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Industry Leading SAFR Facial Recognition for Live Video Integrated with Geutebrück VMS

SEATTLE, April 12, 2021 (GLOBE NEWSWIRE) — SAFR from RealNetworks, Inc. (NASDAQ: RNWK) today announced that its SAFR facial recognition system for live video is now integrated with the Geutebrck G–Core VMS (Video Management System). SAFR for Geutebrck is an AI layer that runs on top of the G–Core VMS which provides advanced video analytics that save time and increase efficiency of surveillance operations. The best–in–class integration features live video overlays that display event details, streamlined enrollment of individuals appearing on the Geutebrck VMS directly into the SAFR identity database, and custom alarms and notifications that notify security personnel of SAFR events directly within the VMS.

With so many cameras deployed, it's impossible for security staff to monitor them effectively. SAFR matches faces appearing in live video feeds against watchlist images more effectively (99.87%), and with less bias, than humans. This enables security personnel to prioritize feeds that require review while providing them the key information they need to respond to persons of interest more quickly. SAFR also recognizes individuals wearing masks with remarkable accuracy (98.85%). The enrolled or reference image is displayed side by side with the face detected in the VMS video. Operators have instant access to the enrolled person's face image to confirm match events.

"Manual monitoring is expensive and inefficient. AI can perform real–time, automated identification of persons of interest, and identify previous offenders the moment they return and before they cause new incidents," said Brad Donaldson, VP, Computer Vision & GM, SAFR. "Our powerful API and plugin architecture makes industry leading integrations such as the one achieved with Geutebrck possible."

The tight integration enables operators to automatically enroll faces into the SAFR database by simply drawing a marquee around a face in the Geutebrck G–Core VMS. Operators can use SAFR's information overlays within the VMS video feeds, making it easy to quickly and accurately separate unknown people and potential threats from authorized personnel. System admins can easily configure which face recognition information is captured and recorded in the VMS. Additionally, operators have the ability to search Geutebrck video feeds for alerts using a person's name, watchlist name, or ID class (threat, no concern, concern, stranger).

“As a world class provider of video security software solutions in mission critical environments, we are thrilled to offer SAFR's superior technology for face recognition as part of a comprehensive solution. The seamless integration of SAFR's AI–powered analytics together with Geutebrck's ultra–robust video management software makes day–to–day operational tasks an effortless experience with the highest reliability,” comments Norbert Herzer, Product Manager, Geutebrck.

About SAFR
SAFR from RealNetworks (https://safr.com) is a high–performance computer vision platform. With fast, accurate, unbiased face recognition and additional face– and person–based AI features, SAFR leverages the power of AI to enhance security and convenience for our customers around the globe. Specializing in touchless secure access, real–time video surveillance, and digital identity authentication, SAFR is optimized to run on virtually any camera or camera–enabled device. Deploy as a standalone solution, integrated with leading video management systems, or directly on your device running on the edge for greater situational awareness and insights to improve operational efficiency. SAFR is headquartered in Seattle, WA, USA with offices around the world.

About Geutebrck
Geutebrck is an international provider of proprietary, high–performance video security software and the corresponding hardware. The medium–sized, owner–managed company with headquarters in Windhagen near Bonn, Germany, was founded in 1970 and has well–known customers in over 70 countries. For more information visit www.geutebrueck.com.

2021 RealNetworks and SAFR are registered trademark of RealNetworks, Inc. All other trademarks, names of actual companies and products mentioned herein are the property of their respective owners.

For more information please contact:

North America
Vronique Froment or Doug Hansel
HighRez for SAFR
Office: +1 603–537–9248
Cell: + 1 603–548–1429

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ae2a68d4–35ad–42c9–af7c–5f68c569426d


GLOBENEWSWIRE (Distribution ID 8214757)

Nyxoah Reports Full Year 2020 Results

Nyxoah Reports Full Year 2020 Results

Conference call and webcast today at 3pm CET / 9am ET

Mont–Saint–Guibert, Belgium "" 9 April 2021 "" Nyxoah SA (Euronext Brussels: 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 full year ended December 31, 2020.

Olivier Taelman, Chief Executive Officer of Nyxoah, said: "2020 was a year marked by key accomplishments for Nyxoah, with important milestones showing focused execution across business units. Despite the Covid–19 pandemic, the impact on Nyxoah's activities was limited and our manufacturing facilities remained operational, with sufficient production to meet our needs."

Key Points

  • Financial
    • 25M round onboarding ResMed as new investor
    • 85M IPO on Euronext Brussels
  • Clinical
    • BETTER SLEEP study enrolment close of 42 implanted patients M6 data to be expected Q2 2021
    • IDE trial approval by FDA in June 2020, with first US and international implants by end 2020
    • EliSA implants on 15 patients for long term safety & efficacy, trial expected to follow patients over a five–year period
  • Commercial
    • Germany G–BA approving NUB reimbursement at a similar reimbursement level as other neurostimulation–based OSA therapies
    • First revenue generation in Germany
  • Operational
    • No production stop despite COVID
    • Tech transfer to a second independent manufacturing site in Belgium started
  • R&D
    • MRI compatibility full body 1.5T and 3T
    • Next Gen of Genio system with improved features for the implantable and external components

Highlights of 2020

  • In 2020, the Company continued to advance its goal of further expanding its footprint and providing more patients suffering from OSA access to the Genio solution, thereby addressing a significant current unmet medical need.
  • The German federal joint committee (G–BA) confirmed in March 2020 that the Genio system is entitled to join the existing NUB for hypoglossal nerve stimulation ("HGNS") systems at a similar reimbursement level as other neurostimulation–based OSA therapies. As a result, the Company generated its first commercial revenue in 2020, albeit that such revenue was limited due to the NUB–specific negotiation path. As of 2021, the reimbursement will move away from NUB into a DRG system which should allow the Company to fully ramp up its German commercialization strategy.
  • Despite Covid–19 related disruptions, the Company was able to continue producing Genio devices in sufficient quantities to meet needs.

Clinical development

  • In November 2020, the Company completed enrolments in the BETTER SLEEP trial, conducted in Australia. In total, 42 patients were enrolled in this pre–marketing study, designed to assess the safety and efficacy / performance of the Genio system for the treatment of OSA in adult patients who either exhibit or do not exhibit a complete concentric collapse ("CCC") of the soft palate. The study is planned to have a 36–month follow–up and the end of the study is expected by the end of 2023. Six–month follow–up results are expected to be available in the second quarter of 2021.
  • If the primary endpoints of this study are reached, the Company plans to request a therapy indication expansion that would allow the Genio system to be used to treat CCC patients that are currently excluded from HGNS. In the meantime, the discussion with the European notified bodies has been initiated. If the Company obtains marketing authorization for the Genio system in the US, the Company plans to leverage the clinical data from the BETTER SLEEP study to expand the authorized indication to include the treatment of CCC patients in the US.
  • In 2020, enrolment continued, but was slowed down due to Covid–19, in the EliSA trial, the Company's multicenter post–marketing trial being conducted throughout Europe which is designed to gather long–term safety and clinical data regarding the Genio system in adult patients suffering from moderate–to–severe OSA. As of 31 December 2020, 15 patients out of the total intended 110 patients were enrolled in the study coming from five different countries (Germany, Switzerland, France, the Netherland, Belgium).
  • In June 2020, the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application for the Company's DREAM trial. This study aims to confirm the safety and effectiveness of the Genio system and is designed to support marketing authorization of the Genio system in the United States. The study will enroll 134 moderate–to–severe OSA patients who failed first line CPAP therapy. Up to 19 US sites in combination with 7 international sites have been selected to participate in the study. By the end of 2020, the first US and international implants took place.

Research and Development

  • Throughout 2020, the Company continued to invest in improving the Genio system with a goal of developing next generation products with improved features with respect to patient comfort, therapy efficacy, reliability and patient and market acceptance.
  • In 2020, the Company performed the Magnetic Resonance Imaging ("MRI") compatibility testing of the Genio system, resulting in CE mark and FDA conditional MR labeling approval in early 2021.

Financial highlights

  • In February 2020, the Company raised 25 million in a private financing round, whereby ResMed Inc. (NYSE:RMD; ASX:RMD), a world–leading digital health company in the OSA field, joined the Company as a new shareholder. All major shareholders at that time participated in this financing round onboarding ResMed Inc.
  • In September 2020, the Company raised 85 million ($100 million) as a result of the initial public offering ("IPO") of new shares of the Company on Euronext Brussels under the symbol "NYXH". The IPO resulted in an initial market capitalization of 375 million (taking into account the exercise in full of the over–allotment option in the framework of the IPO).

Subsequent Events

  • After the close of the financial year, the Company signed an exclusive license agreement with Vanderbilt University (Nashville, TN, USA). This agreement allows Nyxoah to develop new neurostimulation technologies for the treatment of sleep disordered breathing conditions based on inventions and patents owned by Vanderbilt University, which could potentially expand Nyxoah's future pipeline.
  • On February 22, 2021, the Company issued 10,000 shares pursuant to an exercise of subscription rights. Consequently, on the date of this Annual Report, the Company's registered capital amounts to EUR 3,797,765.64, represented by 22.107.609 shares.

Outlook for 2021

Our business, operational, and clinical outlook for 2021 include the following:

  • Ramp up EU revenue and build a dedicated sales team in Germany
  • Obtain reimbursement in Switzerland
  • BETTER SLEEP trial 6 month results, basis for Complete Concentric Collapse ("CCC") therapeutic indication expansion
  • Open second independent manufacturing site in Belgium, in addition to existing site in Israel
  • Complete DREAM pivotal trial enrollment

Full Year 2020 Financial Results
Income Statement

For the first time since its inception, the Company began generating revenue as of July 2020. The revenue of KEUR 69 was generated under the existing HGNS NUB coding in Germany. The total cost of goods sold was KEUR 30.

Operating costs increased to KEUR 11,224 in 2020 from KEUR 7,715 in 2019, or a change of KEUR 3,509, due to increases of activities in all departments. The Company is currently conducting three clinical trials to continue gathering clinical data and obtain regulatory approvals. In June 2020 the Company obtained FDA approval to start the DREAM study in the US. In line with its strategy, the Company continues investing in research and development to improve and develop the next generation of the Genio system and preparing for scaling–up of production capacities.

General and administrative expenses increased by 78% to KEUR 7,522 in 2020 from KEUR 4,226 in 2019. The increase is due to consulting expenses, staff and legal fees to support the Company growth. The increase in consulting and contractors' fees includes variable compensations of KEUR 1,981 related to a cash–settled share–based payment transaction (2019: KEUR 1,199). The increase of KEUR 159 in legal fees is due to services and not to any ongoing disputes.

Research and development expenses increased by 29% to KEUR 3,066 in 2020 from KEUR 2,375 in 2019, before capitalization of KEUR 2,593 in 2020, due to the increase of development costs of the Genio system. Research and development expenses consist of product development, engineering to develop and support our products, testing, consulting services and other costs associated with the next generation of the Genio system that do not meet the development capitalization criteria. The Company continues to invest in improving the Genio system to develop next generation products with improved features with respect to patient comfort, therapy efficacy, reliability and patient and market acceptance. These expenses primarily include employee compensation and outsourced development expenses.

Clinical expenses increased by 50% to KEUR 4,316 in 2020 from KEUR 2,881 in 2019, before capitalization of KEUR 3,263 in 2020. The increase in the expenses was mainly due to an increase in staff and consulting to support the completion of the BETTER SLEEP study implantations, continuous recruitment for EliSA study and the launch of the new DREAM IDE study in the US. Clinical expenses consist of clinical studies related to the development of our Genio system, consulting services and other costs associated with clinical activities. These expenses include employee compensation, clinical trial management and monitoring, payments to clinical investigators, data management and travel expenses for our various clinical trials.

Manufacturing expenses increased by 109% to KEUR 3,802 in 2020 from KEUR 1,812 in 2019, before capitalization of KEUR 3,342 in 2020. The increase in the expenses was mainly due to increases in staff for the production and engineering teams to support capacity and yield improvement, and also due to purchasing raw materials to support increase in the production. Manufacturing and operation expenses consist primarily of acquisition costs of the components of the Genio system, scrap and inventory obsolescence as well as distribution–related expenses such as logistics and shipping costs.

Quality assurance and regulatory expenses increased by 58% to KEUR 1,474 in 2020 from KEUR 928 in 2019, before capitalization of KEUR 1,247 in 2020. The increase in the expenses was due to staff increases and QA & regulatory activities to support manufacturing scaling up process. Quality assurance and regulatory expenses consist primarily of quality control, quality assurance and regulatory expenses. These expenses include employee compensation, consulting, testing and travel expenses.

Therapy development expenses increased by 107% to KEUR 1,864 in 2020 from KEUR 902 in 2019. The increase in the expenses was due to an increase in staff and consulting to support the commercialization in Europe. Therapy development expenses consist of compensation for personnel, spending related to market access and reimbursement activities. Other therapy development expenses include training physicians, travel expenses, conferences and consulting services.

Balance Sheet

The Company started recognizing the development expenditure as an asset as of March 2019, triggered by obtaining CE mark. Development costs primarily include employee compensation and outsourced development expenses. In 2020, the Company had capitalized developments costs of KEUR 9,874.

Property, plant & equipment shows a total additional net book value of KEUR 391 at balance sheet date consequently to leasehold improvements in the Company's offices in Belgium and Israel. Right of use assets shows a total additional increase by KEUR 2,217 due to new leases signed in 2020.

Cash and cash equivalents show a total additional increase of KEUR 86,445. This increase was due to total capital raises of KEUR 103,583, net of transaction costs, in February 2020 and in September 2020 (Initial Public Offering ("IPO")). Cash from financing activities was offset by cash used in the operating activities of KEUR 7,015 and cash used in the investing activities of KEUR 10,693.

The share capital and the share premium have increased, respectively, by KEUR 1,315 and KEUR 103,268 due to the capital increases in cash in 2020 for a total amount KEUR 103,583, net of transaction costs and capital increase in kind (conversion of loan in shares) of KEUR 1,000.

Lease liabilities shows a total additional increase of KEUR 2,242 due to new lease agreements in Belgium and Israel.

Other non–current and current payables have increased by KEUR 1,303 from KEUR 2,820 to KEUR 4,123 due higher cash–settled share–based payment liability of KEUR 473, higher accrued expenses of KEUR 557 and higher payroll related payables of KEUR 134.

Cash Flow Statement

The net cash burn rate for 2020 is a net cash inflow amounting to KEUR 86,445 compared to a net cash outflow of KEUR 10,950 for 2019.

The cash outflow resulting from operating activities amounted to KEUR 7,015 in 2020 compared to KEUR 5,965 in 2019. An increase of cash outflow of KEUR 1,050 due to KEUR 3,768 higher losses mainly from increased general and administrative expenses and therapy development expenses and higher interest and tax paid, net of KEUR 166, offset by KEUR 2,421 higher non–operating cash adjustments (KEUR 2,202 higher share–based payment expense) and a positive variation in the working capital of KEUR 463.

Cash flow from investing activities represented a net cash outflow of KEUR 10,693 for 2020. An increase of KEUR 4,898 compared to 2019 mainly explained by higher capitalization of development expenses in 2020.

The increase in cash inflow from financing activities is primarily due to the IPO completed in September 2020 and the proceeds from the February 2020 capital raise.

Financial Information

The consolidated financial statements have been prepared in accordance with IFRS as adopted by the EU. The financial information included in this press release is an extract of the full IFRS consolidated financial statements, which will be published on 9 April 2021. The statutory auditor, EY Bedrijfsrevisoren /Rviseurs d'Entreprises SRL, represented by Carlo–Sbastien D'Addario, has issued an unqualified audit opinion with emphasis of matter paragraph relating to a restatement for the year 2019 and the balance at 1 January 2019 to reflect the adjustments relating to a share based compensation accrual.

2021 Financial & Events Calendar

  • 09 April 2021 Full Year 2020 Financial and Operating Results & Annual Report
  • 09 June 2021 Annual Shareholders' Meeting
  • 31 August 2021 Interim Financial Report H1, 2021
  • 14–15 September 2021 Baird 2021 Global Healthcare Conference (virtual)

Conference Call & Webcast
Nyxoah will host a conference call with live webcast today at 3pm CET/9am ET. The webcast may be accessed on the Events page of the company's website or by clicking here. A replay of the webcast will be available on the Nyxoah website.

For further information, please contact:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 24 55

Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com

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 CE–validated, patient–centered, next generation hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval and a post–marketing EliSA study in Europe to confirm the long–term safety and efficacy of the Genio system.

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 and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. 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. 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.

Consolidated Income Statement

For the year ended 31 December
(in EUR 000) 2020 2019
Restated *
Revenue 69 –
Cost of goods sold (30) –
Gross Profit 39 –
General and administrative expenses (7,522) (4,226)
Research and development expenses (473) (630)
Clinical expenses (1,053) (848)
Manufacturing expenses (460) (489)
Quality assurance and regulatory expenses (227) (227)
Patents Fees & Related (123) (267)
Therapy Development expenses (1,864) (902)
Other operating income/ (expenses) 459 (126)
Operating loss for the period (11,224) (7,715)
Financial income 62 71
Financial expense (990) (740)
Loss for the period before taxes (12,152) (8,384)
Taxes (93) (70)
Loss for the period (12,245) (8,454)
Loss attributable to equity holders1 (12,245) (8,454)
Other comprehensive (loss) / income
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences (58) 168
Total comprehensive loss for the year, net of tax (12,303) (8,286)
Loss attributable to equity holders1 (12,303) (8,286)
Basic Earnings Per Share (in EUR) (0.677) (0.568)
Diluted Earnings Per Share (in EUR) (0.677) (0.568)

Consolidated Statement of Financial Position

As of and for the year ended 31 December
(in EUR 000) 2020 2019
Restated*
ASSETS
Non–current assets
Property, plant and equipment 713 322
Intangible assets 15,853 5,734
Right of use assets 3,283 1,066
Deferred tax asset 32 21
Other long–term receivables 91 78
19,972 7,221
Current assets
Inventory 55 –
Trade receivables – 60
Other receivables 1,644 2,048
Other current assets 109 11
Cash and cash equivalents 92,300 5,855
94,108 7,974
Total assets 114,080 15,195

EQUITY AND LIABILITIES

Capital and reserves
Capital 3,796 2,481
Share premium 150,936 47,668
Share based payment reserve 2,650 420
Currency translation reserve 149 207
Retained Earnings (60,341) (48,415)
Total equity attributable to shareholders 97,190 2,361
LIABILITIES
Non–current liabilities
Financial debt 7,607 7,146
Lease liability 2,844 735
Pension Liability 37 30
Other payables – 547
10,488 8,458
Current liabilities
Financial debt 616 378
Lease liability 473 340
Trade payables 1,190 1,385
Other payables 4,123 2,273
6,402 4,376
Total liabilities 16,890 12,834
Total equity and liabilities 114,080 15,195

____________________________________

* The year 2019 has been restated to reflect the adjustments as explained in our 2020 Annual Report Note "5.2.3

Consolidated Statement of Cash Flows

For the year ended 31 December
(in EUR 000) 2020 2019
Restated *
CASH FLOWS FROM OPERATING ACTIVITIES
Loss before tax for the year (12,152) (8,384)
Adjustments for:
Finance income (62) (71)
Finance expenses 990 740
Depreciation and impairment of property, plant
and equipment and right–of–use assets 		620 433
Share–based payment transaction expense 2,549 346
Pension–related expenses 7 30
Other non–cash items2 (134) 70
Cash generated before changes in working capital (8,182) (6,836)
Changes in working capital:
Increase in Inventory (55) –
Decrease/(Increase) in Trade and other receivables 365 (1,385)
Increase in Trade and other payables 1,109 2,342
Cash generated from changes in operations (6,763) (5,879)
Interests received 3 8
Interests paid (151) (33)
Income tax paid (104) (61)
Net cash used in operating activities (7,015) (5,965)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property, plant and equipment (562) (51)
Capitalization of intangible assets (10,118) (5,734)
Increase of long–term deposits (13) (10)
Net cash used in investing activities (10,693) (5,795)
CASH FLOWS FROM FINANCING ACTIVITIES
Payment of principal portion of lease liabilities (479) (341)
Repayment of other loan (63) (82)
Recoverable cash advance received 190 1,196
Repayment of recoverable cash advance (55) (40)
Proceeds from convertible loan 1,000 –
Proceeds from issuance of shares, net of transaction costs 103,583 –
Net cash generated/(used) from financing activities 104,176 733
Movement in cash and cash equivalents 86,468 (11,027)
Effect of exchange rates on cash and cash equivalents (23) 77
Cash and cash equivalents at 1 January 5,855 16,805
Cash and cash equivalents at 31 December 92,300 5,855

Consolidated Statement of Changes in Equity

Attributable to owners of the parent
(in EUR 000)

Notes

Capital Share premium Share based payment reserve Currency translation reserve Retained earnings Total
Balance at 1 January 2019* restated " 2,481 47,668 80 39 (39,967) 10,301
Loss for the year (8,454) (8,454)
Other comprehensive income for the year 168 168
Total comprehensive income/(loss) for the year 168 (8,454) (8,286)
Equity–settled share–based payment plan 340 6 346
Total transactions with owners of the Company recognized directly in equity 340 6 346
Balance at 31 December 2019 restated * 2,481 47,668 420 207 (48,415) 2,361
Balance at 1 January 2020 restated * 2,481 47,668 420 207 (48,415) 2,361
Loss for the year (12,245) (12,245)
Other comprehensive loss for the year (58) (58)
Total comprehensive loss for the year – – – (58) (12,245) (12,303)
Equity–settled share–based payment plan 2,230 319 2,549
Issuance of shares for cash 1,304 108,857 110,161
Issuance of shares in kind 11 989 1,000
Transaction cost (6,578) (6,578)
Total transactions with owners of the Company recognized directly in equity 1,315 103,268 2,230 319 107,132
Balance at 31 December 2020 3,796 150,936 2,650 149 (60,341) 97,190

____________________________________

* The year 2019 and the balance at 1 January 2019 has been restated to reflect the adjustments as explained in our 2020 Annual Report Note "5.2.3

1 For the years ending 31 December 2020 and 2019, the loss is fully attributable to equity holders of the Company as the Company does not have any non–controlling interests.
* The year 2019 has been restated to reflect the adjustments as explained in Note "5.2.3

2 The other non–cash items include (i) the impact of the initial measurement and re–measurement of recoverable cash advances (see our 2020 Annual Report notes "5.14 ,"5.24 and (ii) the evolution of the deferred tax assets.
* The year 2019 has been restated to reflect the adjustments as explained in our 2020 Annual Report Note "5.2.3

Attachment


GLOBENEWSWIRE (Distribution ID 1000477389)

PRA’s remote patient monitoring platform selected by Merck KGaA, Darmstadt, Germany to work in combination with its human growth hormone treatment system

RALEIGH, N.C. , April 07, 2021 (GLOBE NEWSWIRE) — PRA Health Sciences (NASDAQ: PRAH) announced today that Merck KGaA, Darmstadt, Germany, known in the United States as EMD Serono, selected PRA's remote patient monitoring platform to work in combination with its human growth hormone (HGH) treatment system. Under this agreement, PRA's remote patient monitoring platform backs Merck KGaA, Darmstadt, Germany's HGH treatment system, including growlinkTM, a mobile app for patients prescribed with HGH treatment, and easypod Connect, a secure platform for healthcare professionals (HCP) in the field of endocrinology to monitor patients' adherence, review injection history, and share information about patients' progression with growth hormone disorder.

"Patients and payers expect us to offer new technologies, such as treatment–supporting apps, with the highest levels of privacy and data security," said Andre Musto, Senior Vice President and Head of Cardiovascular Metabolism & Endocrinology, Merck KGaA, Darmstadt, Germany. "With growlink and easypod Connect, supported by PRA's remote patient monitoring platform, we can offer patients innovative tools to help manage their condition and assure payers of the effective use of treatments while fully respecting their privacy and data security."

Human growth hormone treatments are frequently prescribed for children and adolescents with growth hormone deficiency, a condition that impacts approximately 1:4,000 to 1:10,000 children1 each year in the U.S. Despite the prevalence of growth hormone deficiency and treatment options, one of the biggest challenges is ensuring patients' adherence to the regimen. Adding this layer of technology to HGH treatments better facilitates patient engagement, helps HCPs make better use of patient visits, and ensures the treatment is taken regularly and at the right dosage, optimizing treatment outcome and driving payer confidence.

In a real–world setting, an HCP would use easypod Connect to invite patients to download the mobile app, growlink. Then the patient downloads the mobile app, signs an eConsent form on the app, and syncs the app with Merck KGaA, Darmstadt, Germany's HGH injector medical device, easypod. This device is able to self–regulate the appropriate dosage of HGH based on the treatment protocol. The four–part system "" Merck KGaA, Darmstadt, Germany's mobile app (growlink), connected device (easypod), and HCP platform (easypod Connect ) underpinned by PRA's remote patient monitoring technology "" enables HCPs to see an accurate picture of patients' adherence, height, weight, and other outcomes while offering patients a more convenient way to follow to their treatment regimen and manage their condition.

"For many years, PRA has been focused on designing an end–to–end digital health platform that supports mobile healthcare delivery, such as remote patient monitoring," said Kent Thoelke, Executive Vice President and Chief Scientific Officer, PRA Health Sciences. "Our collaboration with Merck KGaA, Darmstadt, Germany to support growlink and easypod Connect is an example of how the industry is advancing with the patient at the center of our innovation."

PRA hosted a webinar called, How Digital Therapeutics and Remote Patient Monitoring Can Drive Pharmaceutical Product Differentiation, to help create differentiation. Access the replay webinar today.

For more information about PRA's remote patient monitoring solutions, visit www.prahs.com.

1 Stanley T. Diagnosis of Growth Hormone Deficiency in Childhood. HHS Public Access. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279941/

About PRA Health Sciences

PRA Health Sciences is one of the world's leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. PRA's global clinical development platform includes more than 75 offices across North America, Europe, Asia, Latin America, Africa, Australia and the Middle East and more than 19,000 employees worldwide. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 95 drugs. To learn more about PRA, please visit www.prahs.com.

INVESTOR INQUIRIES: InvestorRelations@prahs.com

MEDIA INQUIRIES: Laurie Hurst, Sr. Director, Communications and Public Relations
hurstlaurie@prahs.com | +1 (919) 786–8435


GLOBENEWSWIRE (Distribution ID 8213058)

E3 2021: Game On.

LOS ANGELES, April 06, 2021 (GLOBE NEWSWIRE) — It's "Game On." for E3, as The Entertainment Software Association (ESA) officially unveils plans for a reimagined, all–virtual E3 2021 that will engage video game fans everywhere. With early commitments from Nintendo, Xbox, Capcom, Konami, Ubisoft, Take–Two Interactive, Warner Bros. Games and Koch Media, and more to come, E3 2021 will take place June 12 through June 15.

Developers will be showcasing their latest news and games directly to fans around the world. The ESA will be working with media partners globally to help amplify and make this content available to everyone for free.

"For more than two decades, E3 has been the premier venue to showcase the best that the video game industry has to offer, while uniting the world through games," said Stanley Pierre–Louis, President & CEO of the ESA. "We are evolving this year's E3 into a more inclusive event, but will still look to excite the fans with major reveals and insider opportunities that make this event the indispensable center stage for video games."

While maintaining E3's longstanding position as a central destination for industry networking — where new partnerships and connections between video game publishers, developers and media are made — the digital format for E3 2021 means more people than ever can participate.

The ESA looks forward to coming back together to celebrate E3 2022 in person. In the meantime, see you online this June!

The E3 2021 EPK can be found here: https://e3expo.com/press–kit–21x

About E3

E3 is the world's premier event for computer and video games and related products. The show is owned and operated by the ESA, the US trade association dedicated to serving the business and public affairs needs of the companies developing and publishing interactive games for video game consoles, handheld devices, personal computers, and the internet. For more information, visit www.e3expo.com or follow E3 on Facebook @E3Expo or Twitter @E3.

About the ESA

The Entertainment Software Association (ESA) serves as the voice and advocate for the U.S. video game industry. Its members are the innovators, creators, publishers and business leaders that are reimagining entertainment and transforming how we interact, learn, connect and play. The ESA works to expand and protect the dynamic marketplace for video games through innovative and engaging initiatives that showcase the positive impact of video games on people, culture and the economy. For more information, visit the ESA's website or follow the ESA on Twitter @theESA.

Press Contacts:

Kat Jones, Motiv PR, kjones@motivpr.com

Johner Riehl, Wonacott PR, jriehl@wonacottpr.com


GLOBENEWSWIRE (Distribution ID 8211960)

Shell Invests in LanzaJet to Further Accelerate the Global Commercialization of LanzaJet’s Leading Alcohol-to-Jet Technology to Address the Aviation Sector’s Urgent Need to Decarbonise

CHICAGO, April 06, 2021 (GLOBE NEWSWIRE) — Our world is at an inflection point – one that requires action today, solutions that work, and meaningful progress toward decarbonizing industries and our society. LanzaJet, Inc., a leading sustainable fuels technology company and sustainable fuels producer, announced today that Shell joins as an investor in the company to advance LanzaJet's global growth, accelerate commercialization of its technology, and scale the production of Sustainable Aviation Fuel (SAF).

Shell joins founding investors in LanzaJet, including LanzaTech, Suncor Energy Inc., Mitsui & Co., Ltd., and more recently, British Airways, as well as participation from All Nippon Airways. In addition to its initial investment in LanzaJet and similar to the phased investment approach used with all of the LanzaJet investors, Shell will have the opportunity to make further investments in the construction of larger–scale production facilities over the coming years. This innovative phased investment approach significantly accelerates commercial deployment at a time when reducing emissions, especially of aviation, is increasingly important and demonstrates a joint commitment to creating a resilient, low carbon future. With the right policies to support the uptake and production of SAF, aviation can achieve net–zero emissions.

The investment comes as LanzaJet continues its work to build the first Alcohol–to–Jet (AtJ) facility of its' kind globally, a commercial–scale plant (10 million gallons per year capacity) in Soperton, Georgia, USA. Freedom Pines Fuels, as it's called, continues on schedule with operations beginning in 2022. LanzaJet was launched in June 2020 following nearly a decade of technology development and commercial scale–up through a partnership by LanzaJet's founder, LanzaTech, with the U.S Department of Energy's Pacific Northwest National Laboratory (PNNL). The LanzaJet process can use any source of sustainable ethanol for jet fuel production, including, but not limited to, ethanol made from recycled pollution, the core application of LanzaTech's carbon recycling platform.

LanzaJet's technology is uniquely able to produce up to 90% of its fuels as SAF, with the remaining 10% as renewable diesel. The SAF will be blended with conventional fossil jet fuel and be supplied to airports through the existing supply routes. The technology can flex to produce more diesel and less SAF, as desired. LanzaJet's SAF is approved to be blended up to 50% with fossil jet fuel, the maximum allowed by ASTM, and is a drop–in fuel that requires no modifications to engines, aircraft, and infrastructure. Additionally, LanzaJet's SAF delivers more than a 70% reduction in greenhouse gas emissions on a lifecycle basis, compared to conventional fossil jet fuel. The versatility in ethanol, and a focus on low–carbon, waste–based, and non–food /non–feed sources, along with ethanol's global availability, make LanzaJet's technology a relevant and enduring solution for SAF.

Anna Mascolo, President, Shell Aviation, said:

“LanzaJet's technology opens up a new and exciting pathway to produce SAF using an AtJ process and will help address the aviation sector's urgent need for SAF. It demonstrates that the industry can move faster and deliver more when we all work together. Provided industry, government and society collaborate on appropriate policy mechanisms and regulations to drive both supply and demand, aviation can achieve net–zero carbon emissions. The strategic fit with LanzaJet is exciting. Through our Razen joint venture in Brazil, we have been producing bioethanol for over ten years, and we have already demonstrated production of cellulosic ethanol from waste materials. Our access to feedstocks, experience of optimizing supply chains, and extensive sales and marketing business will hopefully contribute to LanzaJet creating sustainable, robust, and scalable commercial operations, supporting our customers' decarbonisation ambitions for many years to come."

Jimmy Samartzis, LanzaJet CEO, said:

“We've been at a crossroads for years and we're now at a point in time when real solutions matter to address the global need to get to net–zero. At LanzaJet, we're in a unique position with technology that is ready and scaling today to produce lower–carbon, sustainable fuels. Shell's investment and partnership help to further advance our work to do our part to decarbonize aviation globally, a sector with limited other options in the near– and mid–term."

Jennifer Holmgren, LanzaJet Board Chair and LanzaTech CEO, said:

“We have an outstanding group of investors, leading in the energy transition and working across industries to reduce carbon emissions. I am delighted to welcome Shell to the LanzaJet family as we work together to realize our ambition of producing significant volumes of SAF from wastes to help the aviation sector meet their carbon reduction goals."

Quick Facts

  • Sustainable Aviation Fuel (SAF) is fundamental to aviation's progress towards net–zero emissions, and looking forward, LanzaJet's technology provides a ready, scalable, and unique solution that focuses on SAF production today and for tomorrow.
  • Shell's investment further enables LanzaJet's global growth and aligns with Shell's strategy to become a net–zero emissions energy business by 2050, in step with society, providing customers with more and cleaner energy solutions.
  • Shell joins other LanzaJet investors including LanzaTech, Suncor Energy Inc., Mitsui & Co., Ltd., and British Airways, along with participation in LanzaJet by All Nippon Airways (ANA).

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GLOBENEWSWIRE (Distribution ID 8209672)

DraftKings Acquires BlueRibbon, Tel Aviv-Based Leading Global Jackpot and Gamification Company

BOSTON, April 05, 2021 (GLOBE NEWSWIRE) — DraftKings Inc. (Nasdaq: DKNG) today announced that it has acquired Blue Ribbon Software Ltd., a Tel Aviv–based leading global jackpot and gamification company ("BlueRibbon") that provides platform–agnostic, real–time gamification tools that allow for fully customizable jackpot promotions. DraftKings will now be able to enhance the customer experience by integrating BlueRibbon's unique jackpot functionality, including personalized promotions and rewards tailored to the individual customer or jackpots that pay out across DraftKings' various product offerings.

"Integrating BlueRibbon's proprietary, proven technology will enable DraftKings to create dynamic incentives for our users as they engage with our products," said Paul Liberman, DraftKings co–founder and President, Global Technology and Product. "The team at BlueRibbon brings technical and gamification expertise and broad industry experience to DraftKings, and we are excited to leverage this technology to further differentiate our product offerings and engage customers in new ways."

BlueRibbon was founded in 2017 by CEO Amir Askarov and CMO Dan Fischer, veterans of the iGaming industry with decades of experience working within regulated markets. Askarov and Fischer, together with Idan Fridman as CTO, led BlueRibbon's development of jackpot technology that can be applied to any vertical, game or content. Customers are able to enjoy a seamless experience as they play the jackpots, offering a new layer of excitement and anticipation during gameplay.

"We created BlueRibbon to give companies the ability to differentiate themselves within the highly competitive sports betting and iGaming industries with unique and innovative marketing platform," said Askarov. "Joining DraftKings will allow us to continue to build our platform to enhance the player experience and to strengthen our Tel Aviv–based team."

DraftKings intends to fully integrate BlueRibbon's leadership and current employee base, located in Tel Aviv, into its global workforce. In addition, DraftKings intends to increase its hiring in its Tel Aviv office.

DraftKings is live with mobile and/or retail sports betting in 14 U.S. states, more than any other operator, and recently announced the acquisition of VSiN, a multi–platform broadcasting and content company delivering trusted sports betting news, analysis, and data to U.S. sports bettors.

About DraftKings

DraftKings Inc. is a digital sports entertainment and gaming company created to fuel the competitive spirit of sports fans with products that range across daily fantasy, regulated gaming and digital media. Headquartered in Boston, and launched in 2012 by Jason Robins, Matt Kalish and Paul Liberman, DraftKings is the only U.S.–based vertically integrated sports betting operator. DraftKings is a multi–channel provider of sports betting and gaming technologies, powering sports and gaming entertainment for 50+ operators in 17 countries. DraftKings' Sportsbook is live with mobile and/or retail betting operations in the United States pursuant to regulations in Colorado, Illinois, Indiana, Iowa, Michigan, Mississippi, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Virginia and West Virginia. DraftKings' daily fantasy sports product is available in 8 countries internationally with 15 distinct sports categories. DraftKings owns Vegas Sports Information Network, Inc. (VSiN), a multi–platform broadcast and content company. DraftKings is the official daily fantasy partner of the NFL, MLB, NASCAR and the PGA TOUR as well as an authorized gaming operator of the NBA and MLB and an official betting operator of the PGA TOUR.

Forward–Looking Statements
Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995, as amended. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward–looking statements. These forward–looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside DraftKings' control, that could cause actual results or outcomes to differ materially from those discussed in the forward–looking statements. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward–looking statements, see DraftKings' Securities and Exchange Commission filings. DraftKings does not undertake any obligation to update or revise any forward–looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Media Contact
media@draftkings.com
@DraftKingsNews

Investor Contact
investors@draftkings.com


GLOBENEWSWIRE (Distribution ID 8211206)

JETEX LAUNCHES THE WORLD’S MOST EXCLUSIVE IFTAR EXPERIENCE

Dubai, United Arab Emirates, April 05, 2021 (GLOBE NEWSWIRE) — Dubai–based Jetex, a global leader in executive aviation, is inviting residents and visitors to the world's most exclusive Iftar experience in the skies above the UAE offered during the Holy Month of Ramadan.

The once–in–a–lifetime luxury hospitality experience offers breathtaking aerial views of iconic landmarks and natural vistas in the country against the setting sun, apart from an exquisite culinary treat.

The journey commences just before sunset at the Jetex VIP Terminal in Dubai. After being welcomed, the guests are chauffeur–driven to their private jet.

The aircraft will then take–off and follow the sunset towards Abu Dhabi giving travelers magnificent views of some of the UAE's most celebrated destinations from the skies. The crew will choose the most optimal altitude and cruising speed to ensure that passengers enjoy sensational window views throughout the flight.

A delicious iftar will be served once the sun sets midway through the flight. The menu will include traditional Ramadan delicacies prepared with a special Jetex gourmet flair to make the occasion truly memorable. Up in the sky passengers might have to wait about four minutes longer to break their fast as they may spend more time to enjoy the spectacular sunset.

The journey will continue as the aircraft cruises above the rolling dunes of the desert towards Al Ain and onwards to the UAE's mountain range in the East. The spectacular mountain sights will include the country's highest peak Jebel Jais, located in the Hajjar Mountains, and the Hatta Mountains.

Passengers will get a glimpse of the Indian Ocean and Fujairah before the flight continues towards Ras Al Khaimah and follows the azure Arabian Gulf coastline of Umm Al Quwain, Ajman and Sharjah. Finally, passengers will enjoy Dubai's world–famous evening skyline, including the majestic Burj Khalifa, as well as the Palm Islands and The World prior to landing back at the Jetex VIP Terminal.

Upon arrival, they will be invited to enjoy the rest of the evening in one of the lounges of the Jetex VIP Terminal with elegant service and amenities at their leisure.

Adel Mardini, Founder & CEO of Jetex, commented: "Once again, Jetex is taking private jet experience to a next level. "Iftar in the Sky' will give the millennia–old tradition a truly new dimension relevant to the XXI century while providing support to the charity programs of Dubai Cares, which is so relevant and important during the Holy Month of Ramadan. This is a contribution that we are proud to make on behalf of Jetex and our passengers."

The unforgettable travel experience is priced from AED 66,000 for up to six travelers and will be available between 13 April and 12 May 2021. Suhour packages are available as well.

In celebration of the spirit of the Holy Month, Jetex will donate 10% of all proceeds from "Iftar in the Sky' to Dubai Cares, part of Mohammed Bin Rashid Al Maktoum Global Initiatives, to support its programs aimed at empowering underserved children and youth with access to quality education. Since its inception in 2007, Dubai Cares has successfully launched education programs reaching over 20 million beneficiaries in 60 developing countries. The UAE–based global philanthropic organization is also playing a key role in helping achieve the United Nations Sustainable Development Goal (SDG) 4, which aims to ensure inclusive and quality education for all and promote lifelong learning by 2030.

Commenting on the collaboration, Dr. Tariq Al Gurg, Chief Executive Officer at Dubai Cares and Member of its Board of Directors said: "Ramadan represents a time for the community to come together in the spirit of generosity and giving back to those less fortunate. The "Iftar in the Sky' experience by Jetex, gives UAE residents the opportunity to connect with their loved ones for an unforgettable journey while also contributing towards the greater good by supporting less privileged children and youth. We thank Jetex for this meaningful initiative that will help us elevate the reach of our educational programs worldwide."

To ensure the highest levels of safety and comfort of travelers, the aircraft cabin will be thoroughly sanitised using the signature Jetex bipolar ionization technology before and after each flight. Moreover, all the necessary COVID–19 measures and social distancing rules will be in place at all times.

For reservations, please contact Jetex Premier Experience at experience@jetex.com or telephone +971 4 212 4000.

– END –

About Jetex:

An award–winning global leader in executive aviation, Jetex is recognized for delivering flexible, best–in–class trip support solutions to customers worldwide. Jetex provides exceptional private terminals (FBOs), aircraft fueling, ground handling and global trip planning. The company caters to both owners and operators of business jets for corporate, commercial and personal air travel. To find out more about Jetex, visit www.jetex.com and follow us on Instagram, Twitter, Facebook, and LinkedIn.

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GLOBENEWSWIRE (Distribution ID 8211357)

Nyxoah to Delay Full Year 2020 Earnings Release Until April 9, 2021  

Nyxoah to Delay Full Year 2020 Earnings Release Until April 9, 2021

Mont–Saint–Guibert, Belgium "" 2 April 2021 "" Nyxoah SA (Euronext Brussels: NYXH) ("Nyxoah" or the "Company"), a medical technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA), today announced that it will delay its full year 2020 earnings release and subsequent conference call, previously scheduled for April 6, 2021. The Company now intends to report full year financial results for the year ended December 31, 2020 on Friday, April 9, 2021, before the market opens. The Company will host a conference call to discuss full year 2020 financial results on the same day at 3:00 p.m. CET / 9:00 a.m. ET. The details for the conference call can be found below. The delay is required for the Company and its auditors to complete final audit procedures in accordance with PCAOB auditing standards.

Full Year 2020 Financial Results Conference Call:

Date: Friday, April 9, 2021
Time: 3:00 p.m. CET / 9:00 a.m. ET
Webcast: https://channel.royalcast.com/landingpage/nyxoah/20210409_1/

For further information, please contact:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 24 55

Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions and services to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio system, a CE–validated, patient–centered, next generation hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk2 and comorbidities including cardiovascular diseases, depression and stroke.

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion, the DREAM IDE pivotal study for FDA approval and a post–marketing EliSA study in Europe to confirm the long–term safety and efficacy of the Genio system.

For more information, please visit www.nyxoah.com.

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GLOBENEWSWIRE (Distribution ID 1000476285)