Booking Health Expands Access to Stage 4 Cancer Treatment in Germany




Booking Health Expands Access to Stage 4 Cancer Treatment in Germany

Langenfeld, Germany, Sept. 24, 2025 (GLOBE NEWSWIRE) — Booking Health, a leading medical travel facilitator, has announced the expansion of its oncology services to improve international access to advanced stage 4 cancer treatments in Germany. The company now offers comprehensive coordination for patients seeking personalized cancer therapies at top-certified German hospitals, including cutting-edge options like immunotherapy, CAR T-cell therapy, and theranostics.

Advanced cancer treatment

Facing a stage 4 cancer diagnosis can be overwhelming, but late-stage cancer treatment abroad continues to offer hope. For many, the opportunity to access advanced stage 4 cancer treatment in world-famous clinics can make a meaningful difference. Booking Health GmbH helps turn that possibility into reality by connecting international patients with the best oncology centers in Germany.

From obtaining second opinions and personalized treatment plans to managing travel logistics and follow-up care, the company coordinates every step of the process. By doing so, Booking Health GmbH empowers patients to explore life-extending therapies – restoring not only their options but also their sense of control.

Why Choose Germany for Late‑Stage Cancer Treatment?

Accessing advanced cancer therapy in Germany means entering a healthcare system known for its innovative treatments, short waiting times, and internationally accredited institutions. Moreover, German cancer hospitals, such as LMU Klinikum in Munich, offer innovative techniques – including proton and heavy-ion therapy – not widely available elsewhere. 

In addition, research shows that treatment in the country’s certified oncology centers is associated with significantly better survival outcomes, according to a 2023 study published in Deutsches Ärzteblatt International, a leading medical journal. 

To highlight how Germany compares with other major healthcare systems, we offer a side-by-side view of key factors influencing treatment quality and accessibility:

International Comparison

This comparison demonstrates why so many international patients turn to Germany for access to innovative cancer care – it consistently delivers faster access, more advanced therapies, and higher treatment standards.

What Advanced Cancer Treatments Are Available in Germany for Stage 4 Patients?

Patients seeking personalized cancer treatment in Germany now have access to various innovative therapies designed to address even the most advanced cases.

Some of the most promising methods include:

• Immunotherapy and targeted therapy – checkpoint inhibitors and tyrosine kinase inhibitors are now standard of care for many metastatic cancers;
• Dendritic cell vaccines – personalized immunotherapy developed from the patient’s own immune cells, showing strong results in clinical trials;
• CAR T-cell therapy – available for select hematologic malignancies such as leukemia and lymphoma;
• Radioembolization (Y-90) – delivers internal radiation directly into liver tumors through the bloodstream;
• TACE (Transarterial Chemoembolization) – combines localized chemotherapy with embolization to cut off blood supply to the tumor;
• HIPEC (Heated Intraperitoneal Chemotherapy) and PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) – for advanced abdominal cancers, especially ovarian, gastric, and colorectal metastases;
• Hyperthermia therapy – uses focused heat to weaken cancer cells and increase the effectiveness of other treatments like radiotherapy;
• Photodynamic therapy (PDT) – used for superficial tumors or early-stage lung/esophageal cancers, combining light-activated drugs and laser technology;
• Nanotherapy and molecular profiling – used to identify and target mutations for highly individualized treatment.

These advanced options significantly broaden access to innovative cancer care and position Germany as a global leader in personalized oncology. In this country, patients benefit not only from advanced therapies but also from interdisciplinary care teams that continuously adapt treatment strategies based on real-time progress.

What Types of Cancer Can Be Treated in Germany at Stage 4?

Germany offers advanced treatment options for a broad range of stage 4 cancers. Leading oncology centers across the country combine personalized protocols, innovative technologies, and multidisciplinary expertise to manage complex and metastatic cases with improved outcomes.

Here are some of the most commonly treated late-stage cancers in Germany:

• Lung cancer: Over 50% of cases are diagnosed at stage IV. German clinics use immunotherapy (e.g., PD-1/PD-L1 inhibitors), targeted mutations (EGFR, ALK), and advanced radiotherapy to prolong survival and improve quality of life.
• Colorectal and rectal cancer: Personalized treatment plans – including HIPEC, TACE, and targeted agents – have increased 5‑year survival rates by 45-65% compared to standard care. A 16-year German real-world study of over 3,800 metastatic colorectal cancer patients confirms these improved outcomes.
• Breast cancer: Triple-negative and HER2-positive subtypes are treated with combination immunotherapy, antibody-drug conjugates, and CDK4/6 inhibitors – helping patients live longer with fewer side effects.
• Ovarian and peritoneal cancers: Late-stage cases are managed with intraperitoneal chemotherapy, cytoreductive surgery, PIPAC, and PARP inhibitors.
• Prostate cancer: Metastatic prostate cancer patients can access Lutetium-177 therapy (PSMA-targeted radioligand treatment) and hormone-based personalized options. A German multicenter study reports significant PSA declines and extended survival (median overall survival (OS) 31 months).
• Liver and bile duct cancers: Techniques like radioembolization (Y-90), TACE, and immune checkpoint inhibitors are commonly used.
• Pancreatic cancer: Though highly aggressive, stage 4 pancreatic cancer may be treated with experimental options in this country.
• Renal and bladder cancers: Immunotherapy, tyrosine kinase inhibitors, and surgical resection remain key components of care.
• Melanoma: Combination immunotherapy has shown durable responses and improved OS in stage IV cases; 63% OS at 24 months reported in a clinical study.

German hospitals also accept rare or complex metastatic cancers – including head and neck tumors, sarcomas, glioblastomas, and neuroendocrine tumors – offering late-stage cancer treatment to patients who may otherwise have no options.

How to Start the Process: Step-by-Step Guide

Beginning your medical travel for oncology treatment through Booking Health GmbH is simple, personalized, and fully supported. Whether you are seeking a second opinion in Germany, a cancer consultation, or planning to undergo full treatment abroad, every step is organized to reduce stress

Step-by-Step:

• Submit your medical records (diagnosis, scans, lab tests) through the secure online form;
• Receive a medical review and second opinion from leading German oncology experts;
• Get a personalized treatment plan, including estimated costs and hospital availability;
• Choose your preferred clinic from a list of certified cancer centers;
• Confirm your treatment, and receive a booking voucher with your detailed itinerary;
• Let Booking Health organize logistics: visa, flights, accommodation, interpreter;
• Begin treatment in Germany, with 24/7 support from your personal coordinator;
• Access post-treatment follow-up, including telemedicine consultations from home.

How Booking Health Helps Stage 4 Cancer Patients Abroad

Navigating stage 4 cancer treatment can be a challenging experience. Patients often reach this point after undergoing multiple therapies, hearing conflicting medical opinions, and trying to make sense of complex treatment options. In such moments, choosing the right next step is not easy – especially when options are limited or generic.

This is where Booking Health GmbH becomes a vital partner.

With over a decade of experience in medical travel for oncology, Booking Health specializes in helping international patients access personalized cancer treatment in Germany – developed specifically for their medical history, current condition, and therapeutic goals. The company collaborates with leading cancer hospitals in Germany, many of which are certified by the German Cancer Society and offer innovative therapies not always available in a patient’s home country.

Here is what patients receive through Booking Health:

• A complete review and analysis of medical documentation;
• Coordination of second opinions from top oncology experts in Germany;
• Custom-built cancer treatment programs for complex and late-stage cases;
• Selection of the most suitable hospital or university clinic;
• Full organization of travel logistics, including visa, flights, and accommodation;
• A personal medical coordinator and interpreter, available 24/7;
• Guidance throughout the hospital stay and treatment period;
• Follow-up support after returning home;
• Clear, upfront pricing – with no hidden costs and significant savings compared to self-arranged care.

If you are seeking answers or a personalized oncology coordination services – let us help. Start your journey with a consultation from Booking Health GmbH and discover the possibilities of advanced cancer care in Germany.

Key Takeaways – Booking Health for Terminal Oncology Care

Patients with late-stage diagnoses still have options – and Booking Health GmbH makes them accessible.

Here is what you should remember:

• Germany offers access to the best hospitals for stage 4 cancer;
• Innovative treatments like immunotherapy and theranostics are available;
• Booking Health GmbH manages the entire process – from second opinions to follow-up;
• Patients report improved survival and quality of life;
• Treatment is often faster and more affordable than in the UK or US.

Press inquiries

Booking Health
https://bookinghealth.com/
Lena Hanten
marketing@bookinghealth.com 

Zealand Pharma appoints Rachel James-Owens as Vice President, Corporate Communications & Media Relations




Zealand Pharma appoints Rachel James-Owens as Vice President, Corporate Communications & Media Relations

Press release – No. 14 / 2025

Zealand Pharma appoints Rachel James-Owens as Vice President, Corporate Communications & Media Relations

Copenhagen, Denmark, September 24, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the appointment of Rachel James-Owens as Vice President, Corporate Communications & Media Relations.

Rachel brings over 20 years of global pharmaceutical experience across Pfizer and Novartis, spanning sales, commercial, and corporate and executive communications. Most recently, she served as Executive Director, Global Corporate Communications at Novartis Global Health & Sustainability. Prior to that, she led global executive oncology communications at Novartis and held several regional positions at Pfizer. She holds an MBA in Leadership, Culture & Coaching, and is an alum of the Corporate Affairs Leadership Academy, University of Oxford’s Saïd Business School.

Adam Steensberg, Chief Executive Officer of Zealand Pharma, said:

“We are delighted to welcome Rachel to Zealand Pharma at this pivotal time of accelerated growth. With a number of significant milestones ahead, Rachel’s extensive communications leadership experience will be invaluable as we balance near-term opportunities with our long-term journey to become a generational biotech.” 

Rachel James-Owens added:

“Zealand Pharma has an exciting pipeline and a game-changing growth strategy. I am thrilled to be joining at such an important time. There is an incredible culture at Zealand Pharma—one that radiates energy, ambition, and a collaborative spirit. I am looking forward to partnering with Adam and the team as the company continues to grow and create long-term, sustainable impact.”

About Zealand Pharma

Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.

Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma’s business and activities, please visit www.zealandpharma.com.

Forward looking statements

This company announcement contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company’s clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would”, and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Contacts

Adam Lange (Investors)
Vice President, Investor Relations
Zealand Pharma
alange@zealandpharma.com

Neshat Anis Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
neahmadi@zealandpharma.com

Rachel James-Owens (Media)
Vice President, Corporate Communications & Media Relations
Zealand Pharma
RJamesOwens@zealandpharma.com

Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
ZealandPharma@icrhealthcare.com 
+44 (0) 7739 658 783

Hemp Hop Launches 3 High THCa Ice Water Hash and Iconic Flower Strains: October 2025




Hemp Hop Launches 3 High THCa Ice Water Hash and Iconic Flower Strains: October 2025

CHARLOTTE, N.C., Sept. 24, 2025 (GLOBE NEWSWIRE) — Hemp Hop will be kicking off October 2025 with the launch of 3 new high THCa ice water hash concentrates and the return of 3 iconic strains of exotic THCa flower. Known for premium genetics, solventless methods, and consistent quality, Hemp Hop continues to shape the market as both a trusted hemp store and a forward-looking THCa shop.

The latest release combines small-batch craft with data-driven insight, designed to meet the growing demand for solventless concentrates and legendary flowers. Ice water hash, also called bubble hash or ice hash, remains one of the cleanest and most terpene-rich forms of cannabis concentrate, while fan-favorite THCa flower strains keep their place at the core of Hemp Hop’s lineup.

As one of the best places to buy THCa flower, Hemp Hop expands its offerings this October while keeping quality, transparency, and customer trust at the center.

Responding to Market Trends in THCa

The October release will reflect 2 clear shifts in customer demand.

First is the rise of solventless concentrates like bubble hash, also known as ice water hash or ice hash. These products are valued for their purity, terpene retention, and strong cannabinoid levels.

Second is the continued interest in exotic THCa flower, with buyers seeking strains that deliver both flavor and effect.

Hemp Hop is responding to these trends by expanding its lineup across categories. With both local same day THCa delivery in Charlotte, NC and nationwide shipping, the brand continues to grow as the best THCa flower online destination.

New October Lineup of Ice Water Hash

Hemp Hop’s October launch introduces three solventless concentrates crafted through the traditional ice water extraction method, also known as bubble hash or ice hash. By using only cold water and agitation, these hashes preserve terpene richness and cannabinoid potency while delivering a clean, full-spectrum experience.

Each batch is triple-washed for purity, packed fresh in airtight jars, and made to meet the growing demand for premium dabs.

Ice Cream Cake THCa Ice Water Hash

An indica-dominant favorite (63.04% THCa), Ice Cream Cake hash brings creamy vanilla, nutty dough, and sweet gas notes. Its sticky, sand-like texture bubbles under heat, offering euphoric head effects followed by deep body relaxation. Ideal for nighttime use.

Lemon Cherry Delight THCa Ice Water Hash

This sativa-leaning hybrid (77.14% THCa) delivers bright flavors of lemon and cherry with a sweet zest. Smooth and terpene-rich, it uplifts mood while easing stress, balancing mental clarity with mellow body effects.

Muffins & Mimosas THCa Ice Water Hash

A hybrid blend of Mimosa and Blueberry Muffin, this hash (78.04% THCa) layers citrus, blueberry muffin, and vanilla flavors. It offers an energetic lift and clear focus followed by a calm, balanced finish, making it versatile for day or evening sessions.

With these drops, Hemp Hop expands its catalog of solventless dabs, offering customers high-quality ice water hash that reflects both craft and consistency.

Hemp Hop’s October Lineup of Iconic THCa Flowers

Alongside new concentrates, Hemp Hop is bringing back three fan favorites in its exotic THCa flower collection. Known for bold flavor, strong effects, and timeless genetics, these strains have earned their place as staples in the cannabis world. Each one is cultivated with the same care and precision that defines Hemp Hop as a trusted source for premium THCa flower.

Jack Herer THCa Flower

A legendary sativa dominant hybrid, Jack Herer (29.45% THCa) blends Haze with Northern Lights #5 and Shiva Skunk. Its oversized neon green buds sparkle with amber trichomes and carry citrus, lemon, and pine notes. Customers choose Jack Herer for creative energy, sociability, and sharp focus, making it a go to daytime strain.

Super Boof THCa Flower

Winner of multiple awards including Leafly’s Strain of the Year 2024, Super Boof has become a modern icon. A balanced hybrid of Black Cherry Punch and Tropicana Cookies, it features cherry, citrus, and nutty sweetness.

“At 38.97% THCa, Super Boof is the most potent flower we have launched. Customers love its euphoric lift, giggly mood, and relaxing finish,” said Richard Grant, Product Specialist at Hemp Hop.

Durban Poison THCa Flower

Originating from South Africa, Durban Poison is a pure sativa with a classic reputation. Testing at 22.31% THCa, it offers sweet citrus and herbal pine flavors with an earthy aroma. Known for uplifting creativity and focus, Durban Poison is ideal for daytime use and remains one of the most loved landrace strains.

Voices from Hemp Hop

“Our approach has always been simple: listen to our customers and deliver products that reflect what they want most. Every new strain or concentrate we launch comes from a mix of feedback, testing, and close attention to quality. That is why people trust us, and it is what keeps Hemp Hop growing stronger every season,” said Jordan Hall, Founder of Hemp Hop.

Customer Trust and Hemp Hop Standards

Hemp Hop has built its reputation on quality and transparency. Every product is third party lab tested to verify cannabinoid content, terpene levels, and compliance with the 2018 Farm Bill. The company works with trusted indoor cultivators who focus on small batch grows, ensuring freshness and consistency. Customer feedback plays a central role in shaping future strain drops and concentrate batches. As a growing THCa shop, Hemp Hop continues to be trusted nationwide by buyers who value reliability and premium standards.

What’s Next

Looking ahead, Hemp Hop plans to keep its steady rhythm of weekly and seasonal drops. Each release will balance rare genetics with proven favorites, always backed by lab results and customer insight. The company remains committed to freshness, small batch production, and full transparency. With each launch, Hemp Hop reinforces its place as a leader in premium THCa products.

About Hemp Hop

Founded in 2018 and based in Charlotte, NC, Hemp Hop has become a recognized name in premium hemp. The company has earned recognition from the High Times Hemp Cup and the Oregon Growers Cup. Its catalog includes THCa flower, solventless concentrates, and vapes, all backed by third party lab results. Known as the best place to buy thca flower online, Hemp Hop continues to set the standard for quality and trust.

Media Contact
Aman Kodwani
aman@hemphop.co

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/09cad8b2-b90d-48f7-aff9-7e12b3896fad

This press release was published by a CLEAR® Verified individual.

Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS




Kyverna Therapeutics Highlights Potential of KYV-101 in Multiple Sclerosis with Data from Phase 1 Investigator-Initiated Trials to be Presented at ECTRIMS

KYV-101 IIT data demonstrate promising clinical activity, including robust CAR T penetration into the central nervous system (CNS) and improved expanded disability status scale scores (EDSS)

KYV-101 continues to demonstrate a tolerable safety profile, consistent with observations from the first 100 patients treated with KYV-101¹

Encouraging early data of KYV-101 in multiple sclerosis highlights broader potential within neuroimmunology autoimmune diseases

EMERYVILLE, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced updated data from Phase 1 investigator-initiated trials (IITs) of KYV-101 in the treatment of progressive multiple sclerosis (MS) to be presented at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, taking place in Barcelona, Spain from September 24-26, 2025. Data presented will include an oral presentation from Stanford Medicine (Stanford), Department of Neurology & Neurological Sciences and a poster presentation from the University of California, San Francisco (UCSF), Weill Institute for Neurosciences.

“Encouraging KYV-101 IIT data in multiple sclerosis underscores the therapy’s broad potential within neuroimmunology autoimmune diseases, including stiff person syndrome and myasthenia gravis,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are grateful to our partners at Stanford and UCSF for leading these important studies exploring the potential of CAR T-cell therapy in treating a disease that affects millions of people and carries significant unmet need. As data continue to mature, we look forward to using these insights to inform our path forward.”

“In progressive multiple sclerosis, where patients face a steady progression of disability, halting or reversing disease progression is key to addressing a significant unmet medical need,” said Naji Gehchan, M.D., Chief Medical and Development Officer of Kyverna Therapeutics. “Longer follow-up data of KYV-101 across these IITs continue to show promise, with patients demonstrating disease stabilization, or even more encouragingly, an improvement in their disability status – potentially reflecting an immune reset. Notably, KYV-101 was also well-tolerated with no high-grade CRS or ICANS. We are pleased to see these results further reinforce the consistent clinical profile of KYV-101 observed to date across multiple autoimmune indications.”

Phase 1 IIT data for KYV-101 in MS were previously presented by Stanford and UCSF at the 2025 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum and the American Academy of Neurology (AAN) Annual Meeting.

Stanford Oral Presentation

Title: Chimeric Antigen Receptor T Cell (CAR-T) Immunotherapy for Progressive Phenotypes of Multiple Sclerosis: Early Results from a Phase 1, Open-Label, Single Center Study of an Autologous Fully Human Anti-CD19 CAR-T
Presenter: Kristin Galleta, M.D., Clinical Assistant Professor, Adult Neurology, Stanford Medicine
Presentation ID: O027
Date and Time: Wednesday, September 24, 2025, 15:05 CEST

Stanford is conducting an open-label, Phase 1, single-center study of KYV-101 in patients with non-relapsing progressive multiple sclerosis, either secondary progressive MS (SPMS) or primary progressive MS (PPMS). Six patients were enrolled in the study and four have been infused. The oral presentation features data from the four patients who received either 33M (n=3) or 100M CAR+T (n=1) cells dose levels using a bendamustine lymphodepleting regimen, with up to 12 months of follow-up. Key highlights are outlined below:

Safety: KYV-101 was well-tolerated with no serious adverse events (SAEs) or high-grade Cytokine Release Syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity Syndrome (ICANS).

Biological Activity: Data demonstrated robust CAR T-cell expansion in blood and penetration into the CNS, where expansion was detected in the cerebrospinal fluid (CSF) by Day 14 post infusion. Further, the reconstitution of B-cells to a naive phenotype in three patients with six months of follow-up supports a CAR T-induced immune reset (4th patient follow-up data pending).

Efficacy: Stable to improved EDSS was observed in the three patients with six-month follow-up. Clinically meaningful improvement in fatigue scores was observed at the last follow-up (3-12 months) in three patients, with two achieving a substantial clinical improvement in fatigue scores (4th patient follow-up data is pending).

UCSF Poster Presentation

Title: An Investigator Initiated Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants with Treatment Refractory Progressive Multiple Sclerosis
Presenter: Sasha Gupta, M.D., Assistant Professor, Neurology, UCSF Weill Institute for Neurosciences
Poster ID: P792
Date and Time: Thursday, September 25, 2025, 16:30-18:30 CEST

UCSF is conducting an open-label, Phase 1, single-center study of KYV-101 in patients with treatment refractory progressive multiple sclerosis. The poster presentation features data from two patients who have been enrolled in the study and received 33M CAR+T cells with up to 48 weeks of follow-up. Key highlights are outlined below:

Safety: KYV-101 demonstrated a tolerable safety profile with no high-grade CRS or ICANS.

Biological Activity: Data demonstrated successful penetration into the CNS compartment, with CAR T cells observed in the CSF by day 14 based on available data for one patient. In addition, B-cell reconstitution was observed in both patients by 24 weeks. Data available for one patient showed the reconstitution of B-cells to a naive phenotype by 24 weeks of follow-up, supportive of a CAR T-induced immune reset.

Efficacy: Stable to improved EDSS scores were observed for both patients – one at 24 weeks of follow-up and another at 48-weeks of follow-up.

About Multiple Sclerosis

Multiple sclerosis is a chronic autoimmune disease causing neurodegeneration, in which patients can experience a range of symptoms including blurred vision, slurred speech, tremors, numbness, extreme fatigue, problems with memory and concentration, and, in severe cases, the inability to walk or stand. B cells play a significant role in MS by producing autoantibodies that attack the protective sheath around nerves, activating T cells, and increasing inflammation. Current disease-modifying treatments for MS aim to reduce the frequency of disease relapses and delay progression of disability, but the disease remains a chronic condition that will progressively worsen for most patients.

About KYV-101

KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, KYV-101 has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases.

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating patients through the curative potential of cell therapy. Kyverna’s lead CAR T-cell therapy candidate, KYV-101, is advancing through late-stage clinical development with registrational trials for stiff person syndrome and myasthenia gravis, and two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications for the Company to advance into late-stage development. Additionally, its pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, including efficiently expanding into broader autoimmune indications and the potential to increase patient reach with KYV-102 using its proprietary whole blood rapid manufacturing process. For more information, please visit https://kyvernatx.com.

Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the topics to be presented at the ECTRIMS Congress; KYV-101’s potential within neuroimmunology-related autoimmune diseases; KYV-101’s potential to deliver durable drug-free, disease-free remission with a single dose; Kyverna’s engagement with regulators; and Kyverna’s clinical trials, investigator initiated trials and named-patient access data. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts: 

Investors: InvestorRelations@kyvernatx.com 
Media: media@kyvernatx.com 

¹ Includes patients treated in KYSA clinical trials, investigator-initiated trials, and “IH” or “Individueller Heilversuch,” also known as “named-patient basis access”. Similar to expanded access or compassionate use in the United States, IH is a regulatory mechanism in Germany that allows for the supply of a treatment that has not received marketing authorization for an individual patient in response to a request by the treating physician on behalf of the named patient. This option can be pursued for the expected benefit of a patient who has exhausted all available treatment options, under the discretion of the treating physician with the patient’s consent. The use of KYV-101 in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician.

TOMI Environmental Solutions Announces Specialized Service Provider for Healthcare and Mold Remediation




TOMI Environmental Solutions Announces Specialized Service Provider for Healthcare and Mold Remediation

FREDERICK, Md., Sept. 24, 2025 (GLOBE NEWSWIRE) — TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination solutions, today announced a new service provider this quarter, expanding the use of its SteraMist iHP technology. This new provider has invested approximately $185,500 in SteraMist mobile systems and BIT solution, launching its operations for mold and mycotoxins remediation in the healthcare industry. The provider has since secured a major contract to remediate a 400,000-cubic-feet space at a hospital including HVAC decontamination.

“We are incredibly excited to partner with them as they make strides into the healthcare industry,” said Elissa J. (E.J.) Shane, COO of TOMI Environmental Solutions. “Their leadership, which includes a prominent figure in restoration and seasoned personnel, brings unique industry and operating expertise. They have been extensively trained on our technology and are well-prepared to deliver exceptional service.”

This new service provider also has a working relationship with Enviro-Mist Inc., a long-standing exclusive partner of TOMI and experts in mold remediation. Enviro-Mist Inc. continues to use SteraMist for mold remediation as well as the decontamination of pharmaceutical and life sciences facilities throughout the West Coast, including a multi-year service contract for a Pfizer facility.

TOMI™ Environmental Solutions, Inc.: Innovating for a safer world®

TOMI™ Environmental Solutions, Inc. (NASDAQ: TOMZ) is a global decontamination and infection prevention company, providing environmental solutions for disinfection through the manufacturing, sales and licensing of its premier Binary Ionization Technology® (BIT™) platform. Invented under a defense grant in association with the Defense Advanced Research Projects Agency (DARPA) of the U.S. Department of Defense, BIT™ solution utilizes a low percentage hydrogen peroxide as its only active ingredient and uses patented ionized Hydrogen Peroxide (iHP™) technology in all SteraMist systems to create superior disinfection. TOMI products are designed to service a broad spectrum of use sites, including, but not limited to, hospitals and medical facilities, biosafety labs, pharmaceutical facilities, commercial and office buildings, schools, restaurants, meat and produce processing facilities, and police and fire departments.

For additional information, please visit http://www.steramist.com or contact us at info@tomimist.com

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These forward-looking statements include, without limitation, statements relating to TOMI’s products to serve healthcare sectors. Forward-looking statements involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These factors include, but are not limited to, our ability to maintain and manage growth and generate sales, our reliance on a single or a few products for a majority of revenues; the general business and economic conditions; and other risks as described in our SEC filings, including our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by us with the SEC and other periodic reports we filed with the SEC. The information provided in this document is based upon the facts and circumstances known at this time. Other unknown or unpredictable factors or underlying assumptions subsequently proving to be incorrect could cause actual results to differ materially from those in the forward-looking statements. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and we undertake no duty to update such information, except as required under applicable law.

INVESTOR RELATIONS CONTACT:
John Nesbett/Rosalyn Christian
IMS Investor Relations
tomi@imsinvestorrelations.com

Berry Street Earns Recognition from the American Diabetes Association




Berry Street Earns Recognition from the American Diabetes Association

The ADA’s Education Recognition Program certification ensures quality diabetes education and support for people living with diabetes.

NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) — Today, the American Diabetes Association^® (ADA)—the nation’s leading organization committed to fighting diabetes—announced the recognition of Berry Street through their Education Recognition Program (ERP). The diabetes self-management education and support (DSMES) service was originally recognized in February of 2025.

The ADA’s ERP certificate assures that educational services meet the National Standards for DSMES. The corresponding intervention provided is evidence-based and outcome driven. Services apply for recognition voluntarily and ADA-ERP recognition lasts for four years.

“DSMES is an essential part of managing diabetes and is as effective as diabetes medication. Therefore, all people with diabetes benefit from it,” said Barbara Eichorst, MS, RD, CDCES, the ADA’s vice president of health programs. “We applaud Berry Street for its commitment to providing value-based interventions such as DSMES, maximizing corresponding outcomes, and patient experience.”

According to the Centers for Disease Control and Prevention’s (CDC’s) National Diabetes Fact Sheet, there are over 38 million people, or 11.6%, of the U.S. population who have diabetes. While an estimated 29.7 million have been diagnosed, unfortunately 8.7 million people are not aware they have this disease. Each day, nearly 3,300 Americans are diagnosed with diabetes. Many will first learn they have diabetes when they are treated for one of its life-threatening complications—heart disease, stroke, kidney disease, blindness, nerve disease, or amputation. Diabetes is the eighth leading cause of death in the U.S.—in 2021, it contributed to 399,401 deaths. The ADA’s Economic Costs of Diabetes in the U.S. in 2022 report confirms diabetes continues to be one of the nation’s most expensive chronic health care conditions with an estimated cost of diagnosed diabetes of $412.9 billion.

“We know that evidence-based nutrition therapy plays an essential role in chronic disease management, especially diabetes, but many people don’t know it’s even an option. At Berry Street, we’re trying to change that,” said Noah Kotlove, Co-Founder and CEO of Berry Street. “This ADA recognition validates what we’re seeing every day—when people with diabetes have direct access to registered dietitians, clinical nutrition education, and continuous support, they achieve better outcomes.”

Learn more about the ADA’s ERP and other ERP-certified services.

About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation’s leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn). 

About Berry Street
Berry Street is on a mission to transform how Americans eat through nutrition therapy. Berry Street’s platform connects individuals needing evidence-based nutrition care with an expansive network of Registered Dietitians and AI-powered tools. From weight management, diabetes, and heart health to kidney disease, maternal health, and 25+ other conditions, Berry Street’s clinical team delivers personalized nutrition interventions tailored to each patient’s unique physiological and psychological needs, improving outcomes and reducing total cost of care. Berry Street works with some of the largest health plans, as well as leading health systems and innovative care management companies to serve diverse populations across all 50 states. Visit berrystreet.co to learn more.

CONTACT: Contact: Dori Zweig Young
berrystreet@crosscutstrategies.com

WORK Medical Technology Group LTD Partners with Hong Kong Web3.0 Standardization Association to Collaborate on Blockchain and RWA Innovations




WORK Medical Technology Group LTD Partners with Hong Kong Web3.0 Standardization Association to Collaborate on Blockchain and RWA Innovations

Hangzhou, China, Sept. 24, 2025 (GLOBE NEWSWIRE) — WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, today announced that it has entered into a strategic cooperation agreement (the “Agreement”) with Hong Kong Web3.0 Standardization Association Limited (the “Association”), an organization dedicated to standardization research in the Web3.0 sector, with a mission to promote the high-quality development of the global Web3.0 industry through standardization efforts. The partnership is expected to demonstrate resource sharing and complementary strengths, with the goal of pioneering innovation in the Real-world Asset (the “RWA”) sector. In recognition of this collaboration, WORK Medical has also been appointed as a Vice President Unit of the Association.

Caption: Work Medical and Hong Kong Web3.0 Standardization Association Limited sign a strategic cooperation agreement.

Pursuant to the Agreement, WORK Medical and the Association agree to collaborate on comprehensive, systematic and compliant blockchain solutions in areas such as asset tokenization, equity investment, and RWA technology development. Leveraging their respective technological capabilities and resource advantages, the parties aim to jointly explore new technologies and business models to drive mutual growth and strengthen industry influence, with a focus on:

• Asset Tokenization: Combining WORK Medical’s capital resources as a Nasdaq-listed company and its expertise in medical device manufacturing, with the Association’s resources and RWA platform, to advance the tokenization of the high-quality assets owned or invested in by WORK Medical.
• Joint Investment/Financial Vehicles: Integrating industrial and financial resources through co-investments or participation in funds and other investment/financial vehicles to accelerate the RWA market expansion and achieve shared strategic objectives.
• RWA Technology Development: Leveraging the Association’s newly launched RWA registration platform to collaborate on blockchain-based title verification of industry applications, asset issuance, and cross-chain transactions, while ensuring regulatory compliance of data assets and the secure issuance of assets throughout the collaboration.

The Hong Kong Web3.0 Standardization Association Limited is a cross-industry, non-profit organization committed to supporting the growth of Hong Kong’s Web3.0 ecosystem. Its initiatives include promoting technological advancement and industry upgrading, establishing standards, conducting professional research, and providing insights for future development. The Association also supports government policy implementation, enhances public awareness of Web3.0, and trains professionals, endeavoring to contribute to Hong Kong’s vision of becoming a world-leading Web3.0 smart city and a secure, sustainable digital financial hub. In August 2025, it furthered this mission by launching an RWA registration platform.

Mr. Wu Shuang, chief executive officer and chairman of the board of directors of WORK Medical, commented: “We are excited to establish a partnership with the Hong Kong Web3.0 Standardization Association, a milestone in our pursuit of innovation in the RWA domain. We endeavor to participate with the Association in the process of becoming a standard setter in this space while leveraging our strengths to drive innovation and accelerate the commercial adoption of RWA solutions.

About WORK Medical Technology Group LTD
WORK Medical Technology Group LTD, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, is a supplier of medical devices that develops and manufactures Class I and II medical devices and sells Class I and II disposable medical devices through operating subsidiaries in China. The Company has a diverse product portfolio comprising 21 products, including customized and multifunctional masks and other medical consumables. All the products have been sold in 34 provincial-level administrative regions in China, with 15 of them sold in more than 30 countries worldwide. The Company has received a number of quality-related manufacturing designations and has registered 17 products with the U.S. Food and Drug Administration allowing their products to enter the U.S. market. For more information, please visit the Company’s website: https://www.workmedtech.com/corporate.

Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results set forth in the Company’s annual report on Form 20-F and other documents filed by the Company with the U.S. Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

For more information, please contact:
WORK Medical Technology Group LTD
Investor Relations Department
Email: ir@workmedtech.com

Ascent Investor Relations LLC
Tina Xiao
Phone: +1-646-932-7242
Email: investors@ascent-ir.com

Alira Health Becomes First Platinum CRO Partner of the Wound Care Collaborative Community, Expanding Ongoing Work to Advance Wound Healing Innovation




Alira Health Becomes First Platinum CRO Partner of the Wound Care Collaborative Community, Expanding Ongoing Work to Advance Wound Healing Innovation

FRAMINGHAM, Mass., Sept. 24, 2025 (GLOBE NEWSWIRE) — Alira Health announced today that it has become the first Platinum CRO Partner of the Wound Care Collaborative Community (WCCC), demonstrating its continued commitment to advancing research and education in wound healing.

This partnership extends Alira Health’s ongoing collaboration with the WCCC, highlighted by its involvement in the diabetic foot ulcer (DFU) STEADY registry. The registry serves as a critical source of data to inform clinical, access, regulatory, and payer decisions, thereby accelerating innovation in wound care. Future expansions of the registry will include additional indications, such as venous leg ulcer (VLU).

Through this new partnership, Alira Health continues its support of the WCCC’s mission to ensure patients and healthcare professionals have access to safe, effective, and high-quality treatments for chronic wounds. The WCCC brings together clinicians, regulators, payers, industry leaders, and patient advocates to identify methods, tools, and clinical evidence that improve how stakeholders evaluate product safety, quality, and effectiveness.

“The Wound Care Collaborative Community plays a vital role in uniting stakeholders to address the most urgent challenges in wound care,” said Dr. Vickie R Driver, President and Chair of the Board of Directors for the Wound Care Collaborative Community. “Alira Health’s support, along with our history of collaboration, will help us expand key initiatives and advance our shared goal of improving access to wound innovation and patient outcomes.”

In addition to supporting the DFU and VLU registries, Alira Health’s partnership will help advance educational initiatives, including interactive workshops on clinical trial operations for WCCC members and access to Alira Health’s Patient Engagement Certification (PEC) program. The first group of WCCC participants will begin PEC training later this year, gaining skills to embed patient perspectives into wound care research.

“We are honored to continue working with the WCCC and to expand our involvement as a platinum partner,” said Gabriele Brambilla, CEO of Alira Health. “Together, we can build on the foundation we’ve established with the DFU registry and help bring innovative therapies to patients sooner, while strengthening connections between patients, providers, regulators, and industry.”

This announcement marks the beginning of a multi-year collaboration. Alira Health and the WCCC will share updates on research milestones and educational opportunities as these initiatives advance.

About the Wound Care Collaborative Community (WCCC)
The WCCC is a multi-stakeholder initiative dedicated to improving outcomes for patients with chronic wounds. Its mission is to ensure that patients and healthcare professionals have access to safe, effective, and high-quality medical devices and drugs to treat chronic wounds. The WCCC works in a pre-competitive space to identify methods, tools, and clinical evidence that enhance understanding and evaluation of product safety, quality, and effectiveness. Through its initiatives, the WCCC improves product safety, increases patient access to innovative therapies, and reduces costs and time to market. To learn more about the WCCC, please visit www.woundcarecc.org.

About Alira Health
Alira Health is a global healthcare consultancy that partners with life sciences companies to deliver patient-centered solutions. We generate and apply evidence across the product lifecycle through four integrated capabilities: CRO services, consulting, patient engagement training, and technology. Our approach helps clients improve access, adoption, and impact, guided by the voice of the patient. To learn more about Alira Health, please visit alirahealth.com.

CONTACT: PRESS CONTACT
Alira Health: Susan Irving – susan.irving@alirahealth.com

Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option




Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option

VICTORIA, British Columbia, Sept. 24, 2025 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, is pleased to announce the successful closing of its previously announced public offering (the “Offering”) of 14,636,363 common shares of the Company (the “Common Shares”), which includes the full exercise of the option to purchase additional shares granted to the underwriters, at a price to the public of US$5.50 per Common Share for gross proceeds of approximately US$80.5 million, before deducting the underwriting commissions and estimated expenses incurred in connection with the Offering.

“This financing represents a pivotal milestone for Eupraxia, enabling us to accelerate the development of EP-104GI for eosinophilic esophagitis and advance toward our upcoming Phase 2b clinical readout, plus other key clinical and regulatory milestones,” said James Helliwell, CEO of Eupraxia. “The strong participation from leading life-science focused investors validates both our strategy and technology, and with this financing, we believe we are now capitalized into the first quarter of 2028, providing the resources and flexibility to deliver on our vision.”

Cantor and LifeSci Capital acted as joint book-running managers for the Offering. Bloom Burton also acted as co-manager for the Offering.

As previously stated, the Company intends to use the net proceeds from the Offering primarily for the continued advancement of its product pipeline, including the completion of ongoing preclinical studies and clinical trials, regulatory submissions, and associated commercial preparation and manufacturing scale-up activities. A portion of the proceeds will also be allocated to research and development of additional pipeline candidates, business development initiatives, and general corporate purposes, which may include but are not limited to employee salaries, working capital, leases for facilities, administrative expenses, and capital expenditures. The Company may also use a portion of the proceeds to expand its intellectual property portfolio and strengthen its corporate infrastructure to support future growth.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on February 7, 2024, and the Company’s existing Canadian short form base shelf prospectus, (the “Base Prospectus”) dated February 5, 2024. A preliminary prospectus supplement and a final prospectus supplement (the “Supplement”) relating to and describing the terms of the Offering were filed with the securities commissions in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering.

The Supplement and accompanying Base Prospectus can be found on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com, from LifeSci Capital LLC at 1700 Broadway, 40^th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com, or from Bloom Burton Securities Inc. at ecm@bloomburton.com.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

About Eupraxia Pharmaceuticals Inc.

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs.

Notice Regarding Forward-looking Statements and Information

This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “suggests”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (including negative and grammatical variations) of such words and phrases, or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the anticipated use of proceeds from the Offering; expectations around the development of EP-104GI, upcoming Phase 2b clinical trial readouts, and other clinical and regulatory milestones; expected capitalization into the first quarter of 2028; and the potential for the Company’s technology to impact the drug delivery process. Such statements and information are based on the current expectations of Eupraxia’s management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company’s ability to obtain positive results from the Company’s research and development activities, including clinical trials; and the Company’s ability to protect patents and proprietary rights. Although Eupraxia’s management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company’s limited operating history; the Company’s novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the Company’s technology may not be successful for its intended use; the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its product candidates and services; the potential impact of tariffs on the cost of the Company’s active pharmaceutical ingredients and clinical supplies of EP-104IAR and EP-104GI; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company’s ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company’s operations; the Company’s restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company’s common share price; and other risks and uncertainties described in more detail in Eupraxia’s public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.

For investor and media inquiries, please contact:
Danielle Egan, Eupraxia Pharmaceuticals Inc.
778.401.3302
degan@eupraxiapharma.com

or

Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617.283.2856
kgardner@lifesciadvisors.com

SOURCE Eupraxia Pharmaceuticals Inc.

Artios Receives U.S. FDA Fast Track Designation for alnodesertib in ATM-negative Metastatic Colorectal Cancer (mCRC)




Artios Receives U.S. FDA Fast Track Designation for alnodesertib in ATM-negative Metastatic Colorectal Cancer (mCRC)

• U.S. Fast Track designation underscores the strength of the alnodesertib clinical data generated to date and the high degree of unmet need in 3L mCRC

CAMBRIDGE, United Kingdom and NEW YORK, September 24, 2025 – Artios Pharma Limited (“Artios”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its ATR inhibitor, alnodesertib, in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting.

“The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors,” said Mike Andriole, Chief Executive Officer of Artios. “Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease. Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors.”

The designation is supported by encouraging results from the ongoing STELLA Phase 1/2a study, which is evaluating alnodesertib in combination with a low dose of irinotecan. Beyond third-line mCRC, clinical responses were observed in seven additional solid tumor types with ATM deficiency. The combination of alnodesertib plus low-dose irinotecan has a favorable safety profile to date, has been well tolerated, and has been shown to be suitable for long-term dosing.ⁱ

“Patients with third-line colorectal cancer face a dismal prognosis, with current standards of care for third-line mCRC delivering response rates in the single digits. In our studies to date, alnodesertib has demonstrated compelling clinical activity in ATM-negative patients with mCRC as well as in other heavily pretreated cancer types with high endogenous replication stress,” said Ian Smith, Chief Medical Officer of Artios. “These results, together with activity across other solid tumors, highlight alnodesertib’s potential to deliver meaningful benefit where treatment options are limited. The FDA’s Fast Track designation recognizes both the strength of our early clinical data and the urgent need for new therapies, while also providing the opportunity for enhanced interactions with the Agency.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. The Fast Track designation for alnodesertib was granted based on early Phase 1/2 clinical studies that are currently ongoing in the United States. The designation will enable Artios to interact early and more frequently with the FDA to discuss alnodesertib’s development path.

About Alnodesertib
Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). Artios’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency. 

About Artios Pharma Ltd.
Artios is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. Artios’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at www.artios.com for more information about the company.

For more information, please contact:

Trophic Communications
Jacob Verghese or Verena Schossmann
Tel: +49 151 7441 6179
Email: artios@trophic.eu

ⁱ Artios Pharma Reports Differentiated Clinical Activity in STELLA Phase 1/2a Study for Lead Program ART0380