Mainz Biomed Announces 6.0 USD Million Private Placement and Strategic Update

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

Mainz Biomed Announces 6.0 USD Million Private Placement and Strategic Update

17.02.2026 / 15:00 CET/CEST

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


Mainz Biomed Announces 6.0 USD Million Private Placement and Strategic Update

Company to Focus on Pancreatic Cancer Detection Business in the U.S., Strategic Asset Sales and Future Strategic Transaction 

BERKELEY, US – MAINZ, Germany – February 17, 2026 — Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, announced a series of strategic transactions designed to strengthen its liquidity position, transition the business to a focus on its pancreatic cancer detection program in the U.S., and provide flexibility as the Company continues its operations while evaluating growth opportunities and broader strategic alternatives.  

On February 13, 2026, Mainz Biomed N.V. (the “Company”) entered into a securities purchase agreement for a 6.0 USD million private placement with investor David Lazar. The financing will be completed in two tranches of 3.0 USD million each through the issuance of Convertible Non-Redeemable Preferred Stock. The first 3.0 USD million closing was completed on February 13, 2026. The second 3.0 USD million closing is expected to occur following receipt of required stockholder approvals and prior to April 15, 2026. Net proceeds from the private placement are expected to be used to fund ongoing operations, address outstanding liabilities, and preserve the Company’s ability to operate while it pursues strategic initiatives.  In conjunction with the financing the Company named David Lazar as Chairman of the Board of Directors.

“Completing this financing provides the Company with critical runway and stability,” said David Lazar, Chair of the Board of Mainz Biomed. “Our immediate focus is to continue to further develop and evaluate opportunities to grow our pancreatic screening program in the U.S. and stabilize the business. At the same time, we will be disciplined and thoughtful as we explore additional strategic alternatives that can unlock long-term value for stockholders.”

As the Company transitions its focus on developing its pancreatic cancer screening business in the U.S., it will continue to evaluate opportunities to sell its colorectal cancer screening assets while it also winds down its German subsidiary. The Company is currently in discussions with several parties interested in its colorectal cancer assets. This allows the Company to significantly reduce its operating expenses and extend its runway. 

For a complete description of the details of the transaction described above, please review the Company’s Form 8-K filed with the SEC on February 17, 2026.

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

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For investor inquiries, please contact ir@mainzbiomed.com 

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


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Language: English
Company: Mainz BioMed N.V.
Robert-Koch-Strasse 50
55129 Mainz
Germany
Internet: mainzbiomed.com
EQS News ID: 2276560

 
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African Leaders Call for Sustainable Malaria Financing as Progress Stalls and Funding Crisis Deepens

African Leaders Malaria Alliance (ALMA)

/ Key word(s): Financing

African Leaders Call for Sustainable Malaria Financing as Progress Stalls and Funding Crisis Deepens

17.02.2026 / 14:01 CET/CEST

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


The 2025 Africa Malaria Progress Report reveals 270.8 million cases and nearly 600,000 deaths; It warns of potential resurgence, as Heads of State and Government urge increased domestic resource mobilisation, call on partners to honour their commitments, and demand a renewed World Bank Malaria Booster Programme

ADDIS ABABA, Ethiopia, February 17, 2026/APO Group/ — Against a backdrop of stalled progress, declining international funding, and intensifying threats, African Heads of State and Government today issued a unified call for a new era of malaria financing at the 39th African Union Summit in Ethiopia. The African Union Malaria Progress Report 2025, presented by President Advocate Duma Gideon Boko of the Republic of Botswana and Chair of the African Leaders Malaria Alliance (ALMA) (www.ALMA2030.org), warns that without urgent action, the continent risks losing decades of hard-won gains against the disease.

Urgent action required as perfect storm intensifies

The 2025 report reveals that African Union Member States accounted for 270.8 million malaria cases (96% of the global total) and 594,119 deaths (97% of the global total) in 2024. Progress has stalled since 2015, and only five Member States have achieved the 2025  Catalytic Framework targets for reducing malaria incidence or mortality by 75%. These targets are part of the AU Catalytic Framework to End AIDS, TB and Eliminate Malaria in Africa by 2030.

The report warns that a 30% reduction in funding will result in 640 million fewer insecticide-treated nets, 146 million additional malaria cases, 397,000 additional deaths (75% among children under five), and a loss of $37 billion in GDP by 2030. Without urgent action, the report warns that malaria could resurge significantly, with cases potentially exceeding 400 million per year and deaths surpassing one million annually.

“The perfect storm of converging crises threatening malaria elimination has intensified. Official Development Assistance for health in Africa has declined by 70% in just four years, and the Eighth Replenishment of the Global Fund fell significantly short of its $18 billion target. We cannot allow these challenges to reverse decades of progress that have prevented 1.64 billion cases and saved 12.4 million lives since 2000.”

~ President Advocate Duma Gideon Boko, Republic of Botswana, Chair of ALMA

A new era of financing as Africa takes the lead

In response to the funding crisis, African leaders reaffirmed their commitment to domestic resource mobilisation, innovative financing and the development of national health financing sustainability plans. The report highlights that End Malaria Councils and Funds in 12 countries have now mobilised over $200 million through public-private partnerships, demonstrating the power of multisectoral collaboration. Establishing public-private partnerships is essential for delivering sustainable financing. These partnerships can unlock new investments, propelling progress not only toward malaria elimination but also toward universal health coverage. A whole-of-society approach, engaging the private sector, philanthropic foundations, high-net-worth individuals and the diaspora through a public private health accelerator, will reinforce domestic commitments and deliver a win-win partnership.

Countries across the continent are stepping up with increased domestic financing commitments for malaria in 2025. Leaders called on global partners to honour their commitments, renew the World Bank’s Malaria Booster Programme, and align support with national strategies. The original World Bank Malaria Booster Programme (2005-2010) committed over $1 billion with transformative results. Today, African leaders are urging a renewed programme to close funding gaps, deploy next-generation tools, strengthen community health worker programmes, and build climate-resilient health systems. Investing in malaria in this way will also strengthen primary health care, making our health systems more resilient to shock and put us on a path to defeating other health challenges such as neglected tropical diseases.

“Our approach has spanned the full spectrum of what it takes to beat this disease. Tanzania has invested in world-class research and is home to the Ifakara Health Institute, where our scientists are working at the frontier of new technologies, including gene drive–an innovative approach that aims to ensure mosquitoes can no longer transmit the malaria parasite. This is African science, conducted by African researchers, addressing an African challenge.”

~ H.E. Samia Suluhu Hassan, President of the United Republic of Tanzania

New, powerful next-generation tools gaining ground

Despite the challenges, the report highlights significant progress in deploying innovative tools. In 2025, 74% of insecticide-treated nets distributed across Africa were next-generation dual active-ingredient nets, up from just 20% in 2023. These nets are 45% more effective than pyrethroid-only nets against resistant mosquitoes.

Twenty-four countries have now introduced WHO-approved malaria vaccines for children under five, with 28.3 million doses distributed in 2025, up from 10.5 million in 2024. Additionally, WHO prequalified two spatial repellent products in 2025, marking the first new vector control intervention introduced in decades. A record 22 countries planned to implement seasonal malaria chemoprevention in 2025. The malaria innovation pipeline remains stronger than ever.

Promoting health sovereignty through local manufacturing

Leaders emphasised the importance of local manufacturing to ensure affordability, access, and supply chain resilience. Currently, Africa imports 99% of vaccines and 95% of medicines. The report highlights that Nigeria has entered into partnerships for local production of antimalarial treatments and rapid diagnostic tests, and is working to establish the first Africa-manufactured next-generation nets.

The African Medicines Agency, with 31 countries now ratified, and Regional Economic Communities are harmonising regulatory frameworks to accelerate the registration of new commodities across the continent.

“Full deployment of existing and new tools, combined with full funding, could save over 13.2 million lives over the next 15 years and boost African economies by over $140 billion. Every dollar invested in the Global Fund delivers $19 in returns. We have the tools. We need the resources.”

~ Dr. Michael Adekunle Charles, CEO, RBM Partnership to End Malaria

What must be done

The Heads of State and Government issued a clear call to action, urging all Member States to treat malaria as a central pillar of health sovereignty and economic transformation, protect and increase domestic and external funding, and fully implement the priorities of the Catalytic Framework through a Big Push Against Malaria.

Leaders called on international partners to fulfil commitments, align support with national strategies, and invest in the tools and systems that will secure a malaria-free future. They emphasised that the path ahead is challenging. Nevertheless, with determined leadership, the smart use of data, and sustained investment, Africa can bend the curve towards elimination and ensure that future generations grow up free from the threat of malaria.

Distributed by APO Group on behalf of African Leaders Malaria Alliance (ALMA).

Download Image: https://apo-opa.co/4tGjqfi (President Advocate Duma Gideon Boko, Chair of ALMA, speaks at the High-Level Press Conference on Sustainable Malaria Financing, at the 39th AU Summit)

Download Video: https://apo-opa.co/4aQyAqZ (President Adovcate Duma Gideon Boko calls for collective will among his fellow heads of state and multiple sectoral ministers to join hands to finance and support the fight against malaria at scale)

 

Notes to Editors:
The African Union Malaria Progress Report 2025 is available for download at: www.AU.int and www.ALMA2030.org

Media Inquiries:
African Leaders Malaria Alliance:
Thomas Davies
TDavies@alma2030.org
www.ALMA2030.org

African Union Commission:
Molalet Tsedeke
MolaletT@africa-union.org
www.AU.int

African Media Agency:
Leslie-Shamilda Segui
shamilda@africanmediaagency.com
https://apo-opa.co/3MMUB0E

About the Africa Malaria Progress Report: 
The Africa Malaria Progress Report is an annual publication prepared by the African Union Commission, African Leaders Malaria Alliance and RBM Partnership to End Malaria. It tracks progress against the AU Catalytic Framework targets, highlights challenges and threats to malaria elimination, and documents Member State actions to accelerate progress. The report is presented annually to Heads of State and Government at the African Union Summit.

About ALMA:
Founded in 2009, the African Leaders Malaria Alliance (ALMA) is a ground-breaking coalition of African Heads of State and Government working across country and regional borders to achieve a malaria-free Africa by 2030. www.ALMA2030.org


17.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2277546  17.02.2026 CET/CEST

Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

Viromed Medical AG

/ Key word(s): Miscellaneous

Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

16.02.2026 / 10:14 CET/CEST

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


Viromed Medical AG: Globally unique preclinical data base – Saarland validation as key step toward first physical lung application

Rellingen, 16 February 2026 – As part of a scientific press conference on 12 February 2026, Prof. Dr. Hortense Slevogt, study director at Hannover Medical School and Head of the Respiratory Department at the Helmholtz Centre for Infection Research, presented the current status of the preclinical development of cold plasma therapy (Cold Atmospheric Plasma, CAP) for the treatment of severe infectious lung diseases. The study uses the cold plasma technology of Viromed Medical AG (“Viromed”).

Prof. Dr. Slevogt explained that a full disclosure of all data details was deliberately omitted, as publication of the results in a recognized international peer-reviewed journal is imminent. The delay in publication is due to the decision to submit a particularly comprehensive and scientifically high-quality fast-track paper that meets the highest international standards.

According to the study management, the basic research conducted over the past 2.5 years on human lung epithelial models has consistently produced positive results. A significant, pathogen-independent reduction of pathogenic germs was demonstrated, while maintaining a clearly defined therapeutic safety window. Histological analyses and examinations showed no safety-relevant tissue damage within this application window.

To Viromed’s knowledge, there are currently no comparable preclinical study programs worldwide that have investigated a physical cold plasma application directly in pulmonary tissue to this extent. The available data therefore represent, in the company’s assessment, an internationally unique scientific foundation for a non-pharmacological treatment of severe lung infections.

Based on these data, regulatory consultation meetings have already taken place in which the requirements for a potential application in critically ill intensive care patients were clearly defined – particularly with regard to a structured benefit-risk assessment.

The validation study now initiated in the vital lung organ model at Saarland University represents the decisive translational step. With a planned duration of 10 to 12 weeks, the preclinically defined dosing parameters are to be finally confirmed under physiologically realistic conditions. This phase is considered key to transferring the scientifically defined benefit-risk profile into clinical application. The focus is on patients with fulminant lung infections caused by pathogenic germs, in particular ventilator-associated pneumonias (VAP), which continue to show high mortality despite guideline-compliant therapy and in which conventional antibiotic strategies are increasingly losing effectiveness.

In addition, Prof. Dr. Slevogt emphasized the considerable preventive potential of the technology. In the future, CAP could help to prevent severe disease courses at an early stage. The study management also sees significant application potential in the context of influenza-associated bacterial/viral secondary infections.

Against the backdrop of globally increasing antibiotic resistance, high mortality in severe pneumonias, and limited therapeutic alternatives, CAP, in Viromed’s assessment, addresses a significant international unmet need in the intensive care setting.

Uwe Perbandt, Member of the Management Board of Viromed Medical AG: “With a globally unique preclinical data base and a clearly defined therapeutic window, we are at a decisive point of translation. The regulatory discussions have defined the framework conditions for an application in critically ill patients. If the validation at Saarland University confirms these parameters, we see a realistic perspective to initiate the next steps toward clinical application in early summer. We are convinced that a physical, non-pharmacological therapy in the field of severe lung infections will attract international attention. In our view, the coming weeks represent the decisive transition from preclinical validation to clinical reality.”

 

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de

Press contact

E-mail: viromed@kirchhoff.de


16.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A40ZVN7
WKN: A40ZVN
Listed: Regulated Unofficial Market in Dusseldorf, Frankfurt, Hamburg, Tradegate BSX
EQS News ID: 2276884

 
End of News EQS News Service

2276884  16.02.2026 CET/CEST

Eckert & Ziegler and UJF Significantly Increase Production Volume for Actinium-225

Eckert & Ziegler SE

/ Key word(s): Miscellaneous

Eckert & Ziegler and UJF Significantly Increase Production Volume for Actinium-225

16.02.2026 / 11:00 CET/CEST

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


Berlin, Germany and Řež, Czech Republic, 16 February 2026. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) and the Nuclear Physics Institute of the Czech Academy of Sciences (Ústav jaderné fyziky, “UJF”) have successfully transitioned their joint Actinium-225 initiative into larger scale manufacturing using the facilities in Řež and Braunschweig.

With the increased production capacity per run, Eckert & Ziegler is one of a limited number of suppliers worldwide to provide clinically relevant quantities of the highly demanded radioisotope. Actinium-225 is widely regarded as one of the most promising alpha-emitting radionuclides for targeted radiopharmaceutical applications, particularly in the treatment of small tumors and micrometastases. However, global development programs have long been constrained by restricted availability and the technical complexity of isotope production.

“The start for the continuous production of high-quality Actinium-225 represents a strategically important milestone for Eckert & Ziegler,” said Dr. Gunnar Mann, Member of the Executive Board and responsible for Operations at Eckert & Ziegler. “By further expanding our production capacity for radionuclides, we are delivering on our promise to improve global supply security and to advance the development of the next generation of diagnostics and therapeutics.”

Eckert & Ziegler reliably supplies Gallium-68, Lutetium-177, Yttrium-90, and Actinium-225 to leading pharmaceutical companies and research institutions worldwide. With expertise in radioisotope production as well as global logistics and CDMO services, the company is committed to continuously supporting the development and delivery of innovative radiopharmaceuticals.

About Eckert & Ziegler
Eckert & Ziegler SE, with more than 1,000 employees, is a leading specialist in isotope-related components for nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse.
Contributing to saving lives.

Contact
Eckert & Ziegler SE
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Jan Schöpflin, Marketing / Karolin Riehle, Investor Relations
jan.schoepflin@ezag.dekarolin.riehle@ezag.de
Tel.: +49 (0) 30 / 94 10 84-138; www.ezag.com


16.02.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Eckert & Ziegler SE
Robert-Rössle-Str.10
13125 Berlin
Germany
Phone: +49 30 941084-138
Fax: +49 30 941084-0
Internet: www.ezag.de
ISIN: DE0005659700
WKN: 565970
Indices: SDAX, TecDax,
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate BSX
EQS News ID: 2276200

 
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2276200  16.02.2026 CET/CEST

Sartorius Stedim Biotech releases Universal Registration Document 2025

Sartorius Stedim Biotech SA

/ Key word(s): Annual Results

Sartorius Stedim Biotech releases Universal Registration Document 2025

16-Feb-2026 / 09:13 CET/CEST


Aubagne, France | February 16, 2026

Sartorius Stedim Biotech releases Universal Registration Document 2025

Sartorius Stedim Biotech, a leading partner of the biopharma industry, today released its Universal Registration Document 2025 including the Annual Financial Report. The document is available at the following link: https://www.sartorius.com/urd2025  

Financial calendar 
March 24, 2026 | Annual Shareholders’ Meeting   
April 23, 2026 | Publication of the first quarter results for January to March 2026 
July 23, 2026 | Publication of half-year results for January to June 2026 
October 22, 2026 | Publication of nine-month results January to September 2026 

A profile of Sartorius Stedim Biotech 
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a provider of innovative solutions, the company based in Aubagne, France, helps its customers to manufacture biotech medications, such as cell and gene therapies, safely, rapidly, and sustainably. The shares of Sartorius Stedim Biotech S.A. are quoted on the Euronext Paris. The company has a strong global reach with manufacturing and R&D sites as well as sales entities in Europe, North America, and Asia. Sartorius Stedim Biotech regularly expands its portfolio through acquisitions of complementary technologies. In 2025, the company generated sales revenue of around 3 billion euros, according to preliminary figures. Currently, more than 10,200 employees are working for customers around the globe.   
 
Visit our newsroom and follow us on LinkedIn

Contact
Verena Sattel 
External Communications 
+49 551 308 9261 
verena.sattel@sartorius.com 


Attachment

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2275078  16-Feb-2026 CET/CEST

Immunic Announces Oversubscribed Private Placement of up to USD 400 Million to Accelerate Transformation into Commercial-Stage Company

Issuer: Immunic AG

/ Key word(s): Financing

Immunic Announces Oversubscribed Private Placement of up to USD 400 Million to Accelerate Transformation into Commercial-Stage Company

13.02.2026 / 12:30 CET/CEST

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


Immunic Announces Oversubscribed Private Placement of up to USD 400 Million to Accelerate Transformation into Commercial-Stage Company

– Upfront Proceeds of USD 200 Million, with Potential for up to USD 200 Million in Additional Proceeds –

– Expected to Fund Completion of Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis, Initiation of Phase 3 Trial in Primary Progressive Multiple Sclerosis, and Transition into a Commercial Organization –

– Simona Skerjanec, Former SVP, Global Head of Neuroscience and Rare Diseases at Roche, Elevated to Interim Chairperson of the Board of Directors –

– Thor Nagel, Principal at BVF Partners L.P., Joins Board of Directors –

– Simona Skerjanec and Dr. Daniel Vitt to Lead Search for CEO with Commercial Background –

NEW YORK, February 13, 2026 – Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases, today announced the pricing of a private placement with gross proceeds of up to USD 400 million priced at the market under Nasdaq rules. The financing was led by existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors.

Transformation Into Commercial-Stage Company

The proceeds of this financing are expected to support Immunic’s strategic transition from a research and development (R&D)-focused company into a fully integrated commercial entity. In the coming months, the company will prioritize:

  • Completion of the ongoing phase 3 ENSURE clinical trials of vidofludimus calcium in relapsing multiple sclerosis (RMS): Top-line data continues to be expected by the end of 2026. Subsequently, Immunic plans to submit a New Drug Application (NDA) in the United States in mid-2027, with a targeted potential regulatory approval date in 2028. In parallel, Immunic will work on the preparations for the potential commercialization of vidofludimus calcium, including the pre-commercial ramp-up and expansion of the medical and commercial teams.
  • Initiation of a phase 3 clinical program in primary progressive multiple sclerosis (PPMS): Immunic is working towards initiation of a phase 3 clinical program, which is expected later this year and estimated to take approximately 3.5 to 4 years to complete.

With these pivotal programs underway, Immunic is positioning itself to become a leading innovator in next‑generation oral therapies for relapsing and progressive forms of multiple sclerosis (MS). Vidofludimus calcium is uniquely designed to provide direct neuroprotective effects by enhancing neuronal survival and function through nuclear receptor-related 1 (Nurr1) activation, while reducing new inflammatory damage via selective dihydroorotate dehydrogenase (DHODH) inhibition. This first-in-class mechanism has the potential to address the two key biological drivers of disability progression—relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA)—potentially offering advantages over currently available therapies that primarily focus on inflammatory relapses.

Changes in Company Leadership

Immunic’s Co-Founder and Chief Executive Officer, Dr. Daniel Vitt, and the Board of Directors will begin a search for a new CEO with deep commercial expertise in the MS space to lead Immunic through its next stage of growth and into commercialization. Subsequently, Dr. Vitt plans to transition to a new senior executive role focused on strengthening the company’s scientific strategy and driving portfolio advancement. He will continue to support the organization in this capacity and as a member of the Board of Directors.

Concurrent with the transaction, Simona Skerjanec, former SVP, Global Head of Neuroscience and Rare Diseases at Roche, who joined Immunic’s Board of Directors in July 2024, has been elevated to interim Chairperson of the Board of Directors. Dr. Duane Nash, former Chairman, will remain a member of the Board of Directors. Additionally, Thor Nagel, Principal at BVF Partners L.P., has been appointed as a member of the Board of Directors. The Board of Directors intends to explore and evaluate further refreshment in order to better align its future composition with Immunic’s strategic goals and objectives. As part of this refreshment, the Board expects that two new directors will replace existing directors at or prior to Immunic’s upcoming annual meeting with a third director expected to be replaced at or prior to Immunic’s 2027 annual meeting.

“I could not be prouder of the Immunic team and what we have achieved with vidofludimus calcium. I would like to thank BVF and the other investors in the consortium for joining our journey towards potential regulatory approval of vidofludimus calcium. The proceeds from the initial closing are expected to provide sufficient runway through submission of an NDA in the United States in mid-2027 and to start preparations for the potential launch of vidofludimus calcium in RMS, as well as initiation of a phase 3 clinical program in PPMS,” commented Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. “We believe that now is the perfect time to prepare Immunic for its transformation into a highly successful commercial entity. As Immunic evolves from an R&D‑driven organization into a fully-fledged commercial company, I have decided to return to my roots and focus my energy on further strengthening Immunic’s scientific excellence. Together with our new interim Chairperson Simona and other members of our Board of Directors, I look forward to welcoming a new CEO with a strong commercial background in the MS space to lead the next phase of Immunic’s growth and to guide the potential launch of our first pharmaceutical product. I will continue to support this transition process and Immunic’s success in my current and future executive roles and as a member of the Board of Directors.”

“I want to thank Daniel for not only helping to invent vidofludimus calcium, but also for his tremendous leadership in getting the molecule and company to this position,” said Duane Nash, M.D., J.D., M.B.A., member of the Immunic Board of Directors and former Chairman. “I am also delighted that Simona has agreed to take the position of interim Chairperson to steer this evolution. As the former head of Neuroscience and Rare Diseases at Roche, who personally led one of the most successful launches in MS history, she is well positioned to guide Immunic’s commercial transformation efforts. In the 18 months she has been on our Board, her contributions, insights and connections have proven invaluable, and her leadership skills are impeccable. I look forward to helping support Simona and the rest of the Board in any way that I can.”

“I am honored to be in a position to help transform Immunic at this critical juncture,” said Simona Skerjanec, newly appointed interim Chairperson of the Board of Directors of Immunic. “Despite available therapeutic options in MS, it remains a devastating disease for patients and their families and I am committed to help bring new and meaningful therapies to patients. I believe vidofludimus calcium holds the potential to address the underlying unmet need for a direct neuroprotective medicine in MS. I very much look forward to continuing to work with Daniel, Duane and the rest of Immunic’s Board of Directors as we prepare Immunic for a very exciting future.”

Up to USD 400 Million Private Placement

The company has entered into a securities purchase agreement with select accredited investors for up to USD 400 million in gross proceeds through a private placement. Pursuant to the terms of the purchase agreement, the company will issue an aggregate of 229,076,000 pre-funded warrants to purchase shares of the company’s common stock at a price of $0.873 per pre-funded warrant, for upfront gross proceeds of USD 200 million.

In addition, the company will issue warrants to purchase up to an aggregate of 229,076,000 shares of the company’s common stock (or pre-funded warrants in lieu thereof) at an exercise price of $0.873 per share, for up to an additional USD 200 million in gross proceeds to Immunic. These warrants will expire upon the earlier of (a) 30 days after the public announcement of top-line data from the phase 3 ENSURE trials or (b) February 17, 2031. The private placement is expected to close on or about February 17, 2026, subject to customary closing conditions.

The financing was led by existing investor BVF Partners L.P. and included participation from Aberdeen Investments, Avidity Partners, Coastlands Capital, EcoR1 Capital, Janus Henderson Investors, OrbiMed, RA Capital Management, TCGX, Trails Edge Capital Partners, Vivo Capital, Woodline Partners LP, and other institutional investors.

Leerink Partners acted as lead placement agent in connection with the financing. Stifel, Guggenheim Securities, William Blair, LifeSci Capital, B. Riley Securities and Brookline Capital Markets, a division of Arcadia Securities, LLC, also acted as placement agents in connection with the financing.

The company intends to use the net proceeds from the offering to fund its clinical trials and operations and for other general corporate purposes. The proceeds from this private placement, combined with current cash, cash equivalents and marketable securities, are expected to fund operating and capital expenditures to late 2027.

In addition, on February 12, 2026, Immunic entered into a purchase and sale agreement with certain holders of warrants to purchase shares of the company’s common stock that were issued in its May 2025 public offering (the “Series B Warrants”). Pursuant to the terms of the purchase and sale agreement, the company issued to such holders the right to receive a portion of an aggregate 5% royalty on future net sales of vidofludimus calcium in exchange for cancellation of the Series B Warrants held by such participants. The purchase and sale agreement is expected to close on or about February 17, 2026.

Further information regarding the private placement and the purchase and sale agreement can be found in the company’s filings with the Securities and Exchange Commission, including a current report on Form 8-K which is expected to be filed on or about February 13, 2026.

About Immunic, Inc.

Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic and gastrointestinal diseases. The company’s lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: www.imux.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to consummation of the proposed offering and the exercise of warrants to be issued in the offering, Immunic’s development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management’s current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company’s products or product candidates, the protection and market exclusivity provided by Immunic’s intellectual property, risks related to the drug development and the regulatory approval process, the impact of competitive products and technological changes, the company’s ability to close the proposed offering, and the risk that warrants issued in this offering will not be exercised for cash in the future. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned “Risk Factors,” in the company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company’s subsequent filings with the SEC. Copies of these filings are available online at www.sec.gov or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release.

Contact Information

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

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

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


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

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Changes to the Composition of the Lonza Board

  • Sami Atiya is nominated to the Lonza Board for his deep experience in healthcare, robotics, automation and AI acquired from senior roles at ABB, Siemens and other leading companies.
  • Subject to election at the AGM, Sami will also be appointed a member of the Lonza Board Strategy and Innovation Committee.
  • Recently nominated as an Independent Member of the Board, and also subject to election at the AGM, Claudia Süssmuth-Dyckerhoff will be appointed Vice-Chair of the Board and a member of the Remuneration Committee and the Strategy and Innovation Committee.
  • At the 2026 AGM, Jürgen Steinemann, Barbara Richmond will not stand for re-election, as they reach their maximum Lonza Board tenures. Roger Nitsch has also decided not to stand for re-election, in order to focus on his entrepreneurial activities.

Basel, Switzerland, 13 February 2026 – Today, the Lonza Board of Directors announced the nomination of Sami Atiya as an Independent Member of the Board. The Board will propose Sami’s election to shareholders at the Lonza Group Annual General Meeting (AGM) in May 2026. Subject to his election at the AGM, Sami will also be appointed a member of the Strategy and Innovation Committee.

Sami brings extensive leadership experience in healthcare, robotics, automation and AI, all of which are highly relevant to Lonza’s core business. Most recently, Sami spent ten years on the Group Executive Committee of ABB Ltd, with responsibilities across robotics, motion and discrete automation. Prior to this, Sami spent more than 15 years in leadership at Siemens, including responsibility for the Siemens Computer Tomography and Radiation Oncology business. Sami is on the Board of Directors of SGS and the AI Council of the Port Authority of Singapore. Sami holds an MBA from the Massachusetts Institute of Technology (USA), as well as a PhD in Engineering and an MSc in Electrical Engineering from the University of Wuppertal and Karlsruhe (DE).

As previously announced, the Board’s long-term succession planning is further supported by the nomination of Claudia Süssmuth-Dyckerhoff as Vice-Chair of the Lonza Board, bringing a decade of Board experience at companies including Roche. Marion Helmes will transition to Chair of the Audit and Compliance Committee. All nominations demonstrate a structured approach to leadership team succession planning and continuity, in line with the commitment to ensuring robust governance.

As previously announced, Jürgen Steinemann and Barbara Richmond will not stand for re-election at the 2026 AGM following their twelve-year tenures with Lonza. Roger Nitsch, who joined the Lonza Board in 2022, has also decided not to stand for re-election, in order to focus on his other entrepreneurial activities.

Jean-Marc Huët, Chairman of the Board, Lonza, commented: “I am delighted to congratulate Sami on his nomination. With extensive experience in new technologies, such as robotics and automation, Sami’s skillset is highly relevant to our company and business. Together with Claudia Süssmuth-Dyckerhoff, Sami will be an invaluable addition to the Board. I am also very thankful to Barbara, Jürgen and Roger for their continued service, collaboration and contribution to Lonza’s success, and I take this chance to wish them every happiness after they leave the Lonza Board.”

    DocMorris and Infermedica simplify health: from symptoms to solutions with the AI health companion

    DocMorris, a leading company in the fields of online pharmacy, telemedicine and marketplace continues to push ahead with its ‘AI First’ strategy to build an integrated ecosystem of AI-supported services that redefine the patient journey. The October 2025 rollout of the beta phase of the AI-powered health companion in the DocMorris App marked an ongoing shift from a pure service provider to a holistic ‘Health in one click’ ecosystem.

    DocMorris simplifies the healthcare experience by bringing symptom checks, telemedicine, pharmacy access, and additional digital services into a single, around-the-clock platform. This approach empowers patients to take control and have a better understanding of their own medical care, transforming them from passive recipients of services into active decision-makers. The DocMorris health companion acts as a central interface and first point of contact for DocMorris customers, offering them an integrated, comprehensive health experience.

    For many patients, the journey from experiencing the first symptoms to receiving the correct treatment can be long and challenging. DocMorris bridges this gap by forming strategic partnerships with leading AI companies and adding their solutions to its own healthcare ecosystem. An important component is therefore the cooperation with Infermedica, a global leader in AI-powered symptom analysis and patient triage. Embedding their self-service symptom checker into DocMorris’s offerings will enhance the company’s virtual digital care services, enabling customers to check their symptoms online and receive information on the best next steps, as well as understanding the most probable conditions. Unlike standalone tools, the integration of this certified medical device creates a frictionless loop designed around the patient.

    “At DocMorris, we are redefining the patient journey by putting smart technology and convenience at the heart of healthcare. It begins with an AI-driven assessment that carefully analyses your symptoms, providing you with immediate, personalized guidance on the best path forward whether that’s self-care, a video consultation, or an urgent doctor’s visit. By seamlessly integrating these insights with our e-prescription and pharmacy services, we ensure that every patient has instant access to the medication and the professional advice they need”, states David Masó Chief AI Health Officer (CAHO) of DocMorris.

    Infermedica’s medically certified virtual triage into the DocMorris app is a powerful step toward more connected, patient-centric care. By combining intelligent triage with DocMorris’ extensive digital offering, including telemedicine and pharmacy services, we can accelerate access to care and help people navigate the healthcare system with clarity and confidence,” adds Piotr Orzechowski, CEO of Infermedica.

    More information at: DocMorris App – Medikamente per App kaufen

    Media contact Infermedica
    Fabian Fröhlich
    Email: fabian.froehlich@infermedica.com
    Website: www.infermedica.com/de

    Infermedica
    Infermedica is a global leader in AI-powered symptom analysis and patient triage, dedicated to making healthcare more accessible, accurate, and convenient by automating primary care. Operating in over 30 countries and 26 languages, its solutions have powered over 25 million health checks since 2012.

    Media contact DocMorris
    Torben Bonnke, Director Communications
    Email: media@docmorris.com
    Phone: +49 171 864 888 1

    DocMorris
    DocMorris stands for customer-centred, innovative services and a wide range of digital healthcare products. These range from quickly making appointments to see a doctor online on the TeleClinic telemedicine platform to pharmaceutical advice and the supply of prescription and over-the-counter medicines and healthcare products from Germany’s best-known online pharmacy. In addition, there is the marketplace with a broad complementary range of remedies and aids as well as products from the areas of nutrition, beauty and family. DocMorris thus provides its customers with easy access to comprehensive healthcare services in one place with just one click. In the Germany segment, the Swiss company DocMorris AG generated external sales of CHF 1,122.6million in 2025 with 11 million active customers.

    Carl Zeiss Meditec with Weak Start to FY 2025/26

    Carl Zeiss Meditec AG

    / Key word(s): Quarter Results/Quarterly / Interim Statement

    Carl Zeiss Meditec with Weak Start to FY 2025/26

    12.02.2026 / 07:00 CET/CEST

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


     Carl Zeiss Meditec with Weak Start to FY 2025/26
     
    Q1 revenue and earnings significantly below prior year

     

    JENA, 12 February 2026

    Carl Zeiss Meditec generated revenue of €467.0m in the first quarter of fiscal year 2025/26 (prior year: €490.5m), representing a decline of -4.8% (-0.7% adjusted for all currency effects1). EBITA2 amounted to €8.1m (prior year: €35.2m). EBITA margin was 1.7% (prior year: 7.2%).

    Justus Felix Wehmer, Chief Financial Officer of Carl Zeiss Meditec AG, commented:
    “The weak start to the fiscal year in the first quarter highlights the challenges of a market environment increasingly shaped by geopolitical uncertainties, noticeable restraint in investment decisions, and changes in regulatory framework. Against this backdrop, it is now particularly important to accelerate product localization, consistently redefine priorities in R&D, and further strengthen operational efficiency.”

    Declining revenues in both strategic business units

    Revenue development in both strategic business units remained below the prior-year level in the first quarter of fiscal year 2025/26. In addition to significant negative currency effects, revenues were particularly impacted by pull-forward effects from the strong end of fiscal year 2024/25, as well as regional market- and seasonal factors.

    Revenue in the Ophthalmology unit declined -5.1% to €356.9m (fx-adj. -2.4%). Besides currency headwinds, drivers of weak performance were mainly found in product mix based on market dynamics in the APAC region: the IOL segment was subject to the impact of the bifocal lens withdrawal from the current VBP tender in China as announced in December 2025, while a calendar shift for the Chinese New Year delayed the seasonal peak for refractive treatment packs sales.

    In the SBU Microsurgery, revenue also declined by -3.7% year on year to €110.1m (prior year: €114.3m; -0.9% adjusted for currency effects). This decrease was primarily attributable to high equipment deliveries at the end of the previous fiscal year, which resulted in a correspondingly slower start to fiscal year 2025/26.

    In the first quarter of fiscal year 2025/26, recurring revenues accounted for 47.5% of total revenue (prior year: 47.3%).

    Regional Performance: EMEA3 stable, Americas and APAC4 declining

    The EMEA region demonstrated a resilient trend with revenue at €173.6m (prior year: €114.3m; reported -0.2%; fx-adj. +1.2%). Growth was recorded e.g. in the Middle East, downturns were seen in core European markets, particularly Germany, Spain, and the Nordic countries.

    Revenue in the Americas region fell by -12.7% to €116.7m (prior year: €133.7m; fx-adj. -6.2%). This decline reflects a weak investment environment and heightened geopolitical volatility, leading to a general reluctance toward capital expenditure in the US and other key markets.

    Revenue in the APAC region declined -3.3% to €176.7m (prior year: €182.7m; fx-adj. -2.2%). While China remained stable and India/Australia showed positive trend, these results were dampened by downturns in Japan and South Korea.

    Results below prior year due to negative currency effects and unfavorable product mix

    Operating profit (EBITA) amounted to €8.1m in the first quarter of fiscal year 2025/26 (prior year: €35.2m). The decline was primarily driven by a significantly weaker operating result, resulting from negative currency effects and unfavorable product mix, particularly due to lower revenues from neurosurgical microscopes and refractive treatment packs, as well as higher amortization of capitalized research and development expenses. In addition, negative operating leverage impacted on results, as structural costs remained largely stable while revenues fell below the prior-year level.

    EBITA margin amounted to 1.7% (prior year: 7.2%). Adjusted for special items, the EBITA margin stood at 2.2% (prior year: 6.7%). Earnings per share (EPS) for the reporting period amounted to -€0.06 (prior year: €0.18), while adjusted earnings per share totaled €0.03 (prior year: €0.24).

    Outlook for fiscal year 2025/26 temporarily suspended

    As announced through the ad-hoc news on 22 January 2026, the previous forecast of €2.3bn in revenue and an EBITA margin of 12.5% before non-recurring items is expected unlikely to be achieved due to a weak start to the year and a subdued sales outlook in the key markets of the US and China amid geopolitical volatility and weak CapEx spending. In addition, the upcoming new nation-wide volume-based procurement tender for the IOL business in China is expected to cause significant price erosion due to an increased level of Chinese local competition.

    The updated outlook for FY 2025/26, together with news on further reorganization and cost-reduction measures, focusing on accelerating product localization, reprioritizing R&D activities, and implementing additional efficiency initiatives, will be presented as soon as possible, at the latest with the six-month results on 12 May 2026. By then, more detailed assessments are also expected regarding consumption patterns during the Chinese winter season in the refractive market, as well as the outcome of the nationwide volume-based tender for IOLs in China.

     

    Revenue by strategic business unit

    All figures in €m 3 months
    2025/26
    3 months
    2024/25
    Change from prior year % Change from
    prior year % (currency-adjusted)
    Ophthalmology 356.9 376.2 -5.1 -2.4
    Microsurgery 110.1 114.3 -3.7 -0.9
    Consolidated 467.0 490.5 -4.8 -2.1

     
    Revenue by region

    All figures in €m 3 months
    2025/26
    3 months
    2024/25
    Change from prior year % Change from
    prior year % (currency-adjusted)
    EMEA 173.6 174.0 -0.2 +1.2
    Americas 116.7 133.7 -12.7 -6.2
    APAC 176.7 182.7 -3.3 -2.2
    Consolidated 467.0 490.5 -4.8 -2.1

     

     

    Further information on our publication and the Analyst Conference Call on the results for the first three months of fiscal year 2025/26 can be found at 
    https://www.zeiss.de/meditec-ag/investor-relations/finanzkalender/telefonkonferenzen.html

    Contact for investors and press

    Sebastian Frericks
    Head of Group Finance & Investor Relations
    Carl Zeiss Meditec AG
    Phone: +49 3641 220-116
    Email: investors.med@zeiss.com
    www.zeiss.de/presse

     

    [1] Primarily incl. USD and CNY, with the latter arising from German exports invoiced in foreign currencies to the ZEISS Group’s distribution network.

    [2] Earnings before interest, taxes and amortization of intangible assets from purchase price allocation

    [3] Europe, Middle East and Africa

    [4]Asia/Pacific


    12.02.2026 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: Carl Zeiss Meditec AG
    Göschwitzer Str. 51-52
    07745 Jena, Germany
    Germany
    Phone: +49 (0)3641 220-0
    Fax: +49 (0)3641 220-112
    E-mail: investors.med@zeiss.com
    Internet: www.zeiss.de/meditec-ag/ir
    ISIN: DE0005313704
    WKN: 531370
    Indices: MDAX, TecDAX
    Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate BSX
    EQS News ID: 2275236

     
    End of News EQS News Service

    2275236  12.02.2026 CET/CEST

    Aprea Therapeutics Strengthens Global Patent Portfolio in DNA Damage Response (DDR) Cancer Therapeutics, Paving Way for Pipeline Growth

    EQS Newswire / 12/02/2026 / 10:14 UTC+8

    New patents granted in 2025 in Australia and Japan bolster global IP coverage for Aprea’s WEE1 and ATR programs. Core patent families are expected to provide exclusivity into 2045.

    Lead WEE1 inhibitor candidate APR-1051 is advancing in Phase 1 trials, with early clinical proof of concept demonstrated and multiple 2026 data readouts anticipated

    Broad intellectual property protection and ongoing clinical progress position Aprea for long-term value creation

    DOYLESTOWN, Pa., Feb. 12, 2026 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea” or the “Company”), a clinical-stage biopharmaceutical company developing innovative therapies that exploit cancer-specific vulnerabilities while minimizing damage to healthy cells, today announced significant recent expansions of its global intellectual property estate supporting its DDR-focused oncology pipeline.

    Aprea’s patent strategy is designed to secure durable global protection around its proprietary molecules, formulations, and therapeutic applications, to de-risk clinical development and maximize long-term commercial value.

    “Our intellectual property estate is a foundational asset for Aprea and a key component of our long-term strategy to create value and differentiate Aprea within the DDR therapeutics field,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We are building a broad, defensible portfolio across both our WEE1 and ATR programs, strengthened by multiple new patents granted in 2025 in key global markets. This portfolio is designed to protect our core compounds, formulations, and methods of use. By securing broad protection globally into the 2040s, we are positioning our assets for further development, future commercialization and potential strategic transactions with the ultimate goal of bringing new treatment options to patients with difficult-to-treat cancers.”

    The Company’s lead WEE1 inhibitor, APR-1051, is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial in advanced/metastatic solid tumors harboring certain cancer-associated gene alterations. Aprea’s WEE1 kinase inhibitor program is backed by an expanding global patent portfolio. The intellectual property estate includes one provisional U.S. patent application, two pending U.S. patent applications, one issued patent in Australia (issued in 2025) and 13 pending applications outside the United States. If granted, the core patents in the WEE1 family are expected to provide protection through 2042, excluding any additional regulatory exclusivities that may be available. The WEE1 portfolio is expected to protect key program assets, including new chemical entities (e.g., APR-1051), new pharmaceutical compositions comprising those entities, and methods of treating a range of oncology indications.

    The Company’s lead ATR inhibitor, ATRN-119, is currently being evaluated in the ABOYA-119 clinical trial as monotherapy in patients with advanced solid tumors. The Company’s ATR inhibitor program is protected by a robust patent estate. This includes four issued U.S. patents and one pending U.S. application, and one international application, as well as 21 granted patents, including one recently issued in Japan in 2025, and 15 pending applications in international jurisdictions. The ATR portfolios protects new chemical entities, new pharmaceutical compositions comprising those entities, and methods of treating a range of oncological indications. Existing issued patents are expected to remain in force through 2035–2037, excluding any additional regulatory exclusivity that may be available. The pending applications, if granted, could extend intellectual property protection into 2045.

    Aprea filed provisional applications in the U.S. in 2025 covering macrocyclic undisclosed DDR target inhibitors and methods of their preparation and use.

    About Aprea
    Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal, prostate, and breast cancers.

    The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.

    Forward-Looking Statement

    Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, the risk that the proposed private placement and the transactions described herein may not be completed in a timely manner or at all, the failure to realize the anticipated benefits of the private placement and related transactions, market and other conditions, as well as other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.

    Investor Contact:

    Mike Moyer
    LifeSci Advisors
    mmoyer@lifesciadvisors.com

     

    12/02/2026 Dissemination of a Financial Press Release, transmitted by EQS News.
    The issuer is solely responsible for the content of this announcement.

    Media archive at www.todayir.com