Pentixapharm Releases Interim Report for the Third Quarter of 2024

EQS-News: Pentixapharm Holding AG

/ Key word(s): Quarterly / Interim Statement

Pentixapharm Releases Interim Report for the Third Quarter of 2024

12.11.2024 / 17:45 CET/CEST

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

Pentixapharm Releases Interim Report for the Third Quarter of 2024
  • Loss of Pentixapharm Holding AG for the reporting period: €49k
  • No revenue realized during the stub fiscal year through the end of Q3
  • Current liabilities of €487k, mainly from the purchase of Pentixapharm AG shares

Berlin and Würzburg, Germany, November 12, 2024 – Pentixapharm Holding AG (ISIN: DE000A40AEG0), listed in the Prime Standard of the Frankfurt Stock Exchange, today published its consolidated interim report for the stub fiscal year from March 18 to September 30, 2024. Since the spin-off from Eckert & Ziegler SE, through which Pentixapharm AG and Myelo Therapeutics GmbH will be integrated into the group financial statements, was entered into the commercial register on October 2, 2024, this consolidated report includes only the figures for Pentixapharm Holding AG and does not yet contain results for either company.

During the reporting period, Pentixapharm Holding AG reported a loss of €49k, attributed to other operating expenses, primarily fees and charges related to the company’s establishment, acquisition of financial assets, and the spin-off. The interim report also shows no revenue, as operational business activities will commence only after the formal spin-off of Pentixapharm AG and Myelo Therapeutics GmbH.

For the 2024 consolidated annual financial statements, management anticipates a significant increase in losses in the fourth quarter due to the inclusion of Pentixapharm AG and Myelo Therapeutics GmbH from October 2, 2024, with an expected total loss of approximately –€8 million for the fiscal year.

The full interim report is available on the Pentixapharm Holding AG Investor Relations website: www.pentixapharm.com/investors/reports.

About Pentixapharm

Pentixapharm is a clinical-stage biotech company discovering and developing novel targeted radiopharmaceuticals with its offices in Berlin and Würzburg, Germany. It is committed to developing CXCR4 ligand-based first-in-class radiopharmaceutical approaches with a clear commercial pathway for diagnostic and therapeutic programs in a number of hematological and solid cancers, as well as cardiovascular, endocrine and inflammatory diseases.

 

For more information, please contact:

Pentixapharm Holding AG
Phillip Eckert, Investor Relations
ir@pentixapharm.com
Tel. +49 30 94893232
www.pentixapharm.com


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Mainz Biomed and Thermo Fisher Scientific Sign a Collaboration Agreement for the Development of Next Generation Colorectal Cancer Screening Product for Global Markets

Issuer: Mainz BioMed N.V.

/ Key word(s): Alliance

12.11.2024 / 15:00 CET/CEST

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

Mainz Biomed and Thermo Fisher Scientific Sign a Collaboration Agreement for the Development of Next Generation Colorectal Cancer Screening Product for Global Markets

BERKELEY, US and MAINZ, Germany – November 12, 2024 Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today announced a collaborative agreement with Thermo Fisher Scientific Inc. (NYSE: TMO), through its subsidiary Life Technologies Corporation (“Thermo Fisher”), a world leader in supplying life sciences solutions and services.

The collaboration agreement will enable Mainz Biomed and Thermo Fisher to jointly develop and potentially commercialize Mainz Biomed’s Next Generation colorectal cancer screening product. The collaboration will harness Thermo Fisher’s powerful technologies, instrumentation and information translation systems to enable Mainz Biomed to develop the proprietary assays for its mRNA-based next-generation CRC screening tests which are redefining standards in early cancer detection. Mainz Biomed’s flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, demonstrating significant clinical success in both US and European trials.

The collaboration will leverage combined capabilities to deliver testing solutions being developed at Mainz Biomed’s laboratories in Mainz, Germany.

Guido Baechler, CEO of Mainz Biomed, said: “This collaboration with Thermo Fisher will be instrumental to our goal to bring to market a home collection colorectal screening tool with highly effective detection of adenomas. Our product development will be greatly enhanced by Thermo Fisher’s knowledge and scalable, class-leading technologies, providing both partners with a means to accelerate the availability of an innovative new test for colorectal cancer screening around the world.”

Peter Jacobs, Director, EMEA Clinical Business Development, Thermo Fisher Scientific, said: “We are excited at the prospect of working with Mainz Biomed on their next generation screening test and are confident that together we will be able to achieve rapid progress and deliver innovative new assays for the global clinical marketplace.”

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

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About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

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 a pivotal FDA clinical study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

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

For investor inquiries, please contact info@mainzbiomed.com

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


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CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2024 and Provides Business Update

Issuer: CureVac

/ Key word(s): Quarter Results

12.11.2024 / 13:00 CET/CEST

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

CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2024
and Provides Business Update
 

Strengthened Cash, Strategic Refocus and Pipeline Progress Define Transformative Quarter

  • €400 million upfront payment from restructured GSK collaboration reflected in financials, cash position increased to €551 million; expected cash runway re-affirmed into 2028
     
  • CVGBM Phase 1 glioblastoma study showed 77% of patients with antigen-specific T-cell responses; data presented at ESMO, SITC and SNO
     
  • New off-the-shelf program for squamous non-small cell lung cancer started, expected to enter Phase 1 in H2 2025
     
  • New preclinical prophylactic vaccine program for urinary tract infections initiated, supported by positive preclinical data versus protein-based vaccines
     
  • Positive Phase 2 data from seasonal influenza program licensed to GSK demonstrated strong immune responses against challenging influenza B as well as A strains; program progressing to Phase 3, which will be associated with significant milestone payment
     
  • Corporate redesign on track with 30% workforce reduction, expected to yield significant annual cost savings from 2025 onwards and increase operational agility
     
  • Appointment of seasoned industry executive Axel Malkomes as new CFO effective November 11, enhancing financial leadership and strategic execution
     
  • CureVac to host conference call and webcast today at 9 a.m. EST / 3 p.m. CET; details below and under https://www.curevac.com/en/newsroom/events/
     

TÜBINGEN, Germany/BOSTON, USA November 12, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the third quarter and first nine months of 2024 and provided a business update.

Commenting on the quarter Dr. Alexander Zehnder, Chief Executive Officer of CureVac said:

“The third quarter was truly transformative for CureVac. By restructuring our collaboration with GSK, we have embarked on a new chapter of growth and innovation, unveiling new programs that leverage our advanced mRNA technology to tackle critical health challenges. The strategic decisions we’ve made, combined with encouraging initial clinical results, have laid a solid foundation for our future success. We are now strategically aligned, more operationally efficient, and financially empowered to create shareholder value by advancing our portfolio of novel mRNA-based medicines.”

Selected Business Updates

Strategic Redesign

CureVac made meaningful progress in restructuring its operations during the third quarter by implementing significant cost-cutting measures. These include the previously announced 30% workforce reduction, which is on track to be completed by the end of 2024. The goal of the restructuring is to reorganize the company for flexibility in executing immediate priorities while maintaining a strong innovation focus and ensuring long-term value creation. Right-sizing CureVac for future growth allows for continued focused development of a prioritized portfolio, including high-value mRNA projects in oncology, infectious diseases and other areas.

“With funding secured into 2028, and our operational expenses increasingly streamlined by our ongoing redesign, we are in a strong position to expand our R&D efforts across several promising areas,” said Dr. Zehnder. “We will be launching new development programs in the coming quarters and will continue to execute our business and pipeline strategy well into the future.”

Strengthening the Leadership Team

As of November 11, 2024, CureVac welcomed a new Chief Financial Officer, Axel Sven Malkomes. Mr. Malkomes brings over three decades of senior corporate and investment banking experience within the biotech and pharmaceutical industries. Most recently, he served as CFO at Cardior Pharmaceuticals, a private clinical-stage company developing non-coding RNA-based therapeutics for heart disease. During his tenure, he played a crucial role in strategically and financially preparing the company for capital markets, co-leading financing rounds, and supporting potential M&A and partnering transactions, culminating in the successful acquisition of Cardior by Novo Nordisk in 2024.

Before Cardior, Mr. Malkomes was CFO and Chief Business Officer at Medigene AG, a publicly listed cell therapy company. His extensive experience also includes senior healthcare investment banking roles at Barclays and Société Générale, as well as co-heading European healthcare investments at 3i Group plc, a UK-listed private equity firm with over $20 billion in assets under management. Earlier in his career, he held senior leadership positions at Merck KGaA.

Oncology

Expanding oncology development pipeline

CureVac sees significant opportunities to apply precision immunotherapy using mRNA vaccines in large patient populations. The company aims to create earlier treatment options for multiple solid tumor types and is strengthening its clinical development pipeline following two complementary approaches: off-the-shelf cancer vaccines targeting tumor antigens shared across different patient populations and/or tumor types and fully personalized cancer vaccines based on a patient’s individual tumor genomic profile.

CureVac is extending its off-the-shelf cancer vaccine pipeline and has selected an additional clinical candidate for a shared-antigen cancer vaccine targeting squamous non-small cell lung cancer (sqNSCLC). Investigational New Drug (IND) and Clinical Trial Application (CTA) submissions are being prepared for filing in the first half of 2025. Additional discovery work aims to deliver further off-the-shelf cancer vaccines and selection of a second clinical candidate is anticipated in 2026.

In parallel, the program for fully personalized cancer vaccines is progressing and on track with the planned start of a Phase 1 study expected in the second half of 2026.

Clinical off-the-shelf program in glioblastoma

CureVac presented the first clinical data from the Phase 1 study of CVGBM, its off-the-shelf mRNA cancer vaccine candidate, in patients with resected glioblastoma in September 2024 at the European Society for Medical Oncology (ESMO) Congress and in November at the Society for Immunotherapy of Cancer (SITC) and the Society for Neuro-Oncology (SNO) Congresses. Preliminary immunogenicity results in this highly aggressive and challenging cancer indication demonstrate the potential of CureVac’s proprietary second-generation mRNA backbone to enhance the immune system’s capacity for a coordinated defense against the disease.

“As our lead oncology program, CVGBM has demonstrated encouraging initial clinical results in patients with resected glioblastoma,” said Dr. Myriam Mendila, Chief Scientific Officer of CureVac. “Data presented recently at the ESMO, SITC and SNO congresses showed that 77% of evaluable patients exhibited sustained immune response induction over a 99-day monitoring period. Importantly, we believe these data are very promising because the response was led by de novo T-cell generation, which likely plays a crucial role in the success of a cancer vaccine.”

In the fully enrolled dose-escalation Part A, CVGBM monotherapy induced cancer antigen-specific T-cell responses in 77% of 13 evaluable patients. Notably, 84% of these immune responses were generated de novo, inducing T-cell activity in patients without prior immunity to the encoded antigens. Among responding patients, 69% showed CD8+ responses, 31% had CD4+ responses, and 23% had both. 67% of responding patients showed immune responses against multiple antigens. At the recommended 100 µg dose for the expansion part of the study, responses were sustainable over a 99-day monitoring period. Induction of cellular responses was accompanied by systemic cytokine and chemokine activation, indicating innate immune response activation.

The treatment was well tolerated, with no dose-limiting toxicities up to the highest dose of 100 µg. 91% of treatment-related adverse events (TRAEs) were mild to moderate systemic reactions characteristic of mRNA-based therapeutics, resolving within 1-2 days post-injection. Seven patients reported nine severe TRAEs, including four serious adverse events; no grade 4 or 5 adverse events occurred.

The dose-expansion Part B of the study is ongoing at the recommended 100 µg dose. Initial data and a decision on advancing the program to Phase 2 are expected in the second half of 2025.

More information can be found at clinicaltrials.gov (NCT05938387).

Prophylactic Vaccines

Initiation of Urinary Tract Infections Program

CureVac has initiated a new program to address urinary tract infections (UTIs), which are among the most common bacterial infections. UTIs are most commonly caused by uropathogenic Escherichia coli (UPEC) bacteria, which can enter the urinary tract, invade and colonize bladder and kidney tissues. These infections can lead to complications such as kidney damage and urosepsis. UTIs lead to approximately 8-10 million doctor office visits and 1-3 million emergency department visits per year in the U.S. alone.

“Urinary tract infections are extremely common, affecting millions of people each year—often repeatedly—and are increasingly prone to antibiotic resistance,” said Dr. Mendila. “Our encouraging preclinical data show that our investigational vaccine candidates targeting uropathogenic Escherichia coli elicit strong antibody titers and robust T-cell responses, comparing very favorably to recombinant protein-based vaccines. Based on these promising results, we believe there is a significant commercial opportunity for an mRNA solution that offers meaningful benefits to individuals suffering from these infections.”

mRNA technology is ideally suited for developing prophylactic vaccines against bacterial targets like UPEC due to its ability to target specific disease antigens and flexibly combine multiple antigens.

CureVac has conducted preclinical studies with several UPEC vaccine candidates and selected a lead candidate for further preclinical testing. The promising data, which compares favorably to recombinant protein-based vaccines, is being presented at the 12th International mRNA Health Conference in Boston from November 11-14, 2024.

The studies assessed two mRNA vaccine candidates encoding FimH, an antigen facilitating UPEC adhesion to bladder epithelial cells, in mouse and rat models. Both candidates induced high levels of binding antibodies in serum and urine, correlating with high serum functional antibodies, and showed strong induction of antigen-specific CD8+ and CD4+ T-cells. Additionally, both vaccine candidates demonstrated superior immunogenicity compared to protein-based comparator vaccines.

Based on these encouraging preclinical results, CureVac expects to select a clinical candidate in the first half of 2025. An IND application filing is planned in the second half of 2025, aiming to initiate a Phase 1 study in the first half of 2026.

Seasonal Influenza Phase 2 Data – Program Licensed to GSK

In September 2024, GSK announced positive Phase 2 headline data from its seasonal influenza mRNA vaccine program based on CureVac’s second-generation mRNA backbone. According to GSK, the data demonstrated positive immune responses against both influenza A strains as well as historically challenging influenza B strains compared to the current standard of care.

“For many years, developing vaccines that elicit strong immune responses against influenza B strains has been a significant challenge,” said Dr. Mendila. “The recent data from our GSK-licensed seasonal influenza mRNA vaccine program are remarkable because they show we are overcoming one of the greatest hurdles in bringing this type of vaccine to market. This is a significant milestone in seasonal flu vaccine development.”

The interim data met all predefined success criteria in the tested age groups of older and younger adults and suggested an acceptable safety and reactogenicity profile. GSK confirmed that the program is progressing to Phase 3 in 2025, which will be associated with a significant milestone payment for CureVac.

More information can be found at clinicaltrials.gov (NCT06431607).

As previously announced in July 2024, CureVac and GSK restructured their collaboration into a new licensing agreement. Under the new agreement, GSK has assumed full control of the development, manufacturing and global commercialization of mRNA vaccine candidates against influenza and COVID-19, including combinations. All vaccine candidates currently in clinical development are based on CureVac’s proprietary second-generation mRNA backbone.

Financial Update for the Third Quarter and First Nine Months of 2024

Commenting on the financial results, Axel Sven Malkomes, CureVac’s new Chief Financial Officer, said:

“Joining CureVac at this pivotal time is incredibly exciting. Our strengthened cash position, supported by our strategic redesign—including a significant reduction in headcount—provides a solid foundation to execute our strategic objectives. By extending our cash runway into 2028, we can allocate more resources toward our promising R&D pipeline in oncology and infectious diseases. I am committed to ensuring that we maintain financial discipline as we drive forward our mission to develop transformative mRNA medicines and create long-term value for our shareholders.”

Cash Position

Cash and cash equivalents amounted to €550.9 million at the end of September 2024, increasing from €402.5 million at the end of 2023. The company received the €400 million upfront payment from the new GSK licensing agreement in August 2024. In the first nine months of 2024, cash used in operations was mainly allocated to payments related to the termination of raw material commitments for the first-generation COVID-19 vaccine, CVnCoV, amounting to a total of €52 million and the payment of contract manufacturing organization (CMO)-related arbitration awards. All CMO-related arbitrations are closed, with the last payment made in the third quarter of 2024. Looking forward, there will be no further payments related to CVnCoV.

The remaining cash spend was mainly related to ongoing R&D activities. The company reaffirms its expected cash runway into 2028.

Revenues

Revenues amounted to €493.9 million and €520.7 million for the three and nine months ended September 30, 2024, respectively, representing an increase of €477.4 million and €489.5 million, or 2,897% and 1,569%, from €16.5 million and €31.2 million for the same periods in 2023.

The increase year-on-year was primarily driven by the new license agreement with GSK, which was closed in July 2024. CureVac received a non-refundable upfront payment of €400 million. Under the new license agreement, CureVac has no obligation to perform R&D work in connection with the newly granted licenses and GSK is provided with the right to use CureVac’s intellectual property. As such, the upfront payment was fully recognized in the third quarter of 2024 as revenue.

Under previous GSK agreements, upfront and milestone payments were related to R&D activities performed by CureVac over a period of time. Accordingly, related payments were recognized as contract liabilities and recognized as revenue on a pro rata basis over the period R&D activities were performed.

CureVac and GSK agreed in the new license agreement that all unfulfilled performance obligations from prior collaborations relating to R&D services had expired. As a result, the remaining €80.4 million of contract liabilities for prior collaborations were recognized as non-cash revenue in the third quarter of 2024.

€480.4 million of the revenue recognized in the third quarter of 2024 must therefore be seen as a positive one-time event that will not be repeated in the future.

Additionally, in the third quarter of 2024, CureVac reached a development milestone of €10.0 million under the previous GSK collaboration for the Phase 2 transition of the pre-pandemic avian influenza (H5N1) program, which is also fully recognized as revenue in the third quarter of 2024.

The remaining revenues relate to work on the GSK and CRISPR collaborations.

Operating Result

Operating profit amounted to €368.4 million and €221.4 million for the three and nine months ended September 30, 2024, respectively, representing an increase of €422.4 million and €407.6 million from an operating loss of €54.0 million and €186.2 million for the same periods in 2023.

The operating result was affected by several key drivers partially related to the new strategy and the closing of the first-generation vaccine effort in COVID-19:

  • Cost of sales increased year-on-year mainly due to higher arbitration costs for CMO activities related to the first-generation COVID-19 vaccine as well as due to higher personnel expenses related to the restructuring of the organization.
     
  • Research and development expenses increased primarily with increased activity in oncology R&D projects. Additionally, the first nine months of 2024 were impacted by increased expenses related to the litigation to enforce intellectual property rights.
     
  • General and administrative expenses decreased compared to the prior year period mainly driven by lower personnel expenses.
     
  • Other income increased year-on-year due to the sale of raw materials to GSK.
     
  • Other operating expenses increased year-on-year due to a partial impairment of CureVac’s production facility.

    While the production facility was initially planned and set up for commercial (large scale) production, CureVac no longer has large scale production obligations in addition to the strategic re-focus on technology innovation, research and development. Most parts of the production process can be scaled down to provide products for clinical production. Parts of the production process that cannot be scaled down were partially impaired in an amount of €36.6 million.

Financial Result (Finance Income and Expenses)

Net financial result for the three and nine months ended September 30, 2024, amounted to €2.2 million and €8.0 million, or a decrease of €3.1 million and €4.7 million, from €5.3 million and €12.7 million, respectively, for the same periods in 2023. This decrease was mainly driven by lower interest income on cash investments.

Pre-Tax Results

Pre-tax profit was €370.6 million and €229.4 million for the three and nine months ended September 30, 2024, compared to a pre-tax loss of €48.7 million and €173.5 million in the same periods of 2023.

Conference call and webcast details

CureVac will host a conference call and webcast today at 3 p.m. CET / 9 a.m. EST.
Dial-in numbers to participate in the conference call:

U.S. Toll-Free:  +1-877-407-0989

International: +1-201-389-0921

Germany: 0800-182-0040 (landline access) / 0800-184-4713 (cell phone access)

The live webcast link can be accessed via the newsroom section of the CureVac website at https://www.curevac.com/en/newsroom/events/

Corresponding presentation slides will be posted shortly before the start of the webcast.
A replay will be made available at this website after the event.

About CureVac

CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media and Investor Relations Contact

Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Forward-Looking Statements of CureVac

This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac N.V. and/or its wholly owned subsidiaries CureVac SE, CureVac Manufacturing GmbH, CureVac Inc., CureVac Swiss AG, CureVac Corporate Services GmbH, CureVac Belgium SA and CureVac Netherlands B.V. (the “company”) regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potential efficacy of the company’s vaccine and treatment candidates and the company’s strategies, financing plans, cash runway expectations, the timing and impact of restructuring, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,” “will,” “would,” “could,” “potential,” “intend,” or “should,” the negative of these terms or similar expressions. Forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company’s performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company’s industry, the effects of the COVID-19 pandemic on the company’s business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, fluctuations of operating results due to the effect of exchange rates, delays in litigation proceedings, different judicial outcomes or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company’s reports and documents filed with the U.S. Securities and Exchange Commission (the “SEC”). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

 

Cash and Condensed Consolidated Profit and Loss Data

 

         
(in € millions)   December 31, 2023   September 30, 2024  
Cash and Cash Equivalents   402.5   550.9  
           
           
  Three months ended September 30,  
 (in € millions)   2023   2024  
Revenue   16.5   493.9  
Cost of Sales, R&D, SG&A, Other Operating Expenses & Other Operating Income   -70.5   -125.5  
Operating Result   -54.0   368.4  
Financial Result   5.3   2.2  
Pre-Tax Result   -48.7   370.6  
  Nine months ended September 30,  
 
 
 (in € millions)   2023   2024  
Revenue   31.2   520.7  
Cost of Sales, R&D, SG&A, Other Operating Expenses & Other Operating Income   -217.4   -299.3  
Operating Result   -186.2   221.4  
Financial Result   12.7   8.0  
Pre-Tax Result   -173.5   229.4  
           


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Medios AG reports record quarter Q3 2024 with significant increase in earnings and margins (news with additional features)

EQS-News: Medios AG

/ Key word(s): 9 Month figures/Quarterly / Interim Statement

Medios AG reports record quarter Q3 2024 with significant increase in earnings and margins (news with additional features)

12.11.2024 / 08:41 CET/CEST

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

Press release
 

Medios AG reports record quarter Q3 2024 with significant increase in earnings and margins

  • EBITDA pre1 reaches €24.6 million (+42.9%) in the third quarter of 2024, setting a new record
  • EBITDA pre1 margin of 5.0% in the third quarter of 2024
  • Patient-Specific Therapies segment grows by more than 10% in EBITDA pre1 compared to the same quarter of the previous year
  • Revenue in the nine-month period of 2024 up 4.2%, EBITDA pre1 up 20.6%
  • Cash flow from operating activities significantly improved since the beginning of the year to €27.6 million
  • Integration of Ceban on track
  • Outlook for 2024 confirmed

Berlin, 12 November 2024 – Medios AG (“Medios”), a leading provider of Specialty Pharma in Europe, recorded a sustained successful business development in the first nine months of 2024. Revenue in the nine-month period increased by 4.2% to €1,400.5 million (previous year: €1,343.5 million). EBITDA pre1 improved disproportionately by 20.6% to €55.8 million (previous year: €46.3 million). This corresponds to an EBITDA pre1 margin of 4.0% (previous year: 3.4%). In addition, Medios recorded a significant increase in cash flow from operating activities to €27.6 million.

In the third quarter of 2024, the Group’s revenue increased by 0.7% compared to the previous year to €493.2 million (previous year: €489.9 million, analyst consensus: €523.9 million). In the same period, EBITDA pre1 rose sharply by 42.9% to €24.6 million (previous year: €17.2 million, analyst consensus: €24.7 million). The EBITDA pre1 margin was 5.0% (previous year: 3.5%). Medios thus achieved the best quarterly result in its history. This positive development is due in particular to the inclusion of the International Business segment since the beginning of June.

Matthias Gaertner, CEO of Medios AG: “In the third quarter of 2024, we performed exceptionally well, with a particularly strong improvement in the profit margin. On a quarterly basis, our group’s EBITDA pre1 margin is 5%, which is already at the level we are aiming for in 2025. In the Patient-Specific Therapies segment, we achieved the turnaround and increased earnings by more than 10% compared to the same quarter of the previous year despite all the challenges. I am also particularly pleased with the positive contributions from our new International Business segment with Ceban Pharmaceuticals. This successful development reflects the consistent implementation of our expanded growth strategy.”

Operating segments report different developments

The Pharmaceutical Supply segment increased its revenue by 2.0% to €1,191.2 million (previous year: €1,168.0 million) in the first nine months of 2024. The segment’s EBITDA pre1 rose by 9.9% to €37.0 million (previous year: €33.7 million). In the third quarter of 2024, the division’s revenues fell by 7.1 %. EBITDA pre1 rose by 2.7 % year on year due to higher-margin revenues.

In the Patient-Specific Therapies segment, revenue in the third quarter of 2024 fell by 3.5%. EBITDA pre1 increased by 10.3%, having declined in the previous quarters. In the first nine months of 2024, revenue was €161.6 million (previous year: €175.0 million) and thus 7.7% below the figure for the previous year, with €6.0 million of the decline attributable to the sale of Kölsche Blister GmbH in June 2023. In the first half of 2024 in particular, regulatory price adjustments and higher performance-related expenses for the assumption of compounding volumes were added. As a result, the segment’s EBITDA pre1 declined by 6.1% to €16.7 million (previous year: €17.8 million) in the period from January to September 2024 despite the increase in earnings in the third quarter.

The new International Business segment, which includes Ceban Pharmaceuticals B.V. (“Ceban”), fully consolidated since June 2024, generated revenue of €47.3 million in the first nine months of 2024 and contributed €9.8 million to the Group’s EBITDA pre1. The new segment thus achieved an EBITDA pre1 margin of 20.7%. The integration of Ceban into the Medios Group continues to go according to plan.

In August 2024, Medios announced that it would expand its activities in the area of Advanced Therapies and, in doing so, appoint Dr Andreas Schmiede as Vice President Advanced Therapies. Entering the Advanced Therapies market is the next phase of the expanded growth strategy presented in November 2022.

Positive outlook

Medios confirms its forecast for the 2024 financial year. Accordingly, the Company expects revenues of between €1.9 billion and €2.1 billion and EBITDA pre1 of between €82 million and €91 million. The EBITDA pre1 outlook is burdened by the one-month delay in the Ceban control transition as of June 1, 2024 and regulatory price adjustments in Germany; EBITDA pre1 growth will thus be at least 35% (YoY) with a significantly increased EBITDA pre1 margin of approx. 4.3%.

 

Key figures (IFRS)

in € million   9M 2024   9M 2023   ∆ in %   Q3 2024   Q3 2023   ∆ in %
Revenue   1,400.5   1,343.5   4.2   493.2   489.9   0.7
  Pharmaceutical Supply   1,191.2   1,168.0   2.0   403.3   433.9   -7.1
  Patient-Specific
  Therapies
  161.6   175.0   -7.7   54.1   56.0   -3.5
  International Business   47.3   n/a   n/a   35.7   n/a   n/a
  Services   0.5   0.5   -8.7   0.2   0.1   >100
EBITDA pre1   55.8   46.3   20.6   24.6   17.2   42.9
  Pharmaceutical Supply   37.0   33.7   9.9   14.1   13.8   2.7
  Patient-Specific
  Therapies
  16.7   17.8   -6.1   5.9   5.3   10.3
  International Business   9.8   n/a   n/a   7.1   n/a   n/a
  Services   -7.8   -5.3   47.5   -2.5   -1.9   32.6
Cash flow from operating activities   27.6   10.8   >100   -6.5   86.0   n/a

 

The Medios Quarterly Statement as of September 30, 2024 will be available for download on the Investor Relations website.

Important dates for Medios AG in the 2024 financial year:

November 19 CIC Conference – Paris
Dezember 3
 
Berenberg European Conference 2024 –
Pennyhill Park, Surrey, UK

 

1 EBITDA is defined as consolidated earnings before interest, taxes, depreciation and amortization. EBITDA pre is adjusted for special charges for stock options and expenses for M&A activities as well as for performance-related payments for the acquisition of compounding volumes and, from 2024, for expenses for the introduction of an ERP system.

——————-

About Medios AG

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

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

www.medios.ag

Contact

Claudia Nickolaus

Head of Investor & Public Relations, ESG Communications

Medios AG

Heidestraße 9 | 10557 Berlin

T +49 30 232 566 800

ir@medios.group

www.medios.group

 

Disclaimer

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


Additional features:

File: Medios_Q3_2024_EN


12.11.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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


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Marinomed Biotech AG publishes clinical data for decongestant Carragelose nasal spray in peer-reviewed International Journal of General Medicine

EQS-News: Marinomed Biotech AG

/ Key word(s): Study results/Scientific publication

Marinomed Biotech AG publishes clinical data for decongestant Carragelose nasal spray in peer-reviewed International Journal of General Medicine

12.11.2024 / 07:45 CET/CEST

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

Marinomed Biotech AG publishes clinical data for decongestant Carragelose nasal spray in peer-reviewed International Journal of General Medicine

  • Marinomed’s nasal spray containing Carragelose and Sorbitol significantly improves breathing due to its decongestant effect in patients suffering from allergic rhinitis
  • Results of the clinical study showing that the nasal spray is effective and safe were published in the peer-reviewed International Journal of General Medicine
  • Data support the application of Carragelose in allergic indications

Korneuburg, Austria, 12. November 2024 – Marinomed Biotech AG (VSE:MARI) has published the results of a clinical trial with a nasal spray combining the protective effect of Carragelose and the decongestant effect of Sorbitol in the peer-reviewed International Journal of General Medicine. In the clinical trial, patients with allergic rhinitis symptoms including nasal congestion were treated with the Carragelose-Sorbitol nasal spray. The product significantly improved breathing compared to placebo based on the decongestant effect of Sorbitol. These results support the application of the product as a treatment to reduce a blocked nose. Whether this is caused by an allergy or a cold is irrelevant. In contrast to the widely used pharmacologic decongestant nasal sprays, the product does not cause a habituation effect.

“The results show that allergic patients have a significant improvement in breathing already after the first use. Furthermore, the product is also suitable for children from one year of age”, Eva Prieschl-Grassauer, CSO of Marinomed, comments. “The clinical data also support the transition of Marinomed’s Carragelose products to the new Medical Device Regulation (MDR) and benefit our partnering activities.”

In the randomized, double-blind, cross-over trial, adults (18 to 65 years) with a history of grass pollen allergy were exposed to the grass pollen allergens in a challenge chamber. Participants developed rhinitis symptoms including nasal congestion. After developing pronounced allergic nasal symptoms, they were treated either with the Carragelose- and Sorbitol-containing nasal spray or placebo. The study participants were then further exposed to the grass pollen and the nasal airflow was measured. A significant improvement in nasal airflow was observed with the Carragelose- and Sorbitol-containing nasal spray compared to the placebo. The Carragelose-Sorbitol nasal spray has been launched in 2018 and is currently distributed in 11 countries.

About Carragelose®

Carragelose® is a sulfated polymer from red seaweed and a unique, broadly active virus- and allergen-blocking compound. It is known as a gentle, effective, and safe prevention and treatment of various viral respiratory infections. Several clinical and preclinical studies have shown that Carragelose® forms a protective layer on the mucosa that prevents viruses from infecting cells. Laboratory and clinical data have demonstrated that Carragelose® can also inhibit the spreading of SARS-CoV-2.[1],[2] Marinomed is the holder of the IP rights and has licensed Carragelose® for marketing in Europe, North America, Australia, and parts of Asia and Latin America. Marinomed’s portfolio of Carragelose®-containing nasal sprays and oral products can be accessed at https://www.carragelose.com/en/portfolio/launched-products, scientific publications on Carragelose® at https://www.carragelose.com/en/publications.

About Marinomed Biotech AG

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

For further inquiries contact:

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

Disclaimer

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

[1]  https://www.dovepress.com/efficacy-of-a-nasal-spray-containing-iota-carrageenan-in-the-postexpos-peer-reviewed-fulltext-article-IJGM

[2]  https://www.marinomed.com/en/news/marinomed-biotech-ag-shares-positive-clinical-trial-results-for-iota-carrageenan-nasal-spray-in-the-prevention-of-covid-19-1


12.11.2024 CET/CEST This Corporate News was distributed by EQS Group AG. www.eqs.com


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DINAMIQS opens new lab in Zurich

Siegfried AG

/ Key word(s): Expansion

DINAMIQS opens new lab in Zurich

12.11.2024 / 06:30 CET/CEST

Media Release
Zofingen, November 12, 2024

Siegfried (SIX: SFZN), a leading global Contract Development and Manufacturing Organization (CDMO) for the pharmaceutical industry headquartered in Zofingen (Switzerland), reached another milestone on its path to strengthen its offering in the biologics space, particularly in the fast-growing cell and gene therapy market. DINAMIQS, which became part of the Siegfried group in May 2023, inaugurated its cutting-edge laboratories in Zurich’s Bio-Technopark, Switzerland.

The fully equipped lab features high-end pilot-scale equipment, enabling DINAMIQS to provide clinical viral vector development, analytical and manufacturing services to meet the growing needs of the cell and gene therapy market. It is an integral part of DINAMIQS’ 2,500m2 cGMP manufacturing facility for viral vectors, which is currently under construction and set to be operational by the end of 2025. This facility will host up to 1,000L production capacity for the production of viral vectors for R&D, clinical trials and commercial use under one roof.

Marcel Imwinkelried, Chief Executive Officer Siegfried: “Aligned with Siegfried’s strategy EVOLVE+, the new lab facility marks a key milestone in DINAMIQS’ journey to becoming the leading CDMO in the cell and gene therapy space. The team is making significant strides toward bringing DINAMIQS’ capabilities to commercial scale.”

Martin Kessler, Chief Executive Officer DINAMIQS: “We know about the importance of leading process development and analytics for the success of viral vector projects. This is why we have expanded our Swiss labs significantly. From the optimization of genomes to GMP scale-up, our clients now get everything out of one hand.”

  • DINAMIQS, a Siegfried company specialized in viral vector design and manufacturing, inaugurated its new state-of-the-art R&D laboratories in Zurich’s Bio-Technopark
  • The new laboratory capacities house leading technologies in the field of viral vector process development and manufacturing
  • With this expansion, Siegfried is on track to strengthen its position in the fast-growing cell and gene therapy market
Contact  
   
Financial Analysts: Media:
Dr. Reto Suter Peter Stierli
Chief Financial Officer Head Corporate Communications
reto.suter@siegfried.ch peter.stierli@siegfried.ch
Tel. +41 62 746 11 35 Tel. +41 62 746 15 51
   
   

Siegfried Holding AG

Untere Bruehlstrasse 4

CH-4800 Zofingen

 

 

About Siegfried

The Siegfried Group is a global life sciences company with sites in Switzerland, Germany, Spain, France, Malta, the USA and China. In 2023, the company achieved sales of CHF 1.272 billion and employed on 31.12.2023 more than 3700 people at twelve sites on three continents. Siegfried Holding AG is publicly listed on the SIX Swiss Exchange (SIX: SFZN).

Siegfried is active in manufacturing pharmaceutical APIs (and their intermediates) as well as drug products (tablets, capsules, sterile vials, ampoules, cartridges and ointments) for the pharmaceutical industry and provides development services. 

About DINAMIQS

DINAMIQS, a Siegfried company, is a science-driven Contract Development and Manufacturing Organization (CDMO) offering end-to-end viral vector manufacturing solutions. DINAMIQS offers a comprehensive and customized range of manufacturing services, process development, quality control and analytics solutions for genetic medicine companies. It is located in Schlieren-Zurich Bio-Technopark in Switzerland.

Cautionary Statements Regarding Forward-Looking Statements

This media release includes statements concerning the future. They are based on assumptions and expectations that may prove to be wrong. They should be considered with due caution as, by definition, they contain known and unknown risks, insecurities and other factors which could result in a difference in the actual results, financial situation, developments or the success of Siegfried Holding AG or Siegfried Group from the explicit or implicit assumptions made in these statements.

expect more
 

Siegfried AG
Untere Brühlstrasse 4
4800 Zofingen, Switzerland

+41 62 746 11 11
info@siegfried.ch
www.siegfried.ch
 


End of Media Release


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AEVIS VICTORIA SA – Continued organic growth in the third quarter of 2024

AEVIS VICTORIA SA / Key word(s): 9 Month figures

12-Nov-2024 / 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.


Ad hoc announcement pursuant to Art. 53 LR

Fribourg, 12 November 2024

AEVIS VICTORIA SA (AEVS.SW) – Continued organic growth in the third quarter of 2024

AEVIS VICTORIA SA (AEVIS) achieved total revenues of CHF 761.0 million as at 30 September 2024, an increase of 7.1% compared to CHF 710.2 million in 2023. On a comparable basis, organic revenue growth was 6.0%, reflecting solid performance in the healthcare, hospitality and real estate segments.

Swiss Medical Network SA, the group’s healthcare segment, generated total revenues of CHF 594.9 million as at 30 September 2024, an increase of 5.1% over the prior year. This includes organic growth of 3.7%, supported by sustained demand for specialized healthcare services.

MRH Switzerland AG (formerly Victoria Jungfrau AG), the group’s hospitality division, achieved total revenues of CHF 151.6 million, an increase of 12.4% compared to the first nine months of 2023. Organic growth was 11.7%, driven by key destinations such as Interlaken and Zermatt.

The real estate segment also posted strong growth with total revenues of CHF 24.0 million, a 24.8% increase from 2023. This segment continues to benefit from the appreciation of the group’s strategic real estate assets.

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (80%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven luxury hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.


End of Inside Information


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Lonza to Expand Bioconjugation in Visp (CH) with Two Additional Manufacturing Suites

Lonza Group AG

/ Key word(s): Expansion

Lonza to Expand Bioconjugation in Visp (CH) with Two Additional Manufacturing Suites

12.11.2024 / 07:00 CET/CEST

  • The expansion of bioconjugation capabilities will provide additional manufacturing capacity for launch and commercial supply, addressing growing market demand
  • 2,000m2 of manufacturing space will include two additional production suites and supporting infrastructure
  • A significant increase in bioconjugation capacity will enable Lonza to offer expertise to a broad customer base and address the expected increase in approvals

Basel, Switzerland, 12 November 2024 – Lonza, a global development and manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, today announced it will invest in additional bioconjugation capabilities in Visp (CH). The expansion will add two multipurpose 1,200L manufacturing suites and manufacturing-related infrastructure to the existing bioconjugation facility in Visp (CH) for launch and commercial supply. The new capacity will generate approximately 200 new jobs and is expected to be operational from 2028.

The new suites will occupy approximately 2,000m2 and double Lonza’s multipurpose capacity for the launch and commercial supply of bioconjugates. The flexible multi-customer suites are designed to run the increasingly complex and variable processes needed to manufacture antibody-drug conjugates (ADCs) and other bioconjugates maturing through the drug pipeline.

The additional bioconjugation suites will support the growth of Lonza’s leading bioconjugation offering, spanning manufacturing for early phase clinical development, large-scale manufacture for launch and commercial supply, and will include drug product filling capability. This investment follows the recently announced customer-dedicated bioconjugation expansion in Visp (CH).

Christian Morello, Vice President, Head of Bioconjugates, Lonza, commented: “We continue to see strong growth in the bioconjugates space as ADCs and other bioconjugated drugs increasingly progress towards commercialization. This investment in our multipurpose commercial bioconjugation capacity addresses the growing market demand, enables us to support the growth of our customers and offers a flexible and integrated service for manufacturing bioconjugates.”

As part of Lonza’s emission reduction strategy, the manufacturing suites follow sustainability design standards for new builds that include energy-efficient water heating systems, air supply and lighting solutions, leading to a significant decrease in carbon footprint compared to traditional design solutions. In addition, technology for improved cytotoxic liquid waste management will reduce waste by up to 90%.

As a leading CDMO for bioconjugates, Lonza has produced over 1,000 cGMP batches for more than 70 programs since 2006. Lonza offers customers a fully integrated solution, spanning design and lead molecule generation including Synaffix conjugation technology, development, and manufacturing at scales adapted to phase and customer strategy.

About Lonza

Lonza is one of the world’s largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments.

Our business is structured to meet our customers’ complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 3.1 billion with a CORE EBITDA of CHF 893 million in Half-Year 2024. Find out more at www.lonza.com

Follow @Lonza on LinkedIn
Follow @LonzaGroup on X

Lonza Contact Details

Victoria Morgan
Head of External Communications
Lonza Group Ltd

Tel +41 61 316 2283
victoria.morgan@lonza.com

Dr. Martina Ribar Hestericová
Associate Director, Science Communications
Lonza Group Ltd
Tel +41 61 316 8982
martina.ribarhestericova@lonza.com

Daniel Buchta
Head of Investor Relations
Lonza Group Ltd
Tel +41 61 316 2985

daniel.buchta@lonza.com

Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

All trademarks belong to Lonza and are registered in CH, US and/or EU, or belong to their respective third-party owners and are used only for informational purposes.

Privacy Policy link

To immediately delete all the data


End of Media Release


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Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard

EQS-News: Formycon AG

/ Key word(s): Personnel/Contract

Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard

11.11.2024 / 17:41 CET/CEST

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

Press Release // November 11, 2024

Formycon extends Management Board contract for CEO Dr. Stefan Glombitza until 2027 and receives admission to trading in the Prime Standard 

  • Dr. Stefan Glombitza has been appointed as CEO for three more years and will lead Formycon through the next phase of the company’s development
  • Formycon shares will be admitted to the Prime Standard of the Frankfurt Stock Exchange – trading on the regulated market will start on November 12, 2024

Planegg-Martinsried, Germany – The Supervisory Board of Formycon AG (FSE: FYB; “Formycon” or “The Company”) has extended the contract of CEO Dr. Stefan Glombitza until December 31, 2027. The Board thus acknowledges Dr. Glombitza’s outstanding work as Chief Executive Officer (CEO) in recent years and is committed to the continued success of the company’s management. In addition, the shares of Formycon AG were admitted to the Prime Standard of the Frankfurt Stock Exchange today. Trading is scheduled to start on November 12, 2024.

Dr. Stefan Glombitza has been with Formycon AG since 2016 and during this time, has played a key role in the development and growth of the company. Initially responsible for operational development activities as Chief Operating Officer (COO), he was appointed as Chief Executive Officer (CEO) in July 2022. With over 25 years of experience in the international pharmaceutical industry, at Formycon he has built an excellent development platform leading a dedicated team, which has already resulted in approvals for three biosimilars. With the first product launches, he successfully guided Formycon into the commercial stage and has paved the way for further product launches.

“Dr. Glombitza has decisively shaped the strategic and operational development of Formycon in recent years and has significantly strengthened the company’s position in the biosimilar market,” explains Wolfgang Essler, Chairman of the Supervisory Board of Formycon AG. ”Thanks to his leadership, important milestones have been reached and the company has been set on a course for success.. With Dr. Glombitza at the helm, Formycon will further expand its role as one of the leading developers of biosimilars in the international market.”

“I am very pleased to be able to actively drive the growth phase that lies ahead of us, with the goal of fully realizing the tremendous potential of our company in the coming years. With three market-ready biosimilars and a strong pipeline, we have created a solid foundation for our continued growth. Today’s uplisting to the Prime Standard of the Frankfurt Stock Exchange increases our appeal to international investors and improves the tradability of our shares. I would like to thank the supervisory board and the entire Formycon team for their trust, cooperation and commitment, which are the cornerstones of our success,” said Dr. Stefan Glombitza.

As part of the uplisting, the shares of Formycon AG were admitted for trading in the Prime Standard of the Frankfurt Stock Exchange today. The Prime Standard is the segment with the highest transparency requirements in the regulated market and offers Formycon access to a broader group of investors. Inclusion in this segment isintended  to increased international awareness and higher liquidity of the stock. Trading in the Prime Standard is scheduled to start tomorrow, on November 12, 2024.

The company’s securities prospectus required for uplisting can be found at www.formycon.com/en/investor-relations/uplisting.

Further information can be found on our website at: www.formycon.com/en/investor-relations  

 

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/Ranibizumab, Formycon already has a biosimilar on the market in Europe and the USA. Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, received FDA approval; FYB202 is also approved in Europe. Another three biosimilar candidates are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines. Formycon AG is headquartered in Munich and is listed on the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

Contact:
Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110
Sabrina.Mueller@formycon.com 

Disclaimer:
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Relief Therapeutics Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

Relief Therapeutics Holding SA / Key word(s): Study results

11-Nov-2024 / 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 Announces Positive Final Results of RLF-TD011 Clinical Trial in Epidermolysis Bullosa

GENEVA (NOV. 11, 2024) – 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, today announced positive final results from its proof-of-concept, investigator-initiated clinical trial evaluating RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic condition characterized by fragile skin and chronic wounds.

The clinical trial evaluated the effects of RLF-TD011 on microbiome diversity in chronic and acute wounds in EB patients, focusing primarily on the most severe forms of the disease (junctional and dystrophic EB). Effective wound healing is crucial for these patients, as their wounds are vulnerable to colonization or infection by pathogenic microorganisms, which can significantly reduce healing rates, increase the risk of sepsis, and lead to other severe complications. In particular, Staphylococcus aureus frequently colonizes EB wounds, where it contributes to chronic inflammation and disrupts the skin microbiome.

The trial successfully met its primary endpoint. After eight weeks of treatment, RLF-TD011 led to a 24% decrease in S. aureus relative abundance (p=0.01), which correlated strongly (rho=0.64) with wound size reduction. Overall, 78% of treated wounds closed during the treatment period.

Microbiome analysis further showed that RLF-TD011 treatment led to a marked increase in alpha diversity, with an increase in beneficial bacteria within the wound microbiome, effectively reducing S. aureus without disrupting beneficial bacteria. Improvements in microbiome diversity persisted through a four-week post-treatment observation period, evidencing RLF-TD011’s durability effect on the wound environment without signs of regression or exacerbation.

“Epidermolysis bullosa is a devastating blistering skin disease that greatly impairs quality of life, particularly from the pain, itch, and risk of infection associated with open wounds. Evidence of reduction in the load of S. aureus and associated improved wound closure highlights the value of use of an antimicrobial spray during wound care,” said Prof. Amy Paller, Principal Investigator of the study and Chair of Dermatology at Northwestern University in Chicago, U.S.

“These findings support the potential of RLF-TD011 to meaningfully advance wound care for patients with epidermolysis bullosa,” commented Giorgio Reiner, chief scientific officer of Relief. “The data demonstrates RLF-TD011’s antimicrobial efficacy, which is critical for infection management in chronic EB wounds, as well as its role in promoting wound healing. This is an important milestone in the development of RLF-TD011 toward regulatory approval. With this data in hand, we plan to consult with the U.S. Food and Drug Administration to finalize our development and regulatory plan.”

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

ABOUT RLF-TD011
RLF-TD011 is a highly pure, stabilized hypochlorous acid solution developed using Relief’s proprietary TEHCLO™ technology. With strong antimicrobial properties, RLF-TD011 is a sprayable, self-administered solution for targeted wound application while avoiding skin contact and cross-contamination. RLF-TD011 has shown efficacy in accelerating wound closure and reducing infections in certain clinical trials on non-EB wounds. In preliminary cases, EB patients using RLF-TD011 showed improvements in blistering and tissue repair. RLF-TD011 aims to address an unmet need in EB care by efficiently controlling infection and inflammation while reducing antibiotic use and easing the intensive, time-consuming wound care routine required by current treatments. The U.S. Food and Drug Administration granted it orphan drug designation for EB, and Relief plans to seek qualified infectious disease product (QIDP) designation for extended market exclusivity.

ABOUT EPIDERMOLYSIS BULLOSA
Epidermolysis bullosa (EB) is a group of rare, inherited connective tissue disorders characterized by extreme skin fragility, leading to blistering and wounds from minor friction or injury. In severe cases, blisters can develop into chronic wounds or form in internal organs such as the mouth or esophagus, leading to painful wounds, recurrent infections, and a deeply impacted quality of life. EB is classified into several major inherited subtypes, each defined by the depth of blister formation within the skin’s layers: epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), junctional epidermolysis bullosa (JEB) and Kindler syndrome (KS). Treatment is intensive and includes wound care, infection prevention, and pain management. Approximately 500,000 individuals worldwide are affected by EB.

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

CONTACT:
RELIEF THERAPEUTICS Holding SA

Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com

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

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File: Ad hoc


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