Pentixapharm Welcomes CMS Decision to Enhance Reimbursement for Diagnostic Radiopharmaceuticals

EQS-News: Pentixapharm Holding AG

/ Key word(s): Statement

Pentixapharm Welcomes CMS Decision to Enhance Reimbursement for Diagnostic Radiopharmaceuticals

04.11.2024 / 17:26 CET/CEST

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

Berlin and Würzburg, Germany, November 4, 2024 – Pentixapharm, a biopharmaceutical company developing innovative first-in-class radiopharmaceuticals, welcomes the recent announcement by the U.S. Centers for Medicare & Medicaid Services (CMS) to implement separate payments for specialized diagnostic radiopharmaceuticals used in the hospital outpatient setting, extending beyond the transitional pass-through payment period. This significant policy shift could have a direct impact on future reimbursement streams for Pentixapharm’s Ga68-PentixaFor, a diagnostic radiopharmaceutical for which Pentixapharm intends to start a U.S. centric phase III clinical trial next year. The pivotal clinical trial could lead to a U.S. market authorization in primary aldosteronism (PA), one of the major causes of secondary hypertension, as early as 2028.

The CMS pass-through payment period is a temporary reimbursement mechanism under the Hospital Outpatient Prospective Payment System (OPPS). Lasting up to three years, this period provides additional payments for newly introduced medical devices, drugs, and biologicals, encouraging hospitals to adopt cutting-edge technologies by covering their costs beyond standard rates. However, under previous policies, after the pass-through period ended, products would typically revert to standard OPPS payment bundles. With this new policy announcement, CMS has changed this approach, allowing for separate payments beyond the pass-through period for qualifying high-cost diagnostics.

This decision by CMS is highly significant given the size and impact of the Medicare and Medicaid systems, which together insure more than 140 million Americans. As the primary healthcare payer for older adults and individuals with disabilities, CMS’s reimbursement policies shape access to medical innovations across the country. The new rule, effective in 2025, also has the potential to set a market precedent that may influence private insurers to follow CMS’s lead in reimbursing innovative diagnostic tools, further expanding the accessibility of these advanced diagnostics. By providing consistent reimbursement for diagnostic radiopharmaceuticals that exceed a per-day cost threshold of US$630, CMS encourages other insurers to consider similar reimbursement strategies.

The separate payment rule will most likely apply to Pentixapharm’s lead diagnostic compound, Ga68-PentixaFor, following its anticipated approval and the expiration of its pass-through status. Ga68-PentixaFor is a novel tracer for positron emission tomography (PET) imaging used to detect aldosterone-hypersecreting adenomas in patients diagnosed with primary Aldosteronism (PA). With rising prevalence rates for PA, now exceeding 20% in some populations with resistant hypertension, the need for accessible and precise diagnostics is greater than ever.

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.

PentixaFor (Gallium (68Ga) boclatixafortide) is an innovative PET tracer that specifically targets the chemokine-4 receptor (CXCR4), with broad applications in oncological, cardiovascular, and inflammatory diseases. Particularly in hypertension, PentixaFor has the potential to significantly improve patient management by identifying the presence of hormone-secreting adenomas through non-invasive and broadly available PET/CT imaging.

Apart from PentixaFor, the clinical pipeline also encompasses PentixaTher, an Yttrium-90 or Lutetium-177 based therapeutic against non-Hodgkin lymphomas (NHL). Clinical studies for both compounds have already commenced in Europe, including a dose-finding study for PentixaTher and a Phase III registration study for PentixaFor in marginal zone lymphoma. Recently, the EMA granted PRIME status to PentixaFor in the indication PA.

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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MEDICLIN increases consolidated sales and operating result – Management Board confirms annual forecast for 2024

EQS-News: MEDICLIN AG

/ Key word(s): 9 Month figures/Miscellaneous

MEDICLIN increases consolidated sales and operating result – Management Board confirms annual forecast for 2024

04.11.2024 / 14:30 CET/CEST

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

Offenburg, 04 November 2024
MEDICLIN increases consolidated sales and operating result – Management Board confirms annual forecast for 2024

  • MEDICLIN increases consolidated sales for 9M 2024 by 2.0% to EUR 558.2 million
  • Group EBIT of EUR 34.5 million higher than in the same period of the
    previous year (9M 2023: EUR 29.4 million)
  • Occupancy rate up on previous year at 86.0 (9M 2023: 84,4%)
  • Hospital reform expected at the turn of the year
  • The Executive Board confirms the forecast for the year

Offenburg, 04 November 2024: In the first nine months of 2024, MEDICLIN Aktiengesellschaft (MEDICLIN) generated consolidated sales of EUR 558.2 million. This is EUR 11.1 million or 2.0% more than in the first nine months of 2023. The consolidated operating result improved by EUR 5.1 million to EUR 34.4 million compared to the same period of the previous year. A positive business performance in the third quarter and a stable capacity utilisation rate of 86.0% (9M 2023: 84.4%) allow the Executive Board to confirm the annual forecast. For the current financial year, a decline in sales at the upper end of the forecast of -2.0% to 0.0% is expected. The consolidated operating result is now also expected to be at the upper end of the range of EUR 33.0 million to EUR 39.0 million last specified in the first half of the year.

Sales and earnings performance of the segments

In the post-acute segment, sales increased by 7.2% to EUR 361.2 million (9M 2023: EUR 337.0 million). At EUR 38.0 million, the segment operating result was EUR 2.9 million higher than in the same period of the previous year (9M 2023: EUR 35.1 million). The cost of materials ratio rose by 0.3 percentage points to 20.4% (9M 2023: 20.1%). At EUR 73.8 million, the absolute cost of materials was 9.1% higher than in the previous year (9M 2023: EUR 67.6 million). Personnel expenses increased by EUR 8.1 million or 4.5% to EUR 187.4 million compared to the first half of the previous year. The personnel expenses ratio fell to 51.9% (9M 2023: 53.2%).

The acute segment reported a decline in segment sales of EUR 16.3 million or 8.5%. The segment operating result totalled EUR -3.8 million after EUR -5.4 million in the third quarter of 2023. The cost of materials fell by 12.8% to EUR 50.0 million (9M 2023: EUR 57.3 million). The cost of materials ratio fell slightly to 28.5 % (9M 2023: 29.9%). Personnel expenses totalled EUR 106.1 million and were therefore 8.6% lower than in the first nine months of 2023 (9M 2023: EUR 116.1 million). The personnel expenses ratio remained almost unchanged at 60.4% after 60.5% in the same period of the previous year.

Sales in the Other Activities segment totalled EUR 21.5 million was 17.5% higher than the previous year’s figure, i.e. EUR 3.2 million. The nursing care business division contributed EUR 17.5 million to this figure, which corresponds to an increase of 11.3% compared to the previous year (9M 2023: EUR 15.8 million). At EUR 0.3 million, the segment operating result was up on the previous year’s result of EUR

-0.3 million.

Outlook – positive business performance in the third quarter of 2024

“As in previous years, the third quarter is once again the strongest of the current year. Group sales increased by EUR 7.9 million year-on-year to EUR 190.2 million. Profitability for the quarter was also positive with an EBIT margin of 11.8%. We are in a good financial position and confirm the annual forecasts for sales and consolidated operating profit at the upper end in each case due to the positive business develop-ment”, reports Tino Fritz, CFO of MEDICLIN.

Hospital reform expected at the turn of the year

“The hospital reform expected at the turn of the year has not taken rehabilitation into account. We are convinced that the elimination of hospital beds in the acute sector will not lead to fewer, but to more and earlier rehabilitation services. With MEDICLIN HOME, DIRECT and CAMPUS, we set out early on to face up to the developments in the healthcare market and take advantage of the opportunities offered by the outpati-ent and digitalisation of rehabilitation,” says Dr Joachim Ramming, CEO of MEDICLIN.

Thomas Piefke, COO of MEDICLIN, adds: “On 11 October, we opened outpatient orthopaedic rehabilitation at the Staufenburg Klinik in Durbach – as part of the MEDICLIN DIRECT range of services. With the expansion of this service, we are supplementing the existing services for rehabilitation in the areas of cancer, diabetes and obesity and are thus responding to the increasing demand for outpatient orthopaedic therapies. We are thus successfully driving forward outpatientisation at MEDICLIN and consistently implementing our strategy.”

The interim report as at 30 September 2024 is available from today at www.mediclin.de in German and English.

For further information:

MEDICLIN Aktiengesellschaft
Okenstrasse 27
77652 Offenburg

Investor Relations
Ender Gülcan
Phone: 0781/488-326
ender.guelcan@mediclin.de

Public Relations
Dr Janina Lossen
Phone: 0781/488-180
janina.lossen@mediclin.de

www.mediclin.de

About MEDICLIN Aktiengesellschaft (Ticker: MED; WKN: 659 510)
MEDICLIN includes 32 clinics, six care facilities and ten medical care centers. The Group has around 8,300 beds/care places and employs around 10,000 people. In a strong network, MEDICLIN offers the patient integrative care from the first visit to the doctor through the operation and subsequent rehabilitation to outpatient aftercare. Doctors, therapists and nurses work together in a carefully coordinated manner. MEDICLIN designs the care and support of people in need of care according to their individual needs and personal needs.

MEDICLIN ─ a company of the Asklepios Group

 


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CureVac to Present at the 12th International mRNA Health Conference

Issuer: CureVac

/ Key word(s): Conference

04.11.2024 / 13:00 CET/CEST

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

 CureVac to Present at the 12th International mRNA Health Conference
 

TÜBINGEN, Germany/BOSTON, USA – November 4, 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 that new and updated data will be shared in two oral presentations and four posters at the 12th International mRNA Health Conference, taking place in Boston, Massachusetts, November 12-14, 2024.

More detailed preliminary safety, tolerability and immunogenicity data from the dose escalation part of CureVac’s ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be shared in an oral presentation. Initial data from this study was presented last month at the European Society for Medical Oncology (ESMO) Congress demonstrating that treatment with CVGBM monotherapy successfully induced cancer antigen-specific T-cell responses in 77% of evaluable patients, of which 84% of immune responses were generated de novo by the vaccine. Expanded data from the dose escalation portion of the study will also be shared at the upcoming Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting later this week.

A second oral presentation will cover CureVac’s approach to developing optimized LNP delivery, while posters shared at the meeting will provide additional data on how CureVac optimizes its mRNA platform with different approaches as well as highlighting new targets for future development programs. The data to be shared will demonstrate the potential of CureVac’s mRNA platform in technology optimization, oncology, and infectious disease, driving future innovation in the mRNA space.

“With our recent corporate realignment and increased focus on research and innovation to develop meaningful mRNA medicines in different therapeutic areas, CureVac is more committed than ever to extending the horizons of mRNA. We are pleased to be presenting the recently announced promising clinical data from our glioblastoma mRNA vaccine program as well as results from our ongoing research in lipid nanoparticle delivery technology, oncology and infectious diseases,” said Dr. Myriam Mendila, Chief Scientific Officer at CureVac. “These presentations demonstrate the evolution of our long-standing commitment to apply mRNA technology in service to patients across a diverse spectrum of disease areas.”

 

Details on the two oral presentations are below: 

Title: Development of multiepitope mRNA vaccines – first results of Phase I human study in Glioblastoma patients
Session type: Oral Presentation
Date: Thursday, November 14
Time: 1:44 p.m. EST
Presenting Author: Regina Heidenreich, Ph.D., Senior Director Oncology Preclinical Development, CureVac SE

Title:  Development and optimization of lipid nanoparticles for delivery of mRNA vaccines
Session type: Oral Presentation
Date: Thursday, November 14
Time: 9:38 a.m. EST
Presenting Author: Paula Muresan, Ph.D., Research Scientist, CureVac SE

For more information on the conference and program, please visit the website: https://www.mrna-conference.com/

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, 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.


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CureVac Strengthens Leadership Team with Appointment of Seasoned Industry Executive Axel Sven Malkomes as Chief Financial Officer

Issuer: CureVac

/ Key word(s): Personnel

04.11.2024 / 13:03 CET/CEST

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

CureVac Strengthens Leadership Team with Appointment of Seasoned Industry Executive Axel Sven Malkomes as Chief Financial Officer
 

  • Experienced CFO and investment banker with 30-year track record will help drive CureVac’s transformation
     

TÜBINGEN, Germany/BOSTON, USA – November 4, 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 the appointment of Axel Sven Malkomes as Chief Financial Officer, effective November 11, 2024.

Mr. Malkomes joins CureVac at a pivotal moment as the company enters a new chapter of growth and innovation, bringing over three decades of senior corporate and investment banking experience within the biotech and pharmaceutical industries.

“Axel’s appointment corresponds with a significant milestone in CureVac’s evolution,” said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “As we embark on an exciting new phase of corporate development, his extensive expertise and proven leadership in the life sciences sector will be instrumental. Axel will play a key role in advancing our strategic initiatives, strengthening our financial foundation, and enhancing shareholder value. We are thrilled to welcome him to our leadership team.”

“I am honored to join CureVac at such a transformative time in the company’s journey,” said Axel Malkomes. “With its pioneering mRNA technology and the momentum from the recent deal with GSK, CureVac is well-positioned to make significant advancements in developing innovative medicines. I look forward to leveraging my experience in financial management and corporate growth to support CureVac’s mission and contribute to its future success.”

Mr. Malkomes most recently served as CFO at Cardior Pharmaceuticals GmbH, a private clinical-stage biopharmaceutical company pioneering the discovery and development of non-coding RNA-based therapeutics designed to address the root causes of heart disease. During his tenure, he played a crucial role in strategically and financially preparing the company for capital markets, co-leading significant financing rounds, and supported 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. There, he was instrumental in strategically and financially reshaping the company, significantly extending its cash runway and expanding its portfolio of strategic collaborations.

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 operational and corporate leadership positions at Merck KGaA.

Mr. Malkomes began his career in investment banking with institutions such as Dresdner Bank, Donaldson Lufkin Jenrette (which later became Credit Suisse), and Lehman Brothers, focusing on corporate finance, M&A, equity capital markets, and private equity transactions in the healthcare and life sciences sectors.

Since 2022, he has been a member of the Board of Directors of Cellectis SA, a cell and gene editing company listed on NASDAQ and Euronext, where he chairs the audit committee.

Mr. Malkomes holds a degree in business administration from Otto-Friedrich University in Bamberg, Germany, and has completed executive management programs at INSEAD, Kellogg School of Management at Northwestern University, and the Hong Kong University of Science and Technology.

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, 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.


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Original-Research: CS MEDICA A/S (von NuWays AG)

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Original-Research: CS MEDICA A/S – from NuWays AG

04.11.2024 / 09:01 CET/CEST
Dissemination of a Research, transmitted by EQS News – a service of EQS Group AG.
The issuer is solely responsible for the content of this research. The result of this research does not constitute investment advice or an invitation to conclude certain stock exchange transactions.

Classification of NuWays AG to CS MEDICA A/S

Company Name: CS MEDICA A/S
ISIN: DK0061668225
 
Reason for the research: Initiation
Recommendation: Buy
from: 04.11.2024
Target price: EUR 2.30
Target price on sight of: 12 months
Last rating change:
Analyst: Christian Sandherr

Revolutionizing alternative medicine; Initiate with BUY

CS MEDICA, a Danish Med-Tech company founded in 2011, is at the forefront of developing CBD-infused medical devices that offer safe, effective alternatives for autoimmune and stress-related conditions like arthritis, psoriasis, pain and hair loss. The company utilizes CBD’s proven anti-inflammatory and antioxidative properties in >10 products, classified as medical devices or cosmetics and backed by clinical trials. With regulatory approval in major markets such as the EU, U.K. and the U.S., CS MEDICA has established itself as a key player in the rapidly growing alternative medicine space.

CS MEDICA’s capital-light business model focuses on R&D and distribution while outsourcing manufacturing to partners in Europe. This allows the company to scale efficiently while minimizing operational risks. As one of only few CBD-infused medical device company registered for sale in pharmacies, CS MEDICA occupies a unique position at the intersection of the pharmaceutical and cosmetics markets, offering clinically proven products with fewer side effects at competitive price points.

CS MEDICA’s hybrid product formulations, which combine R&D, clinical evidence, compliance, and the benefits of CBD, a natural ingredient, set the company apart from competition. Its flagship line, CANNASEN ®, includes highly effective treatments for pain, skin disorders, and hair loss, with superior bioavailability when applied topically.

Strong growth prospects: Global demand for alternative treatments is booming, with the alternative medicine market projected to grow at a 15.7% CAGR until 2031. CS MEDICA is well-positioned to benefit from this trend. Especially non-European markets such as MENA and APAC offer high growth potentials once the regulatory hurdles have been overcome and social acceptance increased. The company’s private/white-label segment (~ 2/3 of order intake), offers a steady revenue stream, while its CANNASEN® brand continues to expand, contributing to rapid top-line growth.

The market’s strong growth prospects coupled with CS MEDICA’s unique positioning should allow the company to strongly grow its top-line to DKK 108m by FY 2027/28e, implying a 61% CAGR (vs FY 2023/24e). At the same time, thanks to the resulting operating leverage, the EBITDA margin should turn positive, reaching 25%.

We initiate the coverage with a BUY rating and a EUR 2.30 PT based on a SOTP valuation.

You can download the research here: http://www.more-ir.de/d/31171.pdf

For additional information visit our website: www.nuways-ag.com/research

Contact for questions:
NuWays AG – Equity Research
Web: www.nuways-ag.com
Email: research@nuways-ag.com
LinkedIn: https://www.linkedin.com/company/nuwaysag
Adresse: Mittelweg 16-17, 20148 Hamburg, Germany
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Diese Meldung ist keine Anlageberatung oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.
Offenlegung möglicher Interessenskonflikte nach § 85 WpHG beim oben analysierten Unternehmen befinden sich in der vollständigen Analyse.
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Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange

EQS-News: Formycon AG

/ Key word(s): Regulatory Admission/IPO

Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange

04.11.2024 / 06:30 CET/CEST

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

Press Release // November 04, 2024

Formycon applies for admission to the Prime Standard of the Frankfurt Stock Exchange

  • Application for admission to trading on the regulated market (Prime Standard) of the Frankfurt Stock Exchange will be submitted today
  • Trading of Formycon shares on the Prime Standard segment is expected to start on November 12, 2024
  • Company aims to expand its international investor base by continuously increasing share visibility, tradability, and liquidity
  • Additional index listings are targeted following Formycon’s inclusion in the MSCI Germany Small Cap Index in May 2023

Planegg-Martinsried, Germany – Formycon AG (“Formycon” or “The company”) announced today that it is applying to list its shares on the regulated market (Prime Standard) of the Frankfurt Stock Exchange (“uplisting”). The Prime Standard segment maintains the highest transparency standards with above average reporting requirements, specifically aimed at companies with an international investor focus. Through this uplisting, Formycon seeks to strengthen its international market position and enhance its visibility and appeal among investors by meeting the most stringent transparency and disclosure criteria.

The company expects to receive trading approval for the Prime Standard segment of the regulated market on November 11, 2024, with trading set to commence on November 12, 2024. The prospectus required for the uplisting is anticipated to earn BaFin approval on November 8, 2024, and will be made available shortly thereafter on the Formycon website at www.formycon.com/prospectus

“Over the past years, we’ve established Formycon as an internationally recognized, independent specialist for the development of biosimilars. Following FYB201- which is now available in 20 countries and the leading Lucentis® biosimilar in most markets – FYB202 and FYB203 will offer attractive therapeutic options for many patients and markets. This promising operational business development underlines the development potential of our company and forms the basis for the planned uplisting to a higher stock market segment, which sends a strong signal for our presence on the capital market,” says Dr. Stefan Glombitza, CEO of Formycon AG.

“We have been preparing intensely for this step over the past months, and we are thrilled to announce this important milestone for Formycon. With a market capitalization of approximately 870 million euros, the company has reached a stage of growth and maturity that has significantly increased interest from international and institutional investors. Moving to the Prime Standard was essential to provide this investor group—and our existing shareholders—with enhanced access to Formycon’s stock. Looking ahead, this transition also opens the door to potential inclusion in one of Deutsche Börse’s select indices, which would further boost the stock’s visibility and appeal,” explained Enno Spillner, CFO of Formycon AG.

Currently, the company’s shares are traded on the Frankfurt Stock Exchange’s open market (Scale segment) under ISIN DE000A1EWVY8 (WKN A1EWVY). This listing will be discontinued once trading on the regulated market begins. The ISIN and WKN will remain the same following the uplisting.

M.M.Warburg & CO (AG & Co.) is acting as the listing agent for the uplisting.

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:

This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.

 


04.11.2024 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.
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Relief Therapeutics Signs Non-Binding Letter of Intent with Renexxion for Reverse Merger

Relief Therapeutics Holding SA / Key word(s): Merger

04-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 Signs Non-Binding Letter of Intent with Renexxion for Reverse Merger
 

GENEVA (NOV. 4, 2024) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced it has signed a non-binding letter of intent (LOI) with Renexxion, Inc. (Renexxion), a privately-held U.S.-based clinical-stage biotechnology company specializing in gastrointestinal disorders therapies. The proposed reverse merger between Relief and Renexxion aims to create a combined entity with an expanded therapeutic pipeline addressing critical unmet healthcare needs worldwide.

The transaction, if entered into and completed, is expected to strengthen the combined company’s competitive position in the biotech industry while providing new growth initiatives through their complementary resources and expertise. This potential strategic merger is anticipated to enhance shareholder value, broaden access to capital, and accelerate the delivery of innovative therapies to patients.

“The contemplated merger with Renexxion represents an exceptional opportunity to build a more resilient and innovative business that stands to benefit our stakeholders, leveraging Relief’s portfolio and proven expertise in rare and specialty diseases,” said Dr. Raghuram Selvaraju, chairman of the board of directors of Relief. “After an extensive strategic review and careful consideration of multiple alternatives, Relief’s board of directors has determined that this combination with Renexxion is the most promising path to deliver sustained value for our shareholders and accelerate our impact on critical healthcare needs worldwide.”

“This prospective merger will be a transformative step forward in Renexxion’s journey,” said Dr. Peter G. Milner, chairman and CEO of Renexxion. “In partnership with Relief, we will be positioned to redefine the landscape of gastrointestinal healthcare by accelerating the clinical development of naronapride, our lead compound, to address critical unmet needs in conditions such as gastroparesis and PPI-non-responsive symptomatic GERD. The FDA IND clearance for U.S. trials in both of these indications underscores naronapride’s strong safety and efficacy profile, positioning it as a potential best-in-class prokinetic. By combining Relief’s resources and expertise with our proven development framework, we aim to accelerate the delivery of urgently needed treatments to patients and expand the therapeutic areas in which the combined company will operate. Together, we are committed to advancing GI therapeutics and becoming a global leader in this space, with a focus on innovation, patient safety, and impactful outcomes.”

Transaction Overview
Pursuant to the terms of the LOI, the transaction will be structured as an equity combination in which Relief would acquire all outstanding shares of Renexxion in exchange for newly issued shares of Relief to be allocated to the Renexxion shareholders, subject to shareholder approval and other conditions. This exchange is based on pre-determined valuations of each company’s equity interests. Relief’s fully diluted equity is valued at USD 100 million, while Renexxion’s equity is valued at USD 260 million, in each case subject to adjustment based on cash held by each company at closing. The initial merger ratio would therefore allocate approximately 72.2% ownership to Renexxion shareholders and 27.8% to Relief shareholders. Post-transaction, it is anticipated that the shares of the combined entity would continue to trade on the SIX Swiss Exchange and remain quoted in the U.S. on OTCQB.

The LOI also provides for a one-year post-closing reset mechanism to adjust the ownership ratio based on the combined entity’s market value at that time within certain parameters. This provision is intended to protect Relief’s legacy shareholders by ensuring that the ownership distribution continues to accurately reflect performance after the business combination.

Relief and Renexxion will continue negotiations to enter into a definitive merger agreement by December 31, 2024. Completion of the transaction is subject to customary conditions, including (i) the satisfactory completion of additional due diligence, (ii) the execution of a definitive merger agreement, (iii) the completion of a concurrent private financing by Renexxion, and (iv) regulatory and shareholder approvals. There can be no assurance that a definitive agreement will be reached or that the proposed transaction will be entered into or completed as proposed, or at all.

ABOUT RENEXXION
Renexxion, Inc. is a clinical-stage biopharmaceutical company pioneering therapies for gastrointestinal (GI) disorders. Renexxion’s lead compound, naronapride, is a potential best-in-class, highly selective dual-action 5-HT4 agonist/D2-antagonist prokinetic agent designed to enhance GI motility with minimal systemic absorption. Naronapride is currently being studied in a Phase 2 clinical trial for gastroparesis in collaboration with Renexxion’s strategic European partner, a leader in GI therapeutics.

The ongoing multi-center global study (ClinicalTrials.gov ID: NCT05621811) is evaluating naronapride’s efficacy, safety and tolerability in a 320-patient, placebo-controlled Phase 2b (MOVE-IT) trial for gastroparesis. Following recent FDA clearance of the Investigational New Drug (IND) application, the trial has expanded to up to 25 sites across the United States. Top-line results are anticipated in 2025.

Gastroparesis is a serious and often underdiagnosed disorder characterized by delayed gastric emptying, affecting approximately 1.7% of the population in the U.S. and 1% in Europe with gastroparesis-like symptoms. Patients experience debilitating symptoms, such as nausea, vomiting, and bloating, often due to diabetic or idiopathic causes. Existing treatments, like metoclopramide, come with significant safety concerns, including a black-box warning, underscoring the need for safer, more effective alternatives. Naronapride’s unique, topically active 5-HT4 and D2 activity has demonstrated acceleration of gastric emptying in healthy volunteers, and relief of symptoms in a range of Phase 2 studies of functional GI disorders.

Additionally, Renexxion has received FDA IND clearance for naronapride as a potential treatment for proton pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). PPI-nrsGERD affects up to 10 million people in the U.S., with between 10–40% of patients not achieving adequate symptom control from PPIs alone. Published evidence shows that a combination of PPI treatment and GI prokinetics is more effective than PPIs alone for certain patients. As a locally acting prokinetic, naronapride addresses the GI motility issues underlying these symptoms, offering a promising adjunctive treatment. Renexxion, in conjunction with its European partner, has prioritized PPI-nrsGERD as the next focus in its global development plan.

Renexxion has a robust intellectual property portfolio which strengthens its competitive edge in the GI therapeutics sector. Through strategic partnerships, scientific advancements, and a commitment to addressing patients with high-unmet need, Renexxion aims to redefine GI healthcare and deliver transformative solutions for millions of patients worldwide.

For more information, visit Renexxion’s websites at www.renexxion.com and www.rnexltd.ie.

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. The information provided on Renexxion within this press release and on Renexxion’s website is provided by Renexxion. Relief makes no representation or warranty as to the accuracy, completeness, or reliability of such information and disclaims any obligation or liability in connection with it.

Participants in the Solicitation: Relief and Renexxion and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. Relief shareholders and other interested persons may obtain more detailed information regarding directors and officers of Relief in Relief’s Report on Form 20-F for the year ended December 31, 2023, as filed with the SEC on April 30, 2024. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from Relief’s and Renexxion’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that Relief, Renexxion or a combined company intends to file with the SEC.

No Offer or Solicitation: This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Renexxion, Relief or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.

Additional features:

File: Ad hoc


End of Inside Information


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BRAIN Biotech AG and Akribion Therapeutics GmbH sign exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology

EQS-News: BRAIN Biotech AG

/ Key word(s): Contract

BRAIN Biotech AG and Akribion Therapeutics GmbH sign exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology

31.10.2024 / 19:20 CET/CEST

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

BRAIN Biotech AG and Akribion Therapeutics GmbH sign exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology

  • Akribion Therapeutics GmbH financed by strong Venture Capital Consortium with pharma expertise
  • BRAIN can receive up to EUR 92.3 million R&D and commercial milestone fees plus additional royalties in exchange for granting exclusive G-dase E rights for use in Pharma
  • Non-pharma related proprietary CRISPR rights remain with BRAIN Biotech for use in its core business

Zwingenberg, Germany, 31.10.2024 – BRAIN Biotech AG signed an exclusive technology pharma licensing agreement with Akribion Therapeutics GmbH for its genome editing nuclease G-dase E®. In exchange for granting exclusive pharma rights to Akribion, BRAIN Biotech can receive up to EUR 92.3 million R&D and commercial milestone fees. In addition, the company will be entitled to royalties on net sales. The payment structure is based on clinical development progress and market success.

Akribion is led by the two Co-CEOs Lukas Linnig and Dr. Michael Krohn, who will leave BRAIN Biotech in the next weeks to lead Akribion Therapeutics. Lukas and Michael will be joined by an experienced team of scientists and commercial developers. Akribion is financially backed by a venture capital consortium with a strong track record in early-stage pharma ventures.

Adriaan Moelker, CEO of BRAIN Biotech AG, states: “This transaction marks the next important milestone to commercialize and partner projects from our BioIncubator segment which contains highly value-added projects. To successfully develop pharma projects, we have always been looking for strong partners with deep expertise in the sector. This strong venture capital consortium will now help develop this very promising new therapy approach together with the management and scientific team of Akribion Therapeutics, giving the technology the best chance for success whilst allowing BRAIN Biotech to focus on its core business. BRAIN Biotech will continue to realize additional commercialization options for our CRISPR-Cas nucleases outside the exclusively licensed field.”

Lukas Linnig, Co-CEO Akribion Therapeutics GmbH says: “We are pleased to see this transaction unfold with a strong consortium, a committed team and supportive licensing partner in BRAIN Biotech. We look forward to building Akribion Therapeutics as a key player to develop urgently needed medication for patients with life threatening diseases.” Dr. Michael Krohn, Co-CEO Akribion Therapeutics GmbH adds: “This pioneering technology holds the potential to significantly expand the treatment landscape, not only in oncology but across various therapeutic areas but always driven by our commitment to deliver innovative, ethically grounded treatments that improve outcomes for patients facing serious diseases.”

The genome editing nuclease G-dase E® is part of the proprietary CRISPR-Cas genome editing nuclease portfolio of BRAIN Biotech AG and has been developed within the company’s BioIncubator pipeline of highly innovative projects. BRAIN Biotech intends to commercialize and monetize additional projects with high value from its BioIncubator pipeline during the next years.

This transaction remains subject to customary closing conditions.

+++

About BRAIN Biotech

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

About Akribion Therapeutics

Akribion Therapeutics GmbH is an early stage biotech company developing precision oncology treatments. Using a groundbreaking new class of guided cytotoxic nucleases, Akribion aims to broaden the treatment landscape in critical therapeutic areas, with an initial focus in oncology through the use of highly selective cell depletion technology, enabled by specific targeting of RNA biomarkers. This unique technology platform is based on a proprietary family of nucleases termed G-dase® E.

Akribion is committed to using its technology to improve patient treatment in compliance with high ethical standards.

Akribion Therapeutics has been founded in 2024 by an expert team of scientists and Biotech executives, and is headquartered in Zwingenberg, Germany.

For more information, please see LinkedIn.

 

Contact Media

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

Contact Investor Relations

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

 

Disclaimer

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

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

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

 


31.10.2024 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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BRAIN Biotech AG signs exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology with Akribion Therapeutics GmbH for up to EUR 92.3 million milestone fees plus royalties

BRAIN Biotech AG / Key word(s): Contract

BRAIN Biotech AG signs exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology with Akribion Therapeutics GmbH for up to EUR 92.3 million milestone fees plus royalties

31-Oct-2024 / 19:11 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 AG.

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


NOT FOR DISTRIBUTION OR DISSEMINATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR DISSEMINATION WOULD BE UNLAWFUL. OTHER RESTRICTIONS APPLY. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

BRAIN Biotech AG signs exclusive pharma licensing agreement for G-dase E® CRISPR-Cas technology with Akribion Therapeutics GmbH for up to EUR 92.3 million milestone fees plus royalties

Zwingenberg, Germany, 31 October 2024 – BRAIN Biotech AG (ISIN DE0005203947; “BRAIN” or “Company”) signed an exclusive technology pharma licensing agreement with Akribion Therapeutics GmbH (“Akribion”) for its genome editing uclease G-dase E®. In exchange for granting exclusivity for pharma applications to Akribion, BRAIN can receive up to EUR 92.3 million R&D and commercial milestone fees. In addition, the company will be entitled to royalties on net sales. The payment structure is based on clinical development progress and market success of Akribion. Akribion is independently owned from the Company and seed financed by venture capital. Non-Pharma related proprietary CRISPR rights remain with BRAIN for commercialization in its core business.

This transaction remains subject to customary closing conditions.

 

Notifying person:

Martina Schuster

BRAIN Biotech AG

– Investor Relations –

Darmstädter Str. 34-36

64673 Zwingenberg

Deutschland

www.brain-biotech.com

Investor Relations Office

Tel.: +49-(0)-6251-9331-0

Fax: +49-(0)-6251-9331-11

E-Mail: ir@brain-biotech.com

IMPORTANT NOTICE

This announcement may not be published, distributed or released in the United States of America (including its territories and possessions, any state of the United States of America and the District of Columbia), Australia, Canada, Japan or any other jurisdiction in which the publication, distribution or release would be unlawful. This announcement does not constitute an offer of securities of the company for sale or a solicitation of an offer to purchase securities of the company. There will be no public offer of securities of the Company.

End of Inside Information


31-Oct-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Secarna Announces Appointment of Konstantin Petropoulos as Chief Executive Office

EQS-News: Secarna Pharmaceuticals GmbH & Co. KG

/ Key word(s): Personnel

Secarna Announces Appointment of Konstantin Petropoulos as Chief Executive Office

31.10.2024 / 16:03 CET/CEST

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

Martinsried (Munich), Germany, October 31, 2024 – Secarna Pharmaceuticals GmbH & Co. KG, a company redefining the discovery and development of best-in-class oligonucleotide therapeutics today announced the promotion of Konstantin Petropoulos, PhD, MBA, to Chief Executive Officer.  He has served as the Company’s Chief Business Officer since June 2023.  Alexander Gebauer, MD, PhD, is stepping down with immediate effect to focus his efforts on another company, Galimedix Therapeutics, that he has co-founded and is leading. He will continue to support Dr. Petropoulos in his new role to ensure a smooth transition.

“I am excited to take on this new role at Secarna,” said Konstantin Petropoulos. “I joined Secarna because of my strong belief in the Company’s oligonucleotide technology platform and its potential to bring groundbreaking therapies to patients.  My enthusiasm has grown as I’ve seen our partnered programs advance into the clinic and as we produce highly differentiated proprietary preclinical projects. I want to express my deep gratitude for Alexander’s success in growing our platform and progressing our lead program SECN-15, as well as his dedication and tireless energy in helping us to grow and bringing us to where we are today.  I very much look forward to leading Secarna in its next stage, as we deliver best-in-class oligonucleotide therapeutics that offer the possibility of transforming untreatable conditions into treatable ones and profoundly changing the future of medicine.”

“I have worked very closely with Konstantin since he joined Secarna, and he has been highly successful in helping to drive the business,” said Alexander Gebauer. “With my responsibilities increasing elsewhere, it is the right time to hand over the reins.  Konstantin is highly respected by our partners, customers and the Secarna team, and I am convinced Konstantin has the ability to grow Secarna’s business and advance the pipeline. I look forward to continuing to serve as an advisor and am enthusiastic about the Company’s future.”

Konstantin Petropoulos joined Secarna as CBO in June 2023. He previously served as CEO of AMW GmbH. Prior to that, he held senior management positions in business development as well as commercialization at several biotech and pharma companies, including Leukocare AG, Bayer AG and MorphoSys AG. Konstantin has strong industry experience and a solid track record of growing and expanding businesses. He has been responsible for major business development deals, including licensing/co-development agreements and strategic alliances, and brings extensive knowledge of portfolio strategy development, marketing and sales.

Konstantin has a PhD in oncology from the Ludwig-Maximilians-University, Munich, Germany and an MBA from the University of Applied Sciences for Economics and Management.

About Secarna Pharmaceuticals

Secarna Pharmaceuticals is a biopharmaceutical company redefining the discovery and development of best-in-class oligonucleotide therapeutics addressing high unmet medical needs in immuno-oncology and immunology, as well as viral, neurodegenerative and cardiometabolic diseases. Secarna’s mission is to maximize the performance and output of OligoCreator, its proprietary oligonucleotide discovery and development platform, to generate highly specific, safe, and efficacious best-in-class therapeutics. With over 20 discovery and development programs, including both proprietary pipeline projects and partnered programs, Secarna focuses on targets in indications where oligonucleotide-based approaches have clear potential benefits over other therapeutic modalities. www.secarna.com

Contact
Secarna Pharmaceuticals GmbH & Co. KG

Am Klopferspitz 19
82152 Planegg/Martinsried · Germany
Tel.: +49 (0)89 215 46 375

Konstantin Petropoulos, PhD, MBA
Chief Executive Officer
info@secarna.com

For media inquiries contact
MC Services AG

Anne Hennecke/Vera Lang
secarna@mc-services.eu
Tel.: +49.211.52 92 52 15


31.10.2024 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.
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