First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin




First U.S. Commercial Sale of KOMZIFTI™ Triggers $135 Million Milestone Payment to Kura Oncology Under Collaboration and License Agreement with Kyowa Kirin

SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) has been completed. Under Kura’s collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa Kirin, Inc. (collectively, “Kyowa Kirin”), this milestone triggers a $135 million payment from Kyowa Kirin to Kura, which Kura expects to receive prior to year-end. KOMZIFTI was approved by the U.S. Food and Drug Administration on November 13, 2025.

About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™, the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.

Forward-Looking Statements 
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Kura’s expectations regarding the receipt and timing of a milestone payment under its collaboration and license agreement with Kyowa Kirin and future development matters. Factors that may cause actual results to differ materially include risks related to Kyowa Kirin’s ability to make the expected milestone payment, including on the anticipated timing; risks associated with the commercialization of KOMZIFTI; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Kura Contact

Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com

DoctorBox Adds Mainz Biomed’s ColoAlert(R) to Its Portfolio




DoctorBox Adds Mainz Biomed’s ColoAlert(R) to Its Portfolio

DNA-based Colorectal Cancer Screening as a Home Test

BERKELEY, Calif. and MAINZ, Germany, Dec. 02, 2025 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company“), molecular genetics diagnostic company specializing in the early detection of cancer, today announced that its test ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.

Colorectal cancer is one of the most common yet preventable cancers worldwide. In Germany alone, around 60,000 new cases are diagnosed each year — a clear indicator of the need for highly effective early detection measures. By integrating Mainz Biomed’s advanced DNA diagnostics into DoctorBox’s digital healthcare platform, this collaboration establishes a highly innovative model of care that can significantly expand access to ColoAlert.

“With DoctorBox, we are gaining a strong partner that enables us to offer ColoAlert exactly where prevention can take place today — at home,” said Guido Baechler, CEO of Mainz Biomed. “Together, we are lowering barriers to colorectal cancer screening and providing easy access to DNA-based early detection.”

“ColoAlert fits perfectly into our portfolio of next-generation DNA- and RNA-based tests. Thus, innovative colorectal cancer screening becomes another cornerstone of our digital preventive healthcare platform,” said Julian Maar, CEO of DoctorBox.

The DoctorBox app brings together modern preventive healthcare services on a single platform: with over one million registered users and more than ten million test results transmitted, DoctorBox ranks among Europe’s leading digital prevention solutions. The offering includes guideline-based preventive-care reminders – personalized by age, sex, and risk profile. Additional services include at-home tests and locally accessible diagnostics, for example for early detection of colorectal, cervical, and prostate cancer (self-pay or reimbursed). Measures for sexual health, allergies, as well as innovative analyses, digital evaluation and support – including the delivery of findings, recommendations for action, and video consultations directly within the app – are also part of the DoctorBox offering.

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

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About DoctorBox
DoctorBox is setting the new standard for prevention in Europe — made in Germany.
As one of Germany’s leading digital solutions for smart preventive healthcare, DoctorBox empowers more than one million users in Germany and other European countries to manage their health prevention easily, digitally, and independently. Whether through reminders, at-home tests, or local diagnostics, DoctorBox makes preventive healthcare accessible and part of everyday life.
To learn more, visit doctorbox.de.

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 media inquiries
MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu
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.

Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer




Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer

Positive feedback reinforces Silexion’s trajectory toward its planned Phase 2/3 trial initiation in Q2 2026

Company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026

GRAND CAYMAN, Cayman Islands, Dec. 02, 2025 (GLOBE NEWSWIRE) — Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that it has received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of the Company’s planned Phase 2/3 clinical trial for SIL204, the Company’s lead product candidate for locally advanced pancreatic cancer. The guidance follows the Company’s Scientific Advice meeting held with BfArM recently and provides significant regulatory clarity as Silexion prepares its Phase 2/3 clinical trial submissions.

The positive response from BfArM is an important milestone for supporting the acceptability of the proposed Phase 2/3 study design, based on the supporting safety data, and manufacturing specifications. The written feedback covers several core components of the program, including clinical design, dosing plans, patient population strategy, nonclinical support, and CMC/manufacturing considerations, and will be incorporated into Silexion’s upcoming regulatory submissions in Israel, which are expected by the end of 2025, and in Germany, which are expected during the first quarter of 2026.

Ilan Hadar, Chairman and Chief Executive Officer of Silexion, commented: “This written Scientific Advice represents a meaningful step in our regulatory path and provides us with the supporting clarity needed to finalize our Phase 2/3 submission packages. SIL204 continues to progress on schedule, and the engagement with BfArM supports the momentum we have built heading into 2026. We remain highly focused on bringing SIL204 into the clinic and advancing a therapy that we believe has the potential to address critical unmet needs in KRAS-mutated cancers.”

Silexion remains on track to initiate its Phase 2/3 clinical trial of SIL204 in the first half of 2026, pending regulatory clearance. The Company continues to advance all other operational and development activities required for trial launch, including manufacturing readiness, toxicology data integration, and clinical site preparations.  

About Silexion Therapeutics
Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com

Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding Silexion’s business strategy, the regulatory guidance received from BfArM, the Company’s plans and expected timing for completing regulatory submissions in Israel and Germany, the anticipated initiation of the Phase 2/3 clinical trial for SIL204 in the second quarter of 2026, the advancement of operational and development activities required for trial launch, including manufacturing readiness, toxicology data integration, and clinical site preparations, and Silexion’s expectations regarding the future development of SIL204, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them, or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion’s ability to successfully complete preclinical studies and initiate clinical trials; (ii) Silexion’s strategy, future operations, financial position, projected costs, prospects, and plans; (iii) the impact of the regulatory environment and compliance complexities; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion’s future capital requirements and sources and uses of cash, including its ability to obtain additional capital; (vi) Silexion’s ability to maintain its Nasdaq listing; and (vii) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 18, 2025. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.

Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com

Investor Contact:
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com

Amneal to Participate in Upcoming Investor Conferences




Amneal to Participate in Upcoming Investor Conferences

BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that Chirag Patel, Co-Chief Executive and President, and Tasos Konidaris, Chief Financial Officer, will participate in following upcoming investor conferences:

Piper Sandler 2025 Healthcare Conference
Date: December 3, 2025
Fireside Chat: Wednesday, December 3, 2025, at 9:30AM EST
Location: New York, NY

J.P. Morgan 2026 Healthcare Conference
Date: January 12-15, 2026
Presentation: Tuesday, January 13, 2026, at 4:30PM PST
Location: San Francisco, CA

A webcast of the presentations will be available on Amneal’s Investor Relations website at www.amneal.com/investors. Replays will be available for a limited time following each event.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.

Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com

Genvor and Tuskegee University Announce Teaming Agreement to Advance Peptide Research and Sustainable Crop Protection Technologies




Genvor and Tuskegee University Announce Teaming Agreement to Advance Peptide Research and Sustainable Crop Protection Technologies

Woodland, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) — Genvor, Inc. (OTC: GNVR), a pioneer in AI-accelerated peptide technology for sustainable agriculture, today announced it has entered into a formal teaming agreement with Tuskegee University, a premier research institution renowned for innovation in agricultural science and biotechnology. The collaboration seeks to fast-track next-generation peptide technologies through advances in biological manufacturing and the discovery of novel sequences that enhance crop protection, resilience, and nutrient performance.

The agreement establishes a cooperative framework for joint research, testing, and grant-supported development between Genvor and Tuskegee’s Center for Biomedical Research. The partnership provides Genvor access to university research laboratories, scientific instrumentation, and the next generation of agricultural scientists, enabling faster innovation cycles and expanded scientific validation of its proprietary active ingredients.

“This partnership marks a pivotal step in Genvor’s mission to enhance biological crop protection through the power of peptides,” said Chad Pawlak, Chief Executive Officer of Genvor. “Tuskegee University’s scientific excellence and access to world-class research facilities create the perfect environment to accelerate innovation and bring forward solutions that meet the demands of today’s agricultural challenges.”

“Tuskegee University is known for solving the world’s most complex problems and this partnership with Genvor is a meaningful example of that,” said Dr. Mark A. Brown, President and CEO, Tuskegee University. “The research through this relationship exposes our students to crop protection and sustainable agriculture that may ultimately support farming across the country. Tuskegee University has entered its Renaissance Era and this kind of collaboration is a significant part of that.”

“Working with Genvor allows us to translate decades of peptide research into scalable, real-world impact,” said Dr. Jesse Jaynes, Professor of Biochemistry at Tuskegee University’s College of Agriculture, Environment, & Nutrition Sciences, College of Arts and Sciences and IBSC PhD Program and founding scientist behind Genvor’s core technologies. “This collaboration expands the reach of our peptide platforms beyond discovery and into field application, product validation, and sustainable agricultural practice.”

Dr. Timothy Turner, Associate Vice President for Research, Tuskegee University Center for Biomedical Research, added, “We’re thrilled to collaborate with Genvor in advancing peptide technology. The partnership not only deepens our applied research portfolio but also provides valuable training and experience for our students as they engage in innovation that has the potential to transform global agriculture.”

The teaming agreement underscores Genvor’s commitment to science-driven sustainability and strategic partnerships that amplify its impact in the biological crop protection sector. By bridging university research with commercial development, Genvor continues to strengthen its leadership in biologicals, crop resilience, and regenerative agricultural innovation.

About Genvor

Genvor, Inc. (OTC: GNVR) is a biotechnology company pioneering peptide-based solutions for crop protection and plant health. With a focus on sustainable agriculture, Genvor develops and commercializes biological actives that enhance crop performance, reduce chemical inputs, and support regenerative farming systems. Through its partnerships and technology platforms, Genvor is advancing a new era of natural, science-based crop protection For more information, visit www.genvor.com.

About Tuskegee University 

Located in Tuskegee, Alabama, Tuskegee University is a private, state-related and nationally ranked land-grant institution that serves a racially, ethnically and religiously diverse student body of 3,000-plus students. The institution was founded in 1881 by Booker T. Washington and is one of the nation’s historically black colleges and universities (HBCUs). Accredited by the Southern Association of Colleges and Schools Commission on Colleges since 1933, Tuskegee’s academic programs — many accredited by their respective accrediting bodies — currently lead to 41 bachelor’s, 16 master’s and five doctoral degree opportunities. For more information about Tuskegee University, visit www.tuskegee.edu.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based on current expectations and projections about future events and are not guarantees of future performance. Forward-looking statements include, among others, statements regarding the potential benefits, outcomes, and scope of the collaboration between Genvor and Tuskegee University. Actual results may differ materially from those expressed or implied. Factors that could cause such differences include, but are not limited to, research results, funding outcomes, market adoption, and regulatory developments. Genvor undertakes no obligation to update or revise forward-looking statements, except as required by law.

Contacts:

Genvor, Inc.
Investor Relations & Media  
Carly Scaduto
carly@carlyscadutoconsulting.com

Tuskegee University
Thonnia Lee
Vice President of Strategic Communications 
tlee@tuskegee.edu

Tacalyx Appoints Jean Engela as Chief Executive Officer to Spearhead Next Phase of Growth




Tacalyx Appoints Jean Engela as Chief Executive Officer to Spearhead Next Phase of Growth

Berlin, Germany, Dec. 02, 2025 (GLOBE NEWSWIRE) — Tacalyx, a privately held biotech company focused on developing novel TACA (Tumour Associated Carbohydrate Antigens) cancer therapies, announces the appointment of Jean Engela as Chief Executive Officer. Jean Engela brings more than two decades of experience in drug research and development, with a proven track record of leading organisations and assets through key phase transitions and scaling from discovery to clinical stages. The company’s co-founder and former CEO, Dr. Peter Sondermann, will continue to drive scientific innovation at Tacalyx as Chief Scientific Officer.

“We are delighted to welcome Jean as our new Chief Executive Officer. Jean’s unique combination of global experience, biotech vision and leadership makes him ideally suited to lead our next stage of growth. We extend our sincere gratitude to our co-founder, Peter Sondermann, whose leadership has been instrumental in bringing Tacalyx to this stage of success. With Peter now being able to fully focus on advancing our R&D strategy, this leadership transition reflects our evolution into a biotech with the capabilities to scale both innovation and impact,” said Klaus Schollmeier, Chairman of the Board of Tacalyx.

Prior to joining Tacalyx, Jean served as CEO and Board Member of the antibody-drug conjugate (ADC) pioneering company NBE Therapeutics, where he led the company’s evolution from a start-up into a mature biotech with a diversified ADC pipeline. Before NBE Therapeutics, Jean Engela was Executive Drug Development Leader at Boehringer Ingelheim, where he oversaw global development of oncology and immunology programmes, including small molecules, monoclonal antibodies, multi-specific antibodies and T-cell engagers (TCEs). He also led the integration of NBE Therapeutics into Boehringer Ingelheim’s R&D organisation. His extensive experience in guiding companies through the transition from research to clinical stage will be instrumental as Tacalyx prepares to enter its next phase of growth.

Jean Engela, CEO of Tacalyx, commented: “It is a great pleasure to lead Tacalyx as we gain momentum and advance toward becoming a clinical-stage biotech company. Tacalyx unites the essential ingredients for success – groundbreaking science, a dedicated management team, and strong investor support. In the coming months, we look forward to navigating key value inflection points as IND-enabling studies for our lead programme get underway, positioning us to make a meaningful impact for patients suffering from solid tumours”.

Under Jean’s leadership, Tacalyx will continue to build on its extensive knowledge and advance its programmes toward the clinic. Tacalyx is a pioneer in the development of targeted therapeutics that selectively bind tumour-associated carbohydrate antigens (TACAs), which are not found on differentiated, healthy tissue. Anti-TACA-antibodies can be developed into various treatment modalities, including ADCs, TCEs and multi-specifics. With its unique toolbox and deep expertise in glycan biology and chemistry, Tacalyx has generated a pipeline of first-in-class and best-in-class assets that target different TACAs across multiple solid tumour indications. The most advanced compound, TCX-201, is in preclinical development and about to start IND-enabling studies.

About Tacalyx

Tacalyx is a privately held biotech company focused on the discovery and development of Tumour Associated Carbohydrate Antigen (TACA) antibodies to treat cancer. TACAs are formed during malignant transformation in a microevolutionary process. The expression of TACAs is elevated in many cancer cell types which makes them attractive potential targets for cancer treatment. Tacalyx is developing its proprietary technology platform to exploit TACAs as novel targets for antibody-based therapies, including antibody-drug conjugates (ADCs) and other modalities, and has established a proprietary portfolio of programmes.

Tacalyx was founded in 2019 as a spin-out of the Max-Planck-Institute of Colloids and Interfaces (MPICI) in Potsdam, Germany, based on the work of Prof. Dr. Peter Seeberger and Dr. Oren Moscovitz. Tacalyx is headquartered in Berlin, Germany and is backed by top-tier European life sciences investors Boehringer Ingelheim Venture Fund (BIVF), Kurma Partners, High-Tech Gründerfonds (HTGF), coparion, Eurazeo/Idinvest Partners, Creathor Ventures, and Thuja Capital.

For more information, please visit www.tacalyx.com

Contact:
Tacalyx GmbH
Magnusstr. 11
12489 Berlin
Tel.: +49 30 407 237 10
Email: info@tacalyx.com

Media contact:
MC Services AG
Dr. Regina Lutz / Katja Arnold
Tel.: +49 (0)89 210 228 0
E-Mail: tacalyx@mc-services.eu

Rentschler Biopharma and Coriolis Pharma announce strategic collaboration for integrated biopharma solutions




Rentschler Biopharma and Coriolis Pharma announce strategic collaboration for integrated biopharma solutions

• The collaboration unites complementary scientific and technical expertise to provide seamless solutions across the biopharmaceutical value chain
• Clients to benefit from accelerated timelines, as well as reduced complexity and risk in development and manufacturing

LAUPHEIM, Germany and MARTINSRIED, Germany and MUNICH, Dec. 02, 2025 (GLOBE NEWSWIRE) — Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and Coriolis Pharma, a globally operating contract research and development organization (CRDO) and a leader in formulation research and development for biopharmaceuticals, today announced a strategic collaboration.

Together, the companies will offer clients seamless, end-to-end solutions from early formulation through to commercial manufacturing, combining their complementary expertise to accelerate product’s path to market. This collaboration responds to the evolving needs of the biologics market, as increasing complexity in modalities and regulatory expectations drive demand for integrated, science-driven solutions. Clients will benefit from a unified interface and aligned project teams, reducing tech transfer risks and enabling faster progression from early development to clinical and commercial stages.

Coriolis Pharma brings a unique combination of in silico and wet lab formulation and drug product development expertise, scientific depth, and advanced analytical capabilities to this collaboration. With a legacy of scientific excellence and commitment to innovation, Coriolis supports every drug development phase from R&D to GMP. The company’s collaborative approach and deep scientific expertise make them a trusted partner from discovery to commercial manufacturing and lifecycle management.

Rentschler Biopharma brings extensive experience in bioprocess development and manufacturing for multiple biotherapeutics, backed by a strong track record of reliability and quality. With a long-standing commitment to client-centric solutions, the company provides robust support from process development through to commercial supply. By focusing on technical excellence, long-term partnerships, and tailored solutions, Rentschler Biopharma ensures successful outcomes at every stage of the project.

Benedikt von Braunmühl, Chief Executive Officer of Rentschler Biopharma, commented: “This marks an important step for both our organizations and for our global clients, and their patients. Coriolis Pharma shares our focus on technical excellence, reliability, as well as our client-centric approach. By bringing together our individual areas of excellence, bioprocess development and manufacturing on our side, and scientific and analytical expertise in formulation development at Coriolis, we look forward to addressing complex challenges across the biopharmaceutical value chain more efficiently and faster. This collaboration perfectly exemplifies our vision of advancing medicine to save lives. Together.”

Silvia Steyrer-Gruber, Chief Executive Officer of Coriolis Pharma, added: “At Coriolis, we believe that scientific excellence, client-focused innovation, and strong partnerships are key to advancing complex biopharmaceutical programs efficiently and reliably. With Rentschler Biopharma, we have a trusted partner whose process development and manufacturing expertise ideally complements our deep understanding of formulation development and analytical services. This collaboration is a testament to our Coriolis partnering strategy, which fosters synergistic relationships across the biopharma ecosystem. Together, we can provide clients with connected, science-driven solutions that help them move their projects forward towards success. Our teams look forward to working closely with Rentschler Biopharma on this collaboration.”

The integrated service offering will be available to clients starting December 2025. Both organizations have operations in Germany and the United States, providing global reach and local access for clients in key biopharmaceutical markets.

About Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. For further information about the company, please visit www.rentschler-biopharma.com. Follow Rentschler Biopharma on LinkedIn.

About Coriolis Pharma
Coriolis Pharma is a globally operating contract research and development organization (CRDO) and the premier partner for drug product development, analytical services and manufacturing services across a vast array of biological therapeutic modalities. With a focus on liquid and lyophilized drug products, Coriolis expert scientists design and execute platform and custom services to accelerate and derisk client programs right from the start and throughout the entire product lifecycle. Headquartered in Martinsried near Munich, Coriolis offers tailored solutions from early development stages to market approval. Coriolis Pharma stands out for its scientific excellence, innovative analytical methods, and deep understanding of formulation and drug product development. With the establishment of its new laboratory and U.S. headquarters in North Carolina, Coriolis Pharma is expanding its global footprint and bringing its high-quality services closer to clients in the United States. For more information, visit: www.coriolis-pharma.com and follow us on LinkedIn.

Contact:
Rentschler Biopharma SE
Dr. Latika Bhonsle-Deeng
Global Head of Communications
Phone: +49-7392-701-467
communications@rentschler-biopharma.com

Media inquiries:
MC Services AG
Eva Bauer
Phone: +49-89-210228-0
rentschler@mc-services.eu

U.S.
Laurie Doyle
Phone: +1-339-832-0752

Coriolis Pharma
Bettina von Klitzing-Stückle
Marketing Manager
Phone: +49-151-52613897
bettina.klitzing@coriolis-pharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c67e11fa-69bf-4960-bf4d-3970f55057b6

Vandria Reports Positive Phase 1 Target Engagement Data for VNA-318, Supporting Further Development in Alzheimer’s Disease




Vandria Reports Positive Phase 1 Target Engagement Data for VNA-318, Supporting Further Development in Alzheimer’s Disease

Results presented at the 18th Clinical Trials in Alzheimer’s Disease (CTAD) meeting, San Diego, December 1-4

• VNA-318, an oral brain-penetrant small molecule therapeutic modulates a novel target to reduce inflammation and improve mitochondrial function
• First-in-human trial showed a highly favourable safety profile, with VNA-318 well tolerated across all dose levels without any safety concerns
• Single doses of VNA-318 resulted in a statistically significant (p<0.001) and dose-dependent change in a key plasma target engagement biomarker
• Pharmacokinetic data showed exposure to VNA-318 at concentrations predictive of therapeutic efficacy based on pre-clinical studies in both acute pro-cognitive and long-term disease-modifying models of Alzheimer’s disease pathophysiology
• Given its broad mode of action VNA-318 has potential to treat other CNS diseases beyond Alzheimer’s disease
• Vandria is planning the next stage of development, including Phase 2 proof-of-concept trials for VNA-318 and continued pipeline expansion for multiple systemic indications

LAUSANNE, Switzerland, Dec. 02, 2025 (GLOBE NEWSWIRE) — Vandria SA, a clinical stage biotech company developing small molecule therapeutics to restore mitochondrial function and reduce inflammation for the treatment of age-related and chronic diseases, today announces topline results from its first-in-human clinical trial of its lead Central Nervous System (CNS) compound VNA-318.

VNA-318 is a first-in-class, orally bioavailable, and brain-penetrant small molecule targeting a novel protein with a dual mode of action (MoA). Initially, VNA-318 is being developed to address the major unmet medical needs facing patients with Alzheimer’s disease: cognitive impairment and the debilitating loss of function associated with it. Given its broad MoA, VNA-318 has potential to treat other CNS diseases.

The novel target of VNA-318 has genetic associations with several human diseases including Alzheimer’s disease. In pre-clinical mouse models of neurodegeneration and cognitive impairment, VNA-318’s dual MoA resulted in both immediate pro-cognitive and long-term disease-modifying benefits. More specifically, VNA-318 showed an immediate improvement in memory, learning, and cognitive function, as well as long-term reduction in neuroinflammation, reduced toxic protein aggregation, and improved mitochondrial function.

Topline results from the first-in-human trial of VNA-318 are being presented today at the annual meeting of the 18^th Clinical Trials in Alzheimer’s Disease (CTAD) meeting, being held in San Diego December 1-4. The Phase 1 trial, VNA-318-01, is a randomized, double-blind single and multiple ascending dose study designed to assess safety, tolerability, pharmacokinetic (PK) and pharmacodynamic parameters in 92 healthy male subjects [VNA-318-01| ClinicalTrials.gov]. Interim results show excellent safety and tolerability of VNA-318 with no severe or serious adverse events and no adverse events leading to trial discontinuation. The PK data demonstrate a long half-life supportive of once-daily oral dosing and a predictable, dose-linear increase of exposure with low variability. Already with single dosing, a statistically significant (p<0.001) and dose-dependent change in a key target engagement biomarker has been observed. The availability of an easily accessible target engagement biomarker in plasma will be leveraged in VNA-318’s future clinical development.

VNA-318 levels in the cerebrospinal fluid measured during the trial in one cohort confirm that the brain penetration seen in pre-clinical studies translates to humans.  

Klaus Dugi M.D., CEO of Vandria, said: “We are very excited about the results of our first-in-human trial of VNA-318, which ticks all the boxes for a Phase 1 trial – and more. The statistically significant dose-dependent change in a key target engagement biomarker is a very important finding and will be valuable for our Phase 2 clinical development strategy. This, coupled with safety, tolerability and demonstrated brain penetration, as well as pre-clinical data strongly support VNA-318’s advancement in Alzheimer’s disease.

“We believe that VNA-318 has the potential to address unmet medical needs like mild cognitive impairment associated with Alzheimer’s and Major Depressive Disorder, as well as other CNS disorders.” 

Steven Arnold M.D., Professor of Neurology at Harvard Medical School and EGC Endowed Chair in Alzheimer Therapeutic Sciences at Massachusetts General Hospital said “VNA-318 modulates a novel target with genetic associations with Alzheimer’s disease and related neurodegenerative diseases. It is very exciting to see the compelling data from Vandria’s pre-clinical and clinical studies, and the progress VNA-318 is making as it gets closer to being tested in patients.”

Vandria is planning to raise a Series B in 2026 to fund proof-of-concept Phase 2 trials. The global market for Alzheimer’s alone is estimated at $6 billion and is expected to grow at a CAGR of 12% to 2035, driven by an aging population, improved diagnosis, and a growing awareness and understanding of the condition and its implications.

The planned Series B will also be used to progress Vandria’s pre-clinical pipeline of compounds in non-CNS indications such as muscle, lung, and liver diseases.

For further information contact:
Vandria
info@vandria.com

Media Enquiries
Charles Consultants
Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585

About Vandria
Vandria is a clinical stage biotech company developing first-in-class, small molecule precision therapeutics to restore mitochondrial function and reduce inflammation for the treatment of age-related and chronic diseases.

The company’s lead CNS asset, VNA-318, is an orally bioavailable, first-in-class, brain-penetrant, patent-protected small molecule with a dual mode of action designed to improve short term memory and learning, and to have long term disease-modifying effects, as demonstrated in models of neurodegenerative disease such as Alzheimer’s and Parkinson’s disease. The company has a wider portfolio of small molecule modulators against its novel target across a broad range of age-related and chronic diseases of the muscle, lung and liver.

Based at the Biopôle campus in Lausanne Switzerland, the company has raised $32M (CHF28M) in venture finance from +ND Capital, Hevolution Foundation, Dolby Family Ventures and private investors.

Read more: https://vandria.com/
Follow us on LinkedIn: https://www.linkedin.com/company/vandria-sa/about/

CARBIOS and Wankai New Materials sign the definitive agreement establishing a strategic partnership to the large-scale deployment of CARBIOS’s PET biorecycling technology in Asia




CARBIOS and Wankai New Materials sign the definitive agreement establishing a strategic partnership to the large-scale deployment of CARBIOS’s PET biorecycling technology in Asia

Clermont-Ferrand (France), 2 December 2025 (8:45 AM CET). In line with the commitment signed on November 6, 2025¹, CARBIOS (Euronext Growth Paris: ALCRB) and Wankai New Materials (« Wankai »), a listed subsidiary² of Zhink Group, the 3^rd largest PET producer in China and 4^th worldwide, announce the signing of the definitive agreement establishing a strategic partnership for the large-scale deployment of CARBIOS’s PET biorecycling technology in Asia, with the first step being the construction of a PET biorecycling plant in China.

• The two companies have signed on 2 December 2025 the shareholders’ agreement for their joint venture, dedicated to the construction and operation of a first PET biorecycling plant in China, with a processing capacity of 50,000 tons of PET waste.
• Wankai will be the majority shareholder of this company with a 70% stake, while CARBIOS will hold the remaining 30%. The financing of the plant’s construction, estimated at €115 million, will be covered 30% by equity and 70% by debt, with all debt guaranteed by Wankai.
• The plant will be located in Haining (Zhejiang province) on site provided by Wankai, which is already equipped with infrastructure (equipment, waste treatment, etc.), thus reducing the investment cost. Construction is expected to begin during the first quarter of 2026, with commissioning targeted by the first quarter of 2027.
• CARBIOS and Wankai have also approved on 2 December 2025 the license agreement, which will be granted by CARBIOS to the joint venture upon its incorporation.
• CARBIOS and Wankai have committed to a long-term partnership with the ambition to build and operate several PET biorecycling plants in Asia. CARBIOS agrees to exclusively license its PET depolymerization technology in Asia to Wankai for a period of three years, subject to signing licenses with the latter for at least 100 kt per year of additional capacity. This term will be extended in five-year increments if additional licenses for at least 200 kt per year of extra capacity are signed.
• To strengthen the strategic partnership between the two companies, Wankai has committed to subscribe, before 2 June 2026, to a dedicated capital increase of €5 million in the share capital of CARBIOS S.A.³, paid on the basis of an issue price per share of €8.0947, corresponding to the volume-weighted average of the last five trading days preceding the 1^st of December 2025, reduced by a 10% discount.

Vincent Kamel, CEO of CARBIOS: « The signing of this agreement marks the achievement of a major strategic partnership with Zhink Group. We are taking a decisive step forward to accelerate the international deployment of our technology, a key innovation in the fight against plastic pollution. This is a major milestone in bringing our licensing model to life: together, we will help build a more sustainable future. »

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About CARBIOS:
CARBIOS is a biotechnology company that develops and industrializes biological solutions to reinvent the lifecycle of plastics and textiles. Inspired by nature, CARBIOS designs enzyme-based biological processes to break down plastics, with the mission of preventing plastic and textile pollution and accelerating the transition to a circular economy. Its two innovative technologies—dedicated to PET biorecycling and PLA biodegradation—are currently scaling up to industrial and commercial levels. Its industrial demonstration plant for biorecycling has been operational since 2021, and construction of its biorecycling plant is expected to resume before the end of 2025, subject to securing the necessary additional funding. CARBIOS is supported by prestigious brands in the cosmetics, food, and apparel industries, aiming to improve the recyclability and circularity of their products. Nestlé Waters, PepsiCo, and Suntory Beverage & Food Europe are members of a packaging consortium founded by CARBIOS and L’Oréal. On, Patagonia, PUMA, PVH Corp., and Salomon collaborate with CARBIOS in a textile consortium. CARBIOS is part of the global community of B Corp™ certified companies that are transforming their business models to serve the common good.

Visit www.carbios.com to learn more about biotechnology for circular plastics and textiles.

LinkedIn : carbios / Instagram : carbios

Information on CARBIOS shares:

ISIN Code                FR0011648716
Ticker Code                 Euronext Growth: ALCRB
LEI                         969500M2RCIWO4NO5F08

CARBIOS is eligible for the PEA-PME, a government program allowing French residents investing in SMEs to benefit from income tax rebates.

Disclaimer on forward-looking statements and risk factors:
This press release contains forward-looking statements, not historical data, and should not be construed as a guarantee that the facts and data stated will occur. These forward-looking statements are based on data, assumptions and estimates considered reasonable by CARBIOS. CARBIOS operates in a competitive and rapidly evolving environment. It is therefore not in a position to anticipate all risks, uncertainties or other factors that may affect its business, their potential impact on its business or the extent to which the materialization of a risk or combination of risks could lead to results that differ significantly from those mentioned in any forward-looking statement. CARBIOS draws your attention to the fact that forward-looking statements are in no way a guarantee of its future performance and that its actual financial position, results, cash flows, its partnerships and corporate agreements, and the development of the sector in which CARBIOS operates may differ significantly from those proposed or suggested by the forward-looking statements contained in this document. In addition, even if CARBIOS’ financial position, results, cash flows, its partnerships and corporate agreements, and developments in the industry in which it operates are consistent with the forward-looking information contained in this document, such results or developments may not be a reliable indication of CARBIOS’ future results or developments. Readers are also advised to carefully consider the risk factors described in the Universal registration document filed with the French Market Authority (“AMF”), as well as in the half-year financial report available free of charge on the Company’s website. Should all or any part of these risk factors occur or others, in no case whatsoever will CARBIOS be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages. This information is given only as of the date of this press release. CARBIOS makes no commitment to publish updates to this information or on the assumptions on which it is based, except in accordance with any legal or regulatory obligation applicable to it.

For additional information, please contact:

1 https://www.carbios.com/newsroom/en/carbios-and-wankai-new-materials-a-subsidiary-of-zhink-group-are-committed-to-the-large-scale-deployment-of-carbios-pet-biorecycling-technology-in-asia/
2 Wankai New Materials is a company listed on the Shenzhen Stock Exchange (stock code:301216)
3 As a result of this investment, Wankai may appoint a representative to CARBIOS’ Board of Directors. The completion of this investment will be subject to administrative and regulatory approvals in China.

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• 2025 12 02 – CARBIOS and Wankai New Materials sign the definitive agreement establishing a strategic partnership

Enterome OncoMimics™ immunotherapy EO2401 shows survival benefit in Phase 2 glioblastoma trial




Enterome OncoMimics™ immunotherapy EO2401 shows survival benefit in Phase 2 glioblastoma trial

• EO2401 in vivo immune therapy + nivolumab +/- bevacizumab shows survival benefit in first recurrent glioblastoma
• Data presented at 2025 SNO conference by lead investigator

Paris, France – 2 DECEMBER 2025 (08:30 CET)

Enterome, a clinical-stage company pioneering OncoMimics™ peptides, a new class of off-the-shelf, multi-targeted in vivo immune therapies that induce a fast and potent expansion of memory T cells to fight cancer, today announces new survival analyses from Cohort 3 of the Phase 1/2 ROSALIE clinical trial. The data were reported at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting. The ROSALIE trial is evaluating Enterome’s OncoMimics™ immune therapy EO2401 in combination with immune checkpoint inhibitor nivolumab, with or without anti-VEGF therapy bevacizumab, in patients with glioblastoma at first progression/recurrence. Top-line data from the trial had previously been released in November 2023.

The analyses demonstrated a statistically significant survival benefit for patients who underwent a second surgery after their first glioblastoma recurrence when treated with EO2401 in combination with nivolumab and bevacizumab, compared with patients who did not undergo surgery (p = 0.027). Importantly, no survival benefit was observed for the supportive therapies, nivolumab or bevacizumab on a stand-alone basis after surgery, compared with no surgery. The investigators concluded in their poster that: “The data indicate that a randomized study evaluating EO2401 is warranted.”

The poster was presented at SNO by the lead investigator of the trial, David Reardon M.D., and Professor of Medicine at Harvard Medical School and Clinical Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, under the title: “EO2401 peptide immunotherapy + nivolumab +/- bevacizumab in first recurrent glioblastoma: treatment strategy optimization in the phase 1/2 study EOGBM1-18 / ROSALIE (NCT04116658)”. The poster will be made available on the Enterome website.

ROSALIE is a multicenter, open-label, first-in-human study of EO2401 in 100 patients with glioblastoma. EO2401 / nivolumab +/- bevacizumab was well tolerated with a safety profile consistent with the safety profile of nivolumab, and when applicable bevacizumab, except the addition of local administration site reactions. EO2401 plus nivolumab generated fast, strong, and durable specific CD8 T cell immune responses against the EO2401-mimic peptides and target epitopes on tumor associated antigens. Furthermore, the investigators wrote in their poster that the addition of bevacizumab (to EO2401/nivolumab), which exerts strong antiedema properties, and putatively counteracts immunosuppression by VEGF, increased treatment duration and efficacy.

“This finding from the ROSALIE trial in this incredibly challenging patient population is another strong indication of the potential benefit that OncoMimics™ peptides can offer patients across a broad range of cancers,” said Pierre Belichard, Chief Executive Officer of Enterome. “This, and the earlier clinical results make clear that larger, randomized studies of EO2401 are warranted.”

EO2401 is an innovative, off-the-shelf OncoMimics™ multi-targeted in vivo immune therapy composed of three synthetically produced, short non-self HLA-A2 peptides with sequences derived from gut-bacteria (EO2316, EO2317, and EO2318). It is designed to rapidly expand – through peptide molecular mimicry – pre-existing CD8 T cells that cross-react with key glioblastoma tumor associated antigens (TAAs; IL13Ra2, BIRC5/survivin, and FOXM1). EO2401 also includes a universal CD4 helper epitope, UCP2 derived from hTERT, to support and enhance the immune response.

OncoMimics™ peptides consist of bacteria-derived peptide antigens that closely mimic tumor-associated antigens (TAAs). These antigens induce a fast and potent in vivo expansion of cytotoxic memory CD8+ T cells that were primed by gut bacteria, and are cross-reactive with TAAs. Because the peptides are “non-self”, OncoMimics™ peptides avoid the self-tolerance that limits many cancer immunotherapies, enabling rapid, potent, and durable responses. The synthetically produced peptides are designed in silico, mining Enterome’s proprietary database of 23 million commensal bacteria genes. Each product combines multiple high-affinity peptides to broaden target coverage and mitigate tumor heterogeneity.

OncoMimics™ peptides are easy to manufacture, store, distribute and administer as an “off-the-shelf” subcutaneous injection. OncoMimics™ peptides have achieved rapid and potent responses in clinical testing in over 230 patients to date, with a benign safety profile.

Enterome SA (www.enterome.com) is a privately held clinical-stage biopharmaceutical company developing OncoMimics™ peptides, a breakthrough in in vivo immune therapy for cancer. The three most advanced candidates have shown positive early data in Phase 2 clinical development in more than 230 patients across solid tumors and hematological malignancies, showing correlation between clinical efficacy and induced immunogenicity and a benign safety profile, activating large quantities of endogenous memory T-cells.

For more information, please contact:

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• 20251202 – Enterome PR SNO conference (final, approved)