Rodriguez holds a Bachelor’s degree in Nutrition and Biochemistry and a Master’s degree from Sciences Po, Paris, France, and completed an Organization Leadership Program at the Harvard Business School. The board of directors thanked Bernard Gilly, co-founder of the Company in 2012 together with Pr. José-Alain Sahel, for his many years of dedication to the Company and his essential contribution to make LUMEVOQ a life changing therapy. He will remain a director of the Company while he no longer assumes operational responsibilities. Major Estimate Revision • Nov 24
Consensus revenue estimates decrease by 12%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from €2.50m to €2.20m. EPS estimate increased from -€0.62 to -€0.58 per share. Biotechs industry in France expected to see average net income growth of 25% next year. Consensus price target of €1.45 unchanged from last update. Share price fell 9.2% to €0.47 over the past week. Ankündigung • Nov 17
Gensight Biologics S.A. Confirms Second Successful GMP Batch of Lumevoq GenSight Biologics S.A. announced that an independent laboratory confirmed the vg titer from the second drug substance (DS) batch of LUMEVOQ manufactured under conditions compliant with Good Manufacturing Practice (GMP) standards. As a result from the confirmation, the Company became eligible to draw down the second tranche of the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises (the "Bridge Financing"). The drawdown of the second tranche will also trigger the automatic conversion of the convertible bonds from the €6 million first tranche at a conversion price of EUR 0.7122. This second tranche, amounting to €4 million, will extend the Company’s cash runway to mid-December 2023. GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing in order to supplement its working capital requirements and fund its operating expenses beyond that date and until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date. Ankündigung • Nov 14
GenSight Biologics S.A. Announces Preliminary Assay Indicating Successful Manufacture of Second LUMEVOQ® GMP Batch GenSight Biologics S.A. announced that a preliminary assay of the viral genome (vg) titer indicates the successful manufacture of a second batch of drug substance (DS) for LUMEVOQ®, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. The assay, while preliminary, is known to be predictive of the final result at the independent laboratory used for the official release assay. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy from the drug substance of this batch may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. Preparations are underway for the third GMP batch of the campaign planned by the Company. As with the two batches successfully manufactured so far, all of which are outside the context of a validation campaign1, the third batch will generate more process data for a future Marketing Authorisation Application (MAA) submission, provide more experience of the manufacturing process to the operating teams, and help fulfill the immediate requirement of supplying product for the new RECOVER clinical trial and for the potential resumption of an early access program for patients in the beginning of the second quarter of 2024. GenSight Biologics will communicate further in the next few days when the vg titer results are confirmed by the independent laboratory. Upon this confirmation, the Company would be eligible to drawdown the second tranche of €4 million from the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises. The cash runway would be extended to mid-December 2023 with the drawdown of the second tranche of the Bridge Financing for an amount of €4 million. Following the drawdown of the second tranche, GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing beyond that date in order to supplement its working capital requirements and fund its operating expenses until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date. Ankündigung • Sep 27
GenSight Biologics Provides Update on European Medicines Agency Scientific Advice for LUMEVOQ GenSight Biologics provided an update on the scientific advice it received from the European Medicines Agency (EMA) regarding the design of a new Phase III trial for LUMEVOQ, the Company's gene therapy for LHON caused by a mutated ND4 mitochondrial gene. The new study, which will be called RECOVER, will be a randomized controlled trial with a two-arm design: a sham control arm, in which a sham procedure mimics an injection into each eye but no substance is injected into the eye, and a treatment arm, in which subjects will be given bilateral intravitreal injections of LUMEVOQ (also known as GS010) The Agency found that the "proposed study design with bilateral administration appears acceptable to assess the benefits of GS010 in patients who require both eyes to be treated". The proposed study design also contains an open-label provision, in which subjects in the sham arm will be eligible to receive LUMEVOQ bilateral injection if the primary endpoint is met. The Agency provided further guidance on planned statistical analyses and advised on topics that the Company will consider as it refines and finalizes the study design. The RECOVER study is designed to address the questions raised by the EMA's Committee for Advanced Therapies (CAT) when it reviewed the MAA filed in 2020. The Company decided to withdraw the dossier in April 2023 to be able to discuss the Agency's concerns more fully. RECOVER will be able to begin recruiting once the design is finalized; the product is manufactured and released for human use; and approval is obtained from local competent authorities and ethics committees. GenSight expects to initiate the study in second quarter 2024 and to have it completed by second quarter 2026. GenSight also plans to share key aspects of RECOVER's design with other regulatory authorities such as the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA). An initial discussion with the MHRA is scheduled to take place in November 2023. The Company plans to engage with the FDA in the coming months, so that RECOVER results will be accepted by all major regulatory authorities. Ankündigung • Sep 18
GenSight Biologics Announces Successful Manufacture of LUMEVOQ GMP Batch GenSight Biologics announced that the Company's manufacturing partner in the US has successfully manufactured the drug substance (DS) for LUMEVOQ®?, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. The manufacturing of a second GMP DS batch, which will increase the amount that can be made available to patients, is already underway, with vg titer results expected in October 2023. GenSight is planning to manufacture at least 3 GMP batches at commercial scale outside the context of a validation campaign1, to generate more process data for a future Marketing Authorisation Application (MAA) submission, to provide more experience of the manufacturing process to the operating teams, and to fulfil the immediate requirement of supplying product for a possible new clinical trial and for the potential resumption of an early access program for patients in first quarter of 2024. Reported Earnings • Sep 18
First half 2023 earnings released: €0.26 loss per share (vs €0.23 loss in 1H 2022) First half 2023 results: €0.26 loss per share (further deteriorated from €0.23 loss in 1H 2022). Net loss: €12.0m (loss widened 12% from 1H 2022). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 48% per year, which means it is significantly lagging earnings. Major Estimate Revision • Jun 18
Consensus revenue estimates decrease by 17%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from €2.70m to €2.25m. EPS estimate increased from -€0.755 to -€0.625 per share. Biotechs industry in France expected to see average net income growth of 0.3% next year. Consensus price target down from €2.00 to €1.80. Share price rose 13% to €0.86 over the past week. Breakeven Date Change • Apr 27
Forecast to breakeven in 2025 The 2 analysts covering GenSight Biologics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €5.80m in 2025. Average annual earnings growth of 49% is required to achieve expected profit on schedule. Breakeven Date Change • Apr 23
No longer forecast to breakeven The 2 analysts covering GenSight Biologics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €5.80m in 2025. New consensus forecast suggests the company will make a loss of €53.8m in 2025. Breakeven Date Change • Apr 06
Forecast to breakeven in 2025 The 2 analysts covering GenSight Biologics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 34% per year to 2024. The company is expected to make a profit of €5.80m in 2025. Average annual earnings growth of 49% is required to achieve expected profit on schedule. Reported Earnings • Mar 27
Full year 2022 earnings: EPS and revenues exceed analyst expectations Full year 2022 results: €0.60 loss per share (improved from €0.63 loss in FY 2021). Revenue: €4.90m (down 36% from FY 2021). Net loss: €27.6m (loss narrowed 3.6% from FY 2021). Post-clinical trial products Pre-registration: 1 Revenue exceeded analyst estimates by 14%. Earnings per share (EPS) also surpassed analyst estimates by 25%. Revenue is forecast to grow 81% p.a. on average during the next 2 years, compared to a 24% growth forecast for the Biotechs industry in France. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has only increased by 5% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Mar 24
Forecast to breakeven in 2024 The 3 analysts covering GenSight Biologics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 35% per year to 2023. The company is expected to make a profit of €4.70m in 2024. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Ankündigung • Feb 13
GenSight Biologics Announces 1 Year Safety Data and Efficacy Signals GenSight Biologics announced favorable safety data and encouraging efficacy signals at 1 year post-gene therapy administration for the PIONEER Phase I/II clinical trial evaluating GS030 for the treatment of retinitis pigmentosa (RP) in 9 patients, with a follow-up up to 4 years (n=1). RP is a genetic blinding disease that affects between 15,000 and 20,000 new patients each year in the US and the EU for which there is currently no treatment. PIONEER is a first-in-human, multi-center, open-label dose escalation clinical trial evaluating the safety and tolerability of GS030, an optogenetic treatment candidate combining an AAV2- based gene therapy (GS030-DP) with the use of light-stimulating goggles (GS030-MD) in patients with end-stage RP. This therapeutic approach is independent of the causal mutation and therefore applicable to potentially all patients suffering from end-stage RP. Three cohorts of three patients each were administered one of three doses of GS030-DP (5e10 vg; 1.5e11 vg; 5e11 vg) via a single intravitreal injection in their worst affected eye (i.e., the least-seeing eye). A Data Safety Monitoring Board (DSMB) reviewed the safety data of all treated subjects in each cohort and made recommendations before the extension cohort was enrolled. Based on the good safety profile of GS030, the DSMB recommended selecting the highest dose (5e11 vg) for the extension cohort where patients are currently being recruited. The safety and tolerability results in the first three completed cohorts recorded only mild and moderate (grade 1 and 2) ocular adverse events (AEs) but no severe (grade 3) AEs, with a follow-up up to 4 years (n=1). The most common ocular AEs were mild intraocular inflammation responsive to corticosteroid treatment. Intraocular inflammation occurred in 70% of patients and resolved without sequalae in all patients. The first use of GS030-MD was performed 8 weeks after injection under medical supervision and the light-stimulating goggles were well tolerated. Subjects performed multiple training sessions in parallel to scheduled study visits. The patients from the highest dose cohort have reached 1-year post-gene therapy administration, enabling the assessment of efficacy signals at one year for the 3 cohorts. Encouraging signs of efficacy at 1 year were demonstrated in some patients after GS030 optogenetic treatment with a vision that improved from being barely able to perceive light before treatment to being able to locate and count objects, with the best results at the highest dose. Price Target Changed • Nov 16
Price target decreased to €10.67 Down from €14.33, the current price target is an average from 3 analysts. New target price is 212% above last closing price of €3.42. Stock is down 48% over the past year. The company is forecast to post a net loss per share of €0.79 next year compared to a net loss per share of €0.63 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 9 highly experienced directors. Independent Director Maritza McIntyre was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Board Change • Aug 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 9 highly experienced directors. Independent Director Maritza McIntyre was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Jul 28
First half 2022 earnings released First half 2022 results: Net income: (up €8.30m from 1H 2021). Over the next year, revenue is forecast to grow 82%, compared to a 104% growth forecast for the industry in France. Over the last 3 years on average, earnings per share has increased by 28% per year whereas the company’s share price has increased by 24% per year. Board Change • Jul 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 9 highly experienced directors. Independent Director Maritza McIntyre was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Price Target Changed • Apr 27
Price target decreased to €12.50 Down from €14.33, the current price target is an average from 3 analysts. New target price is 532% above last closing price of €1.98. Stock is down 78% over the past year. The company is forecast to post a net loss per share of €0.45 next year compared to a net loss per share of €0.63 last year. Reported Earnings • Apr 11
Full year 2021 earnings: EPS and revenues miss analyst expectations Full year 2021 results: €0.63 loss per share (up from €0.97 loss in FY 2020). Revenue: €7.70m (up 3.5% from FY 2020). Net loss: €28.6m (loss narrowed 16% from FY 2020). Post-clinical trial products Pre-registration: 1 Revenue missed analyst estimates by 38%. Earnings per share (EPS) also missed analyst estimates by 26%. Over the next year, revenue is forecast to grow 182%, compared to a 310% growth forecast for the pharmaceuticals industry in France. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth. Major Estimate Revision • Apr 09
Consensus revenue estimates increase by 19% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from €18.3m to €21.8m. Forecast losses expected to reduce from -€0.58 to -€0.45 per share. Biotechs industry in France expected to see average net income growth of 9.9% next year. Consensus price target down from €14.33 to €12.50. Share price fell 37% to €2.14 over the past week. Price Target Changed • Apr 08
Price target decreased to €12.50 Down from €15.00, the current price target is an average from 3 analysts. New target price is 484% above last closing price of €2.14. Stock is down 71% over the past year. The company is forecast to post a net loss per share of €0.50 next year compared to a net loss per share of €0.97 last year. Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 3 analysts covering GenSight Biologics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of €23.7m in 2024. Average annual earnings growth of 58% is required to achieve expected profit on schedule. Price Target Changed • Nov 08
Price target decreased to €15.00 Down from €17.00, the current price target is an average from 3 analysts. New target price is 175% above last closing price of €5.45. Stock is up 28% over the past year. The company is forecast to post a net loss per share of €0.50 next year compared to a net loss per share of €0.97 last year. Price Target Changed • Nov 05
Price target decreased to €16.00 Down from €17.67, the current price target is an average from 3 analysts. New target price is 200% above last closing price of €5.33. Stock is up 38% over the past year. The company is forecast to post a net loss per share of €0.50 next year compared to a net loss per share of €0.97 last year. Reported Earnings • Aug 02
First half 2021 earnings released: €0.19 loss per share (vs €0.43 loss in 1H 2020) The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: €6.90m (up 111% from 1H 2020). Net loss: €8.30m (loss narrowed 41% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has increased by 53% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Apr 12
Full year 2020 earnings released: €0.97 loss per share (vs €1.09 loss in FY 2019) The company reported a solid full year result with improved revenues and control over costs, although losses increased. Full year 2020 results: Revenue: €7.44m (up 52% from FY 2019). Net loss: €34.0m (loss widened 10% from FY 2019). Products in clinical trials Phase I: 1 Phase III: 1 Post-clinical trial products Pre-registration: 1 Over the last 3 years on average, earnings per share has increased by 7% per year but the company’s share price has increased by 35% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • Mar 11
Full year 2020 earnings released: €0.97 loss per share (vs €1.08 loss in FY 2019) The company reported a solid full year result with improved revenues and control over costs, although losses increased. Full year 2020 results: Revenue: €7.40m (up 51% from FY 2019). Net loss: €34.0m (loss widened 11% from FY 2019). Products in clinical trials Phase I: 1 Post-clinical trial products Pre-registration: 1 Over the last 3 years on average, earnings per share has increased by 7% per year whereas the company’s share price has increased by 8% per year. Analyst Estimate Surprise Post Earnings • Mar 11
Earnings beat expectations, revenue disappoints Revenue missed analyst estimates by 21%. Earnings per share (EPS) exceeded analyst estimates by 82%. Over the next year, revenue is forecast to grow 141%, compared to a 26,375% growth forecast for the Biotechs industry in France. Is New 90 Day High Low • Feb 25
New 90-day high: €9.26 The company is up 56% from its price of €5.94 on 26 November 2020. The French market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 26% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €1.32 per share. 
