Gerresheimer: FDA grants Tentative Approval of SQ Innovation’s Lasix^® ONYU^*

• Innovative combination product of furosemide and on-body device
• Ready-to-market device designed, developed and manufactured by Gerresheimer
• Patented device technology for precise administration

 Düsseldorf, Germany, December 16, 2024. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, announces that the US Food and Drug Administration (FDA) granted SQ Innovation Tentative Approval for Lasix ONYU for the home treatment of fluid overload in congestive heart failure. Lasix ONYU is a combination product consisting of a novel high-concentration formulation of the diuretic furosemide and the Gerresheimer on-body drug delivery device. Tentative Approval indicates here that Lasix ONYU has met the regulatory standards for quality, safety and efficacy required for approval in the United States. Full approval was precluded because the FDA had granted market exclusivity in the USA for a competing product until October 2025. SQ Innovation will seek full approval in the U.S. after the expiration of the regulatory exclusivity period. First products of Lasix ONYU are now expected to be available on the market by the end of 2025. The Tentative Approval of the combination product underscores Gerresheimer’s innovative strength and the market readiness of the Gerresheimer on-body drug delivery device.

 “The FDA’s Tentative Approval is a testament to our product and the people and partners who have contributed to this great endeavor, especially the Gerresheimer team”, says Pieter Muntendam, MD, Founder, President and CEO of SQ Innovation. “It is an important milestone. We look forward to commercializing this highly innovative combination product as soon as we receive final approval with the aim to improve patients’ quality of life and reduce healthcare costs for the elderly.”

“The regulatory authority’s decision underlines the market readiness of our on-body drug delivery device,” said Dietmar Siemssen, CEO of Gerresheimer AG. “It also clearly demonstrates our expertise as an innovative solution provider for our customers, from product design to regulatory submission and large-scale manufacturing. With our on-body devices for both small molecule drug formulations and large molecule biologics we can partner with our customers to address the global megatrend of home treatment, while also providing connectivity to remote therapeutic monitoring platforms.”

Device based on Gerresheimer’s innovative micropump technology

The cartridge-based infusor was designed and developed by Gerresheimer based on its proprietary infusor platform for subcutaneous drug delivery. The core technology is an innovative micropump which enables controlled, precise administration of a drug product according to a defined therapy regimen.

Designed with patient comfort and the environment in mind

The lightweight, compact device is patched onto the patient’s body, making it comfortable for the patient to wear while the drug is gently infused. The user-friendly design features a simple one-button operation with automatic needle insertion and retraction. The Lasix ONYU infusor has two components, a reusable electromechanical component, and a single-use sterile disposable component that is in contact with the drug solution and the body. The reusable component, which is rated for delivery of 48 treatments with diuretic furosemide, is recyclable. Because only the disposable unit requires sterilization, radiation can be used instead of chemical sterilization, and no electronic components end up in medical waste. This two-component concept was developed in line with Gerresheimer’s EcoDesign principles, which aim to increase product lifespan and reduce waste.

Reducing total cost of care and improving patients’ quality of life

The combination product Lasix ONYU also opens up possibilities to reduce the total cost of care. The two-component design results in a lower cost per treatment, because only the disposable part of the device needs to be replaced. Most importantly, the infusor allows for home treatment, reducing the length of hospital stay or avoiding the need for hospitalization for intravenous diuretic administration altogether.

First products expected to be available end of 2025 

In addition to Gerresheimer’s role in design and development Gerresheimer also manages production of the device as a full-service solution provider. The disposable unit for the infusor is, for example, produced at the Gerresheimer facility in Wackersdorf, Germany, on a high-capacity semi-automated line.

SQ Innovation will seek full approval in the U.S. after the competitive product’s regulatory exclusivity period expires in October 2025. First products of Lasix ONYU are now expected to be available on the market by the end of 2025. 

*Legal Notice
The trademark LASIX^® is registered for Validus Pharmaceuticals L.L.C. in the United States and used by SQ Innovation under license.
 

About SQ Innovation
SQ Innovation, Inc. is a privately held Swiss biopharmaceutical company with offices in Zug, Switzerland, and Burlington, MA, USA.  Founded to develop and commercialize innovative, cost-effective therapies for subcutaneous delivery, the company aims to enable at-home treatment for conditions traditionally managed in hospitals. SQ Innovation has developed a novel drug-device combination for treating fluid overload in adult patients with chronic heart failure — a condition typically requiring intravenous administration of medications in a hospital setting. This product, Lasix^® ONYU, was developed with consideration for patients, payors, healthcare providers, and environmental impact. Lasix^® ONYU, received Tentative Approval from the US Food and Drug Administration in October 2024.
www.sqinnovation.com

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The Group offers a comprehensive portfolio of drug containment solutions including closures and accessories, as well as drug delivery systems, medical devices and solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, cartridges, ampoules, tablet containers, infusion, dropper and syrup bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. Gerresheimer supports its customers with comprehensive services along the value chain and in addressing the growing demand for enhanced sustainability. With over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets.  The Group generated revenues of around €2bn in 2023 and currently employs around 13,400 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).   www.gerresheimer.com 

Contact Gerresheimer AG

CHEPLAPHARM ACQUIRES GEMZAR^® FROM LILLY

Binningen/Greifswald, 16 December 2024
 

With the purchase of Gemzar^® from Eli Lilly and Company, which was signed on 2 October 2024 and closed on 13 December 2024, the CHEPLAPHARM Group is once again expanding its existing portfolio in the oncology sector. The transaction includes the transfer of worldwide commercial rights (except South Korea).

CHEPLAPHARM is the global market leader in the acquisition of established originator products from research-based pharmaceutical companies. With the purchase of Gemzar^®, CHEPLAPHARM is acquiring a proven chemotherapeutic agent for the treatment of various types of cancer: non-small cell lung cancer, urothelial, biliary tract, pancreatic, ovarian, cervical and breast cancer. The active substance gemcitabine is included in the WHO Model Lists of Essential Medicines.

‘We are delighted that we were able to successfully close the Gemzar^® transaction in just over two months after signing in October, continuing the good and trustful cooperation with Lilly following the acquisition of the Zyprexa^® portfolio last year,’ says Edeltraud Lafer, CEO of CHEPLAPHARM.

Gemzar^® is a well-established branded medicine that further strengthens CHEPLAPHARM’s existing oncology portfolio. With brands such as Vesanoid^®, Tarceva^®, Xeloda^®, Myocet^®, Paraplatin^® and Taxol^® the company already has a broad and patient-orientated product portfolio for the treatment of various types of cancer.

The transaction includes intellectual property and product registrations.
 

About CHEPLAPHARM

CHEPLAPHARM is a family-owned company with headquarters in Greifswald. For over 20 years, the company has been very successful in taking over well-known and well-established medicines from the research-based pharmaceutical industry and transferring them to an existing global network of partners for production and distribution. In this way, CHEPLAPHARM ensures the continuous supply of these medicines to patients worldwide. In addition to its headquarters in Greifswald, CHEPLAPHARM operates further sites in France, Japan, Russia and Switzerland. The company employs about 750 people worldwide.

Please refer to www.cheplapharm.com for additional information.

Press office:

CHEPLAPHARM ǀ Ziegelhof 24 ǀ 17489 Greifswald ǀ press(at)cheplapharm.com

Media release

Large-scale SPPS capacity in Braine-l’Alleud starts production

Baar, 16 December 2024 – PolyPeptide Group AG (SIX: PPGN), a focused global CDMO for peptide-based active pharmaceutical ingredients, announces the start of production with the new large-scale SPPS capacity at its manufacturing site in Braine-l’Alleud, Belgium.

Following the completion of construction and thorough testing, PolyPeptide commissioned its new solid-phase peptide synthesis (SPPS) capacity in Braine l’Alleud and started production, with the ramp-up planned throughout 2025. The capacity supports the multi-year commercial agreement announced previously in December 2022. The agreement has an annual order value of around EUR 100 million after the ramp-up phase.

To ensure high productivity, the new facility combines PolyPeptide’s proprietary manufacturing technology with an integrated engineering design and advanced automation and process control. Closed material flows and reduced solvent consumption contribute to improved sustainability.

Over the last three years, PolyPeptide invested around EUR 100 million into the new capacity. Its start of production is consistent with the guidance for 2024, and the mid-term outlook communicated by PolyPeptide on 13 August 2024.

Juan José González, CEO of PolyPeptide: “This project is the largest single investment in PolyPeptide’s 70-year history. The start of production is the result of the successful collaboration with our GLP-1 customer over several years. In parallel to the ramp-up ahead of us, we are pursuing our growth strategy with further GLP-1 capacity investments that combine innovative manufacturing technologies with the potential of modularity.”

Contact

PolyPeptide Group AG

Michael Stäheli

Head of Investor Relations & Corporate Communications

michael.staeheli@polypeptide.com

T: +41 43 502 0580

About PolyPeptide

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a focused Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide offers products and services from pre-clinical through to commercial stages, including generics. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

For more information, please visit polypeptide.com.  

@PolyPeptide – follow us on LinkedIn

Disclaimer

This media release has been prepared by PolyPeptide Group AG and contains certain forward-looking statements that reflect the current views of management. Such statements are subject to known and unknown risks, uncertainties and other factors that may cause actual developments to differ materially from those expressed or implied in this release. In particular, the statements related to the guidance for 2024 and mid-term outlook constitute forward-looking statements and are not guarantees of future financial performance. The Group’s actual results of operations could deviate materially from those set forth in the guidance for 2024 and mid-term outlook. As such, investors should not place undue reliance on the statements related to the guidance for 2024 and mid-term outlook. PolyPeptide Group AG is providing the information in this release as of this date and, except as required by applicable laws or regulations, does not undertake any obligation to update any statements contained in it as a result of new information, future events or otherwise.

Relief Therapeutics Announces Final Readout of PKU GOLIKE^® Clinical Trial

Clinical Trial Demonstrates Superior Metabolic Control During Prolonged Fasting in PKU Patients

Results Expected to Promote Awareness and Adoption of PKU GOLIKE^®

GENEVA (DEC. 16, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced the full readout and compelling results from the clinical trial evaluating PKU GOLIKE as a protein substitute for the treatment of phenylketonuria (PKU) in patients during prolonged fasting periods. The study demonstrated that PKU GOLIKE, administered as the last daily dose and compared to standard amino acid protein substitutes, improved metabolic control by reducing harmful phenylalanine (Phe) levels and increasing beneficial tyrosine (Tyr) levels, both essential for brain function and metabolic health.

PKU patients often experience significant fluctuations in blood Phe levels during prolonged fasting periods, particularly at night, when protein breakdown causes Phe concentrations to peak in the early morning. These fluctuations are associated with cognitive difficulties and overall health impacts, making nighttime metabolic control an important focus in PKU management.

The Company-sponsored, randomized, crossover, controlled clinical study was conducted by the Inherited Metabolic Disorders Unit at Birmingham Children’s Hospital, UK, on pediatric patients with classical PKU, the condition’s most severe form. The trial compared PKU GOLIKE to standard amino acid protein substitutes in managing metabolic parameters during overnight fasting, the longest fasting period within 24 hours.

At the end of the one-week treatment period, patients receiving PKU GOLIKE as the last daily protein substitute dose showed a statistically significant reduction in blood Phe levels compared to those receiving standard amino acid substitutes (P=0.0002) and a statistically significant increase in blood Tyr levels (P=0.0113). Compared to baseline levels measured prior to the start of treatment, the PKU GOLIKE group achieved an average 17.8% reduction in blood Phe levels (P=0.0484) and an average 33.8% increase in blood Tyr levels (P=0.0008) upon awakening after the overnight fasting period. In comparison, when treated with standard amino acid protein substitutes, the same patients experienced an average 27.6% increase in blood Phe levels (P=0.0063) and no significant improvement in blood Tyr levels. Blood sample analysis at three early morning time points across the two groups revealed no significant differences in peak Phe levels upon reawakening in either group.

Highlighting the clinical significance of the findings, Prof. Anita MacDonald, principal investigator and leading dietitian in inherited metabolic disorders at Birmingham Children’s Hospital, stated: “Giving one dose of PKU GOLIKE as the final daily dose of protein substitute resulted in consistently better metabolic control in our cohort of patients with PKU. They all had classical PKU and were a particularly challenging group to control.”

These results confirm that PKU GOLIKE’s prolonged-release profile provides superior metabolic control during extended fasting periods compared to standard amino acid protein substitutes. The Company expects these findings to support adoption of PKU GOLIKE among healthcare providers and within the PKU community.

The study findings will be presented in a poster titled A Prolonged-Release Formula Has a Positive Impact on Morning Phenylalanine and Tyrosine Fluctuations in Patients with Classical Phenylketonuria at the 2025 ACMG Annual Clinical Genetics Meeting, March 18-22, 2025, in Los Angeles.

For more information on this study (NCT05487378), please visit clinicaltrials.gov.

ABOUT PHENYLKETONURIA
Phenylketonuria (PKU) is a genetic disorder caused by a deficiency of the enzyme needed to break down phenylalanine (Phe), leading to a toxic buildup of Phe from the consumption of foods containing protein or aspartame. Individuals with PKU lack the ability to metabolize Phe, which is present in many foods. Without treatment, PKU can cause severe neurological and developmental issues. The standard treatment involves a lifelong phenylalanine-restricted diet supplemented with amino acid-based, phenylalanine-free medical foods to prevent protein deficiency and optimize metabolic control.

 ABOUT PKU GOLIKE^®
PKU GOLIKE products are Foods for Special Medical Purposes (FSMPs) for the dietary management of PKU in children and adults. Developed with Relief’s proprietary, patent-protected Physiomimic Technology™ drug delivery platform, PKU GOLIKE products are the first prolonged-release amino acid FSMPs, characterized by a special coating that ensures physiological absorption of the amino acids mirroring that of natural proteins, while also masking the unpleasant taste and odor typically associated with amino acids. PKU GOLIKE products are marketed in the U.S. by Eton Pharmaceuticals Inc. under an exclusive license and supply agreement with Relief, in key European markets by Relief, and in select countries worldwide through licensing and distribution partners.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements, which may be identified by words such as “believe,” “assume,” “expect,” “intend,” “may,” “could,” “will,” or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, but are not limited to, changes in economic conditions, market developments, regulatory changes, competitive dynamics, and other risks or changes in circumstances. This communication is provided as of the date hereof, and Relief undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Relief Therapeutics Announces Filing of Form 15F to Terminate SEC Reporting Obligations

Company to Maintain SIX Swiss Exchange Listing, U.S. ADR Program, and U.S. OTCQB Quotation

GENEVA (DEC. 13, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that it intends to file a Form 15F with the United States Securities and Exchange Commission (SEC) on December 17, 2024. This filing seeks to terminate the registration of its ordinary shares under Section 12(g) of the Securities Exchange Act of 1934 (Exchange Act) and its reporting obligations under Section 15(d) of the Exchange Act.

This filing will not affect the Company’s listing on the SIX Swiss Exchange, where its shares will continue to be traded. Relief will also continue to maintain its Level 1 American Depositary Receipt (ADR) program, with its shares and ADRs continuing to be quoted on the U.S. over-the-counter market (OTCQB).

Upon filing the Form 15F, Relief’s reporting obligations with the SEC, including the filing of annual reports on Form 20-F and reports on Form 6-K, will immediately be suspended. Relief expects these obligations will be fully terminated 90 days following submission of the Form 15F. Relief remains current with its reporting requirements under the Exchange Act, and information regarding the Company, including financial reports and press releases, will continue to be available in English on its website at www.relieftherapeutics.com.

In 2021, Relief filed a Form 20-F registration statement with the SEC to support a potential listing of its securities on a U.S.-regulated stock exchange. As previously reported, the Company subsequently decided not to pursue this listing, and after further evaluation, has now concluded that maintaining its SEC registration is no longer beneficial. This decision will allow Relief to reduce its compliance costs and maintain flexibility in pursuing its strategic objectives. If in future the Company elects to conduct a transformative business transaction, it may reassess pursuit of a regulated exchange listing in the United States.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief’s portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO™ and Physiomimic™ platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit www.relieftherapeutics.com.

CONTACT:
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including whether the Company’s reporting obligations with the SEC will be fully terminated 90 days after its filing of the Form 15F, and those factors described in Relief’s filings with the SIX Swiss Exchange and the SEC could adversely affect Relief. Copies of Relief’s filings with the SEC are available on the SEC EDGAR database at www.sec.gov. Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Berlin, 13 December 2024. Eckert & Ziegler Radiopharma GmbH (Eckert & Ziegler), a leading provider of isotope technology for nuclear medicine and radiopharmaceutical applications, announces the submission of its GalliaPharm® ⁶⁸Ge/⁶⁸Ga Radionuclide Generator for approval in Japan. This will pave the way for broader access to cutting-edge diagnostic tools including ⁶⁸Ga-PSMA-11 in Japan. For GalliaPharm®, Novartis Pharma K.K., will manage safety information and distribution of the product in Japan.

GalliaPharm® is widely used as a high-quality GMP grade generator for Gallium-68, supporting the production of radiopharmaceuticals for positron emission tomography (PET) imaging, particularly in oncology including the diagnosis of prostate cancer through PSMA imaging. An approval in Japan will provide the local healthcare community with an accessible and reliable tool to label Gallium-68 radiopharmaceuticals, offering new precision in diagnostic imaging that may improve early disease detection and patient outcomes.

“This step with the MHLW for us is a critical one,” stated Dr. Deljana Werner, Head of QA and Regulatory Affairs for the Medical Division of Eckert & Ziegler SE. “As a company committed to advancing nuclear medicine globally, we see GalliaPharm®’s entry into the Japanese market as a pivotal opportunity to support medical professionals in enhancing patient care through precise and innovative imaging solutions.”

By seeking approval in Japan, Eckert & Ziegler reinforces its commitment to meeting the specific needs of diverse healthcare markets, tailoring its innovations to support local advancements in nuclear medicine. This step not only underscores the company’s dedication to providing advanced radioisotopes for medical applications worldwide, but also strengthens its position as a trusted partner in the evolving landscape of radiopharmaceuticals.

About Eckert & Ziegler SE
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler SE shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Contact
Eckert & Ziegler SE
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations
jan.schoepflin@ezag.de / karolin.riehle@ezag.de
Tel.: +49 (0) 30 / 94 10 84-138; https://ezag.com

Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England

First patients implanted with Genio at UCLH, London

Mont-Saint-Guibert, Belgium – December 13, 2024, 08:05am CET / 2:05am 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 announced the commercial launch of its Genio system in England, marked by the first successful implants performed at University College London Hospitals (UCLH).

Genio is now covered under the NHS Specialised Services Devices Programme (SSDP), enabling access to innovative therapies through specialized centers of excellence.

The first two patients were successfully implanted by Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon at UCLH. Commenting on the milestone, Mr. Cheong said: “We are proud to be the first hospital in the UK to offer Genio to our OSA patients. Genio is a groundbreaking, clinically proven therapy that addresses the unmet needs of individuals suffering from Obstructive Sleep Apnea.”

Olivier Taelman, CEO of Nyxoah, added: “Today represents an important milestone for Nyxoah as we introduce our Genio neurostimulation solution to treat Obstructive Sleep Apnea in England. Congratulations to Mr. Cheong and his team on this remarkable achievement. We look forward to expanding our collaboration with UCLH and other leading hospitals in England as we continue our mission to make sleep simple for OSA patients.”

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, reflecting Nyxoah’s current expectations and beliefs 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 potential receipt of FDA approval and entrance into the U.S. market. 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 Nyxoah’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 Nyxoah 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, Nyxoah 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 Nyxoah 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
John Landry, CFO
IR@nyxoah.com

For Media
In UK
Kinfolk Communications
rebecca@wearekinfolk.co.uk
gemma@wearekinfolk.co.uk

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

Newron and EA Pharma (a subsidiary of Eisai Co., Ltd.) announce license agreement for evenamide in Japan and other Asian territories

• Newron will receive up to a maximum of €117 million from an upfront payment, development milestones and commercialization milestones, and up to double-digit tiered royalties on net sales
• Evenamide is a unique modulator of the excessive release of glutamate in treatment resistant schizophrenia (TRS) and poorly responding patients with schizophrenia
• Newron expects to begin a pivotal Phase III trial in H1 2025 for evenamide as an add-on therapy to any current anti-psychotic in TRS patients
• Newron continues to pursue further development opportunities for evenamide in other territories

Milan, Italy, Morristown, NJ, USA, and Tokyo, Japan, December 13, 2024, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, and EA Pharma Co., Ltd. (Head Office, Chuo-ku, Tokyo, Japan; President, Hidenori Yabune; “EA Pharma”), a subsidiary of Eisai Co., Ltd., today announced that they have entered into a license agreement to develop, manufacture and commercialize Newron’s innovative modulator of the excessive release of glutamate, evenamide, in Japan and other designated Asian territories.¹

Under the terms of the license agreement, in exchange for full rights in the licensed territories, Newron will receive up to a maximum total of €117 million from EA Pharma, including an upfront payment of €44 million, financial contributions to its upcoming Phase III one-year study to be performed outside of the licensed territories, regulatory and commercialization milestones, and tiered royalties up to a double-digit percentage of net sales for evenamide.

The execution of this agreement, especially the upfront payment of €44 million, is expected to materially impact Newron’s 2024 financial statements.

Stefan Weber, CEO of Newron, commented: “This partnering agreement for evenamide is a key milestone in our goal to offer a truly innovative, evidence-based alternative to patients suffering from schizophrenia, those who are responding poorly to their treatments, or who have become treatment resistant to currently available medications. We are thrilled to work with the EA Pharma team and to have the opportunity to advance evenamide through a Phase III study and towards regulatory submission in Japan and other Asian territories by one of Japan’s leading pharmaceutical companies. Newron will now focus on the initiation of our Phase III one-year study in TRS and expect to start that study outside of the licensed territories in H1 2025. We are also pursuing further development opportunities for evenamide in other territories.”

“EA is thrilled to acquire the license for evenamide in Japan and other Asian territories. Evenamide has a new mechanism of action involving glutamate regulation and is the first in the world with this mechanism of action to demonstrate therapeutic efficacy in clinical trials. It is the result of many years of outstanding research by the Newron team. We believe evenamide has the potential to be transformational for patients suffering from schizophrenia.” said Hidenori Yabune, President of EA Pharma.

Jefferies International Limited (“Jefferies”) acted as the exclusive financial advisor to Newron. Orrick Herrington & Sutcliffe LLP advised as legal counsel to Newron.

About schizophrenia

Approximately 25 million people worldwide are affected by schizophrenia. Despite more than 60 different types of atypical and typical antipsychotics used for schizophrenia globally, a considerable number of patients remain severely ill or resistant to treatment. Overall, 30-50% of patients do not respond to the available medications and are defined treatment resistant. In addition to the patients with treatment-resistant schizophrenia (TRS), another 20-30% are described as “poor responders to anti-psychotic medication,” even if not meeting the criteria for TRS. New findings indicate that patients with TRS have abnormalities in the glutamatergic system, but not in dopaminergic transmission, so there is a huge unmet medical need for a glutamatergic mechanism of action, efficacious both in TRS patients and in those who are poor responders to the current treatments.

About evenamide

Evenamide is the first new chemical entity that has demonstrated significant benefits in this difficult-to-treat patient population, as seen in the potentially pivotal Phase III study 008A trial, as an add-on treatment to second generation anti-psychotics including clozapine, in 291 poorly responding patients with chronic schizophrenia. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS)², and the key secondary endpoint, the Clinical Global Impressions Scale – Severity (CGI-S), were met and showed statistical significance compared to placebo. Importantly, evenamide treatment was associated with statistically significant increase in proportion of patients who experienced “clinically meaningful benefit” on the outcome variables. Evenamide was extremely well tolerated, without any of the usual side effects of available anti-psychotics.

Evenamide development milestones

During Q1 2024, Newron reported final one-year results from study 014/015, a Phase II open label trial evaluating evenamide as an add-on therapy to a single antipsychotic in treatment-resistant patients. The data demonstrated that evenamide as an add-on treatment for patients with TRS was associated with sustained, clinically significant benefits that increased throughout the one-year course of treatment, with more than 70% of patients experiencing a clinically important reduction in disease severity.

Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).

In Q2 2024, the Company announced two sets of data from study 008A, a potentially pivotal four-week randomized, double-blind and placebo-controlled study of evenamide as an add-on therapy in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic. Topline data announced in April confirmed evenamide’s favorable safety and tolerability profile, followed by compelling data from additional analyses reported in May.

The study met the primary endpoint (improvement of the Positive and Negative Syndrome Scale (PANSS) Total Score), and there was no increase in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction or gastro-intestinal side effects, CNS or cardiac effects, or laboratory abnormalities. The study also met the secondary endpoint (improvement of the Clinical Global Impression of Severity (CGI-S)), with a high rate of study completion (96%). No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%).

The totality of these results validated evenamide as the first glutamate modulator to demonstrate efficacy in inadequately responding patients with schizophrenia in a placebo-controlled study.

Newron is expected to initiate a Phase III randomized, double-blind, one-year trial in H1 2025 that will compare evenamide to placebo as add-on treatment in at least 600 patients with treatment-resistant schizophrenia (TRS). The primary efficacy endpoint will be change from baseline in the Positive and Negative Syndrome Scale (PANSS) scores at 12 weeks. Following this initial period, subjects will continue on their assigned treatment until week 52, for demonstration of long-term efficacy and safety and tolerability of evenamide. Newron continues to pursue further development opportunities for evenamide in other territories.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

About EA Pharma

EA Pharma Co., Ltd. is a subsidiary of Eisai Co., Ltd. It was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year’s history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing. For further information on EA Pharma Co., Ltd., please visit https://www.eapharma.co.jp/

References:

[1] Brunei Darussalam, the Kingdom of Cambodia, the Republic of Indonesia, the Lao People’s Democratic Republic, Malaysia, the Union of Myanmar, the Republic of the Philippines, the Republic of Singapore, the Kingdom of Thailand, the Socialist Republic of Vietnam

[2] Positive and Negative Syndrome Scale (PANSS) is widely used in clinical trials of schizophrenia and is considered the “gold standard” for assessment of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)

For more information, please contact:

Newron

Stefan Weber – CEO, +39 02 6103 46 26, pr@newron.com

UK/Europe

Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting, +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland

Valentin Handschin, IRF, +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe

Anne Hennecke / Maximilian Schur, MC Services, +49 211 52925227, newron@mc-services.eu

USA

Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

EA Pharma

EA Pharma Co., Ltd. Corporate Communication Dept., contact_ea@eapharma.co.jp

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

Adhoc release

Disclosure of inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014

Specification of the full-year forecast

Berlin, December 12, 2024 – Medios AG (“Medios”) specifies its full-year forecast as follows: The Company expects revenues of c. €1.85 billion (previous year: €1.8 billion which corresponds to an increase of 2.8%) and EBITDA pre¹ of c. €80 million (previous year: €60.5 million which corresponds to an increase of 32.2%). The EBITDA pre¹ margin is therefore expected to be around 4.3% (previous year: 3.4 %).

Previously, revenues of €1.9 billion to €2.1 billion and EBITDA pre¹ of €82 million to €91 million were expected. Accordingly, an EBITDA pre¹ margin of around 4.3% was previously expected.

¹ EBITDA is defined as consolidated earnings before interest, taxes, depreciation and amortization. EBITDA pre is adjusted for special charges for stock options and expenses for M&A activities and expenses for ERP-System implementation as well as for one-time performance-based payments for the acquisition of compounding volumes.

Disclosing person: Matthias Gärtner, CEO

End of Inside Information

Contact

Medios AG, Heidestraße 9, 10557 Berlin

Telefon: +49 30 232 5668 00; Fax: +49 30 232 5668 01

E-Mail: ir@medios.group; www.medios.group

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About Medios AG

Medios is a leading provider of Specialty Pharma in Europe. With locations in Germany, the Netherlands, Belgium and Spain, the company supports key partners in the supply chain with innovative solutions and intelligent services. Medios has focused on pioneering individualized medicine to make the most innovative therapies available to everyone together with pharmacies, specialist practices and pharmaceutical companies.

Medios AG is Germany’s first listed specialty pharmaceutical company. The shares are listed on the regulated market of the Frankfurt Stock Exchange (Prime Standard) and are included in the SDAX selection index.

www.medios.group

Contact

Claudia Nickolaus

Head of Investor & Public Relations, ESG Communications

Medios AG

Heidestraße 9 | 10557 Berlin

T +49 30 232 566 800

ir@medios.group

www.medios.group

Disclaimer

This communication contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those currently anticipated as a result of various risk factors and uncertainties, including, but not limited to, changes in business, economic and competitive conditions, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. Medios AG assumes no responsibility to update any forward-looking statements contained in this release.