PRESS RELEASE 

Affluent Medical Announces
Participation in Upcoming Scientific Events

Aix-en-Provence, October 8, 2024 – 5:45 p.m. CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – “Affluent”), a French clinical-stage medical technology company specializing in the international development and industrialization of implantable innovative medical devices, today announced that the company will participate in the following upcoming scientific conferences in the fourth quarter, 2024:

EACTS 2024
38th European Association for Cardio-Thoracic Surgery Annual Meeting
Location: Lisbon, Portugal
Date: 09-12 October 2024
Learn more

ICS 2024
54th International Continence Society Annual Meeting
Location: Madrid, Spain
Date: 23-25 October 2024
Learn more

PCR London Valves
Official Course of the European Association of Percutaneous Cardiovascular Interventions
Location: London, United Kingdom
Date: 24-26 November 2024
Booth: #A2
Learn more

“Affluent Medical is dedicated to pioneering minimally invasive solutions that redefine patient care, enhance lives and address pressing medical needs of more than 600 million individuals worldwide affected with urinary incontinence and mitral insufficiency. In the past year, we have made major steps in the development of our medical devices, notably, our important deal with Edward Lifesciences, the global leader in patient-focused medical innovations for structural heart disease, for our mitral valve technologies, as well as encouraging initial performance results for our artificial sphincter Artus”, explained Sébastien Ladet, CEO of Affluent Medical. “As we progress our programs towards the pivotal and approval stages, we are very much looking forward to meeting with leading experts and companies in their respective fields to discuss latest research, patient needs as well as our programs and partnering opportunities.”

During the events, Affluent will be available to discuss the company’s latest advances in the development of its three innovative medical devices as well as their unique potential:

MITRAL RING KALIOS^TM:

Kalios^TM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart surgery. Affluent Medical believes that Kalios^TM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon.

Following positive feedback from the FDA in September 2024, Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025/early 2026, followed by commercial launch, subject to Edwards’ decisions.

MITRAL VALVE EPYGON:

Epygon is the only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve and physiological blood flow, able to be implanted via a transcatheter route. This transcatheter approach avoids an invasive open-heart procedure and associated complications to treat mitral valve insufficiency.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve. This innovative design aims to replicate the anatomy and natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

During the first half of 2024, Affluent Medical accelerated patient evaluations, achieving a fourfold increase in the number of patients included by the end of June 2024 with the goal is to implant up to 10 patients to complete the pilot phase.

URINARY SPHINCTER ARTUS:

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence. Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation in the last 40 years, causing patients to suffer a reduced quality of life associated with the psychological disorders related to the disease.

As of mid-September 2024, seven patients had received an implant, representing over half of the planned patients for the pilot phase of the study. The Company plans to implant a total of 10 patients by Q4 2024 and then launch the pivotal phase of the study.

To schedule a meeting during the upcoming conferences, please contact the company at contact@affluentmedical.com.

About Affluent Medical

Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world’s leading causes of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans.

Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, the Company aims to gradually market its products from 2026, directly or indirectly.

For more information, please visit www.affluentmedical.com

Contacts:

Mainz Biomed Reports Increased Demand for Enhanced ColoAlert, Existing Partners to Transition to New Version

GANZIMMUN Diagnostics to Feature ColoAlert at the 57th Medizinische Woche Baden-Baden
 

BERKELEY, US and MAINZ, Germany – October 8, 2024 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today increasing demand from existing and prospective laboratory partners for its enhanced ColoAlert product that has been launched in July 2024 and is currently being commercialized across Europe and in select international markets. This advanced version of the Company’s colorectal cancer (CRC) screening test is set to become the standard offering for all existing partners, reflecting its proven benefits in optimizing screening efficiency and improving user experience.

Widespread Transition to Enhanced ColoAlert

One of the earliest partners to make the transition is GANZIMMUN Diagnostics, one of Germany’s premier laboratories, which licensed the ColoAlert test. GANZIMMUN will fully implement the enhanced version of the innovative DNA biomarker-based screening product by the beginning of next year, taking advantage of the significant improvements in sample processing and usability that have set a new industry benchmark.

Improving Customer Interest

Partners are particularly drawn to the enhanced features, such as the proprietary DNA stabilizing buffer that ensures reliable results despite varying sample volumes, and the streamlined collection devices that simplify at-home testing for users. These innovations have drastically reduced the need for retesting, offering faster turnaround times for patients, with results available in just 2–3 days from sample arrival.

Promotion at Key Medical Event

GANZIMMUN Diagnostics will showcase the enhanced ColoAlert at the 57th Medizinische Woche Baden-Baden, a medical congress in Germany focusing on complementary medicine, which takes place from October 30 to November 3, 2024. This underscores the increasing role of complementary medicine in cancer prevention and early detection. The event will provide an ideal platform to promote Mainz Biomed’s innovative DNA-based CRC screening test to medical professionals, integrative medicine practitioners, and researchers interested in advanced diagnostic solutions.

“We are excited to support GANZIMMUN in introducing the enhanced ColoAlert at such a prestigious event,” stated Tarrin Khairi-Taraki, VP Commercial Operations at Mainz Biomed. “The 57th Medizinische Woche Baden-Baden provides an excellent opportunity to demonstrate the importance of early colorectal cancer detection and how our innovations are making this process more efficient.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About GANZIMMUN Diagnostics

GANZIMMUN Diagnostics is one of the leading laboratories in Europe for preventive and complementary medicine. A multidisciplinary team comprising more than 420 employees processes approximately 5,500 laboratory orders per day under the leadership of the experienced laboratory physician, Dr. med. Patrik Zickgraf. The comprehensive diagnostic service spectrum, which includes over 4,000 laboratory parameters, includes besides the basic analytics a huge amount of innovative tests such as the ColoAlert.

To learn more, visit https://www.ganzimmun.de/en/

About Mainz Biomed NV

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe and the United Arab Emirates. The Company is currently running a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.
 

For media inquiries

MC Services AG
Anne Hennecke/Caroline Bergmann
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on April 9, 2024. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Marinomed Biotech AG publishes remarkable results showing alleviation of allergic eye inflammation in patients treated with Tacrolimus eye drops in peer-reviewed journal

• Tacrosolv eye drops, a low-dose, aqueous Marinosolv-enabled formulation of Tacrolimus, are safe and effective in alleviating symptoms of allergic rhinoconjunctivitis
• Data from phase II dose-finding clinical trial have been published in peer-reviewed Clinical Ophthalmology journal
• Tacrosolv offers great potential in treatment of inflammatory diseases of the ocular surface

Korneuburg, Austria, 08. October 2024 – Marinomed Biotech AG (VSE:MARI) has published clinical data from the phase II dose-finding clinical trial evaluating the efficacy of Tacrosolv eye drops in patients with allergic rhinoconjunctivitis in the peer-reviewed “Clinical Ophthalmology” journal. The placebo-controlled allergen challenge trial assessed the efficacy and safety of two different doses of Tacrosolv. The results show that the higher dose of Tacrosolv eye drops (0.005% Tacrolimus) significantly reduced ocular symptoms of allergic conjunctivitis, and surprisingly, also the associated nasal allergy symptoms. Remarkably, these results were achieved with a dose that is 20-fold lower than that of the only Tacrolimus eye drop product currently on the market.

Eva Prieschl-Grassauer, CSO of Marinomed, comments: “Tacrolimus is an immunosuppressive compound widely used to prevent organ rejection after transplantation or for treating inflammatory skin and eye diseases. In ophthalmology, there is currently only one marketed product in Asia in which Tacrolimus is used as a suspension. Due to its very low solubility in water and the associated very low bioavailability in the inflamed tissue, it takes days to weeks for the therapy to take effect. With our Marinosolv solubilization technology, we could significantly increase the solubility of Tacrolimus in a water-based formulation, thereby improving bioavailability, lowering the needed dose, and leading to a faster onset of action. The encouraging results of this clinical study show that Tacrosolv is a safe and effective treatment option for ocular inflammation. Tacrosolv has the potential to benefit a multitude of inflammatory eye diseases, where the currently limited treatment options create unmet medical need.”

In the clinical trial, adults with a history of allergic conjunctivitis were randomized to either Tacrolimus or placebo treatment for 8 days. Allergic symptoms were induced by controlled allergen exposure on day 1 and 8. During exposure, participants recorded ocular, nasal and respiratory allergy symptoms. The primary endpoint was the mean Total Ocular Symptom Score (TOSS) on day 8. Objective ocular safety parameters were assessed before, during and after exposure.

On day 8, ocular symptoms (mainly redness and watery eyes) were reduced in participants receiving Tacrosolv compared to placebo treatment. Surprisingly, nasal symptoms (mainly itching and sneezing) were significantly reduced in participants treated with Tacrosolv already after the first application. This is an outstanding finding, as the only currently marketed eye drop formulation (Talymus® ophthalmic suspension 0.1%, marketed in Asia) contains a 20-fold higher concentration of Tacrolimus. In conclusion, treatment with Tacrosolv at the dose and frequency studied is safe and significantly alleviates symptoms in participants suffering from allergic rhinoconjunctivitis.

About Marinosolv®:

Marinosolv® is an innovative technology platform that enables the solubilization and enhances the bioavailability of small molecules and peptides that are hardly soluble in aqueous formulations. Consequently, new treatments of a multitude of diseases can be envisaged. The use of the Marinosolv® technology can facilitate efficient drug delivery with a low systemic off-target activity. Existing drugs and off-patent active ingredients can be improved and re-patented as part of new formulations using Marinosolv®. Under the brand Solv4U, Marinomed provides Marinosolv® formulation development in technology partnerships for active ingredients at all stages of drug discovery and for lifecycle extension. For more information on Marinosolv® or Solv4U, please visit https://www.solv4u.com. Scientific publications on Marinosolv® can be accessed in the “Immunology” tabs at https://www.marinomed.com/en/news/scientific-publications.

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:

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.

Berlin, Germany and Sydney, Australia – 08. October 2024  – Eckert & Ziegler (ISIN DE0005659700, SDAX) and GlyTherix Ltd (GlyTherix), an Australian targeted radiotherapy company specialising in developing antibody radiopharmaceuticals for solid tumors, today announced a new global clinical supply agreement. Eckert & Ziegler will provide its GMP grade non-carrier added Lutetium-177 chloride (n.c.a. Lu-177) for use in GlyTherix’s clinical trials focused on innovative treatments for aggressive and invasive cancers.

GlyTherix’s radiotherapy approach combines Lu-177 with an antibody targeting Glypican-1, a protein found in aggressive cancers, to deliver localized radiation while sparing healthy tissue. Glypican-1 is an attractive tumor target that occurs in several aggressive and invasive cancers including prostate, pancreatic, bladder, lung, glioblastoma and ovarian cancer. GlyTherix plans to use 177Lu-DOTA-Miltuximab® in its planned Australian Phase Ib in early 2025, followed by US Phase II trials in 2026.

Dr. Harald Hasselmann, CEO of Eckert & Ziegler commented, “We are happy to collaborate with GlyTherix in their mission to develop cutting-edge radiopharmaceuticals. Contributing to the success of such innovative treatments in clinical trials and beyond with our high-quality radioisotopes including Lutetium-177 is our distinct goal.”

Dr. Brad Walsh, GlyTherix Chief Executive Officer said, “We are very pleased to partner with Eckert & Ziegler to provide patients with innovative targeted radiotherapy treatments. As GlyTherix advances its clinical trials using the medical radioisotope Lu-177, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality radioisotopes to patients. This agreement with Eckert & Ziegler strengthens our global clinical supply network and underscores our commitment to enhancing our global radiopharmaceutical manufacturing capabilities to meet increase demand”.
 

About Eckert & Ziegler
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 shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.
 

About GlyTherix
GlyTherix Ltd is an Australian targeted radiotherapy company specializing in developing antibody radiopharmaceuticals for solid tumours. Miltuximab® specifically targets Glypican-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue. The company has a strong proprietary and Intellectual Property position covering both Miltuximab® and the antigen Glypican-1. This provides robust and long-term protection for the commercialization of important new treatments to people with little hope.
GlyTherix has completed a ‘First-in-Human’ trial of 12 patients using Miltuximab® with no drug-related adverse. Miltuximab® will be used in a Phase Ib trial as an antibody theranostic. GlyTherix is interested in partnerships or collaborations with larger biotech and pharmaceutical partners.

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; www.ezag.com

GlyTherix
Dr Brad Walsh, CEO
+61 413 231 296
Brad.Walsh@glytherix.com

Relief Therapeutics Announces Promising Preliminary Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

GENEVA (OCT. 8, 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 promising preliminary results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds.

The study was designed to evaluate the effects of RLF-TD011 on microbiome diversity in wounds of patients with dystrophic and junctional EB. Microbiome analysis showed a statistically significant reduction in Staphylococcus aureus and an increase in beneficial bacteria in EB wounds, accompanied by a marked improvement in alpha microbiome diversity. A notable correlation between wound healing, specifically wound size reduction, and Staphylococcus aureus reduction was also observed. Further analyses will be available in the coming weeks.

Culture-based studies have shown that up to 93% of wounds in EB patients are colonized by Staphylococcus species. “Overgrowth of Staphylococcus aureus can lead to infection in our patients with epidermolysis bullosa and inhibits wound healing,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University. The presence of these pathogens contributes to chronic inflammation and alterations in the skin microbiome, both of which exacerbate poor wound healing. The preliminary results showing a reduction in Staphylococcus aureus without disrupting the beneficial bacteria are particularly promising, as they highlight the potential of RLF-TD011 to address a critical need for targeted treatments in EB, ultimately improving patient outcomes.

Additional information about this investigator-initiated study is available at ClinicalTrials.gov (NCT05533866).

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in clinical trials¹. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. The U.S. Food and Drug Administration (FDA) granted it orphan drug designation for EB, and Relief plans to seek QIDP designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus. According to the National Epidermolysis Bullosa Registry, EB affects approximately 19.57 per million live births in the United States. Globally, EB affects about 500,000 people.

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 those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (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.

References
________________________________________________

¹ Lacopi E., et al. The Use of a Novel Super-Oxidized Solution on Top of Standard Treatment in the Home Care Management of Postsurgical Lesions of the Diabetic Foot Reduces Reinfections and Shortens Healing Time. Int J Low Extrem Wounds. 2018 Dec; 17(4):268-274.

Strohal R, et al. The management of critically colonized and locally infected leg ulcers with an Acid-Oxidizing Solution: A pilot study. Adv Skin Wound Care 31(4):163-171, 2018.

Ricci E, et al. The management of chronic ulcers with an AcidOxidizing Solution. J Wound Care 25(8):443-50, 2016.

Abivax Congratulates Victor Ambros and Gary Ruvkun on Their Nobel Prize for the Discovery of microRNA and its Role in Post-Transcriptional Gene Regulation

PARIS, France, October 7, 2024, 10:00 p.m. CEST – Abivax SA (Euronext Paris & Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, is thrilled to extend heartfelt congratulations to Victor Ambros and Gary Ruvkun for being awarded the Nobel Prize in Physiology or Medicine. Their groundbreaking work in the field of microRNA has significantly advanced our understanding of gene regulation and its implications for human health.

Marc de Garidel, CEO of Abivax, said, “The recognition of Ambros and Ruvkun underscores the importance of microRNA research and its potential to transform therapeutic approaches”. He went on to say “At Abivax, we are proud to be at the forefront of innovative therapies that harness the power of microRNAs. Our lead candidate, obefazimod, which is currently being evaluated in a Phase 3 Trial clinical program for Ulcerative Colitis and a Phase 2B Trial for Crohn’s Disease, acts by enhancing expression of microRNA-124 (miR-124), which stabilizes inflammatory pathways to reduce inflammation in patients with chronic inflammatory conditions.”

Didier Scherrer, Chief Scientific Officer at Abivax, stated, “We look forward to further developing obefazimod and contributing to the evolving landscape of treatments for ulcerative colitis and Crohn’s disease with a new mechanism of action, inspired by the pioneering work of luminaries like Victor Ambros and Gary Ruvkun.”

About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with ulcerative colitis (UC) have generated positive data, resulting in the initiation of a pivotal global Phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy
SVP, Investor Relations, Abivax
patrick.malloy@abivax.com
+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “expect,” “plan,” “potential,” “will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024 under the caption “Risk Factors.” These risks, contingencies and uncertainties include, among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Current results are not necessarily indicative of future results. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

aap Implantate AG (“aap” or “Company”) has reached another important milestone in the transition from MDD (Medical Device Directive 93/42/EEC) to MDR (Medical Device Regulation EU 2017/745). In the week from 9 September 2024 to 13 September 2024, the Notified Body mdc medical device certification GmbH audited aap’s quality system according to MDR. The audit was successfully completed. With this important milestone and the first positively audited technical documentation for its Class IIa products in accordance with the MDR, the company is continuing to work with its notified body to ensure a smooth and rapid transition to MDR certification.

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily utilises a broad network of distributors in around 25 countries. In the USA, the company utilises a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both via distribution agents and through partnerships with global orthopaedic companies. The aap Implantate AG share is listed in the General Standard segment of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore only apply on the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

Contact:
If you have any questions, please contact:
aap Implantate AG; R. Di Girolamo; Chairman of the Management Board/ CEO; Lorenzweg 5; D-12099 Berlin
Phone: +49/30/750 19 – 170; Fax: +49/30/750 19 – 290; e-mail: r.digirolamo@aap.de

Relief Therapeutics Reports Positive Results from RLF-OD032 Proof-of-Concept Clinical Study for Phenylketonuria

GENEVA (OCT. 4, 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 reported positive topline results from its proof-of-concept clinical study evaluating RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, for the treatment of phenylketonuria (PKU).

The four-way crossover pilot study compared the pharmacokinetics of Relief’s investigational drug RLF-OD032 with the reference listed drug KUVAN^® powder for oral solution. Topline data showed that RLF-OD032 administered under fed conditions, with or without water intake, achieved peak and total exposure of sapropterin dihydrochloride similar to those achieved by KUVAN^® under fed conditions with water, considering the range required by the FDA for bioequivalence studies.

“The pilot study successfully met its objective and provided valuable data for designing the next stages of our development and regulatory strategy. These results significantly increase the likelihood of meeting regulatory requirements, and we believe RLF-OD032 is well-positioned to achieve bioequivalence versus KUVAN^® in an upcoming pivotal bioequivalence trial,” commented Giorgio Reiner, Chief Scientific Officer of Relief. “The potential for RLF-OD032 to be administered without water, along with its low-volume dosage, illustrates its value as a unique, ready-to-use, and portable solution, offering enhanced convenience and ease of administration for patients managing PKU.”

Relief plans to advance RLF-OD032 into a pivotal bioequivalence trial as part of the 505(b)(2) NDA submission process in the United States and pursuant to the development guidance previously provided by the FDA in a pre-IND meeting.

ABOUT RLF-OD032
RLF-OD032 is an innovative, ready-to-use, portable and highly concentrated formulation of sapropterin dihydrochloride in liquid suspension for oral administration, designed to lower blood phenylalanine levels in adult and pediatric PKU patients. It offers a more patient-friendly solution by significantly reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.

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. However, this diet is highly restrictive and often creates barriers to social interaction, limiting compliance and increasing the risk of poor disease management. Sapropterin dihydrochloride is the first approved drug for PKU for reducing Phe blood levels and allowing patients to follow a less restrictive diet.

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 those described in Relief’s filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (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.

Abivax Announces First Patient Enrolled in ENHANCE-CD, the Phase 2b Trial of Obefazimod in Crohn’s Disease

PARIS, France, October 3, 2024 – 10:00 p.m. CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX; Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases, today announced the first patient was enrolled in its Phase 2b ENHANCE-CD (NCT06456593) trial evaluating obefazimod in patients with Crohn’s disease (CD).

The multicenter, double-blind, randomized, placebo-controlled trial will evaluate the efficacy and safety of obefazimod, administered once daily, in adults with moderately to severely active Crohn’s disease.

Fabio Cataldi, MD, Abivax Chief Medical Officer, said, “The enrollment of the first patient in our Phase 2b trial marks a significant step forward in meeting the need for a convenient, oral, once-daily treatment option for people with moderately to severely active Crohn’s disease. This milestone brings us closer to addressing the unmet needs of patients seeking effective therapies with fewer burdens on their daily lives.”

Trial Design

This trial has 3 treatment phases: a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies. The primary objective for the 48-Week Extension Phase is to evaluate the safety and tolerability of obefazimod compared to placebo in subjects who are enrolled in the Extension Phase.

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About Obefazimod

Obefazimod, Abivax’s lead investigational drug candidate, is an orally administered small molecule that was demonstrated to potentially enhance the expression of a single microRNA, miR-124. Phase 2 clinical trials in patients with UC have generated positive data, resulting in the initiation of a pivotal global phase 3 clinical trial program (ABTECT Program), with first patients enrolled in the United States in October 2022. A Phase 2b clinical trial in Crohn’s disease is ongoing, with the first patient enrolled in October 2024, and exploration of potential combination therapy opportunities in UC is ongoing.

About Abivax

Abivax is a clinical-stage biotechnology company focused on developing therapeutics that harness the body’s natural regulatory mechanisms to stabilize the immune response in patients with chronic inflammatory diseases. Based in France and the United States, Abivax’s lead drug candidate, obefazimod (ABX464), is in phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis. More information on the Company is available at www.abivax.com. Follow us on LinkedIn and on X, formerly Twitter, @Abivax.

Contact:

Patrick Malloy

SVP, Investor Relations

Abivax SA

patrick.malloy@abivax.com

+1 847 987 4878

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, forecasts and estimates, including those relating to the Company’s business and financial objectives. Words such as “continue,” “could,” “expect,” “goal,” “intend,” “objective,” ”will” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning or implying the therapeutic potential of Abivax’s drug candidates, including obefazimod’s potential to provide meaningful benefit to patients suffering from CD, and other statements that are not historical fact. Although Abivax’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks, contingencies and uncertainties, many of which are difficult to predict and generally beyond the control of Abivax, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. A description of these risks, contingencies and uncertainties can be found in the documents filed by the Company with the French Autorité des Marchés Financiers pursuant to its legal obligations including its universal registration document (Document d’Enregistrement Universel) and in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 5, 2024, under the caption “Risk Factors.” These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug candidate, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. Furthermore, these forward-looking statements, forecasts and estimates are only as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Abivax disclaims any obligation to update these forward-looking statements, forecasts or estimates to reflect any subsequent changes that the Company becomes aware of, except as required by law. Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement. This press release is for information purposes only, and the information contained herein does not constitute either an offer to sell, or the solicitation of an offer to purchase or subscribe securities of the Company in any jurisdiction. Similarly, it does not give and should not be treated as giving investment advice. It has no connection with the investment objectives, financial situation or specific needs of any recipient. It should not be regarded by recipients as a substitute for exercise of their own judgment. All opinions expressed herein are subject to change without notice. The distribution of this document may be restricted by law in certain jurisdictions. Persons into whose possession this document comes are required to inform themselves about and to observe any such restrictions.

Prof. Dr. Wiltrud Treffenfeldt leaves Supervisory Board of BRAIN Biotech AG for personal reasons

Zwingenberg, Germany, October 03, 2024 – Professor Dr. Wiltrud Treffenfeldt has informed the Chairman and the other members of the Supervisory Board of the BRAIN Biotech AG that she wishes to resign from her position as an ordinary member of the Supervisory Board of the BRAIN Biotech AG for personal reasons with effect from today. The Supervisory Board has regretfully complied with this request and Prof. Dr. Treffenfeldt will resign from the Supervisory Board as per her wishes as of today, October 03, 2024.

Prof. Treffenfeldt has been a member of the Supervisory Board of BRAIN Biotech AG since October 2020.

The search for a successor to Prof. Treffenfeldt will be initiated by the Supervisory Board and it is intended to present a suitable candidate to the shareholders for election at the Annual General Meeting in March 2025.

The Chairman of the Supervisory Board of BRAIN Biotech AG, Dr. Michael Majerus, expresses his special thanks to Prof. Dr. Treffenfeldt: “Wiltrud Treffenfeldt is a much respected manager and scientist with many years of experience in biotechnology. She has always enriched the discussions in the Supervisory Board with her expertise as well as her personality. I thank her very much for her commitment to BRAIN Biotech AG and wish her – also on behalf of my colleagues on the Supervisory Board and the Executive Board, all the best and every success in her personal and professional future.”

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About BRAIN Biotech

BRAIN Biotech AG is a leading provider of integrated solutions and products in the field of industrial biotechnology. The company specializes in enzymes and proteins, microbial production strains and bioprocesses for biotechnological production methods. BRAIN Biotech focuses on the growth markets of nutrition and life sciences as well as on innovative solutions for environment issues. BRAIN Biotech AG is the parent company of the international BRAIN Biotech Group. Its business activities are divided into three segments: 1. BioProducts: Production and sale of specialty enzymes and proteins; 2. BioScience: Customized solutions based on enzyme engineering, production strain and bioprocess development, and screening for bioactive compounds; 3. BioIncubator: Pipeline of research-intensive development projects. For production, the Group operates fermentation plants in the UK and other production facilities in continental Europe and the USA. BRAIN Biotech has been listed on the Frankfurt Stock Exchange since February 9, 2016 (ticker: BNN; ISIN DE0005203947 / WKN 520394). The company employs around 310 people and generated revenues of EUR 55.3 million in the fiscal year 2022/23. For more information, please visit www.brain-biotech-group.com

Contact Investor Relations BRAIN Biotech

Martina Schuster
Investor Relations
Phone: +49 6251 9331-69
Email: ms@brain-biotech.com
 

Contact Media BRAIN Biotech

Dr. Stephanie Konle
PR & Corporate Communications
Phone: +49 6251 9331-70
Email: stk@brain-biotech.com

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management.

Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors.

BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.