Stock Markets
GeNeuro Reports 2023 Full-Year Results and Provides Corporate Update
- Phase 2 clinical trial of temelimab against neuropsychiatric syndromes of Post-COVID (GNC-501):
- Recruitment completed in November 2023;
- Topline results planned for end of June 2024.
- Cash position of €2.8m as of December 31, 2023, including the €1m pre-financing of Research tax Credit received in January 2024
- Financial visibility into the third quarter of 2024 taking into account the €5m capital increase completed in Q1 2024
GENEVA–(BUSINESS WIRE)–Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 “ GNRO), a biopharmaceutical company focused on halting the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the post-acute sequelae of COVID-19 (PASC, long COVID or post-COVID), reported today its full-year results for the year ended December 31, 2023, and provided a corporate update.
With the completion in February 2024 of a EUR 5 million capital increase, GeNeuro’s cash position provides financial visibility into 3Q 2024 based on its current activities.
2023 was an important year for GeNeuro, with the completion of patient recruitment of our GNC-501 Phase 2 trial evaluating temelimab against post-COVID. GeNeuro is conducting the first personalized medicine clinical trial against neuropsychiatric syndromes affecting Post-COVID patients, and we are now looking forward to the topline results at the end of June 2024. This trial benefits from an important financial backing from the Swiss and European authorities who seek potential therapeutic solutions to address a major public health problem which affects millions of patients, said Jesús Martin-Garcia, CEO of GeNeuro. In our other main indication, multiple sclerosis, we have continued 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.
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PRODUCT DEVELOPMENT HIGHLIGHTS
Multiple Sclerosis (MS)
In MS, GeNeuro is focused on combating neurodegeneration. The Company has completed three Phase 2 clinical trials, the latest, which was completed in 2022, in patients with relapsing-remitting MS under treatment with rituximab, a monoclonal anti-CD20 antibody that is highly potent and effective against the acute course of the disease (inflammatory relapses and brain lesion formation). The results from this study were presented in October 2022 at the ECTRIMS scientific congress and have shown that the primary endpoint of the ProTEct-MS study was met, with results confirming the excellent safety profile and tolerability of higher doses of temelimab administered concomitantly with a high-efficacy anti-inflammatory drug; in addition, efficacy data, obtained in these patients already effectively treated against inflammation, showed that temelimab has a favorable impact on key MRI and liquid measures of neurodegeneration. Given the high costs of the international clinical trials necessary to confirm efficacy and register a product in MS with both the FDA and the EMA, which the Company estimates to exceed €100 million, continued development in MS requires a partnership and GeNeuro has continued discussions with potential partners to define the best development path for combining existing anti-inflammatory treatments, to treat relapses, with temelimab to treat neurodegeneration and disability progression, the key unmet medical need in MS.
Post-COVID
GeNeuro is currently running a Phase 2 clinical trial with temelimab to treat, during six months, patients suffering from severe neurological and psychiatric (neuropsychiatric) symptoms post-COVID. GeNeuro has completed the recruitment of 203 patients in this clinical trial in November 2023, and is expecting its results for June 2024. This trial, partly financed by the Swiss Federal Office of Public Health (FOPH) through a grant of CHF 6.7 million ( €7 million) by the European Investment Bank through a €7 million venture debt financing, results from research conducted following the COVID-19 pandemic and the emergence of post-COVID, leading to published results that (1) evidenced the presence of W-ENV in the serum of patients suffering from acute COVID; (2) evidenced that SARS-CoV-2 is able to induce the in vitro expression of W-ENV in human blood cells of approximately 20% of the samples of healthy volunteers; and (3) have shown that the W-ENV protein is present in more than 25% of post- COVID patients. This placebo-controlled double-blind study is the largest one to date in this indication and the only one based on a precision medicine approach, as each enrolled patient has been tested positively for the presence of W-ENV. This study includes numerous clinical endpoints, including the primary endpoint which is the measure of fatigue in the patients; as there is today no available disease-modifying therapy against post-COVID syndromes, positive results could lead to accelerated processes to make temelimab rapidly available to the millions of patients affected by severe post-COVID in Europe and in the USA.
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Amyotrophic Lateral Sclerosis (ALS)
GeNeuro’s pre-clinical program in ALS, developed in partnership with the NINDS in the United States, has achieved a very strong preclinical proof of concept, published in major scientific publications such as Annals of Neurology, and confirmed by third-party research groups.; The continuation of the Company program towards IND submission, with a timing target of 18 months after such fundraising, requires a specific financing estimated at €7 million.
KEY FINANCIALS 2023
The Board of Directors of GeNeuro reviewed and approved the financial statements for the year ended December 31, 2023. The Statutory Auditors have conducted a review of the annual consolidated financial statements.
GeNeuro (in thousands of EUR) |
|
| 31/12/2023 | 31/12/2022 | ||
Income |
|
| – |
| – |
|
Research and development expenses |
|
|
|
| ||
Research and development expenses |
|
| (12,492.1 | ) | (9,833.2 | ) |
Subsidies |
|
| 1,143.4 |
| 1,825.8 |
|
General and administrative expenses |
|
| (3,008.6 | ) | (3,221.8 | ) |
Operating loss |
|
| (14,357.3 | ) | (11,229.2 | ) |
|
|
|
|
| ||
Net loss for the period |
|
| (14,757.0 | ) | (12,199.8 | ) |
|
|
|
|
| ||
|
|
| 31/12/2023 | 31/12/2022 | ||
Basic losses per share (EUR/share) |
|
| (0.59 | ) | (0.51 | ) |
Diluted losses per share (EUR/share) |
|
| (0.59 | ) | (0.51 | ) |
Due to its development stage, the Company generated no income in 2023 or 2022.
Research & Development expenses increased by €2.7 million in 2023 compared to 2022, due to the expenses incurred in connection with the Post-COVID program, which led to an increase of €2.6 million in studies and research in connection with the GNC-501 clinical trial. R&D payroll expense increased by €0.1 million and other costs remained broadly in line with the levels observed in 2022. Despite the higher level of studies and research expenses, subsidies (under the form of research tax credits linked to R&D activities) decreased by €0.8 million in 2023 over 2022 as the bulk of the Company’s GNC-501 Phase 2 clinical trial activities are conducted out of the Swiss parent and are therefore not eligible for French Research Tax Credit; other subsidies increased from K € 509 to K € 588; these other subsidies include K € 140 of debt cancellation from Bpifrance in connection with the K € 200 reimbursable advance that had been granted to GeNeuro Innovation SAS in 2011, K € 182 from the European Union HERVCOV grant and K € 265 of subsidies accounted for in connection with the Swiss FOPH grant. As a result, net R&D expenses increased by 42%, or €3.3 million in 2022 compared to 2021.
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General and administrative expenses decreased by €0.2 million in 2023, as GeNeuro replaced the cash bonuses for staff and management by stock options, resulting in a reduction of payroll expense by €0.2 million in 2023 compared to 2022.
Cash and cash equivalents amounted to €1.8 million at December 31, 2023, compared to €5.6 million at December 31, 2022. In addition, in January 2024 2024 the Company implemented a €1 million bank non-recourse pre-financing for the 2022 Research Tax Credit and completed in February 2024 a €5 million capital increase. The Company’s reported cash consumption (i.e., cash outflow from operating activities, given the low level of capital expenditures and investment in intangible assets) was €10.1 million in 2023 compared to €13.1 million in 2022; this €3.0 million decrease was due primarily to the positive €3.9 million impact from the change in working capital in 2023 compared to a negative impact of €1.9 million in 2022, as a result of higher trade payables and accrued liabilities and the reduction of other current assets. With the GNC-501 clinical trial ending in June 2024, cash consumption is expected to decrease significantly during 2024.
BUSINESS OUTLOOK
GeNeuro’s priorities for 2024 are focused on the completion of the GNC-501 trial, with topline results planned for end of June 2024 and, subject to positive results, the preparation of a Phase 3 and/or of the temporary marketing authorization. In MS, GeNeuro will continue discussions with potential partners to define the best development path combining temelimab and anti-neuroinflammatory treatments to bring the synergistic benefits of temelimab to MS patients. As for ALS, GeNeuro continues to seek specific funding for this program, which would allow to bring this project to an IND within 18 months.
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2024 FIRST-QUARTER FINANCIAL INFORMATION
On March 31, 2024, the Company had a cash position of €2.9 million. This includes the net proceeds of € 5 million capital increase and the cash consumption for the quarter. The available cash resources provide GeNeuro with good visibility into mid Q3-2024.
For Q1 2024, the cash consumption related to GeNeuro’s operating and investing activities was €2.9 million, compared to €3.0 million for the same period of 2023. The Q1 2024 cash consumption included the reduction of working capital in connection with trade payables for the Phase 2 clinical trial in Post-COVID. The Company expects its quarterly cash consumption to decrease during 2024 as the post-COVID clinical trial will be completed in June 2024.
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 17 patent families protecting its technology.
For more information, visit: www.geneuro.com
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.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20240430799385/en/
GeNeuro
Jesús Martin-Garcia
Chairman and CEO
+41 22 552 4800
investors@geneuro.com
NewCap (France)
Mathilde Bohin / Louis-Victor Delouvrier (investors)
+33 1 44 71 98 52
Arthur Rouillé (media)
+33 1 44 71 94 98
geneuro@newcap.eu
Source: GeNeuro
Accolade, Inc. (NASDAQ:ACCD) Chief Financial Officer Stephen H. Barnes recently engaged in transactions involving the company’s stock, according to the latest SEC filings. Barnes sold a total of $880 worth of common stock at an average price of $7.273 per share to cover tax withholding obligations related to the vesting of Restricted Stock Units (RSUs).
The transactions, which took place on May 17, 2024, were part of a “mandatory sell to cover” transaction and were not discretionary sales by Barnes. This type of sale is commonly used by executives to satisfy tax obligations that arise when equity awards, such as RSUs, vest and are settled.
The RSUs, each representing a contingent right to receive one share of Accolade’s common stock, were converted into 415 shares of common stock. Following the conversion and the subsequent sale to cover taxes, Barnes’s ownership in the company’s common stock stood at 179,366 shares.
Investors often monitor insider transactions as they can provide insights into an executive’s view of the company’s future prospects. However, in this case, the sales were not discretionary and were solely for the purpose of fulfilling tax requirements associated with the RSUs.
Accolade, Inc., headquartered in Plymouth Meeting, Pennsylvania, operates within the business services sector, providing personalized health and benefits solutions designed to improve the experience, outcomes, and cost of healthcare.
The transactions are detailed in the Form 4 filed with the Securities and Exchange Commission, which provides information on trades made by the company’s officers, directors, and beneficial owners.
InvestingPro Insights
Amid recent insider transactions by Accolade, Inc.’s (NASDAQ:ACCD) CFO, investors are closely observing the company’s financial health and stock performance. As per InvestingPro data, Accolade’s market capitalization stands at 586.11 million USD, reflecting the company’s current valuation in the market. Despite challenges, the company has managed to achieve a revenue growth of 14.09% over the last twelve months as of Q4 2024, indicating a potential for expansion and scaling.
According to InvestingPro Tips, Accolade’s stock price has been quite volatile, with a one-month price total return showing a significant decline of -18.07%. This volatility could be a factor for investors to consider, especially for those with a lower risk tolerance. The company’s stock has also fared poorly over the last month, which may influence investor sentiment and the perception of the company’s near-term prospects.
Another key metric that stands out is the company’s gross profit margin, which is reported to be 46.52% for the same period. This suggests that while Accolade is generating a solid profit on its services, its operating income margin of -27.42% highlights operational challenges that are impacting the bottom line.
For investors seeking a deeper understanding of Accolade’s financial position and future outlook, additional InvestingPro Tips are available. With a total of 7 additional tips on the platform, interested parties can gain comprehensive insights into Accolade’s performance and potential investment opportunities. To access these insights and become better informed, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
On Monday, Jefferies revised its financial outlook on Teladoc Health Inc (NYSE:), reducing the stock price target to $14.00 from the previous $16.00 while maintaining a Hold rating. The adjustment follows the evaluation of the company’s first-quarter results and the latest guidance provided by its management. The firm has moderated its expectations for Teladoc’s BetterHelp business, noting that year-over-year comparisons are showing a negative trend.
The firm’s analyst stated that the updated model takes into account the recent quarterly performance and comments from the management team. As a result, the revenue and EBITDA forecasts for the fiscal years 2024 through 2026 have been revised.
The new projections for revenue are now set at $2,625 million for 2024, $2,724 million for 2025, and $2,798 million for 2026. Similarly, the EBITDA estimates have been adjusted to $362 million for 2024, $393 million for 2025, and $414 million for 2026.
These updated figures represent a decrease from the previous estimates, which had the revenue at $2,671 million for 2024, $2,738 million for 2025, and $2,794 million for 2026, with EBITDA at $367 million for 2024, $391 million for 2025, and $409 million for 2026. The changes reflect a more conservative outlook for the company’s performance over the next few years.
The analyst reiterated the Hold rating on Teladoc shares, suggesting that investors maintain their current positions without increasing or decreasing their stake in the company. The revised price target and financial estimates are based on the latest available data and the firm’s analysis of the company’s business trajectory.
Teladoc Health Inc, listed on the New York Stock Exchange, is a telemedicine and virtual healthcare company. It has been closely watched by investors as the telehealth sector experiences shifts in consumer behavior and regulatory environments. The updated guidance from Jefferies provides a current perspective on the company’s financial health and market position.
InvestingPro Insights
As Teladoc Health Inc (NYSE:TDOC) navigates through a challenging period, real-time data from InvestingPro offers additional context to Jefferies’ revised financial outlook. The company’s market capitalization stands at $2.11 billion, reflecting its current valuation in the market.
Despite the downward revision of earnings by analysts, Teladoc’s valuation implies a strong free cash flow yield, suggesting potential for investor returns. Still, it is critical to note that analysts do not expect the company to be profitable this year, which is an important consideration for investors.
On a positive note, Teladoc’s liquid assets surpass its short-term obligations, indicating a degree of financial flexibility. Yet, the firm is trading near its 52-week low and has not been profitable over the last twelve months, factors that might concern investors looking for immediate profitability.
Moreover, the stock has seen a significant price drop over the last three months, which could either signal a buying opportunity for value investors or a red flag for those wary of declining stock performance.
Investors interested in a deeper analysis can find more InvestingPro Tips on Teladoc, including insights on EBITDA valuation multiples and dividend policies. For those looking to leverage these insights, InvestingPro offers additional tips—more than eight for Teladoc alone. To enrich your investment decision-making, consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Top 10 national builder now selling at The Aurora Highlands
AURORA, Colo., May 20, 2024 /PRNewswire/ — Century Communities (NYSE:), Inc.”one of the nation’s largest homebuilders, an industry leader in online home sales, and the highest-ranked homebuilder on Newsweek’s list of America’s Most Trustworthy Companies 2024”announced that it’s joined The Aurora Highlands, a 4,000-acre planned community, boasting exceptional amenities like a park with a carousel and a future Beach Club with indoor and outdoor swimming pools.
Now selling from the mid $500s, the company is offering a mix of ranch and two-story floor plans from its popular Colorado Collection”with select homes featuring walkout basements, covered patios, 3-bay garages and more. In addition, a model home is now available for tours, showcasing the community’s stunning two-story Vail II plan.
Learn more and explore available homes at www.CenturyCommunities.com/AuroraHighlands.
THE AURORA HIGHLANDS
Now selling from the mid $500s
- Ranch and two-story floor plans
- 3 to 5 bedrooms, up to 2,433 square feet
- 2- to 3-bay garages
- Model home for tour (Vail II plan)
- 4,000-acre planned community
- Winged Melody Park with a carousel, playground, garden and live music stage
- Planned Beach Club with indoor and outdoor pools
- Planned Ice and Recreation Center with a hockey rink, basketball court, climbing wall and more
- Quick access to E-470, downtown Denver, the Denver Tech Center, and Denver International Airport
Location:
3422 N. Highlands Creek Parkway
Aurora, CO 80019
303.558.7373
DISCOVER THE FREEDOM OF ONLINE HOMEBUYING:
Century Communities is proud to feature its industry-first online homebuying experience on all available homes in Colorado.
How it works:
- Shop homes at CenturyCommunities.com
- Click “Buy Now” on any available home
- Fill out a quick Buy Online form
- Electronically submit an initial earnest money deposit
- Electronically sign a purchase contract via DocuSign ®
Learn more about the Buy Online experience at www.CenturyCommunities.com/online-homebuying.
About Century Communities
Century Communities, Inc. (NYSE: CCS) is one of the nation’s largest homebuilders, an industry leader in online home sales, and the highest-ranked homebuilder on Newsweek’s list of America’s Most Trustworthy Companies 2024, consecutively awarded for a second year. Through its Century Communities and Century Complete brands, Century’s mission is to build attractive, high-quality homes at affordable prices to provide its valued customers with A HOME FOR EVERY DREAM ®. Century is engaged in all aspects of homebuilding ” including the acquisition, entitlement and development of land, along with the construction, innovative marketing and sale of quality homes designed to appeal to a wide range of homebuyers. The Company operates in 18 states and over 45 markets across the U.S., and also offers title, insurance and lending services in select markets through its Parkway Title, IHL Home Insurance Agency, and Inspire Home Loans subsidiaries. To learn more about Century Communities, please visit www.centurycommunities.com.
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