The Company announces the vesting of an award under the Mothercare plc 2019 long term incentive plan.
Further details of the notifications as required under Article 19 of the EU Market Abuse Regulation are set out below:
Mothercare plc (the “Company”) Transaction notification
1.
Details of the person discharging managerial responsibilities/persons closely associated
a)
Name
Andrew Cook
2.
Reason for notification
a)
Position/Status
CFO
b)
Initial notification/amendment
Initial notification
3.
Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a)
Name
Mothercare PLC
b)
LEI
213800ZL6RPV9Z9GFO74
4.
Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)
Description of the financial instrument, type of instrument and identification code
Ordinary Shares of £0.01 each in the capital of Mothercare plc ISIN: GB0009067447
b)
Nature of transaction
Vesting of nil cost options under the Mothercare plc Long-Term Incentive Plan
c)
Price(s) and volume(s)
Price(s)
Volume(s)
£nil per share
3,000,000*
d)
Aggregated Information
n/a
e)
Date of transaction
25 September 2026 Vesting Date
f)
Place of transaction
London
*Sufficient shares were sold to cover tax and NI liabilities resulting in a balance of 1,561,428. Mr Cook’s total holding is now 8,423,803
Delivering up to 180 FPS on NVIDIA Jetson Thor, Seeing Machines HMR combines state-of-the-art accuracy with low latency and compact model size for embedded deployment
Real-time 3D human geometry in the Unitree G1 Robot
CANBERRA, Australia, Sept. 30, 2026 (GLOBE NEWSWIRE) — Seeing Machines Limited (AIM: SEE), the advanced computer vision company that has helped redefine transport safety through AI-powered human sensing, today published a Technical Paper demonstrating how robots and other Physical AI systems can achieve real-time 3D human understanding directly on embedded hardware, enabling safer and more natural human-machine interaction.
The paper presents Seeing Machines’ Human Mesh Recovery (HMR) technology, a core capability of the Company’s Human-Centred Physical AI Platform, launched in August 2026. Using a single camera view, HMR reconstructs a detailed 3D representation of a person so that a machine can understand their location, posture and movement in real time. This capability is designed for environments where robots and people need to work safely and effectively together, including factories, hospitals, warehouses and other dynamic environments.
Physical AI systems operating around people must do more than detect a person’s presence. To respond safely and effectively as interactions unfold, robots need to understand a person’s position, posture and movement in real time. Until now, high-fidelity 3D human reconstruction has typically required significant computing resources, making real-time deployment on embedded devices challenging.
Seeing Machines’ HMR technology addresses this constraint by delivering detailed 3D human understanding at the edge. Processing information locally allows robots to respond to a person’s position and movement in real time without relying on a remote cloud connection.
The paper demonstrates Seeing Machines HMR’s compelling balance of accuracy, inference speed and model efficiency when deployed on the NVIDIA Jetson Thor hardware. The results demonstrate that high-fidelity 3D human reconstruction can be performed in real time on embedded hardware previously considered unsuitable for this level of scene understanding.
The HMR model supports both standard RGB cameras and RGB-D cameras without increasing its parameter count.
Paul McGlone, CEO of Seeing Machines, said:“For robots to work safely and effectively alongside people, they need to understand more than simply whether someone is present. Our HMR technology delivers a compelling combination of accuracy, latency and model size on embedded hardware, bringing detailed 3D human understanding into real-world environments. This research demonstrates how Seeing Machines’ 25 years of human-sensing expertise can support the next generation of Physical AI.”
HMR is a core capability within Seeing Machines’ broader Human-Centred Physical AI Platform, which combines the company’s expertise in computer vision, human behaviour and safety-critical AI to enable machines to interpret people and their environments in three dimensions.
Seeing Machines brings more than 25 years of experience developing and deploying Human-Centred AI solutions across automotive, commercial fleet, aviation, rail and off-road applications, providing an established foundation for its expansion into robotics and industrial automation.
About Seeing Machines (AIM: SEE): Seeing Machines is a global technology company founded in 2000 and headquartered in Australia, pioneering Human-Centred AI that enables machines to understand people and the environments in which they operate. Combining more than 25 years of Human Factors research with advanced AI, the company develops Safety AI technology that helps machines anticipate risk, make safer decisions in real time, and enable more natural, intuitive human-machine interactions. Seeing Machines combines AI algorithms, embedded processing and optics across its Cabin AI, Cockpit AI and Physical AI platforms, serving automotive, commercial transport, aviation, robotics and industrial automation. The company operates across Australia, the USA, Europe and Asia, supplying technology solutions and services to industry leaders worldwide. www.seeingmachines.com
AI-enabled digital pathology analysis shows aglatimagene significantly increased lymphocyte infiltration and immune engagement with tumor cells compared to standard-of-care radiotherapy alone two years after treatment
NEEDHAM, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) — Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal immunotherapies to improve disease outcomes for patients with cancer, today announced the presentation of new biomarker data from its completed phase 3 clinical trial of aglatimagene besadenovec (aglatimagene) in patients with localized intermediate- to high-risk prostate cancer at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2026.
The Company used digitized hematoxylin and eosin-stained prostate biopsy samples collected at baseline and after treatment with either aglatimagene or placebo, from patients who had completed the 3-injection course (n=647) in the randomized, placebo-controlled phase 3 study (NCT01436968). AI-enabled digital pathology analysis performed on tumor biopsies evaluable for digital analysis (622 pre-treatment and 427 post-treatment collected more than two years after completion of radiation), demonstrates that aglatimagene plus external beam radiation therapy (EBRT) significantly increased intratumoral lymphocyte infiltration and remodeled the tumor microenvironment compared with placebo plus EBRT. Among those patients with residual tumor, aglatimagene increased lymphocyte infiltration within tumor regions and enhanced lymphocyte-tumor engagement.
Key Highlights from ASTRO 2026 Presentation:
The Company previously reported that two years after treatment, 80% of evaluable aglatimagene patients (n=167) had negative prostate biopsies versus 63% of control patients (n=62) (p=0.0018)
Aglatimagene significantly increased overall lymphocytic fraction compared to control (p=0.048), with both arms showing immune activation from radiation therapy (p<0.001) (calculated in all digital-pathology evaluable biopsies; 622 pre-treatment biopsies and 427 post-treatment biopsies analyzed)
In paired biopsies from patients with residual tumor (n=108; aglatimagene n=62, control n=46), aglatimagene significantly increased intratumoral lymphocyte fraction (p=0.006), lymphocyte-tumor enrichment (p=0.003), and lymphocyte-tumor mixing (p<0.001)
“While radiation therapy alone drives immune infiltration into prostate tumors, these data support that aglatimagene produced a qualitatively distinct immune response,” said Francesca Barone, M.D., Ph.D., Chief Scientific Officer of Candel Therapeutics. “The significantly greater lymphocyte infiltration and sustained lymphocyte-tumor engagement which we observed, more than two years after treatment, supports durable immune remodeling rather than transient inflammation. This mechanistic insight may help explain the clinical improvements in disease-free survival and pathologic outcomes we reported in the phase 3 trial.”
“These tissue-level findings provide important biological support for the clinical benefit demonstrated in our phase 3 trial,” said Paul Peter Tak, M.D., Ph.D., FMedSci, President and Chief Executive Officer of Candel. “We believe the convergence of sustained immune remodeling, improved pathologic response, and a clinically meaningful improvement in disease-free survival provides a compelling and coherent picture of aglatimagene’s activity in localized prostate cancer as we advance toward our planned Biologics License Application submission.”
The data was presented by Dr. Barone during the Genitourinary Cancer session at ASTRO 2026 on September 29, 2026, and the poster is titled “Quantitative digital pathology defines immune activation following aglatimagene besadenovec immunotherapy in localized prostate cancer” (Abstract LBA 30).
About aglatimagene besadenovec
Aglatimagene besadenovec (aglatimagene), Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s tumor. After intratumoral administration, HSV-tk enzyme activity results in conversion of prodrug (valacyclovir) into deoxyribonucleic acid (DNA)-incorporating nucleotide analogs, leading to immunogenic cell death in cells exhibiting DNA damage and proliferating cells, with subsequent release of a variety of tumor (neo)antigens in the tumor microenvironment. At the same time, the adenoviral serotype 5 capsid proteins promote inflammation through the induction of expression of pro-inflammatory cytokines, chemokines, and adhesion molecules. Together, this regimen is designed to induce an individualized and specific CD8+ T cell-mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity, based on in situ immunization against a variety of tumor antigens. Aglatimagene has the potential to treat a broad range of solid tumors. Encouraging monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several nonclinical and clinical settings. More than 1,000 patients have been dosed with aglatimagene in clinical trials with a favorable tolerability profile to date, supporting the potential for use with standard of care, when indicated. Aglatimagene is currently not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority for any use.
About Candel Therapeutics
Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf multimodal biological immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. Aglatimagene besadenovec (aglatimagene) is the lead product candidate from the adenovirus platform. The Company completed successful phase 2a clinical trials of aglatimagene in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC), and a pivotal, placebo-controlled, phase 3 clinical trial of aglatimagene in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the FDA and published in The Lancet Oncology. The FDA also granted Fast Track Designation and Regenerative Medicine Advanced Therapy Designation to aglatimagene for the treatment of newly diagnosed localized prostate cancer in patients with intermediate- to high-risk disease, Fast Track Designation in NSCLC, and both Fast Track Designation and Orphan Drug Designation to aglatimagene for the treatment of PDAC.
Linoserpaturev is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma, evaluating the effects of repeat linoserpaturev injections. Initial results were published in Nature and Science Translational Medicine and linoserpaturev received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.
This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs, including expectations regarding planned BLA submission and potential commercial readiness; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat, solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s nonclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; the impact of the Company’s existing and any future indebtedness on its ability to operate its business; the Company’s ability to access any future tranches under its debt facility and to comply with all of its obligations thereunder; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.
Investor Contact Theodore Jenkins Vice President, Investor Relations, and Business Development Candel Therapeutics, Inc. tjenkins@candeltx.com
Chiara Antonelli is a test bench leader. She recently volunteered at a hospital in Africa, to create a photo-reportage for an Italian humanitarian charity. This is her story.
Hello Chiara. Could you please introduce yourself and tell us a little bit more about your current role at Baker Hughes?
Chiara Antonelli
I am Chiara Antonelli. I’m based in Massa, Italy, one of the largest turbomachinery manufacturing plants in this country. I am currently a test bench leader for the turbomachinery string test cell. I coordinate and supervise the testing activities in the plant. It is an exciting job, which I started nine months ago. Previously I was in the planning team for the same department.
I am also a hub leader for the Employee Resource Group Women’s Network and for one of our culture initiatives People First at the local site. Click here to find out more about these Baker Hughes programs.
I really enjoy building a network outside of my direct work team, to feed my curiosity and make new connections.
Tech explainer
What is a turbomachinery string test?
A turbine string test is a factory acceptance test where a complete machinery train—typically a driver (turbine/motor), gearbox, and driven equipment (compressor/pump)—is coupled and tested together as one unit. It simulates site operating conditions to verify mechanical performance, vibration, and thermal behavior, ensuring all components operate properly together before field installation.
To validate the entire system, the string test team will identify vibration or misalignment, and avoid expensive on-site, last-minute modifications.
The components tested are gas turbines, compressors, motors, and auxiliaries connected in a “string”.
The test monitors bearing temperatures, rotor dynamics, and vibration at full speed and load.
Here is an example of how this can also be done virtually.
Question:
Which Baker Hughes technologies go through testing in Massa?
Chiara Antonelli
We test new turbomachinery units manufactured in the Massa and Florence plants, or upgrades to existing units. As a key part of the supply chain, the test bench is the last department once a unit is being packaged and completed, before dispatch for delivery. The customer can ask for additional testing activities, for both new units and upgrades. This is way to ensure quality checks before our products are installed at the customer sites.
When I mention ‘units’, it can be gas turbines or compressors.
The test carried out is for the main skid and its auxiliaries. We test the skid using the same site operating conditions as at the customer’s site.
We use different configurations for the testing of the equipment, to recreate operating conditions as realistically as possible. My team consists of 15 people, divided into mechanical and electrical sub-teams, and is led by Andrea Riccucci, while I oversee the operational activities.
Tech explainer
What is a skid?
A skid is a modular, steel-framed platform holding auxiliary equipment for gas/ steam turbines or compressors, such as fuel conditioning, lube oil systems, or cooling systems. These self-contained units treat, control, or transport fluids and gases to the main item, improving performance and protecting sensitive components from contamination. Baker Hughes technologies cover virtually every application across the oil and gas value chain, and in other industries, too. Power plants, LNG, and pipeline transmission feature some of the most well-known, innovative solutions.
Question:
Could you please explain what your journey through education and previous roles were, to get to where you are today?
Chiara Antonelli
I am a Management Engineer. I graduated from Pisa University, and I originally joined Baker Hughes in 2022 as an intern working on continuous improvement. Since then, I completed my master’s degree while working with this amazing team. The company gave me the opportunity to take both paths in parallel: academic and professional.
Question:
You recently had the opportunity to volunteer for an unusual project in Africa. Can you please describe how this came about?
Chiara Antonelli
Since 2009, I’ve watched my father, who is an anesthetist, pack his suitcase for humanitarian missions. He would come home with vivid stories of new worlds for my brother and me.
Over the years, I came to understand the deeper meaning of such missions: helping others and receiving in return a profound sense of gratitude.
I have been waiting for an occasion to join him for a long time; I just didn’t really know how to access such an opportunity with my career. My brother is a nurse now, so he will be able to do this as part of his job. But for me it was a little less obvious.
I should also mention, I have always loved photography, I practiced it as a hobby but worked freelance during my studies. I have experience with product marketing and wedding photography. Since becoming an engineer, I have kept it alive when I get the opportunity.
Last year, my dad called to let me know the charity Emergenza Sorrisi he was working with needed a reporting photographer during their next humanitarian mission in the Republic of the Congo (RDC). So, he suggested I send my resume, to see if it would be a good fit for me to join them, and I was accepted in the team!
Chiara Antonelli, right, with her father, in the operating room, dressed up and ready for the next patient when in RDC.
As you can imagine, ahead of making it to RDC, we encountered logistical complexities, including last-minute travel arrangements, required vaccinations, and safety checks due to the geopolitical situation.
Once in Brazzaville (RDC), everything I had imagined through my father’s stories took shape — the sounds, the colors, the emotions and experiencing this next to him made it even more meaningful.
I was there for a week. I took it as annual leave from Baker Hughes.
From 8am to 8pm, our daily routine was simple: breakfast, then straight to the hospital. While the medical staff was operating, I was staying with the families and the children awaiting treatment and reporting on the day’s activities for the charity, then back for a quick dinner and a rest.
The language barrier was an issue at times, as local people speak French and unfortunately, I don’t. So, we had to go through team mates to translate. It was so gratifying getting to know the patients, discovering their stories and understanding their culture.
Chiara Antonelli (front row) with the Emergenza Sorrisi team and the local staff, in front of Brazzaville's Hospital entrance
Charity description:
Emergenza Sorrisi ETS (Doctors for Smiling Children) is a humanitarian organization that, since 2007, has been providing free specialized surgical care and medical assistance to the most vulnerable children living in fragile contexts, where access to healthcare is limited or non-existent. Active in more than 31 countries, it carries out missions thanks to the voluntary work of over 300 highly qualified doctors, nurses, and healthcare professionals, and has given a new life to more than 8,000 children.
The organization’s mission focuses on treating severe craniofacial malformations, burn sequelae, and disabling traumas — including those caused by armed conflicts — which compromise vital functions such as breathing, speech, and nutrition, often leading to social exclusion.
Question:
Can you please explain what happens now with the photos you took during the mission?
Chiara Antonelli
The charity relies on donations from corporate organization and the Italian government for example, as well as private donors. The photography is used to help document the organization’s work around the world, for their website, on social media and for presentations to potential patrons. It is important to record a day in the life of the children and families and the benefits of the work of the mission.
In the week I was there, 43 children were operated on, around double what was expected, thanks to the additional support from the local staff. Patients from all over the RDC come to the Brazzaville Children’s Hospital. The mission staff supported screening and specialized interventions on cranial fascial malfunctions. The team took the opportunity to also train local staff while on site.
The main purpose is to make the process sustainable so that local staff and community can benefit during and after the visit from the team from Italy. I truly felt that what they choose to do for the local community is inspiring.
Chiara Antonelli, with one of the patients post-operation, taking photos for the mission
Question:
Now that you are back at work, can you tell us how you feel this experience already has or will influence your work. What did you learn?
Chiara Antonelli
I think I can explain by referring to the Baker Hughes values, grow, collaborate, lead and care, which are relevant here
I believe empathy or care in this instance is one of the main aspects of this journey for me. You never know what the person in front of you is going through in their life. That’s an important perspective to take in everyday interactions with colleagues and people in general.
Making connections and stepping out of your comfort zone is essential to continue to learn. I was not part of the medical staff, yet I was able to help the patients, families and their children as they were waiting to be seen by the doctors and in the operating room. Taking photos and interacting created a distraction in a very tense situation. I realized I could be of some help, even though I am an engineer in ‘real life’. This was very gratifying and meaningful to me. This also resonated with the collaborate value- taking care of each other and understanding others to help them.
I do feel better equipped to lead, in the sustainable energy development context of our industry. As I mentioned earlier, the mission’s aim is to make work methods more sustainable for future operations in the hospital, well beyond the week of planned interventions. This was a key learning for me. When you do something with people at work, you also teach them how to do it themselves, to make it work. This is very important in my daily work for knowledge transfer, both when I am coaching others and learning.
Finally, I am convinced this experience made me grow not only as a leader, but also as a human. Witnessing the relief and gratitude of the parents, after experiencing the stress and the worry for their children, was priceless. To feel all the emotions of this intense experience, while bringing back so many memories is transformative.
Recognition includes Life Sciences Manufacturer CEO of the Year, Podcast Initiative, and Marketing Team of the Year
WALTHAM, Mass., Sept. 30, 2026 (GLOBE NEWSWIRE) — Ardelyx, Inc. (Nasdaq: ARDX), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs, today announced that it received multiple honors at the 2026 PM360 Trailblazer Awards, recognizing the company, its leadership, and the work of teams across the organization.
Ardelyx received the following awards:
Life Sciences Manufacturer CEO of the Year: Mike Raab
Podcast Initiative Gold Winner: Gut Matters: Discoveries and Innovations
Marketing Team of the Year Silver Winner: IBSRELA Marketing Team
“We are honored to receive this recognition from PM360,” said Mike Raab, president and chief executive officer of Ardelyx. “These awards reflect the dedication and creativity of our employees across Ardelyx. From advancing our science and growing our company to elevating patient perspectives and connecting with the communities we serve, our work is grounded in a shared sense of purpose. I am incredibly proud of our team and grateful for their contributions.”
Raab was named Life Sciences Manufacturer CEO of the Year in recognition of his leadership in guiding Ardelyx from an early-stage biotechnology company into a commercial, multi-product biopharmaceutical organization. Since becoming CEO in 2009, Raab has led the company through the development and commercialization of two first-in-class medicines, significant organizational growth, and continued expansion of its development pipeline. He also contributes to the broader biotechnology industry through leadership roles with the Biotechnology Innovation Organization and the Midsized Biotech Alliance of America.
Gut Matters: Discoveries and Innovations received the Gold Podcast Initiative award. Hosted by Johannah Ruddy, DHSc, MEd, senior director of patient advocacy at Ardelyx, and gastroenterologist Andrea Shin, MD, Gut Matters brings together patients, caregivers, advocacy leaders, and medical experts for credible and informative conversations about IBS-C and other disorders of gut-brain interaction. This recognition follows the podcast’s recent Fierce Pharma Marketing Award win.
The IBSRELA Marketing Team received the Silver Marketing Team of the Year award, recognizing the team’s strategic, collaborative, and patient-focused approach.
Together, the awards recognize Ardelyx’s growth as a company and the contributions of its leaders and employees to advancing innovation, supporting patients, and developing new approaches to life sciences education and engagement.
The PM360 Trailblazer Awards recognize outstanding companies, leaders, marketers, teams and initiatives in the life sciences industry. Winners were selected by the PM360 Editorial Advisory Board and announced during the annual Trailblazer Awards Gala held September 29, 2026, in New York City.
About PM360
PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, diagnostics, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharmaceutical marketing professionals to succeed in the complex and highly regulated healthcare environment.
The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: Planning and implementation of cutting-edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the “360” in the title signifies the span of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing a full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.
About Ardelyx Ardelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). The company’s pipeline includes the Phase 3 development of IBSRELA for chronic idiopathic constipation (CIC) and RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. Ardelyx works with partners to develop and commercialize our products outside of the United States. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
Millions of people across the United States face food insecurity, making it harder to stay healthy, manage chronic conditions and focus on everyday life. During Hunger Action Month, CVS Health is highlighting the organizations working every day to ensure individuals and families can access the nutritious meals they need.
Feeding America’s Map the Meal Gap 2026 study underscores the ongoing challenges many families face in putting food on the table. Nearly 48 million people, including 14 million children, experienced food insecurity in 2024. With food insecurity affecting every U.S. community, the findings reinforce the importance of local organizations, community collaborations and innovative programs that help connect individuals and families to nutritious food and support healthier outcomes.
Investing in solutions that meet community needs
Because every community faces different challenges, there is no one-size-fits-all approach to addressing food insecurity. CVS Health supports organizations working on the ground to create solutions tailored to local needs.
In recent years, the company and the CVS Health Foundation have invested in nonprofit organizations helping expand food access, provide medically-tailored meals and strengthen community food systems. Recent investments include support for Feeding America’s Meal Connect platform, which helps reduce food waste while increasing access to nutritious food, as well as Community Servings’ Food is Medicine Accelerator Program, which expands medically tailored nutrition programs through training and fundraising assistance throughout the country.
CVS Health and the CVS Health Foundation have also provided funding to nonprofit organizations focused on food insecurity solutions, including No Kid Hungry, Meals on Wheels of New Jersey, Harlem Grown, Windy City Harvest, Central California Food Bank and other community-based organizations working to support healthier outcomes through nutritious meal programs, prescription food boxes, urban agriculture, and community gardening efforts that increase access to fresh, healthy foods. Recently, CVS Health helped support the opening of a new, school-based food pantry inside Woonsocket High School in Rhode Island, giving local students and families immediate access to essential groceries on campus.
Taking action through volunteerism
Addressing food insecurity requires more than financial support. Volunteers play an essential role in helping food banks and community organizations sort, pack, and distribute food to individuals and families facing hunger.
Throughout the year, CVS Health and Aetna colleagues volunteer with food banks, meal programs, community gardens, and nonprofit organizations across the country, helping strengthen local food systems and support neighbors in need. These volunteer efforts provide critical hands-on support at a time when many food banks are experiencing increased demand and serving more families than ever before.
Hunger Action Month is also an opportunity for customers and community members to get involved. Whether volunteering at a local food pantry, participating in a food drive or supporting a community meal program, even a few hours of service can help organizations expand their reach and provide nutritious food to more people.
Building healthier communities together
Creating healthier communities requires both investment and action. Through volunteer efforts, charitable giving and collaborations with organizations working on the front lines of hunger relief, CVS Health colleagues and customers are helping make a meaningful difference in the lives of neighbors across the country.
This Hunger Action Month, CVS Health encourages everyone to find a way to get involved and help build a future where everyone has access to nutritious food.
Millions of people across the United States face food insecurity, making it harder to stay healthy, manage chronic conditions and focus on everyday life. During Hunger Action Month, CVS Health is highlighting the organizations working every day to ensure individuals and families can access the nutritious meals they need.
Feeding America’s Map the Meal Gap 2026 study underscores the ongoing challenges many families face in putting food on the table. Nearly 48 million people, including 14 million children, experienced food insecurity in 2024. With food insecurity affecting every U.S. community, the findings reinforce the importance of local organizations, community collaborations and innovative programs that help connect individuals and families to nutritious food and support healthier outcomes.
Investing in solutions that meet community needs
Because every community faces different challenges, there is no one-size-fits-all approach to addressing food insecurity. CVS Health supports organizations working on the ground to create solutions tailored to local needs.
In recent years, the company and the CVS Health Foundation have invested in nonprofit organizations helping expand food access, provide medically-tailored meals and strengthen community food systems. Recent investments include support for Feeding America’s Meal Connect platform, which helps reduce food waste while increasing access to nutritious food, as well as Community Servings’ Food is Medicine Accelerator Program, which expands medically tailored nutrition programs through training and fundraising assistance throughout the country.
CVS Health and the CVS Health Foundation have also provided funding to nonprofit organizations focused on food insecurity solutions, including No Kid Hungry, Meals on Wheels of New Jersey, Harlem Grown, Windy City Harvest, Central California Food Bank and other community-based organizations working to support healthier outcomes through nutritious meal programs, prescription food boxes, urban agriculture, and community gardening efforts that increase access to fresh, healthy foods. Recently, CVS Health helped support the opening of a new, school-based food pantry inside Woonsocket High School in Rhode Island, giving local students and families immediate access to essential groceries on campus.
Taking action through volunteerism
Addressing food insecurity requires more than financial support. Volunteers play an essential role in helping food banks and community organizations sort, pack, and distribute food to individuals and families facing hunger.
Throughout the year, CVS Health and Aetna colleagues volunteer with food banks, meal programs, community gardens, and nonprofit organizations across the country, helping strengthen local food systems and support neighbors in need. These volunteer efforts provide critical hands-on support at a time when many food banks are experiencing increased demand and serving more families than ever before.
Hunger Action Month is also an opportunity for customers and community members to get involved. Whether volunteering at a local food pantry, participating in a food drive or supporting a community meal program, even a few hours of service can help organizations expand their reach and provide nutritious food to more people.
Building healthier communities together
Creating healthier communities requires both investment and action. Through volunteer efforts, charitable giving and collaborations with organizations working on the front lines of hunger relief, CVS Health colleagues and customers are helping make a meaningful difference in the lives of neighbors across the country.
This Hunger Action Month, CVS Health encourages everyone to find a way to get involved and help build a future where everyone has access to nutritious food.
Global Phase 2/3 trial evaluates SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer
Integrated regimen combines direct EUS-guided intratumoral delivery to penetrate tumor stroma with subcutaneous dosing; first patient treated at Tel Aviv Sourasky Medical Center (Ichilov)
Grand Cayman, Cayman Islands and Ramat Gan, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) — Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced that the first patient worldwide has been successfully dosed in its Phase 2/3 clinical trial evaluating the Company’s lead candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The treatment was administered at Tel Aviv Sourasky Medical Center (“TASMC” or “Ichilov”) in Israel, marking a defining transition into active clinical execution for the Company’s global therapeutics program.
The trial is a prospective, randomized, controlled, multinational, Phase 2/3, open-label study evaluating the efficacy and safety of SIL204 administered as an integrated therapeutic regimen in combination with standard-of-care chemotherapy, versus chemotherapy alone, in patients with LAPC. The study is structured with an initial safety run-in cohort of approximately 18 patients, followed by global expansion to enroll a randomized cohort of approximately 166 patients. The trial enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 LAPC without distant metastases whose tumors harbor a confirmed KRAS mutation. SIL204 is administered as a first-line regimen alongside standard chemotherapy, with the choice of chemotherapy at the treating physician’s discretion.
In this trial, SIL204 is administered via an innovative dual-route delivery strategy designed to address the anatomical and biological barriers of pancreatic tumors. Treatment combines direct intratumoral administration via an endoscopic ultrasound (EUS)-guided procedure, targeting the primary pancreatic lesion to bypass dense tumor stroma, with subcutaneous abdominal injections designed to provide systemic exposure and address potential micro-metastases.
“Successfully dosing the first patient in our Phase 2/3 clinical trial of SIL204 is a defining operational and clinical milestone for Silexion, transitioning our lead RNAi program into active patient treatment,” said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. “Locally advanced pancreatic cancer is one of the most aggressive and lethal solid tumors, with patients facing a persistent lack of new therapeutic options. By combining direct local tumor penetration with systemic coverage, our integrated regimen is engineered to overcome the critical delivery barriers that have historically limited pancreatic cancer treatments. We are thrilled to initiate dosing at Tel Aviv Sourasky Medical Center and look forward to advancing additional clinical trial sites across Israel and Germany, as we work toward preliminary clinical readouts in the near term to evaluate SIL204’s potential to improve response rates and survival outcomes for patients with locally advanced pancreatic cancer.”
Tel Aviv Sourasky Medical Center serves as the anchor clinical center for the trial in Israel following receipt of institutional ethics approval and authorization from the Israeli Ministry of Health. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany approved under the European Union Clinical Trials Regulation (EU CTR) framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation and are expected to join the Phase 2/3 program in the coming months.
About Silexion Therapeutics Silexion Therapeutics is a pioneering clinical-stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers that have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The Company conducted a Phase 2a clinical trial in its first-generation product candidate, which showed a positive trend in comparison to the control of chemotherapy alone, and is now advancing its lead, second-generation, product candidate, SIL204, a small interfering RNA (siRNA), through Phase 2/3 clinical evaluation. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology and further developing its lead product candidate for locally advanced pancreatic cancer. For more information, please visit: https://silexion.com
Notice Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding the clinical development, timing, enrollment, protocol execution, and anticipated outcomes of the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer; the timing, availability, and potential clinical significance of anticipated preliminary clinical readouts in the near term; the potential of SIL204 to improve response rates, survival outcomes, or other clinical metrics; the therapeutic potential, biological mechanism, and clinical utility of SIL204 and the Company’s integrated treatment regimen; the anticipated activation and onboarding of additional clinical trial sites in Israel and Germany; Silexion’s transition into active clinical execution; and the Company’s future strategy, operations, and milestones, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “may”, “should”, “could”, “might”, “plan”, “possible”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “prospective”, or “potential”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) the ability of Silexion and its participating clinical trial centers to successfully enroll, treat, and evaluate patients in accordance with the study protocol, including the initial safety run-in cohort of approximately 18 patients and the randomized expansion cohort of approximately 166 patients; (ii) the risk that preliminary clinical safety, tolerability, response rate, or survival data may not be achieved, confirmed, or replicated as the trial advances, that early observations may not be predictive of final trial results, or that SIL204 may not demonstrate statistically significant improvements in clinical efficacy compared to chemotherapy alone; (iii) the ability of Silexion to complete standard site activation procedures at additional medical centers in Israel and Germany on anticipated timelines; (iv) Silexion’s strategy, future operations, financial position, projected costs, prospects, and plans; (v) the impact of the regulatory environment and compliance complexities, including site-level approvals, conditions, and clearances required prior to study commencement in each jurisdiction; (vi) expectations regarding future clinical, academic, or commercial partnerships; (vii) Silexion’s future capital requirements and sources and uses of cash, including its ability to obtain additional financing to fund clinical trials; (viii) Silexion’s ability to maintain its Nasdaq listing; and (ix) other risks and uncertainties set forth in the documents filed by the Company with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 17, 2026, and the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 2026. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.
Boca Raton, Florida., Sept. 30, 2026 (GLOBE NEWSWIRE) — Trio Petroleum Corp (NYSE American: TPET) (“Trio” or the “Company”), today announced the acquisition by its Canadian subsidiary of 24 oil wells, with 4 producing and 20 shut-in heavy-oil assets, from Marlin Resources Ltd. (“Marlin”), an active operator in Saskatchewan’s Lloydminster region.
The acquisition would combine approximately 37 barrels of oil per day (“BOPD”) of current production with identified existing-well workover upside, a significant new multilateral drilling opportunity and strategically positioned disposal infrastructure. This transaction represents another achievement in Trio’s strategy to build a substantially larger Canadian oil and gas business.
CummingsMultilateralplus Existing Well Workover GrowthOpportunity
A central development opportunity within the Marlin acquisition is a proposed Cummings multilateral well on the N/2 of Section 9-48-23W3. The proposed well would use multiple horizontal branches from a single surface location to access approximately 4,000 meters of target Cummings reservoir. Trio estimates a CDN$1.2 million drilling and development budget which includes drilling, completion and equipping the well for production. Nearby, a Cummings multilateral development by Canadian Natural Resources (“CNRL”) and other operators support the broader development concept as similar Cummings wells are producing approximately 375 BOPD, thereby supporting adding a major drilling component to the production upside identified in the existing well inventory. In addition, Trio has budgeted a CDN$425,000 workover, reactivation and recompletion program targeting additional production.
Terms
As consideration of the 24 wells, Trio is paying CDN$800,000 in cash and transferring to Marlin an underutilized water disposal asset. The cash purchase price and anticipated development and workover expenses will be funded from Trio’s cash on hand.
Strategic Water Disposal Facility
As part of the transaction, Trio is acquiring a water disposal facility that is better located to support Trio’s existing wells, the acquired wells and future development. The improved location is expected to reduce water-hauling distances and disposal costs while creating opportunities for third-party water-disposal and associated skim-oil revenue.
Robin Ross, Chairman and Chief Executive Officer of Trio Petroleum Corp, stated “We expect this transaction to be far more than the production being acquired today. The existing-well workover program provides a defined path intended to materially increase production, while the Cummings multilateral well adds a significant new drilling opportunity on the acquired lands. Based on current production, we estimate the purchase price per flowing barrel represents a discount to the average market price for comparable producing assets. This acquisition represents another important step in growing Trio’s Canadian asset base.”
ABOUTTRIOPETROLEUMCORP
Trio Petroleum Corp (NYSE American: TPET) is an independent oil and gas company focused on the acquisition, development and optimization of oil and gas properties in North America. The Company’s strategy is centered on acquiring producing assets at attractive valuations, optimizing existing production and identifying opportunities to develop additional production through drilling and other development activities.
All statements in this press release of Trio and its representatives and partners that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Acts”). In particular, when used in this press release, the words “estimates,” “believes,” “hopes,” “expects,” “intends,” “on-track”, “plans,” “anticipates,” “aim,” “goal,” or “may,” derivations of such words, and similar conditional expressions are intended to identify forward-looking statements within the meaning of the Acts and are subject to the safe harbor created by the Acts, although not all forward-looking statements are denoted by such words. Any statements made in this press release other than those of historical fact, about an action, event or development, are forward-looking statements. In this press release, forward-looking statements relate, among other things, to the anticipated operational and financial benefits to Trio of its new acquisition of the assets from Marlin as described herein, as well as Trio’s growth plans and strategies in general. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of significant risks, uncertainties, and other factors, many of which are outside of the Trio’s control, that could cause actual results to materially and adversely differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth in the Risk Factors sections of the Trio reports filed with the Securities and Exchange Commission (SEC). Copies of such documents are available on the SEC’s website, www.sec.gov and on Trio’s website at https://ir.trio-petroleum.com/sec-filings/. Accordingly, readers should not place undue reliance on any forward-looking statements. Trio undertakes no obligation to update these statements for revisions or changes after the date of this press release, except as required by law.
The highest dose group of EP-104GI (Cohort 9) demonstrated durability of symptom responses out to 52 weeks, with 66% of patients (2 of 3) maintaining clinical remission1
The second highest dose group of EP-104GI (Cohort 8b) continued to show meaningful histologic reduction in inflammation and fibrosis with Stage –0.26 and Grade –0.27 in EoEHSS at 36 weeks
The Cohort 8b and Cohort 9 responses are consistent with clinical and histologic responses seen across all cohorts analyzed to date; in total, 9 of 14 patients (64%) have remained in clinical remission 52 weeks after receiving a single administration of EP-104GI
VANCOUVER, British Columbia, Sept. 30, 2026 (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, today announced updated clinical data from the Phase 1b/2a RESOLVE study highlighting the long duration of response, high remission rates and tolerability of EP-104GI for the treatment of Eosinophilic Esophagitis (“EoE”).
“The 52-week and 36-week data from the highest dosing cohorts of the Phase 1b/2a RESOLVE trial further strengthen the observed durable treatment effects of EP-104GI in EoE patients,” said Dr. James Helliwell, Chief Executive Officer of Eupraxia. “In total, we have observed 64% of patients remaining in clinical remission over this 52-week period in addition to clinically meaningful histologic improvements. If achieved, an annual dosing regimen could align well with ACG Guidelines supporting routine endoscopic monitoring of EoE patients.”
“These encouraging efficacy and durability data suggest that EP-104GI may have the potential to treat patients suffering with EoE with a single annual dose,” said Dr. Jeymi Tambiah, Chief Medical Officer of Eupraxia. “We have not observed any treatment-related Serious Adverse Events (SAEs) to date or adverse events related to corticosteroid exposure, such as abnormal changes to glucose levels. Oropharyngeal Candidiasis has not been observed in any of the 10 cohorts to date.”
Key New Findings from the RESOLVE Phase 1b/2a Trial
Symptom Response and Clinical Remission as Measured by SDI
Symptom response is measured in the open-label portion of the RESOLVE study using the Straumann Dysphagia Index (SDI), a measure of both frequency and intensity of dysphagia on a 10-point scale (ranging from 0-9). A reduction compared to baseline in the SDI of at least 3 points is defined as clinical remission1.
Newly reported data include the following:
In Cohort 8b n=4 (20 x 6 mg dose), which was distinguished for Cohort 8 by employing an improved injection technique, the mean reduction in SDI at 36 weeks was 3.3
In Cohort 9 n=3 (20 x 8 mg dose), the mean reduction in SDI at 36 and 52 weeks was 3.0 at both timepoints
In total, the clinical remission rates across cohorts 5-9 (the cohorts for patients who are followed up to 52 weeks) are:
At 12 weeks, 53% (10/19) of patients achieved clinical remission
At 24 weeks, 78% (14/18) of patients maintained clinical remission
At 36 weeks, 61% (11/18) of patients maintained clinical remission
At 52 weeks, 64% (9/14) of patients maintained clinical remission
The clinical remission across these dose cohorts is illustrated in the figure below.
Figure 1 – Patient SDI Clinical Remission Rates from baseline to 52 weeks in Cohorts 5-9 of the Phase 1b/2a portion of the RESOLVE trial. Chart includes only patients that have been followed for 52 weeks.
Tissue Health Outcomes as Measured by Eosinophilic Esophagitis Histology Scoring System (EoEHSS)
EoEHSS is a standardized scale used to estimate esophageal tissue damage in EoE patients. EoEHSS measures both grade (severity) and stage (extent) of inflammatory and fibrotic features of the disease from biopsies.
In the Phase 1b/2a portion of the RESOLVE trial, EoEHSS data were measured on all cohorts at baseline, week-4, week-12, and for patients in Cohorts 5-9 at week 36. Week 36 is the last timepoint at which histologic measurements are made in the study.
New data were reported for Cohort 8b (20 x 6 mg dose). The mean EoEHSS Stage and Grade reductions at week 36 were -0.26 (SD=0.13) and -0.27 (SD=0.20).
Figure 2 – Mean change in EoEHSS from baseline at 4, 12 and 36 weeks for Cohorts 5-8 in the Phase 1b/2a portion of the RESOLVE trial.
Safety and Tolerability Reported to Date in the Phase 1b/2a RESOLVE Study
No treatment-emergent or procedure related SAEs.
No cases of oropharyngeal candidiasis, a commonly reported adverse event associated with the use of swallowed steroids, have been reported.
No cases of adrenal insufficiency or glucose derangement.
EP-104GI has been generally well tolerated at all dose levels, including the highest dose of 8 mg/site at 20 injection sites (Cohort 9).
An updated summary of the above and previously announced clinical trial results is posted in the Investor Section of the Eupraxia Pharmaceuticals website and can be found here.
About the RESOLVE Trial
The Phase 1b/2a portion of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with a history of confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Patients were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8×2.5mg and 12×2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg, 20x4mg, 20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a portion of the RESOLVE trial in the coming months.
The Phase 2b portion of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20x6mg) and 160mg (20x8mg) doses. The interim data from the Phase 2b portion of the RESOLVE trial are expected in December 2026.
Notes 1Karpf et al. (2024) Digestive Diseases and Sciences. 69(10):3853-3862
About Eosinophilic Esophagitis (EoE) EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in the United States and has been identified by the American Gastroenterological Association as rapidly increasing in both incidence and prevalence. Impacts from both symptoms and interventions frequently lead to mental health issues, compounding the disease burden of EoE for both the healthcare system and the individual.
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. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia’s Diffusphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.
Eupraxia’s EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. For further details about Eupraxia, please visit the Company’s website at: www.eupraxiapharma.com.
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”, “indicates”, “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 interpretation of data from the RESOLVE trial, including symptom response, clinical remission, tissue health, the durability of treatment effects and the potential for annual dosing; the Company’s expected timing of reporting additional data from the RESOLVE trial, including the Phase 2b portion thereof; the Company’s product candidates, including their expected benefits with respect to safety, tolerability, efficacy and duration of effect and their potential use in therapeutic areas beyond pain and inflammatory gastrointestinal disease; the expectations regarding the advancement of the Company’s product candidates through clinical development; the results of clinical trials of the Company’s product candidates; the potential for the Company’s technology to impact the drug delivery process; the potential market opportunity for the Company’s product candidates; and potential pipeline indications. 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 possibility that the Company could lose license rights that are important to its business; the possibility that the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the possibility that the Company’s technology may not be successful for its intended use; the fact that the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the possibility that the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the possibility that 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 possibility that the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the fact that 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-104GI; the fact that the Company relies on external contract research organizations to provide clinical and non-clinical research services; the possibility that the Company may not be able to successfully execute its business strategy; the fact that the Company will require additional financing, which may not be available; the fact that 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.
