Category: Partners

Company showcased commitment to compliance, consumer protection and highlighted regulatory leadership and collaboration

MIAMI, FL / ACCESS Newswire / September 16, 2025 / Athena Bitcoin, the number three global operator of bitcoin kiosks with over 3,000 machines in 34 U.S. states, Puerto Rico and 3 countries across Central and South America, participated in the 2025 Money Transmitter Regulators Association (MTRA) Annual Conference on September 9-11, 2025 in Louisville, KY.

Representing Athena was Chief Compliance Officer & Regulatory Counsel, Sam Nazzaro, and Business Analyst, Hans Telge. The MTRA conference serves as a premier forum for state money-transmitter regulators and industry leaders to discuss licensing, supervision, consumer protection, anti-money laundering and Bank Secrecy Act (AML/BSA) compliance, and broader policy developments.

“Compliance and consumer protection are at the heart of Athena’s mission to make Bitcoin accessible in a safe and responsible way,” said Sam Nazzaro. “By engaging proactively with regulators and contributing to conversations around best practices, Athena is helping to strengthen trust in our industry while ensuring our customers have secure, transparent access to Bitcoin.”

MTRA’s mission closely aligns with Athena’s consumer protection, safety and compliance standards, such as employing five attestation screens that appear during every transaction and require users to acknowledge critical information at multiple stages, such as confirming that the wallet belongs to them, recognizing common scam red flags, and verifying they are not acting under external pressure while empowering them to manage their assets outside traditional banking frameworks.

Athena’s participation in MTRA’s Annual Conference underscores the company’s long-standing commitment to compliance leadership, regulatory collaboration, and consumer education. With one of the largest Bitcoin kiosk networks across the Americas, Athena continues to build the next generation of responsible Bitcoin access, while maintaining high standards of trust, transparency, and accessibility.

About Athena Bitcoin Global

Athena Bitcoin Global operates an international network of Athena Bitcoin kiosks, which are free standing kiosks that permit customers to buy or sell Bitcoin in exchange for fiat currencies. The Company places its machines in convenience stores, shopping centers and other easily accessible locations in thirty-four US states and Puerto Rico, and in three countries in Central and South America. Athena Bitcoin Global’s comprehensive fintech platform enables POS merchant payments powered by Athena Pay and the Company provides safe, reliable and personalized trading services through its Athena Plus services. To learn more visit www.athenabitcoin.com  or follow Athena Bitcoin Global on Twitter and LinkedIn.

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the preliminary prospectus filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Athena Bitcoin Global specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Contact:

James McCusker
Alpha Advisory Group for Athena Bitcoin
ABIT@alpha-ir.com

SOURCE: Athena Bitcoin Global

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ORLANDO, FLORIDA / ACCESS Newswire / September 16, 2025 / RedChip Companies, an industry leader in investor relations, media, and research for microcap and small-cap companies, today announced its Platinum Sponsorship of the National Investment Banking Association (NIBA) Annual Convention, taking place September 16-17, 2025, at the Westin Fort Lauderdale Beach Resort in Fort Lauderdale, Florida.

The NIBA Annual Convention is one of the premier gatherings for investment professionals, including broker-dealers, investment bankers, fund managers, and service providers from across the U.S. and abroad. As a Platinum Sponsor, RedChip will play a key role in supporting this year’s event, which will feature two days of networking, presentations, and discussions focused on emerging opportunities in the small-cap marketplace.

“We are proud to support NIBA’s Annual Convention as a Platinum Sponsor,” said Dave Gentry, CEO of RedChip Companies. “For more than three decades, RedChip has been dedicated to connecting microcap and small-cap companies with the investment community. NIBA’s convention provides an invaluable platform to engage with industry leaders, explore market trends, and advance the dialogue on innovation and capital formation as RedChip continues to discover tomorrow’s blue chips today.”

As a Platinum Sponsor of NIBA 2025, RedChip will spotlight its comprehensive investor relations and financial media platform that has helped more than a thousand emerging growth companies achieve greater visibility, liquidity, and market credibility. By combining daily outreach with unmatched multimedia reach, RedChip continues to set the standard for driving tangible outcomes in the microcap and small-cap markets.

RedChip looks forward to connecting with innovators, issuers, capital partners, and dealmakers at NIBA 2025.

About RedChip Companies

RedChip Companies, an Inc. 5000 company, is an international investor relations, media, and research firm focused on microcap and small-cap companies. For 33 years, RedChip has delivered concrete, measurable results for its clients. Our newsletter, Small Stocks, Big Money™, is delivered online weekly to 60,000 investors. RedChip has developed the most comprehensive service platform in the industry for microcap and small-cap companies. These services include the following: a worldwide distribution network for its stock research; retail and institutional roadshows in major U.S. cities; outbound marketing to stock brokers, RIAs, institutions, and family offices; a digital media investor relations platform that has generated millions of unique investor views; investor webinars and group calls; a television show, Small Stocks, Big Money™, which airs weekly on Bloomberg US; TV commercials in local and national markets; corporate and product videos; website design; and traditional investor relation services, which include press release writing, development of investor presentations, quarterly conference call script writing, strategic consulting, capital raising, and more. RedChip also offers RedChat™, a proprietary AI-powered chatbot that analyzes SEC filings and corporate disclosures for all Nasdaq and NYSE-listed companies, giving investors instant, on-demand insights.

To learn more about RedChip’s products and services, please visit:

“Discovering Tomorrow’s Blue Chips Today”™

Follow RedChip on LinkedIn: https://www.linkedin.com/company/redchip/
Follow RedChip on Facebook: https://www.facebook.com/RedChipCompanies
Follow RedChip on Instagram: https://www.instagram.com/redchipcompanies/
Follow RedChip on Twitter: https://twitter.com/RedChip
Follow RedChip on YouTube: https://www.youtube.com/@redchip
Follow RedChip on Rumble: https://rumble.com/c/c-3068340

Subscribe to our Mailing List: https://www.redchip.com/newsletter/latest

Contact:

Dave Gentry
RedChip Companies Inc.
1-407-644-4256
info@redchip.com

SOURCE: RedChip Companies, Inc.

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Clients Trust in Alpine Mar’s Expertise and Industry Reputation to Boost Productivity and Protect Data

FORT LAUDERDALE, FL / ACCESS Newswire / September 16, 2025 / Alpine Mar, a rapidly growing, modern accounting firm, today unveiled an expansive new offering that includes managed IT and IT consulting services. Specifically, Alpine Mar will offer a seamless, fractional external team of IT experts to help clients administer and protect their workplace productivity and collaboration suites; as well as consulting services focused primarily on cybersecurity and AI consulting.

“This new offering extends Alpine Mar’s commitment to modern, tech-forward solutions, adding a highly requested layer of support for our clients,” says Ian A. Schlakman-Holub, CIO of Alpine Mar. “It complements the firm’s existing Audit and Client Accounting Services practices, both of which already leverage technology to enhance operational efficiency. The launch represents a natural evolution of our platform – deepening our value proposition and expanding our capabilities in direct response to client demand.”

Many clients with limited IT resources face significant challenges in managing and protecting their mission-critical workplace applications, with only 14 percent of small- to medium-sized businesses believing they have sufficient security controls in place to protect themselves from increasingly sophisticated threats.

Through its managed IT services, Alpine Mar provides day-to-day administration and protection of workplace productivity platforms such as Google Workspace and Microsoft 365. This includes real-time cybersecurity threat monitoring, incident response, and technical support. Additional services include remote security monitoring for on-site facilities and cloud-based VoIP solutions.

Concurrently, clients are often in need of trusted, expert counsel to help guide their most strategic decisions in the areas of cybersecurity and AI application and tools. To this end, Alpine Mar is now offering comprehensive IT consulting services specializing in cybersecurity, cybersecurity audits, and risk management, expanding beyond workplace productivity suites to clients’ full IT infrastructures. Moreover, AI is a critical area of focus, with three in four companies reporting that they struggle to achieve and scale AI value. Alpine Mar’s AI consulting services will address this exploding client demand for strategic advice in this area.

To learn more or schedule a consultation, visit here.

About Alpine Mar

Alpine Mar was founded in South Florida in 2020 by a group of CPAs who bring experience from some of the world’s largest and most sophisticated organizations. The team prides itself on providing unmatched expertise and service to individuals and businesses of all sizes. Since its inception, Alpine Mar has provided its clients with the latest technology to deliver industry-leading service and results. The firm offers a full range of accounting and finance services, including operational support, tax, audit, finance, and assurance. To learn more, please visit https://alpinemar.com/

Media contact:
Kristina LeBlanc
kristina@notablypr.com
508-930-5636

SOURCE: Alpine Mar

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SIOUX FALLS SD / ACCESS Newswire / September 16, 2025 / Avel eCare is proud to join healthcare organizations nationwide in celebrating Telehealth Awareness Week, September 14-20, 2025. This year, Avel is honoring the week with a unique theme: Powered by People.

“For more than 30 years, our success has been driven by the people behind the care,” said Doug Duskin, CEO of Avel eCare. “Behind every call, every computer screen, and every virtual consult stands a team of dedicated individuals. From clinicians on the front lines to the teams in operations, technology, innovation, sales, and account management, each plays a vital role in working together to improve care and outcomes. They are the real power behind telehealth.”

From critical access hospitals to EMS crews in the field, Avel’s services showcase how telemedicine is fueled by teamwork. Clinicians provide immediate expertise during emergencies, while behind-the-scenes innovators ensure seamless technology, connectivity, and integration. Non-clinical staff-from product innovation to customer support-play an equally vital role, ensuring hospitals, schools, nursing homes, and communities receive reliable, high-quality care.

Throughout Telehealth Awareness Week, Avel will highlight different service lines and teams on its social media channels, showcasing the many ways people across the organization come together to support care delivery throughout the country

“We are Telehealth. We are Avel eCare. And we are Powered by our People.”

Telehealth Awareness Week is a national movement to spotlight the value of telehealth in expanding access, addressing disparities, and supporting healthcare teams. For Avel eCare, it is also a chance to recognize the thousands of team members and partners who make virtual care possible every day.

To learn more, visit www.avelecare.com.

Contact: Jessica Gaikowski, Avel eCare | media@avelecare.com

SOURCE: Avel eCare

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SOUTHLAKE, TX AND AUSTIN, TX / ACCESS Newswire / September 16, 2025 / Allied OMS, the nation’s leading doctor-owned and doctor-led management services organization (MSO) for oral and maxillofacial surgeons, today announced its entry into the Greater Austin market through a partnership with Heart of Texas Oral Surgery.

Led by Dr. Jeff Alford, Heart of Texas Oral Surgery provides the full scope of oral and maxillofacial surgery services, including wisdom tooth removal, dental extractions, dental implants, corrective jaw surgery, treatment for facial pain and injuries, and care for TMJ disorders. With locations in Lakeway and Bastrop, the practice is recognized for surgical excellence, patient-centered care, and deep community roots.

“I was looking for a way to reduce the administrative burden while continuing to grow,” said Dr. Alford. “I also wanted to be part of a network of doctors I could collaborate with and help mentor. Through Allied, I’ve joined a group of peers and taken on a role in our doctor-led recruiting committee – helping shape the next generation of surgeons and raise the bar for both patient care and practice operations.”

The expansion into Austin is part of Allied’s broader Texas strategy to establish a presence in every major metropolitan area, which already includes Dallas, Fort Worth, San Antonio, and Houston.

“As Austin’s population grew rapidly, we recognized the need for additional high-quality surgical access across the region,” said Dan Hosler, CEO of Allied OMS. “Rather than building from scratch, we partnered with a respected practice that is already deeply embedded in its community and aligned with our vision for growth. I was also impressed with Dr. Alford’s growth mindset and his desire to be actively involved at the corporate level. Doctor leadership up and down through our business is a hallmark of what makes us different.”

About Allied OMS
Allied OMS is a doctor-owned, doctor-led, and doctor-governed MSO that partners with oral and maxillofacial surgery practices across the U.S. Combining the autonomy of private practice with the scale and sophistication of institutional support, Allied OMS empowers surgeons to lead the future of their specialty. The company currently supports surgeons in 50+ locations and maintains doctor leadership across all major committees and its Board of Directors. Learn more at www.alliedoms.com.

About Heart of Texas Oral Surgery
Heart of Texas Oral Surgery provides full-scope oral and maxillofacial surgical care to patients across the Greater Austin area through its offices in Lakeway and Bastrop. Led by Dr. Jeff Alford, a board-certified oral and maxillofacial surgeon with a background in both surgical and restorative dentistry, the practice is known for its commitment to clinical excellence, patient comfort, and personalized care. With expertise in wisdom teeth removal, dental implants, jaw surgery, TMJ treatment, and more, Heart of Texas Oral Surgery combines advanced technology with a compassionate approach to deliver outstanding outcomes. Learn more at www.heartoftexasoralsurgery.com.

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Media Contact

Sara Tumen Weinberg
Chief Marketing Officer
Allied OMS
sweinberg@alliedoms.com

SOURCE: Allied OMS

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The Digital Commerce Industry’s first agentic-native closed-loop learning platform that helps retailers, brands and agencies evaluate, enrich, distribute, and monitor their products on Agentic Commerce Engines such as ChatGPT, Google Gemini/AI Mode, Perplexity, Meta.ai, Microsoft Copilot, Grok and Claude.

RALEIGH, NC / ACCESS Newswire / September 16, 2025 / ReFiBuy today announced the general availability of its first product called Commerce Intelligence Engine.

“The ReFiBuy product team has been cooking, building a ground-up solution to the challenges Agentic Commerce presents to retailers, brands and agencies,” said Scot Wingo. “I also want to thank our ten design partners who gave us extremely valuable feedback in the last 90 days as we’ve been putting the finishing touches on the product.”

“ReFiBuy’s Commerce Intelligence Engine has accelerated our understanding of our readiness for Agentic shopping experiences and how GenAI understands our product catalog, “said Josh Krepon, President of US Direct to Consumer and Global Digital, Steve Madden. “The platform’s insights and actionable recommendations enhance our content and visibility for our GenAI digital shelf. The product-level GEO monitoring capabilities will play a key role in futureproofing for this new era of commerce.”

Commerce Intelligence Engine’s Core Six Capabilities

At the heart of the Commerce Intelligence Engine is ReFiBuy’s belief that everything in digital commerce starts and ends with the product catalog.

• Ingest – The Commerce Intelligence Engine starts with the ingestion of the brand or retailer’s product catalog. Our ingestion capability is built with ultimate flexibility pulling the product catalog from any existing system or using web data extraction.

• Evaluate – Evaluate reviews both catalog data and PDPs for each SKU, flagging GEO structural elements that cause Agentic Shopping Agent issues. Then Evaluate assesses titles, images, variations, and existing attributes, while also recommending missing attributes LLMs need for additional context. All findings are summarized in a scorecard across Content Quality, GEO Structure, LLM Semantic Quality, and User Experience.

• Enrich – Based on the customer’s feedback and approval from the Evaluate process, Enrich implements the suggested and approved changes at the product catalog level. The product catalog is now optimized to maximize Agentic Shopping Engine exposure.

• Sync – At any point in the process, customers can export their enriched product catalog to a variety of file formats, or route it directly into existing systems and workflows for further processing or approvals.

• Distribute – At the customer’s request, the Distribute capability delivers the now enriched product catalog to up to six different Agentic Shopping Engines including: ChatGPT, Gemini, Perplexity, Meta.ai, Microsoft Copilot, Grok and Claude.

• Monitor – The Commerce Intelligence Engine’s Monitor capability scans the six Agentic Shopping Engines and score’s a product across three criteria: visibility, data quality and AI Digital Shelf.

Evaluate Capability Details

Once ingested, the system evaluates both the site-structure at the PDP level and the product catalog data level for every SKU in the customer’s catalog.

At the PDP level, Evaluate looks at structural issues and makes recommendations that will optimize the PDP for Agentic Shopping Engine’s web crawlers, agents and agentic browsers to access all the product data, reviews and other information that gives the LLM context on the product. Common issues the system detects are stale/incorrect schema.org data, unintentional bot blockers, and the use of complex JavaScript elements that prevent the agents from ‘seeing’ product content.

At the product catalog level, Evaluate examines every data element of the product catalog (from all sources including PDP, data feed or legacy systems) such as titles, images, all variations and existing attributes. In addition to existing attributes, the Evaluate capability recommends incremental attributes to add to the product catalog to give Agentic Shopping Engines a more complete picture of the product’s capabilities, compatibilities, etc.

Evaluate then takes the recommendations from the PDP structure and the product catalog and produces a detailed per-product scorecard based on four criteria:

1. Product Content Quality – Is the existing PDP-level product catalog data content optimized for GenAI? Typical recommendations include adding more context, improving titles, enhancing existing attributes and adding missing attributes through our enrichment capability.

2. GEO Structure – Many retailer and brand sites have structural issues with bot blockers, bad metadata, incorrect or missing llms.txt and frequently schema.org is missing, outdated or has the wrong data.

3. LLM Semantic Quality – Assesses the semantic coherence and natural language understanding quality of the product descriptions.

4. User Experience – Measures the overall user interface, accessibility and interaction quality of the product page.

Monitor Capability Details

Called GEO by other vendors, instead of looking at high-level ‘sentiment’, the Monitor feature takes a subset sample of the customer’s product catalog, goes to out to seven Agentic Shopping Engines (ChatGPT, Gemini, Perplexity, Microsoft Copilot, Meta.ai, Grok and Claude), where it executes product-level prompts designed to replicate shopper behavior. Monitor then records screen shots of the Agentic Shopping Engines’ detailed responses

Monitor then evaluates each Agentic Shopping Engine’s product-level prompt response across three criteria:

• Visibility – Initially, due to bot blocking, structural problems and other issues, a large portion of a customer’s products are not even ‘indexed’ or trained on by the Agentic Shopping Engines. This is the pre-requisite for showing up at all.

• Data Quality – Once a product’s visibility has been verified and the product is being displayed by the Agentic Shopping Engine, Monitor verifies all the product information displayed is correct including: in-stock status, variation details, attributes, ratings are all being pulled in correctly, the correct images are shown, and the right product detail page link is provided to the agent or the human user. Also, all pricing information, any free shipping or other offers are verified to make sure the Agentic Shopping is presenting the shopper with the most compelling and competitive offer.

• AI Digital Shelf – Finally, Monitor evaluates each product’s ‘AI Digital Shelf’. ReFiBuy believes every retailer and brand’s goal should be to have their product ‘own the product card’ meaning that when the human or agent go to buy the product, they win the top spot, and the zero-sum game of the purchase. The AI Digital Shelf reports to the customer their relative position on the product card as well as total transparency around competitor’s positioning, pricing and how they are representing the same products.

Together the scores and details of these three areas give the customer a first-of-its-kind 360-degree view of exactly what the customer experiences are at the Agentic Commerce Engine level.

First Closed-Loop Learning Software System

Once the customer’s product catalog has been through the Commerce Intelligence Engine for the first time, the Monitor three criteria scoring is evaluated and acted on.

If the customer’s product is not visible, if there are data errors or if it does not ‘own the product card’, the Monitor capability alerts the Evaluate/Enrich agents and the customer with details of the problem(s) detected at the Agentic Shopping Engines. The Evaluate/Enrich agents then work with the customer’s input to recommend solutions and then distributes a repaired product catalog to the appropriate engine with fixes for the issues detected by Monitor. Finally, the Monitor capability evaluates that the fix has resolved the problem and if it hasn’t, the cycle repeats until all products are completely optimized. As the Agentic shopping engines change and various product catalog strategies are implemented by ReFiBuy’s agents, the system learns and adapts without code changes.

Complete Flexibility with Existing Systems and Workflows

Founded by ecommerce veterans, ReFiBuy knows that today’s digital leaders at brands, retailers and agencies have invested hundreds of millions in ecommerce platforms PIMs, ERPs and a variety of other systems. Also, modern digital commerce teams operate using complex well-oiled workflows. Because of these existing systems and workflows, ReFiBuy’s Commerce Intelligence Engine is designed to be completely flexible and integrate seamlessly with the customer’s existing systems and workflows.

For example, for our ‘ingest’ and ‘sync’ capabilities instead of bespoke system-to-system integrations, ReFiBuy has built an Agentic integration capability that automatically creates integrations to existing systems, maps the correct fields, tests, deploys and monitors the integration. Or if the customer wants to get started quickly, the system can jump-start using web data extraction.

About ReFiBuy

Founded by Scot Wingo (Founder of ChannelAdvisor/Rithum, co-host of The Jason & Scot Show), Cameron Bowe (ChannelAdvisor), James Frawley (ChannelAdvisor, MikMak), and Derek Conlin (ChannelAdvisor, Walmart), ReFiBuy is an AI-native company focused on revolutionizing digital commerce with Agentic AI. By helping retailers, brands and agencies navigate Agentic Commerce and optimize how consumers Research, Find, and Buy their products.

More information can be found at: www.refibuy.ai

Media resources are available at: https://www.refibuy.ai/media-resources

Media contact: Rebecca Ross – rebecca@refibuy.ai

Social Links:

• LinkedIn: https://www.linkedin.com/company/refibuy

SOURCE: ReFiBuy

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MIRA advances Ketamir-2 in the clinic for neuropathic pain while broadening development into neuropsychiatric disorders such as PTSD

MIAMI, FLORIDA / ACCESS Newswire / September 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive results demonstrating that its oral drug candidate Ketamir-2 restored normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD). Ketamir-2 is currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date.

“Restoring behavior to normal in a stressed PTSD model represents an important step forward,” said Erez Aminov, CEO of MIRA Pharmaceuticals. “These findings support our decision to broaden the scientific evaluation of Ketamir-2 beyond neuropathic pain into neuropsychiatric disorders such as PTSD. Looking ahead, we plan to explore opportunities for potential collaborations, including with military and government institutions, given the significant unmet need for effective PTSD treatments.”

This proof-of-concept validation study was conducted in a small group of rats using the Single Prolonged Stress (SPS) model, a widely accepted paradigm for inducing inescapable stress that mimics PTSD symptoms in animals. Animals were exposed twice to a predator stressor (bobcat urine), which is known to induce “depression-like” symptoms and changes in active/passive coping. Increased immobility after stress exposure reflects enhanced affective impairment or reduced stress resilience. Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days.

Behavioral assessments included anxiety- and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping strategies.

Outcome: stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 reversed these types of behaviors, restoring them toward the level observed in non-stressed animals. This initial validation supports the study design, and a larger follow-on PTSD study is ongoing.

“These preliminary results reinforce the therapeutic potential of Ketamir-2 in PTSD,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA. “We observed consistent reversal of stress-induced behavioral changes, supporting continued investigation of Ketamir-2 across neuropsychiatric disorders.”

PTSD: A Major Unmet Need

• PTSD affects an estimated 13 million adults in the United States each year, with approximately 6% of U.S. adults experiencing PTSD at some point in their lives.

• The economic and social burden of PTSD is estimated at $232 billion annually in the U.S., driven by lost productivity, medical care, and disability.

• The treatment landscape is limited:

  • Only two FDA-approved medications exist for PTSD (sertraline and paroxetine, both SSRIs), which provide limited relief and are often poorly tolerated (FDA PTSD treatments).

  • Psychotherapies such as CBT and EMDR can be effective, but access, adherence, and dropout rates remain significant challenges.

• The U.S. Department of Defense and Veterans Affairs continue to invest heavily in novel PTSD research, underscoring the urgent need for safer and more effective solutions for service members and veterans.

About Ketamir-2

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and demonstrates no significant off-target activity across a broad receptor panel. Ketamir-2 was designed to capture the therapeutic efficacy of ketamine while minimizing the unwanted dissociative and other central nervous system side effects that limit ketamine’s clinical use. The U.S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Previous animal studies have also shown Ketamir-2’s superior efficacy versus ketamine, pregabalin, and gabapentin in neuropathic pain models.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA’s management related thereto contain “forward-looking statements,” which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA’s current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA’s control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA’s potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA’s programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA’s website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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Preliminary analysis showed the 2025-2026 formula of Spikevax generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across age groups

Clinical findings reinforce preclinical data supporting recent FDA approval of 2025-2026 formula of Spikevax

CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The data from an ongoing Phase 4 clinical trial evaluating the safety, tolerability and immunogenicity of the 2025-2026 formula of Spikevax showed, on average, greater than an 8-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals 12 through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. The safety profile of the vaccine was consistent with previous studies, with no new safety concerns identified.

Recent surveillance data from the U.S. Centers for Disease Control and Prevention (CDC) shows the U.S. wastewater viral activity for COVID-19 is high, and LP.8.1 and its familial strains, XFG and NB.1.8.1, continue to dominate. ^[1],[2] This preliminary analysis confirms Moderna’s updated COVID-19 vaccine is a strong match to today’s top circulating strains in the U.S.

These clinical findings also reinforce preclinical data that supported the recent U.S. Food and Drug Administration (FDA) approval of the 2025-2026 formula of Spikevax, which is approved by the FDA for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older. Spikevax has also been granted approval by regulators in Canada, Europe, Japan, Mexico, Switzerland and more.

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.

Spikevax® is a registered trademark of Moderna.

What is SPIKEVAX® (COVID-19 Vaccine, mRNA)?
SPIKEVAX is a vaccine to protect you against COVID-19. SPIKEVAX is for people who are:

• 65 years of age and older, or

• 6 months through 64 years of age at high risk for severe COVID-19.

Vaccination with SPIKEVAX may not protect all people who receive the vaccine.

IMPORTANT SAFETY INFORMATION

You or your child should not get SPIKEVAX® if you had a severe allergic reaction after a previous dose of SPIKEVAX or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.

What are the risks of SPIKEVAX?
There is a very small chance that SPIKEVAX could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of SPIKEVAX. For this reason, the healthcare provider may ask you or your child to stay for a short time at the place where you or your child received your vaccine. Signs of a severe allergic reaction can include:

• Trouble breathing

• Swelling of your face and throat

• A fast heartbeat

• A rash all over your body

• Dizziness and weakness

• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving Spikevax, particularly during the 2 weeks after receiving a dose of the vaccine: chest pain, shortness of breath, feelings of having a fast-beating, fluttering, or pounding heart. Additional symptoms in children may include fainting, irritability, poor feeding, lack of energy, vomiting, pain in the abdomen, or cool, pale skin.

Other side effects that have been reported include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection or in the groin, swelling (hardness), and redness

• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, fever, rash, irritability/crying, sleepiness, and loss of appetite.

• Fainting and febrile seizures (convulsions during a fever) were also reported

Tell the healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have any allergies

• had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine

• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)

• have a fever

• have a bleeding disorder or are on a blood thinner

• are immunocompromised or on a medicine that affects your immune system

• are pregnant or plan to become pregnant

• are breastfeeding

• have received any other COVID-19 vaccine

• have ever fainted in association with an injection

These may not be all the possible side effects of SPIKEVAX. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov.

Please click for SPIKEVAX Full Prescribing Information and Information for Recipients and Caregivers.

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 ability of Moderna’s COVID vaccines to trigger an immune response and to protect against circulating SARS-CoV-2 variants; and the safety of Moderna’s COVID vaccines. 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, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, 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

View the original press release on ACCESS Newswire

VANCOUVER, BC / ACCESS Newswire / September 16, 2025 / Avino Silver & Gold Mines Ltd. (TSX:ASM)(NYSE American:ASM)(FSE:GV6) announces that it has been added to the Market Vectors Junior Gold Miners Index (“MVGDXJTR”) and the VanEck Junior Gold Miners ETF (“GDXJ”), effective at market close on September 19, 2025 pursuant to the GDXJ’s semi-annual review and quarterly rebalance.

“We are excited to be included in the VanEck Junior Gold Miners ETF, a milestone that reinforces the investment case for Avino Silver & Gold Mines Ltd.,” said David Wolfin, President and CEO. “This inclusion reflects the hard work and dedication of our entire team and positions Avino to attract a broader base of institutional and retail investors. With La Preciosa advancing on plan, we are poised to execute on our clear path to transformational growth and becoming Mexico’s next intermediate primary silver producer.”

The GDXJ is a globally recognized exchange-traded fund that tracks small-cap companies primarily involved in gold and silver development and mining. Inclusion in this ETF may increase Avino’s common share liquidity and further position Avino as attractive investment opportunity for investors seeking exposure to industry leading silver and gold projects.

For more information on MVGDXJTR and GDXJ, please visit:

https://www.marketvector.com/indexes/hard-asset/mvis-global-junior-gold-miners

https://www.vaneck.com/us/en/investments/junior-gold-miners-etf-gdxj/overview/

About Avino:

Avino is a silver producer from its wholly owned Avino Mine near Durango, Mexico. The Company’s silver, gold and copper production remains unhedged. The Company intends to maintain long-term sustainable and profitable mining operations to reward shareholders and the community alike through our growth at the historic Avino Property and the strategic acquisition of the adjacent La Preciosa which was finalized in Q1 2022. Early in 2024, the pre-feasibility Study on the Oxide Tailings Project was completed. This study is a key milestone in our growth trajectory. As part of Avino’s commitment to adopting sustainable practices, we have been operating a dry stack tailings facility for more than one year now with excellent results. We are committed to managing all business activities in a safe, environmentally responsible, and cost-effective manner, while contributing to the well-being of the communities in which we operate. We encourage you to connect with us on X at @Avino_ASM and on LinkedIn at Avino Silver & Gold Mines. To view the Avino Mine VRIFY tour, please click here.

This news release contains “forward-looking information” and “forward-looking statements” (together, the “forward looking statements”) within the meaning of applicable securities laws and the United States Private Securities Litigation Reform Act of 1995This information and these statements, referred to herein as “forward-looking statements” are made as of the date of this document. Forward-looking statements relate to future events or future performance and reflect current estimates, predictions, expectations or beliefs regarding future events and include, but are not limited to, statements with respect to the expected operations at the Company’s mineral properties. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives or future events or performance (often, but not always, using words or phrases such as “expects”, “anticipates”, “plans”, “projects”, “estimates”, “envisages”, “assumes”, “intends”, “strategy”, “goals”, “objectives” or variations thereof or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative of any of these terms and similar expressions) are not statements of historical fact and may be forward-looking statements. These forward-looking statements are made as of the date of this news release. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the future circumstances, outcomes or results anticipated in or implied by such forward-looking statements will occur or that plans, intentions or expectations upon which the forward-looking statements are based will occur. While we have based these forward-looking statements on our expectations about future events at the date that such statements were prepared, the statements are not a guarantee that such future events will occur and are subject to risks, uncertainties, assumptions and other factors which could cause events or outcomes to differ materially from those expressed or implied by such forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

For Further Information, Please Contact:

Investor Relations
Tel: 604-682-3701
Email: IR@avino.com

SOURCE: Avino Silver & Gold Mines Ltd.

View the original press release on ACCESS Newswire

Successful logistics trial supports commercial qualification pathway

HESPERIA, CA / ACCESS Newswire / September 16, 2025 / 5E Advanced Materials, Inc. (“5E” or the “Company”) (NASDAQ:FEAM)(ASX:5EA), a development stage company focused on becoming a vertically integrated global leader and supplier of refined borates and advanced boron derivative materials, today announced the successful completion of a key logistics milestone in its commercial qualification process with a major global specialty glass manufacturer serving critical end-markets including mobile electronics, advanced telecommunications, and life sciences applications.

As part of this process, boron-rich material was packaged and shipped in an ocean freight container from 5E Advanced Materials’ California operations to Taiwan via the Port of Los Angeles. The material successfully completed a 20-day international transit and was received on-site for a handling trial, where 5E’s product passed all required specifications. The customer has now advanced 5E to the next phase for full-scale product testing within its production system.

“This marks a critical step in progressing toward commercial validation and long-term supply agreements,” said Paul Weibel, Chief Executive Officer of 5E Advanced Materials. “Successfully completing this logistics and handling milestone demonstrates our ability to deliver high-quality material through global supply chains and aligns with our broader strategy to serve high-value applications in glass, magnets, semiconductors, and energy technologies.”

This advancement builds on the pilot trial completed earlier this year and reflects continued progress in aligning 5E Advanced Materials’ technical, operational, and commercial readiness with key customer requirements in advanced manufacturing sectors.

About 5E Advanced Materials, Inc.
5E Advanced Materials, Inc. (NASDAQ:FEAM)(ASX:5EA) is focused on becoming a vertically integrated global leader and supplier of refined borates and advanced boron materials, complemented by calcium-based co-products, and potentially other by-products such as lithium carbonate. The Company’s mission is to become a supplier of these critical materials to industries addressing global decarbonization, energy independence, food, national security and the defense sector. The Company believes factors such as government regulation and incentives focused on domestic manufacturing and supply chains and capital investments across industries will drive demand for end-use applications like solar and wind energy infrastructure, neodymium-ferro-boron magnets, defense applications, lithium-ion batteries, and other critical material applications. The business is based on the Company’s large domestic boron resource, which is located in Southern California and designated as Critical Infrastructure by the Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency.

Forward Looking Statements
Statements in this press release may contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, and include, but are not limited to, statements regarding the Company’s ability to progress to full-scale product testing, enter into long-term supply agreements, and become a vertically integrated global leader in borates and advanced boron materials. Any forward-looking statements are based on 5E’s current expectations, forecasts, and assumptions and are subject to a number of risks and uncertainties that could cause actual outcomes and results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, statements regarding the Company’s ability to progress to full-scale product testing, enter into long-term supply agreements, and become a vertically integrated global leader in borates and advanced boron materials. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in 5E’s most recent Annual Report on Form 10-K and its other reports filed with the SEC. Forward-looking statements contained in this announcement are based on information available to 5E as of the date hereof and are made only as of the date of this release. 5E undertakes no obligation to update such information except as required under applicable law. These forward-looking statements should not be relied upon as representing 5E’s views as of any date subsequent to the date of this press release. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of 5E.

For further information contact:
Michael MacMillan or Paola Ashton
PRA Communications
team@pracommunications.com
Ph: +1 (604) 681-1407

SOURCE: 5E Advanced Materials, Inc.

View the original press release on ACCESS Newswire