All 154,053 new shares have been subscribed at these issue terms and conditions by a total of eleven investors, including members of the Supervisory and Management Boards.

The Company is continuing to negotiate with another investor regarding a possible second capital increase of a further 154,053 new shares to be issued from the authorized capital 2024, which would be issued in accordance with the authorization to exclude the statutory subscription rights of existing shareholders. The actual implementation of this second capital increase is dependent on the outcome of the specific negotiations with the investor, the conclusion of the respective transaction documents and the adoption of a resolution by the Company’s Management Board and Supervisory Board. For the second capital increase, a report on the planned exclusion of statutory subscription rights must also be published at least two weeks before the required Supervisory Board resolution. In addition, the approval of the restructuring administrator (still pending for the second capital increase) is required due to the ongoing restructuring proceedings.

+++ End of ad-hoc announcement +++

Mainz Biomed Announces Petra Smeltzer Starke to Join Company as Brand Ambassador

Strategic Alliance with Former White House Senior Adviser to Focus on Awareness of Mainz Biomed’s Products and the Importance of Early Detection  

BERKELEY, US and MAINZ, Germany – September 18, 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, announced today the addition of Petra Smeltzer Starke as a Brand Ambassador for the Company.  As Brand Ambassador she will help the Company in the development and dissemination of messaging focused on the importance of early detection of colorectal cancer.

“We are excited about Petra joining our team as Brand Ambassador.  Her broad and deep experience will be invaluable to us as we bring our next generation colorectal cancer screening product to market, with the intention to launch a pivotal PMA trial by the end of 2025,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. 

Petra Smeltzer Starke commented, “I am proud and excited to work with Mainz Biomed as they push the envelope on the early detection of colorectal cancer and importantly the detection of pre-cancerous polyps.”

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

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About Petra Smeltzer Starke

Petra Smeltzer Starke’s phenomenal career started from studying international business, trade, and diplomacy at the Prague School of Economics while supporting herself as a model. Petra’s passion for Fashion translates into her modeling successes notwithstanding, Starke finished both undergraduate and graduate degrees at the top of her class and moved to the United States to attend law school at Georgetown University.

Starke was first in her class in law school & practiced law at the international law firm of O’Melveny & Myers, LLP representing many political nominees and appointees during the Bush Administration. Starke was subsequently recruited for the Obama Presidential Transition and later the Obama White House where she served as General Counsel to the White House Council of Economic Advisors and Senior Advisor to the President. Starke has Counseled American Presidents, and global Diplomatic Leaders around the world, and established a phenomenal international network. Starke’s expertise helped the Biden-Harris Transition Team – ethics and avoiding conflicts of interest.

About Mainz Biomed NV

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

For media inquiries

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

For investor inquiries, please contact info@mainzbiomed.com

Forward-Looking Statements

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

Immunic Presents Key Vidofludimus Calcium Data at the 40^th Congress of ECTRIMS, Highlighting Its Therapeutic Potential in Multiple Sclerosis

– Vidofludimus Calcium Consistently Reduced Neurofilament Light Chain Levels, Compared to Placebo, in the Interim Analysis of the Phase 2 CALLIPER Trial, Across Age and Disability Levels at Baseline For All Progressive Multiple Sclerosis Subtypes – 

– Clinical Signal Shown for Vidofludimus Calcium on Post COVID Fatigue May Be Related to Epstein-Barr Virus Reactivation; Preventing This Reactivation May Contribute to Fatigue Reduction in Multiple Sclerosis Patients – 

– Preclinical Data Showed Improved Neuronal Survival, Likely Driven by Vidofludimus Calcium’s Induction of Nurr1 Activation, as Demonstrated by Primary Target Gene Regulation –

– In Preclinical Experiments, Vidofludimus Calcium Reduced or Prevented Development of Pathogenic Peripheral T Helper Cells, Which Could be One of the Treatment Pathways in Multiple Sclerosis –

NEW YORK, September 18, 2024 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), highlighting Immunic’s lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium’s (IMU-838) therapeutic potential in multiple sclerosis (MS). The data will be presented in an oral poster presentation and three ePosters at this conference, being held September 18-20, 2024, in Copenhagen, Denmark. Additionally, members of Immunic will be available throughout the event at booth #60.

“Having four poster presentations on our lead asset, vidofludimus calcium, at the prestigious ECTRIMS Congress, illustrates the strength of the data generated for our drug candidate, to date, and its potential to become a new treatment option for MS,” stated Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We are particularly excited to have the opportunity to present data on various aspects of vidofludimus calcium’s profile, including the neurofilament light chain (NfL) interim data from our phase 2 CALLIPER trial, antiviral data suggesting an effect on reducing fatigue, Nurr1 target data supporting a neuroprotective profile, and pathogenic T cell data further supporting the drug’s anti-inflammatory effects.”

Dr. Vitt added, “As previously reported, in the interim analysis of our CALLIPER trial, we observed a clear separation from placebo in serum NfL levels among all patients with progressive multiple sclerosis (PMS) as well as its subtypes. These observations support the potential effectiveness of vidofludimus calcium in slowing disease progression in PMS and further substantiate its neuroprotective capabilities through the activation of Nurr1. Our next major data readout for this asset is the CALLIPER top-line data, which we expect to release in April of next year. We believe that, if the CALLIPER trial is successful in showing a beneficial effect of vidofludimus calcium, this data, along with that from the ENSURE program and vidofludimus calcium’s already established, strong safety and tolerability profile, may allow for a meaningful clinical differentiation of vidofludimus calcium compared to other MS medications, providing potentially attractive commercial positioning.”

Dr. Vitt continued, “Fatigue is one of the most common and most debilitating symptoms for both post-Covid Syndrome (PCS) and MS. Third-party research has recognized Epstein-Barr virus (EBV) reactivation as a potential cause for PCS fatigue. Notably, data has demonstrated not only vidofludimus calcium’s antiviral effects, but also its potential ability to prevent reactivation of EBV. We aim to confirm vidofludimus calcium’s potential to reduce fatigue in MS patients in our ongoing CALLIPER and phase 3 ENSURE trials and in the recently initiated investigator-sponsored phase 2 RAPID_REVIVE trial in PCS patients. Additionally, results from an animal model suggest that vidofludimus calcium reduces or prevents the development of pathogenic peripheral T helper cells. Besides its effect on pathogenic immune cells, preclinical evidence further suggests a neuroprotective role of vidofludimus calcium via activation of Nurr1. Preclinical data support Nurr1-driven direct neuroprotective effects by vidofludimus calcium enhancing neuronal survival and indirect effects by reducing neurotoxic activation of microglia cells. The combination of neuroprotective and anti-inflammatory effects of vidofludimus calcium represents a potential beneficial profile for effective treatment of MS.”

Oral Poster Presentation:

• Title: Serum Neurofilament Changes in Progressive MS: Exploring the Impact of Vidofludimus Calcium by Age and Disability in the CALLIPER Study Interim Analysis
• Presenting Author: Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio
• Poster Number: P753
• Session Title: Poster Session 2
• Date: Thursday, September 19, 2024
• Time: 4:45 pm – 6:45 pm CEST

In the phase 2 CALLIPER trial interim analysis of 203 patients, serum NfL levels were reduced by 22.4% (p=0.01, post hoc) after 24 weeks of vidofludimus calcium treatment compared to placebo, with consistent treatment effects across each progressive MS subtype, including primary progressive MS as well as active and non-active secondary progressive MS. The vidofludimus calcium group showed a 10% decrease in NfL versus a 20% increase for placebo among those with an Expanded Disability Status Scale (EDSS) score ≤ 5.5; and a 2% decrease for vidofludimus calcium versus a 12% increase for placebo among those with an EDSS score >5.5. Similarly, among patients aged ≤ 45 years, the reduction was 11.6% for vidofludimus calcium versus a 15% increase for placebo, while for those aged > 55 years, it was a 10% decrease versus a 13% increase, respectively. The data suggest that vidofludimus calcium treatment consistently reduces NfL levels compared to placebo across different patient subgroups based on age and disability scores at baseline. 

ePosters:

• Title: Exploring the Potential of Vidofludimus Calcium to Reduce Fatigue in Multiple Sclerosis by Preventing Epstein-Barr Virus Reactivation
• ePoster Number: P1119

Analysis of the antiviral activity of vidofludimus calcium in vitro revealed a dose-dependent reduction of lytic EBV reactivation in B cells and an anti-EBV effect in epithelial cells. Results of a post-hoc analysis of PCS symptoms in the phase 2 CALVID-1 trial indicated a potential contribution of vidofludimus calcium to the prevention of long-term fatigue. 80% of patients who received placebo reported fatigue compared to 50% who received 45 mg vidofludimus calcium. Fatigue decreased in both treatment groups in the next 9-17 weeks to 33% for placebo and 17% for vidofludimus calcium. A clinical signal for vidofludimus calcium on PCS fatigue was observed which might be related to EBV reactivation. By preventing this reactivation, vidofludimus calcium may contribute to fatigue reduction in MS patients as well. This hypothesis will be further assessed by determining effects on fatigue using patient questionnaires as well as analyses of the anti-EBV effect in the ongoing CALLIPER, ENSURE, and RAPID_REVIVE clinical trials.

• Title: Vidofludimus Calcium Activity on Nurr1 in Preclinical Models: A Potential Neuroprotective Function in Multiple Sclerosis
• ePoster Number: P1410

Vidofludimus calcium enhanced the expression of Nurr1 target genes important for neuronal survival, such as brain derived neurotrophic factor (BDNF) and superoxide dismutase 1 (SOD1), in a rat neuronal cell line. Additionally, it upregulated key Nurr1 target genes, such as tyrosine hydroxylase (TH) and vesicular monoamine transporter 2 (VMAT2), in human microglial and murine neuronal cell lines, which could contribute to neuronal protection. Vidofludimus calcium protected neurons under pro-apoptotic conditions, reduced gene expression of IL-6, TNF and IFN in human microglia stimulated with lipopolysaccharide (LPS), and increased BDNF levels in human peripheral blood mononuclear cells (PBMCs) stimulated with LPS. Vidofludimus calcium effectively attenuated disease severity in an experimental autoimmune encephalomyelitis (EAE) model. Treatment with vidofludimus calcium led to reduced immune cell infiltration, including decreased numbers of pathogenic T cells producing IL-17A, GM-CSF, and IFNγ. Preliminary data showed that mice receiving vidofludimus calcium exhibit elevated levels of BDNF in the blood and enhanced expression of Nurr1 and its target gene TH in the central nervous system. 

• Title: Vidofludimus Calcium Shows T Helper Cell Modulatory Effects in Murine Experimental Autoimmune Encephalomyelitis: One of the Potential Mode of Action Pathways for MS Treatment
• ePoster Number: P1390

Vidofludimus calcium given prophylactically reduced disease severity and prevented disease development (63% and 15% symptom free in vidofludimus calcium and vehicle, respectively). This was reflected in the strong reduction of infiltrating T helper (Th) cells in the spinal cord as well as reduced numbers of proinflammatory Th cells in the periphery (draining lymph nodes, dLN). Vidofludimus calcium treatment, given after symptom onset, reduced disease progression compared to vehicle. This was supported by lower numbers of infiltrating proinflammatory Th cells into the spinal cord, while no significant difference was seen in the periphery compared to vehicle. The effect of vidofludimus calcium was assessed on myelin oligodendrocyte glycoprotein (MOG) antigen-specific Th cells (2D2) on day 7 after disease induction. Although vidofludimus calcium seems to increase MOG-specific follicular T helper (Tfh) cells in the periphery (dLN), the progression to develop into pathogenic Th cells was inhibited and the development of regulatory T cells was increased. Overall, vidofludimus calcium reduces or prevents development of pathogenic peripheral Th cells.

All poster presentations will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations.

About Vidofludimus Calcium (IMU-838)

Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, vidofludimus calcium is a known inhibitor of the enzyme dihydroorotate dehydrogenase (DHODH), which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of vidofludimus calcium. Vidofludimus calcium has been observed to selectively act on hyperactive T and B cells while leaving other immune cells largely unaffected and enabling normal immune system function, e.g., in fighting infections. To date, vidofludimus calcium has been tested in more than 1,800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. 

About Immunic, Inc. 

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

Cautionary Statement Regarding Forward-Looking Statements 

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic’s development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the COVID-19 pandemic, increasing inflation, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 22, 2024, and in the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release. 

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

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

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

Relief Therapeutics Completes Clinical Phase in RLF-OD032 Proof-of-Concept Study; Topline Results Expected in October 2024
 

GENEVA (SEPT. 18, 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 that it has completed dosing in its proof-of-concept clinical study of RLF-OD032 for the treatment of phenylketonuria (PKU), a rare inherited disorder affecting phenylalanine metabolism.

The primary objectives of the study include the comparison of RLF-OD032 to a currently marketed sapropterin dihydrochloride product, with a focus on bioavailability under fed and fasting conditions. The Company expects topline results in October 2024. These results will inform further development of RLF-OD032 toward a pivotal trial and potential regulatory submission under the 505(b)(2) NDA pathway in the United States.

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

ABOUT 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.

Viromed Medical AG plans to acquire all shares in ActivCell Group AG by way of a capital increase against contribution in kind with exclusion of subscription rights

Pinneberg, 17 September 2024 – Viromed Medical AG (Ticker: VMED; ISIN: DE000A3MQR65; “Viromed”; the “Company”) plans to acquire all shares in ActivCell Group AG, Switzerland, and thus strategically expand its product portfolio. To this end, the Company has today signed a term sheet with the owners of ActivCell Group AG and will immediately enter into further negotiations with the objective of concluding an agreement. With the acquisition of ActivCell Group AG, Viromed expands the treatment spectrum of its products with additional indications and expects an accelerated market launch in the European Union with its own cold plasma product series.

ActivCell Group AG is active in the development and manufacture of cold plasma therapy pens and has received approval for its products (CE-Notified-Body-No. 0297) in category 2a in accordance with the EU directive 2017/745 on medical devices (Medical Device Regulation, MDR) for use in skin and wound treatment in human medicine.

The transaction is expected to be completed in the current 2024 financial year. The purchase price for the 100% takeover of ActivCell Group AG is expected to be in the mid-single-digit million-euro range. The purchase price is to be paid exclusively by granting new shares in the Company by making partial use of the Authorized Capital 2022 by means of a capital increase against contributions in kind, excluding shareholders’ subscription rights.

The closing of the transaction is subject to a final agreement with the shareholders of ActivCell Group AG.

Contact Viromed Medical AG

Uwe Perbandt
CEO
Flensburger Strasse 18
25421 Pinneberg
Germany
Email: kontakt@viromed-medical.de
www.viromed-medical-ag.de

Cinven to sell minority stake in SYNLAB to strategic investor Labcorp

International private equity firm, Cinven, has reached an agreement to sell an indirect minority stake in SYNLAB, a leader in medical diagnostic services and specialty testing in Europe, to strategic investor Labcorp. Labcorp is a global leader of innovative and comprehensive laboratory services headquartered in the United States. Labcorp will acquire the indirect minority stake through an intermediate holding company established to hold the investment with SYNLAB and will be represented on the holding company board along with Cinven and the other co-investors. The purchase price for this indirect minority stake of 15 percent was approximately €140 million.

SYNLAB offers a full range of innovative and reliable medical diagnostic services to patients, practising doctors, hospitals and clinics, governments and corporates. With more than 27,000 employees, including over 2,000 medical experts, SYNLAB operates in over 30 countries across four continents and has leading positions in many markets. The company performed approximately 600 million laboratory tests and achieved revenues of €2.64 billion in 2023.

SYNLAB has made significant progress under Cinven’s ownership and the leadership of CEO, Mathieu Floreani. The combination of a successful buy-and-build strategy, growth investments and a series of commercial and operational initiatives have enabled SYNLAB to achieve strong organic growth and successfully navigate a challenging market environment over the last two years. Key initiatives included:

• Making significant investments in state-of-the-art laboratory and information technology to enhance efficiency and improve the customer experience;
• Establishing a strong track record of partnerships with public hospitals;
• Improving the accessibility of medical diagnostic services for consumers and expanding the availability of the latest innovations and specialty testing across its network;
• Advancing medical research in partnership with the scientific community, publishing more than 300 articles annually in scientific journals;
• Strengthening the capabilities and global network of SYNLAB through a successful track record of strategic and bolt-on acquisitions;
• Expanding into new markets internationally, particularly across Latin America; and
• Supporting the development and implementation of a strong ESG and sustainability programme.

Anastasya Molodykh-McFarlane, Senior Principal and member of Cinven’s Healthcare sector team, stated:

“We are very pleased to welcome Labcorp as a shareholder in SYNLAB. We have great respect for the long-term growth story and healthcare excellence at Labcorp and believe that Labcorp’s investment underscores the future potential of SYNLAB. The investment by Labcorp is another significant milestone in Cinven’s strong Healthcare track record.”

Glenn Eisenberg, Chief Financial Officer, Labcorp, commented:

“Our investment in SYNLAB as a minority shareholder provides Labcorp with a role on the co-investors’ holding company board and the commitment to explore possible opportunities in the future to bring Labcorp’s innovative specialty tests to markets in Europe, consider possible procurement collaborations, evaluate opportunities to support advances in clinical trials and enrollment and improve personalized care.”

Mathieu Floreani, CEO of SYNLAB, added:

“With Cinven, SYNLAB has a strong majority shareholder who knows the company and the sector very well. Together, we have built the leading European clinical laboratory and medical diagnostic services company. Through Labcorp’s minority investment, SYNLAB now receives additional backing from a strategic investor that is deeply embedded in the diagnostics market. I am excited to continue our development together with the Cinven team and Labcorp and explore opportunities to bring Labcorp’s innovative specialty tests into markets across Europe.”

Completion of the transaction is expected in the first quarter of 2025 and is subject to regulatory approvals.

Media contacts

About Cinven

Cinven is a leading international private equity firm focused on building world-class global and European companies. Its funds invest in six key sectors: Business Services, Consumer, Financial Services, Healthcare, Industrials and Technology, Media and Telecommunications (TMT). Cinven has offices in London, New York, Frankfurt, Paris, Milan, Madrid, Guernsey and Luxembourg.

Cinven takes a responsible approach towards its portfolio companies, their employees, suppliers, local communities, the environment and society.

Cinven Capital Management (V) General Partner Limited, Cinven Capital Management (VI) General Partner Limited, Cinven Capital Management (VII) General Partner Limited and Cinven Capital Management (SFF) General Partner Limited are each authorised and regulated by the Guernsey Financial Services Commission, and Cinven Limited is authorised and regulated by the Financial Conduct Authority.

In this press release ‘Cinven’ means, depending on the context, any of or collectively, Cinven Holdings Guernsey Limited, Cinven Partnership LLP, and their respective Associates (as defined in the Companies Act 2006) and/or funds managed or advised by any of the foregoing.

For additional information on Cinven please visit www.cinven.com and www.linkedin.com/company/cinven/.

About Labcorp

Labcorp(NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions.We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities.The company’s more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA and performed more than 600 million tests for patients around the world.Learn more about us atwww.labcorp.com.

About SYNLAB

SYNLAB Group is the leader in medical diagnostic services and specialty testing in Europe. The Group offers a full range of innovative and reliable medical diagnostics to patients, practising doctors, hospitals and clinics, governments and corporates.

Providing the leading level of service within the industry, SYNLAB is the partner of choice for routine and specialty diagnostics in human medicine. The Group continuously innovates medical diagnostic services for the benefit of patients and customers.

SYNLAB operates in more than 30 countries across four continents and holds leading positions in most markets, regularly reinforcing the strength of its network through a proven acquisition strategy. More than 27,000 employees, including over 2,000 medical experts, contribute every day to the Group’s worldwide success.

SYNLAB performed around 600 million laboratory tests and achieved revenues of €2.64 billion in 2023.

More information can be found on www.synlab.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements with respect to the benefits of Labcorp’s indirect minority investment in SYNLAB, potential opportunities to bring Labcorp’s innovative specialty tests to market in Europe, potential procurement collaborations between Labcorp and SYNLAB and potential support for advances in clinical trials and the expected timing to close the transaction.

Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the parties control, including without limitation: (i) the risk that the transaction may not be completed in a timely manner or at all; (ii) expected timing to closing; (iii) the failure to satisfy closing conditions, including the receipt of certain regulatory approvals; (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the transaction agreements; (v) potential difficulties with employee retention and employee relations; (vi) the trading price of Labcorp’s stock, competitive actions and other unforeseen changes and general uncertainties in the marketplace;  (vii) changes in government regulations; (viii) customer purchasing decisions, including changes in payer regulations or policies; (ix) other adverse actions of governmental and third-party payers; (x) changes in testing guidelines or recommendations; (xi) the impact of global geopolitical events; (xii) the effect of public opinion on each party’s reputation; (xiii) adverse results in material litigation matters, if applicable; (xiv) the impact of changes in tax laws and regulations; (xv) failure to maintain or develop customer relationships; (xvi) failure in information technology, systems or data security; (xvii) personnel costs; (xviii) inflation, and (xix) increased competition. These factors, in some cases, have affected and in the future (together with other factors) could affect Labcorp’s ability to implement its business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any forward-looking statements.

Labcorp has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the other Labcorp filings with the SEC. The information in this press release should be read in conjunction with a review of Labcorp’s filings with the SEC including the information in the company’s most recent Annual Report on Form 10-K, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

Classification of NuWays AG to SynBiotic SE

SynBiotic transformation: Reaching new operational high(t)s

Topic: The new CEO Daniel Kruse has been in charge for roughly one year now. The implemented structural changes to the company coupled with regulatory changes in Germany, especially the loss of the narcotic drug status of medical cannabis, should become visible in strong improved financials.

Today, SynBiotic is a Buy-and-Build operator in the European hemp, cannabis and cannabinoid market with an objective to establish a fully integrated platform-company with activities across the entire value chain from cultivation to production and retail, essentially from the field to the shelf.

Dynamic market growth. SynBiotic is active across three end markets, recreational cannabis, industrial hemp and medical cannabis. All three markets should benefit from favourable trends. Demand for industrial hemp is seen to 4x until 2030, carried by regulatory changes and novel food classification of CBDbased products. At the same time, demand for medical cannabis should 10x vs 2023, thanks to the Cannabis Act, which took effect in April. While recreational cannabis (regulated commercial market for cannabis sales) has so far not been approved, the market for i. a. cannabis seeds and gardening equipment is now a legally growing.

SynBiotic looks set to strongly benefit from those favorable market dynamics. Until the end of FY27e, we expect group sales to reach € 40.8m (vs. € 3.9m in FY23), implying a roughly 80% CAGR. Above all, this is seen to be carried by the medical cannabis segment, which should contribute some € 29m.

Additional pockets of growth could come from further acquisitions as per its Buy and Build strategy. In fact, we would expect another add-on until the end of the year.

More importantly, with strongly growing sales, SynBiotic should be on track to reach break-even by FY25e. This should also be possible thanks to the new CEO’s implemented cost-saving measures such as significantly reduced personnel expenses (FY23 -55% yoy; FY24e -19% vs FY22). During the subsequent years, the company looks set to reach double-digit EBIT margins (eNuW: by 2027e).

With only a few listed players in the German cannabis space, SynBiotic offers a unique opportunity to invest into a vertically integrated company that is also active in a variety of different end markets. We reinitiate the coverage with a BUY rating and a € 12.40 PT (old: € 9) based on DCF.

You can download the research here: http://www.more-ir.de/d/30801.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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Press Release // September 17, 2024

 
Formycon will present clinical data on its ustekinumab biosimilar candidate FYB202 at the EADV Congress in Amsterdam and the UEG Week in Vienna
 

Planegg-Martinsried – Formycon AG (FWB: FYB) will present clinical study data of its ustekinumab biosimilar candidate FYB202 at this year’s European Academy of Dermatology & Venerology (EADV) congress, taking place in Amsterdam from September 25 to 28, 2024. The randomized, double-blind, multicenter VESPUCCI Phase III study met the primary endpoint, demonstrating similar efficacy of FYB202 and the reference drug Stelara^® in patients with moderate to severe psoriasis vulgaris (plaque psoriasis). The ePoster presentation shows details of the study design as well as the primary and secondary endpoints.

In addition, Formycon will present study data focusing on the pharmacokinetics of the ustekinumab biosimilar candidate FYB202 at the United European Gastroenterology (UEG) Week from October 12 to 15, 2024 in Vienna. In the Phase I pharmacokinetics study FYB202 showed bioequivalence to the reference drug for all primary endpoints.

Both posters were designed in cooperation with Fresenius Kabi, Formycon’s commercialization partner for FYB202.

Presentation details:

EADV Congress

• Session: ePoster
• Poster-ID: P0984
• Title: A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the proposed biosimilar ustekinumab (FYB202) with reference ustekinumab in patients with moderate-to-severe plaque psoriasis
• Room: Poster Area
• Date: September 25 – 28, 2024

UEG Week

• Session:  ePoster incl. audio/video presentation on demand
• Poster-ID: PP0593
• Title: Proposed ustekinumab Biosimilar FYB202: Pharmacokinetic equivalence demonstrated in a randomised, double-blind, parallel-group, single-dose trial in healthy subjects (RUSTIC)
• Speaker: Sigrid Balser, Vice President Clinical Development & Operations, Formycon AG
• Room: Poster Area
• Date: October 13 – 15, 2024

¹ Stelara^® is a registered trademark of Johnson & Johnson

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. FYB203/aflibercept, received FDA approval. Another four 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.

Gerresheimer: EcoVadis Gold with further improved score

• Gerresheimer among the top 3 % of all rated companies
• Overall result increased to 76/100 points
• Award underlines consistent implementation of the sustainability strategy

Düsseldorf, September 16, 2024 – Gerresheimer, an innovative systems and solutions provider and global partner for the pharma, biotech and cosmetics industries, has once again been awarded Gold by the sustainability rating provider EcoVadis. EcoVadis evaluates the management systems of companies in the categories of environment, labor and human rights, ethics and sustainable procurement. More than 130,000 companies worldwide have their sustainability performance assessed by EcoVadis. In 2024, Gerresheimer was again among the top 3% of all companies assessed by EcoVadis and among the top 1% in the industry. The rating result rose to 76 out of 100 points (2023: 74 out of 100 points). The rating result underlines Gerresheimer’s progress in implementing its sustainability strategy. Sustainability is an integral part of Gerresheimer’s corporate strategy formula g.

 “Our sustainability standards are high, and our goals are ambitious,” explains Dietmar Siemssen, CEO of Gerresheimer AG. “Independent external assessments such as the one from EcoVadis confirm the maturity of our management system, which we use to consistently embed sustainability in our company. EcoVadis Gold is both an award and an incentive for us to continuously improve our sustainability performance.”

Gerresheimer among the top 3% in the industry

Since 2011, Gerresheimer has been using EcoVadis to have its sustainability management in the four different dimensions assessed by an independent body. In 2022, Gerresheimer achieved gold status for the first time with 68 out of 100 points. In 2024, the company was once again able to increase its score to 76 out of 100 points. Gerresheimer is thus not only among the top 3% of all companies assessed by EcoVadis, but also among the top 1% in the industry.

Comprehensive evaluation catalog and detailed monitoring
EcoVadis’ extensive Corporate Social Responsibility (CSR) assessment catalog is based on internationally recognized standards such as the UN Global Compact, the conventions of the International Labour Organization (ILO), the standards of the Global Reporting Initiative (GRI), the ISO 26000 standard, the CERES principles and the UN Guiding Principles on Business and Human Rights. The EcoVadis rating thus covers a wide range of information on the performance of companies in the areas of the environment, labor and human rights, ethics and sustainable procurement, taking into account industry-specific characteristics. As part of its 360° monitoring, EcoVadis also includes a wide range of publicly available information such as news, NGO reports, government publications and court rulings in its assessment.

Transparency and independent external evaluation

Gerresheimer aims to provide transparent, well-founded and comparable information on the targets, measures and results of its sustainability activities in accordance with best practice standards.

Gerresheimer publishes an annual sustainability report and discloses relevant data on the EcoVadis platform and as part of the CDP rating. In addition, MSCI, Sustainalytics and ISS assess the company’s sustainability performance. An overview of Gerresheimer’s external sustainability ratings can be found here.

About Gerresheimer 
Gerresheimer is an innovative systems and solutions provider and a global partner for the pharma, biotech and cosmetic industries. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With 35 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets. With around 12,000 employees, the company generated revenues of around €2bn in 2023. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).  
www.gerresheimer.com 

Contact Gerresheimer AG