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TAMPA, FLORIDA / ACCESS Newswire / October 13, 2025 / Wellgistics Health, Inc. (“Wellgistics” or the “Company”) (NASDAQ:WGRX), a leader in next-generation pharmaceutical distribution, digital prescription routing, and AI-powered hub fulfillment, today announced the re-appointment of Prashant Patel, RPh as President, Interim-CEO and Member of the Board of Directors. Mr. Patel had resigned from the positions of President & Member of the Board of Directors in August 2025.

The Company also appointed Mr. Eric Sherb as Interim-CFO and appointed Mr. Donald Fell, Mr. Steven D. Lee, and Mr. Howard Doss to the Board of Directors. Mr. Fell will serve on the Nominating Committee and Compensation Committee, Mr. Lee will serve on the Ethics Committee, and Mr. Doss will serve as Chairman on the Audit Committee. Concurrent with this announcement, the Company announced the departures of CEO Brian Norton, CFO Mark DiSiena, and COO Tony Madsen from executive management. Ms. Rebecca Shanahan and Mr. Michael Peterson also departed the Board of the Directors.

Mr. Patel previously served as a Director, Chief Strategy Officer and Vice Chairman of the Board of Directors Wellgistics from 2023 until August 8, 2025. Mr. Patel also previously served on the board of Scienture from its acquisition of TRxADE Group, Inc., a Nevada corporation from 2014 until 2025. He is an entrepreneur and a registered Pharmacist with experience in multiple aspects of the pharmaceutical supply chain. He founded several starts ups, including a Retail/Community Pharmacy before expanding into pharmaceuticals distribution and sales, focusing on pharmaceutical disposal and reverse distribution. He has also been a consultant to several return logistics pharmaceutical companies over the years.

Mr. Sherb is a Certified Public Accountant with 16 years of experience in accounting advisory, auditing, and mergers and acquisitions, including capital markets experience with IPOs, direct listings, registration statement filings, and ongoing SEC and PCAOB compliance. He has served as CFO for several NASDAQ and OTC clients, including, most recently, Scienture Holdings (NASDAQ: SCNX), a specialty products pharmaceutical company. He began his career at PricewaterhouseCoopers and subsequently served as Audit Manager at RBSM LLP, and Senior Manager at CFGI. Since 2018, he has been a founder and owner of EMS Consulting Services, LLC, a company assisting Emergency Medical Services agencies.

“We’d like to thank Brian and his team for directing the Company towards greater transparency via blockchain enabled technology and new ways to create efficiencies for pharmacies and patients,” said Wellgistics Health Chairman Suren Ajjarapu, RPh. “As we focus our execution strategy to fit our capital position, we are excited to see Mr. Prashant Patel, a trained pharmacist who has spent decades optimizing how independent pharmacies operate, return to Wellgistics to rationalize our portfolio and deliver on the verticals that will allow us to scale as rapidly”.

“With the emerging disintermediation of the biopharmaceutical supply chain – including the ability of direct sales to consumers – such as TrumpRx.com – the independent pharmacy is going to become the only healthcare professional really engaging with consumers, especially in rural areas,” said Prashant Patel, RPh, President, Interim-CEO and Member of the Board of Directors of Wellgistics Health. “I intend to streamline and focus the operations to drive new unique revenue opportunities for pharmacies that will allow us to capture more revenue and more data that will help us build our pharmacy artificial intelligence strategy.”

About Wellgistics Health, Inc.

Wellgistics Health (NASDAQ:WGRX) delivers medications from manufacturer to patient-faster, smarter, and more affordably. Its integrated platform connects 6,500+ pharmacies and 200+ manufacturers, offering wholesale distribution, digital prescription routing, direct-to-patient delivery, and AI-powered hub services such as eligibility, adherence, onboarding, prior authorization, and cash-pay fulfillment. As a PBM-agnostic alternative, Wellgistics provides end-to-end solutions designed to restore access, transparency, and trust in U.S. healthcare.

For more information, visit www.wellgisticshealth.com.

Forward-Looking Statements

This press release may contain forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When Wellgistics Health uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate,” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. These forward-looking statements include, without limitation, statements regarding Wellgistics Health’s strategy and descriptions of its future operations, prospects, and plans. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause actual results to differ materially. Additional factors are discussed in Wellgistics Health’s filings with the SEC, available at www.sec.gov.

Media & Investor Contact

Media:
media@wellgisticshealth.com

Investor Relations:
IR@wellgisticshealth.com

Investor Relations Contact

Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor
New York, NY 10036
Office: (646) 893-5835
Email: info@skylineccg.com

SOURCE: Wellgistics Health, Inc.

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MONTREAL, QC / ACCESS Newswire / October 13, 2025 / Vision Marine Technologies Inc. (NASDAQ:VMAR) (“Vision Marine” or the “Company”), a global leader in electric marine propulsion, proudly announces its collaboration with Shaun Torrente Racing (STR), led by multiple world champion powerboat racer Shaun Torrente, to equip the new Sterk 31e with STR’s state-of-the-art jackplate technology.

The Sterk 31e represents a milestone in the evolution of electric boating, translating Vision Marine’s high-voltage electric technology into a luxury day cruiser available for consumers. This partnership brings together Sterk’s award-winning European design, Vision Marine’s industrialized E-Motion™ propulsion systems, and STR’s race-bred performance expertise to deliver extended range, precision handling, and high-performance acceleration in a versatile platform.

A Look Back: From Record Speeds to Consumer Boats
In 2023, Vision Marine with Shaun Torrente set the world electric boat speed record at 116 mph at the Lake of the Ozarks Shootout, demonstrating its engineering leadership and ability to push the boundaries of high-voltage marine propulsion. The Sterk 31e extends that achievement from racing demonstrations to scalable consumer adoption, marking the first twin-E-Motion™ integration purpose-built for market readiness.

Shaun Torrente Racing’s contribution provides the performance edge that defines the Sterk 31e. By integrating STR’s precision jackplate systems-developed and refined through world-championship racing-the Sterk 31e achieves optimal trim, improved hydrodynamics, and maximized battery efficiency. This technology, proven on the racecourse and adapted for consumer use, enables faster acceleration, superior handling, and efficiency gains that elevate the boat into a class of its own.

“The Sterk 31e is more than just a striking electric boat-it is a benchmark for what a consumer-ready twin-motor electric setup should be,” said Maxime Poudrier, Chief Operating Officer at Vision Marine. “This project shows what happens when manufacturers partner with Vision Marine: they gain not only a certified and industrialized propulsion system but also access to a network of collaborators and distribution that accelerates time to market.”

Milan Sterk, founder of Sterk Yachts, added: “Our mission at Sterk Yachts has always been to blend performance and innovation with a family-oriented boating experience. The Sterk 31 is designed to be versatile, equally at home thrilling enthusiasts with its performance as it is welcoming families for unforgettable days on the water. Partnering with Vision Marine and STR allows us to deliver all of this, now in an electric format that represents the future of boating.”

“As a racer, I know how much precision determines performance,” said Shaun Torrente, founder of Shaun Torrente Racing. “We’ve taken the same race-winning engineering that earned world championships and applied it to the Sterk 31e. The twin-motor setup with STR jackplates gives this boat the speed, efficiency, and control that no other consumer electric boat can match. This is racing DNA made available to everyday boaters.”

The Sterk 31e will be revealed in-water at the 2025 Fort Lauderdale International Boat Show (FLIBS), further underscoring Vision Marine’s strategy of pairing proprietary propulsion technology with leading OEMs to accelerate consumer adoption of high-voltage electric solutions. Beyond this debut, manufacturers integrating Vision Marine’s E-Motion™ propulsion technology gain access to a broader ecosystem of collaboration-benefiting from the Company’s established partnerships, high-performance engineering capabilities, and Nautical Ventures’ award-winning retail and service network, which together enable faster go-to-market execution and increased consumer visibility.

About Vision Marine Technologies Inc.
Vision Marine Technologies Inc. (NASDAQ:VMAR) is a disruptive marine company offering premium boating experiences through its industrialized high-voltage electric propulsion systems and multi-brand retail operations. The Company’s E-Motion™ technology, the first fully certified 180 HP electric outboard powertrain, has been integrated into more than 24 recreational boat platforms. With the acquisition of Nautical Ventures, an award-winning dealership network operating nine locations across Florida, Vision Marine has become North America’s first vertically integrated marine technology and retail enterprise.
For more information, please visit visionmarinetechnologies.com

About Sterk
STERK Yachts is a premium boat manufacturer known for blending modern design, high-performance engineering, and sustainable innovation. Based in Germany, STERK Yachts is dedicated to redefining the boating experience by integrating cutting-edge technology with meticulous craftsmanship. The company offers a range of high-quality, precision-built boats that cater to both luxury and performance-driven customers.

For more information, please visit sterkyachts.com

About Shaun Torrente Racing
Shaun Torrente Racing (STR) is a high-performance marine engineering and racing firm founded by multiple world champion powerboat racer Shaun Torrente. The company designs and manufactures precision-engineered marine components-including its race-proven adjustable jackplate systems-used by leading offshore teams and performance boat builders worldwide. STR is also an authorized Mercury Racing dealer and service center, bringing championship-level expertise to both competition and consumer applications.
For more information, please visit shauntorrenteracing.com

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements are based on current expectations, assumptions, and projections and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited to, market acceptance of electric propulsion technology, operational execution, competitive dynamics, and regulatory changes. Vision Marine undertakes no obligation to update or revise forward-looking statements except as required by law.

Investor Relations Contact
Bruce Nurse
(303) 919-2913
bn@v-mti.com

https://investors.visionmarinetechnologies.com

SOURCE: Vision Marine Technologies Inc

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The Enterprise Advantage: HTML to PDF C# at Scale

Iron Software CEO explains how Chromium-based PDF generation delivers consistency as browser market evolves

CHICAGO, IL / ACCESS Newswire / October 13, 2025 / As Perplexity AI’s $34.5 billion bid for Google Chrome reshapes industry conversations, Iron Software is highlighting why enterprises choose standards-based document infrastructure that delivers consistent results regardless of market dynamics.

IronPDF, Iron Software’s flagship product, is built on the rendering standards set by Chromium, ensuring modern HTML/CSS compatibility across platforms. This standards-based foundation provides the reliability that mission-critical workflows require.

“Chromium has established proven rendering standards for modern web content,” says Cameron Rimington, CEO of Iron Software. “When enterprises choose IronPDF, they’re building on those established standards. Whether it’s a boarding pass, financial contract, or compliance report, developers know their documents will render exactly as expected, reliably.”

The Enterprise Advantage: HTML to PDF C# at Scale

Enterprise clients including NASA, Tesla, Qatar Airways, and 3M depend on IronPDF to deliver reliable document workflows across industries for tasks like:

• Airlines: Consistent boarding pass formatting across all systems

• Finance: Reliable contract generation meeting regulatory standards

• Healthcare: Accurate insurance documentation supporting patient care

• Manufacturing: Precise technical specifications for global operations

For developers, IronPDF provides practical documentation such as its HTML to PDF C# tutorial

Building on Proven Standards with C# HTML to PDF

While the browser market evolves, IronPDF’s architecture demonstrates the value of standards-based development. Built on the rendering standards set by Chromium, Iron Software provides enterprises with:

• Predictable Output: Documents render identically across environments

• Modern Compatibility: Full support for current HTML/CSS standards

• Enterprise Scale: Proven performance handling millions of documents

• Developer Confidence: Familiar tools and reliable documentation

Developers looking to integrate PDFs into business applications can explore IronPDF’s example workflow for C# HTML to PDF

Market Leadership Through Reliability

As industry dynamics shift and new players enter the market, Iron Software emphasizes that enterprise success depends on choosing proven, stable infrastructure. IronPDF’s Chromium-based approach ensures that whether processing HTML to PDF conversions or generating complex reports, the output meets enterprise standards.

“The browser market will continue evolving, but web rendering standards remain constant,” Rimington concludes. “Enterprises choose IronPDF because they can build their critical workflows with confidence. That’s the foundation of real digital transformation-solutions that just work, consistently, at enterprise scale.”

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Iron Software Launches $10,000 Developer Writing Contest Following Viral OpenAI Job Posting Highlighting Human Content Value

Chicago company capitalizes on renewed focus on technical writing expertise with global competition for developers

Chicago, IL – October 13, 2025 – Following widespread discussion sparked by OpenAI’s viral $393,000 content strategist job posting, Iron Software today announced the launch of its first Developer Writing Contest, offering $10,000 in prizes to celebrate the technical writing skills that even AI companies are paying premium rates to secure.

OpenAI’s job listing went viral across social media last month when the ChatGPT creator sought a human content strategist at nearly $400,000 annually, highlighting the enduring value of human creativity in an AI-dominated world. The Iron Software contest directly addresses this market demand by providing a platform for developers to showcase the exact skills that major tech companies are now prioritizing.

“The OpenAI job posting proved what we’ve always known-great technical writing is incredibly valuable and can’t be automated away,” said Cameron Rimington, CEO of Iron Software. “While they’re paying one person nearly $400K, we’re investing $10,000 to discover and reward the next generation of developer voices who can explain complex concepts clearly.”

Contest Details and Prizes: Focus on C# HTML to PDF and Document Automation

The Developer Writing Contest invites developers and technical writers worldwide to submit original, human-written articles exploring document automation, PDF workflows, and related programming challenges. Topics may include practical implementations such as HTML to PDF in C#, tutorials, OCR integration, or Excel processing solutions.

Prize Structure:

• 1st Place: $5,000 USD cash

• 10 Runner-Up Prizes: $500 USD Iron Software vouchers each

Key Requirements:

• Submission Deadline: January 10, 2026

• Eligible Content: Tutorials, case studies, thought leadership pieces, or PDF automation solutions

• Publishing Platforms: Articles must be published on developer-focused sites such as DEV, DZone, HackerNoon, InfoQ, TechCrunch, The New Stack, Visual Studio, Telerik, or C# Corner.

• Contest Page: ironsoftware.com/ironpdf-writing-contest

Expert Judging Panel

Entries will be evaluated by industry leaders including:

• Jeff Fritz – Microsoft Principal Program Manager and Executive Producer of .NET Conf

• Milan Jovanović – Microsoft MVP and Solution Architecture Expert

• Cameron Rimington – CEO, Iron Software

• Jacob Mellor – CTO, Iron Software

Evaluation Criteria: Technical accuracy, clarity and structure, originality, and community impact.

“Developers learn best from other developers,” said Jeff Fritz, Microsoft Principal Program Manager. “The OpenAI situation showed us that even the most advanced AI companies recognize this truth. I’m excited to see practical, creative articles that solve real challenges and help the community grow.”

“Strong technical writing has become a competitive advantage for companies,” added Milan Jovanović, Microsoft MVP. “This contest gives developers an opportunity to demonstrate expertise that’s clearly in high demand-and get rewarded for skills that major tech companies are paying premium rates to secure.”

Industry Context and Market Opportunity

Recent data shows content job postings have surged 134.5% year-over-year, with emerging roles like AI Content Creator underscoring the rising value of communication skills in the AI era. The Iron Software contest taps into this trend by spotlighting technical writers who can bridge the gap between complex technology and practical implementation.

The contest launch also coincides with the continued growth of IronPDF, Iron Software’s flagship library, which has achieved over 15.2 million NuGet downloads as of September 2025-demonstrating strong developer adoption and trust in Iron Software’s technical documentation and support.

“Technical writing is having its moment,” said Milan Jovanović. “We’re seeing technical writers command six-figure salaries at major tech companies. This contest gives developers a chance to showcase these valuable skills and potentially launch careers in an increasingly lucrative field.”

Participation and Timeline

Developers can begin submitting entries immediately, with winners announced within four weeks of the January 10, 2026 deadline. Results will be published on Iron Software’s website, blog, and LinkedIn.Developers can begin submitting entries immediately, with winners announced within four weeks of the January 10, 2026 deadline. Results will be published on Iron Software’s website, blog, and LinkedIn.

About Iron Software

Founded in 2015, Iron Software celebrates its 10th anniversary in 2025, marking a decade of helping developers solve complex document and data processing challenges. Today, Iron Software is recognized as the default solution for .NET libraries worldwide, powering mission-critical applications with IronPDF, IronOCR, IronXL, and the full Iron Suite. Trusted by global leaders Iron Software continues to deliver compliance-ready formats and robust support for enterprises across industries.

CONTACT:

Anne Lazarakis
anne.lazarakis@ironsoftware.com
+1 (312) 500 3060

SOURCE: Iron Software

View the original press release on ACCESS Newswire

ATLANTA, GA / ACCESS Newswire / October 13, 2025 / The Arthur M. Blank Family Foundation today announced a landmark $50 million, 10-year scholarship investment to support students at four of Atlanta’s Historically Black Colleges and Universities (HBCUs). The funding will provide gap scholarships intended to increase the number of students graduating from Clark Atlanta University, Morehouse College, Morris Brown College and Spelman College.

For many students, financial barriers-not academics-stand in the way of earning their diplomas. The foundation’s investment in gap scholarships is designed to overcome the financial barrier, helping more students complete their education. Beginning in 2026, the program is projected to support nearly 10,000 students, helping raise graduation rates across Atlanta’s HBCUs and serve as a model for other philanthropies to expand investment in HBCU student success.

“Atlanta holds a special place in my heart and will always be an integral part of our family foundation’s giving,” said Arthur M. Blank, chairman, Arthur M. Blank Family Foundation. “We know Spelman, Morris Brown, Morehouse and Clark Atlanta are vital to Atlanta’s future, and we are deeply committed to supporting the students who will carry that legacy forward. We recognize that these campuses, like many across the country, are home to generations of students whose promise inspires us. Our hope is that by helping more students earn their degrees, launch successful careers and become alumni who give back, we are investing in a cycle of opportunity that benefits young people and their families in Atlanta and communities across the nation for years to come.”

Investing in Student Success

“Even a small financial gap can be the difference between walking across the graduation stage or walking away,” said Fay Twersky, president, Arthur M. Blank Family Foundation. “We are proud to stand with Atlanta’s HBCUs and help more students achieve their dreams. These grants are a material investment in hope.“

Students who are in good academic standing and have fully exhausted other financial options, including scholarships, federal grants, state assistance and loan programs, will be eligible to receive funding at the discretion of their respective institution. The funding will largely support students in their junior and senior years, when financial stress can be most acute as family resources may be spread thin or additional siblings begin college.

Continuing a Legacy of HBCU Support
In addition to its $50 million investment, the Arthur M. Blank Family Foundation has maintained a longstanding commitment to HBCUs, including:

$10 million to Spelman College for the Arthur M. Blank Innovation Lab

$6 million for athletic field refurbishments at Clark Atlanta, Albany State, Miles College and Savannah State

$3 million to Morris Brown College to digitize a one-year hospitality credential

$400,000 to Morehouse College Golf Program with PGA TOUR Superstore

New football helmets for Morehouse College and Clark Atlanta University student-athletes

Economic and Community Impact

The scholarships are expected to fuel long-term benefits for students and the broader community:

HBCU graduates will earn 57% more in their lifetimes than they would without a degree.

An HBCU graduate working full-time can expect to earn $1M+ in additional income over the course of their career.

Atlanta’s HBCUs contribute $1 billion in annual economic impact to the region.

HBCU Presidents on the Impact of Scholarship Funding

Dr. George T. French Jr., President, Clark Atlanta University
“This transformative gift empowers Clark Atlanta students to succeed and lead globally. It provides the critical resources they need to graduate and prepare for leadership in the global marketplace.“

Dr. F. DuBois Bowman, President, Morehouse College
“This monumental investment will empower our students to remain focused on their academic studies and ensure that their talent, ambition, hard work, and integrity, not financial hardship, will determine their futures.”

Dr. Kevin E. James, President, Morris Brown College
“The Blank Foundation’s commitment provides critical support for Morris Brown students in their educational journeys. It removes economic barriers that have historically stood in the way of achieving their aspirations.”

Rosalind “Roz” Brewer, Interim President, Spelman College
“This investment affirms that every Spelman scholar deserves access to a world-class education. It expands our ability to bridge financial gaps and support students through to graduation.“

About the Arthur M. Blank Family Foundation

The Arthur M. Blank Family Foundation is a philanthropy founded to help transform lives and communities by uniting people across differences to find common cause. Started in 1995 by Arthur M. Blank, co-founder of The Home Depot, the foundation has granted more than $1.5 billion to charitable causes. Our collective giving areas are Atlanta’s Westside, Democracy, Environment, Mental Health and Well-Being, and Youth Development. Across these areas, we take on tough challenges by uniting the courage and compassion of our communities so we can all thrive together.

In addition to the priority areas of giving, the foundation oversees a large portfolio of grants including support of essential Atlanta nonprofit institutions, such as Children’s Healthcare of Atlanta and Shepherd Center, and enduring founder-led initiatives, such as veterans and the military and stuttering, among others. The foundation will also continue to guide the six associate-led giving committees operating across the Blank Family of Businesses. For more information, please visit www.blankfoundation.org.

SOURCE: Arthur M. Blank Family Foundation

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FOSTER CITY, CA / ACCESS Newswire / October 13, 2025 / MATRIXX Software, a global leader in monetization solutions, proudly celebrates the 25th anniversary of the 3GPP SA5 Charging Working Group, a global community that has transformed telecom monetization from its earliest days to the dawn of 6G.

Founded in 2000 in Cork, Ireland, the SA5 Charging Working Group has been at the heart of every major advance in mobile charging, from the first harmonized voice and messaging usage records to today’s real-time, API-driven monetization and AI-ready charging for 6G. Over the past quarter of a century, the group’s work has enabled billions of users worldwide to connect, communicate and innovate.

“Cork 2000 was the first time we sketched a charging architecture that worked across operators. We couldn’t imagine then that it would scale to billions of users,” said MATRIXX Software’s Gerald Görmer, chair of the SA5 Charging Sub-Working Group. “The commitment to precision and collaboration remains unchanged, and as we complete Release 19, we’re ready to charge the future.”

Under MATRIXX Software’s leadership, the SA5 Charging Working Group has delivered groundbreaking achievements, including the Converged Charging System (CCS), unified online and offline charging and the integration of charging into the Service-Based Architecture (SBA) for 5G and beyond. Release 19 marks the completion of the 5G Advanced charging model, setting the stage for new frontiers in energy efficiency, AI/ML monetization and cross-domain charging.

“As we move toward 6G and an ecosystem driven by APIs and intelligent AI agents, charging will continue to uphold the core values of fairness, transparency and trust-principles first defined in Cork 25 years ago,” stated Marc Price, chief technology officer of MATRIXX Software. “We are proud to guide this community and look forward to the breakthroughs ahead.”

MATRIXX Software congratulates the entire SA5 Charging Working Group on 25 years of technical rigor, global cooperation and relentless evolution. Every mobile call placed, every video streamed, every API called and every AI agent invoked that results in a charge owes a debt to this group’s work.

For more information, please visit https://www.matrixx.com/blog/25-years-of-3gpp-charging/.

About MATRIXX Software

MATRIXX Software delivers a dynamic billing, monetization and charging solution proven at scale. Global service providers like Telefónica, IoT providers like Tata Communications and network-as-a-service providers like DISH rely on MATRIXX to overcome the limitations of existing billing applications. MATRIXX provides a unified platform that transforms and simplifies billing operations across consumer, enterprise and wholesale businesses. With MATRIXX, operators can rapidly configure, deploy and monetize personalized offerings, enabling commercial innovation and real-time customer experiences that drive revenue and growth.

Media Contact
mediainquiry@matrixx.com

SOURCE: MATRIXX SOFTWARE

View the original press release on ACCESS Newswire

mRNA-4359 has advanced into the Phase 2 portion of the ongoing Phase 1/2 trial

CAMBRIDGE, MA / ACCESS Newswire / October 12, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that clinical, safety and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in checkpoint inhibitor-resistant/refractory(CPI-R/R) melanoma patients will be presented at the 2025 European Society for Medical Oncology (ESMO) Congress, October 17-21, 2025, in Berlin, Germany. mRNA-4359 is an investigational immune-evasion targeted cancer antigen therapy (CAT) that encodes epitopes of two common immune escape pathways, PD-L1 and IDO1, to elicit antigen-specific T cell responses that may directly kill tumor cells and deplete tumor suppressor cells.

The presentation includes data from 29 participants with CPI-R/R melanoma who have had ≥1 prior checkpoint inhibitor (CPI) therapy. Participants received the combination therapy at 400 µg (n=14) or 1,000 µg (n=15), given intramuscularly every three weeks for up to nine doses. Across all evaluable patients, the objective response rate (ORR) was 24% and disease control rate (DCR), or the combination of patients achieving tumor response and stable disease, was 60%. Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67% (6 of 9 participants), with treatment successfully inducing peripheral antigen-specific T cell responses and novel T cell receptor clones. The median duration of response (DOR) was not reached. The improved efficacy in PD-L1+ patients supports PD-L1 as a potential predictive biomarker in this high unmet need population.

“While early, today’s mRNA-4359 melanoma data in highly CPI-refractory metastatic patients are unique in the field and incredibly promising for future development options. We are encouraged by its potential to address such a high unmet need for many patients,” said Dr. Kyle Holen, Head of Development, Therapeutics and Oncology, Moderna. “Where other checkpoint inhibitors restore non-specific T cell activity, mRNA-4359 encodes two critical immune escape pathways to help generate new, target-directed T cells. This could enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. We are proud to present these data and to demonstrate the role our mRNA-based therapies could play in transforming the lives of those affected by cancer.”

mRNA-4359 in combination with pembrolizumab demonstrated a consistently manageable safety profile, with no new immune-related adverse events (AEs). mRNA-4359 continues to be evaluated in an ongoing phase 1/2 study (NCT05533697) as a monotherapy and in combination with pembrolizumab in patients with advanced melanoma and non-small cell lung cancer (NSCLC).

“After failing to respond to first-line immunotherapy, existing options for PD-L1+ patients are limited, underscoring a clear need for effective, tolerable therapies,” said Prof. David J. Pinato, Clinical Professor of Experimental Cancer Therapeutics at Imperial College London and Consultant Medical Oncologist at Imperial College Healthcare NHS Trust and lead author and presenter of the abstract. “mRNA-4359 has the potential to rebalance the tumor microenvironment to overcome this immunotherapy resistance. These data are encouraging as we continue to investigate the potential of mRNA-4359.”

The details of the presentation are as follows:

• Mini Oral Presentation #1515MO: Clinical Outcomes and PD-L1 Expression Analyses from a Trial of mRNA-4359 Plus Pembrolizumab in Checkpoint Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma

• Time: Friday, October 17, 2025, 2:00 – 3:30 PM CET

• Location: Nuremberg Auditorium – Hall 5.2

• Presenter: David J. Pinato

Moderna’s Oncology Investor & Analyst Event

Moderna will host a live webcast for investors and analysts on Friday, October 17, 2025, at 6:00 PM CET (12:00 PM ET), which will be available under “Events and Presentations” in the Investors section of the Moderna website at investors.modernatx.com. A replay of the webcast will be archived on Moderna’s website for at least 30 days following the presentation.

About mRNA-4359

mRNA-4359 is an immune-evasion targeted cancer antigen therapy that encodes broad epitopes of PD-L1 and IDO1. With its dual mechanism of action, it elicits antigen-specific T-cell responses to simultaneously: (1) kill tumor cells expressing PD-L1 and IDO1, and (2) deplete immunosuppressive cells that shield the tumor from attack. This is hypothesized to rebalance the tumor microenvironment into an immune-permissive state, supporting sustained and durable anti-tumor activity with a manageable safety profile.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of Moderna’s mRNA-based therapies for cancer patients; the potential of PD-L1 as a predictive biomarker; the response rate and safety profile of mRNA-4359; and the potential for mRNA-4359 to enable broader and more durable immune responses for patients who have not had success with prior lines of therapy. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire