Geneva - GeNeuro, a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, long-COVID or post-COVID), today reported its half-year financial results for the period ending June 30, 2023 and provided a corporate update.
Key Financials
On September 26, 2023, the Board of Directors of GeNeuro reviewed and approved the financial statements for the six-month period ended June 30, 2023. The auditors have conducted a review of the condensed consolidated interim financial statements.
'GeNeuro is currently running the first biomarker-based medicine clinical trial against neuropsychiatric syndromes affecting Long-COVID patients. This ground-breaking trial benefits from the important financial backing by the Swiss and European authorities who seek credible potential therapeutic solutions to address a major public health problem which affects millions of patients. As a reminder, in March 2023 GeNeuro entered into a EUR25 million credit agreement with the European Investment Bank ('EIB'), supported by the InvestEU program. With the recent opening of new sites in Madrid, Spain, and in Rome, Italy, the clinical trial now counts fourteen sites recruiting patients in Switzerland, Spain and Italy, and we aim to present the top-line results in Q2 2024,' said Jesus Martin-Garcia, CEO of GeNeuro. 'Following the presentation of our successful ProTEct-MS Phase II results in MS, we continue our discussions with potential partners to define the best development path combining temelimab and anti-inflammatory treatments to treat relapses and disability progression, the key unmet medical need in MS.'
'As we had previously announced, our available cash resources provide GeNeuro with financial visibility into Q3 2024', said Miguel Payro, Chief Financial Officer at GeNeuro. 'The financial results for the first half of 2023, which are largely in line with our expectations, reflect the significant increase in activity in connection with our long-COVID trial. Indeed, during the first half of 2023 our gross R&D expenses increased by 30% compared to the same period of 2022, due to the ramp-up of our GNC-501 Phase 2 clinical trial treating long-COVID patients with severe neurological and psychiatric symptoms with temelimab. At the same time, the amount of subsidies and grants has reduced from EUR1.2 million to EUR0.7 million, as the bulk of our R&D activities are conducted by the Group's Swiss parent. As for our general and administrative expenses, they have increased by 17%, largely due to the effect of inflation on a number of cost items, to the continued decrease of the euro vs. the Swiss franc (minus 4.5% during 1H 2023) and to a resumption of travel activities to meet investors and partners. Overall, the operating loss has increased from EUR4.9m to EUR7.1m in 1H 2023. This loss is broadly in line with our expectations. Thanks to the drawdown in March of the first tranche of EUR7.0 million from the EIB financing for our Long-COVID program, our financial visibility is confirmed into 3Q 2024.'
Cash burn from operating and investing activities in 1H 2023 was EUR4.7m, compared to EUR2.5m in 1H 2022, which benefited from the collection of EUR3.0 million from the first instalment from the Swiss Federal Office for Public Health (FOPH) subsidy for the long-COVID trial. Excluding this instalment from the 1H 2022 numbers, cash burn was lower by EUR0.8m during the first half of 1H 2023. The Company expects its cash consumption to remain stable during the second half of 2023 as the long-COVID clinical trial advances.
About GeNeuro
GeNeuro's mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which represent 8% of human DNA. GeNeuro is based in Geneva, Switzerland and has R&D facilities in Lyon, France. It has rights to 18 patent families protecting its technology.
Contact:
Tel: +33 1 44 71 98 52
Disclaimer
This press release contains certain forward - looking statements and estimates concerning GeNeuro's financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words such as 'anticipate,' 'believe,' 'can,' 'could,' 'estimate,' 'expect,' 'intend,' 'is designed to,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'objective,' 'should,' or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management's current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the Company's control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.
GENEURO SA 
