New Risk • May 04
New major risk - Financial data availability The company's latest financial reports are more than a year old. Last reported fiscal period ended December 2023. This is considered a major risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. In the worst case scenario, it may be facing other major going concern issues jeopardizing its viability as a listed company. Currently, the following risks have been identified for the company: Major Risks Latest financial reports are more than 1 year old (reported December 2023 fiscal period end). Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-€14m). Revenue is less than US$1m. Market cap is less than US$10m (€1.91m market cap, or US$2.16m). New Risk • Nov 18
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Negative equity (-€14m). Earnings have declined by 8.6% per year over the past 5 years. Revenue is less than US$1m. Market cap is less than US$10m (€1.92m market cap, or US$2.03m). Minor Risks Latest financial reports are more than 6 months old (reported December 2023 fiscal period end). Shareholders have been diluted in the past year (19% increase in shares outstanding). Price Target Changed • Jul 02
Price target decreased by 49% to €2.05 Down from €4.00, the current price target is an average from 2 analysts. New target price is 791% above last closing price of €0.23. Stock is down 86% over the past year. The company is forecast to post earnings per share of €0.03 next year compared to a net loss per share of €0.59 last year. Announcement • Jun 28
GeNeuro Announces Results of the Gnc-501 Study in Post-Covid-19 Syndrome GeNeuro SA announced the GNC-501 clinical trial is a Phase 2 study in patients suffering from post-COVID-19 neuropsychiatric diseases, testing temelimab against placebo. The study enrolled over 200 patients in Switzerland, Spain and Italy who had tested positive for HERV-W ENV. The top-line results from this study show that treated patients had no clinically meaningful improvement compared to placebo on the primary endpoint measuring the improvement of fatigue with the PROMIS SF7a test. The majority of secondary endpoints did not show an effect either. The treatment was very well tolerated and safe, consistent with previous clinical trials in other indications. Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures. The Company will continue to analyze complete results once they become available, including additional biomarkers. GeNeuro thanks all the study participants, the investigators and all other site personnel for their commitment that made this novel study possible. The learnings from this study will certainly advance the knowledge of this new disease affecting millions of persons worldwide. Announcement • May 18
GeNeuro SA Announces Last Patient Last Visit in Its Post-Covid Trial and Confirms Top-Line Results by End of June 2024 GeNeuro SA announced that the last patient enrolled in the GNC-501 trial of temelimab against post-COVID has now completed the study. The trial "Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" (GNC-501) is a randomized, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the safety and the efficacy of the treatment with temelimab, a monoclonal antibody neutralizing the pathogenic HERV-W ENV protein. The trial has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy. All patients included in the study were tested positive for the expression of the HERV W-ENV protein, which is a key factor in the activation of the innate immune response and is suspected to have a major role in the persistence of inflammation and in the broad spectrum of neurological symptoms affecting patients with post-COVID. Over 1/3 of the patients screened had detectable W-ENV protein expression in blood, suggesting that temelimab could become a relevant treatment option for a large subset of this underserved patient population. All enrolled patients received 6 intravenous infusions of temelimab or placebo (1 to 1 randomization) over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelIMab on the improvement in fatigue and cognitive impairment measures. Announcement • Mar 21
Geneuro SA Announces Appointments of Board of Directors GeNeuro SA at its Extraordinary General Meeting (EGM) of March 18, 2024, approved election of two new Members of the Board of Directors, Mrs. Sandrine Flory, Chief Financial Officer of Institut Mérieux, and Mr. Pascal Lemaire, Chief Financial Officer of Servier. New Risk • Feb 19
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 19% 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 (13% average weekly change). Negative equity (-€5.5m). Earnings are forecast to decline by an average of 29% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€13m net loss in 2 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (€32.6m market cap, or US$35.1m). Announcement • Feb 02
GeNeuro SA has completed a Follow-on Equity Offering in the amount of €4.900246 million. GeNeuro SA has completed a Follow-on Equity Offering in the amount of €4.900246 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 4,666,901
Price\Range: €1.05
Transaction Features: Subsequent Direct Listing Announcement • Dec 11
Geneuro S.A. Recommends Continuing the Trial Evaluating Temelimab in Long Covid Without Modifications GeNeuro announced that, as planned in the Study Protocol, the Independent Data Monitoring Committee met to review the unblinded safety and efficacy data of the first 90 patients after three months of treatment. Based on the planned interim analysis of efficacy and safety data, which included an analysis for futility, the IDMC recommended to "continue the trial without any modifications". The study "Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" is a randomized, placebo-controlled, biomarker-based Phase 2 clinical trial evaluating the effect of temelimab treatment on the clinical course of these symptoms. This trial enrolled 203 patients in 14 clinical centers in Switzerland, Spain and Italy, who were affected by neurological syndromes post-COVID, and who tested positive to the presence of W-ENV in their blood. W-ENV is expected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro's precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant. Results are expected in June 2024. New Risk • Dec 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 32% 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 (12% average weekly change). Negative equity (-€5.5m). Earnings are forecast to decline by an average of 32% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Less than 1 year of cash runway based on current free cash flow (-€15m). Currently unprofitable and not forecast to become profitable over next 2 years (€13m net loss in 2 years). Market cap is less than US$100m (€26.1m market cap, or US$28.1m). Breakeven Date Change • Dec 08
Forecast to breakeven in 2024 The analyst covering GeNeuro expects the company to break even for the first time. New forecast suggests losses will reduce by 20% to 2023. The company is expected to make a profit of €1.10m in 2024. Announcement • Nov 29
GeNeuro Announces Completion of Recruitment of its Long-COVID Phase 2 Trial and Confirms Top-Line Results for June 2024 GeNeuro announced the completion of the recruitment of its Phase 2 trial evaluating temelimab against long-COVID. The trial “Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome” is a randomized, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the effect of the treatment with temelimab on the clinical course of these symptoms. The trial has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy. All enrolled patients receive 6 intravenous infusions of temelimab or placebo (1 to 1 randomization) over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelimab on the improvement in fatigue and cognitive impairment measures. The recruitment of the trial has already demonstrated that the expression of the pathogenic W-ENV protein, triggered by the SARS-CoV-2 infection, may continue long after the acute phase has been resolved. Over one third of the patients presenting long-COVID syndromes who were screened were positive to the presence of W-ENV in their blood. W-ENV is suspected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro’s precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant. The development of temelimab (GNbAC1) is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years within Institut Mérieux and INSERM before GeNeuro was founded in 2006. HERVs have been incorporated into the human genome during the evolution of mankind and typically remain “silent genes”, but may be activated under certain conditions and were found to be involved in the development of auto-immune diseases. The viral envelope protein encoded by the HERV-W family (W-ENV) has been found to be pro-inflammatory and pathogenic to nervous system cells. W-ENV is found in the brains of MS patients, and particularly in active lesions. In two Phase II multiple sclerosis trials Temelimab has shown promising results on MRI features and liquid biomarkers related to neurodegenerative processes such as brain atrophy. Temelimab is a neutralizing anti-W-ENV-antibody; by this capacity it simultaneously blocks inflammatory and neurodegenerative processes. Given that W-ENV has no known physiological function, temelimab has demonstrated a good safety and tolerability profile in the current study, with no effect on the patient’s immune system, which bears out the profile observed in all clinical trials carried out to date. New Risk • Oct 20
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€5.5m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. 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 (-€15m free cash flow). Share price has been highly volatile over the past 3 months (11% average weekly change). Negative equity (-€5.5m). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (€9.5m net loss next year). Market cap is less than US$100m (€38.0m market cap, or US$40.3m). New Risk • Oct 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of French stocks, typically moving 5.9% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (€9.5m net loss next year). Share price has been volatile over the past 3 months (5.9% average weekly change). Market cap is less than US$100m (€32.6m market cap, or US$34.2m). Announcement • Sep 12
GeNeuro SA Announces Recent Study Demonstrates the Strong Link Between SARS-CoV-2 Infection and HERV-W Activation in Hospitalized Psychotic Patients GeNeuro SA announced, in collaboration with Professor Marion Leboyer from the FondaMental Foundation, and Dr Ryad Tamouza, head immunologist for the immuno-psychiatry team, the publication in the leading scientific publication Translational Psychiatry of a new study showing that over 80% of the patients hospitalized in a psychiatry department near Paris during the first wave of the COVID-19 pandemic had been exposed to SARS-CoV-2, i.e., 1.6 times more than for the control group. 27% of patients with non-vaccinal SARS-COV-2 positive serology corresponded to the previously described mental disorder subgroup associating HERV-W expression. These results are confronted to those of a recent study has shown showing that the SARS-CoV- 2 virus causing COVID-19 can trigger the activation of the HERV-Wretrovirus, which may result in post-infectious syndromes or diseases associated with persistent HERV-W ENV expression in genetically predisposed individuals. Several specific factors explaining asymptomatic or unrecorded COVID-19 in these in-patients, hospitalized in the Psychiatry Department of the Creteil-Paris VII university hospital in France have also been suggested. The authors conclude that this now well defined subgroup of inflammatory psychoses calls for the development of a differential therapeutic approach in psychoses and more specifically through the identification and development of further HERV-related precision medicine therapies. Preliminary results of this study were presented in 2022 at the Schizophrenia International Research Society (SIRS) Conference, in Florence, Italy, in the dedicated session on HERVs and psychoses chaired by Prof. Robert Yolken (Johns Hopkins University, Baltimore, USA). Announcement • Jul 26
GeNeuro SA to Report First Half, 2023 Results on Sep 29, 2023 GeNeuro SA announced that they will report first half, 2023 results on Sep 29, 2023 New Risk • Jul 07
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: €12m Forecast net loss in 2 years: €11m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. 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 (-€13m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€11m net loss in 2 years). Market cap is less than US$100m (€41.8m market cap, or US$45.8m). Board Change • Jun 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 3 highly experienced directors. Independent Director Philippe Archinard was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 25
GeNeuro SA, Annual General Meeting, Jun 14, 2023 GeNeuro SA, Annual General Meeting, Jun 14, 2023, at 15:00 Central European Standard Time. Location: head office, 3, chemin du Pré-Fleuri, 1228 Plan-les-Ouates Geneva Switzerland Price Target Changed • Nov 16
Price target decreased to €5.55 Down from €6.55, the current price target is an average from 2 analysts. New target price is 243% above last closing price of €1.62. Stock is down 57% over the past year. The company is forecast to post a net loss per share of €0.88 next year compared to a net loss per share of €0.32 last year. Board Change • Nov 16
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Hedi Ben Brahim was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Apr 27
Price target decreased to €5.55 Down from €6.55, the current price target is provided by 1 analyst. New target price is 83% above last closing price of €3.04. Stock is down 40% over the past year. The company is forecast to post a net loss per share of €0.33 next year compared to a net loss per share of €0.32 last year. Board Change • Apr 27
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 4 experienced directors. 2 highly experienced directors. Independent Director Hedi Ben Brahim was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Major Estimate Revision • Jun 18
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 losses forecast to reduce from -€0.73 to -€0.17 per share. Revenue forecast unchanged from €10.4m at last update. Biotechs industry in France expected to see average net income growth of 0.07% next year. Consensus price target of €6.55 unchanged from last update. Share price was steady at €3.66 over the past week. Is New 90 Day High Low • Jan 26
New 90-day high: €3.92 The company is up 46% from its price of €2.69 on 28 October 2020. The French market is up 15% over the last 90 days, indicating the company outperformed over that time. However, its price trend is similar to the Biotechs industry, which is also up 46% over the same period. Is New 90 Day High Low • Dec 23
New 90-day low: €2.60 The company is down 18% from its price of €3.18 on 24 September 2020. The French market is up 14% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 32% over the same period. Is New 90 Day High Low • Nov 10
New 90-day low: €2.62 The company is down 16% from its price of €3.13 on 11 August 2020. The French market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 13% over the same period. Is New 90 Day High Low • Oct 21
New 90-day low: €3.00 The company is down 14% from its price of €3.48 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. Is New 90 Day High Low • Oct 05
New 90-day low: €3.01 The company is down 19% from its price of €3.70 on 07 July 2020. The French market is down 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 7.0% over the same period.