Day: November 7, 2024

Posted on

Zenas BioPharma to Participate in Upcoming Healthcare Investor Conferences

WALTHAM, Mass, Nov. 07, 2024 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies, today announced the Company’s participation at the following healthcare investor conferences:

  • Guggenheim’s Inaugural Healthcare Innovation Conference on November 12, 2024, in Boston, MA
  • Jefferies London Healthcare Conference on November 19, 2024 presentation at 4:00 p.m. to 4:25 p.m. GDT, in London
  • Citi’s 2024 Global Healthcare Conference on December 3, 2024 presentation at 9:30 a.m. to 10:10 a.m. ET, in Miami, FL
  • Evercore ISI HealthCONx Conference on December 4, 2024 presentation at 1:20 p.m. to 1:40 p.m. ET, in Coral Gables, FL

Live webcasts and archived replays of the Company’s presentations at the Jefferies, Citi and Evercore conferences can be accessed under “Events and Presentations” in the Investors and Media section of the Zenas BioPharma website.

About Zenas BioPharma, Inc.

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative immunology-based therapies for patients in need. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s mechanism of action and chronic dosing regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on X at @ZenasBioPharma and LinkedIn.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:
Matthew Osborne
Investor Relations and Corporate Communications
Matt.osborne@zenasbio.com

Media Contact:
Argot Partners
Zenas@argotpartners.com

GlobeNewswire Distribution ID 9268589

Posted on

ATNi Launches 5th Global Access to Nutrition Index as Industry and Policy Makers Grapple with Food Polycrisis

UTRECHT, The Netherlands, Nov. 07, 2024 (GLOBE NEWSWIRE) — Today, ATNi launches the 5th edition of the Global Access to Nutrition Index, the largest yet, assessing the world’s 30 largest food and beverage manufacturers and over 52,000 products, representing 23% global market share.

One in five deaths globally is associated with a poor diet. One out of eight adults are affected by obesity, 150 million children are too short for their age because of poor nutrition, and close to a third of women of reproductive age, and half of children, consume inadequate micronutrients.

The Index reveals some important progress. More companies are setting targets to improve their portfolio healthiness, now using internationally recognized Nutrient Profiling Models (NPMs) to classify products as ‘healthier’.

However, overall, there have been only marginal improvements in key metrics such as healthiness of product portfolios. Concurrently, the estimated sales values of company’s healthier products have increased, showing consumers are increasingly purchasing healthier products. Worryingly, product portfolio healthiness was found to be lowest in low-income countries, highlighting disparities in product offerings across different markets and income groups.

Global Index 2024 – key findings

Product Healthiness

Among the 52,414 products analyzed from 30 companies using the Health Star Rating (HSR) system, 31%—a total of 16,467 products—met the healthier threshold (3.5 stars and above out of 5), representing an estimated 34% of the companies’ combined sales in 2022. ATNi challenges companies to derive at least half their sales from healthy products by 2030. Today only 30% of companies are meeting this target.

Differences by market and income

Overall food product healthiness in low- and lower middle-income countries scored much lower (mean HSR 1.8) than in high-income countries (mean HSR 2.3). At the aggregate level, the share of ‘less healthy’ products which the 30 assessed companies are marketing is higher in low- and middle-income countries than in high-income countries.

Reporting and disclosures

30% of companies assessed, now use an internationally recognized Nutrient Profiling Model to report on portfolio healthiness, with 20% doing so to report on overall percentages of global sales. While the quality, coverage, and transparency of this reporting varies significantly, this shift reflects the growing appetite for reporting against (inter-)national standards.

Marketing

No company has a policy to fully prohibit marketing unhealthy foods to children under 18 across all marketing channels and techniques, as recommended by the World Health Organization (WHO). Four companies have taken positive steps, raising their age thresholds to 16 years while only two are marketing ‘healthier’ products defined by a government-endorsed model.

ATNi calls on

Companies: voluntarily stop marketing to under 18s, improve product portfolio healthiness and fully disclose sales from healthy and unhealthy products using an internationally recognised Nutrient Profiling Model.

Governments: regulate and build an enabling environment that helps companies protect public health. Well-designed fiscal policies to make healthier foods more affordable and less healthy foods more expensive are also needed.

Responsible investors: help hold the companies to account by investing in those acting responsibly, considering the financial costs of long-term ill health caused by current food environment and products.

“’Health is wealth.’ We know this is true, but most food companies have not yet placed nutrition as core to their business. There is progress, but our findings show overall subpar performance and weaknesses in the market.”

Greg S. Garrett, Executive Director, ATNi

“Only 31% of the 52,000+ food products assessed by ATNi meet the health criteria. This is not good enough. Companies need to start doing better demonstrating that they care about the public health of their consumer base.”

Jessica Fanzo, Professor of Climate and Director of the Food for Humanity Initiative, Columbia University

Media Contact – Philip Eisenhart

Philip.eisenhart@accesstonutrition.org

GlobeNewswire Distribution ID 1001011759

Posted on

MLL Legal Selects Anaqua’s AQX Law Firm Platform to Enhance IP Management and Drive Operational Efficiency

Leading Swiss law firm adopts scalable, intuitive solution to strengthen IP management capabilities

BOSTON, Nov. 07, 2024 (GLOBE NEWSWIRE) — Anaqua, the leading provider of innovation and intellectual property (IP) management technology, today announced that MLL Legal, one of Switzerland’s largest law firms, has selected Anaqua’s AQX® Law Firm platform to enhance its IP management capabilities for its clients.

MLL Legal is known for its expertise in innovative sectors such as fintech, blockchain, artificial intelligence, and life sciences. With over 250 professionals, including 150 lawyers, MLL Legal operates from offices in Zurich, Geneva, Lausanne, Zug, as well as international locations in London and Madrid. The firm is consistently recognized in prestigious legal publications and rankings for its extensive knowledge in commercial law. MLL Legal has been one of Switzerland’s leading law firms in the field of IP for decades.

By adopting Anaqua’s AQX Law Firm platform, MLL Legal will replace its current IP management system with a unified, scalable solution that integrates email archiving, document sharing, and workflow enhancements—all with an emphasis on design and trademark management. The platform’s multi-tiered access controls offer customizable security ensuring the safe handling of sensitive client data, while its collaborative features facilitate seamless teamwork both within the firm and with external clients.

“We chose Anaqua primarily for three reasons: its robust reporting tools, the intuitive user experience, and the out-of-the-box system functionality,” said Franziska Schweizer, head of the IP Prosecution Team at MLL Legal. “The AQX platform’s reporting tools enable us to quickly generate clear and comprehensible reports without the need for manual processing. This efficiency allows our team to focus more on delivering high-quality legal advice.”

Bob Romeo, CEO of Anaqua, added: “MLL Legal’s decision underscores the growing demand for innovative IP solutions within the European legal market. Our platform’s capabilities are designed to ensure increased efficiency and flexibility, enabling law firms like MLL Legal to better manage their clients’ IP portfolios while providing exceptional service.”

About Anaqua

Anaqua, Inc. is a premium provider of integrated technology solutions and services for the management of intellectual property (IP). Anaqua’s AQX® and PATTSY WAVE® IP management solutions combine best practice workflows with big data analytics and technology-enabled services to create an intelligent environment that informs IP strategies, enables IP decisions and streamlines IP processes. Today, nearly half of the 100 largest U.S. patent applicants and global brands, as well as a growing number of law firms worldwide, use Anaqua’s solutions. Over one million IP executives, lawyers, paralegals, administrators and innovators use the platform for their IP management. The company is headquartered in Boston, with additional offices in the United States, Europe, Asia, and Australia. For more information, please visit anaqua.com or LinkedIn.

Company Contact:
Amanda Glagolev
Director, Communications
Anaqua
617-375-5808
aglagolev@anaqua.com

GlobeNewswire Distribution ID 9267069

Posted on

Nyxoah Reports Third Quarter Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports Third Quarter Financial and Operating Results
FDA approval on track for first quarter 2025, U.S. commercial team build out in progress
Company fully funded with cash until mid 2026

Mont-Saint-Guibert, Belgium – November 6, 2024, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.

Recent Financial and Operating Highlights

  • Presented compelling DREAM data results at International Surgical Sleep Society in September.
  • Raised €24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
  • Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
  • Reported third quarter sales of €1.3 million, representing 30% growth versus third quarter 2023.
  • Total cash position of €71.0 million at the end of the quarter, €95.6 million proforma including the €24.6 million raised.

“Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval.”

Third Quarter 2024 Results

CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)

  For the three months ended September 30,   For the nine months ended September 30,
  2024   2023   2024   2023
Revenue 1,266   976   3,258   2,524
Cost of goods sold (482)   (336)   (1,217)   (930)
Gross profit € 784   € 640   € 2,041   € 1,594
Research and Development Expense (7,902)   (6,568)   (22,573)   (19,330)
Selling, General and Administrative Expense (8,042)   (5 058)   (20,396)   (16,794)
Other income/(expense) 180   −   430   265
Operating loss for the period €(14,980)   €(10,986)   €(40,498)   €(34,265)
Financial income 1,138   2,178   4,615   3,592
Financial expense (3,043)   (1,033)   (5,480)   (2,765)
Loss for the period before taxes €(16,885)   €(9,841)   €(41,363)   €(33,438)
Income taxes (173)   2,229   (724)   1,119
Loss for the period €(17,058)   €(7,612)   €(42,087)   €(32,319)
               
Loss attributable to equity holders €(17,058)   €(7,612)   €(42,087)   €(32,319)
               
Other comprehensive income/(loss)              
Items that may not be subsequently reclassified to profit or loss (net of tax)              
Currency translation differences (209)   (10)

(221)

(88)
Total comprehensive loss for the year, net of tax €(17,267)   € (7,622)   €(42,308)   €(32,407)
Loss attributable to equity holders €(17,267)   € (7,622)   €(42,308)   (32,407)
               
Basic loss per share (in EUR) €(0.496)   €(0.266)   €(1.346)   €(1.166)
Diluted loss per share (in EUR) €(0.496)   €(0.266)   €(1.346)   €(1.166)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)

(in thousands)

      As at
      September 30,
2024		   December 31, 2023
ASSETS          
Non-current assets          
Property, plant and equipment     4,461   4,188
Intangible assets     49,558   46,608
Right of use assets     3,635   3,788
Deferred tax asset     53   56
Other long-term receivables     1,475   1,166
      € 59,182   € 55,806
Current assets          
Inventory     5,272   3,315
Trade receivables     2,504   2,758
Other receivables     2,992   3,212
Other current assets     1,837   1,318
Financial assets     42,299   36,138
Cash and cash equivalents     28,678   21,610
      € 83,582   € 68,351
Total assets     € 142,764   € 124,157
           
EQUITY AND LIABILITIES          
Capital and reserves          
Capital     5,908   4,926
Share premium     290,906   246,127
Share based payment reserve     8,943   7,661
Other comprehensive income     (84)   137
Retained loss     (200,966)   (160,829)
Total equity attributable to shareholders     104,707   € 98,022
           
LIABILITIES          
Non-current liabilities          
Financial debt     19,143   8,373
Lease liability     2,636   3,116
Pension liability     47   9
Provisions     398   185
Deferred tax liability     12   9
      €22,236   € 11,692
Current liabilities          
Financial debt     399   364
Lease liability     1,151   851
Trade payables     7,109   8,108
Current tax liability     2,495   1,988
Other payables     4,667   3,132
      € 15,821   € 14,443
Total liabilities     € 38,057   € 26,135
Total equity and liabilities     € 142,764   € 124,157

Revenue
Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023.

Cost of Goods Sold

Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%.

Research and Development
For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023.

Operating Loss
Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities.

Cash Position
As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €5.6 million per month during the third quarter 2024.

Third Quarter 2024
Nyxoah’s financial report for the third quarter 2024, including details of the consolidated results, are available on the investor page of Nyxoah’s website (https://investors.nyxoah.com/financials).

Conference call and webcast presentation
Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, beginning at 10:30pm CET / 4:30pm ET.

A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah’s Q3 2024 earnings call webcast. For those not planning to ask a question of management, the Company recommends listening via the webcast.

If you plan to ask a question, please use the following link: Nyxoah’s Q3 2024 earnings call. After registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a minimum of 10 minutes before the start of the call.

The archived webcast will be available for replay shortly after the close of the call.

About Nyxoah
Nyxoah is reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.

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 announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

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 reporting data from Nyxoah’s DREAM U.S. pivotal trial; receipt of FDA approval; entrance to the U.S. market; and the anticipated closing and use of the proceeds from the offering. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Contacts:

Nyxoah
Loïc Moreau
IR@nyxoah.com

For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com

In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu

Attachment


GlobeNewswire Distribution ID 1001011732

Posted on

Riyadh International Jazz Festival Joins Prestigious World Network.

Riyadh: The Music Commission announced that the Riyadh International Jazz Festival joined the World Jazz Network, one of the leading international gatherings for jazz talent exchange, enhancing Saudi Arabia's cultural presence at the global level. With this step, the Riyadh International Jazz Festival becomes part of a network that brings together top jazz festivals and cultural institutions worldwide. The network connects music professionals and audiences, fostering an exchange of expertise and knowledge within the jazz community. It aims to enrich the global jazz scene, enhance community bonds, and build connections among audiences worldwide, contributing to creativity and the development of art. According to Saudi Press Agency, each year, network partners gather at the Amersfoort World Jazz Festival, a platform for sharing ideas and visions, creating meaningful opportunities for international collaboration in the jazz field. The membership of the Riyadh International Jazz Festival in the network represent s a strategic move that reflects Saudi Arabia's commitment to developing arts and culture, providing a rich musical experience for both the local community and festival visitors from around the world. The festival, organized by the Music Commission, is a global musical event that attracts prominent jazz musicians and creators from around the world, while providing creative spaces for Saudi talent to showcase diverse musical styles. The festival also features various musical activities and art exhibitions, enhancing the visitor experience and reinforcing the Kingdom's status as a global destination for culture, arts, and creativity.

Posted on

NEOM, Saudi Falcons Club Partner to Protect Falcons.

NEOM: In a landmark initiative, the Saudi Falcons Club's Hadad Program has partnered with NEOM to enhance falcon habitats within NEOM's expansive Nature Reserve. This strategic collaboration marks a significant effort toward preserving endangered falcon species and reviving their natural nests. The alliance was announced at the Hadad Annual Meeting 2024, hosted by NEOM, and aligns with NEOM's dedication to conserving 95% of its land for nature, setting new benchmarks in environmental conservation and wildlife rehabilitation. According to Saudi Press Agency, the partnership is reflective of Saudi Arabia's broader objectives under Vision 2030, which aim at sustainable development and environmental protection. The first phase saw the successful organization of the Hadad Annual Meeting in NEOM, which gathered key stakeholders such as the National Center for Wildlife, the Special Forces for Environmental Security, the Royal Commission for AlUla, and the King Salman bin Abdulaziz Royal Reserve. The initiative's s econd phase is set to focus on reviving four to six inactive mountain peregrine falcon nests within NEOM's Nature Reserve, utilizing best-in-class environmental practices. This effort is intended to promote natural falcon reproduction and maintain ecological balance within the region. In the third phase, the success of these nest revival efforts will be evaluated, with an announcement to follow regarding the number of falcons produced through this initiative.

Recent Post