Nyxoah Announces 2024 Strategic Priorities

Nyxoah Announces 2024 Strategic Priorities

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

2024 Strategic Priorities

  • Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. 12-month efficacy data1 on the first 34 DREAM patients and safety data on all DREAM patients were presented at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success.
  • File the fourth and final module in the modular PMA submission. Anticipate submitting the final module shortly after announcing DREAM results.
  • Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded market access to secure reimbursement at launch.
  • Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Recently announced investigator-sponsored data in Europe demonstrating Genio’s® success in treating CCC patients.
  • Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

“Since Nyxoah’s founding we have been guided by the mission to improve the lives of OSA patients. This led to the development of the patient-centric Genio HGNS system. Genio’s single-incision, leadless, upgradable design powered and controlled by a wearable resonated with clinicians and patients and led to a strong European launch. Genio’s bilateral stimulation enables treatment of CCC, and the label was subsequently expanded to include these patients, whose only treatment option after failing CPAP up until then was major palate surgery,” commented Olivier Taelman, Chief Executive Officer.

“In our ongoing effort to provide patients greater control over their therapy, thereby making sleep simple again, we then received approval for Genio 2.1. Genio 2.1 offers patients daily feedback on therapy usage and autonomy to adjust stimulation amplitude within pre-defined boundaries, improving patient comfort and compliance without the need for a surgical procedure to replace the implantable component.”

“We are now on the cusp of the most significant milestone in the Company’s history with the reporting of DREAM results in the coming months. We expect to complete the PMA submission shortly after and are accelerating manufacturing and commercial investments to ensure we are fully prepared to replicate our European success in the U.S. With an approaching U.S. launch and continued growth in Europe, we are excited for the coming years.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

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

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313


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

Attachment

GlobeNewswire Distribution ID 1000909240

Quantexa Partners with the Anti-Human Trafficking Intelligence Initiative (ATII) to Intensify the Fight Against Human Trafficking

Quantexa to provide category-leading AI-enabled technology, training, and industry expertise to ATII to improve how data is used in the identification and investigation of human trafficking

NEW YORK, Jan. 11, 2024 (GLOBE NEWSWIRE) — Today, Quantexa, a global leader in Decision Intelligence (DI) solutions for the public and private sectors, announced its official corporate sponsorship and Advisory Council membership of the Anti-Human Trafficking Intelligence Initiative (ATII), to mark National Human Trafficking Awareness Day. The ATII is a US-based nonprofit organization whose mission is to fight human trafficking and child exploitation by providing data to advance the prevention, detection, investigation, and reporting mechanisms required to identify potential traffickers and criminal organizations. The International Labor Organization estimates that 50 million1 people are victims of human trafficking globally, with human trafficking operating as a $150 billion2 industry around the world.

Quantexa will provide groundbreaking Decision Intelligence technology, alongside its industry-leading expertise in AI-driven financial crime prevention and detection through training and joint industry engagement. Together, Quantexa and ATII will make pioneering global human trafficking risk data available to more organizations to transform anti-human trafficking efforts and joint initiatives between the private and public sectors.

The Quantexa Decision Intelligence Platform enables organizations to automate data ingestion and matching at unmatched scale and apply graph analytics to visually identify often hard-to-detect activity related to financial crime. Providing access to a wider set of data points specific to human trafficking will enable investigators to take a more robust approach to anti-human trafficking measures. This data, overlaid with persona-based typologies and red flag identification protocols will accelerate the ID of potential human trafficking involvement more quickly, efficiently, and accurately.

“Partnering with Quantexa grants us access to innovative AI technology that will take our mission to fight human trafficking to the next level, transforming our existing processes and providing our partners with improved data to inform investigations faster and more efficiently,” said Aaron Kahler, Founder and CEO of ATII. “Working with Quantexa will put ATII’s data in the hands of more organizations across the public and private sectors, to help detect and eliminate more instances of human trafficking as we work together towards ensuring this type of data is routinely available to investigators.”

“We’re proud to partner with the Anti-Human Trafficking Intelligence Initiative to support the valuable work that the organization is doing to stop human trafficking,” said Clark Frogley, North American Head of Financial Crime Solutions at Quantexa. “Human trafficking is often enabled by illegal financial activity and Quantexa’s deep experience helping organizations to monitor, detect, and investigate financial crimes makes us the ideal partner to support ATII’s mission. This partnership will aid organizations to reinforce their ESG and anti-money laundering (AML) efforts which are critical to stopping human trafficking.”

For more information on global challenges and solutions related to human trafficking, please listen to this podcast featuring Chris Bagnall, Director of Financial Crimes Solutions at Quantexa, Chris Kemp, Director of Enterprise Operations at the ATII and Karim Rajwani, ATII Advisory Council Chairman on Moody’s Talks.

About Quantexa
Quantexa is a global data and analytics software company pioneering Decision Intelligence that empowers organizations to make trusted operational decisions by making data meaningful. Using the latest advancements in big data and AI, Quantexa’s Decision Intelligence platform uncovers hidden risk and new opportunities by providing a contextual, connected view of internal and external data in a single place. It solves major challenges across data management, KYC, customer intelligence, financial crime, risk, fraud, and security, throughout the customer lifecycle.

The Quantexa Decision Intelligence Platform enhances operational performance with over 90% more accuracy and 60 times faster analytical model resolution than traditional approaches. Founded in 2016, Quantexa now has more than 675 employees and thousands of users working with billions of transactions and data points across the world. The company has offices in London, Dublin, Brussels, Malaga, UAE, New York, Boston, Toronto, Sydney, Melbourne, and Tokyo.

For more information, please visit www.quantexa.com or follow us on LinkedIn.

Media Enquiries 
C: Emma Hedges, Executive Vice President, Fight or Flight
E: Quantexa@fightorflight.com

C: Adam Jaffe, SVP of Corporate Marketing
T: +1 609 502 6889
E: adamjaffe@quantexa.com
– or –
RapidResponse@quantexa.com

________________________________

1 International Labour Organization (ILO), Walk Free and International Organization for Migration (IOM), “Global Estimates of Modern Slavery: Forced Labour and Forced Marriage,” 2022

2 International Labour Office (ILO), “Profits and Poverty: The Economics of Forced Labour,” 2014

GlobeNewswire Distribution ID 1000908209

EMGA Secures a Commitment for USD 30.0 Million Senior Debt Finance for Citizens Development Business Finance PLC in Sri Lanka

LONDON, Jan. 10, 2024 (GLOBE NEWSWIRE) — Emerging Markets Global Advisory LLP (EMGA), an investment bank specializing in emerging markets, has successfully secured a commitment for USD 30.0 million in senior debt finance for Citizens Development Business Finance PLC (CDB) based in Sri Lanka. EMGA originated, structured, and negotiated this financing arrangement, with the financial support provided by the U.S. International Development Finance Corporation (DFC).

Sajeev Chakkalakal, EMGA’s Head of Investment Banking commented, “Despite the challenges we faced, we are delighted to have delivered again an innovative funding solution for CDB. We believe this marks a significant milestone, in being the first external funding commitment secured for a Sri Lankan NBFI in several years. It will also allow for CDB to continue to support SMEs, including female-owned enterprises, as well as the renewable energy sector in the country.”

Jeremy Dobson, EMGA’s Chief Operating Officer commentated, “CDB’s strong financial standing enabled EMGA to navigate the prevailing macroeconomic headwinds in Sri Lanka to secure the commitment for this funding. This achievement not only underscores EMGA’s expertise in navigating complex financial landscapes, but also highlights the successful collaboration between EMGA, CDB, and DFC in setting a positive precedent for a leading Sri Lankan financial institution to secure external funding in challenging economic climates.”

Maryam Khosharay, DFC’s Deputy Vice President of the Office of Development Credit commented, “We are very glad to continue DFC’s commitment to bolstering investments in Sri Lanka especially those advancing financing for women and green assets in times of economic difficulty and high energy prices.”

Commenting on the transaction, Director Corporate Finance of CDB Roshan Abeygoonewardena opined that CDB has been continually strengthening the bottom of the pyramid as an overarching ethos of its sustainability agenda. “For us women entrepreneurs, especially in the micro and SMEs is where the wheels of the economy turn. Prioritizing women’s empowerment in our business model with access to finance which in turn will spur financial independence and inclusivity will be the panacea in adding fillip to Sri Lanka’s development and economic agenda.”

Emerging Markets Global Advisory LLP (EMGA), based in London and New York helps financial institutions and corporates seeking new debt or equity capital. EMGA’s multi-national team combine the decades of experience necessary to complete transactions within most emerging countries, including Sri Lanka. EMGA continues to expand its geographic reach, solidifying its place as a preeminent, emerging market focused, niche investment bank.

Citizens Development Business Finance PLC (CDB) stands among the five largest non-Bank financial institutions in Sri Lanka and is one of the most innovative financial institutions in the country, with a strong commitment to sustainability, exemplary corporate governance, accountability, and transparency. It is renowned for disrupting the financial services industry with far-reaching technological innovations and cutting-edge financial solutions.

The U.S. International Development Finance Corporation (DFC) is the U.S. Government’s development finance institution. DFC partners with the private sector to finance solutions to the most critical challenges facing the developing world today. We invest across sectors including energy, healthcare, infrastructure, agriculture, and small business and financial services. DFC investments adhere to high standards and respect the environment, human rights, and worker rights.

Contact details
info@emergingmarketsglobaladvisory.com

GlobeNewswire Distribution ID 1000908217

Distinguished Scientists with Breakthroughs in Gene Therapy for Neuromuscular Diseases, and Revolutionary RNA Discoveries , Announced as King Faisal Prize Laureates in Medicine & Science

Professor Jerry Mendell and Professor Howard Chang, among other eminent figures, were selected to win the 46th session of the Prize

Riyadh, Saudi Arabia, Jan. 10, 2024 (GLOBE NEWSWIRE) — Professor Jerry Mendell was announced this year’s laureate in King Faisal Prize for Medicine for his groundbreaking contributions to screening, early diagnosis, and treatment of neuromuscular disorders, and Professor Howard Chang was announced this year’s laureate in King Faisal Prize for Science in the field of Biology for his pioneering work in uncovering the significance of long non-coding RNAs in gene regulation and function and his collaborative efforts in advancing genome-wide methodologies to identify DNA regulatory regions. Other laureates’ names were announced to win King Faisal Prize in 2024 for enriching humanity with invaluable achievements and discoveries, and excelling in the fields of Islamic Studies and Serving Islam.

Professor Jerry Mendell’s work lies in the screening, early diagnosis, and treatment of patients with spinal muscular atrophy (SMA), Duchenne muscular dystrophy (DMD), and limb girdle muscular dystrophies. The Prize’s Medicine topic for 2024 was “Management of Peripheral Disabilities”.

Spinal muscular atrophy (SMA) used to be considered the primary genetic contributor to infant mortality. Around 95% of infants that were diagnosed with SMA, did not survive beyond the age of two. Babies with SMA type 1 are missing a gene called survival motor neuron gene 1 (SMN1) which is vital for their development and its absence prevents them from moving, talking, swallowing, and eventually breathing. Professor Mendell, the Director of Gene Therapy Center at Nationwide Children’s Hospital and Curran Peters Chair in Pediatric Research, used gene-therapy to deliver a healthy gene (SMN1) to patients’ cells. He was the first to demonstrate the safety and efficacy of high doses of AAV-mediated gene transfer therapy for individuals diagnosed with SMA type 1. Adeno-associated viral vectors (AAV) are engineered viruses specifically designed to deliver DNA, and in the context of SMA treatment, they carry the genetic encoding of the healthy SMN gene. His therapeutic approach has garnered worldwide approval, and in 2019 the U.S. Food and Drug Administration granted approval for the first-ever gene therapy treatment for pediatric patients under 2 years of age diagnosed with SMA.

Gene-therapy has also been used by Professor Mendell to correct the genetic mutations for patients suffering from the most common form of muscular dystrophy; Duchenne muscular dystrophy (DMD), a progressive neuromuscular disease. In patients with DMD, genetic mutations prevent cells from making dystrophin; a protein responsible for developing and maintaining healthy muscle tissue. While initial symptoms in DMD patients manifest in skeletal muscles, the condition progresses to impact the heart and respiratory functions. Gene therapy serves to rectify this genetic abnormality, enabling the body to generate dystrophin and impede the ongoing degeneration of muscle tissue. In June 2023, the U.S. Food and Drug Administration approved the first treatment for pediatric patients 4-5 years old with DMD using the novel gene-therapy co-invented by Professor Mendell and Professor Louise Rodino-Klapac; a post-doctoral fellow in Mendell’s lab at the time. A single injection treatment involves administering a micro-dystrophin gene into an adeno-associated virus serotype (AAVrh74), facilitating the delivery of missing or corrected genes to cells.

Professor Mendell has been involved in clinical trials for gene therapy for limb-girdle muscular dystrophy (LGMD) including types 2E, 2B, and 2D. LGMD is an umbrella term that represents several rare types of muscular dystrophy that cause muscle weakness in shoulders, upper arms, hips, and upper legs. It is a chronic condition that affects people of all ages. In one of his studies, Prof. Mendell and his team used a single injection of a low dose of a gene therapy vector to address the primary cellular deficit associated with LGMD2B. The approach repaired the injured muscle fibers, reducing degeneration, and enhancing muscle function.

As author of over 400 papers, Prof. Mendell was elected to the National Academy of Medicine in 2021. He was also recognized by the American Society of Gene and Cell Therapy (ASGCT) with a Translational Science Award in his Name. Science Magazine awarded him the Breakthrough Achievement Award in 2017 for SMA Gene Therapy.

As for this year’s Science Prize in the field of Biology, Professor Howard Chang was announced the laureate, for unveiling the intrinsic role of long non-coding RNAs in gene regulation and function, and for his collaborative endeavors in advancing genome-wide methodologies identifying DNA regulatory regions. Such findings are significantly influencing the realms of molecular biology and genetics, contributing to a deeper understanding of intricate human diseases. His research addresses how large sets of genes are turned on or off together, a key point that helps understand normal development, cancer, and aging.

Professor Howard Chang, a physician-scientist, Professor of Dermatology and Genetics, and Virginia and D.K. Ludwig Professor of Cancer Research at Stanford University, has made significant contributions to the field of RNA medicines. His lab’s work has focused on understanding the roles of long noncoding RNAs (a genetic material found in cells) in biological regulation and their potential therapeutic applications. He discovered long sequences of RNA that, in contrast to the better-known messenger (mRNAs) responsible for protein synthesis, do not encode proteins. Prof. Chang discovered that these sequences play a role in influencing DNA accessibility. They act like a magnet for other RNA molecules and alter mRNA splicing, to affect gene expression, among other duties. Despite not encoding proteins, lncRNAs are crucial for controlling the timing and amount of protein production, impacting the overall function and behavior of cells.

In every human cell, 2 meters of DNA are packed in a 10-micron nucleus, so most of the DNA is highly compacted making most of it inaccessible except for the active DNA elements that the cell is using and reading. Discovering the location of these accessible elements provides insights into the cell’s “software”. Prof. Chang’s lab has pioneered techniques to map the landscape of chromatin; the substance that forms chromosomes and consists of DNA and proteins that structure the genome and control gene expression. One groundbreaking technique innovated by Chang’s lab was the Assay of Transposase Accessible Chromatin, which used an enzyme called Tn5 transposase which copies and pastes DNA. This technique led to a million-fold improvement in the sensitivity and hundred-fold improvement in the speed of mapping regulatory DNA – the epigenome- in human cells.

His work unraveled mechanisms and targets in various human diseases, notably cancer, immunity, and development. His recent investigations into extrachromosomal DNA in cancer revealed key findings. Prof. Chang also established the RNA Medicine Program at Stanford, which works to accelerate the discovery and translation of RNA science into human therapeutics.

Prof. Chang’s honors include the NAS Award for Molecular Biology, Outstanding Investigator Award of the National Cancer Institute, Paul Marks Prize for Cancer Research, Judson Daland Prize of the American Philosophical Society, and the Vilcek Prize for Creative Promise. His work was honored by the journal Cell as a Landmark paper over the last 40 years and by Science as “Insight of the decade”.

In addition to Medicine and Science, King Faisal Prize recognized this year the achievements of an outstanding thinker and scholar in the field of Islamic Studies and exemplary leaders who played a pivotal role in serving Islam, Muslims, and humanity at large.

Professor Wael Hallaq, the Avalon Foundation Professor in the Humanities at Columbia University, was selected to receive the “Islamic Studies” prize in “Islamic Legislations and their Contemporary Applications” for 2024. He has provided an academic reference, parallel to the traditional Orientalist writings, that influenced universities around the world. This was evident in his numerous works that were translated into many languages, and his success in establishing a guideline for the development of Islamic legislation.

As for the Service to Islam Prize, the Japan Muslim Association and Dr. Mohammad Sammak, were announced as co-laureates for this year’s 2024 prize.

King Faisal Prize for Arabic Language & Literature for 2024 on the topic of “Non-Arab Institutions and their Endeavors to Promote Arabic” was withheld due to nominated works not elevating to the criteria of the prize.

King Faisal Prize’s laureates names for 2024 were announced today in Riyadh Saudi Arabia, by HRH Prince Turki Alfaisal and the Prize’s Secretary General Dr. Abdulaziz Alsebail. Since 1979, King Faisal Prize in its 5 different categories has awarded 295 laureates who have made distinguished contributions to different sciences and causes. Each prize laureate is endowed with USD 200 thousand; a 24-carat gold medal weighing 200 grams, and a Certificate inscribed with the Laureate’s name and a summary of their work which qualified them for the prize.

Attachments

Maysa Shawwa
King Faisal Foundation
Maysa.Shawwa@kff.com

GlobeNewswire Distribution ID 9015914

[INVNT GROUP]™ the Global Brand Storytelling Agency Portfolio, Expands to South Asia Opening Tenth Office in Mumbai, India

Mumbai, India, Jan. 10, 2024 (GLOBE NEWSWIRE) — [INVNT GROUP] The Global BrandStory Project™, announces its expansion into South Asia opening its tenth office across seven countries in Mumbai, India. The move aligns with the Group’s vertical and horizontal growth strategy, which supports the increasing demand for innovative brand storytelling in one of the fastest-growing markets including Tata Motors, Hitachi Vantara, Samsung, Amazon, Unilever, Sun Pharmaceutical, and more.

With a significant presence already established in key locations such as New York, London, Sydney, Singapore, Dubai, San Francisco, Detroit, Washington D.C, and Stockholm, the addition of Mumbai to [INVNT GROUP]’s global footprint marks another step in bolstering its services to both local and multinational clients.

“We are excited to extend our reach and expertise to South Asia, a region that is rapidly emerging as a hub for technological and marketing communications innovation. Establishing a base in Mumbai is not solely a strategic decision but also a response to our client’s growing needs to engage and build wider and deeper communities. It reinforces our commitment to delivering impactful brand stories globally and locally, catering to the unique challenges and opportunities in the region. Our goal is to create unparalleled brand experiences that resonate deeply with local audiences and set new standards in creativity and strategic execution on the global stageWe’re also thrilled to welcome Laveesh Pandey, who joins our team with the perfect experience to drive the group’s expansion in the region,” said Scott Cullather, President & CEO of [INVNT GROUP], and CEO of INVNT.ATOM.

Laveesh Pandey has been appointed Managing Director of [INVNT GROUP] South Asia, reporting into Scott Cullather and Kristina McCoobery, INVNT CEO and [INVNT GROUP], COO. Pandey, previously Chief Operating Officer at Starlight Gaming, joins the global agency with over two decades of experience in the Media & Entertainment industry. Having held key positions at MindShare, Reliance Entertainment, Zapak Digital Entertainment and Clockwork Events, Pandey brings a deep knowledge of technology, gaming, experiential marketing, and advertising, with his award-winning leadership powering transformative B2B and B2C brand experiences.

“I am elated to lead [INVNT GROUP]’s expansion into South Asia, particularly in the dynamic and crowded Indian market. Brands in this region are eager for innovative ways to stand out, and we are here to deliver a blend of global best practices with deep local insights. In a world that is rapidly evolving, our focus is on connecting brands with their most important communities and audiences in meaningful, authentic, and engaging ways. With [INVNT GROUP]’s diverse capabilities, we are set to redefine brand storytelling in the vibrant South Asian market, creating real impact through the next great era of brand engagement in this region,” said Laveesh Pandey, Managing Director of [INVNT GROUP] South Asia.

INVNT™ also welcomes Abhishek Pandey as Producer (previously Senior Manager of Operations & Client Relations at MidasNext Media), and Varun Parashar as Manager of Account Services (previously Marketing & Community Lead at Starlight Gaming).

With this expansion, [INVNT GROUP] continues to uphold its vision of engaging audiences everywhere by crafting compelling and impactful brand stories across all platforms.

For more information, please visit [INVNT GROUP].

###

ABOUT [INVNT GROUP]
[INVNT GROUP] THE GLOBAL BRANDSTORY PROJECT™ is a growing portfolio of complementary disciplines designed to help forward-thinking organizations everywhere, impact the audiences that matter, anywhere, with offices in New York, London, Sydney, Singapore, Dubai, San Francisco, Mumbai, Stockholm, Detroit, and Washington D.C. Led by President and CEO, Scott Cullather, [INVNT GROUP]™ was established as a growing evolution of the live global brand storytelling agency INVNT™, with a vision to provide engaging, well-articulated, impactful brand stories across all platforms.

The GROUP consists of: modern brand strategy firm, Folk Hero™; creative-led culture consultancy, Meaning; production studio & creative agency, HEVĒ™; events for colleges and universities, INVNT Higher Ed; digital innovation division, INVNT.ATOM™; creative multimedia experience studio, Hypnogram™ITP Live (Any Venue Video, Thunder Audio, In Sync), portfolio of full-service production for live entertainment; and the original live global brand storytelling agency, INVNT.

Attachment

Jhonathan Mendez de Leon
[INVNT GROUP]
Jmendezdeleon@invnt.com

GlobeNewswire Distribution ID 9015785

Fortrea Establishes Industry Partnership with Veeva and Advarra to Streamline Patient and Site Clinical Trial Experience

Companies partner to provide patients and sites with easy access to study information in one integrated solution

DURHAM, N.C., Jan. 09, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced an industry partnership with founding members Veeva Systems Inc., a leading provider of industry cloud solutions for the global life sciences industry, and Advarra, a leading provider of clinical research technology for clinical research investigator sites and sponsors, to deliver an integrated patient- and site-centric solution that streamlines the clinical trial experience.

In an industry faced with complex challenges to clinical trial execution, Fortrea is establishing an alliance of industry partners—beginning with founding members, Veeva and Advarra—to tackle some of these challenges head-on. Many sites are burdened by administrative operations that have multiple, complex technologies with limited interoperability. This impacts their ability to focus on what matters most—the patients—and improving their recruitment and experience participating in clinical studies.

Fortrea, Veeva and Advarra are partnering to offer a seamless, unified technology solution that integrates best-in-class technologies and leverages Fortrea’s process expertise. This will help ease the administrative burden for patients and sites and increase the accessibility of clinical trials for the public.

“We heard from our Site Advisory Board that the multitude of technologies used on a study is one of their greatest challenges,” said Fortrea Chief Operating Officer and President of Clinical Services Mark Morais. “Working with industry-leading partners and founding members, Veeva and Advarra, we’re taking action to remove complexities so we can address the pain points of sites and patients and make a difference. We are leveraging our unique vantage point in the industry that enables us to layer our expertise over the tech and data ecosystems from best-in-class partners—adding to our alliance as we go—to dramatically simplify the experience for patients, sites and sponsors.”

For sites, the partnership is set to deliver:

  • a cloud-based, simplified sign-on experience for Fortrea-run studies
  • access to study technologies through a single dashboard
  • a unified environment with a single repository for study documents and records

For patients, the solution is being designed to offer:

  • easy-to-access, step-by-step, visit-by-visit support and education throughout a patient’s trial journey
  • a simplified user experience through a single platform
  • self-referral functionality to search and find studies in their disease area of interest
  • ongoing patient support and education via an online portal or mobile app
  • a simplified mobile and web application for consenting and responding to outcome surveys

“Veeva is helping to advance clinical trials with connected applications that reduce the burden of participating for patients, streamline execution for research sites and increase transparency for sponsors,” said Jim Reilly, vice president, Veeva Development Cloud Strategy. “Extending our partnership with Fortrea to deliver Veeva Clinical Platform applications will meet the unique needs of patients, sites and sponsors while significantly improving study data quality and collaboration with sites.”

“Advarra’s mission is to break the silos that impede clinical research, so we are excited to provide our Longboat solution and IRB services as part of this innovative and collaborative partnership aimed at reducing site and patient burden,” said Elisa Cascade, chief product officer at Advarra.  “By leveraging our Longboat solution, Fortrea will deliver a reimagined clinical research experience that will improve both protocol compliance and site and patient engagement throughout the clinical trial process.”

Learn more about how Fortrea is driving healthcare innovation throughout the world at Fortrea.com. For more information on the technology platforms, visit Veeva Clinical Platform and Advarra Longboat.

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team of about 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter) @Fortrea.

Fortrea Contacts:
Fortrea Media: Galen Wilson – 703-298-0802, media@fortrea.com
Fortrea Media: Kate Dillon – 646-818-9115, kdillon@prosek.com

GlobeNewswire Distribution ID 9015283

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023

Mont-Saint-Guibert, Belgium – January 9, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced certain preliminary, unaudited results for the fourth quarter and full year ended December 31, 2023.

Preliminary, Unaudited Fourth Quarter and Full Year 2023 Results

  • Revenue for the fourth quarter of 2023 is anticipated to be approximately €1.8 million, a 40% increase over the fourth quarter of 2022 and an 87% increase over the third quarter of 2023.
  • Revenue for the full year 2023 is anticipated to be approximately €4.3 million, a 41% increase over the full year 2022.
  • Ended the year with 48 active German accounts.

“We are excited with the strong preliminary fourth quarter sales, which are anticipated to be nearly double from last quarter. This anticipated growth reflects both strong underlying demand for Genio and focus on streamlining the patient referral pathway through initiatives such as our direct-to-consumer online campaigns launched in March,” commented Olivier Taelman, Chief Executive Officer. “This performance throughout 2023 sets the stage for an exciting 2024, as in a few months we expect to report data from our DREAM US pivotal trial, file for FDA approval, begin preparations to enter the US market, and begin to see contribution from the ResMed commercial partnership in Germany.”

The preliminary, unaudited revenue results described in this press release are estimates only and are subject to revision until Nyxoah reports its full financial results for 2023 in its Annual Report on Form 20-F.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

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

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

Attachment

GlobeNewswire Distribution ID 1000908020

Institutional Investors’ Enthusiasm Grows for Innovative Private Equity Fund

Investors with deep pockets seek refuge in GDP Capital’s PE-BOND Fund amidst turbulent markets

Key Investment Sectors

Private Equity and other investment sectors are operatingin challenging and unpredictable environments today

KUALA LUMPUR, Malaysia, Jan. 09, 2024 (GLOBE NEWSWIRE) — The COVID-19 pandemic has unleashed unprecedented economic turmoil, resulting in contracting markets and dwindling returns worldwide.

Private Equity and other investment sectors find themselves navigating an exceptionally challenging and unpredictable landscape. In an environment with limited profitable opportunities, preserving dry powder appears to be a prudent choice. An alternative, however, has emerged—a haven for investors with substantial resources.

Private Equity and other investment sectors are operatingin challenging and unpredictable environments today

Private Equity and other investment sectors are operating
in challenging and unpredictable environments today

Introducing GDP Capital’s PE-BOND Fund LP, one of Private Equity’s latest offerings poised to make waves on the international stage. In today’s dismal or negative return environment, this fund has the potential to significantly enhance your return on investment while offering a sense of security.

GDP Capital’s investment structure is nothing short of unique, possibly the first of its kind. Here’s why it stands out:

  • A Private Equity structure fortified with the security of a bond.
  • Investments are channelled into government-approved projects.
  • Capital invested is backed by government guarantees and repaid within a 10-year horizon.
  • GDP Capital secures equity in the involved companies and their respective projects, each contributing dividend.

The Fund mandates a minimum commitment above US$25 million, making it ideally suited for Sovereign Wealth Funds, Retirement Funds, Institutional Investors, Endowments, Insurance Companies, Banks, Family Offices, and major investment firms.

A Balance of High Returns and Capital Safety:

“While structuring the fund, we overcame numerous hurdles to satisfy governmental, legal, regulatory, and investor requirements. After two years of meticulous development, potential investors are displaying keen interest,” commented Gurmit S. Sidhu, the founder and Managing Director of GDP Capital Limited, on the fund and its offerings.

With an adept team comprising tax and legal advisors, investment bankers, and political analysts, GDP Capital Limited stands ready to support top-tier investors in surpassing their investment objectives.

This unique investment Fund, set to launch in January 2024, is spearheaded by GDP Capital Limited, a Private Equity Fund Manager incorporated in the British Virgin Islands (BVI) and regulated by the BVI Financial Services Commission (BVI FSC).

GDP PE-BOND Fund LP represents an extraordinary opportunity for investors seeking capital safety and accelerated returns.

Explore the Merits Further:

Astute investors who recognize the benefits offered by GDP Capital may wish to delve deeper into its merits. For additional details, please visit: www.gdpcapitalltd.com

About GDP Capital Limited:

GDP Capital Limited is a Private Equity Fund Manager incorporated in the British Virgin Islands (BVI) and regulated by the BVI Financial Services Commission (BVI FSC). The firm collaborates with stable and investor-friendly governments seeking funding for priority projects to expedite economic development and achieve real GDP growth.

Funding is extended for viable and strategically significant government projects contributing to sustainable economic growth. While initially focusing on Asia, the company has expansion plans for other global regions. Given the substantial funding requirements of governments, GDP Capital provides institutional investors with the assurance of government guarantees, facilitating investments ranging from US$100 million to US$1 billion.

Media Contact:
Investor Relations
pr@gdpcapitalltd.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2a9a601f-7cd5-459c-b4f7-f42d96113ccd

GlobeNewswire Distribution ID 9014950

Recursion Adds New Chemical Entity Targeting Fibrotic Diseases to Late Discovery Pipeline

Potential First-in-Class Novel Molecule with Novel Target In-Licensed from Collaboration with Bayer

SALT LAKE CITY, Jan. 04, 2024 (GLOBE NEWSWIRE) — Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced it has signed an agreement with Bayer AG to in-license a new chemical entity that emerged from the companies’ fibrosis research collaboration. The compound represents a novel approach to treating fibrotic diseases with compelling early data suggesting the potential to reverse disease-related fibrotic processes, including immuno-mesenchymal dysfunction.

“Since initiating our research collaboration with Bayer in 2020, we have worked diligently to apply the power of the Recursion OS to identify and advance potential candidates in challenging areas of disease biology,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “We are excited to bring this asset into our internal pipeline and accelerate the compelling science behind this program while our research collaboration with Bayer focuses on precision oncology.”

Recursion applied phenotypic screening of human cells to identify small molecules that reverse the phenotypic features of disease-state fibrocyte cells into those of healthy-state cells. Leveraging the power of Recursion’s Maps of Biology and Chemistry revealed a relationship between small molecule hits and a novel target that could impact fibrotic diseases. The most promising small molecule hits were confirmed as potent inhibitors of this novel target in validation experiments, and lead optimization studies are currently ongoing.

Fibrotic diseases are a significant cause of morbidity and mortality worldwide with high unmet need for patients. One of the biggest challenges in the treatment of fibrotic diseases is the underlying complex biology and the associated difficulty in discovering disease-modifying drug targets. Recursion’s technology is uniquely suited to accelerate discoveries in these and other complex areas of disease biology.

About Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology, and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in Toronto, Montréal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on Twitter and LinkedIn.

Media Contact
Media@Recursion.com

Investor Contact
Investor@Recursion.com

Forward-Looking Statements
This document contains information that includes or is based upon “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995, including, without limitation, those regarding early and late stage discovery, preclinical, and clinical programs; licenses and collaborations; prospective products and their potential future indications and market opportunities; Recursion OS and other technologies; business and financial plans and performance; and all other statements that are not historical facts. Forward-looking statements may or may not include identifying words such as “plan,” “will,” “expect,” “anticipate,” “intend,” “believe,” “potential,” “continue,” and similar terms. These statements are subject to known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements, including but not limited to: challenges inherent in pharmaceutical research and development, including the timing and results of preclinical and clinical programs, where the risk of failure is high and failure can occur at any stage prior to or after regulatory approval due to lack of sufficient efficacy, safety considerations, or other factors; our ability to leverage and enhance our drug discovery platform; our ability to obtain financing for development activities and other corporate purposes; the success of our collaboration activities; our ability to obtain regulatory approval of, and ultimately commercialize, drug candidates; our ability to obtain, maintain, and enforce intellectual property protections; cyberattacks or other disruptions to our technology systems; our ability to attract, motivate, and retain key employees and manage our growth; inflation and other macroeconomic issues; and other risks and uncertainties such as those described under the heading “Risk Factors” in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K. All forward-looking statements are based on management’s current estimates, projections, and assumptions, and Recursion undertakes no obligation to correct or update any such statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law.

GlobeNewswire Distribution ID 9012419