Latest news with #Nyxoah
Yahoo
7 days ago
- Business
- Yahoo
Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Nyxoah Announces Preliminary Results for the Second Quarter of 2025 Mont-Saint-Guibert, Belgium – August 11, 2025, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited financial results for the second quarter of 2025 and other business updates. Preliminary, Unaudited Second Quarter 2025 Financial Results and Business Updates Announced on August 8, 2025, that the U.S. Food and Drug Administration (FDA) has approved the Genio® system for a subset of adult patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Press Releases | Nyxoah Investors Revenue for the second quarter of 2025 is anticipated to be approximately €1.3 million, a 73% increase over the second quarter of 2024. Operating expenses for the second quarter of 2025 are anticipated to be approximately €20.7 million, a 50% increase over the second quarter of 2024. Cash, cash equivalents and financial assets are anticipated to be approximately €43.0 million at June 30, 2025. The Company also has a term debt facility with €27.5 million of remaining availability which can be drawn down in two equal tranches subject to revenue and other financial milestones. The Company expects to close patient enrollment in its ACCCESS clinical trial prior to enrolling all 106 potential patients. The study will continue, with the patients currently enrolled, with the co-primary endpoints, Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates, assessed at 12 months post implant and followed for five years. The Company reorganized its global R&D function and expects to transition all ongoing R&D activities from Israel to the U.S. and Belgium. The Company received notice that Inspire Medical Systems, Inc. ('Inspire') filed a lawsuit against the Company in the United States alleging infringement of certain patents owned by Inspire. The Company is well prepared, has the means and intends to vigorously defend itself in this matter. 'We are pleased with the growth we saw in the second quarter, which provides further evidence that our commercial proof of concept in Germany has been successful,' commented Olivier Taelman, Chief Executive Officer. 'With FDA approval in hand, we expect to take the lessons learned from Germany and apply them to the U.S. as we bring our unique Genio system to the U.S. In addition, we believe that the patient population currently enrolled in the ACCCESS study will provide statistically significant results, which along with the outcomes from prior clinical evidence, will provide meaningful data with respect to the safety and efficacy of using Genio therapy in the patient population suffering from Complete Concentric Collapse ('CCC'). Patients with CCC represent a significant unmet need in the treatment of OSA as no FDA approved treatment currently exists.' The preliminary, unaudited financial results described in this press release, including preliminary revenue and operating expenses for the second quarter of 2025 and preliminary cash, cash equivalents and financial assets as of June 30, 2025, are estimates only. These financial results could change as a result of further review. Accordingly, you should not place undue reliance on this information. Complete financial results for the second quarter of 2025 will be announced and issued on Monday, August 18, 2025 after NASDAQ market close. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q2 2025 Earnings Call Webcast. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the U.S. Food and Drug Administration (FDA) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. For more information, please visit Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device. FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Company's financial results for the second quarter ended June 30, 2025; the Company's estimates of revenue and operating expenses for the second quarter of 2025 and cash, cash equivalents and financial assets as of June 30, 2025; the Genio system; planned and ongoing clinical studies of the Genio system, including the ACCCESS study; the potential advantages of the Genio system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio system; the Company's commercialization strategy and entrance to the U.S. market; the Company's plans to transition its ongoing R&D activities to the U.S. and Belgium; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press NyxoahJohn Landry, CFOIR@ For MediaIn United StatesFINN Partners – Alyssa Paldo In International/GermanyMC Services – Anne Hennecke nyxoah@ In Belgium/FranceBackstage Communication – Gunther De Backer gunther@ 531708903v.1 Attachment Preliminary Results 2Q and 1st Half 25 PR-531708903-v5Sign in to access your portfolio
Business Insider
09-08-2025
- Health
- Business Insider
Nyxoah receives FDA approval for Genio system
Nyxoah (NYXH) announced that the FDA has approved the Genio system for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index of greater than or equal to 15 and less than or equal to 65. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Business Insider
23-05-2025
- Business
- Business Insider
Kepler Capital Reaffirms Their Buy Rating on Nyxoah (NYXH)
Kepler Capital analyst Christophe dombu maintained a Buy rating on Nyxoah (NYXH – Research Report) on May 21 and set a price target of €14.50. The company's shares closed yesterday at $8.32. Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter According to TipRanks, dombu is ranked #8607 out of 9537 analysts. Currently, the analyst consensus on Nyxoah is a Strong Buy with an average price target of $14.49, implying a 74.16% upside from current levels. In a report released on May 19, Cantor Fitzgerald also reiterated a Buy rating on the stock with a $14.00 price target. The company has a one-year high of $11.87 and a one-year low of $5.55. Currently, Nyxoah has an average volume of 156K.
Yahoo
14-05-2025
- Business
- Yahoo
Nyxoah SA (NYXH) Reports Q1 Loss, Lags Revenue Estimates
Nyxoah SA (NYXH) came out with a quarterly loss of $0.63 per share versus the Zacks Consensus Estimate of a loss of $0.49. This compares to loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -28.57%. A quarter ago, it was expected that this company would post a loss of $0.50 per share when it actually produced a loss of $0.49, delivering a surprise of 2%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Nyxoah , which belongs to the Zacks Medical Info Systems industry, posted revenues of $1.12 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 29.71%. This compares to year-ago revenues of $1.33 million. The company has not been able to beat consensus revenue estimates over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Nyxoah shares have lost about 27.8% since the beginning of the year versus the S&P 500's gain of 0.1%. While Nyxoah has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Nyxoah: mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.54 on $2.12 million in revenues for the coming quarter and -$2.25 on $15.16 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Info Systems is currently in the top 20% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Veeva Systems (VEEV), is yet to report results for the quarter ended April 2025. The results are expected to be released on May 28. This provider of cloud-based software services for the life sciences industry is expected to post quarterly earnings of $1.74 per share in its upcoming report, which represents a year-over-year change of +16%. The consensus EPS estimate for the quarter has been revised 0.2% lower over the last 30 days to the current level. Veeva Systems' revenues are expected to be $727.99 million, up 11.9% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Nyxoah SA (NYXH) : Free Stock Analysis Report Veeva Systems Inc. (VEEV) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Bahrain News Gazette
08-05-2025
- Business
- Bahrain News Gazette
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025 Mont-Saint-Guibert, Belgium – Wednesday May 7, 2025, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ('Nyxoah' or the 'Company'), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the Company will release financial results for the first quarter of 2025 on Wednesday, May 14, 2025. Company management will host a conference call to discuss financial results that day beginning 2:00pm CET / 8:00am ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q1 2025 Earnings Call Webcast . For those not planning to ask a question of management, the Company recommends listening via the webcast. If you plan to ask a question, please use the following link: Nyxoah's Q1 2025 Earnings Call . After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call. The archived webcast will be available for replay shortly after the close of the call. About Nyxoah Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors' therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study. For more information, please visit . Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States FORWARD-LOOKING STATEMENTS Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. Contacts: Nyxoah John Landry, CFO [email protected] For Media In United States FINN Partners – Alyssa Paldo [email protected] In International/Germany MC Services – Anne Hennecke [email protected] In Belgium/France Backstage Communication – Gunther De Backer [email protected] Attachment ENGLISH_Q1 Earnings Call Announcement_FINAL GlobeNewswire Distribution ID 1001095238
