September 2021 – Page 135

September 1, 2021

Hundreds Flee During Four Days of Fighting in Myanmar’s Shan State

Four days of continuous fighting between Myanmar’s military and a rebel army in northern Shan state’s Lashio city, near the country’s border with China, have left at least 17 junta troops dead and forced hundreds of civilians to flee their homes to safety, local media and residents said Tuesday.

Clashes began on Aug. 28 when military troops attacked members of the Myanmar National Democratic Alliance Army (MNDAA), the formal name of the Kokang army, and escalated the following day throughout Lashio’s townships of Pangsang, Kyukoke and Mongko, local sources told RFA’s Myanmar Service.

Four civilians, including a 10-year-old child, were killed in shelling by military troops on Aug. 29, said a resident of Lashio—a city of 130,000 people populated by Shan, the country’s second largest ethnic group, majority Burmans and Chinese.

“They fire heavy artillery, and the local civilians don’t see it coming,” the source said, speaking on condition of anonymity.

“Many civilians have been killed by the shelling. An entire family was killed in a blast two days ago. We are living in fear, as the shelling comes out of nowhere. We are all terrified by the artillery blasts.”

A resident of Mongko township, who also declined to be named, said that fighting also occurred on Monday and broke out again on Tuesday around 7:00 a.m. between the villages of Mongko and Mangmao.

“The villagers have fled their homes,” the resident said. “I don’t know where they are fleeing to. I don’t know the exact number of causalities. I heard some soldiers were killed in the fighting.”

MNDAA soldiers display weapons and ammunition confiscated from government troops in northern Shan state's Mongko township, in an undated photo. MNDAA — MNDAA soldiers display weapons and ammunition confiscated from government troops in northern Shan state’s Mongko township, in an undated photo. MNDAA

Displaced persons

Myanmar’s military overthrew the democratically elected NLD government on Feb. 1, claiming the party had stolen the country’s November 2020 ballot through voter fraud. The junta has yet to provide evidence of its claims and has violently repressed anti-coup protests, killing at least 1,040 people and arresting 6,069 others, according to the Bangkok-based Assistance Association for Political Prisoners (AAPP).

Amid nationwide turmoil, the military has stepped up offensives in remote parts of the country, triggering fierce battles with local People’s Defense Force (PDF) militias and some of the dozens of ethnic armies that control large swathes of territory along Myanmar’s periphery.

Volunteers assisting civilians in Lashio told RFA on Tuesday that more than 800 civilians had fled the fighting in the area over the past four days.

“We’ve got more than 700 IDPs (internally displaced persons) now,” said a volunteer in Mongko, where the refugees are temporarily sheltering at a Buddhist monastery and a church.

“They need mostly food and medicine. So far, we have been taking care of them with donations from the town residents. Additionally, there are no drivers or vehicles to transport commodities for these IDPs. We can transport medicines. But most drivers are too scared to drive out of town.”

Additionally, residents and volunteers said that more than 130 civilians had fled fighting in Mongko township near Post No. 102 on the border with China, adding to the 700 IDOs sheltering in the town center.

Soldiers killed

Sources in the area told RFA that the military had “lost many soldiers” during the past four days of clashes.

The MNDAA released a statement on Monday that included photos of machine guns, rifles, pistols and ammunition its fighters had captured from the military, as well as confiscated uniforms with insignias denoting the ranks of Major and Captain.

The Kachin Waves media outlet, based in neighboring Kachin state, reported Tuesday that the MNDAA and residents had discovered the discarded bodies of 17 government troops who were killed during fighting near Phaingkaung village in Mongko township.

Attempts by RFA to contact junta spokesperson Major Ge Zaw Min Tun for further information about the recent fighting and military casualties went unanswered Tuesday.

In April, three ethnic armed groups that support Myanmar’s anti-junta protest movement, including the MNDAA, killed 14 police officers and burned their station to the ground in a dawn raid in Naungmon, south of Lashio.

The raid sparked fierce fighting in Khar Shwe village outside Lashio as the military regime sent helicopters to attack ethnic rebels with the Three Brotherhood Alliance, which also includes the Arakan Army (AA) and the Ta’ang National Liberation Army (TNLA).

Reported by RFA’s Myanmar Service. Translated by Ye Kaung Myint Maung. Written in English by Joshua Lipes.

September 1, 2021

Nyxoah Issues First Half 2021 Financial Results

REGULATED INFORMATION

Nyxoah Issues First Half 2021 Financial Results

Mont-Saint-Guibert, Belgium – August 31, 2021, 10:30pm CET / 4:30pm 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 announced its unaudited condensed consolidated interim financial statements for the first half of 2021.

Highlights

$97.8 million Nasdaq IPO gross proceeds
On track to complete US DREAM trial enrollment
€355 thousand revenue generated in Europe, compared to no revenue for the six months ended June 30, 2020, driven mainly in Germany
Increased commercial activities in Germany with 12 active accounts in Q2, up from 2 in Q1 2021
Announced BETTER SLEEP study top-line results that showed primary safety and performance endpoints met, with statistically significant mean reduction in the AHI score in full patient population including Complete Concentric Collapse (“CCC”) patients
To submit full BETTER SLEEP study data to a medical journal for publication and announce results following further analyses
Integrated Vanderbilt University technology into our scientific and technology department pipelines including collaboration with US and German key opinion leaders

“In the first half of 2021, we kept pace with our initiatives to deliver significant new accomplishments. In less than 12 months, we completed our second IPO with a Nasdaq listing, further strengthening our balance sheet; made important gains in commercial activities in Germany, our initial commercial proof of concept market; advanced clinical programs, including data to potentially expand our addressable market to include CCC patients; and maintained focused investments in new products and technologies,” said Olivier Taelman, CEO of Nyxoah. “In the second half, we look forward to further accelerating our commercial activities in existing markets, enter new markets, scale up, and advance clinical programs, including enrollment completion of our US DREAM study in the fourth quarter.”

First Half 2021 Results

	For the six months ended June 30
	2021	2020
(in thousands)
Revenue	€ 355	€ −
Cost of goods sold	(115)	−
Gross profit	€ 240	€ −
General and administrative expenses	(4 777)	(2 400)
Research and development expenses	(1 255)	(56)
Clinical expenses	(631)	(509)
Manufacturing expenses	(2 171)	(207)
Quality assurance and regulatory expenses	(642)	(86)
Patents fees & Related	(793)	(107)
Therapy Development expenses	(1 502)	(761)
Other operating income / (expenses), net	(97)	184
Operating loss for the period	€ (11 628)	€ (3 942)
Financial income	43	82
Financial expense	(899)	(416)
Loss for the period before taxes	€ (12 484)	€ (4 276)
Income taxes	(124)	(24)
Loss for the period	€ (12 608)	€ (4 300)

Loss attributable to equity holders	€ (12 608)	€ (4 300)
Other comprehensive loss
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences	192	(89)
Total comprehensive loss for the year, net of tax	€ (12 416)	€ (4 389)
Loss attributable to equity holders	€ (12 416)	€ (4 389)

Basic Earnings Per Share (in EUR)	€ (0.570)	€ (0.262)
Diluted Earnings Per Share (in EUR)	€ (0.570)	€ (0.262)

Revenue

Revenue was €355 thousand for the six months ended June 30, 2021, compared to no revenue for the six months ended June 30, 2020. The increase in revenue was attributable to the Company’s commercialization of the Genio® system mainly in Germany, and to a lesser extent, Spain and Belgium.

Cost of Goods Sold

Cost of goods sold was €115 thousand for the six months ended June 30, 2021, compared to no cost for the six months ended June 30, 2020. The increase in cost of goods sold was attributable to the sales of the Genio® system in Europe.

General and Administrative Expenses. General and administrative expenses increased by €2.4 million, or 99 %, from €2.4 millionfor the six months ended June 30, 2020 to €4.8 million for the six months ended June 30, 2021 mainly due to an increase in consulting and contractors’ fees. The increase in consulting and contractors’ fees includes variable compensations for an amount of €0.3 million for the six months ended June 30, 2020 and €1.9 million for the six months ended June 30, 2021 related to a cash-settled share based payment transaction and an increase of consultant services to support the company in legal, finance, tax and IT matters.

Research and Development Expenses. Before capitalization of €0.6 million for the six months ended June 30, 2021 and €0.6 million for the six months ended June 30, 2020, research and development expenses increased by €1.1 million or 173 %, from €0.7 million for the six months ended June 30, 2020, to €1.8 million for the six months ended June 30, 2021, due to an increase in staff and consulting costs to support our R&D activities. The Company started as of January 2021 to amortize its intangible assets. This explains the significant increase of depreciation expenses for the six months ended June 30, 2021, compared to the six months ended June 30, 2020.

Clinical Expenses. Before capitalization of €3.1 million for the six months ended June 30, 2021, and €1.4 million for the six months ended June 30, 2020, clinical expenses increased by €1.8 million, or 96%, from €1.9 million for the six months ended June 30, 2020, to €3.7 million for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff and consulting to support the completion of the BETTER SLEEP trial implantations, continuous recruitment for the EliSA trial and the ongoing DREAM IDE trial in the United States.

Manufacturing Expenses. Before capitalization of €0.3 million for the six months ended June 30, 2021, and €1.2 million for the six months ended June 30, 2020, manufacturing expenses increased by €1.0 million, or 72% from €1.4 million for the six months ended June 30, 2020, to €2.4 million for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff, in production and engineering team to support capacity and yield improvement. In addition, manufacturing expenses increased for the six months ended June 30, 2021, compared to the same period of 2020 due to the increase demand of our Genio^® system for non-commercial purposes (clinical trials, development activities, etc) and, therefore, the increase of associated production costs.

Quality Assurance and Regulatory Expenses. Before capitalization of €0.2 million for the six months ended June 30, 2021, and €0.5 million for the six months ended June 30, 2020, quality assurance and regulatory expenses increased by €0.3 million, or 44% from €0.6 million for the six months ended June 30, 2020, to €0.9 million for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff and QA & regulatory activities to support manufacturing scaling up process.

Patent Fees & Related Expenses. Before capitalization of €0.2 million for the six months ended June 30, 2020, patents fees and related expenses increased by €0.5 million, or 199 % from €0.3 million for the six months ended June 30, 2020, to €0.8 million for the six months ended June 30, 2021, due to expenses related the in-licensing agreement with Vanderbilt University.

Therapy Development Expenses. Therapy development expenses increased by €0.7 million or 97 % from €0.8 million for the six months ended June 30, 2020, to €1.5 million for the six months ended June 30, 2021. The increase in the expenses was mainly due to an increase in staff and consulting, to support the launch of the commercialization in Europe.

Other Operating Income / (Expenses). The Company had other operating expenses of €0.1 million for the six months ended June 30, 2021, and other operating income of €0.2 million for the six months ended June 30, 2020, the evolution being mainly due to the impact of the initial measurement and re-measurement of the financial debt.

Operating Loss

The Company realized a net loss of €12.6 million for the six months ended June 30, 2021, compared to a net loss of €4.3 million for the six months ended June 30, 2020, due to increases of activities in all departments.

Cash Position

Cash and cash equivalents totaled €79.2 million on June 30, 2021, as compared to €23.9 million on June 30, 2020.

Net cash used in operations was €8.4 million for the six months ended June 30, 2021 compared to €4.0 million for the six months ended June 30, 2020. The increase of €4.3 million was primarily due to an increase in a loss for the period of €8.2 million that was mainly attributable to increased general and administrative expenses, research and development expenses, manufacturing expenses and therapy development expenses, which were offset by a positive variation in the working capital and other non-cash transactions of €3.9 million.

Net cash used in investing activities was €4.5 million for the six months ended June 30, 2021 compared €3.7 million to the six months ended June 30, 2020.

Net cash used in financing activities for the six months ended June 30, 2021 was €289 thousand compared to €25.7 million of net cash provided by financing activities during the six months ended June 30, 2020. The decrease was due to the fact that no financing rounds have been organized in the first half of 2021.

Outlook for 2021

The Company’s business, operational, and clinical outlook for 2021 include the following expected milestones and goals:

Begin marketing in Switzerland with approved DRG, as well as additional European countries by the second half of 2021
Ramp up EU revenue through dedicated sales team in Germany
Open second independent manufacturing site in Belgium
Complete DREAM pivotal trial enrollment in the fourth quarter of 2021

First half-year report 2021
Nyxoah’s financial report for the first half of 2021, including details of the unaudited condensed consolidated financial statements, 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 to open to the public tomorrow, September 1, 2021, at 3:00 p.m. CET / 9:00 a.m. ET, which will also be webcasted. To participate in the conference call, please dial one of the following numbers:

Conference ID: 7468474

USA:                             (844) 260-3718
Belgium:                       0800 73264
International:                (929) 517-0938

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 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 has completed the BETTER SLEEP study in Australia and New Zealand for therapy indication expansion and is currently conducting 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 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. 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
Fabian Suarez, Chief Financial Officer
corporate@nyxoah.com
+32 (0)10 22 24 55

Gilmartin Group
Vivian Cervantes
IR@nyxoah.com

Attachment

ENGLISH – 1H Results PR_FINAL

September 1, 2021

Dozens of Top NLD Officials Detained on Corruption Charges Since Myanmar Coup

Myanmar’s junta has detained nearly four dozen high-ranking officials from the deposed National League for Democracy (NLD) on charges of corruption since seizing power seven months ago in a bid to tarnish the party’s image at a time of heightened political rivalry, legal analysts said Tuesday.

Among the 45 charged under Sections 55, 56 and 63 of the country’s anti-corruption law since the Feb. 1 coup are NLD leader and former state counselor Aung San Suu Kyi, former mayor of the capital Naypyidaw Dr. Myo Aung, five former regional and state chief ministers, two former cabinet ministers, and a former speaker of a regional parliament, according to reporting by RFA’s Myanmar Service.

Those found guilty face up to 15 years in prison and fines.

Chu Chu and Nang Shwe Myint, the wives of Sagaing Region Chief Minister Dr. Myint Naing and Shan State Chief Minister Dr. Lin Htut, told RFA that the charges against their husbands and other NLD officials are laughable, as the party has always sought to root out corruption as one of its principal platforms.

“We have fought all along against corruption because we don’t accept it—the NLD has always worked to rid the country of corruption, which it despises,” Chu Chu said.

“Do you think [party members] would violate this law themselves? [The junta] just uses any charge it wants. Our conscience is clear. I can say without a doubt that we have never committed any acts of corruption.”

Nang Shwe Myint said it is “unbelievable” that nearly all the NLD’s state and regional chief ministers have been prosecuted for graft.

“[The junta] just does what it wants,” she said. “I strongly believe the [NLD leaders] have done nothing like the corruption they are accused of. I have nothing else to say about these bogus charges.”

Documents and data obtained by RFA list other NLD officials in detention for corruption as Naypyidaw Deputy Mayor Ye Min Oo, Mandalay Region Chief Minister Dr. Zaw Myint Maung, Magway Region Chief Minister Dr. Aung Moe Nyo, Bago Region Chief Minister Win Thein, Rakhine State Prime Minister Nyi Pu, Kayin State Chief Minister Nang Khin Htwe Myint, Kachin State Chief Minister Dr. Khet Aung, and Mon State Prime Minister Dr Aye Zan.

Two former NLD union ministers charged with corruption are Minister for Religion and Culture Thura Aung Ko and Minister for Social Welfare, Relief and Resettlement Win Myat Aye. Of the two, Thura Aung Ko was arrested by the military, but Win Myat Aye is on the run. Magway Region Hluttaw Speaker U Tar and Yangon Region Social Affairs Minister Naing Lin and other regional and state cabinet ministers have also been charged under anti-corruption laws.

Bid to ‘damage reputations’

The junta has said the NLD government “failed to follow proper procedures” and “abused power for personal gain,” squandering state finances. Coup leader Senior General Min Aung Hlaing told a meeting of junta officials in Naypyidaw on Aug. 23 that the Anti-Corruption Commission is “investigating illegal activities under the previous government.”

But legal analysts told RFA that the military’s bid to prosecute the NLD’s leaders on corruption charges is aimed at tarnishing the party’s image at a time of heightened political rivalry in the country.

“To open charges of corruption against those who hold office amid intense political competition is mainly to damage their reputations and also to suppress their opposition activities,” veteran lawyer Khin Maung Myint told RFA.

“We have seen this in many cases. Whether the charges are true or not will only be found out after the two sides appear in court and find a decision.”

Saw Than Htut, the brother of Karen State Prime Minister Nang Khin Htwe Myint, said the junta is seeking to justify long prison terms for NLD members, including Aung San Suu Kyi, who spent some 15 years under house arrest under the country’s former military junta until her release in 2010.

“The reason the military is suing all these leaders on corruption charges, including Daw Aung San Suu Kyi and chief ministers of various states and regions, is so that they can hold onto power,” he said.

“Of course, our leader is such a shrewd person. She is clean and our NLD leaders have worked to fight corruption all along.”

While RFA has been able to identify 45 NLD leaders who are facing prosecution under Myanmar’s anti-corruption law, sources say the number of actual arrests and imprisonments is likely to be much higher.

Reported by RFA’s Myanmar Service. Translated by Khin Maung Nyane. Written in English by Joshua Lipes.