Biotest’s Yimmugo® launches in the United States

Biotest AG

/ Key word(s): Product Launch

Biotest’s Yimmugo® launches in the United States

09.10.2025 / 17:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

 

Biotest’s Yimmugo® launches in the United States

 

Dreieich, Germany, October 9, 2025. Biotest AG, a specialist in innovative haematology, clinical immunology and intensive care medicine and part of Grifols, a global healthcare company and leading producer of plasma-derived medicines, proudly announces the official launch of Yimmugo®, its innovative intravenous polyvalent human normal immunoglobulin (IVIg) to treat primary immunodeficiencies, in the United States.

This is a significant milestone in the company’s global growth strategy and represents the first U.S.-approved medicine in Biotest’s portfolio.

This important achievement is made possible through the close collaboration with Kedrion Inc., a recognized leader in plasma-derived therapies, which will become Biotest’s U.S. distribution partner for this treatment.

A Breakthrough for Patients – A Milestone for Biotest
Yimmugo® is designed to meet critical patient needs in the treatment of primary immune deficiencies, which are believed to affect one in every 1,200 people in the United States. With its entry into the U.S. market—the world’s largest plasma protein market—Biotest reinforces its mission to improve and save the lives of patients worldwide.

Yimmugo® is produced in Biotest’s “Next Level” production facility in Dreieich, Germany, using a state-of-the-art manufacturing process. The treatment was successfully introduced in Europe at the end of 2022 and will now reach U.S. patients, following FDA approval in 2024.

“This launch is a major step forward in expanding access to treatment for U.S. patients living with primary immunodeficiencies. It also reinforces our commitment to broadening the reach of our therapies,” said Dr. Jörg Schüttrumpf, CEO of Biotest AG. “Our collaboration with Kedrion ensures that Yimmugo® reaches those who need it most, backed by Kedrion’s deep expertise and trusted commercial network in the United States.”

The U.S. launch of Yimmugo® represents a cornerstone in Biotest’s long-term strategy and highlights the company’s continuous growth trajectory. It demonstrates Biotest’s commitment to innovation, patient focus, and international expansion.

“With Yimmugo® now available in the U.S., Biotest takes a bold step into the future,” added Enrico D’Aiuto, Head of Commercial Operations at Biotest. “We are proud of this achievement, grateful to our teams and partners, and optimistic about the impact Yimmugo® will have on patients’ lives.”

 

About Biotest

Biotest is a supplier of biological medicines derived from human plasma. With a value chain ranging from preclinical and clinical development to global marketing, Biotest specialises primarily in the fields of clinical immunology, haematology and intensive care and emergency medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin, which are produced from human blood plasma and used to treat diseases of the immune system or the blood-forming systems. Biotest employs more than 2,500 people worldwide. Since May 2022, Biotest has been part of the Grifols Group, Barcelona, Spain (www.grifols.com).

IR contact:

Dr. Monika Baumann (Buttkereit)
Telephone: +49-6103-801-4406
Email: ir@biotest.com

PR contact:

Miriam Oehme
Telephone: +49 -152 07016 992
Email: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.com

Ordinary shares: WKN: 522720; ISIN: DE0005227201
Preference shares: WKN: 522723; ISIN: DE0005227235
Listed: Open market: Berlin, Düsseldorf, Hamburg/Hanover, Munich, Stuttgart, Tradegate

 

Disclaimer
This document contains forward-looking statements on the overall economic development and the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on the company’s current plans, estimates, forecasts and expectations and are therefore subject to risks and uncertainties that could cause the actual results to differ materially from the expected development. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

 


09.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2210812  09.10.2025 CET/CEST

SYNLAB expands investment in Italy with opening of flagship Medical Centre in Florence

SYNLAB

/ Key word(s): Expansion

SYNLAB expands investment in Italy with opening of flagship Medical Centre in Florence

09.10.2025 / 15:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


New SYNLAB Manifattura Firenze Medical Centre marks a milestone in the Group’s international growth strategy, strengthening local healthcare through innovation and care excellence

SYNLAB, a leader in medical diagnostic services and specialty testing in Europe, officially inaugurated its largest medical centre in Italy today: SYNLAB Manifattura Firenze. Located in the heart of one of Italy’s most ambitious urban regeneration projects, the new centre is a strategic investment in the future of healthcare, combining cutting-edge diagnostics, patient-centred care and sustainable infrastructure.
Spanning over 4,000 square metres across four floors, the centre is designed to serve over 200,000 patients annually. It is equipped with the latest diagnostic technologies and offers a comprehensive range of services, including laboratory testing, advanced imaging, specialist consultations, and a dedicated women’s health area. Over 80 healthcare professionals will work at the facility, which is fully integrated into SYNLAB’s regional network in Tuscany, comprising over 40 blood collection points, ten medical centres and a central laboratory in Calenzano.

“The opening of SYNLAB Manifattura Firenze is a powerful demonstration of our commitment to advancing high-quality, highly specialised diagnostics across our global network. From Europe to Latin America, SYNLAB enables personalised medicine by combining cutting-edge technology, medical excellence and a deep understanding of local healthcare needs. This new centre reflects our ambition to deliver sustainable, patient-focused solutions that support healthier lives wherever we operate, and represents another significant milestone in our international journey” said Mathieu Floreani, CEO of SYNLAB Group.

The facility was designed with a strong focus on patient experience, sustainability and efficiency. Built in just over two years, it meets the highest environmental standards, with energy-saving systems, reduced emissions, and optimised patient flows to ensure comfort and care continuity.
The opening of the Florence centre follows a series of strategic developments by SYNLAB in Italy, including the recent acquisition of the Pavanello Group, a well-established diagnostics provider in the Veneto region. These investments reflect SYNLAB’s long-term commitment to expanding its presence and enhancing healthcare access across the country.

“We believe that innovation and proximity go hand in hand,” said Andrea Buratti, CEO of SYNLAB Italy. “With Manifattura Firenze, we are creating a space where people feel welcomed, supported, and empowered to take care of their health – from prevention to diagnosis and beyond.”

– End –

For more information:

Media contact:
Steffi Susan Kim, FTI Consulting
steffi.kim@fticonsulting.com
+49 (0) 171 5565 996
Investor contact: ir@synlab.com

About SYNLAB

  • SYNLAB Group is a leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments, and corporates.
  • Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.
  • SYNLAB operates in more than 20 countries across four continents and holds leading positions in most markets, regularly reinforcing the strength of its network through a proven acquisition strategy. More than 24,000 employees, including over 2,000 medical experts, contribute every day to the Group’s worldwide success.
  • SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.62 billion in 2024.
  • More information can be found on www.synlab.com


09.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2210638  09.10.2025 CET/CEST

Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

Heidelberg Pharma AG

/ Key word(s): Quarterly / Interim Statement

Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

09.10.2025 / 07:03 CET/CEST

The issuer is solely responsible for the content of this announcement.


Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025

  • Leading ADC candidate HDP-101 continues to demonstrate favorable safety and tolerability profile; clinical trial progresses into ninth cohort with increased dose of 175 µg/kg
  • Delay in significant milestone payment leads to extensive cost-saving measures, including a 75% reduction in workforce and focus on leading ADC project HDP-101
  • Presentation of new clinical data of HDP-101 at the International Myeloma Society (IMS) Annual Meeting; several patients from cohort 8 show initial objective efficacy after only a few doses
  • Adjustment of guidance following strategic focus

Ladenburg, Germany, 9 October 2025 – Heidelberg Pharma AG (FSE: HPHA) reported today on its operational progress as well as on the Group’s financial figures for the first nine months of fiscal year 2025 (1 December 2024 – 31 August 2025).

Professor Andreas Pahl, CEO of Heidelberg Pharma AG, commented: “In light of the delayed milestone payment, we have decided to prioritize our projects and implement a comprehensive cost-saving program. We deeply regret having to take these measures and would like to thank all affected colleagues for their many years of commitment, dedication, and valuable contributions to Heidelberg Pharma.

The measures we’ve decided on also affect our guidance, which we adjusted a few days ago.

The clinical development of our leading project HDP-101 remains promising. In cohorts 5 to 8, we observed an overall response rate of 36%, and in cohort 8, the preliminary overall response rate is 50%. HDP-101 has a strong safety and tolerability profile, and these data underscore the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.”

Key operational developments within the company and among its partners

  • Developments at partner Telix unrelated to the ATAC technology: On 27 August 2025, partner Telix Pharmaceuticals Limited, Melbourne, Australia (Telix) received a Complete Response Letter (CRL) from the FDA for the diagnostic agent TLX250-CDx. The FDA identified deficiencies in the CMC (Chemistry, Manufacturing and Controls) package. According to Telix, the company immediately began addressing the deficiencies and will promptly request a Type A meeting with the FDA. New timelines will be communicated as soon as they are available.
    Under the license agreement with Telix, Heidelberg Pharma is entitled to milestone payments and double-digit royalties if the product receives marketing approval. In 2024, Heidelberg Pharma sold a portion of the future royalties to HealthCare Royalty (HCRx) and is entitled to receive USD 70 million from HCRx following FDA approval of TLX250-CDx, with reductions if approval is granted after the end of 2025. As the payment condition has not yet been met, the milestone payment is delayed accordingly.
  • Strategic focus and cost-saving measures: Due to the delayed milestone payment, Heidelberg Pharma announced on 25 September 2025, after the end of the reporting period, a comprehensive program to streamline operations and reduce costs. As the milestone payment from HCRx is still expected, but delayed and potentially lower than anticipated, this measure was necessary to extend the company’s cash runway.
    In the future, Heidelberg Pharma will focus on the further development of its lead ADC candidate HDP-101, which is currently in a Phase I/IIa clinical trial. The second clinical program, HDP-102, will be temporarily paused. For the third ADC, HDP-103, the company still plans to prepare the documentation for a clinical trial application.
    Early research activities will be phased out. Heidelberg Pharma will explore opportunities to out-license its preclinical programs.
    The current workforce will be reduced companywide by approximately 75% by mid-2026.
  • HDP-101 development program: HDP-101, an Amanitin-based antibody-drug conjugate targeting the BCMA antigen, is being tested in a Phase I/IIa open-label, multicenter study for the treatment of relapsed or refractory multiple myeloma, a cancer of the bone marrow. The first part of the study is a Phase I dose escalation study to determine the safe and optimal dosage of HDP-101 for the Phase IIa part of the study. The first eight patient cohorts and dose levels were completed with no evidence of dose-limiting toxicities.
    The eighth cohort, with a dose of 140 µg/kg, proved to be safe and well tolerated. All patients were dosed and have completed the observation period. HDP-101 consistently demonstrated a very good safety and tolerability profile. In addition, there are promising signs of clinical efficacy. In half of the patients, initial efficacy was observed after the first doses. Two patients achieved partial response and one patient achieved very good partial response. This builds on earlier positive results, including a patient from cohort 5 who had previously undergone several different therapies and has now achieved complete response with no detectable tumor cells while on ongoing monotherapy with HDP-101. In addition, several patients from different cohorts showed objective improvements and promising antitumor activity, further supporting the therapeutic potential of HDP-101 in heavily pretreated patients with relapsed or refractory multiple myeloma.
    Based on these results, the Safety Review Committee recommends continuing the study in cohort 9 with an increased dose of 175 µg/kg in one dosing arm. The cohort has already been started, and the first patient dosed.
  • HDP-102 development program: HDP-102 is an ADC targeting CD37, which is overexpressed on B-cell lymphoma cells. Preclinical studies have shown excellent anti-tumor efficacy in in vivo studies as well as good tolerability. Heidelberg Pharma intends to develop HDP-102 for specific indications of non-Hodgkin lymphoma.
    At the end of May, Heidelberg Pharma announced the dosing of the first patient with HDP-102. Three patients were treated with 40 µg/kg in the first cohort. Initial data showed promising results. The treatment is well tolerated, and initial signs of biological activity were observed even at the very low dose. Two patients showed stabilization of the disease with regression and reduction of lymph nodes. The safety committee recommended increasing the dose of HDP-102 to 65 µg/kg in cohort 2.
    Due to the current financial situation of the company, the study is being temporarily paused, and no further cohorts are being opened at this time. Patients in cohort 1 will continue to be treated with HDP-102 as long as there is no progression of the disease.
  • HDP-103 development program: HDP-103 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). The antibody used binds to PSMA, a membrane antigen that is overexpressed on prostate cancer cells. It is a promising target for ATAC technology as it has limited expression in normal tissues.
    The clinical team is working on the study application for a Phase I clinical trial. As part of the current focus, partners are being sought for the clinical development of HDP-103 outside China. This does not affect the development cooperation with Huadong in its license territory.
  • HDP-104 and HDP-201 development program: The ADC projects HDP-104 and HDP-201 target guanylyl cyclase-C (GCC), a receptor that is expressed on the surface of intestinal cells and cancer cells in various gastrointestinal tumors. HDP-104 uses Amanitin as its payload, while HDP-201 uses the topoisomerase inhibitor exatecan. Heidelberg Pharma is currently not pursuing further development of either project, and is seeking a partnership.

Events after the end of the reporting period

  • New clinical data on HDP-101 presented at International Myeloma Society Annual Meeting 2025: At the Annual Meeting of the International Myeloma Society (IMS) in Toronto, Canada, in mid-September, Professor Jonathan L. Kaufman, clinical investigator for the study and David Bankes Glass Professor, Department of Hematology and Medical Oncology, Emory University, Atlanta, USA, presented new results from eight patient cohorts in the ongoing study evaluating HDP-101 in multiple myeloma. In cohort 8, HDP-101 consistently demonstrated a very good safety and tolerability profile and encouraging signs of clinical efficacy. Biological activity of HDP-101 was observed in several patients, and one patient has already achieved very good partial remission.

Adjustment of the risk and opportunity report

Financial risks – Liquidity – Risk of insolvency

An expected milestone payment of USD 70 million from HCRx did not materialize, as the payment condition – market approval of the diagnostic agent TLX250-CDx by the FDA – is currently not fulfilled. The lack of cash inflow jeopardizes the continued existence of the Group and/or the consolidated companies.

To enable the companies of the Heidelberg Pharma Group to meet their payment obligations, a decision was made on 25 September 2025, to strategically focus on the leading ADC candidate HDP-101, discontinue all early-stage research activities, and reduce the workforce by 75%.

Once these measures have been implemented and based on the current planning, the company’s financing range will be extended until mid-2026.

In addition to the liquidity risk that threatens the company’s existence, it cannot be ruled out that other risks, including general risks (business model) and financial risks (impairment of short- or long-term assets) will also increase.

Results of operations, financial position and net assets

The Heidelberg Pharma Group, as of the reporting date consisting of Heidelberg Pharma AG and its three subsidiaries Heidelberg Pharma Research GmbH, HDP G250 AG & Co. KG, and HDP G250 Beteiligungs GmbH, reports consolidated figures. The two latter companies, which were newly established in the previous year, are not operationally active and affiliated to the parent company like Heidelberg Pharma Research GmbH.

The reporting period referred to below relates to the period from 1 December 2024 to 31 August 2025 (9M 2025).

In the first nine months of the 2025 financial year, the Group generated sales revenues and income totaling EUR 6.4 million (previous year: EUR 7.6 million) and is in line with the updated planning. The sales revenues included in this figure fell from EUR 5.2 million the previous year to EUR 1.4 million. Other income amounted to EUR 5.0 million and was thus significantly higher than the previous year’s level of EUR 2.4 million due exchange rate gains (EUR 3.2 million).

Operating expenses, including depreciation, amounted to EUR 28.2 million in the reporting period (previous year: EUR 22.8 million) and are broken down as follows: Cost of sales decreased to EUR 0.2 million (previous year: EUR 1.5 million) and corresponds to 1% of total costs. Research and development costs of EUR 21.0 million increased compared to the same period last year (EUR 15.7 million). This increase is due to the planned significantly higher costs for the Phase I/IIa study with HDP-101. R&D costs continue to represent the largest cost item, accounting for 74% of operating expenses. Administrative costs, which include the costs of holding activities, the stock exchange listing and the executive management board, increased to EUR 5.0 million compared to the same period last year (EUR 4.7 million), which is mainly due to higher personnel costs. Administrative costs account for 18% of operating expenses. Other expenses for business development, marketing and commercial market supply activities, which mainly include personnel and travel expenses, but also expenses for exchange rate differences (EUR 1.1 million), doubled compared to the previous year from EUR 1.0 million to EUR 2.0 million and represented 7% of operating expenses.

The financial result, which is mainly made up of interest income on bank balances, amounted to EUR 0.7 million (previous year: EUR 1.0 million). Despite the full repayment of the shareholder loan last year, the decrease is attributable to a lower investment volume and lower interest rates.

The net loss for the first nine months of the financial year increased to EUR 21.1 million compared to the previous year’s figure of EUR 14.3 million. The increase is mainly due to higher operations expenses. Earnings per share deteriorated accordingly from EUR -0.31 in the previous year to EUR -0.45 in the reporting period.

Cash amounted to EUR 22.9 million at the end of the third quarter (30 November 2024: EUR 29.4 million; 31 August 2024: EUR 36.6 million). Excluding financing effects (shareholder loans, sale of receivables), Heidelberg Pharma recorded an average cash outflow of EUR 2.8 million per month in the first nine months of the fiscal year (previous year: EUR 2.6 million).

Total assets as of 31 August 2025 amounted to EUR 54.1 million and were therefore below the figure at the comparative reporting date of 30 November 2024 (EUR 60.7 million). Equity (EUR 10.5 million) also decreased as a result of the loss for the period compared to the end of the 2024 financial year (EUR 30.9 million).

Financial outlook for 2025

The guidance issued on 21 March 2025 for the current financial year was adjusted on 6 October 2025.

The Heidelberg Pharma Group expects sales and other income for the financial year 2025 between EUR 7.5 million and EUR 9 million (previously: EUR 9 million to EUR 11 million). Operating expenses are expected to range between EUR 36 million and EUR 40 million (previously: EUR 40 million to EUR 45 million).

Based on these adjustments, an operating result (EBIT) between EUR -28.5 million and EUR -31 million is expected (previously: EUR -30 million to EUR -35 million).

As part of the strategic focus, long-term and short-term assets are still being reviewed for impairment. They could prove to be only partially or no longer recoverable, resulting in value adjustments. Such non-cash depreciation on assets would lead to additional operating expenses in the current fiscal year, which in turn could have a negative impact on the operating result beyond the aforementioned range of between EUR -28.5 million and EUR -31 million.

For 2025, Heidelberg Pharma anticipates cash requirements of EUR 14 million to EUR 17 million (previously: EUR 50 million to EUR 55 million anticipated inflow). Monthly cash outflow is expected to range between EUR 1.2 million and EUR 1.5 million per month (previously: EUR 4.2 million and EUR 4.6 million inflow). Based on current planning and available funds, the Company’s financing is secured until mid-2026.

The Executive Management Board, in accordance with the Supervisory Board, is in talks with the main shareholders and other parties to secure financing in the medium term.

The complete set of figures for the interim financial statements is available at http://www.heidelberg-pharma.com/ “Press & Investors > Announcements and Reports > Financial Reports > Interim announcement of 9 October 2025. A conference call on this interim announcement will not be offered.

Key figures for the Heidelberg Pharma Group

In EUR thsd. 9M 2025 1
EUR thsd.
9M 2024 1
EUR thsd.
Earnings    
Sales revenue 1,436 5,248
Other income 4,988 2,368
Operating expenses (28,179) (22,849)
of which research and development costs (21,042) (15,650)
Operating result (21,756) (15,233)
Earnings before tax (21,054) (14,259)
Net loss for the period / Comprehensive income (21,054) (14,259)
Basic earnings per share in EUR (0.45) (0.31)
     
Balance sheet as of the end of the period    
Total assets 54,052 65,775
Cash 22,869 36,569
Equity 10,530 35,823
Equity ratio2 in % 19.5 54.5
     
Cash flow statement    
Cash flow from operating activities (24,818) (22,749)
Cash flow from investing activities (179) (266)
Cash flow from financing activities 18,428 16,106
     
Employees (number)    
Employees as of the end of the period3 126 109
Full-time equivalents as of the end of the period3 114 98

1 The reporting period begins on 1 December and ends on 31 August.
2 Equity / total assets
3 Including members of the Executive Management Board
Rounding of exact figures may result in differences.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38 29
Email: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg
 
IR/PR support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228 40
Email: katja.arnold@mc-services.eu
 

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 and is currently on a temporary hold. 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.

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, 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.


09.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210160

 
End of News EQS News Service

2210160  09.10.2025 CET/CEST

Gerresheimer: Business performance and slower market growth require guidance adjustment

Gerresheimer AG

/ Key word(s): Profit Warning/Quarter Results

Gerresheimer: Business performance and slower market growth require guidance adjustment

08.10.2025 / 23:58 CET/CEST

The issuer is solely responsible for the content of this announcement.


Gerresheimer: Business performance and slower market growth require guidance adjustment

  • Preliminary results for 9M 2025: Revenues +14.6%, Adjusted EBITDA +7.2% 
  • Organic development: Revenues -1.8%, Adjusted EBITDA -7.5%
  • Subdued demand in the cosmetics and oral liquids segment continues
  • Separation of Moulded Glass progressing according to plan; independent division within new segmentation from 2026
  • Updated guidance for 2025: Organic revenue decline of -2% to -4%, adjusted EBITDA margin around 18.5 to 19%
  • Transformation program initiated to increase performance and reduce costs

Duesseldorf, October 8, 2025. Gerresheimer, an innovative system and solution provider and global partner for the pharma, biotech, and cosmetics industries, is adjusting its guidance for the 2025 financial year in light of the preliminary results for the third quarter of 2025 and slower-than-expected market growth. According to preliminary figures, revenues in the third quarter of 2025 declined organically by -1.2% compared to the same period last year, with an organic adjusted EBITDA margin of 18.8%. According to preliminary results, Gerresheimer generated positive free cash flow of EUR 21 million in the third quarter of 2025. Revenue growth and the adjusted EBITDA margin for the first nine months of the 2025 financial year are lower than expected overall. Although the company expects the fourth quarter to be stronger than the third quarter due to production ramp-ups for drug delivery systems, revenues for the full year 2025 are now expected to decline organically between -4% and -2% (previously organic revenue growth 0 to 2%), and the adjusted EBITDA margin is expected to be around 18.5% to 19% (previously around 20%). In the first nine months of the 2025 financial year, preliminary figures show that revenues rose by 14.6% to EUR 1,681.4 million (9M 2024: EUR 1,467.0 million), while adjusted EBITDA rose by 7.2% to EUR 313.9 million (9M 2024: EUR 292.7 million). Organic development compared with the pro forma figures for the same period last year continued to show significant market influences, including subdued demand in the cosmetics market and in the area of containment solutions for oral liquids. According to preliminary results, organic revenues declined by 1.8% in the first nine months, while adjusted EBITDA fell by 7.5%. The organic adjusted EBITDA margin was 18.8% (9M 2024: 19.9%). In view of slower market growth and business development in 2025, Gerresheimer has initiated a transformation program to reduce costs and improve performance. 

“The operative performance of our business in the first nine months is clearly below our expectations,” said Dietmar Siemssen, CEO of Gerresheimer AG. “Our goal is to grow faster than the overall market again in the medium and long term. The expansion of our product portfolio to include systems and solutions for biologics and the implementation of our growth projects will contribute considerably to this.”

Plastics & Devices: High demand for drug delivery systems

According to preliminary figures, the Plastics & Devices division generated revenues of EUR 972.6 million in the first nine months of the 2025 financial year (9M 2024: EUR 820.1 million). In absolute terms, revenues rose by 18.6% mainly due to the inclusion of Bormioli Pharma. Organic revenues also grew by 2.6% compared to the pro forma figures for the same period of the previous year. Strong demand for drug delivery systems compensated for the market weakness in plastic containment solutions for oral liquids.

Adjusted EBITDA grew by 6.8% to EUR 222.6 million (9M 2024: EUR 208.5 million). In organic terms, adjusted EBITDA was 6.6% below the pro forma figures for the same period of the previous year. The organic adjusted EBITDA margin of 22.9% (9M 2024: 25.2%) reflects lower capacity utilization at Oral Liquids and start-up costs for the ramp-up of new production lines for drug delivery systems.

Primary Packaging Glass: Subdued demand for cosmetics and oral liquids continues

According to preliminary figures, the Primary Packaging Glass division generated revenues of EUR 714.4 million in the first nine months of the 2025 financial year (9M 2024: EUR 648.0 million). In absolute terms, revenues rose by 10.3% due to the inclusion of Bormioli Pharma. Organically, revenues declined by 6.9% compared with the pro forma figures for the same period of the previous year. The organic decline in revenues was due, among other things, to continued subdued demand in the cosmetics business and in the oral liquid business in the pharmaceuticals sector. Demand for our Gx RTF vials developed positively.

Adjusted EBITDA rose by 6.2% to EUR 127.2 million (9M 2024: EUR 119.7 million). In organic terms, adjusted EBITDA was 7.2% below the pro forma figures for the same period of the previous year. The decline in adjusted EBITDA is primarily attributable to a decrease in demand in the Moulded Glass business segment. The organic adjusted EBITDA margin remained unchanged at 18.0% (9M 2024: 18.0%).

Stronger Q4 expected compared to Q3 2025, 2025 guidance adjusted

Gerresheimer expects a stronger fourth quarter 2025 compared to the third quarter 2025, mainly due to planned production ramp-ups for drug delivery systems. However, organic growth in the fourth quarter will not be able to fully compensate for the business performance of the first nine months of 2025. Based on the business performance to date and slower market growth, the company is therefore adjusting its guidance for the 2025 financial year. Revenues are expected to decline organically by between -4% and -2% (previously organic revenues growth of 0-2%), and the adjusted EBITDA margin is expected to be around 18.5 to 19% (previously around 20%). 

Separation of Moulded Glass is progressing – separate division from 2026

As part of the integration of Bormioli Pharma into the Gerresheimer Group, Gerresheimer has already begun to establish the combined Moulded Glass business as a global, independent unit. Hans-Norbert Topp, an internationally experienced manager with a proven track record, has been appointed to head the business unit. In August 2025, Gerresheimer announced its intention to separate the Moulded Glass business and subsequently initiate a sales process in order to position itself in the future as a system and solution provider purely for the pharma and biotech industries. The separation process is progressing according to plan. From the 2026 financial year, the Moulded Glass business will be managed as a separate division as part of a new segmentation. The sale process is being prepared for 2026.

Transformation program launched

Against the backdrop of slower market growth and adjusted guidance for the 2025 financial year, Gerresheimer has already initiated measures to reduce costs, increase performance, and improve free cash flow. The comprehensive transformation program that Gerresheimer will now implement includes even more selective investment planning with a clear focus on free cash flow, measures to increase operational and sales excellence, and optimization of the global production network. A newly created Transformation Office reporting directly to the CFO will drive the program forward.

The quarterly report for the third quarter of 2025 with the final results will be published on October 10 on the Gerresheimer website here:
 

https://www.gerresheimer.com/en/investors/archive

 

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

Media  
Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264
jutta.lorberg@gerresheimer.com                       
Marion Stolzenwald
Senior Manager Corporate Communication
T +49 172 2424185
marion.stolzenwald@gerresheimer.com
 
Investor Relations
 
Guido Pickert
Vice President Investor Relations
T +49 211 6181 220
gerresheimer.ir@gerresheimer.com
 
Thomas Rosenke
Senior Manager Investor Relations
T +49 211 6181-187
gerresheimer.ir@gerresheimer.com


08.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


Language: English
Company: Gerresheimer AG
Peter-Müller-Str. 3
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210278

 
End of News EQS News Service

2210278  08.10.2025 CET/CEST

Gerresheimer AG: Business performance and slower market growth require adjustment of guidance for 2025

Gerresheimer AG / Key word(s): Profit Warning/Quarter Results

Gerresheimer AG: Business performance and slower market growth require adjustment of guidance for 2025

08-Oct-2025 / 22:09 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Gerresheimer AG: Business performance and slower market growth require adjustment of guidance for 2025

Duesseldorf, October 8, 2025. Gerresheimer AG (ISIN: DE000A0LD6E6, “Gerresheimer”) is adjusting its guidance for the financial year 2025.

This is due to lower business performance in the third quarter of 2025, continued subdued demand in the cosmetics market as well as in containment solutions for oral liquid medications.

According to preliminary figures, revenue in the third quarter of 2025 amounted to EUR 560.7 million, adjusted EBITDA to EUR 103.4 million, and fx normalized adjusted EPS to EUR 0.77. Organic revenue growth in the third quarter of 2025 was -1.2% compared to the same period last year, with an organic adjusted EBITDA margin of 18.8%. According to preliminary results, Gerresheimer generated positive free cash flow of EUR 21 million in the third quarter of 2025.

According to preliminary results for the third quarter, revenue growth and the adjusted EBITDA margin for the first nine months of the 2025 financial year are lower than expected overall. Even taking into account the expected stronger fourth quarter of 2025 compared to the third quarter of 2025, the guidance for the 2025 financial year is therefore not achievable.

For the 2025 financial year, the company now expects organic revenue to decline by between -4% and -2% compared with the previous year (previously organic revenue growth: 0% to 2%) and an adjusted EBITDA margin around 18.5 to 19% (previously: around 20%). The company expects adjusted EPS to decline in the mid-double-digit percentage range compared to the previous year (previously: low double-digit percentage range).

Against the backdrop of the business performance and weaker market growth, Gerresheimer has initiated measures to reduce costs, increase performance, and improve free cash flow. The company will implement a comprehensive transformation program. The program includes more selective investment planning, measures to increase operational and sales performance, and optimization of the global production network. A newly created Transformation Office reporting directly to the CFO will drive the program forward.

_______________________

End of inside information

Gerresheimer will publish its preliminary results for the third quarter and the first nine months of the financial year 2025 today due to the guidance adjustment.

A conference call on the preliminary results will take place on Thursday, October 9, 2025, at 8:30 a.m. CEST.

Registration under:
https://www.webcast-eqs.com/gerresheimer-2025-09

Gerresheimer will publish its quarterly statement for the third quarter of 2025 with the final results on its website on October 10.

 

Contact Gerresheimer AG

Investor Relations

Guido Pickert
Vice President Investor Relations

T +49 152 900 14145
gerresheimer.ir@gerresheimer.com

 

Media

Jutta Lorberg
Head of Corporate Communication
T +49 211 6181 264

jutta.lorberg@gerresheimer.com

End of Inside Information


08-Oct-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


Language: English
Company: Gerresheimer AG
Peter-Müller-Str. 3
40468 Duesseldorf
Germany
Phone: +49-(0)211/61 81-00
Fax: +49-(0)211/61 81-121
E-mail: gerresheimer.ir@gerresheimer.com
Internet: http://www.gerresheimer.com
ISIN: DE000A0LD6E6
WKN: A0LD6E
Indices: MDAX (Aktie)
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210260

 
End of Announcement EQS News Service

2210260  08-Oct-2025 CET/CEST

Cantourage is responding to potential developments resulting from new legal regulations with focused internationalization and strategic product diversification

Cantourage Group SE

/ Key word(s): Market Report

Cantourage is responding to potential developments resulting from new legal regulations with focused internationalization and strategic product diversification

08.10.2025 / 13:01 CET/CEST

The issuer is solely responsible for the content of this announcement.


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 notes at the end of this announcement must be observed.

Berlin, October 8, 2025 – The German government today passed a cabinet resolution that includes far-reaching changes to the prescription and distribution of medical cannabis. According to the draft bill, prescriptions will initially only be issued after a personal doctor-patient consultation. For repeat prescriptions, a personal consultation must take place once every four quarters – under this condition, a prescription can also be issued via telemedicine in the following quarters. In addition, medical cannabis flowers may only be sold directly in local pharmacies.

The proposed changes will be discussed in the Bundestag in the next step. Amendments to the law are to be expected in the further parliamentary process. However, if the draft law is passed in its current form, this could at least temporarily weigh on demand for medical cannabis flowers in Germany – especially since many patients currently use telemedicine services for prescriptions.

“The medical use of cannabis is an expression of sustainable development and has already become widely accepted in society. We consider the proposed legal changes to be inappropriate, as they would make access to medical cannabis more difficult, potentially reduce demand for cannabis flowers, at least temporarily, and thus jeopardize a growing industry and jobs in Germany. At Cantourage, we remain committed to providing safe, high-quality, and responsible medical care to patients,” says Philip Schetter, CEO of Cantourage.

Cantourage has taken a position on the proposed legislative changes in a statement dated August 1, 2025: Details can be found here.

Cantourage is closely monitoring legislative developments in Germany. The company has been responding to the changing environment for quite some time with a consistent strategy of expansion and diversification.

Cantourage has recently expanded its business activities significantly, particularly in the dynamically growing markets of Poland and the United Kingdom. These international activities not only contribute to further strengthening the company, but also offer additional resilience to possible changes in the German market environment.

At the same time, Cantourage is continuously adapting its product portfolio in Germany to meet changing requirements and continue to ensure the supply of patients. Cantourage thus remains a reliable partner in the field of medical cannabis supply and will continue to respond flexibly and solution-oriented to regulatory changes in the future.

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, under the ticker symbol “HIGH”.

Contact Investor Relation
ir@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 of Regulation (EU) 2017/1129 (Prospectus Regulation).


08.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


Language: English
Company: Cantourage Group SE
Feurigstraße 54
10827 Berlin
Germany
E-mail: info@cantourage.com
Internet: https://www.cantourage.com/
ISIN: DE000A3DSV01
WKN: A3DSV0
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2210008

 
End of News EQS News Service

2210008  08.10.2025 CET/CEST

Relief Therapeutics and NeuroX, Successor to MindMaze, Sign Definitive Agreement for Business Combination

Relief Therapeutics Holding SA / Key word(s): Mergers & Acquisitions

Relief Therapeutics and NeuroX, Successor to MindMaze, Sign Definitive Agreement for Business Combination

08-Oct-2025 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

The issuer is solely responsible for the content of this announcement.


Relief Therapeutics and NeuroX, Successor to MindMaze, Sign Definitive Agreement for Business Combination

  • Companies sign definitive agreement following previously announced binding term sheet
  • Transaction to create an expanded, SIX-listed, commercial-stage, AI-driven, scalable health tech company
  • Combined company to be renamed MindMaze Therapeutics Holding SA upon closing
  • Positioned as a global leader in evidence-based neurotherapeutic solutions for neurological diseases and brain disorders
  • Over 250 hospitals and rehabilitation centers, thousands of home sessions deployed, and multiple pharma collaborations establish robust commercialization footprint
  • Proprietary neuro-data engine and responsible AI framework will enable scalable precision medicine for neurological diseases based on more than 30,000 patients
  • Secured a unique reimbursement code (CAT-3) to support the delivery of its home-based neurotherapeutic training in the United States
  • Over the past decade MindMaze has raised and invested more than USD 350 million to establish clinical evidence, demonstrate significant medico-therapeutic outcomes and market disease-modifying platforms including stroke, Parkinson’s and at-risk aging
  • Closing expected in December 2025, subject to customary conditions and approvals

GENEVA and LAUSANNE (Oct. 8, 2025) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTFRLFTY) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, and NeuroX Group SA (NeuroX), a privately held company focused on digital neurotherapeutics and brain health technologies, today announced they have entered into a definitive agreement to combine their businesses.

The proposed combination will create a publicly listed, AI-based therapeutics platform integrating software-delivered, disease-modifying clinical interventions with pharmacological treatments and a comprehensive brain health platform. NeuroX contributes a clinically validated, de-risked portfolio supported by multiple milestones achieved across technological development, regulatory approvals, and market access, as well as a solid network of pharmaceutical partners.

AI and Data Platform for Precision Neurology

The MindMaze proprietary technology stack integrates multimodal data collected across thousands of patients in clinical and real-world settings. In the future, the platform will build on advanced machine learning and federated AI models to personalize neurorehabilitation, predict recovery trajectories, and optimize pharmacological and digital treatment combinations.

All technologies are developed in compliance with EU AI Act principles, GDPR, MDR, and FDA Software as a Medical Device (SaMD) frameworks, ensuring transparency and clinical-grade data integrity.

Commercial-Stage Footprint and Reimbursement Readiness

NeuroX’s clinically validated digital neurotherapeutic suite is currently deployed in over 250 clinics and rehabilitation centers globally. Its solutions are supported by a unique U.S. Category III reimbursement code (CAT-3), enabling scalable and recurring revenue generation.

Over the past decade, more than USD 350 million has been invested to build this data-rich therapeutic platform, supported by strong evidence of improved clinical and medico-economic outcomes in stroke, Parkinson’s disease, and at-risk aging. Additional R&D initiatives target multiple sclerosis, spinal cord injury, traumatic brain injury, and Alzheimer’s/dementia.

Gregory Van Beek, vice-chairman of the board of directors of Relief, said: “Over the past months, our collaboration with NeuroX has confirmed the potential of combining our businesses. With today’s signing, we are advancing a transaction that represents a compelling and risk-balanced, high-growth investment case. The combined company will stand as an attractive complement to other innovative technology and healthcare SMEs listed on SIX, while offering Relief shareholders exposure to a differentiated therapeutic platform. We are confident this is a well-structured and value-creating transaction for our investors.”

Tej Tadi, founder of MindMaze, added: “Finalizing this agreement is a pivotal step in our ongoing journey. Over the years we have built a de-risked platform through sustained investment, clinical validation, regulatory approvals and reimbursement milestones, and we are now ready to scale. Partnering with Relief and accessing the public markets will enable us to broaden adoption of our precision neurology solutions and expand collaborations across pharma and healthcare.”

Leadership and Governance

Upon completion of the transaction, the combined company will be guided by Tej Tadi, founder of MindMaze, supported by NeuroX’s current executive leadership team and additional key hires underway. Relief’s chief financial officer will continue in that role. Other members of Relief’s current executive committee will assume management positions, focusing on Relief’s existing business and supporting the NeuroX platform.

At an upcoming extraordinary general meeting, Relief’s board of directors will propose the election of four new members. Gregory Van Beek, the sole incumbent director, will continue to serve on the board of directors to ensure continuity and support the integration of the two companies.

Transaction Terms

The transaction is based on agreed equity valuations of CHF 100 million for Relief, a premium to its current market capitalization, and CHF 1 billion for NeuroX.

Under the terms of the agreement, NeuroX shareholders shall contribute all their NeuroX shares to Relief in exchange for newly issued SIX-listed Relief shares, at a fixed exchange ratio of 140 Relief shares per NeuroX share. Based on this exchange ratio and reflecting an agreed relative valuation of 10-to-1 on a fully diluted basis in favor of NeuroX, Relief will issue 140,000,000 new ordinary shares to acquire NeuroX. Following completion, Relief expects to have 152,584,419 ordinary shares outstanding, excluding 1,500,398 treasury shares and subject to adjustments for any outstanding options exercised prior to closing.

The transaction has been approved by the boards of directors of both companies and is expected to close in December 2025. Completion remains subject, inter alia, to approval of the transaction by Relief’s shareholders and to the admission of the newly issued Relief shares for listing and trading on the SIX Swiss Exchange. Upon closing, Relief will be renamed MindMaze Therapeutics Holding SA.

NeuroX is in advanced discussions to secure a new CHF 200 million equity commitment through a share subscription facility with Relief’s shareholder Global Emerging Markets (GEM), in addition to an existing equity commitment to be contributed by Relief representing an additional CHF 50 million.

The combined company will also seek to uplist its OTC ADR program to a Level III as soon as practicable after closing the business combination, expanding visibility and access to U.S. investors.

Additional Information

Relief will convene an extraordinary general meeting to submit to shareholders the proposals required to implement the contemplated transaction, including the issuance of new shares to NeuroX shareholders and the election of new members to the board of directors.

Relief and NeuroX intend to host a joint press conference on or around the day of the extraordinary general meeting. An investor presentation with additional information on the combined company is currently available for download on Relief’s website.

YUMA Capital is acting as financial advisor for the transaction.

ABOUT NEUROX
NeuroX is a Swiss-based, commercial-stage company that in 2025 acquired strategic assets of MindMaze Group SA and MindMaze SA (MindMaze), including intellectual property and the MindMaze® brand, through a pre-pack transaction in connection with MindMaze’s debt restructuring moratorium.

MindMaze has developed first-of-its-kind neurotherapeutics that provide disease-modifying motor and cognitive treatments for neurological diseases and brain disorders. These neurotherapeutics are delivered through proprietary software and hardware, underpinned by an advanced brain technology platform that integrates wearables and sensors, and provides digital assessments as well as telehealth services. The unique suite of MindMaze solutions is delivered globally across the continuum-of-care, both in-clinic and in patients’ home, to successfully address some of neurology’s major unmet needs. NeuroX has already partnered with leading pharmaceutical companies that use its proprietary technology across multiple clinical trials.

Over the last decade, MindMaze has raised and invested more than USD 350 million to establish clinical evidence, demonstrate significant medico-economic outcomes, and market MindMaze’s disease-modifying therapeutic platform across neurological diseases, including stroke, Parkinson’s disease, and at-risk aging. In the United States, MindMaze has received a unique reimbursement code (CAT-3) to support the delivery of its home-based neurotherapeutic training. Its R&D pipeline focuses on adjacent neurological diseases, such as spinal cord injury, multiple sclerosis, traumatic brain injury, and Alzheimer’s disease/dementia.

Moved by the mission to accelerate the brain’s ability to recover, the MindMaze platform innovates by combining software-delivered behavioral treatments, drugs, devices, data, and AI to establish a new paradigm of precision medicine in neurology and neural repair.

ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company dedicated to advancing treatment paradigms and improving the lives of patients with rare and debilitating diseases. With core expertise in drug delivery systems and drug repurposing, Relief’s clinical pipeline includes innovative treatments designed to address critical unmet medical needs in rare dermatological, metabolic and respiratory conditions. The Company has also successfully brought several approved products to market through licensing and distribution partnerships. 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

MindMaze
pr@mindmaze.com

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

No offer or solicitation – This press release does not constitute (i) a prospectus within the meaning of the Swiss Financial Services Act or under any other applicable laws, (ii) a solicitation of proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (iii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Relief, NeuroX, or any of their respective affiliates. No securities may be sold in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration, exemption from registration, or qualification under the securities laws of such jurisdiction. This press release should not be regarded as investment advice or offering material of any kind and is provided for information purposes only, nor shall it or any part of it form the basis of, or be relied upon in connection with, any contract or investment decision.

This announcement is not for publication or distribution, directly or indirectly, in or into the United States, Canada, Australia, Japan, or any other jurisdiction in which such distribution would be unlawful.

Additional features:

File: Ad hoc release


End of Inside Information


Language: English
Company: Relief Therapeutics Holding SA
Avenue de Secheron 15
1202 Geneva
Switzerland
Phone: +41 22 545 11 16
E-mail: contact@relieftherapeutics.com
Internet: https://relieftherapeutics.com
ISIN: CH1251125998
Valor: 125112599
Listed: SIX Swiss Exchange
EQS News ID: 2209572

 
End of Announcement EQS News Service

2209572  08-Oct-2025 CET/CEST

Heidelberg Pharma AG Announces Updated Guidance

Heidelberg Pharma AG / Key word(s): Change in Forecast

Heidelberg Pharma AG Announces Updated Guidance

06-Oct-2025 / 15:58 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Ad hoc announcement – Disclosure of inside information under Article 17 of Regulation (EU) No 596/2014

Heidelberg Pharma AG Announces Updated Guidance

Ladenburg, Germany, 6 October 2025 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announces that it has adjusted its guidance for the current fiscal year published on 21 March 2025, due to current focus and cost-saving measures.

The Heidelberg Pharma Group expects sales and other income for the financial year 2025 between EUR 7.5 million and EUR 9 million (previously: EUR 9 million to EUR 11 million). Operating expenses are expected to range between EUR 36 million and EUR 40 million (previously: EUR 40 million to EUR 45 million).

Based on these adjustments, an operating result (EBIT) between EUR -28.5 million and EUR -31 million is expected (previously: EUR -30 million to EUR -35 million).

As part of the strategic focus, long-term and short-term assets are still being reviewed for impairment. They could prove to be only partially or no longer recoverable, resulting in value adjustments. Such non-cash depreciation on assets would lead to additional operating expenses in the current fiscal year, which in turn could have a negative impact on the operating result beyond the aforementioned range of between EUR -28.5 million and EUR -31 million.

For 2025, Heidelberg Pharma anticipates cash requirements of EUR 14 million to EUR 17 million (previously: EUR 50 million to EUR 55 million anticipated inflow). Monthly cash consumption is expected to range between EUR 1.2 million and EUR 1.5 million per month (previously: EUR 4.2 million and EUR 4.6 million inflow). Based on current planning and available funds, the Company’s financing is secured until mid-2026.

End of Inside Information


Information and Explanation of the Issuer to this announcement:

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 and is currently on a temporary hold. 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.

Contact
Heidelberg Pharma AG
Sylvia Wimmer
Director Corporate Communications
Tel.: +49 89 41 31 38-29
E-mail: investors@hdpharma.com
Gregor-Mendel-Str. 22, 68526 Ladenburg
 
IR/PR-Support
MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
Tel.: +49 89 210 228-40
E-mail: katja.arnold@mc-services.eu  
 
International IR/PR-Support
Optimum Strategic Communications
Mary Clark, Zoe Bolt, Aoife Minihan
Tel: +44 20 3882 9621
E-mail: HeidelbergPharma@optimumcomms.com
 

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.


06-Oct-2025 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


Language: English
Company: Heidelberg Pharma AG
Gregor-Mendel-Str. 22
68526 Ladenburg
Germany
Phone: +49 (0)89 41 31 38 – 0
Fax: +49 (0)89 41 31 38 – 99
E-mail: investors@hdpharma.com
Internet: www.heidelberg-pharma.com
ISIN: DE000A11QVV0
WKN: A11QVV
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2208738

 
End of Announcement EQS News Service

2208738  06-Oct-2025 CET/CEST

Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with New Clinical Findings at EANM 2025

Pentixapharm Holding AG

/ Key word(s): Study results/Research Update

Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with New Clinical Findings at EANM 2025 (news with additional features)

06.10.2025 / 11:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


 

Pentixapharm Highlights Expanding CXCR4 Radiopharmaceutical Platform with
New Clinical Findings at EANM 2025
 

  • Clinical data from independent investigator-initiated studies using [⁶⁸Ga]Ga-PentixaFor demonstrate potential to improve diagnosis in Primary Aldosteronism
  • First-in-human findings with [¹⁷⁷Lu]Lu-PentixaTher in bladder cancer show early therapeutic activity, further validating CXCR4 as a clinically relevant target
     

Berlin, Germany, October 6, 2025 – Pentixapharm Holding AG (Frankfurt Prime Standard: PTP), an advanced clinical-stage biotech developing novel radiopharmaceuticals, today announced the presentation of extensive clinical data from independent investigator-initiated studies assessing Pentixapharm’s CXCR4-targeting diagnostic lead candidate, [68Ga]Ga-PentixaFor, at the ongoing Annual Congress of the European Association of Nuclear Medicine (EANM 2025) in Barcelona, Spain.

At EANM 2025, four oral presentations and seven e-posters feature new data on [68Ga]Ga-PentixaFor PET/CT imaging in Primary Aldosteronism (PA) – a condition frequently underdiagnosed despite being one of the leading causes of secondary hypertension. These presentations include comparative clinical trial results, evaluating [68Ga]Ga-PentixaFor against adrenal venous sampling (AVS), the current invasive gold standard for subtyping PA. The data demonstrate the high potential of [68Ga]Ga-PentixaFor to significantly improve subtyping of patients, thereby enabling better therapy decisions, and more precise patient management in PA.

Complementing these results in cardiovascular and endocrine disease, the scientific program at EANM 2025 also showcases the expanding role of Pentixapharm’s CXCR4-targeted platform in oncology. Among the highlights are first-in-human data on Pentixapharm’s therapeutic candidate [¹⁷⁷Lu]Lu-PentixaTher, in patients with bladder cancer. The early findings demonstrate initial signs of therapeutic activity, adding to the growing body of evidence supporting [¹⁷⁷Lu]Lu-PentixaTher as a precision treatment candidate for CXCR4-positive malignancies.

“The strong scientific presence of our CXCR4 program at EANM 2025 reflects both the clinical relevance of our platform and the growing recognition of CXCR4 as a key target across multiple disease areas,” said Dr. Dirk Pleimes, CEO/CMO of Pentixapharm AG. “The findings in Primary Aldosteronism highlight how our lead candidate, [⁶⁸Ga]Ga-PentixaFor, could transform the diagnosis of hypertensive patients while the oncology data further validate CXCR4 as a cornerstone target for our radiopharmaceutical platform. The wealth of CXCR4-directed research presented at EANM highlights the diagnostic value of CXCR4-targeted imaging, reinforcing the strength and versatility of our approach. Together, these findings demonstrate how Pentixapharm is expanding the boundaries of radiopharmaceuticals across cardiovascular, endocrine, and oncologic diseases.”

 

About CXCR4

CXCR4 is a well-characterized cell membrane receptor with a pivotal role in the bone marrow microenvironment. It is highly overexpressed in multiple aggressive blood cancers – including acute myeloid leukemia, multiple myeloma, and large B-cell lymphoma – where it drives tumor growth and metastasis. CXCR4 has been clinically validated in multiple of these hematologic cancers, making it a validated high-value target in areas of high unmet medical need.

Beyond oncology, CXCR4 is being explored as a diagnostic imaging target in cardiovascular and endocrine disorders, particularly Primary Aldosteronism (PA), a condition accounting for an estimated 5–10% of all hypertension cases, corresponding to roughly 100–200 million people worldwide. In PA, CXCR4 expression is elevated in benign adrenal tumors, making it a valuable tool for functional diagnosis, PA sub-typing, and lateralization of aldosterone overproduction.

Its dual diagnostic and therapeutic potential illustrates CXCR4’s versatility as a first-in-class target for next-generation radiopharmaceuticals, enabling both precision diagnostics and targeted radioligand therapy.

 

About Pentixapharm

Pentixapharm is an advanced clinical-stage biotech expanding the boundaries of radiopharmaceuticals. Headquartered in Berlin, Germany, the company develops first-in-class ligand- and antibody-based radiopharmaceuticals designed to transform patient care across oncology and beyond. Its late-stage pipeline is anchored by CXCR4-targeted programs, including a Phase 3-ready diagnostic candidate for primary aldosteronism and pioneering therapeutic programs in a number of hematological and solid cancers. Furthermore, Pentixapharm is advancing a next-generation antibody platform targeting CD24, an emerging immune-escape marker over-expressed in multiple hard-to-treat cancers. Complemented by reliable isotope supply from Eckert & Ziegler, and a robust global clinical network, Pentixapharm is uniquely positioned to deliver innovative radiopharmaceuticals that address high unmet need, improve patient outcomes, and create significant growth opportunities in one of the fastest-growing areas of precision medicine.

 

Pentixapharm Investor and Media Contact

ir@pentixapharm.com


Additional features:

File: 20251005 – Pentixapharm PR EANM Conference EN


06.10.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: Pentixapharm Holding AG
Robert-Rössle-Straße 10
13125 Berlin
Germany
E-mail: info@pentixapharm.com
Internet: https://www.pentixapharm.com/
ISIN: DE000A40AEG0
WKN: A40AEG
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2208564

 
End of News EQS News Service

2208564  06.10.2025 CET/CEST

Invitation: Straumann Group 2025 third-quarter results webcast

Date: Wednesday, October 29, 2025

Time: 10:30 – 11:30 a.m. CET

 

 

Straumann Group will publish its 2025 third-quarter results on Wednesday, October 29, 2025, at approximately 7:00 a.m. CET through the usual channels.

 

The live audio webcast is aimed at investors, financial analysts, and journalists. The Group’s top management will review the performance and answer questions. The presentation and Q&A session will be held in English.

 

The webcast can be accessed via www.straumann-group.com/webcast and a recording will be available afterwards.

 

Should you wish to ask a question during the Q&A, please pre-register for the conference call using this link. We also recommend downloading the presentation in advance via the direct link in the media release at www.straumann-group.com before joining the conference call.

 

 

With kind regards

Straumann Group Corporate Communications & Investor Relations