Sigyn Therapeutics Issues Shareholder Update Regarding Potential Merger and Asset Sale Initiatives

Sigyn Therapeutics, Inc.

/ Key word(s): Manufacturing

Sigyn Therapeutics Issues Shareholder Update Regarding Potential Merger and Asset Sale Initiatives

13.03.2026 / 17:08 CET/CEST

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


Dear Shareholders and Interested Parties,

Prior to our formation of Sigyn Therapeutics, I was the founder of Aethlon Medical and oversaw the development of the Aethlon HemopurifierTM from concept to becoming the first therapy to receive multiple FDA “Breakthrough Device” designations and first medical device cleared by FDA to treat a pandemic virus. TIME magazine named the HemopurifierTM a “Top 25 Invention” and a “Top Eleven Medical Breakthrough.” During my tenure, Aethlon became Nasdaq-listed and had a peak-market value of approximately $200 million.

At Sigyn Therapeutics, we have developed CardioDialysisTM to address relevant therapeutic targets underlying a wide range of life-threatening disease conditions.  These include clinically significant drivers of cardiovascular disease (leading cause of death worldwide), as well as relevant pathogenic and inflammatory molecules that fuel sepsis, the leading cause of in-hospital mortality. Based on invitro study results, CardioDialysisTM also offers a potential therapeutic solution to address traumatic brain injury (TBI) and other disorders whose recovery would benefit from a reduction of systemic inflammation.  Our TBI indication has recently emerged to become asset whose value we hope to leverage through a strategic transaction.

Our opportunity to treat cardiovascular disease is straightforward, yet among the most significant opportunities in healthcare. Lipoprotein apheresis devices that reduce the presence of cholesterol-transporting lipoproteins in the bloodstream reduce heart attacks, strokes and other major adverse cardiovascular events (MACE) to a far greater extent than cardiovascular disease drugs. However, the availability of lipoprotein apheresis is limited to fewer than 60 specialized apheresis centers in the United States. Whereas CardioDialysisTM targets cholesterol-transporting lipoproteins plus inflammatory molecules and is designed for use on dialysis machines already located at more than 7,500 dialysis clinics in the United States alone.

At present, there is no approved therapy to address sepsis. The leading treatment candidate is the PMX hemoadsorption device, which removes endotoxin from the bloodstream.  The PMX device has been advanced through groundbreaking clinical studies conducted by industry colleagues at Spectral Medical, a Toronto Stock Exchange company whose market value is approximately $300 million. Should the PMX device receive FDA market clearance, it may become notable that CardioDialysis has been validated to reduce the presence of sepsis inducing bacterial toxins (including endotoxin) and a broad-spectrum of inflammatory mediators from human blood plasma.  In the meantime, I encourage you to follow Spectral Medical.

While I am proud of our advancements at Sigyn Therapeutics, it was not our intent be an OTC traded company at this point in our endeavors.  In my previous company, we became public through a merger with an established OTC company and subsequently were able to conduct a successful uplist to Nasdaq financing.

At Sigyn Therapeutics, we also became public through a merger with an established OTC company yet failed to execute on an uplist to Nasdaq financing. The financing was a firm commitment offering led by a FINRA member broker-dealer and was supported by the same lead investor and advisory team that got us across the goal at my previous company.  However, it was not anticipated that Nasdaq would request to review and approve our investors prior to obtaining an effective registration statement from SEC. For those not familiar with the process, this was a real catch-22 as investors are not supposed to be solicited prior to a registration statement being deemed effective by SEC. Inversely, SEC wanted to know if we had contingent listing approval from Nasdaq prior to deeming our registration statement effective.  Recognizing the futility of our efforts, we eventually withdraw the registration statement underlying our uplist to Nasdaq financing.

While share price and exchange does not impact the ability of our therapies to address life-threatening disease conditions, it has clearly impacted our ability capitalize our endeavors without harming shareholder value. I encourage you to review my January 15th shareholder update which highlights our strategies to navigate forward with reduced shareholder dilution. Included among these is the sale of certain assets and a potential merger with a Nasdaq listed company at risk of not meeting the forthcoming $5 million minimum market value of listed securities (MVLS) requirement that will soon be necessary for continued listing on Nasdaq.

https://www.sigyntherapeutics.com/investors/news-events/press-releases/detail/118/sigyn-therapeutics-issues-shareholder-update-highlighting

In closing, I thank you for taking the time to read my update. For those who have inquired, we have 2,330,042 shares outstanding as of March 11, 2026. If you have questions or comments, I can be reached 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
Inventor CEO
Email: jj@SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This 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.


13.03.2026 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.



2291428  13.03.2026 CET/CEST

Medacta Group SA: Medacta Group reports record results in Full Year 2025 and upgrades mid-term guidance

Medacta Group SA / Key word(s): Annual Results/Annual Results

Medacta Group SA: Medacta Group reports record results in Full Year 2025 and upgrades mid-term guidance

13-March-2026 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


 

Media Release – Ad-hoc announcement pursuant to Art. 53 LR                          

 

Medacta Group reports record results in Full Year 2025 and upgrades mid-term guidance

 

  • FY 2025 revenue accelerated to Euro 683.8 million, up 18.5% in c.c.1 or 15.8% in Euro
  • Adjusted EBITDA grew by 19.1% to Euro 190.8 million
  • Adjusted EBITDA margin advanced to 29.0% in c.c. 1 up 190 bps yoy
  • Net profit rose by 31.0% yoy to Euro 95.5 million incl. one-off gains
  • Operating cash flow grew by 42.5% to Euro 152.7 million
  • The Board of Directors is proposing a distribution of CHF 1.10 per share (2024: CHF 0.69), an increase of 59.4% yoy
  • Outlook 2026: Medacta is targeting a revenue growth in the range of 10% to 14% in constant currency and an expansion of the adjusted EBITDA margin of around 50bps vs. the prior year (27.9%), in constant currency, subject to unforeseen events.
  • Mid-term outlook: Revenue compound annual growth rate (CAGR) (2024–2027E) in constant currency is expected to range between 12% and 15%, with a gradual improvement of the adjusted EBITDA margin vs. 2025, in constant currency, subject to unforeseen events.

 

CASTEL SAN PIETRO, 13 March 2026 – Medacta Group SA (“Medacta”, SIX: MOVE) today announces its full year 2025 results.

Francesco Siccardi, CEO of Medacta, commented: “I am very pleased to report another year of strong organic sales growth in the high teens, together with a significant expansion of our adjusted EBITDA margin. These industry leading results confirm the unique position of Medacta. Our vigorous focus on differentiating innovations for minimally invasive techniques and personalized solutions, the surgeon-specific structured medical education and the constant expansion of our sales force are the key pillars of our successful strategy. I thank the entire Medacta team for its efforts in delivering such excellent results.”

 

Our achievements in 2025

2025 marks Medacta’s 10 years of success of Kinematic Alignment in combination with Medacta’s Ball-in-Socket design for total knee replacement. This was a milestone that underscores our dedication to sustainable innovation and improving patient outcome. Kinematic Alignment is a surgical technique designed to restore the natural knee function to its pre-arthritic state. This innovative approach has gained the attention and continues to find a growing consensus in the global orthopedic community.  

At the beginning of March 2025, Medacta announced the acquisition of Parcus Medical, a Florida based specialist provider of sports medicine and arthroscopy solutions. The acquisition excellently complements Medacta’s portfolio in sports medicine. Parcus Medical is integrated into Medacta’s Sportsmed within the Extremities business line. As part of the acquisition, Medacta also took over Parcus’ Medical US manufacturing site in Sarasota (Florida), allowing Medacta to also be vertically integrated in Sportsmed and to have the first non-Swiss based manufacturing plants. The acquisition of Parcus Medical contributed approximately 1.5% to Group revenue in 2025.

In 2025, Medacta progressed to further strengthen and optimize its supply chain. Medacta has almost finalized its new fully automated warehouse in Italy. This new setup will facilitate and reduce handling costs primarily in Europe, Middle East and Africa (EMEA).

In early September 2025, Medacta completed the first phase of the planned extension of its production and office site in Rancate, Ticino, Switzerland.

The company will continue its expansion plan in 2026, aiming to accommodate increased demand to support future growth, while creating numerous new jobs.

In 2025, Medacta added another 258 employees globally, reaching 2’165 employees in total. 

 

Key figures

(Euro million, except for earnings per share data) 31.12.2025 31.12.2024
Revenues 683.8 590.6
Gross profit 458.7 399.4
Profit for the period 95.5 72.9
Alternative performance measures    
(Euro million) 31.12.2025 31.12.2024
EBITDA 201.5 156.6
Adjusted EBITDA* 190.8 160.2
Adjusted EBITDA margin* 27.9% 27.1%
Operating cash flow 152.7 107.1
Free cash flow 15.7 8.3

 

(Euro million, except for employees) 31.12.2025 31.12.2024
Total assets 917.6 792.2
Total equity 456.6 379.7
Equity ratio 49.8% 47.9%
Number of employees 2’165 1’907

* Adjusted in 2025 for business combinations (Euro -11.3 million) and MDR transition costs (Euro 0.6 million). The reconciliation is provided in the “Alternative Performance Measures” section of the 2025 Annual Report.

 

Sustained above-market growth of 18.5% in constant currency

In 2025, Medacta recorded Group revenue of Euro 683.8 million, an increase of 18.5% in constant currency and an increase of 15.8% in Euro.

Medacta reported another year of outstanding growth in all geographic markets and continued superior growth across all business lines. This was achieved by the constant launch of our differentiating innovations across all business lines, our continued efforts in medical education and the attraction of new surgeons supported by our expanded sales force. 

Substantial revenue growth across all geographic areas

Medacta achieved substantial growth rates across all geographies. The largest contributions to growth came from Asia Pacific and North America, growing 23.0% and 19.0% respectively, followed by EMEA increasing 15.2%, all in c.c.. Latin America, which is the smallest geographic area, advanced a superb 42.2% in c.c..

Revenue distribution by geographic area:

(Euro million) FY 2025 FY  2024 Growth
in Euro
Growth in
constant currency
EMEA* 327.5 283.7 15.4% 15.2%
North America 204.5 179.3 14.1% 19.0%
Asia Pacific 134.8 115.1 17.1% 23.0%
Latin America 17.0 12.4 36.7% 42.2%
TOTAL 683.8 590.6 15.8% 18.5%

* Europe, Middle East and Africa

Excellent revenue expansion across all product lines

Hip revenues rose again in double-digits by 11.9% in c.c., to Euro 270.5 million, with particularly outstanding performance in Asia Pacific and North America. The growth was mainly the result of Medacta’s excellent Anterior Minimally Invasive Surgery (AMIS) platform, which allows an easily reproducible technique that delivers significant benefits to patients, surgeons as well as healthcare systems [1,2,3].

Knee revenues advanced by another outstanding 20.7% in c.c. to Euro 284.1 million. All geographic regions contributed to this growth, but mainly attributable to North America as well as EMEA. Next to Medacta’s personalized Kinematic Alignment platform MyKA, GMK SpheriKA, the first knee implant specifically designed for the Kinematic Alignment technique, promoted this excellent performance. In 2025, the global roll-out of GMK SpheriKA further advanced including the UK, Canada and Japan. 2025 saw an additional boost in the adoption of the NextAR Knee system as well as for cementless and SensiTiN, Medacta’s low-ion-release, options.

Extremities, which include both, Shoulder and Sportsmed, delivered another notable revenue growth of 46.2% in c.c. to Euro 72.1 million with both sub-businesses contributing to this great progress. In particular, Medacta’s Shoulder System, supported by advanced technologies such as Medacta’s MyShoulder patient-specific cutting guidesas well as NextAR Shoulder Augmented Reality surgical application delivered an excellent performance, achieving market leading position in key geographies.

Spine revenues increased by 12.2% in c.c. to Euro 57.0 million. The good acceleration was strongly sustained by Medacta’s technologies, particularly by NextAR Spine, and the Rod Optimizer platform, which support surgeons in designing the optimal surgical strategy based on each patient’s individual anatomy and helps to streamline the surgical workflow. An expansion was seen across all geographies but was primarily supported by EMEA as well as Asia Pacific.

Revenue distribution by business line:

(Euro million) FY  2025 FY 2024 Growth
in Euro
Growth in
constant currency
Hip 270.5 247.3 9.4% 11.9%
Knee 284.1 241.2 17.8% 20.7%
Extremities** 72.1 50.3 43.4% 46.2%
Spine 57.0 51.8 10.2% 12.2%
TOTAL 683.8 590.6 15.8% 18.5%

** Extremities include Shoulder and Sportsmed revenues

Gross profit

In 2025, gross profit advanced to Euro 458.7 million compared to Euro 399.4 million in 2024 reflecting an increase of 14.8% year-on-year. The corresponding gross profit margin was 67.1% compared to 67.6% over the same period in the previous year. The softening was the result of unfavorable FX impacts, which were partially offset by operational efficiencies realized. 

Adjusted EBITDA margin

Adjusted EBITDA grew to Euro 190.8 million compared to Euro 160.2 million in 2024, representing a year-on-year increase of more than 19%.  The corresponding 2025 adjusted EBITDA margin climbed to 29.0% in constant currency or 27.9% in Euro. This compares to an adjusted EBITDA margin of 27.1% in Euro in 2024. The margin expansion was the result of efficiency gains and lower costs, mainly in sales and marketing as compared to the same time period last year. Reported EBITDA was Euro 201.5 million compared to Euro 156.6 million, an increase of 28.7% year-on-year.

Adjusted EBIT

Adjusted EBIT for the period rose to Euro 114.3 million compared to Euro 94.4 million in 2024, reflecting an increase of more than 21% against the previous year. The corresponding adjusted EBIT margin was 16.7% in 2025 compared to 16.0% in the prior year, representing an improvement of 70 basis points year-on-year.

Net profit for the year

In 2025, the net financial result was Euro -9.8 million versus Euro -3.1 million in the previous year. The Group’s effective tax rate was 17.2% in 2025.

Profit for the period increased by 31.0% to Euro 95.5 million compared to Euro 72.9 million in 2024. The increase was the result of a higher operating profit and the bargain purchase gain recognized on the Parcus acquisition. In 2025, the corresponding net profit margin was 14.0% compared to 12.3% in 2024.

Cash flow

Medacta delivered a cash flow from operating activities of Euro 152.7 million in 2025 compared to Euro 107.1 million in the same period in 2024, representing an increase of 42.5% year-on-year.

Capital expenditures amounted to Euro 137.0 million in 2025 versus Euro 98.9 million compared to 2024. A good 80% of capital expenditures were investments in instruments and production expansions to sustain future growth.

Free cash flow was Euro 15.7 million compared to Euro 8.3 million in 2024, reflecting an improvement of almost 90%.

Solid balance sheet

Medacta’s balance sheet remained robust at the end of December 2025. Total assets increased to Euro 917.6 million vs. Euro 792.2 million at the end of 2024. The equity ratio strengthened to 49.8% at the end of December 2025 compared to an equity ratio of 47.9% at the end of December 2024.

Net debt to adjusted EBITDA ratio improved to 0.88x at the end of 2025 compared to 0.99x at the end of 2024.

Dividend proposal

At the Annual General Meeting on 5 May 2026, the Board of Directors will propose a dividend distribution of 1.10 CHF per share (0.69 CHF in 2024), an increase of 59.4% against the prior year. 

 

Outlook 2026

Medacta is targeting a revenue growth in the range of 10% to 14% in constant currency and an expansion of the adjusted EBITDA margin of around 50bps vs. the prior year (27.9%), in constant currency, subject to unforeseen events.

Mid-term outlook

Revenue compound annual growth rate (CAGR) (2024–2027E) in constant currency is expected to range between 12% and 15%, with a gradual improvement of the adjusted EBITDA margin vs. 2025, in constant currency, subject to unforeseen events.

For further financial details, please refer to the 2025 Annual Report, which can be accessed at: https://www.medacta.com/EN/financial-reports-and-presentations

Webcast Today at 3:00 p.m. (CET)

Medacta Group SA will present its Full Year 2025 results during a webcast today at 3:00 p.m. (CET). The call will be hosted by Francesco Siccardi (CEO) and Corrado Farsetta (CFO) and will be held in English.

Live-Link:  https://87399.choruscall.eu/links/medacta260313.html

Dial-in numbers for conference call only:

Belgium: +32 28948063
Denmark: +45 32727525
France: +33 170918704
Germany: +49 6917415712
Ireland: +353 15269444
Italy: +39 02 802 09 11
Spain: +34 917699498
Sweden: +46 850510030
Switzerland: +41 225954728
UK: +44 1 212818004
USA: +1 718 7058796

  

Contact

Medacta
Anja Pomrehn
Group VP Sustainability and Investor & Media Relations
Phone: +41 91 696 14 95

pomrehn@medacta.ch

 

About Medacta

Medacta is a global key player specializing in the design, production, and distribution of innovative, personalized, and sustainable solutions for joint replacement, sports medicine, and spine surgery. Established in 1999 in Switzerland, Medacta is committed to improving the care and well-being of patients and maintains a strong focus on healthcare sustainability. Through close collaboration with expert surgeons globally, continuous investments in R&D, and the adoption of cutting-edge technologies, Medacta’s innovation prioritizes minimally invasive surgery and personalized solutions for every patient. Through the M.O.R.E. Institute, Medacta supports surgeons with a comprehensive and tailored program dedicated to the advancement of medical education. Medacta is headquartered in Castel San Pietro, Switzerland. Follow us on Medacta.com, Medacta TV, YouTube, LinkedIn and X.

 

Disclaimer

This media release has been prepared by Medacta Group SA (‘Medacta’ and together with its subsidiaries, ‘we’, ‘us’ or the ‘Group’). The information contained in the media release does not purport to be comprehensive and is not to be taken as containing any securities advice, recommendation, offer or invitation to subscribe for, purchase or redeem any securities regarding Medacta.

 Forward-looking information

This media release has been prepared by Medacta and includes forward-looking information and statements concerning the outlook for its business. These statements are based on current expectations, estimates and projections about the factors that may affect its future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as ‘expects’, ‘believes’, ‘estimates’, ‘targets’, ‘plans’, ‘outlook’ or similar expressions. Although Medacta believes that its expectations reflected in any such forward-looking statement are based upon reasonable assumptions, it can give no assurance that those expectations will be achieved.

 Related Trademarks

Medacta Group Related Trademarks are registered at least in Switzerland. The products and services listed below may not be all-inclusive, and other Medacta products and services not listed below may be covered by one or more trademarks. The products and services below may be covered by additional trademarks not listed below. Note that Swiss trademarks may have foreign counterparts. AMIS®, GMK® SpheriKA, MyShoulder®, MyKA™, SensiTiN™, NextAR™, NextAR™ Spine.

 Notes

1)Alternative Performance Measures:

This media release contains certain financial measures of historical performance that are not defined or specified by IFRS, such as “constant currency”, “EBITDA”, “adjusted EBITDA”, “Free Cash Flow”, “adjusted Free Cash Flow”, “Net Debt” and “Leverage”. These Alternative Performance Measures (APMs) should be regarded as complementary information to, and not as a substitute for the IFRS performance measures. For definitions of APMs, together with reconciliations to the most directly reconcilable IFRS line items, please refer section headed “Alternative Performance Measures” of the 2025 Annual Report. The 2025 Annual Report is available and can be accessed at:

 https://www.medacta.com/EN/financial-reports-and-presentations .

 Above-market revenue growth:

This press release contains information that refers to “above-market revenue growth”, which is in reference to data from The Orthopaedic Industry Annual Report® published by Orthoworld® Inc., published May 2025.     

References

[1] Vasina PG, Rossi R, Giudice GM, Palumbi P. Hip arthroposthesis through the anterior minimally invasive approach. Sphera 2010;6(12) – Speciale Ortopedia

[2] Christofilopoulos P, Roussos C, Lädermann A, Lübbeke A, Hoffmeyer P. Socioeconomic aspects of total hip arthroplasty. A comparison between anterior minimally invasive surgery and standard lateral approach. Poster at the 12th EFORT Congress, Copenhagen, Denmark: 1-4 June 2011.

[3] Sebečić B, Starešinić M, Culjak V, Japjec M. Minimally invasive hip arthroplasty: advantages and disadvantages. Med Glas (Zenica). 2012 Feb;9(1):160-5. PMID: 22634930.


End of Inside Information


Language: English
Company: Medacta Group SA
Strada Regina
6874 Castel San Pietro
Switzerland
Phone: +41 91 696 6060
E-mail: info@medacta.ch
Internet: www.medacta.com
ISIN: CH0468525222
Listed: SIX Swiss Exchange
EQS News ID: 2290722

 
End of Announcement EQS News Service

2290722  13-March-2026 CET/CEST

Galimedix Therapeutics earns milestone payment in ophthalmology partnership with Théa Open Innovation

Galimedix, Inc.

/ Key word(s): Miscellaneous

Galimedix Therapeutics earns milestone payment in ophthalmology partnership with Théa Open Innovation

12.03.2026 / 13:00 CET/CEST

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


Galimedix Therapeutics earns milestone payment in ophthalmology partnership

with Théa Open Innovation

  • Galimedix receives milestone payment for successful completion of Phase 1 trial with orally administered GAL-101
  • Phase 1 results show the compound to be clinically safe and well-tolerated, with a pharmacokinetic profile supporting advancing to Phase 2
  • Payment provides Galimedix with an important operational runway to proceed with plans for additional clinical development in Alzheimer’s disease and other indications

Kensington, MD, USA and Munich/Martinsried, Germany, March 12, 2026 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize and reshape the treatment of serious eye and brain diseases, today announced the achievement of a key milestone in its collaboration with Théa Open Innovation (“TOI”), a subsidiary of ophthalmic specialty pharmaceutical company, Laboratoires Théa. Galimedix has successfully completed the Phase 1 trial with orally administered GAL-101, which has triggered an undisclosed milestone payment to the Company. The eye drop formulation of GAL-101 is currently in Phase 2 development for the treatment of geographic atrophy, a severe form of dry age-related macular degeneration (AMD).

“We are pleased with the achievement of this milestone for GAL-101,” said Céline Olmiere, Director of Théa Open Innovation. “This highly innovative drug candidate has the potential to significantly impact dry AMD patients who are at risk of going blind. Our collaboration with Galimedix supports continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists and their patients around the world.”

“We are gratified to have the strong support of Théa Open Innovation in developing GAL-101 and excited to see such solid results in the Phase 1 trial,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman of Galimedix Therapeutics. “Importantly, this milestone payment provides Galimedix with significant operational runway and will allow us to advance our development plans for GAL-101 in Alzheimer’s disease and other supportive R&D work.”

As previously announced, the Phase 1 results showed oral GAL-101 to be well tolerated and clinically safe, with an excellent pharmacokinetic profile, effectively crossing the blood-brain barrier, strongly supporting advancing the oral formulation in Phase 2 development in Alzheimer’s disease and other indications.

In March 2023, TOI and Galimedix entered into a strategic partnership in ophthalmology for the development and commercialization of GAL-101 in Europe, the Americas, the Middle East and Africa. Under the terms of the agreement, Galimedix received an upfront technology access fee and is eligible to receive further success-based milestone payments as well as royalties on net sales. TOI is fully funding the remaining development of GAL-101 in dry AMD and will take charge of the registration and commercialization of the drug in ophthalmology. Galimedix is responsible for the conduct of the mid-stage clinical trials. TOI also made a direct investment into Galimedix, demonstrating its strong interest in the value of the Galimedix pipeline, including in Alzheimer’s disease.

About GAL-101
GAL-101 is a small molecule targeting misfolded amyloid beta (Aβ) monomers and thus preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eye drops) formulations. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the brain and retina, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease. GAL-101 initially is being developed for the treatment of dry age-related macular degeneration (AMD), glaucoma, and Alzheimer’s disease.

In pre-clinical testing, the compound has been shown to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. GAL-101 has also demonstrated the potential for neuroprotection and for symptomatic alleviation in pre-clinical models of Alzheimer’s disease. Additionally, orally available GAL-101 has shown no antibody-specific immunological side effects (e.g., ARIA), very low systemic toxicity, robust storage stability, and easy and inexpensive manufacturing. Strong efficacy has also been demonstrated in relevant ophthalmic pre-clinical models, protecting neuronal retinal cells from toxic damage. In Phase 1 testing, both the oral and eye drop forms of GAL-101 demonstrated an excellent safety and tolerability profile. In addition, oral GAL-101 was shown to effectively cross the blood-brain barrier. The eDREAM Phase 2 study (NCT06659549) in dry AMD/geographic atrophy with GAL-101 eye drops is ongoing.

About Galimedix Therapeutics, Inc.
Galimedix is a Phase 2 clinical-stage private biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in Alzheimer’s disease, dry age-related macular degeneration and glaucoma, Galimedix’s initial areas of focus. For more information, please visit our website at https://www.galimedix.com and follow us on LinkedIn.

About Théa and Théa Open Innovation
Théa is the leading independent European pharmaceutical company specializing in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Its products are available in 75 countries around the world.
Théa Open Innovation, a subsidiary of Théa, is dedicated to set up partnerships with biotech/pharma companies and academic institutions to help bring the most innovative products in eye care to the market.
To learn more, visit www.thea.com and www.theaopeninnovation.com.

Contact 
Alexander Gebauer, MD, PhD
Galimedix Therapeutics, Inc.

Co-founder and Executive Chairman
info@galimedix.com

Media inquiries:

Anne Hennecke  U.S.
MC Services AG  Laurie Doyle
Tel: +49 (0)170 7134018  Tel: +1-339-832-0752
galimedix@mc-services.eu   


12.03.2026 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.


2289574  12.03.2026 CET/CEST

Merger with impact: MG Health and Canify form an international leading medical cannabis provider

Issuer: Canify AG

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

Merger with impact: MG Health and Canify form an international leading medical cannabis provider

12.03.2026 / 11:00 CET/CEST

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


Herrsching, Germany / Maseru, Lesotho (12/03/2026) – Canify AG, a company specializing in the processing and marketing of medical cannabis products, and MG Health Limited, Africa’s first EU-GMP certified producer of medical cannabis flowers and extracts, today announce their planned merger. In a signed Memorandum of Understanding (MoU), both companies have agreed to expand their successful two-year collaboration into a combined holding structure. The group will be a fully vertically integrated medical cannabis platform spanning EU GMP-certified production, pharmaceutical processing, and multi-market distribution, with commercial presence in more than 7 countries including Germany, the United Kingdom, Australia, and Poland, as well a unique global supplier network.

The two companies have worked closely together since Q4 2024, when MG Health began supplying Canify with medical cannabis flower on a consistent basis. That proven supply relationship now forms the operational foundation for a full merger.  “Mutual trust has grown out of our good working relationship – and so it is only logical to take our cooperation to the next level,” says Sascha Mielcarek, CEO of Canify AG. “We share not only quality standards, but also a common attitude: patients are at the center of everything we do. Our shared vision is to create a globally active pharmaceutical company with a clear focus on the highest quality standards and clinical innovation.”

The planned merger will create a vertically integrated structure that is unique in the European medical cannabis market. The combined group will control every critical step in the pharmaceutical value chain: from EU GMP-certified flower cultivation and extraction at MG Health’s facility in Lesotho, through pharmaceutical processing regulatory management, and multi-channel distribution via Canify’s established network of pharmacy partnerships and its direct-to-patient Canify Clinics platform.

MG Health’s production platform provides the combined group with a significant structural cost advantage. Operating at 2,000 metres altitude in the Maluti Mountains of Lesotho, the facility benefits from optimal growing conditions, low energy costs, and year-round natural light, enabling pharmaceutical-grade production at a fraction of the cost of European indoor facilities. Beyond operational efficiency, MG Health has invested meaningfully in the local community, creating hundreds of sustainable jobs, expanding local infrastructure, and delivering education and development programmes for employees, their families, and surrounding communities.

“As a company that puts people first, we don’t see economic success as an end in itself, but as a means to enable positive and sustainable change within our society,” says Andre Bothma, CEO of MG Health. “This principle shapes our daily actions in Lesotho – from responsible, sustainable management and long-term employment prospects to targeted education initiatives. In Canify, we have found a partner who shares these values and will carry them forward with us.”

“The merger gives us the opportunity to align our processes across the entire value chain with expertise and regulatory frameworks—and thus complement each other perfectly,” explains Mielcarek. For example, Canify’s existing international supplier network can be optimally aligned with MG Health’s expanded production and processing capacities. “At the same time, with MG Health, we are strengthening an approach that combines pharmaceutical excellence, social responsibility, and environmental sustainability.”

The combined group will pursue an ambitious international growth strategy. Building on active export supply chains in Australia, the United Kingdom and Poland besides the core market in Germany, the merger memorandum includes planned market expansion into Switzerland and further European markets.

Completion of the merger is subject to the finalisation of definitive agreements, and receipt of all necessary regulatory approvals. However, both parties are convinced that this will be completed timeously and that this first step will lay the foundation for sustainable growth, innovative care concepts, and long-term stable patient care.

About Canify AG:
Canify AG is a licensed pharmaceutical company specializing in medical cannabis. Canify’s products are based on scientific data, cutting-edge technology, and a commitment to helping patients. Canify’s approach is to make the cannabis business as easy and convenient as possible for pharmacies and wholesalers. Canify also offers customized production and market access solutions for third-party providers, setting standards in terms of quality, production capacity, and delivery times. In addition, Canify treats patients with individual cannabis therapy via telemedicine or in medical practices under the Canify Clinics brand. Canify AG consistently meets the highest standards of European GMP guidelines and offers transparency and traceability from cultivation to the patient.

About MG Health Limited:
MG Health is a vertically integrated manufacturer of medical cannabis flowers and extracts. The production facility is located at an altitude of 2,000 meters in the pristine mountainous landscape of the Kingdom of Lesotho in southern Africa. In this pure and untouched environment, MG Health produces safe and effective medical cannabis products of consistently high quality in accordance with the strictest pharmaceutical standards. MG Health is the first EU GMP-certified African medical cannabis company and currently exports its products to the United Kingdom, Australia, Germany, South Africa, and the Czech Republic. MG Health focuses on implementing a plant-to-patient philosophy and building a sustainable future for all.

Further information is also available on our websites:
www.canify.com / www.canify-pharma.de

www.mghealth.com

Contacts for press inquiries:
Kathrin Konyen                                               Luke van der Nest
Press officer Canify AG                                  Commercial Director  MG Health Ltd
press@canify.com                                                          info@mghealth.com
+49(0)173/6790782                                                      +266 5928 3540
 


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

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Consultation process at Bichsel completed

On 24 February 2026, Galenica announced its intention to discontinue pharmaceutical production at its subsidiary Bichsel at the end of 2026 for economic reasons and to focus its business on home care services. Bichsel has now completed the consultation process that was initiated as part of this announcement. The Board of Directors and the Executive Committee have carefully reviewed the proposals submitted by the employee representatives during the consultation process. However, the process confirmed that production has been in deficit for years and that the existing facilities and buildings cannot be maintained despite continuous investments in recent years. As a result, continued operation is not economically viable under any scenario. The Board of Directors has therefore decided to close the production division at the end of 2026.

Comprehensive social plan

The originally anticipated reduction of 170 jobs can be reduced slightly by 18 jobs and now affects 152 jobs. In addition, an evaluation will be carried out over the coming weeks to determine how many employees can be employed within the Galenica network. Employees will be informed of their personal situation in the coming days. All affected employees will be supported by a comprehensive social plan. Among other things, the plan takes into account the age and years of service and includes provisions for cases of hardship. In addition, the affected employees will be supported in finding new employment. The constructive proposals submitted by the employee representatives have been incorporated into the social plan and have made a significant contribution to its design.

Supporting customers

Bichsel is in close contact with its customers and will support them during the transition phase as well as the search for alternative suppliers. Production will be continued and planned until the mid-year in such a way that Bichsel will be able to supply its customers with the most important products until approximately the end of the year. The extemporaneous formulations business will be taken over by the Galenica company Laboratoire Golaz in Lausanne. These products are particularly important for doctors and their patients and are sold through pharmacies.

MindMaze Therapeutics Appoints HealthTech Veteran Zach Henderson as CEO to Accelerate Global Commercial Scale

MindMaze Therapeutics Holding SA / Key word(s): Personnel

MindMaze Therapeutics Appoints HealthTech Veteran Zach Henderson as CEO to Accelerate Global Commercial Scale

12-March-2026 / 07:00 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


MindMaze Therapeutics Appoints HealthTech Veteran Zach Henderson as CEO to Accelerate Global Commercial Scale

Former Rune Labs and Glooko executive to lead MindMaze’s next phase of growth, focusing on U.S. market expansion and the delivery of scalable, AI-driven neurorestorative care.

Geneva, Switzerland – March 12, 2026 MindMaze Therapeutics Holding SA (SIX: MMTX) (MindMaze Therapeutics, or the Company), a global leader in brain technology and precision neurotherapeutics, today announced the appointment of Zach Henderson as Chief Executive Officer. Mr. Henderson joins at a pivotal inflection point as the Company invests in scaling its existing commercial presence, focused on accelerating adoption of its FDA-cleared platform in the United States to address the widening supply-demand gap in neurological care.

With over 30 years of experience, Mr. Henderson has a proven track record of scaling healthcare technology platforms and driving significant recurring revenue growth. His most recent role as Chief Commercial Officer at Rune Labs and his prior tenure as CEO of PKG Health underscore his expertise in commercializing AI-driven solutions for complex chronic conditions like Parkinson’s.

“MindMaze has built the industry’s most rigorous clinical foundation. Our mission now is to translate that scientific leadership into widespread market adoption,” said Walid Hanna, Chairman of the Board. “Zach’s operational depth and success across global markets make him the ideal leader to drive our commercial expansion and deliver value to our shareholders.”

The global healthcare system faces a critical shortage of neurologists and specialized therapists (PT/OT), leaving millions of patients with stroke, Parkinson’s disease, and Alzheimer’s with insufficient access to recovery. MindMaze is redefining this paradigm by shifting care from episodic, clinic-bound sessions to continuous, data-driven neurorestoration accessible at scale in both clinical and home settings.

“I am honored to lead MindMaze as we solve one of healthcare’s most pressing capacity challenges,” said Zach Henderson. “By digitizing the neuro-restorative journey, we are providing a scalable solution to a global shortage of specialized care providers. We are redefining the standard of care for tens of millions of patients worldwide.”

Mr. Alexandre Capet has been appointed Chief Operating and Strategy Officer continuing his service as a standing member of the Company’s Executive Committee.

About MindMaze Therapeutics
MindMaze Therapeutics (SIX: MMTX) is a global leader in brain technology, dedicated to redefining the recovery trajectory for patients with neurological platform-based digital treatments. By integrating advanced software, proprietary sensors, and AI-driven data analytics, MindMaze Therapeutics provides a seamless continuum of care from the acute hospital phase to outpatient treatment to the home-based therapy. The Company’s FDA-cleared and CE-marked neurotherapeutics are designed to address the systemic shortage of specialized clinicians, offering scalable, reimbursable solutions for stroke, Parkinson’s disease, and other brain disorders. With a commitment to rigorous clinical validation and a robust R&D pipeline, MindMaze Therapeutics is operationalizing the future of neurorestorative medicine.

For more information, visit www.mindmazetherapeutics.com.

Media & Investor Contacts
Investor Relations:

Jeremy Meinen, Chief Financial Officer
ir@mindmazetherapeutics.com
Media Inquiries:
VSC for MindMaze Therapeutics
mindmazetherapeutics@vsc.com 

DISCLAIMER
This press release contains forward-looking statements, which may be identified by words such as “believe,” “assume,” “expect,” “intend,” “may,” “could,” “will,” or similar expressions. These statements are based on current plans and assumptions and are subject to risks and uncertainties that could cause actual results, financial condition, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, business, economic, financial, regulatory, and competitive factors, as well as the Company’s ability to execute its strategy. This communication is provided as of the date hereof, and MindMaze Therapeutics undertakes no obligation to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

Additional features:

File: Ad hoc release_MindMaze_CEO Appointment


End of Inside Information


Language: English
Company: MindMaze Therapeutics Holding SA
Avenue de Secheron 15
1202 Geneva
Switzerland
Phone: +41 22 545 11 16
Fax: +41 22 545 11 17
E-mail: contact@relieftherapeutics.com
Internet: www.mindmazetherapeutics.com
ISIN: CH1251125998
Listed: SIX Swiss Exchange
EQS News ID: 2290004

 
End of Announcement EQS News Service

2290004  12-March-2026 CET/CEST

BioVersys Announces First Patient Dosed in Phase 2b Clinical Trial of AlpE in Pulmonary Tuberculosis

 

Basel, Switzerland. March 12, 2026, 7am CET. 

  • Under the BioVersys and GSK collaboration agreement, AlpE clinical development advances with first patient dosed in Phase 2b trial within UNITE4TB, following completion of a Phase 2a in adults with drug-susceptible pulmonary TB (DS-TB) in combination with RZE.[1]
  • In the new Phase 2b trial in adults with DS-TB, AlpE will be dosed for two months together with RZE, patients then continue only with RH[2] for 18 weeks.
  • Phase 2b results are expected by the end of 2027.
  • In addition, BioVersys plans to initiate a Phase 2 trial in TB meningitis in H1 2026.

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical 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, that the first patient has been dosed in a  pulmonary TB Phase 2b clinical trial, evaluating the efficacy, safety and pharmacokinetics of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs (NCT05807399).

In this new Phase 2b trial, a portion of the recruited adults with drug sensitive pulmonary tuberculosis (DS-TB) will be dosed for 2-months with RZE in combination with AlpE, followed by 18 weeks with RH alone, to assess efficacy, safety and pharmacokinetics of AlpE. The study is being conducted in six African countries under the European Union’s IMI2 UNITE4TB project, with the Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich as the trial sponsor. Through this Phase 2b TB drug combination trial, BioVersys and its partner GSK are progressing the development of this unique combination and taking the next step in terms of dose finding and potential positioning of AlpE in future TB drug regimens. This trial is expected to read-out by the end of 2027.

Preceding this Phase 2b trial, AlpE underwent a second Phase 2a trial in which AlpE was assessed over 14 days in an open-label trial in combination with first line TB drugs. Top-line data is expected to be available Q2 2026. AlpE was generally well tolerated in this trial, supporting the progression into Phase 2b. BioVersys also plans to initiate a Phase 2 trial in meningeal TB in H1 2026.

Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. AlpE’s development has been strongly supported by European Union and European Pharmaceutical Industry through Innovative Medicines Initiative (IMI2) Joint Undertaking, EDCTP and now UNITE4TB. The compound represents a novel concept to overcome resistance and potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB, as demonstrated in a previous 7-day early bactericidal activity Phase 2a clinical trial, recently published in the New England Journal of Medicine,[3] which provided a first human proof-of-concept. In 2023, the fixed-dose combination of AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis by the U.S. Food and Drug Administration (FDA), and similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA).

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Alpibectir consistently shows promise as a new therapeutic option in combination with ethionamide for addressing tuberculosis. It’s considered to be generally well tolerated with a promising safety profile demonstrated across a number of Phase 1 and Phase 2 clinical trials, and has already demonstrated clinical proof of concept, with 7-day early bactericidal activity similar to isoniazid in patients with tuberculosis in a Phase 2a study. We are now excited to investigate AlpE in this longer clinical study, in combination with first-line TB drugs.”

Prof. Michael Hoelscher, Director, Institute of Infectious Diseases and Tropical Medicine and Principal Investigator of the STEP2C trial: “With the evaluation of alpibectir, UNITE4TB is testing its fifth novel drug candidate in its innovative Phase 2b regimen selection platform, where we evaluate how novel assets are best combined with other licensed or new drugs. This approach will help to derisk the chance of progressing the wrong combination into Phase 3. LMU Hospital is proud to be the sponsor of a trial for such a promising drug.“

David Barros-Aguirre Head of Global Health Medicines R&D, GSK and UNITE4TB Project Lead: “Tuberculosis (TB) remains a major public‑health threat, disproportionately affecting vulnerable communities in high‑burden countries. Advancing alpibectir‑ethionamide (AlpE) into a Phase 2b trial, in combination with first‑line TB drugs, represents an important step in addressing isoniazid resistance and evaluating the potential of this combination for the treatment of other forms of drug‑resistant TB. Through our longstanding partnership with BioVersys and UNITE4TB, we remain committed to changing the trajectory of the TB epidemic.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “We are grateful to all our partners for their support of the clinical development of AlpE for TB patients. The unique clinical trial platform, UNITE4TB, provides the ideal opportunity to investigate AlpE’s potential benefit for TB patients. UNITE4TB is a landmark EU IHI program public and private partnership setting new standards in TB drug development and future regimen finding. We are excited to include AlpE in this program and investigate it alongside other novel assets with the potential to transform the future care for TB patients.”

 

 

 

About tuberculosis (TB)

Tuberculosis (TB) remains one of the leading causes of death worldwide. It is caused by the bacterial pathogen Mycobacterium tuberculosis (Mtb). According to the WHO Global Tuberculosis Report 2025, an estimated 10.7 million people developed TB in 2024, and approximately 1.23 million died from TB.

Drug resistance continues to pose a major challenge. There were about 390,000 people who developed rifampicin-resistant TB (RR-TB) or multidrug-resistant TB (MDR-TB) in 2024. MDR-TB remains a public health crisis and a health security threat, with global treatment success rates at only 71%.

The major burden of TB is concentrated within 30 high TB burden countries, accounting for 87% of the global total in 2024. Of those, the top eight countries for TB cases worldwide were, India (25%), Indonesia (10%), the Philippines (6.8%), China (6.5%), Pakistan (6.3%), Nigeria (4.8%), the Democratic Republic of the Congo (3.9%) and Bangladesh (3.6%). Globally, 8.3 million people were reported as newly diagnosed with TB in 2024, Significantly, it remains that 3.2% of new TB cases and 16% of previously treated cases are MDR/RR-TB.

 

About Alpibectir

Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to, lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity.

 

About UNITE4TB

UNITE4TB is one of nine projects within the AMR Accelerator. Working across a global clinical trials network, UNITE4TB conducts regulatory standard Phase 2 clinical trials to accelerate clinical evaluation of novel drugs and combinations of drugs for tuberculosis (TB). Innovative adaptive trial designs, treatment response biomarkers, pharmacokinetic-pharmacodynamic models and Artificial Intelligence / Deep Learning techniques are integrated across study protocols, deploying cutting-edge methodologies to find antibiotic regimens with the highest likelihood of improved clinical efficacy.

 

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101007873. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, Deutsches Zentrum für Infektionsforschung e. V. (DZIF), and Ludwig-Maximilians-Universität München (LMU). EFPIA/AP contribute 50% of funding, whereas the contribution of DZIF and the LMU University Hospital Munich has been granted by the German Federal Ministry of Education and Research.

 

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). It was set up to improve health by speeding up the development of, and patient access to, the next generation of medicines, particularly in areas where there is an unmet medical or social need. It works by facilitating collaboration between the key players involved in healthcare research, including universities, pharmaceutical companies, other companies active in healthcare research, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators. This approach has proven highly successful, and IMI projects are delivering exciting results that are helping to advance the development of urgently-needed new treatments in diverse areas. IMI projects are now managed by the Innovative Health Initiative (IHI), which builds on the successes of IMI and is a cross-sectoral public-private partnership involving a wider range of health industries.

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 ready), and tuberculosis (alpibectir, Phase 2a, 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

 

 

 

 

This communication reflects the author’s view. Neither IHI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.

 

 

 

 

 

 

 

 

 

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.

 


[1] RZE in TB treatment refers to rifampicin (R), pyrazinamide (Z) and ethambutol (E), key first-line drugs in standard therapy for DS-TB.

[2] RH in TB treatment refers to rifampicin (R) and isoniazid (H), key first-line drugs in standard therapy for DS-TB.

[3]The Revival of Ethionamide by Alpibectir (BVL-GSK098), Michel Pieren et al, 2026; https://www.nejm.org/doi/full/10.1056/NEJMc2504287

PolyPeptide delivers strong revenue growth and marked improvement in profitability

PolyPeptide Group / Key word(s): Annual Results

PolyPeptide delivers strong revenue growth and marked improvement in profitability

12-March-2026 / 06:30 CET/CEST

Release of an ad hoc announcement pursuant to Art. 53 LR

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


Media release – ad hoc announcement pursuant to Art. 53 LR

PolyPeptide delivers strong revenue growth and marked improvement in profitability

Baar, 12 March 2026 – PolyPeptide Group AG (SIX: PPGN), a specialized global CDMO for peptide-based active pharmaceutical ingredients, today announced its annual results for 2025 and guidance for 2026:

  • Revenue of EUR 389.3 million, representing growth of 15.6% versus prior year; at constant currency rates, growth was slightly higher at 16.0%
  • EBITDA of EUR 46.8 million versus EUR 25.4 million in 2024 (+84.4%) with margin increase of 4.5 percentage points to 12.0% versus 7.5% in 2024, primarily reflecting higher production volumes, improved operational performance and product mix
  • Net cash flows from operating activities of EUR 77.5 million versus EUR 89.4 million in 2024, driven by increased profitability and preparations for future growth with customer support
  • Capital expenditures of EUR 110.0 million, 28.2% of revenue, versus EUR 87.8 million and 26.1% of revenue in 2024, reflecting investments across PolyPeptide’s global manufacturing site network to meet strong customer demand
  • The ramp-up of the new large-scale SPPS facility in Belgium was successfully completed in 2025, achieving target utilization rate at year-end
  • PolyPeptide remains well positioned to meet its mid-term outlook to double revenue reported for 2023 by 2028, with the EBITDA margin expected to approach 25% by 2028, and capital expenditures of 15% to 20% of revenue over the mid-term horizon and on average to ensure capacity also beyond 2028
  • Guidance 2026: Revenue growth of 20% to 25% versus 2025, at constant currency rates. EBITDA margin expected to continue to rise, reaching mid- to high-teens. Capital expenditures expected to be in line with the mid-term outlook of 15% to 20% of revenue
  • The audio webcast and conference call will take place today at 9:00 am CET (for access details, please see page 5)

Juan Jose Gonzalez, CEO of PolyPeptide: “In 2025, we delivered strong financial progress, with revenue increasing by 16% at constant currency rates and EBITDA rising by 84%. These improvements were driven by robust peptide metabolic demand, better operational execution, and disciplined investment across our global network. With strong customer demand and clear visibility into upcoming programs, we remain confident in our ability to continue advancing toward our midterm targets.”

Key figures1

 

kEUR 2025 2024 Change
Revenue 389,327 336,792 15.6%
EBITDA 46,755 25,350 84.4%
EBITDA in % of revenue 12.0% 7.5% 4.5 ppts
Operating result (EBIT) 8,689 -7,364 218.0%
Operating results (EBIT) in % of revenue 2.2% -2.2% 4.4 ppts
Result for the year -21,169 -19,564 -8.2%
Result for the year in % of revenue -5.4% -5.8% 0.4 ppts
Earnings per share (EUR), basic -0.64 -0.59 -8.2%
Return on net operating assets (RONOA) 1.6% -1.6% 3.3 ppts
Cash and cash equivalents (end of year) 74,589 68,277 9.2%
Net cash flow from operating activities 77,510 89,399 -13.3%
Capital expenditure 109,978 87,839 25.2%
Capital expenditure in % of revenue 28.2% 26.1% 2.2ppts
Total assets (end of year) 825,959 756,576 9.2%
Equity ratio (end of year) 41.2% 47.2% -6.0ppts
Employees (# of FTEs, average) 1,395 1,291 8.1%

Revenue

In 2025, PolyPeptide generated EUR 389.3 million in revenue, representing a 15.6% increase versus 2024 (+16.0% at constant currency rates).

Development revenue increased by 29.9% and commercial revenue increased by 7.9%, driven by the successful ramp-up of the new large-scale SPPS capacity in Braine l’Alleud, further improved utilization of existing assets, and continued strong demand for peptide-based therapeutics. The revenue share related to metabolics further increased to 57% (vs. 40% in 2024)2.

Throughout 2025, PolyPeptide remained committed to meeting the needs of its customers and maintaining a rich development pipeline. The active custom projects pipeline at the end of 2025 included 196 (201) projects, with 30 (32) projects for phase III. The number of commercial projects supported during 2025 increased to 68 (65).

Footnotes

1 This media release and key figures table include references to operational indicators and alternative financial performance measures (APM) that are not defined or specified by IFRS. These APM should be regarded as complementary information to and not as substitutes for the Group’s consolidated financial results based on IFRS. For the definitions of the main operational indicators and APM used, including related abbreviations, as well as for selected reconciliations to IFRS, please refer to the section “Definitions and reconciliations” of the Annual Report 2025.

2 The revenue share related to oncology declined to 10% (vs. 17% in 2024). Going forward, PolyPeptide will no longer separately disclose the revenue share related to oncology, as its external reporting will focus on metabolics as the main growth driver.

Profitability

In 2025, PolyPeptide delivered a marked improvement in profitability. Gross profit for 2025 was EUR 66.6 million versus EUR 39.3 million in 2024, and EBITDA was EUR 46.8 million (+84.4%) versus EUR 25.4 million in 2024. The EBITDA margin increased by 4.5 percentage points to 12.0% versus 7.5% in 2024.

The increase in EBITDA reflects an improvement of EUR 21.4 million, driven by higher production volumes, improved operational performance and product mix, as well as the ramp-up of the large-scale SPPS facility in Braine-l’Alleud (EUR +1.4 million), which was partially offset by exceptional costs from ERP-related investments (EUR -4.1 million). With an 8.1% increase in average full-time equivalents, personnel expenses were EUR 16.4 million (+13.4%) higher versus 2024, reflecting ongoing preparations for further growth, including the ramp-up of new assets and continued organizational development.

The operating result (EBIT) in 2025 was EUR 8.7 million versus EUR -7.4 million in 2024. The financial result was EUR -28.7 million versus EUR -10.8 million in 2024, driven mainly by an unfavorable revaluation of intercompany loans based on foreign exchange movements (unrealized) and non-cash financing components related to contract liabilities, while interest expense was broadly in line with prior year. The result for the year was EUR -21.2 million versus EUR -19.6 million in 2024.

Cash flow and financing

The increased profitability and preparations for growth with customer support contributed to a strong operating cash flow. Net cash flows from operating activities reached EUR 77.5 million in 2025 versus EUR 89.4 million in 2024. Inventories increased by EUR 7.9 million (+5.4% versus year-end 2024), reflecting an improved inventory turnover driven by disciplined working capital management and the Company’s procurement improvement initiative. Contract liabilities recorded further net inflows of EUR 27.4 million, bringing net proceeds from customer prepayments between 2023-2025 to EUR 156.2 million and reflecting continued customer support for capacity expansion initiatives.

Net cash flows from investing activities were EUR -111.7 million versus EUR -91.0 million in 2024, bringing free cash flow to EUR -31.4 million versus EUR 2.4 million in 2024. With net inflows from financing activities in the amount of EUR 33.8 million (2024: EUR -25.3 million), cash and cash equivalents at the end of 2025 were at EUR 74.6 million versus EUR 68.3 million at the end of 2024.

PolyPeptide announced the expansion of its existing credit facilities in May 2025. As at the end of 2025, EUR 20 million was outstanding under the unsecured short-term credit facility with the Group’s main shareholder. EUR 51 million remained available under the EUR 151 million committed revolving credit facility (RCF), with advanced negotiations for a further increase of the RCF ongoing. In addition, the capital band and conditional share capital for financing created at the general meeting held on 9 April 2025 (“AGM 2025”) provide the Group with further flexibility.

Capacity expansion

In 2025, capital expenditures reached EUR 110.0 million or 28.2% of revenue, in line with the Company’s revised guidance and reflecting investments across PolyPeptide’s manufacturing sites to meet strong customer demand.

The large-scale solid-phase peptide synthesis (SPPS) asset in Braine-l’Alleud, Belgium achieved its target utilization rate at the end of 2025. During ramp-up, optimization measures were identified, raising potential revenues from the asset from ~EUR 100 million to EUR ~125 million. The newly added SPPS capacity at the site in Strasbourg, France, has become operational and is expected to ramp up production throughout 2026. In Malmö, Sweden, PolyPeptide achieved a significant milestone for its SPPS capacity expansion, where the pre-built modules were successfully delivered and installed in September 2025. The modules are currently undergoing mechanical completion and are on track to start ramp-up in 2027. In Torrance, plans were made in late 2025 to expand downstream capacity.

Throughout 2025, PolyPeptide engaged with customers to discuss their mid- and long-term capacity requirements as well as the evaluation of optimal manufacturing locations within the Group’s network. With geopolitical uncertainty remaining an important consideration, PolyPeptide’s manufacturing network across three continents puts the Group in a strong position to serve customers locally, as needed.

The Group continued to advance the specialization of its network as it transitions from laboratory-scale production to an industrialized manufacturing model. This increased focus on allocating activities to the sites best equipped to meet specific customer needs involved shifting projects between locations, supported by the necessary technology transfers, regulatory documentation and filings. Over time, these measures are expected to enhance operational efficiency, increase output, and contribute to revenue growth.

As part of its large-scale capacity expansion, PolyPeptide uses proprietary manufacturing technology with an integrated engineering design, advanced automation, and process control to ensure high productivity, safety, and sustainability. The Company also strives to leverage the potential for modularity and optimize the SPPS reactor size to reduce project complexity, while shortening time to market and enhancing flexibility.

Organizational progress

In 2025, the talent agenda has been further focused on enhancing the organization with industrial-scale manufacturing and supply chain capabilities, while strengthening competences for strategic growth readiness. To enhance PolyPeptide’s scalability, a new provider has been selected for the future enterprise resource planning system (ERP) to bolster the Group’s control mechanisms. To mobilize the program, technical experts were hired in 2025 to drive the ERP implementation and to support a seamless rollout across all sites.

After the successful close of the 2025 financial year, the Company announces a transition within the financial leadership of the Group. Marc Augustin has resigned as Chief Financial Officer and member of the Executive Committee for personal reasons effective 31 March 2026. During his tenure, Mr. Augustin successfully led the transformation of PolyPeptide’s global finance function, including the launch of the Group’s strategic ERP upgrade. The Board of Directors thanks him very much for his valuable contributions and wishes him well in his future endeavors. To ensure continuity, Tim Brandl, currently Director Financial Planning & Analysis and Investor Relations, will assume the role of Interim Chief Financial Officer effective 1 April 2026. Mr. Brandl joined PolyPeptide in May 2024, with broad experience in corporate finance and strategy at Lonza, and in venture capital investment management at Mountain Partners AG. In this interim role, Mr. Brandl will report directly to CEO Juan Jose Gonzalez, who will represent the finance function on the Executive Committee. The Board of Directors, together with Mr. Gonzalez, has initiated a structured search process to appoint a permanent Chief Financial Officer.

Mid-term outlook and guidance for 2026

The progress made in 2025 positions PolyPeptide well to meet its mid-term outlook. PolyPeptide targets doubling revenue reported for 2023 by 2028, with profitability approaching an EBITDA margin of 25% by 2028. Over the mid-term horizon and on average, PolyPeptide expects capital expenditures of 15% to 20% of revenue to ensure capacity also beyond 2028.

For 2026, PolyPeptide’s priority is to meet the strong and increasing customer demand. The ramp-up at the new large-scale SPPS facility in Belgium was completed successfully in 2025, providing a strong foundation for continued growth in 2026. PolyPeptide expects revenue to grow 20-25% in 2026 versus 2025, at constant currency rates. The EBITDA margin is expected to continue to rise, reaching mid- to high-teens based on top-line growth and further progress in operations, which will be partially offset by preparations for future growth as well as the ERP implementation previously announced. Growth is expected to be balanced across the year, with both the first and second halves contributing meaningfully to revenue and EBITDA development. Capex is expected to be in line with the Group’s mid-term outlook of 15-20% of revenue.

From a financing perspective, PolyPeptide expects further improvements in profitability and cash flow, customer funding support for large capacity expansion projects, and the utilization of its credit facilities.

As PolyPeptide continues to invest for growth, it will not be proposing the payment of a dividend to the AGM 2026.

Results documentation, audio webcast and conference call

PolyPeptide Group will hold an audio webcast today at 9:00 am CET, where CEO Juan Jose Gonzalez and CFO Marc Augustin will present a business update and annual results for 2025. Please click here to join the audio webcast. To ask questions during the Q&A session, you must dial in to the moderated telephone conference. Participants may pre-register here and will receive dedicated dial-in details to easily access the call. Please dial in 5 to 10 minutes prior to the start.

A replay of the event will be available in the Results Center after the results presentation.

All results documents, including the media release, the results presentation, the Annual Report 2025 as well as the updated time series, will be available from around 6:30 am CET in the PolyPeptide Results Center.

Contact

PolyPeptide Group AG
Tim Brandl
Director FP&A and Investor Relations
tim.brandl@polypeptide.com
T: +41 43 502 0580

About PolyPeptide

PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 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 includes forward-looking information and statements concerning the outlook for the Group’s business. These statements are based on current expectations, estimates and projections about the factors that may affect the Group’s future performance. These expectations, estimates and projections are generally identifiable by statements containing words such as ‘expects’, ‘believes’, ‘estimates’, ‘targets’, ‘plans’, ‘projects’, ‘outlook’ or similar expressions. There are numerous risks, uncertainties and other factors, many of which are beyond PolyPeptide Group AG’s control, that could cause the Group’s actual results to differ materially from the forward-looking information and statements made in this media release and that could affect the Group’s ability to achieve its stated targets. The important factors that could cause such differences include, among others: timing and strength of its customer’s product offerings, relationships with employees, customers and other business partners; strategies and initiatives of competitors; manufacturing capacity and utilization; quality issues; supply chain matters; the ability to continue to obtain sufficient financing to meet growth initiatives and liquidity needs; legal, tax or regulatory disputes; and changes in the political, social and regulatory framework in which the Group operates, or in economic or technological trends or conditions, including currency fluctuations, inflation and consumer confidence, on a global, regional or national basis. Although PolyPeptide Group AG believes that its expectations reflected in any such forward-looking statement are based upon reasonable assumptions, it can give no assurance that those expectations will be achieved.

In particular, the statements related to the mid-term outlook and guidance for 2026 constitute forward-looking statements and are not guarantees of future financial performance. The Group’s actual results of operations could deviate materially from those set forth in the mid-term outlook and guidance for 2026 as a result of the factors described above or other factors. As such, investors should not place undue reliance on the statements related to the mid-term outlook and guidance for 2026.

Except as otherwise required by law, PolyPeptide Group AG disclaims any intention or obligation to update any forward-looking statements as a result of developments.

Alternative financial performance measures (APM)

This media release contains references to operational indicators, such as active custom projects and commercial projects, and APM that are not defined or specified by IFRS, including revenue at constant currency rates, EBITDA, EBITDA margin, net operating assets, return on net operating assets (RONOA), capital expenditures (Capex), free cash flow, net cash, and headcount. These APM should be regarded as complementary information to and not as substitutes for the Group’s consolidated financial results based on IFRS. These APM may not be comparable to similarly titled measures disclosed by other companies. For the definitions of the main operational indicators and APM used, including related abbreviations, as well as for selected reconciliations to IFRS, refer to the section “Definitions and reconciliations” in PolyPeptide Group AG’s Annual Report 2025.

For the purposes of this media release, unless the context otherwise requires, the term ‘the Company’ means PolyPeptide Group AG, and the terms ‘PolyPeptide’, ‘the Group’, ‘we’, ‘us’ and ‘our’ mean PolyPeptide Group AG and its consolidated subsidiaries.

Additional features:

File: PolyPeptide_FY-2025_Media release


End of Inside Information


Language: English
Company: PolyPeptide Group
Neuhofstrasse 24
6340 Baar
Switzerland
Phone: +41435020580
E-mail: mediateam@polypeptide.com
Internet: www.polypeptide.com
ISIN: CH1110760852
Valor: 111076085
Listed: SIX Swiss Exchange
EQS News ID: 2289898

 
End of Announcement EQS News Service

2289898  12-March-2026 CET/CEST

Results of the 2026 Annual General Meeting for the 2024/25 financial year of BRAIN Biotech AG

BRAIN Biotech AG

/ Key word(s): AGM/EGM

Results of the 2026 Annual General Meeting for the 2024/25 financial year of BRAIN Biotech AG

11.03.2026 / 17:05 CET/CEST

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


Results of the 2026 Annual General Meeting for the 2024/25 financial year of BRAIN Biotech AG
 

ZWINGENBERG, Germany, March 11, 2026 – At today’s Annual General Meeting of BRAIN Biotech AG (Frankfurt Stock Exchange / BNN / ISIN DE0005203947 / WKN 5203949), shareholders approved all agenda items with a broad majority.

Dr. Ursula La Cognata of Berlin, the managing partner of ybe (Your Biotech Experts Partnership), was elected to the Supervisory Board by the Annual General Meeting for a term of four years. She had already been appointed by the Darmstadt Local Court as a new member of the Supervisory Board, effective 11 July 2025, until the next Annual General Meeting.

In his statement to shareholders, Supervisory Board Chairman Dr. Michael Majerus said: “We remain convinced that BRAIN Biotech AG has many positive development opportunities thanks to its successful product business, its strong market position in contract research, the expected revenues from the monetization initiatives as well as licensing of pharmaceutical projects, and further product innovations from the BRAINBioIncubator.”

Agile organizational structure enables fast and flexible customer solutions

In his speech, CEO Adriaan Moelker commented on the company’s strategy, stating: “We remain convinced that our two-pillar strategy, with the product-oriented BRAINBiocatalysts segment on the one hand and the BRAINBioIncubator segment on the other, is the right strategy. This approach enables us to continue to monetize our investments, achieve scientifically based breakthroughs, and organically expand a profitable, scalable, enzyme-focused business. Here we can offer our customers truly unique selling points.

According to Moelker, one of the group’s unique selling points is that, due to its relatively small size, it can respond quickly and flexibly to customer needs with short communication channels and offer innovative biotechnological solutions. The CEO emphasized the importance of maintaining this advantage, even when the company experiences stronger growth in the future.

Moelker also reported on the consolidation of the production and sales for enzymes and food ingredients for the baking and beverage industries at the new location in the Netherlands. The new building, which will house a modern baking application center, a laboratory, and production areas, is nearing completion.

A total of 61.82 % of the share capital, including postal votes, was represented at the time of voting. The detailed voting results and all other documents relating to the 2026 Annual General Meeting are available on the BRAIN Biotech AG website:

https://www.brain-biotech-group.com/en/investors/annual-general-meeting/annual-general-meeting-2026/

 

Contact Media

Dr. Stephanie Konle, PR & Corporate Communications

Phone: +49 6251 9331-70

Email: stk@brain-biotech.com

Contact Investor Relations

Martina Schuster, Investor Relations

Phone: +49 6251 9331-69

Email: ms@brain-biotech.com

 

BRAIN Biotech

The BRAIN Biotech Group is a leader in researching, developing, and producing specialty enzymes, focusing on the food and life sciences industries. In addition, the group develops microbial production strains and scalable bioprocesses for the economic production of specialty enzymes and other proteins. BRAIN Biotech also offers customized biological solutions to the industry for more sustainable products and efficient processes.

BRAIN Biotech AG is the parent company of the BRAIN Biotech Group. The company´s activities are divided into two business segments: BRAINBiocatalysts (development, production, and distribution of specialty enzymes, microorganisms, and ingredients) and BRAINBioIncubator (research-intensive development projects and pharmaceuticals).

BRAIN Biotech operates its own fermentation facilities in the UK and has additional production sites in continental Europe and the US. BRAIN Biotech AG has been listed on the Frankfurt Stock Exchange since February 9, 2016 (Ticker symbol: BNN; ISIN: DE0005203947 / WKN: 520394). In the 2024/25 fiscal year, the group generated revenue of € 49.6 million with around 280 employees. For more information, visit: www.brain-biotech-group.com.

 

The BRAIN Biotech Group on social media and on the internet:

BRAIN Biotech Gruppe

Web: www.brain-biotech-group.com

LinkedIn: https://www.linkedin.com/company/brainbiotech

Threads: https://www.threads.net/@brainbiotechag

Bluesky: https://bsky.app/profile/brain-biotech-group.com

X: https://x.com/BRAINbiotech

Youtube: https://www.youtube.com/channel/UCS33HJqku674X22UQ8QIsyg

 

Biocatalysts Ltd (Production, Distribution)

Website: https://www.biocatalysts.com/

LinkedIn: Biocatalysts Ltd on LinkedIn / BRAIN-Biocatalysts Life Science Solutions on LinkedIn

 

BRAIN Biotech Zwingenberg (Technologies & R&D Services)

Website: www.brain-biotech.com

LinkedIn: BRAIN Biotech Technologies & Services

 

AnalyticonDiscovery (R&D)

Web: https://ac-discovery.com/

LinkedIn: https://www.linkedin.com/company/analyticon-discovery/

 

Disclaimer

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

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

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

 

 


11.03.2026 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: BRAIN Biotech AG
Darmstädter Straße 34-36
64673 Zwingenberg
Germany
Phone: +49 (0) 62 51 / 9331-0
Fax: +49 (0) 62 51 / 9331-11
E-mail: ir@brain-biotech.com
Internet: www.brain-biotech.com
ISIN: DE0005203947
WKN: 520394
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2289868

 
End of News EQS News Service

2289868  11.03.2026 CET/CEST

Curatis and Neupharma announce exclusive licensing agreement to develop and market corticorelin (C-PTBE-01) for the treatment of peritumoral brain edema in Japan

  • Japan is one of the world’s most important pharmaceutical markets after the US and Europe.

  • Neupharma’s team has extensive experience in developing and successfully commercialising orphan drugs as well as speciality care medicines in Japan, including a blockbuster drug.

  • The agreement with Neupharma includes upfront and milestone payments of up to CHF 83.5 million as well as royalties of up to 20% on sales.

  • The population of available patients eligible for corticorelin treatment associated with peritumoral brain edema is estimated at 60,000 in Japan and 500,000 worldwide. Global market potential is forecasted to exceed USD 1 billion annually.

Liestal, Switzerland, and Tokyo, Japan, 11 March 2026: Curatis Holding AG (SIX: CURN) and Neupharma Co., Ltd. (“Neupharma”), a Japanese pharmaceutical company specializing in oncology, immunology, pulmonology and cardiology disorders, today announce an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan.

Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialize corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumor-associated condition for which no approved targeted therapies currently exist. Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%.

The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.

At the same time, preparatory work for the pivotal Phase 3 study for approval in the US and Europe as well as global partnering activities are proceeding as planned.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin demonstrated the potential to substantially reduce, or in some cases completely replace, steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. The estimate for the potential market opportunities for corticorelin is therefore over USD 1 billion per year. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.