Immunic to Participate in Scientific and Investor Conferences in October

NEW YORK, October 1, 2025 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and investor conferences in October:

• October 4-7: UEGW 2025 – United European Gastroenterology Week. Immunic’s R&D team will attend this conference in Berlin, Germany. Data on IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), will be presented in an oral presentation, a publication, and an ePoster, all of which will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

• Title: IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration, Showed Positive Effects on Gut Hormone Levels in Celiac Disease Patients in a Phase 1 Clinical Study
• Presenting Author: Amelie Schreieck, Ph.D., Senior Manager Biomarker Development at Immunic
• Presentation Number: OP053
• Publication Number: AS-UEG-2025-01463
• Session Title: Molecular medicine: Understanding the mechanism allows therapy
• Session Date: Monday, October 6, 2025
• Session Time: 8:30 – 9:30 am CEST (2:30 – 3:30 am ET)
• Location: Room A3

• Title: Biomarkers of Extracellular Matrix Remodeling Reflect Pharmacodynamic Effects of IMU-856, an Oral Epigenetic Modulator of Barrier Regeneration
• Presenting Author: Marta Sorokina Alexdόttir, Ph.D., Scientist, Nordic Bioscience
• ePoster Number: PP0290
• Session Title: Posters 3: SMALL INTESTINAL
• Session Date: Saturday, October 4, 2025
• Session Time: 9:00 am – 5:00 pm CEST (3:00 – 11:00 am ET)
• Location: Science Lounge

• October 5-8: 17th International Congress of the International Society of Neuroimmunology (ISNI). Evelyn Peelen, Ph.D., Head of Research at Immunic, will present data on Immunic’s orally available lead-asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in a poster presentation at this conference in Chiba, Japan. The poster will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

• Title: Nurr1 Activator Vidofludimus Calcium Exhibits Signs of Neuroprotection in Preclinical Models
• Presenting Author: Evelyn Peelen, Ph.D., Head of Research at Immunic
• Abstract ID: 213
• Session Title: Poster Session 2
• Session Date: Tuesday, October 7, 2025
• Session Time: 6:20 – 7:40 pm JST (5:20 – 6:40 am ET)
• Location: Room 101B-105

• October 9: Roth’s 4th Annual Healthcare Opportunities Conference. Daniel Vitt, Ph.D., Chief Executive Officer of Immunic, will participate in a panel discussion at this conference in New York. Dr. Vitt and Glenn Whaley, Chief Financial Officer of Immunic, will also participate in one-on-one investor meetings. To schedule a meeting, please contact your Roth representative or Jessica Breu at: jessica.breu@imux.com.
  • Panel 4: Next Wave of Innovation in Underserved Indications
  • Panel Time: 2:00 – 2:55 pm ET
  • Location: Presidents’ Ballroom

• October 23: H.C. Wainwright, HCW @ Home with Immunic. Dr. Vitt and Jason Tardio, President and Chief Operating Officer of Immunic, will participate in a virtual fireside chat at 11:00 am ET. The fireside chat will be available to the public at the following link: https://journey.ct.events/view/c58a0a38-ded6-4b2d-9dc7-629cf83de9d8 and on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com. 

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to management’s and employee’s participation in scientific and investor conferences. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

Immunic, Inc.
Jessica Breu
Vice President Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com

US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com

US Media Contact
KCSA Strategic Communications
Caitlin Kasunich
+1 212 896 1241
ckasunich@kcsa.com

Gerresheimer Expands Wertheim Site with new Production Facility for Ready-to-fill Vials

• New production hall for RTF vials and innovative EZ-fill Smart packaging platform
• Best possible protection for sensitive biologics
• Total investment volume of around EUR 30 million
• Around 50 new jobs for skilled workers from the region

Düsseldorf/Wertheim, Germany, October 1, 2025. Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has officially started construction of a new production facility at its Wertheim site, Germany with a groundbreaking ceremony. By mid 2027, high-quality ready-to-fill (RTF/RTU) vials are expected to roll off the production line in a new 4,000 m² production hall in the innovative EZ-fill Smart packaging platform. At its Wertheim site, Gerresheimer employs around 160 people to produce injection vials and ampoules. The planned expansion is expected to create a further 50 jobs for skilled workers from the region. Wertheim will be the second Gerresheimer production site, alongside Querétaro, Mexico, to offer RTF vials in the innovative EZ-fill Smart packaging platform. Gerresheimer is investing a total of around EUR 30 million in the construction and technical equipment of the new production building. The expansion underlines Gerresheimer’s position as a leading system and solution provider to the pharma and biotech industry, especially for injectable biopharmaceuticals.

“The expansion in Wertheim is an example of how we are implementing our growth strategy by expanding our portfolio with specialized systems and solutions for biopharmaceuticals,” explains Dietmar Siemssen, CEO of Gerresheimer AG.

“EZ-fill Smart is the next-generation packaging platform for ready-to-fill vials. Together with our Gx Elite RTF Vials, this high-value solution delivers optimal product quality and the best possible protection for sensitive biopharmaceuticals”, adds Volker Rekowski, Senior Vice President Europe & Asia Tubular Glass at Gerresheimer.

Center of excellence for vials and ampoules

The Wertheim site, which has been producing pharmaceutical ampoules since 1957, has been part of the Gerresheimer Group since 1989. It is Gerresheimer’s European Center of Excellence for high-value Gx Elite vials and ampoules, and in the future also for pre-sterilized “ready-to-fill” (RTF) vials. The last investment at the site was made in 2022 in new production lines for Gx Elite vials. The injection vials of the “Elite” performance level are characterized by very high break resistance, precisely maintained tolerances, and maximum surface quality. After about two years of planning, a state-of-the-art production infrastructure for RTF/RTU vials is now being built in Wertheim. The RTF/RTU vial market is expected to grow at a compound annual growth rate of around 13% until 2030¹.

EZ-fill Smart for best possible protection and efficient filling

With the new production hall, the Gx Elite Vials manufactured at the Wertheim Site will also be available as pre-sterilized “ready-to-fill” (RTF/RTU) versions in the EZ-fill Smart packaging platform. EZ-fill Smart is the next-generation packaging platform for RTF vials. Advantages include even less particles and, in the future, the possibility to use vaporized hydrogen peroxide (VHP) as an alternative, environmentally friendly and resource-saving sterilization method. EZ-fill Smart is compatible with all standard fill & finish lines, enabling flexible, safe, and cost-efficient filling processes. Combined with Gx Elite vials, EZ-fill Smart ensures highest protection for sensitive and expensive drugs such as novel biologics.

GMP Class C cleanroom

The RTF processing and packaging of the vials in the EZ-fill Smart format is planned to take place in the new production hall in an approximately 800 m² GMP Class C clean room (GMP = Good Manufacturing Practice). The new production infrastructure will thus meet the highest pharmaceutical requirements, as specified, for example, in Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products in the EU.

Energy efficiency and sustainability

The planned new building combines energy efficiency and sustainability in both construction and its technical systems. A 175 kWp photovoltaic system will be installed on the roof of the new building, with the remaining surface being greened. The entire power supply will come from 100% renewable sources.

Around 50 new jobs for professionals from the region

In the first expansion phase, around 50 new jobs for skilled workers from the region will be created by 2028. The production capacity for RTF/RTU vials in the new production hall can be further increased in the coming years.

¹Prescient & Strategic Intelligence: Global RTF/RTU Vials Market (CAGR 14.5% 2021 to 2030) and Gerresheimer estimate

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. Together with Bormioli Pharma, the Group generated revenues of around EUR 2.4bn in 2024 and currently employs around 13,600 people. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).    
www.gerresheimer.com 
 

Contact Gerresheimer AG

PRESS RELEASE

Viromed Medical AG drives forward market launch of new products in the first half of 2025 and expands strategic partnerships

Rellingen, October 01, 2025 – Viromed Medical Group (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, has published its 2025 half-year report, which includes consolidated interim financial statements for the first time. The company can look back on a successful first half of 2025, which was marked by a strategic acquisition, new collaborations, and promising study results. Operational activities focused on the development of further products based on innovative cold plasma technology, preparations for approvals, and the conduct of preclinical and clinical studies.

With the integration of pharmedix GmbH, Viromed expanded its portfolio to include healthcare products in the fields of medicine, nutrition, and cosmetics. The collaboration with relyon plasma GmbH secured the series production of the innovative cold plasma products ViroCAP® and PulmoPlas®. Viromed also made significant progress in clinical development: initial results in the treatment of ventilator-associated pneumonia (VAP) in intensive care patients confirmed the high potential of PulmoPlas®. This was complemented by exclusive distribution partnerships in Asia, in the veterinary sector, and in the European cosmetics market, which are opening up new growth markets. Recent preclinical study data from the Hannover Medical School (MHH) underscore the great medical potential of cold plasma therapy, which could prevent thousands of deaths each year.

With the first-time consolidation of Viromed Medical AG, Viromed Medical GmbH, and pharmedix GmbH, the economic situation is now presented at group level. Consolidated revenues of EUR 2.4 million were achieved in the first half of 2025. Overall, there was a net loss for the period of EUR 0.8 million, mainly due to expenses for the preparation of the market launch of ViroCAP® and PulmoPlas®. The company’s equity amounted to EUR 6.6 million as of June 30, 2025, corresponding to an equity ratio of 39.9%.

Viromed plans significant growth for 2025 and confirms its forecast for the full year. The Viromed Medical Group’s revenue is expected to rise from EUR 1.37 million in 2024 to between EUR 8 million and EUR 10 million. The company also expects a slightly positive result, primarily driven by the operating business of the acquired pharmedix GmbH.

The 2025 half-year financial statements are available on the Viromed Medical AG website.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de

Not for release, publication or distribution, directly or indirectly, in or into the United States of America, Australia, Canada or Japan or any other jurisdiction in which such release, publication or distribution would be unlawful. The important notices at the end of this release must be observed.

Berlin, October 1, 2025 – Cantourage Group SE (ISIN: DE000A3DSV01, “Cantourage”) today announced a significant step in expanding its capital markets presence. Manuel Taverne, a seasoned capital markets professional, has been appointed as Head of Investor Relations. In this role, he will lead Cantourage’s investor relations activities with a particular focus on strengthening engagement across European financial markets.

With more than 20 years of experience in capital markets and strategic financial communications, Mr. Taverne brings deep expertise in building and maintaining strong investor relations. His appointment underlines Cantourage’s commitment to proactively advancing its capital markets strategy and fostering closer ties with institutional and private investors alike.

“By bringing Manuel Taverne on board, we gain an accomplished capital markets expert with outstanding knowledge and extensive experience. I am excited to work with him as we continue to expand our investor engagement,” said Philip Schetter, CEO of Cantourage.

Cantourage’s goal is to more clearly communicate its position as one of Europe’s leading providers of medical cannabis to the investment community. “Our innovative business model and platform strategy set us apart from the competition – yet the uniqueness of our approach has not been fully recognized by the market to date,” Schetter continued. “That is why we are intensifying our investor relations efforts – to present our equity story with greater clarity, transparency, and proactivity.”

About Cantourage

Cantourage is a leading European company for the production and distribution of medical cannabis. Cantourage enables growers worldwide to sell products in European medical markets. Founded in 2019, the company works with more than 60 cannabis growers from 18 countries. Cantourage ensures the highest pharmaceutical quality standards along the value chain and offers products in all relevant market segments: dried flowers, extracts, dronabinol and cannabidiol. The company has been listed on the Frankfurt Stock Exchange since November 11, 2022 and is listed under the ticker symbol “HIGH”.

More information: www.cantourage.com

This announcement does not constitute an offer to the public or a solicitation of anoffer to sell securities to the public, in particular not within the meaning ofRegulation (EU) 2017/1129 (Prospectus Regulation).

Mainz Biomed to Present the Future of Colorectal Cancer Screening at WEO CRC Screening Committee Meeting

BERKELEY, US and MAINZ, Germany – September 30, 2025 – Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, is pleased to announce its participation in the upcoming Colorectal Cancer (CRC) Screening Committee Plenary Meeting and Expert Working Group (EWG) Sessions hosted by the World Endoscopy Organization (WEO), taking place on October 3^rd, 2025, in Berlin, Germany.

This high-level gathering brings together global leaders in colorectal cancer screening to evaluate emerging technologies, exchange scientific insights, and help shape future strategies for early detection and prevention of CRC. As part of the session titled “Evaluation of New Tests”, Dr. Lena Krammes, Senior Scientist at Mainz Biomed, will present findings from the Company’s ongoing work in RNA-based diagnostics.

Dr. Krammes’ talk, titled “From Detection to Prevention – Early Evidence from RNA-based Screening Test for Precancerous Lesions Compared to Different FIT Cut-offs,” will showcase clinical data from the eAArly DETECT study, generated in 2024 highlighting the potential of stool RNA testing to identify both colorectal cancer and precancerous lesions. Key findings include:

• 97% sensitivity and 97% specificity for detecting colorectal cancer
• 82% sensitivity for advanced adenomas
• 100% detection of advanced adenomas with high-grade dysplasia

These results underline the potential for RNA-based testing to play a significant role not only in early detection of CRC, but also in prevention, by identifying high-risk lesions before cancer develops.

Mainz Biomed’s participation reflects its commitment to contributing to the global effort to improve CRC screening outcomes. The World Endoscopy Organization is a global non-profit organization dedicated to promoting high-quality endoscopy and the advancement of digestive health. Through its Colorectal Cancer Screening Committee, WEO works to promote CRC screening activities worldwide and support the implementation of screening programs, including fecal immunochemical tests (FIT), stool-based tests, and endoscopic procedures.

“We are honored to take part in this prestigious meeting,” said Guido Baechler, CEO of Mainz Biomed. “The invitation to join these expert discussions reinforces our belief that we are making important contributions toward developing effective, next-generation screening tools that can prevent colorectal cancer before it starts.”

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

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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. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA 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 blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@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 March 31, 2025. 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.

PRESS RELEASE

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

Rellingen, September 30, 2025 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, announces the start of a comprehensive in vivo and ex vivo study on living lungs. The in vivo and ex vivo tests are part of the ongoing study on the treatment of ventilator-associated pneumonia (VAP) using cold atmospheric plasma and are being conducted in collaboration with Hannover Medical School (MHH).

Prof. Dr. Hortense Slevogt, scientific director of the study at Hannover Medical School, emphasizes: “The results so far are groundbreaking. If the use of cold atmospheric plasma also proves safe in living lung tissue, it could potentially revolutionize the treatment of ventilated patients.”

Uwe Perbandt, CEO of Viromed Medical AG, explains: “Our study is the first of its kind and is one of the most comprehensive in the field of pulmonology worldwide. This gives us a significant competitive advantage. Our goal is to use cold plasma therapy to significantly reduce mortality from VAP and all bacterial or viral lung infections worldwide.“

Building on promising in vitro results, which showed 100% effectiveness of cold plasma technology against MRSA without damaging human lung tissue, the study is now entering its decisive next phase. For the first time, the interaction between the respiratory epithelium, bacterial infection, and cold plasma therapy will be investigated under realistic conditions—Viromed is thus closing a significant gap in international medical research.

The detailed results of the in vivo and ex vivo study will be published in a fast-track paper.

Viromed Medical AG is a pioneer in the field of cold plasma technology. With proprietary technologies, globally unique cell culture models, and close collaboration with leading university centers and research institutes, the company has a significant research and development advantage over its competitors.

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de

PL BioScience Announces Conferences Attendance

Aachen, Germany, September 30, 2025 – PL BioScience GmbH, a German life science company specializing in the production and development of Human Platelet Lysate (HPL) for cell expansion, today announced its participation in six life sciences conferences this fall.

Meet our management team and marketing colleagues at one of the upcoming conferences:

Festival of Biologics
September 30 – October 2 in Basel, Switzerland
Anna Kolkmann (Sales Manager) and Maria Noronha (Marketing Specialist) will be present
Booth: 501C
Scheduling meetings is possible through the Terrapinn Event App

BioJapan
October 8 – 10 in Yokohama, Japan
Jungsoo Park (VP Marketing & Sales) and Kana Miyakubi (Sales Account Manager) will be present
Booth: B-68 at the EU-Japan Centre for Industrial Cooperation Pavilion

Innovative Therapies Days 2025
October 9 – 10 in Besançon, France
Silver Sponsor of the conference
Cécilia Mesa (Sales Manager) will be present and exhibit a poster
Booth: 6
Scheduling meetings is possible through the B2Match platform

CPHI Frankfurt 2025
October 28 – 30 in Frankfurt, Germany
Hatim Hemeda (CEO & Co-Founder), Christian Wilkes (CFO & Co-Founder) and Jungsoo Park will be present
Booth: 4S115
Scheduling meetings and contacting are possible through the CPHI Event Planner App

BIO-EUROPE 2025
November 3 – 5 in Vienna, Austria
Hatim Hemeda and Christian Wilkes will be present
Scheduling meetings through the partneringONE system

Cell 2025
November 11 – 12 in London, United Kingdom
Network & Programme Sponsors
Silke Isenhardt (Field Application Scientist) and Maria Noronha (Marketing Specialist) will be present and exhibit a poster
Booth: 54
Contact will be possible through the event app from November

About PL BioScience:

PL BioScience GmbH, a life science company located in Aachen, Germany, specializes in the production and development of Human Platelet Lysate (HPL). The company has pioneered proprietary technology to produce fully artificial HPL, allowing for a fully lab-made, scalable supply of HPL. PL BioScience currently offers a comprehensive portfolio of donor-derived, natural HPL products tailored for a range of applications – the ELAREM^TM platform. From academic and preclinical research to cell therapy and biopharmaceutical manufacturing, ELAREM™ ensures seamless translations of regenerative medicine breakthroughs – from the lab to patients in need. PL BioScience is the only company worldwide holding a patent for the gamma-irradiation of HPL, covering the manufacturing process for ELAREM™ Ultimate-FD PLUS.

For more information on PL BioScience and the ELAREM™ platform, visit: https://www.pl-bioscience.com/

Contact:
Dr. Hatim Hemeda, CEO
PL BioScience GmbH
+49(0)24195719-100
info@pl-bioscience.com

Media contact:
MC Services AG
Raimund Gabriel, Dr. Regina Lutz
+49 (0)89 210 228 0

U.S.: Catherine Featherston
+1-203-444-4393
E-Mail: plbioscience@mc-services.eu

REPRONOVO ANNOUNCES CLINICAL TRIAL APPROVAL NOTICE FOR RPN-001 IN CHINA

• The approval enables initiation of RPN-001 Phase 1 trial in China
   
• Key regulatory milestone in the global development of RPN‑001
   

Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 – ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that China’s National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN‑001 as a potential treatment for male infertility associated with low serum testosterone.

“Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo,” said Joan-Carles Arce, MD, PhD, Chief Scientific & Medical Officer of ReproNovo. “With this approval, we will soon have active clinical programs in the U.S. and China, two of the world’s largest healthcare markets, which reinforces our commitment to global development in reproductive medicine.”

RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo’s global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway.

“We are committed to expanding access to innovative therapies where few treatment options currently exist,” said Jean Duvall, Chief Executive Officer of ReproNovo. “With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women’s health innovation.”
 

ABOUT REPRONOVO:
ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. Our team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market. Lead clinical compound, RPN-001 (leflutrozole), is being developed to treat male infertility. RPN-002 (nolasiban) is a first-in-disease and first-in-class molecular entity being developed to manage adenomyosis and increase the probability of embryo implantation in women undergoing assisted reproductive technology (ART) treatments. Both assets are Phase 2 ready. ReproNovo is financed by Jeito Capital, AXA IM Alts, founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn.
 

ABOUT RPN-001 (leflutrozole):
RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. The small molecule inhibits the enzyme aromatase, suppressing testosterone conversion to estradiol, thereby normalizing testosterone levels. Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. RPN-001 is currently being evaluated in a U.S. Phase 2 trial (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1). ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.
 

CONTACT INFORMATION:
ReproNovo
Rue de Langallerie 11
1003 Lausanne, Switzerland
info@repronovo.com
 

MEDIA CONTACT:
MC Services AG
Brittney Sojeva
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Abivax Announces Acceptance of Additional Late-Breaking Abstract from the ABTECT Phase 3 Induction Trials to be Presented at 2025 United European Gastroenterology (UEG) Meeting

• Late Breaking Abstract titled EFFICACY AND SAFETY OF OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: RESULTS FROM TWO, PHASE 3, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 8-WEEK INDUCTION TRIALS (ABTECT-1 & 2) to be presented Sunday, October 5 at 5pm CEST

PARIS, France – September 29, 2025 – 10:05 PM CEST – Abivax SA (Euronext Paris: FR0012333284 – ABVX / Nasdaq: ABVX) (“Abivax” or the “Company”), a clinical-stage biotechnology company developing innovative therapies to address chronic inflammatory diseases, today announced the presentation of a second late breaking abstract for its lead drug candidate, obefazimod, for the treatment of moderately to severely active ulcerative colitis (UC) at The United European Gastroenterology Congress, taking place October 4-7, 2025, in Berlin, Germany.

“The acceptance of this additional late-breaking abstract underscores the significance of the ABTECT Phase 3 induction trial results which demonstrate the statistically significant and clinically meaningful clinical activity and impressive safety and tolerability profile of obefazimod in patients with moderately to severely active ulcerative colitis during the 8-week induction trials.  These findings are crucial steps towards potentially offering a novel, first-in-class oral treatment option for patients who urgently need new therapeutic approaches to achieve and maintain remission,” said Fabio Cataldi, MD, Chief Medical Officer of Abivax.

Obefazimod data to be presented:

 
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.

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. Words such as “anticipate,” “expect,” “potential” and variations of such words and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements concerning the Company’s expectations for the potential therapeutic benefit of obefazimod, and the Company’s participation at industry conferences. 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 its Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 24, 2025 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, and the availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. 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 made 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 for 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.

PRESS RELEASE

Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma

• HDP-101 continues to demonstrate a favorable safety profile with no dose-limiting toxicities observed
• Early evidence of clinical activity observed in Cohort 8, highlighted by a very good partial response observed in one patient

Ladenburg, Germany, 25 September 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the initiation of Cohort 9 in its ongoing Phase I/IIa dose escalation trial of HDP-101, the Company’s lead ATAC candidate for the treatment of relapsed or refractory multiple myeloma.

The Safety Review Committee (SRC) has confirmed that the 140 µg/kg dose level administered in Cohort 8 was safe and well tolerated. Based on these findings, the study is now progressing into Cohort 9 with an escalated dose of 175 µg/kg, administered in one dosing arm. Cohort 9 has already opened.

Eight patients were dosed in Cohort 8 and all patients completed the observation period, demonstrated a favorable safety and tolerability profile throughout. Encouraging signs of clinical activity have also emerged. Patients showed biological activity of HDP-101, and a very good partial response has already been observed in one patient. This adds to earlier positive outcomes, including one patient from Cohort 5 who is still on treatment and achieved complete remission, with no detectable tumor cells after ongoing HDP-101 monotherapy following multiple prior treatments. In addition, several patients across different cohorts have shown objective responses and promising anti-tumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, said: “Our lead ATAC candidate HDP-101 continues to demonstrate a strong safety and tolerability profile across all treated patients. The results from Cohort 8 demonstrate encouraging signs of clinical activity of HDP-101, including a very good partial response in one patient. These early efficacy signals are promising as we advance HDP-101 through the ongoing dose escalation study.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HDP-101 in this patient population.

About Heidelberg Pharma

Heidelberg Pharma is a biopharmaceutical company working on a new treatment approach in oncology and developing novel drugs based on its ADC technologies for the targeted and highly effective treatment of cancer. ADCs are antibody-drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. Selected antibodies are loaded with cytotoxic compounds, the so-called payloads, that are transported into diseased cells. Inside the cells, the toxins then unleash their effect and kill the diseased cells.

Heidelberg Pharma is the first company to use the compound Amanitin from the green death cap mushroom in cancer therapy. The biological mechanism of action of the toxin represents a new therapeutic modality and is used as a compound in the Amanitin-based ADC technology, the so-called ATAC technology.

The lead candidate HDP-101 is a BCMA ATAC in clinical development for multiple myeloma. A second ATAC candidate, HDP-102, has recently started clinical development in Non-Hodgkin Lymphoma. HDP-103 against metastatic castration-resistant prostate cancer and HDP-104 targeting gastrointestinal tumors such as colorectal cancer have completed preclinical development. Heidelberg Pharma is open for partnering.

The company is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH.

ITAC™, ETAC™ are pending trademark applications of Heidelberg Pharma Research GmbH.

This communication contains certain forward-looking statements relating to the Company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will” “should” “future”, “potential” or similar expressions or by a general discussion of the Company’s strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results of operations, financial condition, performance, or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such forward-looking statements to reflect future events or developments.