Classification of First Berlin Equity Research GmbH to MPH Health Care AG

Company Name:	MPH Health Care AG
ISIN:	DE000A289V03
Reason for the research:	9M Kennzahlen
Recommendation:	Kaufen
from:	18.12.2024
Target price:	€108
Target price on sight of:	12 Monate
Last rating change:	–
Analyst:	Ellis Acklin

First Berlin Equity Research hat ein Research Update zu MPH Health Care AG (ISIN: DE000A289V03) veröffentlicht. Analyst Ellis Acklin bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von EUR 108.

Zusammenfassung:
MPH meldete mit den Neunmonatskennzahlen einen guten Wertzuwachs. Der Nettoinventarwert (NAV) stieg in der 9M Periode um 20% und im Jahresvergleich um 39% auf €300 Mio. Der NAVPS bewegte im Gleichschritt dazu und landete bei €70,10. Die Aktien von M1 Kliniken legten im Zeitraum von Januar bis September um 50% zu, angetrieben von der positiven Dynamik des florierenden Prejuvination-Geschäfts. Das Management von CR Energy geht davon aus, dass sich die Ergebnisse des Jahres 2024 in das zweite Halbjahr verschieben werden, wies jedoch darauf hin, dass ihre Beteiligungen Terrabau und Solartec im ersten Halbjahr einen Gewinn von €9,5 Mio. erzielten. Die CRE-Aktien lagen im Neunmonatszeitraum rund 18% im Minus. M1 eröffnet weiterhin Schönheitskliniken (jetzt: 63 Standorte) auf dem Weg zu ihrem Ziel von 150 bis 200 Zentren bis JE29, und die CRE-Geschäftsbereiche Clean Energy und hochwertiger, erschwinglicher Wohnraum florieren trotz eines weiteren Gegenwinds für die Immobilienmärkte. Wir bekräftigen unser Kursziel von €108 und unser Kaufen-Votum.

First Berlin Equity Research has published a research update on MPH Health Care AG (ISIN: DE000A289V03). Analyst Ellis Acklin reiterated his BUY rating and maintained his EUR 108 price target.

Abstract:
MPH reported good value uplift with nine month reporting. NAV rose some 20% during the first nine months of ’24 and was up 39% Y/Y to €300m, while NAVPS moved in lockstep landing at €70.1. M1 Kliniken shares were up 50% during the January-to-September period spurred by the positive momentum of the thriving prejuvination business. Meanwhile, CR Energy management expect 2024 results to be backloaded into H2 but noted that the Terrabau and Solartec holdings racked up €9.5m in profit during H1/24. CRE shares were down around 18% at the 9M juncture. M1 continues to open clinics (now: 63) on the way to its YE29 goal of 150 to 200 centres, and CRE’s clean energy and quality, affordable housing businesses continue to flourish, despite another headwind year for the property markets. We stick to our Buy rating with an unchanged €108 TP.

Bezüglich der Pflichtangaben gem. §34b WpHG und des Haftungsausschlusses siehe die vollständige Analyse.
 

You can download the research here: http://www.more-ir.de/d/31569.pdf

Contact for questions:
First Berlin Equity Research GmbH
Herr Gaurav Tiwari
Tel.: +49 (0)30 809 39 686
web: www.firstberlin.com
E-Mail: g.tiwari@firstberlin.com

The European industrial hemp and cannabis group SYNBIOTIC SE (ISIN DE000A3E5A59 | WKN A3E5A5) announced a strategic partnership with GOC NEXUS OPERATIONS GmbH on 13 December 2024. This collaboration marks a significant step in the further development and optimisation of cannabis processing in Europe. As part of this partnership, SYNBIOTIC will make a strategic investment in GOC NEXUS OPERATIONS GmbH, which will use a globally innovative process for the microbiological decontamination of cannabis GACP raw materials into EU GMP medicinal products in Germany.

Microbiological decontamination is currently one of the biggest challenges for producers of medicinal cannabis. The innovation here lies in the use of cold plasma, which is already widely used in industry and medicine. The ability to clean surfaces and kill microbes while protecting the target structures makes cold plasma a valuable tool in various fields. Due to the comprehensive IP protection for the cold plasma treatment of cannabis in combination with a worldwide application licence, the parent company GOC NEXUS Holding has exclusive access rights in the field of cannabis processing. The technology combines several advantages regarding the decontamination of cannabis. It is an effective and environmentally friendly innovation compared to conventional disinfection methods and will revolutionise the processing of cannabis in the coming years and represent a new gold standard.

The technology is the first sustainable solution as it does not require the use of ionising radiation, heat or chemicals, produces no environmentally hazardous waste products and uses minimal energy. Cold plasma produces reactive species that can effectively kill bacteria, viruses and fungi without damaging the plant structure. This is particularly important with cannabis, as the quality and integrity of the product is vital to the entourage effect.

Unlike many chemical disinfectants, cold plasma-treated cannabis is free of chemical residues after treatment. This makes it safer for the environment and patients. The process enables fast decontamination processes and therefore short production times. This gentle technology preserves the original organoleptic properties of the product, such as taste, smell, structure, colour and effect. The process can be integrated relatively easily into existing supply chains, which makes it attractive for manufacturers.

The technology was originally adapted in Canada for the processing of cannabis and has already been tested by numerous Canadian customers. Due to the high demand, a centre for the consumer cannabis market has already been set up in Canada and is currently being put into operation. At the same time, the technology is being validated at the Laupheim site in Germany by GOC NEXUS OPERATIONS for EU GMP certification, which will be completed by mid-2025.

In addition, GOC NEXUS OPERATIONS is already preparing for vertical integration. To this end, there are plans to supplement contract manufacturing in the area of packaging and market release of pharmaceuticals. This combination will enable GOC NEXUS OPERATIONS to map all processes downstream of pre-drying for its partner SYNBIOTIC.

“We are very pleased to be working with GOC NEXUS and combining our strengths. Our MedCan subsidiaries such as WEECO Pharma can now offer their customers organoleptically enhanced products while safely meeting pharmaceutical standards in terms of microbiology,” said Daniel Kruse, Managing Director SYNBIOTIC. “This partnership is an important step in our strategy to grow through innovation and collaboration.”

“The collaboration with SYNBIOTIC opens up new opportunities and strengthens our ability to offer first-class services,” added Dr David Surjo, Managing Director of the GOC NEXUS companies. “We look forward to our joint success and the positive impact this partnership will have for patients in Germany, enabling us to offer patients premium radiation-free products through reliable supply chains.”

The first production facility is to be built at the new site in Laupheim, which will serve as a blueprint for future global scaling. To this end, the company has developed a modular concept for the process environment that will facilitate future scaling and significantly accelerate the establishment of new production facilities. Talks are already underway with international partners to expand the business model.

About GOC NEXUS OPERATIONS
GOC NEXUS OPERATIONS specialises in the pharmaceutical contract manufacturing of medicinal cannabis in Germany along the value chain and will in future cover all process steps from pre-drying to market release. It is a subsidiary of GOC NEXUS Holding, which is the licence holder for the cold plasma treatment of cannabis.

Publisher
SYNBIOTIC SE
Daniel Kruse
Managing Director
Münsterstraße 336
40470 Düsseldorf
Germany

Media Contact
Rüdiger Tillmann
SYNBIOTIC
Public Relations Manager
E-mail ruediger.tillmann@synbiotic.com
Mobile +49 170 9651451
c/o JOLE.group

About SYNBIOTIC
SYNBIOTIC is a publicly listed group of companies in the hemp and cannabis sector with a buy-and-build investment strategy focussed on the EU.
The Group covers the entire value chain from cultivation to production and retail – from the field to the shelf. The subsidiaries’ core businesses are research and development, production and the commercialisation of hemp, CBD and cannabis products.
SYNBIOTIC is pursuing a clear pan-European strategy to further expand along the value chains of its business areas – hemp and CBD, medical cannabis and consumer cannabis – and thus cover the relevant growth markets while increasing opportunities for investors through diversification.

Marinomed Biotech AG: Requirements for successful completion of the restructuring proceedings achieved

• Funds deposited for cash quota and to cover legal costs
• European Investment Bank (EIB) agrees to standstill declaration
• Implementation of the restructuring plan and the Company’s sustainable continued existence are to be secured by the sale of the Carragelose business

Korneuburg, Austria, 17. December 2024 – Marinomed Biotech AG (VSE:MARI) announces that all necessary conditions for the completion of the ongoing restructuring proceedings without self-administration have been met. The funds for the cash quota and for the costs of the proceedings have been deposited with the insolvency administrator. Within the next two weeks, the creditors’ cash quotas will be paid out from these funds. In addition, a standstill agreement has been concluded with the EIB for the payment of the cash quota until the end of April 2025. The standstill was necessary because Marinomed will only receive the first partial payment from the sale of the Carragelose business after the closing. This can take up to three months. All requirements have thus been met to end the restructuring proceedings and the administration by the insolvency administrator. 

At the final court hearing on November 14, 2024, all present creditors approved the submitted restructuring plan. The plan provides for a quota of 30% payable within the next two years. If milestone payments from the sale of the Carragelose business exceed planned revenues during this period, a super quota of up to 7% will be distributed. As reported previously, Marinomed has also entered into an agreement with the EIB for the planned issue of a convertible bond in the amount of kEUR 424.

A key element of the fulfillment of the restructuring plan is the already signed sale of the Carragelose business to Unither Pharmaceuticals. The closing of the transaction is, among other things, subject to shareholder approval. The approval is expected to be obtained at an extraordinary general meeting on December 19, 2024. Furthermore, the sale is intended to finance ongoing operations and the commercialization of the Marinosolv projects. Necessary funds have been secured through cost saving measures, the execution of two capital increases, the issuance of the convertible bond to the EIB and cash flow from operating activities.

“We have experienced very challenging months. Despite the difficulties, we have been able to develop a restructuring plan that provides an acceptable solution for our creditors and ensures the stable financing of the Company. The two capital increases that have been carried out are also significant for securing our cash situation. We are grateful for the continued support and trust placed in us,” says Andreas Grassauer, CEO of Marinomed.

“The proceeds of up to EUR 20 million from the sale of the Carragelose business are sufficient to finance the restructuring plan, the commercialization of the Marinosolv projects and the further development of the Solv4U unit. With this sale, we are therefore laying the foundation for the long-term positive development of the Company,” adds Pascal Schmidt, CFO of Marinomed.

About Marinomed Biotech AG

Marinomed Biotech AG is an Austrian, science-based biotech company with a growing development pipeline and globally marketed therapeutics. The Company develops innovative patent-protected products in the therapeutic areas immunology and virology based on the platform Marinosolv® and the virus-blocking activity of Carragelose®. The Marinosolv® technology improves the solubility and bioavailability of hardly soluble compounds and is used to develop new therapeutics for autoreactive immune disorders. The virology segment includes Carragelose®-based over-the-counter (OTC) products to prevent and treat respiratory viral infections that are partnered in more than 40 countries. The Company is headquartered in Korneuburg, Austria, and is listed on the Vienna Stock Exchange (VSE:MARI). For further information, please visit: https://www.marinomed.com.

For further inquiries contact:

Marinomed Biotech AG PR & IR: Lucia Ziegler T: +43 2262 90300 158 E-Mail: pr@marinomed.com  E-Mail: ir@marinomed.com

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as “anticipate,” “believe”, “estimate”, “expect”, “intend”, “plan”, “project” and “target”. Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise. Marinomed, Marinosolv® and Carragelose® are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only.

 

Classification of First Berlin Equity Research GmbH to M1 Kliniken AG

Company Name:	M1 Kliniken AG
ISIN:	DE000A0STSQ8
Reason for the research:	9M Hauptkennzahlen
Recommendation:	Kaufen
from:	17.12.2024
Target price:	€28
Target price on sight of:	12 Monate
Last rating change:	–
Analyst:	Ellis Acklin

First Berlin Equity Research hat ein Research Update zu M1 Kliniken AG (ISIN: DE000A0STSQ8) veröffentlicht. Analyst Ellis Acklin bestätigt seine BUY-Empfehlung und bestätigt sein Kursziel von EUR 28,00.

Zusammenfassung:
Das florierende Beauty-Geschäft von M1 Kliniken blieb auch im 3. Quartal die tragende Säule des Konzerns und ebnete den Weg für ein gutes Umsatz- und Ergebniswachstum. Der Konzernumsatz lag nahe an unserer Prognose, aber das operative Ergebnis übertraf unsere Schätzung um 9%, da das Beauty-Segment ein EBIT-Wachstum von 41% J/J verzeichnete. Die Hauptkennzahlen des Segments Trade blieben mit einer EBIT-Marge von 2% bei einem Umsatz von €67 Mio. im Septemberquartal stabil. M1 betreibt nun 63 medizinische Fachzentren, nachdem in diesem Jahr 4 neue Praxen in Deutschland und eine weitere in Österreich eröffnet wurden. Wir haben unsere Schätzungen für 2024 angehoben, um der 9M/24-Outperformance Rechnung zu tragen, und behalten unsere Kaufempfehlung mit einem unveränderten Kursziel von €28 bei.

First Berlin Equity Research has published a research update on M1 Kliniken AG (ISIN: DE000A0STSQ8). Analyst Ellis Acklin reiterated his BUY rating and maintained his EUR 28.00 price target.

Abstract:
M1 Kliniken’s thriving Beauty business remained the group mainspring in Q3 paving the way for good sales and earnings growth. Group turnover was close to FBe, but operating income overshot our estimate by 9% on the back of 41% Y/Y EBIT growth registered by the Beauty segment. Meanwhile, Trade segment KPIs remained stable with a 2% EBIT margin on €67m in turnover for the September quarter. M1 now operates 63 treatment centres after opening 4 new practices in Germany and another one in Austria this year. We have nudged our 2024 targets higher to account for the 9M/24 outperformance and remain Buy-rated on M1 with an unchanged €28 target price.

Bezüglich der Pflichtangaben gem. §34b WpHG und des Haftungsausschlusses siehe die vollständige Analyse.

 

You can download the research here: http://www.more-ir.de/d/31553.pdf

Contact for questions:
First Berlin Equity Research GmbH
Herr Gaurav Tiwari
Tel.: +49 (0)30 809 39 686
web: www.firstberlin.com
E-Mail: g.tiwari@firstberlin.com

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

Media
Jutta Lorberg Head of Corporate Communication T +49 211 6181 264 jutta.lorberg@gerresheimer.com	Marion Stolzenwald Senior Manager Corporate Communication T +49 172 2424185 marion.stolzenwald@gerresheimer.com
Investor Relations
Guido Pickert Vice President Investor Relations T +49 152 900 14145 gerresheimer.ir@gerresheimer.com	Thomas Rosenke Senior Manager Investor Relations T: +49 211 6181-187 gerresheimer.ir@gerresheimer.com

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.