Day: September 1, 2021

South Bend, IN, Sept. 01, 2021 (GLOBE NEWSWIRE) — (via Blockchain Wire) SIMBA Chain, the technology company that has eliminated the complexities of blockchain app development and reduced energy usage thus opening the door to a world of users, has closed a  $25 million Series A funding round led by Valley Capital Partners. The round received additional participation from the Notre Dame Pit Road Fund, Elevate Ventures, Stanford Law School Venture Fund, and individuals affiliated with Kohlberg, Kravis & Roberts (KKR), Amazon, Apple, Facebook, SpaceX, Gap, Estee Lauder, AppLovin, Microsoft, Moelis & Company, Stanford University, the Golden State Warriors, the founders of Lightspeed Venture Partners and New Enterprise Associates and other individual investors.

SIMBA Chain, a startup incubated at the University of Notre Dame, offers a simple, time and energy efficient method for deploying blockchain technology in the most secure and complex environments. Its state-of-the-art technology autogenerates a robust family of APIs that support permissioned and public blockchains, allowing customers to launch blockchain applications without hiring costly consultants or consuming valuable tech expertise. And, because SIMBA Chain allows users to select from a wide range of blockchain technologies, with portability across these chains, the company provides a level of flexibility and customization that traditional blockchain approaches cannot support.

SIMBA Chain’s technology is currently used by the U.S. Airforce, Army, Navy and Marines, as well as Boeing and a host of customers across a wide range of commercial applications, said CEO and co-founder Joel Neidig. “Demand for our Web3 smart contracts platform has accelerated across all of our markets much quicker than we anticipated. Users across multiple spectrums have embraced and validated the SIMBA Chain model, which simplifies development of smart contracts. The market has also responded positively to our support of multiple blockchains, including Ethereum, Avalanche, RSK, Stellar, and many others, making SIMBA Chain-based applications simple, highly portable and sustainable.”

Steve O’Hara, managing partner at Valley Capital Partners of Menlo Park, California, said, “Since its founding in 2017, SIMBA Chain has distinguished itself by solving the incredibly hard problem of making blockchain technology, which is inherently complex and difficult to master, accessible to literally anyone who wants to realize the advantages blockchain has to offer. Thanks to the intellectual depth and insatiable curiosity of its team, SIMBA Chain has succeeded in establishing impressive beachheads in the defense and enterprise markets – a rare thing to see in emerging frontier technologies like blockchain. We are excited to support SIMBA Chain at this pivotal time.”

With the additional funding, SIMBA Chain plans to scale sales, marketing, and development, and to dedicate resources to emerging enterprise level opportunities such as non-fungible tokens. SIMBA Chain expects business enterprises, academic institutions, and others will use its software to manage and monetize digital and physical assets as well as to launch business models that don’t exist today.

“This is one of the more exciting blockchain companies I’ve seen in a while,” observed Joseph Grundfest, a Stanford Law School professor, former commissioner of the Securities and Exchange Commission and member of Stanford’s Center for Blockchain Research. “SIMBA Chain solves a very big problem; most companies don’t know how to adopt or manage blockchain technology. SIMBA Chain makes that easy and cheap, so it’s a bit like Stripe for the blockchain. Also, by writing on energy-efficient blockchains, SIMBA Chain’s ‘green solution’ responds to concern that some blockchains contribute to global warming.”

Despite the past year’s economic disruptions, SIMBA Chain has remained laser focused on unleashing blockchain’s potential for enterprise, government, and education as the first examples of what will certainly be numerous use cases. Over the last 18 months, SIMBA Chain has achieved the following milestones:

• Grown revenue by 360 percent.
• Closed paid programs with the U.S. Air Force, U.S. Army, U.S. Navy, and U.S. Marine Corp to develop secure, immutable, blockchain-based solutions critical to U.S. national security and warfighter effectiveness.
• Secured contracts with more than 30 institutions of higher learning in the United States, United Kingdom and Australia that are using the SIMBA Chain platform in their schools of business and law.
• Surpassed 6,000 users.
• Developed a digital marketplace using non-fungible tokens for a major university.

Joining the SIMBA Chain Board of Directors are Steve O’Hara, Valley Capital Partners; Phil Koen, former CEO of Savvis and Intermedia, and former president of Equinix; and Mike Lempres, former EIR at Andreessen Horowitz, and former chief legal and risk officer and Board of Directors member, Coinbase.

Said Neidig, “”The entire SIMBA Chain team is elated by this new investment and what it represents. We are grateful to everyone who has recognized our potential, and we look forward to the future.”

About SIMBA Chain, Inc.
SIMBA Chain’s cloud-based enterprise platform enables universities, industry, governments, and individual programmers to quickly develop and deploy Web 3.0 distributed applications (dApps) across many blockchain platforms. SIMBA Chain was founded in 2017 through a DARPA grant awarded to the University of Notre Dame and ITAMCO and has received multiple awards, including a 2020 U.S. Small Business Administration Tibbetts Award, TechPoint’s 2019 Mira Award for New Product of the Year, and 1st Source Bank’s 2019 Commercialization Award. SIMBA Chain’s ecofriendly, energy efficient platform supports Avalanche, Ethereum, Consensys Quorum, Binance Smart Chain, RSK, Stellar, Hyperledger, and other blockchain protocols. Learn more.

Contact:
Joel Neidig
CEO and Co-founder
SIMBA Chain
+15749144446
info@simbachain.com
https://simbachain.com

SHANGHAI, China and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS) announced today the completion of the rolling submission of the Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for toripalimab in combination with gemcitabine and cisplatin for first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

The FDA recently granted Breakthrough Therapy Designation (“BTD”) for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for 1^st line treatment of recurrent, locally advanced or primary metastatic non-keratinizing nasopharyngeal carcinoma (“NPC”) and earlier in 2020 granted BTD for toripalimab monotherapy for patients with recurrent or metastatic non-keratinizing NPC with disease progression on or after platinum-containing chemotherapy. BTD is intended to expedite the development and regulatory review of drugs where preliminary clinical evidence demonstrates substantial improvement over existing therapies for a severe or life-threating disease. Drugs with BTD will be granted more frequent FDA interaction and intensive guidance – including that from senior FDA officials – on the development program and ability to participate in various forms of expedited FDA review programs to provide patients with new therapy as soon as possible.

“Toripalimab was approved for marketing early this year in China as the world’s first immune checkpoint inhibitor to treat advanced NPC, an aggressive tumor with limited treatment options,” said Patricia Keegan, MD Chief Medical Officer of Junshi Biosciences. “Toripalimab showed remarkable efficacy in the treatment of advanced NPC according to the results from POLARIS-02 and JUPITER-02 studies, as recognized by inclusion in plenary and other presentations at leading international medical professional conferences and publications in highly respected scientific journals. We look forward to working closely with the FDA in the review of this BLA and with our U.S. partner, Coherus, to bring this new treatment option forward as expeditiously as possible for patients in the U.S.”

“Toripalimab, the foundation stone of our emerging immuno-oncology franchise, demonstrated compelling efficacy in the pivotal studies supporting the BLA for nasopharyngeal carcinoma,” said Denny Lanfear, Coherus CEO. “As data read out from the extensive set of pivotal clinical trials potentially supporting a broad range of additional indications, we expect toripalimab to maintain a consistently strong efficacy profile.  We will continue to work with our partner, Junshi Biosciences, to advance toripalimab through FDA approval.”

The submission is supported by the results from “POLARIS-02” and “JUPITER-02”. The POLARIS-02 study is a multi-center, open-label, pivotal Phase II clinical study, results of which were published online in January 2021 in Journal of Clinical Oncology. The JUPITER-02 study is a randomized, double blind, placebo-controlled pivotal Phase 3 clinical trial, results of which were recently presented at the ASCO plenary session (#LBA2) and published in the August 2021 on-line edition of Nature Medicine.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Ceherus plan to file additional toripalimab BLAs with the FDA over the next three years for multiple cancers and highly prevalent cancers.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

UDENYCA® is a trademark of Coherus BioSciences, Inc.

Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

Humira® is a registered trademark of AbbVie Inc.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, or any indication; Coherus’ and Junshi Biosciences’ plans to file additional toripalimab BLAs with the FDA over the next three years for other clinical indications; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021

and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Contact Information:
IR Contact:
McDavid Stilwell
Coherus BioSciences, Inc.
mstilwell@coherus.com
+1 (650) 395-0152

Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
+1 (949) 903-4750

September 1, 2021Amsterdam, the Netherlands – Royal Philips (NYSE: PHG; AEX: PHIA) today announced an update in connection with the June 14, 2021 recall notification* for specific Philips sleep and respiratory care devices that was issued to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices. More than half of the affected devices in use globally are in the US. The vast majority (>80%) of the registered affected devices in the US to date are in the first-generation DreamStation product family.

Philips received authorization from the US Food and Drug Administration (FDA) for the rework of the affected first-generation DreamStation devices [1], which consists of replacement of the PE-PUR sound abatement foam with a new material. Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the US with DreamStation 2 CPAP devices. Philips remains in dialogue with the FDA with respect to other aspects of the recall notification and mitigation plan in the US [2].

Philips is initiating the repair and replacement programs in other countries as well and expects to have these underway in the majority of its markets by the end of September 2021. The company intends to complete the repair and replacement programs within approximately 12 months.

“We fully recognize that the timeframe for remediation of the affected devices places patients in a difficult situation,” said Frans van Houten, CEO of Royal Philips. “We are mobilized to deliver a solution to them as fast as possible. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients. We urge patients with affected active devices to register these on the dedicated recall notification website.”

More information on the recall notification, as well as instructions for customers, users, and physicians can be found at www.philips.com/src-update. Patients with affected devices currently in use are requested to register their products on this website to facilitate the repair and replacement program.

*         This is a recall notification for the US only, and a field safety notice for the rest of the world. In the US, the recall notification has been classified by the FDA as a Class I recall.
[1]        This includes DreamStation CPAP, Auto CPAP; Dream Station Bi-Level PAP; DreamStation ASV; and DreamStation ST, AVAPS devices.
[2]        The remaining affected devices for remediation in the US can be found at www.philips.com/src-update.

For media information, please contact:

Ben Zwirs
Philips Global Press Office
Tel.: +31 6 15213446
E-mail: ben.zwirs@philips.com

Derya Guzel
Philips Investor Relations
Tel.: +31 20 59 77055
E-mail: derya.guzel@philips.com

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and enabling better outcomes across the health continuum from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 77,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Forward-looking statements
This release contains certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items. Examples of forward-looking statements include statements made about the strategy, estimates of sales growth, future EBITA, future developments in Philips’ organic business and the completion of acquisitions and divestments. By their nature, these statements involve risk and uncertainty because they relate to future events and circumstances and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these statements.

Singapore, Aug. 31, 2021 (GLOBE NEWSWIRE) — AscendEX, a global digital asset trading platform with a comprehensive product suite, is thrilled to announce the listing of the Kava Swap token (SWP) under the pair USDT/SWP on September 1st at 1 p.m. UTC.

Kava is focused on democratizing financial services and making them openly accessible to anyone, anywhere in the world.  Kava Chain is a decentralized, permissionless, censorship-resistant blockchain built with the Cosmos SDK. This means it operates much like other Cosmos ecosystem blockchains, and is designed to be interoperable with other chains.

Kava.io is the first cross-chain Decentralized Finance (DeFi) hub providing applications and services to the world’s largest cryptocurrencies. Kava’s platform operates as a decentralized bank for digital assets connecting users with products like stablecoins, loans, and interest-bearing accounts so that they can do more and earn more with their digital assets. For example, sers can deposit their digital assets and use them as collateral to borrow Kava’s crypto-backed stablecoin, USDX. The native swap token (SWP), launching Monday Aug. 30, allows users to swap and engage with multiple assets across different chains.

Kava Swap is a cross-chain liquidity hub for all DeFi apps and financial services. Its purpose is to enable the aggregation of capital where it can then be deployed seamlessly across different blockchain ecosystems, DeFi apps, and financial services. At its core, Kava Swap is a cross-chain Autonomous Market Making (AMM) Protocol that leverages the Kava platform’s DeFi infrastructure, cross-chain bridges, and security. Kava Swap delivers users a seamless way to swap between assets of different blockchains and deploy their capital into market-making pools where they can earn handsome returns.

The Kava Protocol is the set of rules and behaviors built into the Kava Chain that enables advanced DeFi functionality like permissionless borrowing and lending. Like most Cosmos ecosystem blockchains, the automated transaction behaviors known as “Smart Contracts” are hardcoded into the protocol. They are referred to as “modules” in the Cosmos Ecosystem. The Kava App uses a special kind of module called a CDP. Hard Protocol is an application that runs on Kava Chain. It does not have its own blockchain. It builds upon the Kava Protocol and adds new functionality, expanding the Kava Ecosystem to include an autonomous money market protocol.

The HARD token is a unique token on the Kava Chain. It is given as a reward for supplying and borrowing on the Hard app. KAVA, the native token of the KAVA protocol, is used as a Proof of Stake (POS) staking asset, which ensures the finality and safety of loans on the protocol and also acts as the ‘lender of last resort’ in certain situations. The Kava Chain is secured by its native token KAVA and it is used across the full chain as a transport and a store of value. It is given as a reward for minting USDX on the Kava app. USDX is a stable coin loosely pegged to the US Dollar. It is minted when a Kava CDP is opened. KAVA, SWP, and HARD are all governance tokens, meaning holders can vote on the rules and proposed new features of the protocols.

About AscendEX 

AscendEX is a global cryptocurrency financial platform with a comprehensive product suite including spot, margin, and futures trading, wallet services, and staking support for over 150 blockchain projects such as bitcoin, ether, and ripple. Launched in 2018, AscendEX services over 1 million retail and institutional clients globally with a highly liquid trading platform and secure custody solutions. AscendEX has emerged as a leading platform by ROI on its “initial exchange offerings” by supporting some of the industry’s most innovative projects from the DeFi ecosystem such as Thorchain, xDai Stake, and Serum. AscendEX users receive exclusive access to token airdrops and the ability to purchase tokens at the earliest possible stage. To learn more about how AscendEX is leveraging best practices from both Wall Street and the cryptocurrency ecosystem to bring the best altcoins to its users, please visit www.AscendEX.com.

For more information and updates, please visit:

Website: https://ascendex.com

Twitter: https://twitter.com/AscendEX_Global

Telegram: https://t.me/AscendEXEnglish

Medium: https://medium.com/ascendex

About Kava Swap

Kava Labs is focused on democratizing financial services and making them openly accessible to anyone, anywhere in the world. Kava is the first cross-chain Decentralized Finance (DeFi) hub providing applications and services to the world’s largest cryptocurrencies. Kava’s platform operates as a decentralized bank for digital assets connecting users with products like stablecoins, loans, and interest-bearing accounts so that they can do more and earn more with their digital assets.

For more information and updates, please visit:

Website: https://www.kava.io/

Twitter: https://twitter.com/Kava_Swap

Telegram: https://t.me/KavaSwap

Medium: https://medium.com/kava-labs

Marketing Department
AscendEX
marketing@ascendex.com

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

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• ENGLISH – 1H Results PR_FINAL