New Analysis of 13,560 Patients Demonstrates DecisionDx®-Melanoma Stratifies Risk Across Histological Subtypes; Findings to be Presented at Fall Clinical Dermatology Conference




New Analysis of 13,560 Patients Demonstrates DecisionDx®-Melanoma Stratifies Risk Across Histological Subtypes; Findings to be Presented at Fall Clinical Dermatology Conference

This new histological subtype data confirms DecisionDx-Melanoma’s clinical value across the spectrum of melanoma

Castle Biosciences will also present validation data on its atopic dermatitis pipeline test

FRIENDSWOOD, Texas, Oct. 24, 2025 (GLOBE NEWSWIRE) — Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that it is presenting data on its DecisionDx®-Melanoma test and its pipeline atopic dermatitis (AD) gene expression profile (GEP) test at the 25^th Annual Fall Clinical Dermatology Conference®, taking place Oct. 23–26, 2025, in Las Vegas, Nevada.

“The DecisionDx-Melanoma test has demonstrated clinically significant risk stratification of melanoma. This current study with 13,560 patients is unique in that the clinically relevant risk stratification was seen and reported across histological subtypes of melanoma,” said Etan Marks, D.O., board-certified pathologist, hematopathologist and dermatopathologist at Advanced Dermatology in Delray Beach, Florida. “This study is particularly important as it demonstrates that DecisionDx-Melanoma provides consistent risk stratification across varying types of melanoma and reinforces its value in providing important prognostic information to inform risk aligned management plans, even for patients with different subtypes of melanoma.”

Details regarding Castle’s posters are included below:

DecisionDx-Melanoma
Title: The 31-gene expression profile test stratifies melanoma-specific survival across histological subtypes in patients with cutaneous melanoma

• Lead Author: Etan Marks, D.O.
• Summary: Cutaneous melanoma (CM) subtypes, such as superficial spreading and nodular melanoma, vary in how often they occur and in their outcomes. Even among patients with the same subtype, differences in tumor biology can lead to very different prognoses. In a real-world cohort of 13,560 patients with stage I–III CM from Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (NCI’s SEER) Program Registries, DecisionDx-Melanoma stratified melanoma-specific survival (MSS) across different tumor subtypes. For example, five-year MSS in nodular melanoma was 98.5% for patients with Class 1A (lowest risk) test results versus 82.3% for patients with Class 2B (highest risk) test results; similar stratification was observed across superficial spreading, lentigo maligna and unspecified subtypes. These results suggest that the test provides clarity in overall risk beyond histology, supporting more informed treatment planning and potentially improved outcomes.

Title: The 31-gene expression profile identifies patients at risk of developing early distant metastases and can guide risk-appropriate surveillance strategies

• Lead Author: Merve Hasanov, M.D., The Ohio State University Comprehensive Cancer Center, Columbus, Ohio
• Summary: This study demonstrates that DecisionDx-Melanoma can identify early-stage CM patients (American Joint Committee on Cancer (AJCC) stage I-II, n=1,661) at higher risk of distant metastasis (DM) not only to the central nervous system (CNS), but also to the lung, liver and bone. Patients with Class 2B (highest risk) results had significantly higher DM rates compared to Class 1A (lowest risk) patients across all sites (e.g., CNS 7.4% vs. 0.9%; lung 7.4% vs. 1.2%; p<0.001). Class 2B patients also had significantly lower five-year DM-free survival, with elevated risk persisting several years after diagnosis. These findings support combining DecisionDx-Melanoma with AJCC staging to identify high-risk patients for tailored surveillance and earlier detection strategies.

Pipeline AD GEP test
Title: The 487-gene expression profile test guides systemic therapy selection to improve outcomes for patients with atopic dermatitis: Results from a prospective, multi-center trial.

• Lead Author: Jonathan I. Silverberg, M.D., Ph.D., MPH, George Washington University School of Medicine and Health Sciences, Washington, D.C.
• Summary: Systemic therapy selection in AD is often trial-and-error, leaving up to half of patients inadequately controlled on biologics targeting the Th2 pathway or on Janus kinase (JAK) inhibitors (JAKi). For many patients, first-line therapy does not achieve adequate disease control, causing delayed improvement, patient dissatisfaction and increased healthcare usage. Data from Castle’s prospective development and validation study show that Castle’s pipeline AD test can classify the patient’s underlying disease biology as having a Th2 Molecular Profile or a JAKi Responder Profile to help guide treatment decision-making. These results demonstrate that Castle’s pipeline test can identify a group of patients with AD who are significantly more likely to experience rapid and deep responses to JAK inhibitors. Understanding the underlying biology that is driving an individual patient’s symptoms may help shift AD care from trial-and-error prescribing to more personalized treatment, potentially improving treatment success and patient satisfaction, and lowering healthcare costs.

“We are pleased to see the results of our prospective, multicenter development and validation study demonstrate clinically meaningful and statistically significant differences between patients who have a JAKi responder profile who are treated with a JAKi compared to those treated with a Th2-targeted therapy,” said Matthew Goldberg, M.D., senior vice president, medical, at Castle Biosciences.

Derek Maetzold, president and chief executive officer of Castle Biosciences, stated, “We would like to thank the 49 U.S. clinical sites who worked with us to achieve this dataset and look forward to seeing the impact that our test may have on improving the outcomes of patients with moderate-to-severe AD.”

About DecisionDx-Melanoma
DecisionDx-Melanoma is a 31-gene expression profile (31-GEP) risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through June 30, 2025, DecisionDx-Melanoma has been ordered more than 210,000 times for patients diagnosed with cutaneous melanoma. Learn more at www.CastleBiosciences.com.

About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide treatment decisions for patients with moderate-to-severe atopic dermatitis. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. 

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements
This press release contains 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, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: DecisionDx-Melanoma’s ability to provide (i) comprehensive, personalized results to guide risk-aligned management decisions for patients diagnosed with stage I-III cutaneous melanoma, and (ii) precise and clinically meaningful risk stratification; DecisionDx-Melanoma’s performance versus other tests currently on the market; the ability of Castle’s pipeline AD test to (i) classify a patient’s underlying disease biology to help guide systemic therapy selection, and (ii) identify patients with AD who are significantly more likely to experience rapid and deep responses to JAK inhibitors; and the potential to shift AD care from trial-and-error prescribing to personalized treatment. The words “believe,” “can,” “may” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com

Media Contact:
Allison Marshall
amarshall@castlebiosciences.com

Source: Castle Biosciences, Inc.

Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production




Genenta and Anemocyte Announce Strategic Partnership to Advance Off-The-Shelf LVV Plasmid DNA Production

MILAN, Oct. 24, 2025 (GLOBE NEWSWIRE) — Genenta Science (Nasdaq: GNTA), a pioneer Company in immuno-oncology, and ANEMOCYTE, a leading provider of advanced therapy and nucleic acids solutions, today announced a strategic collaboration with a focus on off-the-shelf lentiviral vector (“LVV”) Plasmid DNA technology platform. This new agreement builds and expands on the existing successful partnership between the two companies, which has focused on the production of Plasmid DNA.

The partnership leverages Genenta’s robust and well-tested LVV Plasmid DNA technology, a platform developed from the foundational research of Professor Luigi Naldini, co-founder of Genenta. This established and proven technology will enable ANEMOCYTE to enhance its offering to clients, providing a reliable source of top-quality materials from R&D to GMP grade, from preclinical to commercial stages.

“Our expanded collaboration with ANEMOCYTE represents a natural progression of a successful partnership in plasmid DNA manufacturing,” said Pierluigi Paracchi, CEO at Genenta Science. “By making our clinically validated LVV Plasmid DNA technology platform available to ANEMOCYTE and its clients, we are contributing to the reliable and scalable development of advanced therapy programs across the industry.”

Marco Ferrari, CEO at ANEMOCYTE added, “Our collaboration with Genenta has already yielded excellent results. By formalizing this new partnership, we are ensuring our clients have access to a robust, well-established platform for their advanced therapy programs, backed by Genenta’s extensive track record.”

This collaboration marks a significant milestone for both companies and underscores their shared commitment to supporting the life science industry with innovative and reliable solutions.

About Anemocyte: Anemocyte is a Biotech Manufacturing Organization (“BMO”) based in Italy, offering comprehensive development and manufacturing services and providing innovative solutions and products from R&D to GMP. Specialized in the research, development, and production of pDNA and mRNA, Anemocyte brings over 25 years of expertise in innovative therapies and related starting materials.

About Genenta Science: Genenta Science (Nasdaq: GNTA) is a clinical-stage immuno-oncology company developing a proprietary hematopoietic stem cell therapy for the treatment of a variety of solid tumor cancers. Genenta’s first-in-class product candidate is Temferon™, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow-derived myeloid cells and enables a durable and targeted response. Genenta has completed a Phase 1 trial for newly diagnosed Glioblastoma Multiforme (“GBM”) patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and the inhibition of myeloid-induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta’s treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Forward-Looking Statements
Statements in this press release may contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the funding to be provided by the Mandatory Convertible Bond, the completion and timing of Genenta’s phase 2A clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its phase 1 clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied.Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.

Genenta Science Media
Tiziana Pollio, Mobile: +39 348 23 15 143
Email: tiziana.pollio@genenta.com

Anemocyte Media
Telephone +39 0299372311
Email: media@anemocyte.com
www.anemocyte.com

Vistin Pharma ASA: Invitation to Q3 2025 conference call




Vistin Pharma ASA: Invitation to Q3 2025 conference call

Oslo, Norway, 24 October 2025

Vistin Pharma ASA (VISTN) will release its third quarter and YTD 2025 results on Friday 31st of October 2025. Vistin Pharma will host a conference call for all shareholders and interested parties on the same day at 08:30 CET. There will be a Q&A session following the management discussion.

The conference call will be held in English.

The third quarter conference call will be available via web and audio through the following access points:

Webcast: https://edge.media-server.com/mmc/p/zojifvb6

Telephone conference (online registration):
https://register-conf.media-server.com/register/BI4b6411bcd117427f8df81e59f7b2fd65

*****

For further information, please contact:

Alexander Karlsen
CFO
+47 97053621
alexander.karlsen@vistin.com

About Vistin Pharma | www.vistin.com

Vistin Pharma is a Norwegian pharmaceutical company producing Metformin Hydrochloride (API). The Metformin is also available as Direct Compressible lubricated granules. As a solely dedicated European Metformin producer, Vistin Pharma is a well-positioned supplier to leading pharmaceutical companies. Vistin Pharma is headquartered in Oslo, Norway, and has highly qualified employees and a dedicated manufacturing facility in Kragerø.

Vistin Pharma ASA: Invitation to Q3 2025 conference call




Vistin Pharma ASA: Invitation to Q3 2025 conference call

Oslo, Norway, 24 October 2025

Vistin Pharma ASA (VISTN) will release its third quarter and YTD 2025 results on Friday 31st of October 2025. Vistin Pharma will host a conference call for all shareholders and interested parties on the same day at 08:30 CET. There will be a Q&A session following the management discussion.

The conference call will be held in English.

The third quarter conference call will be available via web and audio through the following access points:

Webcast: https://edge.media-server.com/mmc/p/zojifvb6

Telephone conference (online registration):
https://register-conf.media-server.com/register/BI4b6411bcd117427f8df81e59f7b2fd65

*****

For further information, please contact:

Alexander Karlsen
CFO
+47 97053621
alexander.karlsen@vistin.com

About Vistin Pharma | www.vistin.com

Vistin Pharma is a Norwegian pharmaceutical company producing Metformin Hydrochloride (API). The Metformin is also available as Direct Compressible lubricated granules. As a solely dedicated European Metformin producer, Vistin Pharma is a well-positioned supplier to leading pharmaceutical companies. Vistin Pharma is headquartered in Oslo, Norway, and has highly qualified employees and a dedicated manufacturing facility in Kragerø.

Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President




Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President

AMSTERDAM, Oct. 24, 2025 (GLOBE NEWSWIRE) — Polpharma Group, one of the largest pharmaceutical groups operating across Central and Eastern Europe and Central Asia, announces a planned leadership transition.

Effective January 1, 2026, Markus Sieger will step down as CEO of the Group , after a decade of dedicated service. He will continue to support the strategic development of the Group as a member of the Supervisory Board, in line with the succession plan agreed upon at the start of his tenure.

Under Markus Sieger’s leadership, Polpharma Group has achieved significant growth – both financially and in its mission to build a purpose-driven organization: “We help people live healthy lives in a healthy world.” The company has become a trusted partner to healthcare systems across Europe and Central Asia, delivering high-quality, affordable medicines to millions of patients.

Jerzy Starak, owner of Polpharma Group, expressed his appreciation: “On behalf of the entire Polpharma community, I extend my heartfelt thanks to Markus for his outstanding commitment and vision over the past ten years. His leadership was instrumental in navigating the company through a dynamic and challenging landscape, strengthening our values, and setting a strategic course for the future. I am pleased that Markus will continue to be part of our team as a member of the Supervisory Board.”

At the same time, Polpharma Group is pleased to announce the appointment of Sebastian Szymanek as its new CEO, effective January 1, 2026. Sebastian currently serves as the President of the Management Board of Zakłady Farmaceutyczne Polpharma S.A. in Poland.

With nearly 30 years of experience in the pharmaceutical industry, Sebastian brings a deep understanding of both generic and innovative sectors. He joined Polpharma in 2007 and has held several key leadership roles within the commercial division. In 2014, he became the General Manager for Poland, and from 2017 to March 2021, he served as President of the Management Board of Polpharma Biuro Handlowe. Since September 2021, he has led Zakłady Farmaceutyczne Polpharma S.A. as President of the Management Board.

Throughout his 18-year tenure at Polpharma, Sebastian has played a pivotal role in transforming the company into a dynamic market leader. His contributions span strategic project execution, cross-functional team leadership, and strengthening the company’s market position both domestically and internationally.

Nick Haggar, Chairman of the Supervisory Board of Polpharma Group, commented:
“I am confident that Sebastian is the right person to lead Polpharma Group into its next chapter. His deep knowledge of the organization, proven leadership capabilities, operational focus, and unwavering commitment to our mission make him the ideal choice to guide the Group’s continued growth and innovation.”

About the Polpharma Group

The Polpharma Group is a leading regional manufacturer of pharmaceuticals. It is active in the markets of Central and Eastern Europe, the Caucasus, and Central Asia. For over 90 years, it has enjoyed the trust of patients, healthcare professionals, and business partners, offering modern medicines, active substances, and innovative solutions to patients and business partners around the world. Every year, Polpharma Group factories produce 400 million packages of medicines, which are sold directly or through a network of partners in over 40 countries around the world. The Polpharma Group comprises : Zakłady Farmaceutyczne Polpharma S.A. in Poland, Zakłady Farmaceutyczne Santo in Kazakhstan, and companies Farmaprojects in Spain, 089Farm in Germany, and Swiss Pharma International in Switzerland. The Group employs 5,600 people.

For media inquiries, please contact:

Beata Zduńczyk-Golędzinowska
Head of Corporate Communications
rzecznik@polpharma.com

Source: Polpharma Group

Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President




Polpharma Group Announces Leadership Transition – Sebastian Szymanek appointed as its new President

AMSTERDAM, Oct. 24, 2025 (GLOBE NEWSWIRE) — Polpharma Group, one of the largest pharmaceutical groups operating across Central and Eastern Europe and Central Asia, announces a planned leadership transition.

Effective January 1, 2026, Markus Sieger will step down as CEO of the Group , after a decade of dedicated service. He will continue to support the strategic development of the Group as a member of the Supervisory Board, in line with the succession plan agreed upon at the start of his tenure.

Under Markus Sieger’s leadership, Polpharma Group has achieved significant growth – both financially and in its mission to build a purpose-driven organization: “We help people live healthy lives in a healthy world.” The company has become a trusted partner to healthcare systems across Europe and Central Asia, delivering high-quality, affordable medicines to millions of patients.

Jerzy Starak, owner of Polpharma Group, expressed his appreciation: “On behalf of the entire Polpharma community, I extend my heartfelt thanks to Markus for his outstanding commitment and vision over the past ten years. His leadership was instrumental in navigating the company through a dynamic and challenging landscape, strengthening our values, and setting a strategic course for the future. I am pleased that Markus will continue to be part of our team as a member of the Supervisory Board.”

At the same time, Polpharma Group is pleased to announce the appointment of Sebastian Szymanek as its new CEO, effective January 1, 2026. Sebastian currently serves as the President of the Management Board of Zakłady Farmaceutyczne Polpharma S.A. in Poland.

With nearly 30 years of experience in the pharmaceutical industry, Sebastian brings a deep understanding of both generic and innovative sectors. He joined Polpharma in 2007 and has held several key leadership roles within the commercial division. In 2014, he became the General Manager for Poland, and from 2017 to March 2021, he served as President of the Management Board of Polpharma Biuro Handlowe. Since September 2021, he has led Zakłady Farmaceutyczne Polpharma S.A. as President of the Management Board.

Throughout his 18-year tenure at Polpharma, Sebastian has played a pivotal role in transforming the company into a dynamic market leader. His contributions span strategic project execution, cross-functional team leadership, and strengthening the company’s market position both domestically and internationally.

Nick Haggar, Chairman of the Supervisory Board of Polpharma Group, commented:
“I am confident that Sebastian is the right person to lead Polpharma Group into its next chapter. His deep knowledge of the organization, proven leadership capabilities, operational focus, and unwavering commitment to our mission make him the ideal choice to guide the Group’s continued growth and innovation.”

About the Polpharma Group

The Polpharma Group is a leading regional manufacturer of pharmaceuticals. It is active in the markets of Central and Eastern Europe, the Caucasus, and Central Asia. For over 90 years, it has enjoyed the trust of patients, healthcare professionals, and business partners, offering modern medicines, active substances, and innovative solutions to patients and business partners around the world. Every year, Polpharma Group factories produce 400 million packages of medicines, which are sold directly or through a network of partners in over 40 countries around the world. The Polpharma Group comprises : Zakłady Farmaceutyczne Polpharma S.A. in Poland, Zakłady Farmaceutyczne Santo in Kazakhstan, and companies Farmaprojects in Spain, 089Farm in Germany, and Swiss Pharma International in Switzerland. The Group employs 5,600 people.

For media inquiries, please contact:

Beata Zduńczyk-Golędzinowska
Head of Corporate Communications
rzecznik@polpharma.com

Source: Polpharma Group

Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases




Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases

First patient enrolled in randomized, placebo-controlled study

Bensheim, 24. October 2025 – Neurodegenerative diseases represent one of the biggest challenges of our time. In Germany alone, there are currently around 1.8 million people living with dementia, a figure that is set to rise to 2.7 million by 2050. Increased life expectancy, combined with the growing number of patients, is having an increasingly significant impact on those affected, their families, and national healthcare systems.

Despite advances in research, there is still a lack of treatment options that are effectively capable of providing symptomatic relief and sustainably improving patients’ quality of life.

Within this context, there is a need to develop additional therapeutic options based on robust clinical evidence. Cannabis-based medicines (CbM), particularly in the form of full-spectrum extract, represents a potential area of research due to its potential to modulate the neurophysiological systems involved in degenerative processes.

Toward this objective, the NEUROBIS study is being launched in Italy, a phase II, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy in terms of quality of life and safety of CbMs in neurodegenerative diseases.

This 36-month-long clinical trial has been authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022) and involves 180 patients suffering from amyotrophic lateral sclerosis (ALS), Parkinson’s disease, or Alzheimer’s disease. The first patient has already been enrolled, marking a milestone in clinical research on the use of CBMs as a supportive treatment.

The clinical trial is led by Professor Letizia Mazzini, an internationally renowned neurologist and researcher with over 30 years of experience in the study of neurodegenerative diseases, director of the ALS Center in Novara, and one of Italy’s leading experts on motor neuron diseases.

“We are proud to launch this pioneering clinical trial in Italy,” states Professor Mazzini. “Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis as an additional option for patients suffering from neurodegenerative diseases. Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”

Bernhard Babel, CEO of Avextra, highlights the strategic value of this research initiative: “The launch of the NEUROBIS study represents a major step forward in our clinical research program. Thanks to our standardized full-spectrum extract, developed based on the highest quality and consistency standards, we’re working towards improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”

About Avextra

Building trust through research and patient-focused innovation: German biotech company Avextra is committed to advancing cannabis-based prescription medicines. Avextra is investing specifically in research, with six pioneering studies currently being conducted in Germany to pave the way for the regulatory approval we are aiming for. Our goal: to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.

Learn more at www.avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/

Avextra Media Enquiries:
For media enquiries or to set up an interview please contact:
E-Mail: press@avextra.com
Phone: +49 30 408174037 

Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases




Avextra Supports Phase II Clinical Trial in Italy on Cannabis-based medicines for Neurodegenerative Diseases

First patient enrolled in randomized, placebo-controlled study

Bensheim, 24. October 2025 – Neurodegenerative diseases represent one of the biggest challenges of our time. In Germany alone, there are currently around 1.8 million people living with dementia, a figure that is set to rise to 2.7 million by 2050. Increased life expectancy, combined with the growing number of patients, is having an increasingly significant impact on those affected, their families, and national healthcare systems.

Despite advances in research, there is still a lack of treatment options that are effectively capable of providing symptomatic relief and sustainably improving patients’ quality of life.

Within this context, there is a need to develop additional therapeutic options based on robust clinical evidence. Cannabis-based medicines (CbM), particularly in the form of full-spectrum extract, represents a potential area of research due to its potential to modulate the neurophysiological systems involved in degenerative processes.

Toward this objective, the NEUROBIS study is being launched in Italy, a phase II, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy in terms of quality of life and safety of CbMs in neurodegenerative diseases.

This 36-month-long clinical trial has been authorized and funded by the Italian Ministry of Health (Ricerca Finalizzata 2022) and involves 180 patients suffering from amyotrophic lateral sclerosis (ALS), Parkinson’s disease, or Alzheimer’s disease. The first patient has already been enrolled, marking a milestone in clinical research on the use of CBMs as a supportive treatment.

The clinical trial is led by Professor Letizia Mazzini, an internationally renowned neurologist and researcher with over 30 years of experience in the study of neurodegenerative diseases, director of the ALS Center in Novara, and one of Italy’s leading experts on motor neuron diseases.

“We are proud to launch this pioneering clinical trial in Italy,” states Professor Mazzini. “Thanks to our collaboration with Avextra, we are combining clinical expertise and innovation to rigorously explore the therapeutic potential of medical cannabis as an additional option for patients suffering from neurodegenerative diseases. Our goal is to generate high-quality scientific data that can translate into real clinical benefits.”

Bernhard Babel, CEO of Avextra, highlights the strategic value of this research initiative: “The launch of the NEUROBIS study represents a major step forward in our clinical research program. Thanks to our standardized full-spectrum extract, developed based on the highest quality and consistency standards, we’re working towards improving patients’ quality of life and offering new treatment options based on robust and verified evidence.”

About Avextra

Building trust through research and patient-focused innovation: German biotech company Avextra is committed to advancing cannabis-based prescription medicines. Avextra is investing specifically in research, with six pioneering studies currently being conducted in Germany to pave the way for the regulatory approval we are aiming for. Our goal: to improve the reimbursement of cannabinoids for seriously ill patients in pain management and palliative care in the long term.

Learn more at www.avextra.com and stay up to date at LinkedIn: LinkedIn.com/company/avextra-ag/

Avextra Media Enquiries:
For media enquiries or to set up an interview please contact:
E-Mail: press@avextra.com
Phone: +49 30 408174037 

Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025




Updated MDNA11 Clinical Data from the ABILITY-1 Study to be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025

TORONTO and HOUSTON, Oct. 23, 2025 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer and autoimmune diseases, announced today that updated MDNA11 clinical data will be presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2025 taking place December 10-12, 2025, in London, United Kingdom.

Updated clinical data from the Phase 1/2 ABILITY-1 Study evaluating MDNA11, an emerging best-in-class IL-2 therapy, as a monotherapy and in combination with pembrolizumab, will be presented by Dr. André Mansinho, a principal investigator of the study.

Details for the presentations are as follows:

Title: ABILITY-1, a phase 1/2 of MDNA11, a next-generation IL-2 agonist, alone or with pembrolizumab in advanced solid tumors: interim analysis
Presenter: Dr. André Mansinho, MD MSc, Assistant Professor, Faculty of Medicine, University of Lisbon
Date: December 10, 2025

Following the conclusion of the ESMO Immuno-Oncology 2025 Congress, a copy of the presentation will be available on the “Events and Presentations” page of Medicenna’s website.

About Medicenna Therapeutics

Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s first-in-class targeted PD-1 x IL-2 bispecific, MDNA113, is in development for solid tumors and was designed using the Company’s proprietary BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and T-MASK™ (Targeted Metalloprotease Activated SuperKine) platforms. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively.

For more information, please visit www.medicenna.com, and follow us on X and LinkedIn.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts, such as statements on the therapeutic potential and safety profile of MDNA11. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage pre-clinical or clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.

The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.

This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this new release.

Investor/Media Contact:

Shushu Feng
Investor Relations, Medicenna Therapeutics
(416) 964-5442
ir@medicenna.com