Curia Collaborates with Corning to Advance Biopharmaceutical Continuous-Flow Development and Manufacturing Programs

Collaboration marks the first global installation of Corning’s G1 production system to support higher-quality API-chemical production using inherently safer flow-chemistry technology

ALBANY, N.Y., March 23, 2023 (GLOBE NEWSWIRE) — Curia, a leading contract research, development and manufacturing organization, today announced a collaboration with Corning Incorporated to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration with Corning’s Advanced-Flow™ Reactor (AFR) team includes the first installation of Corning’s G1 production system, designed for the continuous industrial production of active pharmaceutical ingredients (API).

Continuous flow chemistry is critical for the development and manufacture of pharmaceutical intermediates and APIs, and provides advantages compared with traditional batch processing. It is an inherently safer technology that delivers faster and more robust material production with a higher selectivity of desired products.

“Innovation in drug development and production calls for safety at high speed,” said Christopher Conway, president, Research & Development, Curia. “The implementation of Corning’s G1 Production Reactor at our Albany facility expands our capability to provide scalable solutions that address complex development and manufacturing requirements facing the pharmaceutical industry. Using advanced technology and standardized workflows, Curia offers continuous flow chemistry from targeted development to commercial scale globally.”

The G1 production reactor includes an updated set of dosing lines and controls that enable continuous operations and compliance to cGMP standards.

“Collaborating with an innovation-focused company like Curia will help drive advancements in the chemical-processing industry,” said Alessandra Vizza, business director, Corning Advanced-Flow Reactors. “The implementation of Corning’s G1 production system can deliver a host of benefits. The system is an inherently safer technology that will help Curia reduce time to market with higher-quality chemical and API processing, increased efficiency of chemical and API synthesis, and lower production costs.”

“Additionally, the space-saving, energy-conserving, and waste-reducing benefits of Corning’s AFR Technology may help customers reduce the environmental impact of their manufacturing business – a key attribute as the field continues to gain momentum in the U.S. and around the world,” said Vizza.

Curia’s expertise and global network of facilities, combined with Corning’s continuous flow technology, can help drive business efficiencies and, ultimately, improve patients’ lives.

About Curia
Curia is a leading contract research, development, and manufacturing organization providing products and services from R&D through commercial manufacturing to pharmaceutical and biopharmaceutical customers. Curia’s nearly 4,000 employees at 29 locations across the U.S., Europe, and Asia help its customers advance from curiosity to cure. Learn more at CuriaGlobal.com.

About Corning Incorporated
Corning (www.corning.com) is one of the world’s leading innovators in materials science, with a 170-year track record of life-changing inventions. Corning applies its unparalleled expertise in glass science, ceramic science, and optical physics along with its deep manufacturing and engineering capabilities to develop category-defining products that transform industries and enhance people’s lives. Corning succeeds through sustained investment in RD&E, a unique combination of material and process innovation, and deep, trust-based relationships with customers who are global leaders in their industries. Corning’s capabilities are versatile and synergistic, which allows the company to evolve to meet changing market needs, while also helping its customers capture new opportunities in dynamic industries. Today, Corning’s markets include optical communications, mobile consumer electronics, display, automotive, solar, semiconductors, and life sciences.

Curia Contact Information:
Sue Zaranek
+1 518 512 2111
corporatecommunications@CuriaGlobal.com

Corning Contact Information:
Sarah Pakyala
+1 607 974 4902
pakyalasi@corning.com

GlobeNewswire Distribution ID 8794440

GMAC Task Force Revamps Business Education Admissions Reporting Standards

Revision aims to support business schools in today’s ranking efforts and help prospective candidates compare programs on leveled playing field

RESTON, Va., March 23, 2023 (GLOBE NEWSWIRE) — The Graduate Management Admission Council (GMAC), a global association representing leading business schools, today released an updated version of the Graduate Management Education Admissions Reporting Standards. The revision, led by a task force of 14 GMAC member schools, aimed to ensure the standards align with the shifting landscape of graduate business education and today’s best practices of identifying gender, race and ethnicity, and undergraduate majors, among other criteria commonly used in the admissions process.

According to GMAC’s annual survey on prospective students worldwide, candidates rely heavily on school websites and rankings in their program selection process. The 2023 survey of thousands of business school aspirants – to be published early next month – shows that school websites and published program rankings were the top two factors in the decision making of individuals considering applying for graduate business degrees. Informed by this finding, GMAC believes it is vitally important that the information presented to prospective students is anchored in a common definition of the terms used by schools and various publications in collecting the data for reporting.

“This work, initiated in response to a strong desire for consistency and transparency from the business school community we serve, is being done to create trust with and among business school admissions professionals, especially those who are new to the field. Without a doubt, adopting the standardized reporting criteria at a large scale would allow prospective students and rankings organizations alike to compare apples to apples and oranges to oranges across the wide spectrum of program options available in the market today,” said Joy Jones, CEO of GMAC. “On behalf of the Council, I extend our sincerest gratitude to the task force for the time, effort, and care dedicated to revising and promoting the standards.”

“The task force invested many hours reviewing survey questionnaires and collecting data, as well as discussing proposed revisions over calls and with stakeholders at conferences, to address the tough questions from the business school community on how we can better reflect the many changes in the industry – and the society – we encounter today. For example, there is a growing acknowledgement and respect for identity preferences and an interest in segments like first generation and military students,” said Marci Armstrong, professor of practice, marketing at Southern Methodist University’s Cox School of Business and co-chair of the task force revising the standards. “Rest assured, we were fully aware of the stakes at hand and did not just rubber-stamp the new standards.”

In 2019, GMAC formed a task force to revise the MBA Reporting Criteria – first published by GMAC in 2000 and adopted by approximately 200 business schools – into Graduate Management Education Admissions Reporting Standards. The standards, subsequently endorsed by GMAC members in the summer of 2020, were meant to be revisited every two years to ensure they continue to guide business schools in distributing reliable, accurate, useful, and comparable admissions data for prospective students and rankings organizations. A new task force was organized at the beginning of 2022 to tackle the review and revision of the standards in three sections – school and program information, application process, and admissions reporting and class profile, supplemented by region and areas of study classifications.

“In the past three years – particularly in response to the global pandemic – our industry has innovated and grown tremendously. A prime example is the delivery of online programs,” said Nita Swinsick, associate dean of graduate & executive degree programs admissions at Georgetown University’s McDonough School of Business and co-chair of the task force. “While the traditional on-campus, two-year MBA remains the most sought-after graduate management degree, there are a great number of programs offering a wide range of flexibility and length and still lead to successful business careers.”

“GMAC will continue to be a steward of the standards and will publish a list of schools and corresponding programs that decide to adopt and remain in compliance with the standards. Adopting and complying schools can also receive a badge from GMAC for use in their outreach materials to signal to candidates, ranking publishers and other stakeholders their compliance with the standards,” said Sabrina White, vice president of school and industry engagement at GMAC. “It is our hope that more members of the business school community – as well as ranking publishers – will begin leveraging these standards to benefit the people aspiring to better themselves and the world through graduate management education.”

Business schools, ranking agencies and other stakeholders worldwide that wish to obtain a copy of or start adopting the latest reporting standards may reach out to GMAC at datastandards@gmac.com.

About GMAC

The Graduate Management Admission Council (GMAC) is a mission-driven association of leading graduate business schools worldwide. GMAC provides world-class research, industry conferences, recruiting tools, and assessments for the graduate management education industry as well as resources, events, and services that help guide candidates through their higher education journey. Owned and administered by GMAC, the Graduate Management Admission Test™ (GMAT™) exam is the most widely used graduate business school assessment.

More than 12 million prospective students a year trust GMAC’s websites, including mba.com, to learn about MBA and business master’s programs, connect with schools around the world, prepare and register for exams and get advice on successfully applying to MBA and business master’s programs. BusinessBecause and The MBA Tour are subsidiaries of GMAC, a global organization with offices in China, India, the United Kingdom, and the United States.

To learn more about our work, please visit www.gmac.com

Media Contact:

Teresa Hsu
Sr. Manager, Media Relations
Mobile: 202-390-4180
thsu@gmac.com 

GlobeNewswire Distribution ID 8794409

UNFI EQUITY ALERT: ROSEN, NATIONAL INVESTOR COUNSEL, Encourages United Natural Foods, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important Deadline in Securities Class Action – UNFI

NEW YORK, March 22, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of securities of United Natural Foods, Inc. (NYSE: UNFI) between March 10, 2021 and March 7, 2023, both dates inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 19, 2023.

SO WHAT: If you purchased United Natural Foods securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the United Natural Foods class action, go to https://rosenlegal.com/submit-form/?case_id=13471 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 19, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) that, despite its cost saving Value Path initiative, United Natural Foods had not invested in improving its data management and related infrastructure; (2) that, as a result, the Company could not respond adequately to cost changes, such as inflationary pressure; (3) that, as a result, the Company could not appreciate the benefits of procurement gains and inventory gains achieved during fiscal 2022; (4) that, as a result of the foregoing, the Company’s profitability would be materially adversely impacted; and (5) and that as a result of the foregoing, Defendant’s positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the United Natural Foods class action, go to https://rosenlegal.com/submit-form/?case_id=13471 or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686-1060
Toll Free: (866) 767-3653
Fax: (212) 202-3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com

GlobeNewswire Distribution ID 8793630

Nyxoah Reports Fourth Quarter and Full Year 2022 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports Fourth Quarter and Full Year 2022 Financial and Operating Results
Completed all 115 implants in the DREAM U.S. pivotal study

Mont-Saint-Guibert, Belgium – March 22, 2023 09:05pm 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 reported financial and operating results for the fourth quarter and full year 2022.

Recent Financial and Operating Highlights

  • Completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected early next year.
  • Filed the first module in the modular PMA submission.
  • Submitted 12-month data1 on the first 34 DREAM patients as a late-breaking abstract to 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.
  • Achieved quarterly sales of €1.3 million resulting in a sequential German market share gain.
  • Ended the year with 38 active German accounts, up from 12 entering 2022.
  • Strengthened supply chain with Belgium manufacturing facility receiving clearance from the EU notified body.
  • Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC). Implant completion expected in 2024.
  • Total cash position of €94.8 million at the end of 2022.

2023 Key Objectives

  • Focus on patient follow up in the DREAM study resulting in reaching the primary endpoints.
  • U.S. regulatory, manufacturing and market access readiness.
  • Drive further revenue and market share growth in Germany.

“With all 115 implants completed in the DREAM study and our first PMA module submitted, we achieved key milestones towards U.S. FDA approval. Our attention now focuses on patient follow up. With the clearance of our second manufacturing site, we have strengthened our supply chain to meet increasing demand,” commented Olivier Taelman, Nyxoah Chief Executive Officer.

Mr. Taelman continued, “Commercially in Europe, we are excited to see the continued demand growth for Genio in Germany. Our growing experience with CCC patients in Europe, driven by our expanded label, reinforces our confidence in our ongoing U.S. ACCCESS study.”

Fourth Quarter and Full Year 2022 Results

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS FOR THE THREE MONTHS AND YEARS ENDED DECEMBER 312022 AND DECEMBER 31, 2021 (in thousands)

For the three months ended December 31,  For the year ended December 31,
2022 2021 2022 2021
Revenue €1,307 €295 €3,084 €852
Cost of goods sold (465) (105) (1,150) (303)
Gross profit 842   190 1,934   549
Research and Development Expense (4,575) (3,335) (15,861) (12,344)
Selling, General and Administrative Expense (5,363) (3,937) (18,855) (14,712)
Other income/(expense) 46 539 283 265
Operating loss for the period (9,050)   (6,543) (32,499) (26,242)
Financial income (4,609) 3,603 6,763 3,675
Financial expense 1,153 (588) (4,320) (2,072)
Loss for the period before taxes (12,506) (3,528) (30,056) (24,639)
Income taxes (790) (2,720) (1,169) (2,980)
Loss for the period (13,296) (6,248) (31,225) (27,619)
             
Loss attributable to equity holders (13,296) (6,248) (31,225) (27,619)
Other comprehensive income/(loss)
Items that may not be subsequently reclassified to profit or loss (net of tax)
Remeasurements of post-employment benefit obligations, net of tax 70 (68) 70 (68)
Items that may be subsequently reclassified to profit or loss (net of tax)
Currency translation differences (82) (17) (96) 121
Total other comprehensive income/(loss) (12)   (85)   (26)   53
Total comprehensive loss for the year, net of tax (13,308) (6,333) (31,251) (27,566)
Loss attributable to equity holders (13,308)   (6,333)   (31,251)   (27,566)
Basic loss per share (in EUR) €(514) €(238) €(1,209) €(1,161)
Diluted loss per share (in EUR) €(514) €(238) €(1,209) €(1,161)

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL INFORMATION – CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF DECEMBER 31, 2022 AND
DECEMBER 31, 2021 (in thousands)

As of December 31,
2022 2021
ASSETS
Non-current assets
Property, plant and equipment €2,460 €2,020
Intangible assets 39,972 25,322
Right of use assets 3,159 3,218
Deferred tax asset 47 46
Other long-term receivables 173 164
45,811 30,770
Current assets
Inventory 882 346
Trade receivables 1,463 226
Other receivables 1,775 2,286
Other current assets 1,284 1,693
Financial assets 76,968
Cash and cash equivalents 17,888 135,509
  100,260 140,060
Total assets 146,071   170,830
EQUITY AND LIABILITIES
Capital and reserves
Capital 4,440 4,427
Share premium 228,275 228,033
Share based payment reserve 5,645 3,127
Other comprehensive income 176 202
Retained loss (118,212) (87,167)
Total equity attributable to shareholders 120,324 148,622
 
LIABILITIES
Non-current liabilities
Financial debt 8,189 7,802
Lease liability 2,586 2,737
Pension liability 80
Provisions 59 12
Deferred tax liability 5
  10,834   10,636
Current liabilities
Financial debt 388 554
Lease liability 719 582
Trade payables 4,985 3,995
Current tax liability 3,654 2,808
Other payables 5,167 3,633
  14,913 11,572
Total liabilities 25,747   22,208
Total equity and liabilities 146,071 170,830

Revenue

Revenue was €1.3 million for the fourth quarter ending December 31, 2022, compared to €295,000 for the fourth quarter ending December 31, 2021. Revenue for the full year of 2022 was €3.1 million, compared to €0.9 million for the full year of 2021. The increase in revenue was attributable to the Company’s commercialization of the Genio® system, primarily in Germany.

Cost of Goods Sold

Cost of goods sold was €465,000 for the three months ending December 31, 2022, representing a gross profit of €0.8 million, or gross margin of 64.4%. This compares to total cost of goods sold of €105,000 in the fourth quarter of 2021, for a gross profit of €190,000, or gross margin of 64.4%.

For the full year ending December 31, 2022, total cost of goods sold was €1.2 million, representing a gross profit of €1 million, or gross margin of 62.7%. This compares to total cost of goods sold of €303,000 for the full year of 2021, for a gross profit of €0.5 million or gross margin of 64.4%.

Research and Development Expenses

Research and development expenses were €4.6 million for the three months ending December 31, 2022, versus €3.3 million for the prior year period, reflecting the Company’s investments in the development of next generation versions of the Genio® system as well as ongoing clinical studies, most notably DREAM in the U.S.

For the full year ending December 31, 2022, research and development expenses were €15.9 million, versus €12.3 million for the full year of 2021.

Selling, General and Administrative Expenses

Selling, general and administrative expenses rose to €5.4 million for the fourth quarter of 2022, up from €3.9 million in the fourth quarter of 2021. This was due primarily to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah’s corporate infrastructure. The Company expects to continue adding headcount across the organization ahead of the U.S. commercial launch.

For the full year ending December 31, 2022, selling, general and administrative expenses were €18.9 million, up from €14.7 million for the full year 2021 due to increased commercial efforts in Germany and investments in Nyxoah’s corporate infrastructure.

Operating Loss

Total operating loss for the fourth quarter and full year 2022 was €9.1 million and €32.5 million, respectively, versus €6.5 million and €26.2 million in the fourth quarter and full year 2021, respectively. This was driven by the acceleration in the Company’s R&D spending, as well as ongoing commercial and clinical activities.

Cash Position
As of December 31, 2022, cash and financial assets totaled €95 million, compared to €135.5 million on December 31, 2021. Total cash burn was approximately €3.4 million per month during 2022.

Full year report 2022
Nyxoah’s financial report for the full year of 2022, including details of the audited consolidated results, 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 open to the public today at 10:30pm CET / 4:30pm ET, which will also be webcast. To participate in the conference call, please access the following link to register for a dial-in number: https://register.vevent.com/register/BI84592a0d5f1d4395a204ebca89873f13

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 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 US 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; 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, 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.

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