Sigyn CEO Note: First-In-Industry Attributes of CardioDialysisTM to Treat Cardiovascular Disease

Sigyn Therapeutics, Inc.

/ Key word(s): Manufacturing

Sigyn CEO Note: First-In-Industry Attributes of CardioDialysisTM to Treat Cardiovascular Disease

11.12.2025 / 17:35 CET/CEST

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


Dear Readers, 

Kidney dialysis sustains and extends the lives of approximately four million individuals with end-stage renal disease (ESRD). We are advancing CardioDialysisTM to extend the lives of individuals with cardiovascular disease, the leading cause of death worldwide. 

A primary objective of cardiovascular disease therapies is to reduce the incidence of heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). LDL-C reducing statins (Lipitor, Crestor, and Zocor), the leading class of drugs to treat cardiovascular disease are associated with 25% reductions in MACE.

Source Publication Link:

https://pmc.ncbi.nlm.nih.gov/articles/PMC12359277/

Whereas the American Heart Association (AHA) recently reported the use of blood purification to reduce LDL-C and Lipoprotein(a) levels (lipoprotein apheresis) is associated with 75% to 95% reductions in MACE.

Source Publication Link:    

https://www.ahajournals.org/doi/10.1161/ATV.0000000000000177

When taking these factors into consideration, I want to highlight first-in-industry attributes of CardioDialysis that could expand the use of blood purification to treat cardiovascular disease and potentially allow for us to improve upon the MACE reductions reported by the American Heart Association. 

Overcoming a Major Barrier for Treatment Adoption 

As per the AHA report, blood purification to reduce circulating levels of LDL-C and Lipoprotein(a), otherwise known as lipoprotein apheresis, is an FDA-approved precedent proven to reduce MACE in those with cardiovascular disease.  However, the broad adoption of lipoprotein apheresis is constrained by delivery infrastructure, with treatments being limited to approximately 60 specialized apheresis centers in the United States.

CardioDialysis is not constrained by delivery infrastructure as it is deployed for use on dialysis machines already located at more than 7,500 kidney dialysis clinics in the U.S. alone.  Lipoprotein apheresis devices do not operate on dialysis machines.  

Broad-Spectrum Clearance of Cardiovascular Disease Targets

Invitro blood purification studies have validated the ability of CardioDialysis to address a broad-spectrum of therapeutic targets, including inflammatory molecules that contribute to cardiovascular disease progression, yet are not addressed with market-approved therapies.  To date, the clearance of twelve therapeutic targets (all below 200nm in diameter) from human blood plasma has been demonstrated. CardioDialysis has also been observed to be safe and well tolerated in porcine animal studies conducted at the University of Michigan. 

Early Clinical & Commercialization Opportunity in Dialysis Patients 

We have an early clinical and commercialization opportunity to treat cardiovascular disease in end-stage renal disease (ESRD) patients as CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments.

The U.S. Renal Data System (USRDS) reports that cardiovascular disease accounts for 67% of ESRD patient deaths and its incidence is up to 20 times higher in ESRD patients as compared to the general population.  As recently reported in the Journal Nature, drugs to treat cardiovascular disease have not reduced cardiovascular events in dialysis patients. Additionally, circulating levels of cholesterol-transporting lipoprotein(a), which is not addressed with an approved drug, are 2-4 times higher in ESRD dialysis patients as compared to the general population.

Beyond high mortality rates, cardiovascular disease is a substantial initial market opportunity, given an estimated 550,000 ESRD patients receive ~85 million dialysis treatments in the U.S. each year.  

An Executable Clinical Strategy

Unless you have previously advanced an extracorporeal blood purification therapy through FDA’s Center for Devices and Radiological Health (CDRH), you may not appreciate the elegance of our clinical strategy.  Historically, human clinical studies of devices to treat life-threatening disease conditions often face the daunting challenge to identify and enroll subjects in a hospital intensive care unit (ICU) setting.  

Whereas our clinical plan is to enroll ESRD patients to participate in a study conducted at their kidney dialysis clinic, with the administration of CardioDialysis occurring during their regularly scheduled dialysis treatments. This is an efficient yet executable clinical strategy that applies to both our human feasibility (safety) and pivotal efficacy study that will be required for market approval consideration. As a result, the time and cost to conduct our studies should be significantly reduced. 

Strategic Value to the Dialysis Industry 

When considering that cardiovascular disease is the leading cause of ESRD deaths, a reduction in MACE would be expected to extend ESRD patient lives.  Based on average annual per-patient revenues of $65,000, top-line dialysis industry revenues could be increased by $2.8 billion for each month that the lives of U.S. dialysis patients are extended. CardioDialysis also introduces a potential pathway for the dialysis industry to treat cardiovascular disease in the general population, which is the commercial focus of lipoprotein apheresis.  In this regard, we envision the possibility that current “Kidney Dialysis Clinics” could be transformed into future “Renal and CardioDialysis Treatment Centers.”

Thank you for reading my note. If you have questions or comments, please contact me at jj@sigyntherapeutics.com

Sincerely, Jim 

About Sigyn Therapeutics™

Sigyn Therapeutics is developing dialysis-like therapies to address cardiovascular disease and cancer. The Company’s therapeutic candidates are designed to improve and extend the quality of patient lives, and their successful clinical advancement offers to provide strategic value to the dialysis and biopharmaceutical industry.

Sigyn CardioDialysis™ is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.

The Company’s development pipeline is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.

To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com

CONTACT:

Sigyn Therapeutics, Inc.
Jim Joyce
CEO, Inventor
Email: jj@SigynTherapeutics.com 

Cautionary Note Regarding Forward-Looking Statements

The information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” “potentially” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company’s ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company’s ability to manufacture Sigyn Therapy, the Company’s ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K, and in the Company’s other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

News Source: Sigyn Therapeutics, Inc.


11.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2244398  11.12.2025 CET/CEST

Expansion of the Management Board of M1 Kliniken AG

M1 Kliniken AG

/ Key word(s): Personnel

Expansion of the Management Board of M1 Kliniken AG

11.12.2025 / 10:00 CET/CEST

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


Expansion of the Management Board of M1 Kliniken AG

Berlin, 11. December 2025 – The Supervisory Board of M1 Kliniken AG has appointed Ms. Katharina Zimmnau to the Executive Board of M1 Kliniken AG with effect from 10. December 2025. Ms. Zimmnau has been CFO of M1 Kliniken AG since June 1, 2025.

“I am very pleased to welcome Ms. Zimmnau to the team. With her many years of experience in accounting, controlling, and process design, she will play a key role in shaping the further development of our profitable growth trajectory”, says Attila Strauss, CEO of M1 Kliniken AG.

 

 

About M1 Kliniken AG

M1 Kliniken AG is the leading fully integrated provider of medical aesthetic services in Europe and Australia. With a clear strategic focus, high standardization, and consistent scalability, the Group currently operates 58 clinics in ten countries under the M1 Med Beauty brand. All treatments are performed exclusively by qualified physicians and adhere to uniform, high medical standards, while being offered at market-leading prices. Since late 2018, M1 has systematically driven its international expansion, which forms the basis for scalable future growth and the further development of its global market position. With the M1 Schlossklinik in Berlin, the Group operates one of Europe’s largest and most modern clinics for plastic and aesthetic surgery, featuring four operating theaters and 35 beds.

 

Contact:
M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
T: +49 (0)30 347 47 44 14
M: ir@m1-kliniken.de


11.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: M1 Kliniken AG
Grünauer Straße 5
12557 Berlin
Germany
Phone: +49 (0)30 347 47 44 14
Fax: +49 (0)30 347 47 44 17
E-mail: ir@m1-kliniken.de
Internet: https://www.m1-kliniken.de
ISIN: DE000A0STSQ8
WKN: A0STSQ
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Basic Board), Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2243968

 
End of News EQS News Service

2243968  11.12.2025 CET/CEST

SCHOTT Pharma delivers on full-year revenue and profitability targets

SCHOTT Pharma AG & Co. KGaA

/ Key word(s): Annual Report/Annual Results

SCHOTT Pharma delivers on full-year revenue and profitability targets

11.12.2025 / 07:00 CET/CEST

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


SCHOTT Pharma delivers on full-year revenue and profitability targets

  • Revenue of EUR 986.2m reflects a 5.8% growth at constant currencies
  • EBITDA margin at constant currencies increased to 28.4% (prior year: 26.9%)
  • Successful expansion of high-value solutions (HVS) – revenue share increased to 57% (prior year: 55%)
  • Guidance for FY 2026: 2-5% revenue growth at constant currencies and EBITDA margin of around 27%

SCHOTT Pharma, a pioneer in drug containment solutions and delivery systems, has successfully concluded its fiscal year 20251.Revenue rose to EUR 986.2m, representing an increase of 5.8% at constant currencies (reported +3.0%). Full-year EBITDA grew even stronger and amounted to EUR 280.3m, up 11.5% at constant currencies (reported +8.8%). The corresponding EBITDA margin was 28.4% (reported 28.4%).

Amid the challenging macroeconomic environment, SCHOTT Pharma once again delivered excellent results, and we met our targets for both revenue and profitability. While our core solutions remain a very solid and profitable business, we have effectively continued to focus on increasing the revenue share of our high-value solutions through product innovation, capacity expansions, and strong partnerships,” said SCHOTT Pharma’s CEO Andreas Reisse. “As we expect the market to remain difficult, we target a revenue growth of 2-5% for fiscal year 2026 and an EBITDA margin of around 27%. This represents a bridge year, as we anticipate market dynamics to pick up again going forward. We update our mid-term guidance and now project a revenue CAGR of 6-8% and an incremental increase of our EBITDA margin over the coming years.”

Reinhard Mayer, CFO of SCHOTT Pharma, adds: “The disciplined execution of our strategy in 2025 has further strengthened SCHOTT Pharma’s financial foundation and bolstered our resilience against the backdrop of geopolitical uncertainties. Over the last six years, we have invested around EUR 800m in our global manufacturing network, particularly for high-value solutions. At the same time, we have further improved our efficiency through automation and digitization, which is also reflected in the positive development of our EBITDA margin. Looking ahead, we remain committed to investing in innovation, capacity and operational excellence to drive sustainable, profitable growth alongside our mid-term expectations.”

Profitable growth driven by high-value solutions

SCHOTT Pharma’s positive development was driven by the Drug Containment Solutions segment (DCS), where revenue increased 11.9% at constant currencies (reported +5.6%) to EUR 548.0m. High-value solution products like sterile ready-to-use cartridges and vials as well as specialty vials for innovative biologic drugs performed particularly well. As a consequence, the segment’s HVS revenue share grew by 6pp to 23%. EBITDA in the DCS segment rose to EUR 127.5m, marking a significant surge of 34.9% at constant currencies (reported +26.0%) due to a favorable product mix and efficiency gains. The corresponding margin went up by 4.0pp to 23.5% (reported 23.3%).

Revenue in the Drug Delivery Systems (DDS) segment were at EUR 438.8m, representing a slight decline of 1.3% at constant currencies (reported: 0.0%). The lower demand for polymer syringes was offset by the sustained high demand for prefillable glass syringes. EBITDA decreased by 9.9% at constant currencies (reported -8.2%) to EUR 152.8m, mainly due to lower utilization as well as ramp-up costs for the new prefillable glass syringe manufacturing facility in Hungary. The segment´s EBITDA margin was at 34.6% at constant currencies (reported 34.8%), down 3.3pp on the previous year’s figure.

Solid cash generation and high growth investments

SCHOTT Pharma’s operating cash flow came in at EUR 179.9m in the reporting year, after EUR 224.8m in 2024. This was mainly due to a higher working capital need and timing of tax payments, which more than offset the EBITDA improvement. At EUR 144.8m, CAPEX was on par with the previous year’s level, as the company continued to invest in capacity expansion, particularly for high-value solutions.

Earnings per share for the reporting year were EUR 0.97 (prior year: EUR 0.99). The Management Board and Supervisory Board will propose a dividend of EUR 0.18 per share for FY 2025 at the Annual General Meeting on February 3, 2026. That would result in a payout ratio of 18% of the profit for the period.

Addressing market needs, preparing for future growth

In fiscal year 2025, SCHOTT Pharma launched several product innovations addressing major market trends, such as the increasing demand for solutions that enable the safe and easy self-administration of injectable drugs at home; the growing and increasingly diverse range of sensitive biologics; as well as the need for a more sustainable manufacturing and reliable supply of drugs and vaccines. The portfolio additions include sterile large-volume syringes and cartridges made of glass and polymer, which further strengthen the company’s product range of high-value solutions.

At the same time, SCHOTT Pharma continued to execute its multi-year expansion plan and achieved important milestones. The company opened a new production site in Serbia and celebrated the groundbreaking for a new facility for sterile ready-to-use cartridges in Hungary.

Outlook

SCHOTT Pharma expects revenue growth at constant currencies of 2-5% for fiscal year 2026 and the EBITDA margin to be around 27%. The sales growth will be entirely driven by the DCS segment. At the same time, the DDS segment will be impacted by the unexpected revised market outlook of a key customer resulting in lower glass syringes demand. Product mix effects and a temporary underutilization of capacities in DDS, as well as ramp-up costs for new factories in Serbia and Hungary is impacting the EBITDA margin in 2026.

Based on this, SCHOTT Pharma updates its mid-term outlook for 2027 to 2029 to a revenue CAGR of 6-8% and expects the EBITDA margin to improve over the coming years towards 30%.

New CEO appointed

On November 5, 2025, SCHOTT Pharma announced that Christian Mias will succeed Andreas Reisse as CEO, effective May 1, 2026. Mias has 20 years of management experience, thereof more than 18 years within the SCHOTT group. There, he has held leadership positions across various business units and continents, in which he drove profitable growth by optimizing processes, improving productivity, and increasing earnings quality. His career also included roles at SCHOTT Tubing, which manufactures glass tubing for the pharmaceutical sector, including for SCHOTT Pharma, where he gained significant experience in the pharmaceutical industry.

 

For additional news about SCHOTT Pharma, please visit our media center.

                                                                                                                                         

Key figures FY 2025

  Group DCS DDS  
(in EUR m) FY 25 FY 24 Δ Δ
cc2
FY 25 FY 24 Δ Δ
cc2
FY 25 FY 24 Δ Δ
cc2
Revenue 986.2 957.1 +3.0% +5.8% 548.0 518.7 +5.6% +11.9% 438.8 438.7 0.0% -1.3%
HVS revenue share 57% 55% +2pp   23% 17% +6pp   100% 100% nm  
EBITDA 280.3 257.6 +8.8% +11.5% 127.5 101.3 +26.0% +34.9% 152.8 166.4 -8.2% -9.9%
EBITDA margin 28.4% 26.9% +1.5pp   23.3% 19.5% +3.8pp   34.8% 37.9% -3.1pp  
EBITDA margin cc2 28.4%       23.5%       34.6%      
EBIT 200.8 192.6 +4.3%   89.2 66.3 +34.5%   112.5 137.1 -17.9%  
EBIT margin 20.4% 20.1% +0.3pp   16.3% 12.8% +3.5pp   25.6% 31.2% -5.6pp  
Profit for the period 147.0 150.3 -2.2%                  
Earnings per share
(in EUR)
0.97 0.99 -2.0%                  
Cash flow from
operating activities
179.9 224.8 -44.9                  
Cash flow from
ongoing investing activities
-143.1 -143.8 +0.7                  
Free cash flow 36.8 81.0 -44.2                  
Total cash CAPEX -144.8 -145.3 +0.5                  
                             

 

Key figures Q4 2025

  Group DCS DDS
(in EUR m) Q4 25 Q4 24 Δ Δ
cc2
Q4 25 Q4 24 Δ Δ
cc2
Q4 25 Q4 24 Δ Δ
cc2
Revenue 247.0 237.1 +4.2% +6.6% 134.1 118.7 +13.1% +19.2% 113.0 118.5 -4.6% -6.0%
HVS revenue share 59% 60% -1pp   24% 19% +5pp   100% 100% nm  
EBITDA 67.0 66.1 +1.3% +2.9% 28.0 16.9 +65.3% +78.5% 38.3 45.1 -15.1% -16.5%
EBITDA margin 27.1% 27.9% -0.8pp   20.8% 14.3% +6.5pp   33.9% 38.1% -4.2pp  
EBITDA margin cc2 26.9%       21.3%       33.8%      
EBIT 44.9 48.1 -6.8%   17.1 8.0 >100%   27.3 36.3 -24.6%  
EBIT margin 18.2% 20.3% -2.1pp   12.8% 6.7% +6.1pp   24.2% 30.6% -6.4pp  
Profit for the period 33.3 34.2 -2.5%                  
Earnings per share
(in EUR)
0.22 0.22 0.0%                  
Cash flow from
operating activities
52.2 75.4 -23.2                  
Cash flow from
ongoing investing activities
-55.0 -64.1 +9.1                  
Free cash flow -2.8 11.3 -14.1                  
Total cash CAPEX -55.5 -64.7 +9.2                  

Differences in the total numbers in the tables may be due to rounding, and differences in group revenue may result from consolidation and reconciliation effects. / nm = not meaningful

1The fiscal year runs from October to September. Q4 2025 therefore relates to the period from July 2025 to September 2025.
2cc = at constant currencies

Webcast

CEO Andreas Reisse and CFO Reinhard Mayer will speak at an analyst and investor conference call at 11:00 a.m. CET on 11 December 2025 to discuss the Q4 and FY 2025 results. The audio webcast can be followed via the following link. The accompanying presentation is available on the IR website: www.schott-pharma.com/investor-relations

 

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs containment solutions grounded in science to ensure that medications are safe and easy to use for people around the world. Every minute, more than 30,000 people receive an injection packed in a SCHOTT Pharma product. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of around 4,800 people from over 65 nations works at SCHOTT Pharma to contribute to global health. The company is represented in all main pharmaceutical hubs with 17 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. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 986 million in the fiscal year 2025. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is majority owned by 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. Further information at www.schott-pharma.com

 

Press contact

Lea Kaiser

PR & Communications Manager

Tel.: +49 (0) 151 68917195

E-Mail : lea.kaiser@schott.com

 

Katrin Schreyer

Global Communications Manager

Tel.: +49 (0) 171 116 7544

E-Mail : katrin.schreyer@schott.com

 

 

Investor Relations contact

Tobias Erfurth

Head of Investor Relations

Jasko Terzic

Senior Manager Investor Relations

E-Mail: ir.pharma@schott.com


11.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: SCHOTT Pharma AG & Co. KGaA
Hattenbergstraße 10
55122 Mainz
Germany
E-mail: ir.pharma@schott.com
Internet: https://ir.schott-pharma.com/
ISIN: DE000A3ENQ51
WKN: A3ENQ5
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2243572

 
End of News EQS News Service

2243572  11.12.2025 CET/CEST

BioVersys Announces BV100 Phase 3 Initiation and Provides a Business Update

 

Basel, Switzerland. December 11, 2025, 7am CEST

 

 

  • BV100 Phase 3 in Ventilator Associated Bacterial Pneumonia initiated with first country submission completed and first patients to be dosed in the coming months – Phase 3 read-out expected in H2 2027
  • Significant value inflection points achieved in 2025 including: Successful IPO on SIX Swiss Exchange extending cash runway to 2028, Strong BV 100 Phase 2 data generated in VABP, Global Research Collaboration with Shionogi for BV500, alpibectir progressed to Phase 2 trial in pulmonary TB, and BV100 selection by ADVANCE-ID for upcoming Phase 2b, mostly financed by Wellcome
  • Strong news flow expected in 2026 including: 1st DSMB review for BV100 Phase 3, Interim data read-out for BV100 Phase 2b and Read-out of Phase 2 alpibectir in pulmonary tuberculosis by partner GSK

 

 

BioVersys AG, a multi-asset, late-stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria, announced today the initiation of its lead asset BV100 Phase 3 clinical program and provides a business update summarizing the Company’s progress in 2025 and the events expected in 2026.

Initial Public Offering in Q1 2025

Following successful capital raising activities in 2024, the promising advancement in the Company’s pipeline and the related positive clinical data generated, BioVersys completed its IPO on the SIX Swiss Exchange on February 7, 2025, marking the first IPO of a biotech company in Switzerland in seven years and the largest IPO in the past five years on any European exchange. The IPO added proceeds of CHF 76.7 million and further strengthened BioVersys’ financial position, funding the company’s operations into 2028, including the completion of the BV100 Phase 3 trial in Ventilator Associated Bacterial Pneumonia (VABP), Hospital acquired Bacterial Pneumonia (HABP) and Blood Stream Infections (BSI).

BV100 Phase 3 initiated following strong Phase 2 data in VABP

BV100, the Company’s novel antibiotic candidate, has advanced into a global registration Phase 3 study program in drug-resistant infections. The trial will include clinical sites in the US, Europe, Latin-America, Asia and China. The Phase 3 will employ a similar study design to the successful Phase 2 trial, which demonstrated a clear survival benefit, where BV100 treatment resulted in a 50% relative reduction in all-cause mortality (ACM) in VABP patients suffering from carbapenem resistant Acinetobacter baumannii (CRAB) infections compared with best available therapy, and was generally safe and well tolerated.

Following successful end of Phase 2 meetings with the US FDA and EMA Emergency Task Force, BioVersys initiated the BV100 Phase 3 clinical program in December 2025 by submitting the clinical trial applications (CTA) to first regional and national regulatory authorities. Upon regulatory approvals within the coming months, site initiations and dosing of first patients will follow. This timeline is consistent with previous guidance on last patient last visit and top line data available for the Phase 3 towards the end of H2 2027.

BioVersys had also begun BV100’s clinical trial geographic expansion into China, with the first healthy volunteer dosed with BV100 in a mandatory Phase 1 trial. The trial precedes the inclusion of Chinese clinical sites by late 2026 into the just initiated single Global Phase 3 registration program.

In addition to the registrational Phase 3 program necessary to gain regulatory approval in the US, EU and China, BioVersys is also planning to conduct a Phase 2b in a similar patient population, but comparing BV100 to best available therapy instead of Colistin in the Phase 3 program. This different study design compared to the Phase 3 study, aims at providing real world evidence of clinical practices in particular in settings with very high drug resistance levels. While BioVersys was initially expecting to fully finance this Phase 2b trial, we are delighted that the trial was selected for conduct and funding by ADVANCE-ID, a clinical trial network centered at the Saw Swee Hock School of Public Health, National University of Singapore and significantly financed by Wellcome. The Phase 2b trial is expected to start in H1 2026 and will be conducted by ADVANCE-ID under the supervision of BioVersys. Thanks to the generous contribution of Wellcome which is contributing SGD 22 million (c. USD 17m or CHF 14m) to ADVANCE-ID, the financial contribution of BioVersys has been significantly reduced.

BV500 in non-tuberculous mycobacteria (NTM) infections (in collaboration with Shionogi)

The BV500 NTM program aims to develop a potential new, best-in-class medicine for NTM infections in the approximatively 250,000 patients per year affected with this pulmonary disease predominantly in North America and Asia. As announced earlier this year, BioVersys has entered into a global research collaboration and exclusive license option agreement with the Japanese Pharmaceutical leader Shionogi. This partnership ensures accelerated progression of the BV500 program towards jointly selecting candidates for clinical development. BioVersys received a CHF 5 million upfront payment and, upon the license agreement, is eligible for development, regulatory and sales milestone of up to CHF 479 million, as well as royalties on future sales.

Alpibectir in pulmonary and meningeal tuberculosis (partnered with GSK)

This is currently being developed in combination with Ethionamide (AlpE) under partnership with GSK. In Q1 2025, GSK initiated a Phase 2 early bactericidal activity trial for AlpE in combination with first-line TB drugs in pulmonary tuberculosis. This trial is run within UNITE4TB, a European Union and European Pharmaceutical funded Innovative Medicines Initiative (IMI2) joint undertaking. The trial is progressing well and remains on track to report topline data for the first part of the trial by Q2 2026.

 

BioVersys also reported in 2025 that AlpE was granted Orphan Designation by the EMA Committee for Orphan Medicinal Products, which followed the earlier Orphan Drug Designation by the US FDA.

 

A Phase 2 trial in meningeal tuberculosis, to be conducted by BioVersys together with a French and African academic consortium, is planned to initiate in 2026.

 

Upcoming key milestones in 2026 and 2027

  • Q1 2026: First patients dosed in the BV100 Phase 3 global registration study
  • H1 2026: Alpibectir Phase 2 start in meningeal tuberculosis
  • Q2 2026: Alpibectir Phase 2 first part readout in pulmonary tuberculosis
  • H2 2026: BV100 Phase 2b interim data analysis
  • H2 2026: BV 100 Phase 3 1st Data Safety Monitoring Board (DSMB) review
  • H1 2027: BV100 Phase 3 2nd DSMB review
  • H2 2027: BV100 Phase 3 top line data

 

 

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “2025 has been a year of significant achievements and progress for BioVersys. Our IPO early in the year strengthened our financial position, enabling us to deliver multiple value-generating milestones over the next two years towards our first drug approval. The clinical development of our lead asset BV100 is going ahead as planned, with the Phase 3 now started and expecting to dose the first patients in the next few months. We remained focused on cash burn efficiency, notably by entering into a research collaboration with Shionogi, as well as being chosen by the ADVANCE-ID network for conduct of the planned Phase 2b study which significantly reduces our financial contribution. We are also pleased with the significant progress of our second clinical stage asset alpibectir in partnership with GSK. 2026 will provide significant value inflection points of further evidence of the clinical benefit of our differentiated assets. We would like to thank the BioVersys team who is working tirelessly to deliver on our promises, as well as our investors for their continued trust and support.”

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact

Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com

For Media: media@bioversys.com

www.bioversys.com

 

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 

Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada 

Formycon AG

/ Key word(s): Alliance/Agreement

Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada 

09.12.2025 / 13:04 CET/CEST

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


Presse Release // December 09, 2025

Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada 

  • Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206
  • Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellence
  • Agreement structure includes in total mid-teens-million-euro upfront and 2025 milestone payments, alongside additional development and regulatory milestones and a mid-double-digit-gross-profit-share upon launch
  • Clinical development phase of FYB206 nearly completed; primary endpoint data expected in the first quarter of 2026

Planegg-Martinsried, Germany; Ahmedabad, India Formycon AG (FSE: FYB, “Formycon”) and Zydus Lifesciences Limited (including its subsidiaries and affiliates, “Zydus”), today jointly announced that they have entered into a strategic partnership for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab), in the U.S. and Canada.

Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada. Meanwhile, FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the data package, Formycon will prepare the dossier and submit the biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) in due course.

Dr. Stefan Glombitza, CEO of Formycon, commented: “Partnering with Zydus for the U.S. and Canada marks an important milestone for us. Zydus is an established, high-revenue player with a compelling and forward-looking oncology strategy. It has a strong commercial footprint in the U.S., where it generates nearly half of its global revenue and maintains a robust, scalable presence across key commercial channels. By commercializing over 225 FDA-approved products, including injectables and hospital-use medicines, Zydus has shown solid execution strength in complex launches, supporting the high-quality implementation of FYB206. With a streamlined clinical development program, Formycon has secured a leading role among the developers of a pembrolizumab biosimilar and Zydus´ decision to join forces with us underscores their strong confidence in our expertise in developing complex biosimilar medicines for highly regulated countries. Continuing our indicated partnering approach, we are teaming up with strong local partners at attractive commercial terms as we work together to deliver meaningful value for patients and healthcare systems.”

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated: “We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda® across U.S. and Canada. This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organizational growth and deliver maximum value to patients through expanded access to affordable oncology care.”

Upon signature of the agreement, Formycon will be eligible to receive mid-teens-million-euro upfront and milestone payments in 2025. In addition, Formycon will be eligible for further payments linked to the achievement of defined development and regulatory milestones, which in total are expected to amount to a mid–double-digit-million-euro range. Upon market launch, Formycon will obtain a mid–double-digit-share of the gross profits generated in the territory.

Pembrolizumab is a humanized monoclonal antibody that belongs to the group of immune checkpoint inhibitors and is used to treat a variety of tumors. With its broad range of indications in oncology and global sales of US$ 29.5 billion in 20242, Keytruda® is currently one of the world’s best-selling drugs, underscoring the substantial oncology demand and market potential across the world.

1) Keytruda® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.
2)
https://www.merck.com/news/merck-announces-fourth-quarter-and-full-year-2024-financial-results/ Merck Announces Fourth-Quarter and Full-Year 2024 Financial Results – Merck.com

 
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 and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – 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, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.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.

 


09.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: 089 864667 100
Fax: 089 864667 110
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Indices: SDAX,
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2242500

 
End of News EQS News Service

2242500  09.12.2025 CET/CEST

Cantourage appoints new member to its Management Board: Monique Jaqqam becomes Chief Financial Officer – Supervisory Board prolongs CEO Philip Schetter’s mandate by five years

Cantourage Group SE

/ Key word(s): Personnel

Cantourage appoints new member to its Management Board: Monique Jaqqam becomes Chief Financial Officer – Supervisory Board prolongs CEO Philip Schetter’s mandate by five years

09.12.2025 / 08:00 CET/CEST

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


Not for release, publication or distribution, directly or indirectly, in or intothe United States of America, Australia, Canada or Japan or any otherjurisdiction in which such release, publication or distribution would be unlawful. The important notes at the end of this announcement need to be observed.

 

Berlin, December 9, 2025 – The Supervisory Board of Cantourage Group SE has appointed Mrs. Monique Jaqqam to the Management Board as Chief Financial Officer (CFO) with effect from January 1, 2026. In her new role, Mrs. Jaqqam will be responsible for finance, HR, legal, and IT. With her appointment, the Management Board of Cantourage Group SE expands to two members. Mrs. Jaqqam’s mandate is for five years.

In addition, the Supervisory Board has extended CEO Philip Schetter’s mandate for another five years, sending a clear signal of continuity and stability in corporate management.

“We are convinced that Mrs. Jaqqam’s proven financial expertise is an ideal addition to our Management Board team,” says Christian Schreyer, Chairman of the Supervisory Board of Cantourage Group SE. “Together with Mr. Philip Schetter (CEO), she will continue to drive the Group’s profitable growth.”

“I look forward to working with Monique Jaqqam. With her deep financial expertise, she strengthens our organization in precisely those areas that are essential for our further growth. Together, we will consistently shape the next phase of Cantourage’s development,” says Philip Schetter, CEO of Cantourage Group SE.

“In a dynamic growth environment, a resilient financial architecture is crucial. My goal is to consistently strengthen these structures and thus support the further growth of the Cantourage Group in a sustainable and transparent manner,” said Monique Jaqqam, commenting on her appointment as CFO.

About Monique Jaqqam

Monique Jaqqam holds a degree in business administration and has been Group CFO of the Future Group in Berlin since August 2023. She has more than 20 years of international management experience in finance, private equity, real estate, and hospitality. Previously, she was Group CFO at Basecamp Student and held senior finance positions at Kempinski Hotels. Her focus is on financial transformation, building modern financial structures, and supporting complex transactions.

Monique Jaqqam to take over as CFO of Cantourage Group SE on January 1, 2026

Monique Jaqqam to take over as CFO of Cantourage Group SE on January 1, 2026

About Cantourage
Cantourage is a leading European producer and distributor of cannabis flowers and cannabis-based medicinal preparations and drugs. The Berlin-based company was founded in 2019 by industry pioneers Norman Ruchholtz, Dr. Florian Holzapfel and Patrick Hoffmann. With an experienced management team and its “Fast Track Access” platform, Cantourage enables producers from around the world to become part of the growing European medical cannabis market faster, easier and more cost-effectively by processing and distributing their cannabis raw materials and extracts. In this context, Cantourage ensures compliance with the highest European pharmaceutical quality standards at all times. The company offers pharmaceutical-grade products in all relevant market segments: dried flower, extracts, dronabinol and cannabidiol. Cantourage was listed on the Frankfurt Stock Exchange on 11 November 2022 and is listed under ISIN DE000A3DSV01

Further information: www.cantourage.com

Investor Relations contact at Cantourage
Manuel Taverne
taverne@cantourage.com

 

This announcement does not constitute a public offer or an advertisement for a public offer to sell securities, in particular not within the meaning of Regulation (EU) 2017/1129 (Prospectus Regulation).

 


09.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Cantourage Group SE
Feurigstraße 54
10827 Berlin
Germany
E-mail: info@cantourage.com
Internet: https://www.cantourage.com/
ISIN: DE000A3DSV01
WKN: A3DSV0
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt (Scale), Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2242076

 
End of News EQS News Service

2242076  09.12.2025 CET/CEST

Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)

Newron Pharmaceuticals S.p.A.

/ Key word(s): Study

Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)

08.12.2025 / 07:00 CET/CEST

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


Newron announces the US initiation of its ENIGMA-TRS 2 Phase III global clinical study with evenamide as an add-on therapy for patients with treatment-resistant schizophrenia (TRS)

ENIGMA-TRS 2 is a global, randomized, double-blind, placebo-controlled 12-week Phase III clinical study designed to enroll at least 400 patients; topline results are expected by Q4 2026

Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately or are resistant to existing antipsychotic therapies

Newron’s ENIGMA-TRS program (ENIGMA-TRS 1, started in August 2025, and ENIGMA TRS 2) aims to establish evenamide as the first approved add-on therapy for TRS, providing a new treatment option for a patient population with high morbidity and mortality

Morristown, NJ, USA, and Milan, Italy, December 8, 2025, 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 the initiation of its ENIGMA-TRS 2 Phase III clinical study in the US, following approvals from the US Food and Drug Administration (FDA) and the Institutional Review Board (IRB). The first site to initiate the study will be the Semel Translational Research Center for Neuropsychiatry (TRCN), University of California, Los Angeles (UCLA). The remaining US sites participating in ENIGMA-TRS 2 are expected to initiate the study shortly. Regulatory submissions are currently being made in the other countries that are expected to participate in this trial in the coming months.

This study addresses a significant unmet medical need in patients with treatment-resistant schizophrenia who are not responding to their current second-generation antipsychotic medication. Previous studies in patients who are inadequate responders and with treatment-resistant schizophrenia have demonstrated clinically meaningful benefits of evenamide with no evidence of intolerance”, said Prof. Stephen Marder, Director of the Section on Psychosis at the UCLA Semel Institute for Neuroscience and Human Behavior, principal investigator for the study. 

ENIGMA-TRS 2: A Global Phase III Study Bringing New Hope to Patients with TRS in the US and other countries

ENIGMA-TRS 2 is a Phase III, global, 12-week, randomized, double-blind, placebo-controlled trial evaluating the efficacy, safety, and tolerability of evenamide 15 mg twice daily as an add-on therapy to current antipsychotics, including clozapine, compared to placebo, in patients suffering from TRS. Eligible patients must meet the Treatment Response and Resistance In Psychosis (TRRIP) international consensus criteria for TRS.

The ENIGMA-TRS 2 study design has been approved by the US FDA and the study will enroll at least 400 patients across the US, Europe, Asia, and Latin America. Prior to randomization, patients undergo a 42-day screening period, during which their TRS diagnosis, plasma levels of their background antipsychotic medication, and adherence to protocol-defined eligibility criteria will be evaluated by an Independent Eligibility Assessment Committee (IEAC) comprising leading international experts in the field of schizophrenia research.

The primary assessment of efficacy and safety will be performed 12 weeks after randomization to treatment; topline results are expected in Q4 2026.

Earlier clinical trials (Phase II studies 014/015 and Phase III study 008A) demonstrated that evenamide, when added to standard antipsychotic therapy, was well tolerated and safe. Importantly, evenamide may lead to clinically meaningful improvements for people who fail to respond or become resistant to other antipsychotic treatments. Patients in previous trials experienced increasing and sustained symptom improvement, suggesting that evenamide’s unique mechanism of action of modulating excessive glutamatergic activity in the brain could represent a crucial novel approach in the treatment of schizophrenia.

The ENIGMA-TRS pivotal Phase III program consists of ENIGMA-TRS 1 and ENIGMA-TRS 2. ENIGMA-TRS 1, initiated in August 2025 and currently enrolling patients on all three target continents, is an international, one-year, double-blind, placebo-controlled study in at least 600 patients to evaluate the efficacy, tolerability, and safety of two daily doses: 15mg and 30mg. Both studies represent a key component of Newron’s global development strategy for evenamide, targeting patients with schizophrenia, experiencing treatment resistance to current antipsychotics. According to current literature, up to 50% of patients suffering from schizophrenia are classified as treatment-resistant, underscoring the urgent need for new, effective therapeutic options.

Prof. Marder’s comments reflect his professional assessment as a study investigator and do not constitute an endorsement by the University of California, Los Angeles.

About treatment-resistant schizophrenia (TRS)

A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.

About evenamide

Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, explaining the long-term effects seen in clinical studies. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, 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. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. 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 / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, 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.


08.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Newron Pharmaceuticals S.p.A.
via Antonio Meucci 3
20091 Bresso
Italy
Phone: +39 02 610 3461
Fax: +39 02 610 34654
E-mail: pr@newron.com
Internet: www.newron.com
ISIN: IT0004147952
WKN: A0LF18
Listed: Regulated Unofficial Market in Dusseldorf (Primärmarkt); SIX
EQS News ID: 2241432

 
End of News EQS News Service

2241432  08.12.2025 CET/CEST

Evotec closes sale of Just – Evotec Biologics’ Toulouse site to Sandoz

Evotec SE

/ Key word(s): Agreement

Evotec closes sale of Just – Evotec Biologics’ Toulouse site to Sandoz

08.12.2025 / 07:00 CET/CEST

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


  • All closing requirements satisfied following announcement of a non-binding term-sheet agreement in July and signing of contract in November
  • Agreement includes approximately US$ 350 m in cash for Just – Evotec Biologics manufacturing site in Toulouse and upfront technology license fees to Evotec’s continuous manufacturing platform
  • In addition, Evotec eligible for license fees, and development revenues including success-based milestones adding up to more than US$ 300 m over the coming years, replacing existing contractual commitments
  • Transaction covering royalties on a portfolio of up to ten biosimilars in technical and early development targeting more than US$ 90 bn of originator net sales
  • Sale immediately earnings accretive, improving Evotec’s short, mid and long-term revenue mix, profit margins, and capital efficiency
 

Hamburg, Germany, 08 December 2025:
Evotec SE (Frankfurt Stock Exchange: EVT, SDAX/TecDAX, Prime Standard, ISIN: DE0005664809, WKN 566480; NASDAQ: EVO) today announced the closing of its previously reported sale of the Just – Evotec Biologics Toulouse site plus an indefinite technology license to Evotec’s continuous manufacturing platform technology to Sandoz AG (SIX: SDZ / OTCQX: SDZNY), effective 05 December 2025. In total, potential payments may exceed US$ 650 m plus royalties on a portfolio of up to 10 biosimilar molecules, of which six have an originator net sales value of US$ 90 bn.

The transaction with Sandoz is accelerating the implementation of Evotec’s strategy through better monetization of its technology and transitioning to an asset-lighter business model. Evotec is delivering on sharpening its focus on its core strengths and is well on track for sustainable and profitable growth. Sandoz’s acquisition of Just – Evotec Biologics’ Toulouse site is an endorsement of the pioneering J.POD platform and its potential to revolutionize biologics manufacturing. 

Dr Christian Wojczewski, Chief Executive Officer of Evotec, said: “This transaction is a pivotal step in Evotec’s transition to a scalable technology provider for next-generation biologics development. By selling the Just – Evotec Biologics Toulouse site and a license for using our pioneering continuous manufacturing technology to Sandoz, we are not only unlocking significant value today but also paving the way for a more efficient, sustainable, and accessible future for biologic medicines.“

With the closing of the transaction, Evotec will continue to serve its customers in the U.S. and Europe with capacity for molecular design, upstream, downstream, analytical and formulation development as well as first-in-human to commercial biologics GMP manufacturing. In parallel, Evotec plans to enable its partners to lower the time and costs of biologics manufacturing with its paradigm shifting continuous manufacturing technology and assets beyond its own capacity via a technology license model.

 

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

 

For further information, please contact:

Media
Susanne Kreuter 
VP Head of Strategic Marketing 

Susanne.Kreuter@evotec.com 

Investor Relations
Volker Braun
EVP Head of Global Investor Relations & ESG
Volker.Braun@evotec.com


08.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: SDAX, TecDAX
Listed: Regulated Market in Berlin, Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 2241082

 
End of News EQS News Service

2241082  08.12.2025 CET/CEST

Sandoz completes strategic acquisition of Just-Evotec Biologics EU SAS, asserting biosimilars leadership

  • Expands in-house development and manufacturing capabilities for biosimilars, consolidating position as undisputed leader in the sector
  • Strengthens position to capture projected >USD 300 billion biosimilars Loss of Exclusivity (LoE) market opportunity over the next decade¹
  • Acquisition includes Just-Evotec Biologics EU SAS site in Toulouse and indefinite licence to cutting-edge continuous-manufacturing technology
  • Complements ongoing investments in Slovenia, building end-to-end in-house biosimilar development and manufacturing network across Europe
  • Fully aligned with existing capital-expenditure commitments; no impact on 2025 full-year guidance

Basel, December 8, 2025 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the completion of the acquisition of Just-Evotec Biologics EU SAS (JEB SAS) from Evotec SE. The deal includes the Toulouse development and manufacturing site and an indefinite licence to cutting-edge continuous-manufacturing technology for biosimilars.

This milestone fully aligns with the Sandoz biosimilar strategy, expanding in-house drug substance development and manufacturing capabilities and leveraging continuous-manufacturing technology to boost efficiency and scalability. It further positions Sandoz to capitalize on the projected >USD 300 billion global biosimilars LoE market over the next decade¹.

Richard Saynor, CEO of Sandoz, said: “Biosimilars are the fastest-growing segment of our pipeline as the need of patients and healthcare systems for these critical medicines continues to grow rapidly. This acquisition is a pivotal step toward advancing our ambition to consolidate our position as the undisputed leader in biosimilars. It gives us greater control over our pipeline development and underscores our unwavering commitment to expanding access to high-quality, affordable biologics for millions of patients worldwide.”

The fully automated, high-throughput continuous-manufacturing platform represents a transformative leap in biosimilar production. Sandoz has secured an indefinite license to this cutting-edge technology, which enhances operational efficiency, ensures flexibility and enables cost-effective scalability.

The acquisition complements ongoing investments in Slovenia, reinforcing the Sandoz strategy to build a robust, end-to-end in-house biosimilars network across Europe. By co-locating drug-substance development and manufacturing capabilities and leveraging cutting-edge continuous-manufacturing technology, Sandoz creates operational synergies that support its leadership position in this rapidly growing market. The Slovenian site will focus on large-scale fed-batch drug substance manufacturing, while the Toulouse site will specialize in small-scale continuous manufacturing. 

The transaction is in line with existing capital-expenditure commitments and does not impact 2025 guidance. Effective from today, all JEB SAS employees have joined Sandoz.

About Sandoz agreement with JEB

In May 2023, Sandoz and JEB announced a strategic partnership that supported Sandoz portfolio expansion and continued development of its early-stage biosimilar pipeline, by providing access to JEB’s continuous-manufacturing technology platform. The proprietary fully automated and high-throughput technology platform was a strategic addition to Sandoz integrated drug-substance development and manufacturing network.

In July 2024, Sandoz secured long-term commercial supply access to JEB’s biosimilar manufacturing facility in Toulouse, along with additional capacity for drug substance development.

On July 30, 2025, Sandoz signed a non-binding term-sheet to acquire JEB’s biosimilars manufacturing facility in Toulouse, including an indefinite license to continuous-manufacturing technology.

On November 4, 2025, Sandoz announced the signing of an agreement with Evotec SE to acquire all issued and outstanding equity interests of JEB SAS, which includes the Toulouse manufacturing site and an indefinite licence to the continuous-manufacturing technology.

Pictures will be available at around 14:00 CET via this link: https://www.sandoz.com/sandoz-completes-strategic-acquisition-just-evotec-biologics-eu-sas-asserting-biosimilars

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

REFERENCES

1 Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035.

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.  

 

CONTACTS

Global Media Relations contacts

Investor Relations contacts

Global.MediaRelations@sandoz.com

Investor.Relations@sandoz.com

Alexis Kalomparis
+41 792 790285

Craig Marks
+44 7818 942 383

Chris Lewis
+49 174 244 9501

Tamara Hackl
+41 79 790 5217

Gregor Rodehueser
+49 170 574 3200

Silvia Siegfried
+41 79 795 9061

Xlife Sciences AG Announces Exit of 12 Project Companies to Grupo Landsteiner and the Creation of a Scalable Transcontinental Life Sciences Platform

Under the agreement, Landsteiner will integrate Xlife Sciences’ platform technologies, biotech programs, medtech devices and AI-enabled solutions into its operations, while both organizations enter a long-term strategic collaboration. Together, they will align innovation, production and commercialization capabilities to create a unified engine for sustainable value creation.

Structured as an asset purchase, the transaction enables joint execution while allowing Xlife Sciences to continue advancing its innovation model. The newly formed entity, combining Grupo Landsteiner and the acquired Xlife Sciences assets, will serve as a dynamic platform for accelerated development, industrial scale-up and global market expansion. The entity intends to pursue a NASDAQ listing in 2026, leveraging the complementary scientific, operational and financial strengths of both organizations.

This strategic transaction also provides Landsteiner with exclusive access to more than 40 universities, leading researchers, key industry partners and global investors. The partnership supports national efforts to strengthen oncology capabilities in Mexico while initiating concrete steps to improve local access to advanced cancer care. Substantial infrastructure investments by international investors will enable the new entity to build a comprehensive oncology ecosystem in Mexico and drive breakthrough innovations positioned to influence patient care worldwide.

Key highlights for stakeholders

Proven commercial and manufacturing base:
Landsteiner operates two GMP-certified facilities with over 115 million units annual capacity, 300+ product registrations and deep government and private-sector networks across Latin America. Supported by a workforce of nearly 1.000 employees, Landsteiner is creating revenues of about USD 150 million.

Diversified, de-risked innovation portfolio:
Xlife Sciences contributes 12 assets spanning:

  • Platform technologies (solubility enhancement, 3D screen printing)
  • Biotech (oncology, next-generation gene therapy, TNF-alpha antibody, obesity immunotherapy)
  • Medtech (NeuroMex early neurodegeneration screening device)
  • AI/digital health (MDR-certified prostate cancer diagnostics)

Sustainable growth foundation:
Landsteiner’s commercial business is projected to grow at 30% CAGR through 2028, generating cash flow to advance the pipeline and reduce reliance on dilutive capital.

The binding framework sets the stage for a vertically integrated, transcontinental life sciences company linking Swiss and European innovation with Latin American manufacturing and commercialization, while enabling U.S. capital-market access through NASDAQ listing.

Oliver R. Baumann, CEO of Xlife Sciences AG, said: «This collaboration is a decisive step in building a global life sciences platform that combines our scientific innovation with Landsteiner’s operational scale. It positions our assets for near-term commercialization and long-term growth, creating substantial value for our shareholders

Miguel Granados, Chairman and CEO of Grupo Landsteiner, added: «Partnering with Xlife Sciences integrates a powerful innovation engine into our commercial infrastructure. Together, we will accelerate scientific progress, expand global market access, and create a sustainable value pathway for investors, partners, and patients

 

Financial calendar

Annual Report 2025 28 April 2026
Annual Shareholders Meeting 2026 26 June 2026
Half-Year Report 2026 24 September 2026