ROSEN, A LEADING LAW FIRM, Encourages Stanley Black & Decker, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – SWK

NEW YORK, May 16, 2023 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the common stock of Stanley Black & Decker, Inc. (NYSE: SWK) between October 28, 2021 and July 28, 2022, both dates inclusive (the “Class Period”), of the important May 23, 2023 lead plaintiff deadline.

SO WHAT: If you purchased Stanley Black & Decker securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Stanley Black & Decker class action, go to https://rosenlegal.com/submit-form/?case_id=13771 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 23, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) rising interest rates, inflation, and trends in returning to work away from home were in fact quickly eroding then heightened demand for Stanley’s tools and outdoor products; (2) the heightened, extraordinary demand Stanley had enjoyed as a result of the COVID-19 pandemic in 2021 and 2022 was returning to 2019 pre-pandemic levels; (3) Stanley’s operations were already showing signs of slowing demand; (4) as a result of reorganization, share repurchasing, and dividend growth, Stanley lacked the cash to react with agility to changes in demand; (5) as a result of Stanley’s inability to react to a sharp decline in demand, the Company’s results and metrics, particularly sales volume, were severely negatively impacted; and (6) as a result, the Company’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Stanley Black & Decker class action, go to https://rosenlegal.com/submit-form/?case_id=13771 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

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Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

GlobeNewswire Distribution ID 8840717

Nyxoah Reports First Quarter 2023 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2023 Financial and Operating Results

Mont-Saint-Guibert, Belgium – May 16, 2023 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2023.

Recent Financial and Operating Highlights

  •  Completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected in the first quarter of 2024.
  •  Initiated the modular PMA submission with the filing of the first module.
  •  Submitted 12-month data1 on the first 34 DREAM patients as a late-breaking abstract to SLEEP 2023 demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. The abstract will be presented in a late-breaking poster session on June 6th. These data are preliminary and not conclusive of final DREAM success.
  •  Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC). Implant completion expected in 2024.
  •  Hired Christoph Eigenmann as Chief Commercial Officer.
  •  Raised €19 million from new and historical shareholders including ResMed, Cochlear and Robert Taub, Nyxoah’s Chairman and Founder.
  •  Ended the quarter with 40 active German accounts and quarterly sales of €441 thousand.
  •  Expanded European market access with first implants in Austria.
  •  Strengthened the supply chain with the Belgium manufacturing facility receiving clearance from the EU notified body.

“In 2023, our focus is in the U.S. on DREAM patient follow up resulting in reaching the primary endpoints. I am excited by the data on the first 34 patients and look forward to sharing the full abstract results at SLEEP 2023 next month. Our increasing conviction in DREAM outcomes is accelerating investment in our commercial organization, starting with the addition of Christoph as Chief Commercial Officer,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Christoph’s hire, along with the €19 million raised from key investors, puts us in a strong position as we embark on our next stage of growth.”

First Quarter 2023 Results

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS ENDED MARCH 31, 2023  (in thousands)

        For the three months ended March 31
2023   2022
Revenue €441 €660
Cost of goods sold   (175) (289)
Gross profit €266 €371
Research and Development Expense   (6,157) (3,595)
Selling, General and Administrative Expense (5,551) (4,193)
Other income/(expense) 46 136
Operating loss for the period   €(11,396) €(7,281)
Financial income 625 1,576
Financial expense   (958) (788)
Loss for the period before taxes €(11,729) €(6,493)
Income taxes   (182) (208)
Loss for the period €(11,911) €(6,701)
     
Loss attributable to equity holders €(11,911) €(6,701)
Other comprehensive loss  
Items that may be subsequently reclassified to profit or
loss (net of tax)
Currency translation differences   (28) ( 102)
Total comprehensive loss for the year, net of tax €(11,939) €(6,803)
Loss attributable to equity holders   €(11,939) €(6,803)
Basic Loss Per Share (in EUR) €(0.460) €(0.260)
Diluted Loss Per Share (in EUR) €(0.460) €(0.260)

 UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF MARCH 31, 2023 (in thousands)

    As at
March 31
2023
  December 31 2022
ASSETS
Non-current assets      
Property, plant and equipment €2,721 €2,460
Intangible assets 42,447   39,972
Right of use assets 3,669 3,159
Deferred tax asset     50   47
Other long-term receivables 169 173
    €49,056   €45,811
Current assets      
Inventory     1,249   882
Trade receivables 1,499 1,463
Other receivables     1,419   1,775
Other current assets 1,663 1,284
Financial assets 62,403 76,968
Cash and cash equivalents 33,664 17,888
  €101,897 €100,260
Total assets €150,953 €146,071
   
EQUITY AND LIABILITIES
Capital and reserves    
Capital 4,859 4,440
Share premium 243,488   228,275
Share based payment reserve   6,582 5,645
Other comprehensive income 148   176
Retained loss   (130,051) (118,212)
Total equity attributable to shareholders €125,026 €120,324
     
LIABILITIES
Non-current liabilities    
Financial debt 8,381   8,189
Lease liability   3,112 2,586
Pension liability 25  
Provisions   74 59
Deferred tax liability  
€11,592 €10,834
Current liabilities    
Financial debt 390   388
Lease liability   711 719
Trade payables 5,012   4,985
Current tax liability 3,619   3,654
Other payables 4,603   5,167
  €14,335 €14,913
Total liabilities €25,927 €25,747
Total equity and liabilities €150,953 €146,071

Revenue

Revenue was €441,000 for the first quarter ending March 31, 2023, compared to €660,000 for first quarter ending March 31, 2022.

Cost of Goods Sold

Cost of goods sold was €175,000 for the three months ending March 31, 2023, representing a gross profit of €266,000, or gross margin of 60.3%. This compares to total cost of goods sold of €289,000 in the first quarter ending March 31, 2022, for a gross profit of €371,000, or gross margin of 56.2%.

Research and Development Expenses

Research and development expenses were €6.2 million for the three months ending March 31, 2023, versus €3.6 million for the prior year period, driven by an acceleration in clinical activities, notable the start of the ACCCESS study.

Selling, General and Administrative Expenses

Selling, general and administrative expenses rose to €5.6 million for the first quarter of 2023, up from €4.2 million in the first quarter of 2022. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.

Operating Loss

Total operating loss for the first quarter 2023 was €11.4 million versus €7.3 million in the first quarter of 2022. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash Position
As of March 31, 2023, cash and financial assets totaled €96.1 million, compared to €94.9 million on December 31, 2022.  Total cash burn was approximately €4.9 million per month during the first quarter of 2023.

First Quarter 2023 Report
Nyxoah’s financial report for the first quarter of 2023, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation 
Nyxoah will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number: https://edge.media-server.com/mmc/p/imeku8f7

A question-and-answer session will follow the presentation of the results. To access the live webcast, go to https://investors.nyxoah.com/events. 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 is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/.

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; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, 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
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313


1 For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

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GlobeNewswire Distribution ID 1000810492

South Korean President, Canadian PM Discuss Boosting Cooperation

South Korean President Yoon Suk Yeol met on Wednesday with Canadian Prime Minister Justin Trudeau who is visiting Seoul and discussed ways to boost cooperation between the two countries in all fields, specially the major minerals.

They also discussed prospects of cooperation between the two countries and shared their viewpoints pertaining to several regional and international files of common interest, including human rights status in North Korea.

Trudeau paid a three-day official visit to South Korea during which he would participate in the third summit between the two countries that marks the 60th anniversary of establishing their diplomatic relations.

Source: Qatar News Agency

QSFA Announces Activation of Professional Sporting Activities For Children

Qatar Sports For All Federation (QSFA) has activated the program of professional sporting activities that are directed towards children through conducting field trips to schools within the QSFA endeavors to propagate the culture of sports and improve the community’s health in all directions and segments. The program comprises an ambitious and holistic package with 183 activities in the current year.

Within the framework of cooperation with schools, the Hamza Bin Abdul Mottalib Preparatory School for Boys conducted a combination of fitness tests for students to identify their fitness level and issue guidance concerning the importance of pursuing proper methods to preserve a healthy weight and help prevent obesity among students.

During the field trip, the importance of preserving the physical activity was explained through practicing sports rigorously for students and raise their confidence in themselves and nurture their sport spirit on condition that it should not contradict with their academic achievement.

The QSFA seeks to educate and train students on practicing sports through pursuing a proper scientific method under the supervision of professional trainers, as field trips to schools across Qatar are set to continue Thursday, specially that such activities receive high turnout from students and pupils who participate in all sports activities.

Source: Qatar News Agency

An upcoming meeting of the Joint Committee 6 + 6 on electoral laws in Morocco in the coming days.

The Nova news agency quoted Libyan sources as saying that the Joint Committee for the Preparation of Electoral Laws in Libya (6 + 6), consisting of the House of Representatives and the state, will meet at the end of this week in Morocco.

The joint committee held its first meeting on April 5 at the headquarters of the House of Representatives in Tripoli, while a second meeting was held in Libya in early May.

The official spokesman for the House of Representatives, “Abdullah Blehaq,” said that the last meeting witnessed a convergence of views among the members of the Electoral Laws Committee, adding that it was also agreed on a working mechanism for the committee.

Source: Libyan News Agency