Eckert & Ziegler Completes Change of Legal Form to SE

EQS-News: Eckert & Ziegler Strahlen- und Medizintechnik AG

/ Key word(s): Miscellaneous

Eckert & Ziegler Completes Change of Legal Form to SE

19.03.2024 / 10:53 CET/CEST

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

Berlin, 19.03.2024. Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700) today completed its change of legal form to a Societas Europaea (SE) with entry in the company’s commercial register and will in future operate as Eckert & Ziegler SE.

Eckert & Ziegler SE has a dualistic management system consisting of a management body (Executive Board) and a supervisory body (Supervisory Board). The corporate bodies of Eckert & Ziegler SE are therefore, as at Eckert & Ziegler Strahlen- und Medizintechnik AG, the Executive Board, the Supervisory Board, and the General Meeting.

All shareholders hold the same number of shares in Eckert & Ziegler SE as they did in Eckert & Ziegler Strahlen- und Medizintechnik AG before the change of legal form. The number of no-par value shares issued remains unchanged. Trading will continue seamlessly. The conversion in the shareholders’ securities accounts will take place automatically. The previous ISIN DE0005659700, WKN 565970 and the ticker symbol EUZ will remain unchanged.

About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Your contact:
Eckert & Ziegler SE, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, karolin.riehle@ezag.de, www.ezag.com 

 


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Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

EQS-News: Heidelberg Pharma AG

/ Key word(s): Financing

Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

19.03.2024 / 09:47 CET/CEST

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

PRESS RELEASE

Heidelberg Pharma announces receipt of non-refundable upfront cash payment following the successful closing of its royalty purchase agreement with HealthCare Royalty

Ladenburg, Germany, 19 March 2024 – Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced the formal closing of the royalty purchase agreement with HealthCare Royalty (HCRx) for Zircaix®, signed earlier this month.

Under the terms of the agreement, Heidelberg Pharma has received an upfront, non-refundable cash payment of USD 25 million and is furthermore eligible to receive up to USD 90 million in total from the partial sale of its future royalties on the worldwide sales of Zircaix® (TLX250-CDx, 89Zr-DFO-girentuximab), a radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and management of clear cell carcinomas. Heidelberg Pharma developed the antibody as therapeutic and diagnostic agent up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian-headquartered company based in Melbourne, in 2017 for further development. Telix submitted the Biologics License Application submission for Zircaix® in December 2023.

Heidelberg Pharma will utilize this funding to further advance its proprietary toolbox of novel payloads and first-in-class Amanitin-based Antibody Conjugate pipeline, including lead candidate HDP-101 which is currently progressing in a Phase I/IIa study for the treatment of multiple myeloma.

Dr. George Badescu, Chief Business Officer at Heidelberg Pharma, said: “The funding from the royalty purchase agreement with HealthCare Royalty is enabling us to further advance Heidelberg Pharma’s leading expertise in the field of ADC research and development. The upfront payment strengthens the Company’s liquidity, and along with future anticipated payments, should extend our cash runway. The funds will be used to advance the expansion of our ADC pipeline including our preclinical projects HDP-102, HDP-103 and HDP-201.”

About Heidelberg Pharma
Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary ATAC technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. The proprietary technology platform is being applied to develop the company’s own therapeutic ATACs as well as in third-party collaborations.

The proprietary lead candidate HDP-101 is a BCMA-ATAC in clinical development for multiple myeloma. Further ATAC candidates are being developed against different targets such as CD37, PSMA or GCC each in the indications non-Hodgkin’s lymphoma, metastatic castration-resistant prostate cancer or gastrointestinal tumors such as colorectal cancer.

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

ATAC® is a registered trademark of Heidelberg Pharma Research GmbH in the EU and the USA.

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

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


19.03.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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ActiTrexx treats first patient with novel regulatory T cell therapy against Graft-versus-Host Disease

EQS-News: ActiTrexx GmbH

/ Key word(s): Study

ActiTrexx treats first patient with novel regulatory T cell therapy against Graft-versus-Host Disease

19.03.2024 / 10:00 CET/CEST

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

ActiTrexx treats first patient with novel regulatory T cell therapy against Graft-versus-Host Disease

  • Phase Ib/II study with Actileucel, a novel cellular product based on activated regulatory T cells for prevention of Graft-versus-Host Disease (GvHD)
  • Clinical study evaluates the safety and feasibility of Actileucel treatment as well as frequency and severity of GvHD
  • Actileucel is the first regulatory T cell therapy from an unmatched third-party donor

Mainz, Germany, 19 March 2024 – ActiTrexx GmbH, a clinical-stage company focusing on the activation of regulatory T cells, has treated the first patient with Actileucel, its novel cell therapy for the prevention and treatment of Graft-versus-Host Disease (GvHD) in patients receiving an allogeneic haematopoietic stem cell transplant as treatment for haematological malignancies such as acute leukemia. Actileucel is generated by activating regulatory T cells isolated from an unmatched, third-party donor via a fast proprietary process with a vein-to-vein time of 24 hours.

GvHD is a severe and potentially life-threatening complication that can arise after an allogeneic haematopoietic stem cell transplantation and affects about 50 % of recipients. GvHD occurs when the stem cell donor’s T cells attack the patient’s tissues, leading to a range of symptoms that can affect the skin, gastrointestinal tract, and liver. Currently, immunosuppressants are used to treat GvHD, but they have limited effectiveness and come with severe side effects. Consequently, the 3-year mortality rate of GvHD patients remains high. Actileucel uses activated regulatory T cells from a second donor, who does not need to match the patient’s tissue markers, to control or prevent GvHD.

Prof. Dr. Andrea Tüttenberg, CEO of ActiTrexx, said: “GvHD can lead to life-long symptoms for the patient and is a major cause for the high mortality rate of blood stem cell transplantation. Our goal is to tamper the overshooting immune response with Actileucel, to reduce the risk and severity of GvHD, ultimately improving patient outcomes and quality of life. The treatment of the first patient with Actileucel marks a significant milestone in our mission to address this critical unmet need of patients undergoing bone marrow transplantation.”

Objective of the prospective open, single-arm non-randomized multicentric Phase Ib/II study is to evaluate safety and feasibility of Actileucel treatment. Ten patients who have recently received a blood stem cell transplantation as treatment for leukemia will receive a single treatment with Actileucel. Patients will be treated early after transplantation in three cohorts with increasing doses of Actileucel with a follow-up of six months. Primary endpoint is the safety and tolerability of the Actileucel treatment, while secondary endpoints include an assessment of the frequency and severity of GvHD in treated patients as well as of the feasibility of Actileucel manufacturing. The trial will run at two sites in Germany, the III. Medical Clinic of the University Medical Center Mainz and the University Hospital Carl Gustav Carus in Dresden.

“Allogeneic stem cell transplantation is able to cure patients with acute Leucemia – but half of them suffer from GvHD, need immunosuppressive medication with high infection rates and risk for lethal complications. Especially patients who did not respond to our immunosuppressive treatment are at risk. The main goal is to identify strategies to prevent patients from developing GvHD, so we are very hopeful and enthusiastic to conduct this clinical trial with Actileucel,” said Dr. Eva Wagner-Drouet, Principal Investigator and Head of the Center for Cellular Immunotherapy and Stem Cell Transplantation of the University Medical Center Mainz.

“Unlike the currently available treatments, we are targeting the root-cause of the overshooting immune reaction in GvHD by using regulatory T cells. Preclinical data demonstrated that Actileucel can significantly attenuate an already existing GvHD, and even largely prevent the development of the disease when given early after transplantation as a prophylactic treatment. In contrast to currently approved cell therapies, Actileucel offers a streamlined manufacturing process by using cells that can be taken from any healthy third-party donor,” commented Dr. Helmut Jonuleit, CSO of ActiTrexx.

About GvHD
GvHD is a life-threatening side effect of allogeneic haematopietic stem cell transplantation. Donor lymphocytes react against tissue antigens in the recipient and cause severe organ and tissue damage, that often takes a chronic course. GvHD is primarily triggered by the donor’s CD4+ T cells, whose activity is controlled by regulatory T cells. About 50% of patients develop the disease with a significantly increased mortality rate within 3 years after transplantation. Once developed, patients suffer from the often life-long symptoms.

About Actileucel
Actileucel is a cellular therapeutic agent that contains optimally activated regulatory T cells, the natural guardian cells of our immune system. Regulatory T cells modulate the activity of T cells and prevent unwanted inflammatory reactions. Actileucel suppresses the undesired activation of CD4+ T cells in the transplant, prevents the development of GvHD and promotes the development of a healthy immune system in the patient. The cellular therapeutic Actileucel is classified as an Advanced Therapy Medicinal Product (ATMP), produced in an automated process within 24 hours and ready for clinical use in patients.

About ActiTrexx
ActiTrexx is a clinical phase biotech company developing a platform of cellular and biologic therapies for overshooting T cell mediated autoimmune and autoinflammatory diseases with high medical unmet need. The first product candidate, Actileucel, is a cell therapy based on regulatory T cells that are activated in a proprietary ultrafast process, and is in clinical Phase Ib/II for the treatment of Graft-versus-Host Disease (GvHD) after blood stem cell transplantation. ActiTrexx GmbH was founded in 2020 as a spin-off from the University Medical Center Mainz and is backed by LBBW Venture Capital GmbH, High-Tech Gründerfonds (HTGF), Investitions- und Strukturbank Rheinland-Pfalz (ISB) and MediVentures GmbH. www.actitrexx.de
 

Contact
ActiTrexx GmbH
Prof. Dr. Andrea Tüttenberg, CEO             
Tel.: +49 (0)6131-173186
E-Mail: info@actitrexx.de
Media requests
MC Services AG
Katja Arnold / Dr. Regina Lutz
Tel.: +49 (0)89 210 228 0
E-Mail: actitrexx@mc-services.eu

 


19.03.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group AG.
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Newron presents 2023 financial results and provides 2024 outlook

EQS-News: Newron Pharmaceuticals S.p.A.

/ Key word(s): Annual Report

Newron presents 2023 financial results and provides 2024 outlook

19.03.2024 / 07:00 CET/CEST

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

Newron presents 2023 financial results and provides 2024 outlook

Milan, Italy, March 19, 2024, 07:00 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2023, and provided an outlook for 2024.

Highlights 2023:

Evenamide (Schizophrenia)

  • Compelling efficacy results across multiple investigation timepoints up to and including one-year from study 014/015 evaluating evenamide as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS)
  • Presentation of data to the medical community at several international scientific conferences, highlighting the clinically meaningful response to evenamide in TRS patients, across various timepoints
  • Publication of data from study 014 and results from first 100 patients of study 015 in peer-reviewed journal, the International Journal of Neuropsychopharmacology, outlining the continued improvement in symptoms of psychosis in TRS patients treated with evenamide
  • The findings from study 014/015 support the initiation of a potentially pivotal, Phase III, randomized, double-blind, placebo-controlled study with evenamide as an add-on treatment in patients with TRS
  • Study 008A, a potentially pivotal study of evenamide (30 mg bid) in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic, completed patient enrollment; top-line results are expected in April 2024

Xadago®/safinamide (Parkinson’s disease)

  • Newron and its partners reached agreement with generic pharmaceutical manufacturers who submitted Paragraph IV Notice Letters regarding Abbreviated New Drug Applications in the US
  • In Europe, Supplementary Protection Certificates (SPCs) have been approved in most territories of relevance

Corporate

  • Newron’s senior management team strengthened by two key promotions: Laura Faravelli, previously Director Business Development at Newron, was promoted to Vice President Business Development; Roberto Galli, Vice President Finance since 2012, was promoted to Chief Financial Officer
  • Gillian Dines appointed as Non-Executive Director to the Board of Newron at the AGM 2023
  • Margarita Chavez appointed as advisor to the Board of Newron; she is nominated for election as Non-Executive Director to the Board at the next Ordinary AGM on April 17, 2024
  • Post-period, Newron entered into an agreement for the subscription of up to 2.05 million newly issued shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare, to finance the Company’s operations beyond the current key inflection points in its pipeline
  • Post-period, agreement with European Investment Bank (EIB) to extend the near-term tranche repayment dates of Newron’s 2018 financing agreement

Stefan Weber, CEO of Newron, commented: Against a backdrop of challenging global biotechnology market conditions, we have continued to make huge strides in advancing our evenamide development program for treatment-resistant schizophrenia (TRS) through the clinic. We have reported multiple data sets across three different study timepoints, each showing compelling evidence of the benefit of evenamide in schizophrenia patients no longer responding to their first- or second-generation antipsychotic treatments. Post-period, we also optimized our financing structure by agreeing with the EIB to extend the near-term tranche repayment dates of our financing agreement. And we welcomed an institutional investor that signed a subscription agreement for new shares to finance our operations beyond the current key inflection points in the pipeline. We thank our shareholders for their ongoing support and for sharing our vision to improve the lives of patients suffering from diseases of the CNS, by now for 25 years, since Newron was founded.

Evenamide

Newron made substantial progress across its evenamide development program over the reporting year and into early 2024. The published compelling data is demonstrating the benefit of the Company’s new chemical entity for patients with TRS:

  • In Q1 2023, Newron disclosed interim analyses of study 014, a Phase II, international, randomized, open label, rater-blinded trial evaluating evenamide (7.5, 15 or 30 mg bid) as an add-on to a single antipsychotic (excluding clozapine) in patients with moderate to severe TRS, not responding to their current antipsychotic medication, and study 015, its extension to one year of treatment. Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint. The results at the six-week, six-month and one-year timepoints demonstrated a clinically important and sustained improvement in symptoms, and importantly, a substantially greater benefit at one-year than at the six-week and six-month datapoints.
  • Topline data from all 161 patients at the six-week primary endpoint were reported in March. Although the primary objective of the study was safety and tolerability of evenamide, efficacy over baseline was also assessed. The mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and the Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared to baseline (p<0.001). The results from the complete study population of 161 patients were fully consistent with the findings from the first 100 patients at this timepoint. Notably, evenamide was safe and well-tolerated at all doses, with almost all (95%) patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).
  • In the beginning of Q4, Newron provided data from the full study population in the extension study (study 015) at the 36th ECNP Congress in Barcelona, Spain, demonstrating the positive effect of evenamide at six months of treatment. Results showed that benefits continued to accrue over time, and many patients who did not respond early achieved clinically important benefits later on in the study. Remarkably, following treatment with evenamide, approximately 40% of patients at six months no longer met the protocol severity criteria used to diagnose TRS.
  • These data were further strengthened, post-period in January 2024, with the final results from study 015 reviewing all study participants after one year of treatment. The data showed that treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment. Gradual and sustained improvement was demonstrated across all efficacy scales used. More than 70% of patients experienced clinically important reduction in disease severity. Review of the efficacy data indicated that treatment with evenamide resulted in approximately 50% of patients at one-year no longer meeting any of the protocol severity criteria used to diagnose treatment resistance. Significantly 25% of all patients achieved “remission” (no/minimal symptoms for at least six months), never described before in TRS patients. Moreover, in contrast to common clinical experience, no patient relapsed during the one-year treatment period.

The durability and longevity of these clinical benefits is unprecedented in this indication and suggest that the glutamate modulating effect of evenamide could lead to a progressive and long-standing alteration in brain processes, synergizing with the effect of the antipsychotic to which the patient had become resistant. The next R&D activities will be:

  • In their totality, the results from study 014/015 support the initiation of a potentially pivotal Phase III, randomized, double-blind, placebo-controlled study of evenamide as an add-on treatment in patients with TRS, which will hopefully confirm the benefit of evenamide seen so far. If approved, the compound would be the first add-on drug that improves the symptoms of TRS, offering a much-needed new therapeutic option for those who are not responding to existing antipsychotics.
  • Newron is also investigating evenamide in a potentially pivotal study (study 008A) in a separate indication, in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid). Patient enrollment has completed and results from this study are expected in April 2024.

Xadago®/safinamide

In partnership with Zambon and Supernus, Newron continued to further develop and market its product, Xadago®/safinamide. In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by some generic manufacturers of an Abbreviated New Drug Application ANDA to the US Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of the three US patents listed in the FDA Orange Book for Xadago®, Newron and its partners Zambon and Supernus have reached settlement agreement with said generic manufacturers, thus resolving the legal action. All three patents remain valid and in force. Under the agreement, the generic manufacturers will be allowed to enter the US market with a safinamide mesylate drug product no earlier than December 1, 2027. In the EU, Supplementary Protection Certificates (SPCs) have already been approved in most territories of relevance; Newron and Zambon are confident that upon completion of the still ongoing procedures and targeted activities, the SPCs will be granted in all key territories.

ESG reporting

The Annual Report 2023 provides further transparency on Newron’s corporate ESG commitments. The relevant section covers information on the following topics: employee aspects, environmental aspects including climate, social aspects, human rights, and anti-corruption as well as cyber security – given their relevance to Newron and its stakeholders and given the Company’s ability as a company to have a positive impact on the listed areas. Newron’s 2023 ESG Report follows the most recent edition of the Directive on Information relating to Corporate Governance (Annex 7) of SIX Exchange Regulation (SER).

Financial key takeaways 2023:

  • In 2023, Newron reported a net loss of EUR 16.2 million, slightly lower compared to EUR 17.5 million in 2022
  • Cash used in operating activities has decreased to EUR 10.1 million from EUR 11.1 million in 2022
  • Xadago® revenues from Zambon increased from EUR 6.0 million in 2022 to EUR 9.0 million in the reporting year
  • Newron’s R&D expenses have risen to EUR 13.2 million from EUR 12.0 million in 2022
  • G&A expenses slightly increased from EUR 7.4 million in 2022 to EUR 7.5 million
  • Cash and Other current financial assets as of December 31, 2023 were at EUR 12.6 million, compared to EUR 22.8 million at the beginning of the year

Post-period, in March 2024, Newron announced it has entered into an agreement for the subscription of up to 2.05 million shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare, raising gross proceeds of up to EUR 15.0 million (at current exchange rate CHF-EUR). Under the agreement, the fund subscribes to an initial 750,000 newly issued shares at a subscription price of EUR 7.33 per share, which corresponds to gross proceeds of approximately EUR 5.5 million. In addition, the fund has a right to subscribe to an additional up to 1,300,000 newly issued shares until no later than January 31, 2025, at a subscription price to be calculated pursuant to an agreed formula. The share subscriptions are governed by the capital increase authorised by Newron’s shareholders in 2018 and approved and empowered by the Company’s Board of Directors in 2023. Newron intends to use the net proceeds of the fundraise for general corporate purposes, including the financing of its operations and research programs and for the development of current and future pipeline products. Newron also continues to seek opportunistic additions to its pipeline portfolio.

Post-period, and also in March 2024, Newron announced that the Company has agreed with the European Investment Bank (EIB) to extend the near-term tranche repayment dates of its loan agreement. Under the amendment to certain terms of the financing agreement with the EIB, the repayment of tranches one to three (out of a total of five) has been shifted substantially, with tranche one now scheduled for repayment by 25 November 2025, tranche two by April 2026 and tranche three by June 2026. The EIB qualifies now for certain performance-based remuneration. Newron appreciates the support of the EIB in helping the Company to align its contractual obligations with the potential timing of certain upcoming inflection points from its pipeline.

Financial Summary (IFRS) 2023 and 2022:

In thousand EUR (except per share information)

  2023 2022
Licence income from contracts with customers 58 14
Royalties from contracts with customers 6,735 5,936
Other income from contracts with customers 2,264 144
Revenue 9,057 6,094
Research and development expenses, net (13,152) (12,005)
Operating Result (11,629) (13,302)
Financial result, net (4,571) (4,170)
Net loss (16,224) (17,493)
Loss per share (0.91) (0.98)
Cash used in operating activities (10,140) (11,092)
Cash, cash equivalents and Other current financial assets 12,599 22,774
Total assets 25,866 37,195

Newron’s Annual Report 2023 is available for download on the Company’s website at:
www.newron.com/investors/reports-and-presentation/year/2023

Outlook 2024:

Following the remarkable evenamide data to date, Newron plans to initiate a potentially pivotal trial evaluating evenamide in TRS, once preparations are completed and a partner has been identified. If this trial replicates the data published in study 014/015, the Company believes there will be substantial improvements in the treatment paradigm and outlook for TRS patients. Newron is also primed to report data from study 008A, a potentially pivotal study assessing evenamide in schizophrenia patients not deemed to be treatment resistant. If positive, this would be the first well-controlled study to demonstrate the clinical utility of evenamide in schizophrenia patients who show an inadequate response to treatment with atypical antipsychotics.

Newron is continuing to have a productive dialogue with industry players around potential future collaboration opportunities for evenamide. The Company also continues to review the CNS landscape for opportunities to expand its drug development pipeline.

Newron’s total available cash resources together with the initial proceeds deriving from the subscription agreement signed post-period, will fund the Company’s planned development programs and operations well into 2025 and well beyond the current key value inflection points in our pipeline.

Media/analyst/investor Conference Call today at 3 pm CET

Newron’s management team will present today the 2023 full-year results and provide an update and guidance for 2024. Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers:

  • Switzerland/Europe: +41 (0)58 310 50 00
  • United Kingdom: +44 (0)207 107 0613
  • United States: +1 (1)631 570 5613

The presentation is available at www.newron.com/investors/reports-and-presentation/year/2023

2024 Shareholders’ Meeting Agenda:

Newron’s Board of Directors has approved the below agenda for the April 17, 2024, Shareholders’ Ordinary and Extraordinary meeting, which will take place at the Company’s registered office (Via Antonio Meucci 3) in Bresso (Mi), Italy, starting at 10 am CET. The formal invitation to shareholders will be issued and disclosed in the statutory papers on or around March 26, 2023. The full invitation and supporting material will be made available on the Company’s website (www.newron.com/investors/shareholders-meeting) on the same day.

The agenda is as follows:

Ordinary part

  1. Approval of the financial statements as at 31 December 2023. Update – as per art. 2447 Civil Code – regarding the freezing of 2022 Newron’ standalone losses. Connected and consequent resolutions;
  2. Appointment of a new members of the Board of Directors, for the financial years 2024 and 2025 and, therefore, until the approval of the financial statements as of December 31st, 2025, as follows:
    1. determination of the relevant number,
    2. proposal to appoint Margarita Chavez*, in quality of new non-executive director
    3. Determination of the remuneration

Connected and consequent resolutions.

Extraordinary part

  1. Proposal to amend Art 14 of the by-laws. Related and consequential resolutions;
  2. Proposal of attribution to the Board of Directors of powers, pursuant to art. 2443 of the Civil Code, exercisable during the next 5 years, to increase the share capital, in one or more times, for a maximum amount of Euro 357.636,00, in addition to any premium, with or without option rights, pursuant to art. 2441, paragraphs 1 and/or 4, first and second part, and/or 5, 6 of the Civil Code. Related and consequential resolutions;
  3. Proposal of attribution to the Board of Directors of powers, pursuant to art. 2443 of the Civil Code, exercisable  during the next 5 years, to increase the share capital, in one or more times, for a maximum amount of Euro 107.291,00, in addition to any premium, with exclusion of the option rights, pursuant to art. 2441, paragraphs 5, 6 and/or 8 of the Civil Code, for one or more stock option plans. Related and consequential resolutions;

*   Margarita Chavez brings to Newron over 20 years of dealmaking expertise and leadership in the pharmaceutical industry. Most recently, she was Managing Director of AbbVie Ventures, where she led investments and built biotech companies across the US and Europe.  Ms. Chavez also served as a board member for several biotech companies across the US and Europe. As a Director in Abbott’s Global Pharmaceutical Licensing & Acquisitions Division, she was involved in the successful in-licensing of Elagolix and the acquisitions of Solvay, ImmuVen and the Lupron franchise. Before joining Abbott, Ms. Chavez practiced as a corporate and securities lawyer in the Silicon Valley, advising tech and biotech companies on strategic transactions including IPOs and mergers and acquisitions. She received her bachelor’s degree from Santa Clara University and her juris doctor from Santa Clara University School of Law (both California). Ms. Chavez is currently a Venture Partner at Wellington Partners and has been acting as advisor to Newron’s board since October 1, 2023.

Financial calendar

  • AGM and EGM 2024: April 17, 2024
  • Half-year report 2024: September 19, 2024

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO, +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting, +44 20 3727 1000, SCnewron@fticonsulting.com

Switzerland
Valentin Handschin, IRF , +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Caroline Bergmann, MC Services, +49 211 52925222, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


19.03.2024 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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PolyPeptide publishes invitation to the annual General Meeting 2024

PolyPeptide Group

/ Key word(s): AGMEGM

PolyPeptide publishes invitation to the annual General Meeting 2024

19.03.2024 / 07:00 CET/CEST

Media release

PolyPeptide publishes invitation to the annual General Meeting 2024

Baar, 19 March 2024 – PolyPeptide Group AG (SIX: PPGN), a focused global CDMO for peptide- and oligonucleotide-based active pharmaceutical ingredients,
published today the invitation to the third annual General Meeting which will take place on 10 April 2024 at the Chollerhalle in Zug.

At PolyPeptide Group AG’s (the “Company”) third annual General Meeting which will take place on 10 April 2024 at the Chollerhalle in Zug (the “AGM 2024”), six current members of the Board of Directors will stand for re-election. Dorothee A. Deuring has decided not to stand for re-election as a member of the Board of Directors. The Board of Directors thanks Ms. Deuring for her contribution. Peter Wilden is proposed for re-election as Chair of the Board of Directors, and Philippe Weber and Peter Wilden as members of the Remuneration and Nomination Committee.

The Board of Directors further proposes to the AGM 2024 the deletion of art. 25 para. 3 of the Company’s Articles of Association relating to the aggregate compensation for consulting services to the Company provided by members of the Board of Directors. The proposed deletion shall eliminate any concerns regarding a possible impairment of the objectivity and independence of the members of the Board of Directors.

Further proposals include, among others, the re-election of the Statutory Auditors and the Independent Proxy as well as the approval of the maximum aggregate amount of compensation of the Board of Directors and Executive Committee. The shareholders will also be asked to approve the Management Report, Statutory Financial Statements and Consolidated Financial Statements, in each case, for the financial year 2023 as well as the Remuneration Report 2023 and the report on non-financial matters for the financial year 2023, both in separate consultative votes.

The invitation to the AGM 2024 with the detailed proposals and explanations can be found on the Company’s website.

Contact

PolyPeptide Group AG
Michael Stäheli
Head of Investor Relations & Corporate Communications
michael.staeheli@polypeptide.com
T: +41 43 502 05 80

 

About PolyPeptide

PolyPeptide Group AG with its consolidated subsidiaries (“PolyPeptide”) is a focused Contract Development & Manufacturing Organization (CDMO) which specializes in the development and manufacturing of synthetic peptides and oligonucleotides used as active pharmaceutical ingredients (API) or intermediates in therapeutic products. It also produces a range of generic peptides and peptides used in cosmetics. The Group mainly serves pharmaceutical and biotech companies. By supporting its customers, PolyPeptide contributes to the health of millions of patients across the world. PolyPeptide provides its offering from pre-clinical through to commercial stages. Its active custom projects pipeline reflects the opportunities from novel drug therapies in development to fight both widespread and rare diseases. Established in 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India.
PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.

For more information, please visit polypeptide.com.  

@PolyPeptide – follow us on LinkedIn

 

Disclaimer

This media release has been prepared by PolyPeptide Group AG and contains certain forward-looking statements that reflect the current views of management. Such statements are subject to known and unknown risks, uncertainties and other factors that may cause actual developments to differ materially from those expressed or implied in this release. PolyPeptide Group AG is providing the information in this release as of this date and, except as required by applicable laws or regulations, does not undertake any obligation to update any statements contained in it as a result of new information, future events or otherwise.


Additional features:

File: PolyPeptide_Publication of AGM 2024 Invitation_EN


End of Media Release


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Medios acquires Dutch market leader in pharmaceutical compounding services

Medios AG / Key word(s): Mergers & Acquisitions/Expansion

Medios acquires Dutch market leader in pharmaceutical compounding services

18-March-2024 / 20:41 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.


Medios acquires Dutch market leader in pharmaceutical compounding services

Berlin, March 18, 2024 – Medios AG (“Medios”), the leading provider of Specialty Pharma Solutions in Germany, acquires Ceban Pharmaceuticals B.V. (“Ceban”), a fast-growing pharmaceutical compounding platform operating in the Netherlands, Belgium and Spain. With the combination with Ceban, Medios internationalizes its business model and realizes an important step to create a European Specialty Pharma platform. Ceban is expected to generate in 2023 revenue of c. €160 million and an EBITDA after certain adjustments of c. €29 million (EBITDA margin of c. 18%).

Medios acquires a 100% interest in Ceban from funds managed by Bencis. The purchase price consists of a cash component of €235.3 million plus 1.7 million new Medios shares valued at approx. €23.9 million, based on the closing price of the Medios shares in the XETRA trading system of Frankfurt Stock Exchange on March 14, 2024. The new Medios shares held by the Sellers of Ceban will be subject to a hard lock-up of 24 months.

The purchase price is financed by Medios from existing cash and a €200 million committed credit facility. The 1.7 million new shares in Medios will be issued out of authorized capital against contribution in kind without subscription rights for shareholders.

The completion of the transaction is subject to the fulfilment of customary closing conditions and is expected to occur in the second quarter of 2024.

Assuming the completion of the acquisition of Ceban in Q2, Medios expects revenue in the FY 2024 to reach €1.9 to €2.1 billion along with an EBITDA pre1 of €82 to €91 million, realizing a margin of around 4.3% based on the mean value of the respective revenue and EBITDA pre1 range.

Disclosing person: Matthias Gärtner, CEO

1 EBITDA is defined as consolidated earnings before interest, taxes, depreciation and amortization. EBITDA pre is adjusted for special charges for stock options and expenses for M&A activities and expenses for ERP-System implementation as well as for one-time performance-based payments for the acquisition of compounding volumes.

End of Inside Information

Contact

Medios AG, Heidestraße 9, 10557 Berlin
Telefon: +49 30 232 5668 00; Fax: +49 30 232 5668 01
E-Mail: ir@medios.agwww.medios.ag

——————-

About Medios AG

Medios AG is the leading provider of Specialty Pharma Solutions in Germany. As a competence partner and expert, Medios covers all relevant aspects of the supply chain in this field: from pharmaceutical supply to the manufacture of patient-specific therapies including blistering. The focus is on optimal patient care via specialized pharmacies.

Medios AG is Germany’s first listed Specialty Pharma company. The shares (ISIN: DE000A1MMCC8) are listed on the Regulated Market of the Frankfurt Stock Exchange (Prime Standard).

 www.medios.ag

Contact

Claudia Nickolaus
Head of Investor & Public Relations, ESG Communications
Medios AG
Heidestraße 9 | 10557 Berlin
T +49 30 232 566 800
c.nickolaus@medios.ag

www.medios.ag

About Bencis:

Bencis is an independent investment company that supports business owners and management teams in achieving their growth ambitions. Working out of offices in Amsterdam, Brussels and Düsseldorf, Bencis has been investing in strong and successful businesses in the Netherlands, Belgium and Germany since 1999.

www.bencis.com

Disclaimer

This release is a mandatory announcement pursuant to Art. 17 of the Market Abuse Regulation (MAR). The assessments contained therein are, as always, subject to the disclaimer provided below.

Cautionary note regarding forward-looking statements/No duty to update

This notification contains forward-looking statements that are subject to certain risks and uncertainties. Future results may significantly deviate from currently expected results, specifically due to various risk factors and uncertainties such as changes in business, economic, and competitive circumstances, exchange rate fluctuations, uncertainties about legal disputes or investigations, and the availability of financial resources. Medios AG assumes no responsibility whatsoever for updating the forward-looking statements contained in this notification except as legally required.

 

 

End of Inside Information


18-March-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Medios acquires Dutch market leader in pharmaceutical compounding services

EQS-News: Medios AG

/ Key word(s): Mergers & Acquisitions/Expansion

Medios acquires Dutch market leader in pharmaceutical compounding services

18.03.2024 / 20:46 CET/CEST

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

Medios acquires Dutch market leader in pharmaceutical compounding services

Important first step in building the leading European Specialty Pharma platform – Mid-term targets to be reached already in 2025

Berlin, March 18, 2024 – Medios, the leading provider of Specialty Pharma Solutions in Germany, today announced the acquisition of Ceban Pharmaceuticals B.V. (“Ceban”). Ceban is a fast-growing leading pharmaceutical compounding platform with operations in the Netherlands, Belgium, and Spain. In 2023, Ceban is expected to realize revenue of c. €160 million and an EBITDA-adjusted of c. €29 million corresponding to a margin of c. 18% in 2023.  The acquisition marks an important step in Medios’ growth strategy aimed at building the leading European Specialty Pharma platform.

Highlights:

  • Ceban is the Dutch market leader in compounding and has growing market positions in Belgium and Spain.
  • The acquisition strongly positions Medios to benefit from the significant growth in homecare, clinics, and hospitals in the Netherlands and Belgium.
  • Value creation through diversification, leveraging synergy and cross-selling opportunities.
  • Ceban’s internationally experienced management team will stay in the company and further drive growth in existing and new geographies.
  • The purchase price for 100% of Ceban shares includes a cash component of €235.3 million and 1.7 million Medios shares.
  • Medios preliminary figures for 2023: Group revenue increased by c. 11.0% to around €1.8 billion; EBITDA pre1 increased by 10.3% to around € 60.5 million with an accordingly stable EBITDA pre1 margin of 3.4%.
  • Assuming the completion of the acquisition of Ceban in the second quarter of 2024 Medios expects a substantial increase in revenue and margin for FY 2024: revenue in a range of €1.9 to €2.1 billion and in a range of EBITDA pre from €82 to €91 million, which reflects a margin of around 4.3% based on the mean value of the respective revenue and EBITDA pre1 range.
  • Mid-term outlook for FY 2025: Revenue of around €2.15 billion and EBITDA pre of approx. €110 million reflecting a margin of 5.1% in FY 2025.

Matthias Gaertner, CEO of Medios: “The acquisition of Ceban is an important milestone for our European expansion strategy. With its market leading position in the Netherlands and growing market positions in Belgium and Spain, Ceban is excellently positioned for further growth and highly profitable. Through our established Specialty Pharma platform in Germany, we are also creating cross-selling opportunities and synergies in procurement. Moreover, the portfolio of Ceban offers a strategic diversification of our activities, while tapping into attractive growth markets. All in all, this is a truly transformative transaction for Medios. I am extremely proud that we once again can deliver on our promises and expect to deliver on our ambitious mid-term targets already in 2025.”

Jeroen van der Hamsvoort, CEO of Ceban Pharmaceuticals: “We are excited to become part of Medios. Its nationwide network of pharmacies provides us access to the interesting and sizable German market, in which Medios has built an impressive leading position. Moreover, the strategy of Medios fits seamlessly with our international strategic ambitions. Medios’ strong and long relationship with major pharmaceutical companies will allow us to benefit from a solid supply chain, excellent product availability, and a very strong purchase power. We look forward to building the leading European Specialty Pharma platform together.”

Strategic rationale

The leading European Specialty Pharma platform

The acquisition of Ceban is an important milestone in the execution of Medios’ strategy to build the leading European Specialty Pharma platform. It enables Medios to set up an international network of GMP laboratories to become the preferred partner for compounding of personalized medicines.

Synergies

Furthermore, combining both companies’ strengths offers significant mutual strategic, operational, and commercial synergies, such as procurement savings. The combined platform and network create immediate upselling and cross-selling opportunities in complementary geographical markets.

Diversification

With this step Medios not only diversifies geographically but it will also diversify the offering of Medios as it adds complementary products and services. The acquisition of Ceban gives Medios an outstanding position in the Dutch pharmaceutical market. Ceban’s leading pharmacy, hospital, and clinic network in the Netherlands combined with Medios’ in-depth knowledge and experience in sterile compounding, positions the company well to exploit further growth potential in the attractive Dutch market. It also strongly positions the company to drive further growth in Belgium and Spain and to expand into additional European countries. Medios’ unique network of c. 800 specialized partner pharmacies in Germany can be leveraged to expand distribution of Ceban’s APIs (active pharmaceutical ingredients) in Germany, the largest pharmaceutical market in Europe.

Ceban pharmaceuticals

Ceban has a market leading position in pharmaceutical compounding in the Netherlands, a top-3 position in Belgium and a top-5 position in Spain. It supplies around 3,300 pharmacies and more than 200 hospitals and it owns a chain of pharmacies with 23 own pharmacies in the Netherlands.

The company covers the entire value chain – from the procurement of APIs to sterile and nonsterile compounding of pharmaceuticals and supply via public and hospital pharmacies to home care services including the assistance of patients at home. Ceban has long-lasting relationships with parties across the chain and is strongly positioned to benefit from the significantly growing demand for pharmaceutical compounding by clinics, pharmacies, and hospitals. 

Ceban has been growing its revenue at an average organic growth rate of more than 10% over the last three years, to a preliminary revenue of c. €160 million in 2023. The preliminary EBITDA-adjusted amounts to c. €29 million in 2023, resulting in a respective margin of c. 18%.

Ceban will continue to operate under its own brand names. Ceban’s strong and experienced management team has committed to remain fully involved to further drive growth in already existing markets and in new geographies within Europe.

Transaction details

Medios will acquire a 100% interest in Ceban Pharmaceuticals B.V. from funds managed by Bencis. The purchase price for the transaction includes a cash component of €235.3 million and 1.7 million new Medios shares valued approx. €23.9 million*. The newly issued shares will be subject to a hard lock-up period of 24 months.

The purchase price is financed by Medios from existing cash and an already committed credit facility. The 1.7 million new shares will be issued out of authorized capital against contributions in kind.

The completion of the transaction is subject to the fulfilment of customary closing conditions. The closing of the transaction is expected for the second quarter of 2024.

Preliminary financials FY 2023

Based on preliminary and unaudited figures (IFRS), Medios has reached its guidance and once again grew strongly in the financial year 2023. From January to December 2023, Consolidated revenue increased by c. 11.0% to around €1.8 billion (previous year: €1.61 billion) and thus met the most recent forecast. EBITDA pre1 increased by 10.3% to around € 60.5 million (previous year: €54.9 million) exceeding the most recent forecast of around €60 million. Accordingly, the EBITDA pre1 margin remained at the previous year’s level of 3.4%.

New guidance for 2024 and outlook for 2025 

Assuming the completion of the acquisition of Ceban in the second quarter of 2024, Medios expects revenue in a range of €1.9 to €2.1 billion in the FY 2024 along with an EBITDA pre1 in a range of €82 to €91 million, reflecting a margin of around 4.3% based on the mean value of the respective revenue and EBITDA pre range.

With the realization of synergies and further organic growth Medios expects for FY 2025 revenue to grow to around €2.15 billion and an EBITDA pre of around €110 million, which reflects an increased EBITDA pre1 margin of c. 5.1%.

 

* Based on the closing price of the Medios shares in the XETRA trading system of Frankfurt Stock Exchange on March   14, 2024.

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

——————-

About Medios AG

Medios AG is the leading provider of Specialty Pharma Solutions in Germany. As a competence partner and expert, Medios covers all relevant aspects of the supply chain in this field: from pharmaceutical supply to the manufacture of patient-specific therapies including blistering. The focus is on optimal patient care via specialized pharmacies.
Medios AG is Germany’s first listed Specialty Pharma company. The shares (ISIN: DE000A1MMCC8) are listed on the Regulated Market of the Frankfurt Stock Exchange (Prime Standard).

 www.medios.ag

 

About Ceban Pharmaceuticals

Ceban has modern GMP-compliant manufacturing facilities for sterile and nonsterile pharmaceutical compounding and the repacking of APIs. Ceban also owns the “Medsen” chain of 23 pharmacies in the Netherlands. Ceban currently supplies a total of around 3,300 pharmacies and more than 200 hospitals in the Netherlands, Belgium, and Spain with APIs, and both sterile and non-sterile compounded medicines. Sterile preparations include ophthalmic preparations, analgesics, and antibiotics; non-sterile preparations cover antipsychotics, antiemetics, analgesics, diuretics, and antibiotics.

www.cebanpharma.com

 

About Bencis:

Bencis is an independent investment company that supports business owners and management teams in achieving their growth ambitions. Working out of offices in Amsterdam, Brussels and Düsseldorf, Bencis has been investing in strong and successful businesses in the Netherlands, Belgium and Germany since 1999.

www.bencis.com

 

Contact

Claudia Nickolaus
Head of Investor & Public Relations, ESG Communications
Medios AG
Heidestraße 9 | 10557 Berlin
T +49 30 232 566 800
c.nickolaus@medios.ag
www.medios.ag

 

Disclaimer

This communication contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those currently anticipated as a result of various risk factors and uncertainties, including, but not limited to, changes in business, economic and competitive conditions, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing.

 


18.03.2024 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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SCHOTT Pharma to Expand in the U.S. with New Prefillable Syringe Manufacturing Facility

EQS-News: SCHOTT Pharma AG & Co. KGaA

/ Key word(s): Strategic Company Decision/Expansion

SCHOTT Pharma to Expand in the U.S. with New Prefillable Syringe Manufacturing Facility

18.03.2024 / 18:40 CET/CEST

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

SCHOTT Pharma to Expand in the U.S. with New Prefillable Syringe Manufacturing Facility in Wilson, North Carolina
18 March 2024, Mainz, Germany

  • With $371 million investment, new site to add over 400 jobs to the region
  • First U.S. manufacturing facility to fill demand for domestic supply of glass and polymer prefillable syringes that deliver mRNA, GLP-1, and other therapies

SCHOTT Pharma plans to make Wilson, North Carolina home to its newest site. The investment is supported by $21 million in state and local incentive awards and will expand SCHOTT Group’s presence in the United States, a strategic market in its growth plan.

SCHOTT Pharma a pioneer in pharmaceutical drug containment solutions and delivery systems, will build the first U.S. facility to manufacture prefillable polymer syringes required to meet the need for deep-cold storage and transportation of mRNA medications. In addition, the site will have the capability to produce glass prefillable syringes for GLP-1 therapies, for example to treat diseases such as diabetes or obesity. The project will add 401 jobs to the region and include a total investment of $371 million, with groundbreaking expected by the end of 2024, and projected operations starting in 2027.

The new site will expand the U.S. supply chain for in-demand syringes that deliver lifesaving injectable medicines, vaccines, and other fields of applications, allowing SCHOTT Pharma to triple its contribution of glass and polymer syringes to the U.S. market by 2030. Bringing production to the U.S. will reduce lead times and slash transportation costs, as well as protect against future shortages of critical drugs and ensure pandemic preparedness.

“As drug manufacturers develop and expand the use of mRNA, GLP-1, and other biologic therapies that require precise drug stability and storage properties, SCHOTT Pharma will be able to fill those orders quickly and efficiently here in the U.S.,” said Andreas Reisse, CEO of SCHOTT Pharma. “The impact of this facility will go far beyond local job creation in North Carolina and will relieve stress on the entire pharmaceutical industry supply chain.”

The top 30 global pharma companies and more than 1,800 customers rely on SCHOTT Pharma containers and systems, including the U.S. and global leaders in the pharmaceutical and biotech categories. Many of these companies have designated SCHOTT Pharma as a critical supplier of one or more of the most essential components within their supply chain. On average, more than 25,000 injections per minute are provided to patients worldwide through a product produced by SCHOTT Pharma.

“Wilson County stood out in a nationwide search for a number of reasons, particularly for its favorable pool of local talent and its proximity to the Research Triangle area, which hosts numerous universities, healthcare companies, and biopharma resources,” said Christopher Cassidy, President of SCHOTT North America. “Expanding operations in the U.S. addresses rapidly growing demand for our high-value solutions.”

“North Carolina’s pro-growth and low-tax policies, along with the $40 million investment in the new biologics training facility at Wilson Community College, are paying off for Wilson County and the BioPharma Crescent,” said North Carolina Senator Buck Newton.  “SCHOTT Pharma’s $371 million capital investment and 401 high-wage jobs will strengthen our local economy.  We look forward to a long and successful future for them here in Wilson.”

For over two decades, SCHOTT Pharma has been manufacturing vials at its Lebanon, PA, facility, serving as a reliable partner for the pharmaceutical industry. Being that the U.S. is a key strategic market for the entire SCHOTT Group, the company underwent a nationwide site selection process for a campus-like property to serve further growth opportunities. While SCHOTT is not guaranteeing additional investment to support other markets at this time, the site in Wilson, North Carolina offers the possibility of future expansion.

The project location is contingent on final real estate negotiations. SCHOTT Pharma partnered with several organizations throughout the project, including the North Carolina Department of Commerce and the Economic Development Partnership of North Carolina, the North Carolina General Assembly, the North Carolina Community College System, Commerce’s Division of Workforce Solutions, Wilson County, the City of Wilson, the Wilson Economic Development Council, the North Carolina Biotechnology Center, and the Biomanufacturing Training and Education Center at North Carolina State University.

About SCHOTT Pharma
Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from pre-fillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023. Further information at schott-pharma.com.

Contacts: 
Lea Kaiser
Corporate Communications Manager
Tel.: +49 6131 66 2422
E-Mail: lea.kaiser@schott.com    

Jasko Terzic, CFA 
Head of Investor Relations 
IR.Pharma@schott.com 
 


18.03.2024 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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aap Implantate AG: Capital increase from authorized capital with exclusion of subscription rights

aap Implantate AG / Key word(s): Capital Increase

aap Implantate AG: Capital increase from authorized capital with exclusion of subscription rights

18-March-2024 / 12:35 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.


Publication of inside information pursuant to Article 17 of Regulation (EU) No 596/2014

The Management Board of aap Implantate AG (“Company“) resolved today, with the approval of the Supervisory Board, to increase the Company’s share capital against cash contributions by issuing new no-par value bearer shares with a pro rata amount of the share capital of EUR 1.00 per share of the Company (“New Shares“), making partial use of the authorized capital and excluding shareholders’ subscription rights (“Capital Increase“). The capital increase will increase the company’s share capital from the current EUR 8,966,474.00 by EUR 896,647.00 to EUR 9,863,121.00 by issuing 896,647 New Shares. The capital increase thus corresponds to just under 10% of the existing share capital. The New Shares will carry dividend rights from January 1, 2024. The issue price per New Share is EUR 1.10.

The capital increase serves to strengthen the company’s equity base. The New Shares will be issued by way of a private placement to a selected investor. The gross issue proceeds from the capital increase amount to EUR 986,311.70.

*****

—————————————————————————————————————————————–

aap Implantate AG share (ISIN DE000A3H2101) – General Standard/Regulated Market – All German stock exchanges –

 

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily uses a broad network of distributors in around 25 countries. In the USA, the company relies on a hybrid sales strategy through its subsidiary aap Implants Inc. Sales are conducted both through distribution agents and through partnerships with global orthopedic companies. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

 

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to adapt them to future events or developments.

 

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo; Chairman of the Management Board; Lorenzweg 5; 12099 Berlin

Tel.: 030/750 19 – 170; Fax: 030/750 19 – 290; E-mail: R.DiGirolamo@aap.de

Contact:
Contact:
aap Implantate AG; Fabian Franke; Investor Relations; Lorenzweg 5; D-12099 Berlin Tel.: ++49/30/750 19 – 134; Fax.: ++49/30/750 19 – 290; f.franke@aap.de

End of Inside Information


18-March-2024 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


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Mainz Biomed: Webinar on Early Detection of Colorectal Cancer – Exploring New Laboratory Diagnostic Options

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

18.03.2024 / 13:01 CET/CEST

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

Mainz Biomed: Webinar on Early Detection of Colorectal Cancer – Exploring New Laboratory Diagnostic Options

BERKELEY, US – MAINZ, Germany – March 18th 2024 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a leader in molecular genetics diagnostic solutions for early cancer detection, in collaboration with Ganzimmun, will host an educational webinar on Early Detection of Colorectal Cancer: New Laboratory Diagnostic Options which is taking place on March 20, 2024.

Designed for pharmacists, physicians, and healthcare professionals, this online training session aims to shed light on innovative laboratory diagnostic approaches for colorectal cancer screening. Set against the backdrop of March’s Colorectal Cancer Awareness Month, the webinar will delve into the significance of genetic markers and the advancements in screening techniques that offer a more accurate risk assessment and early detection. Attendees will have the opportunity to earn continuing education credits, with two certification points from ÄK and one from BDH.

Event Details:

  • Educational Webinar for medical community in German language
  • Title: Darmkrebs-Früherkennung: Neue labordiagnostische Optionen (Early Detection of Colorectal Cancer: New Laboratory Diagnostic Options)
  • Speaker: Jürgen Fuhrländer, Senior Consultant Medical Sciences
  • Certification: 2 ÄK points, 1 BDH point
  • Target Audience: Pharmacists, Physicians, Healthcare Professionals
  • Hosts: MainzBiomed, Ganzimmun
  • Date: March 20, 2024
  • Time: from 07:00 PM to 08:15 PM (CET)
  • Location: Online
  • Cost: Free

For more information and to register, please visit Mainz Biomed’s official website or https://www.ganzimmun.de/service/akademie/fortbildungskalender?event_uid=onlineseminar332.

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

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About ColoAlert®

ColoAlert®, Mainz Biomed’s flagship product, delivers high sensitivity and specificity in a user-friendly, at-home colorectal cancer (CRC) screening kit. This non-invasive test can be indicative of tumors as determined by analyzing tumor DNA, offering better early detection than fecal occult blood tests (FOBT). Based on PCR-technology, ColoAlert® detects more cases of colorectal cancer than other stool tests and allows for an earlier diagnosis (Dollinger et al., 2018). The product is commercially available in select EU countries through a network of leading independent laboratories, corporate health programs and via direct sales. To receive marketing approval in the US, ColoAlert® will be evaluated in the FDA-registration trial ‘ReconAAsense.’ Once approved in the US, the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

About Colorectal Cancer

Colorectal cancer (CRC) is the third most common cancer globally, with more than 1.9 million new cases reported in 2020, according to World Cancer Research Fund International. The US Preventive Services Task Force recommends that screening with stool DNA tests such as ColoAlert® should be conducted once every three years starting at age 45. Each year in the US, 16.6 million colonoscopies are performed. However, roughly one-third of US residents aged 50-75 have never been screened for colon cancer. This gap in screening represents a $4.0B+ total market opportunity in the US.

About Mainz Biomed N.V.  

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 based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples. ColoAlert® is currently marketed across Europe. The Company is 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. To learn more, visit mainzbiomed.com.   

For media inquiries

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

In the U.S.:
Blueprint Life Science Group
Hershel Berry
+1 415 505 3749
hberry@bplifescience.com  

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 7, 2023. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


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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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