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Phase 1/2 H5 avian flu vaccine study shows positive interim results

Company has been notified that HHS will terminate Moderna’s award for late-stage development of pre-pandemic influenza vaccines

CAMBRIDGE, MA / ACCESS Newswire / May 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype.

The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and Human Services (HHS); however, today Moderna received notice that HHS will terminate the award for the late-stage development and right to purchase pre-pandemic influenza vaccines.

“While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,” said Stéphane Bancel, Chief Executive Officer of Moderna. “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”

The Phase 1/2 study evaluated a two-dose regimen of Moderna’s investigational avian influenza vaccine. mRNA-1018 demonstrated a rapid, potent and durable immune response. At baseline, pre-existing immunity was minimal, with only 2.1% of participants showing hemagglutination inhibition (HAI) antibody titers ≥1:40, an HAI titer considered to correlate with protection. At Day 43, three weeks after the second vaccination, 97.8% of participants achieved titers ≥1:40 with a 44.5-fold increase of titers from baseline.

The investigational vaccine was generally well-tolerated, with no dose-limiting tolerability concerns observed. Most solicited adverse reactions were Grade 1 or 2 and did not increase significantly with number of doses or between first and second doses. Further data is expected to be submitted for presentation at an upcoming scientific meeting.

Moderna will explore alternatives for late-stage development and manufacturing of the H5 program consistent with the Company’s strategic commitment to pandemic preparedness.

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 clinical development of mRNA-1018, the safety and immunogenicity data from the Phase 1/2 study; the cancellation of the development contract for Moderna’s pandemic flu program by the U.S. Department of Health and Human Services; and the exploration of alternative paths for development of the vaccine program. 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
Global Head of 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

TEL AVIV, IL / ACCESS Newswire / May 28, 2025 / Over the last few weeks, it’s become increasingly clear that Europe is rethinking its long-held stance on nuclear power. Countries like Denmark, Germany, and Spain are pivoting from prior bans and phase-outs toward the reintegration of nuclear energy into their decarbonization agendas.

The May 27th CNBC report confirmed what many of us in the industry have been anticipating: energy independence and long-term grid stability are now taking priority over political resistance to legacy nuclear policies.

This isn’t just a European trend. In the United States, the nuclear conversation is also heating up. Just last week, the Trump administration issued two executive orders to accelerate the development and deployment of nuclear energy infrastructure. One order clears regulatory red tape for advanced nuclear projects, while the other earmarks new federal support for the deployment of small modular reactors (SMRs) in rural and off-grid communities. Taken together, they signal a dramatic shift toward treating nuclear not as an ideological debate but as a national security and resilience imperative.

As Chief Business Officer of Brenmiller Energy, I view this shift not just as a reversal of prior sentiment but as a turning point for how the world will design and connect energy systems for the next generation. At the center of this new approach is flexibility – a trait nuclear energy alone doesn’t possess. However, it can with thermal energy storage (TES) in its supporting cast.

The Flexibility Problem: Why Baseload Isn’t Enough

Nuclear power excels in providing a consistent baseload of energy. But that strength becomes a liability in today’s dynamic energy market. Grids increasingly require responsive assets that can ramp up or down in real time to match volatile demand curves shaped by solar and wind variability. This is where TES, particularly our bGen™ system, comes into play.

At Brenmiller Energy, we’ve long understood the strategic value of decoupling energy generation from energy consumption. Our thermal storage technology enables energy – whether from renewable sources or nuclear reactors – to be stored as heat and dispatched when needed, 24/7/365.

This unique service isn’t theoretical. Our commercial partnerships and pilot projects, including with ENEL, the largest European energy provider by customer count, Tempo Beverage in Israel, Entelios in Germany, and others, has already proven the reliability and scalability of bGen™ for industrial energy users in a real-world setting. What ENEL saw in the flexible thermal application, and what many utilities are now beginning to understand, is that TES acts as a critical interface between legacy infrastructure and the demands of next-generation systems.

As Europe advances its green hydrogen and renewable integration targets, policymakers are finally confronting the hidden costs of intermittency and grid inflexibility. Nuclear offers dependable generation but not agility. That’s where TES fills the gap. It manages the mismatches between supply and demand, mitigating the risks of repeating the very same rigidity issues that led to nuclear phase-outs in the first place.

From Concept to Commercial Readiness

Consider our recent milestone in Spain: the SolWinHy Cádiz project, an off-grid, green methanol production facility, secured €25 million in funding, with €7 million explicitly allocated to Brenmiller’s bGen™ thermal storage. Why? Because in an island-mode operation that’s disconnected from the national grid, energy flexibility isn’t a luxury. It’s a requirement.

That same logic applies to nuclear. Advanced nuclear reactors are smaller, modular, and more widely deployable. But without a load-following mechanism, they still suffer from the same mismatch between generation capacity and real-time grid needs. TES provides that mechanism.

And serving that need isn’t a far-off vision. With over $40 million in deployable bGen™ infrastructure and a pipeline of global projects underway, Brenmiller Energy is uniquely positioned and able to meet this moment. We believe that with the right supporting technology, like bGen, the nuclear revival on both sides of the Atlantic doesn’t need to clash with the renewable agenda. The two can – and must – work in tandem. However, this will only happen with enabling technologies like TES, which can seamlessly connect these assets into a cohesive, responsive, and resilient energy network.

At Brenmiller Energy, we’re not just watching the shift – we’re helping to power it. As policy evolves, so too must infrastructure. Nuclear energy without flexibility is a missed opportunity. The most excellent news during nuclear’s second chance is that legacy rigidity is no longer a concern. With bGen TES technology included to complement, nuclear gets a foundational building block of the new energy economy.

And as we’ve demonstrated with ENEL, SolWinHy, Tempo Beverage, and others, we’re not just theorizing; we’re putting our innovative assets into practice. We’re proud to say that, as of now, we’re the only known TES provider who can.

By Doron Brenmiller
Chief Business Officer, Brenmiller Energy (NASDAQ:BNRG)

About bGen™

bGen™ ZERO is Brenmiller’s TES system, which converts electricity into heat to power sustainable industrial processes at a price that is competitive with natural gas. The bGen™ ZERO charges by capturing low-cost electricity from renewables or the grid and stores it in crushed rocks. It then discharges steam, hot water, or hot air on demand according to customer requirements. The bGen™ ZERO also supports the development of utility-scale renewables by providing critical flexibility and grid-balancing capabilities. bGen™ ZERO was named among TIME’s Best Inventions of 2023 in the Green Energy category and won Gold in the Energy Storage and Management category at the 2025 Edison Awards.

About Brenmiller Energy Ltd.

Brenmiller Energy helps energy-intensive industries and power producers end their reliance on fossil fuel boilers. Brenmiller’s patented bGen™ ZERO thermal battery is a modular and scalable energy storage system that turns renewable electricity into zero-emission heat. It charges using low-cost renewable electricity and discharges a continuous supply of heat on demand and according to its customers’ needs. The most experienced thermal battery developer on the market, Brenmiller operates the world’s only gigafactory for thermal battery production and is trusted by leading multinational energy companies. For more information visit the Company’s website at https://bren-energy.com/ and follow the company on X and LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Statements that are not statements of historical fact may be deemed to be forward-looking statements. For example, the company is using forward-looking statements in this press release when it discusses: that the Company’s bGen™ system installation at Purchase College will reduce 550 metric tons of CO2 emissions annually; that TES modularity enables flexible and efficient deployment across diverse infrastructure; and that as more public entities prioritize net-zero transitions, scalable and proven solutions like our bGen™ can provide a suitable solution. Without limiting the generality of the foregoing, words such as “plan,” “project,” “potential,” “seek,” “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements. Readers are cautioned that certain crucial factors may affect the company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this press release. Factors that may affect the Company’s results include, but are not limited to: the company’s planned level of revenues and capital expenditures; risks associated with the adequacy of existing cash resources; the demand for and market acceptance of our products; impact of competitive products and prices; product development, commercialization or technological difficulties; the success or failure of negotiations; trade, legal, social and economic risks; and political, economic and military instability in the Middle East, specifically in Israel. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company’s Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC on March 4, 2025, which is available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contact:

investors@bren-energy.com

SOURCE: Brenmiller Energy

View the original press release on ACCESS Newswire

Clear Start Tax Warns That Tax Debt May Result in Passport Denial or Revocation – and What Taxpayers Can Do About It

IRVINE, CA / ACCESS Newswire / May 28, 2025 / If you owe back taxes to the IRS, your next trip abroad could be in jeopardy. According to Clear Start Tax, a trusted tax resolution firm, the IRS has the legal authority to restrict or revoke a taxpayer’s passport when unpaid federal tax debt reaches a certain threshold.

Under a 2015 law known as the Fixing America’s Surface Transportation (FAST) Act, the IRS can certify “seriously delinquent tax debt” to the U.S. State Department, triggering a block on passport renewal or even revocation. For frequent travelers, business professionals, or anyone planning international travel, the consequences can be both unexpected and severe.

What Counts as “Seriously Delinquent Tax Debt”?

According to IRS guidelines, seriously delinquent tax debt includes:

• An unpaid federal tax balance of $62,000 or more (adjusted annually for inflation)

• A final notice of intent to levy has been issued

• The taxpayer has not entered into a resolution such as an installment agreement or offer in compromise

“Most taxpayers don’t realize that unresolved tax debt can directly impact their ability to travel,” said the Head of Client Solutions at Clear Start Tax. “We’ve assisted clients who were surprised to learn their passport applications were denied due to IRS enforcement-and it often happens at the worst possible time.”

Who Is Most Likely to Face Passport Restrictions?

Clear Start Tax notes that taxpayers most likely to be impacted by passport restrictions include:

• Those with longstanding back tax balances

• Individuals who have ignored multiple IRS notices

• Taxpayers unaware of their debt reaching the enforcement threshold

• Business owners or self-employed individuals with multiple years of unpaid returns

How to Avoid Losing Passport Privileges

Fortunately, travel restrictions can often be lifted once the taxpayer enters into a formal resolution with the IRS. Clear Start Tax helps clients prevent or reverse passport actions through programs such as:

• Installment Agreements – Formal monthly payment plans to regain good standing

• Offer in Compromise (OIC) – Settle the debt for less than what’s owed

• Currently Not Collectible (CNC) status – Pause collections due to financial hardship

• Immediate case review and IRS communication for urgent travel situations

“Passport holds can be resolved-but only if you act before your departure date,” added the Head of Client Solutions. “We help clients resolve tax issues quickly so travel plans aren’t disrupted.”

Clear Start Tax: Helping Taxpayers Stay on Track-And On the Move

Whether you’re planning a vacation, traveling for work, or renewing your passport for future use, tax debt should never be a reason to miss out. Clear Start Tax provides:

• Full IRS account review to assess passport risk

• Resolution strategies tailored to urgency and financial status

• Ongoing compliance support to prevent future restrictions

• Fast-tracked communication with the IRS when timing matters

About Clear Start Tax

Clear Start Tax is a full-service tax liability resolution firm that serves taxpayers throughout the United States. The company specializes in assisting individuals and businesses with a wide range of IRS and state tax issues, including back taxes, wage garnishment relief, IRS appeals, and offers in compromise. Clear Start Tax helps taxpayers apply for the IRS Fresh Start Program, providing expert guidance in tax resolution. Fully accredited and A+ rated by the Better Business Bureau, the firm’s unique approach and commitment to long-term client success distinguish it as a leader in the tax resolution industry.

Need Help With Back Taxes?
Click the link below:
https://clearstarttax.com/qualifytoday/

Contact Information

Clear Start Tax
Corporate Communications Department
seo@clearstarttax.com
(949) 535-1627

SOURCE: Clear Start Tax

View the original press release on ACCESS Newswire

NEW YORK CITY, NEW YORK / ACCESS Newswire / May 28, 2025 / FLOKI, the people-powered crypto ecosystem, is going primetime.

In a major national visibility push, FLOKI has entered into a sweeping three-month media partnership with New to The Street, one of the most trusted and widely distributed financial media platforms in the U.S. The campaign will spotlight FLOKI’s dynamic ecosystem-including its flagship MMORPG Valhalla-and its mission to deliver real-world crypto utility to a global audience.

The campaign features:

• Biographical interviews airing nationwide on Fox Business and Bloomberg TV

• Over 150 commercials across CNBC, Bloomberg, and FOX Business

• Times Square billboard dominance (20x per hour)

• Live and virtual investor events targeting brokers, family offices, and accredited investors

• Weekly content distribution to New to The Street’s 2.47M+ YouTube subscribers and across its growing social platforms

“FLOKI is one of the most innovative and community-driven platforms in crypto today,” said New to The Street Founder Vince Caruso. “This campaign ensures they get the national stage and financial audience they deserve.”

From Times Square to Bloomberg: What’s in the Campaign?

Each month, FLOKI leadership will appear in two long-form interviews airing as sponsored programming across Fox Business and Bloomberg TV-reaching over 219 million U.S. households.

FLOKI’s banner and Valhalla visuals will be featured on the Reuters 42nd Street digital billboard, airing 20 times per hour, four weeks a month. The campaign’s creative spotlight centers on the upcoming Valhalla mainnet launch set for June 30, 2025.

Additionally, over 150 commercials per month will run across financial TV networks, with a secondary Bloomberg commercial push beginning in month two. The partnership also includes 3 monthly press releases, NYSE interview recaps, and earned media syndication across ABC, NBC, CBS, and FOX affiliate networks.

FLOKI will also participate in:

• Broker-hosted meet-and-greet events

• Intimate investor dinners in NYC

• Virtual presentations for family offices and accredited investors

“I’m very excited about this partnership and sharing how FLOKI is making blockchain better than we found it,” said Pedro Vidal, FLOKI’s Community Relations Officer. “This campaign expands our reach and reveals the powerful utility within the FLOKI ecosystem. I’m dually proud and excited!”

About FLOKI

FLOKI is the people’s cryptocurrency and utility token of the Floki Ecosystem. With over 550,000 holders, FLOKI aims to be the world’s most recognized and widely used cryptocurrency, driven by utility, philanthropy, community, and marketing. Its global brand has been featured in strategic campaigns reaching billions.

floki.com
@RealFlokiInu

About TokenFi

TokenFi is FLOKI’s sister project focused on simplifying crypto and asset tokenization. With a no-code interface, TokenFi empowers users to launch or tokenize real-world assets with ease, targeting the trillion-dollar tokenization market.

tokenfi.com
@tokenfi

About Valhalla

Valhalla is FLOKI’s metaverse blockchain-based MMORPG, inspired by Norse mythology. Players discover, tame, and battle creatures called Veras in a player-driven economy. The mainnet launch is slated for June 30, 2025.

valhalla.game

About New to The Street

New to The Street is a premier financial media brand known for its weekly long-form interviews with CEOs, innovators, and emerging public and private companies. Broadcasting as sponsored programming on Bloomberg and Fox Business, New to The Street reaches over 219 million households weekly, in addition to its 2.51M+ YouTube subscribers and 714K+ social media followers across LinkedIn, Twitter, Instagram, and Facebook. The brand also delivers earned media pickup on ABC, NBC, and CBS affiliates and dominates outdoor exposure in NYC with billboards in Times Square and the Financial District.

Website: newtothestreet.com

Media Contact: Monica@NewtoTheStreet.com

SOURCE: New To The Street

View the original press release on ACCESS Newswire

CHICAGO, IL / ACCESS Newswire / May 28, 2025 / The proliferation of fake documents generated by artificial intelligence has reached a critical level. From diplomas to bank powers of attorney, purchase orders, emails, and press releases, everyone is now exposed to significant legal, financial, and reputational risks.

In regulated sectors such as banking and finance, press releases must be authentic, timestamped, and tamper-proof. That is exactly what Certidox provides: ensuring that any content published by an organization – including official communications – remains authentic, traceable, and immune to sophisticated forgery attempts.

This technology will be presented by Rémy EISENSTEIN on May 29 at the ULCC Networking Extravaganza held at the Union League Club of Chicago.

Certidox enables instant verification of the authenticity of any document – paper or digital – and ensures ongoing monitoring through real-time alerts in case of changes or revocation. Based on patented end-to-end encryption and operating without any third-party trust, Certidox guarantees absolute confidentiality: no data is ever stored in plain text on its servers.

Thanks to its open-source code, Certidox also provides total transparency: it can be freely audited, verified, and integrated into any IT system.

The applications of Certidox technology are numerous:

• For everyone: email content

• For banks: account holder attestations, payment instructions, credit documents

• For law firms and notaries: powers of attorney, contracts, court rulings

• For businesses: purchase orders, quotes, regulated press releases

• For education: diplomas, transcripts, certificates (as demonstrated with the TrustDiplomas application)

“In a world where everything can be copied, altered, or forged in seconds by artificial intelligence, we offer a sovereign, transparent, and tamper-proof solution. Certidox restores value to documentary proof,” says Rémy EISENSTEIN, Founder.

Press Contact:
Rémy A. EISENSTEIN – remy@certidox.com
+1 (630) 895-4089
https://certidox.com

SOURCE: Certidox

Related Documents:

• pressreleasecertidoxcertified

View the original press release on ACCESS Newswire

AUSTIN, TX / ACCESS Newswire / May 28, 2025 / Volcon ePowersports (Nasdaq:VLCN) (“Volcon” or the “Company”), the first all-electric, off-road powersports company, is pleased to announce the launch of a new floor plan financing and retail financing program provided by Dealer Direct Financial, a department of First Community Bank. This initiative will enable Volcon’s network of dealers to finance their inventory purchases, providing them with enhanced access to the Company’s groundbreaking electric off-road vehicles.

The floor plan will provide flexible financial solutions designed to support inventory acquisition and drive sales of Volcon’s cutting-edge products. By facilitating dealer access to affordable financing, Volcon aims to expand its market presence and ensure that customers nationwide can experience the next generation of off-road adventure with the Company’s electric vehicles.

“We are excited to offer this floor plan program to our dealer network, which will empower them to grow their businesses while helping accelerate the adoption of our all-electric off-road vehicles,” said John Kim, CEO of Volcon. “This program reflects our commitment to strengthening dealer relationships and furthering our mission to revolutionize the powersports industry with sustainable, high-performance electric vehicles.”

The new floor plan program is a significant step in Volcon’s strategy to scale its operations and support its growing network of dealers as they meet increasing demand for Volcon’s innovative electric powersports offerings.

“We’re proud to partner with Volcon in supporting their innovative approach to the powersports market,” said Steve Wilcoxon, president of Dealer Direct Financial. “Our floor plan program is designed to give dealers the flexibility and access they need to meet customer demand and grow their businesses. By offering tailored financing solutions, we’re helping bring Volcon’s electric off-road vehicles to more showrooms-and more riders-across the country.”

About Volcon

Based in the Austin, Texas area, Volcon was founded as the first all-electric power sports company producing high-quality and sustainable electric vehicles for the outdoor community. Volcon electric vehicles are the future of off-roading, not only because of their environmental benefits but also because of their near-silent operation, which allows for a more immersive outdoor experience.

Volcon’s vehicle roadmap includes both motorcycles and UTVs. Its first product, the innovative Grunt, began shipping to customers in late 2021 and combines a fat-tired physique with high-torque electric power and a near-silent drive train. The Volcon Grunt EVO, an evolution of the original Grunt with a belt drive, an improved suspension, and seat, began shipping to customers in October 2023. The Brat is Volcon’s first foray into the wildly popular eBike market for both on-road and off-road riding and is currently being delivered to dealers across North America. In 2024, Volcon entered the rapidly expanding LUV and UTV market and shipped its first production MN1 unit in October 2024. The new MN1 and HF1 products empower the driver to explore the outdoors in a new and unique way that gas-powered units cannot. They offer the same thrilling performance of a standard LUV / UTV without the noise (or pollution), allowing the driver to explore the outdoors with all their senses.

Volcon Contacts

For Media: media@volcon.com
For Dealers: dealers@volcon.com
For Investors: investors@volcon.com
For Marketing: marketing@volcon.com

For more information on Volcon or to learn more about its complete eBike, motorcycle and side-by-side line-up, visit: www.volcon.com

For more information about First Community Bank’s Dealer Direct program, call 870-376-7123 or visit https://dealerdirectfinancial.com.

Forward-Looking Statements

Some of the statements in this release referenced in this release are forward-looking statements, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, whether floor plan program will increase dealer purchases of Volcon products. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. The Company has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors. Any forward-looking statements contained in this release speak only as of its date. The Company undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the SEC, which are available on the SEC’s website, www.sec.gov.

About Dealer Direct Financial

Dealer Direct Financial is a department of First Community Bank, headquartered in Batesville, Arkansas. The program was established in 2005 in response to a need among local manufacturers for floor plan and retail financing solutions. Since its inception, Dealer Direct Financial has experienced significant growth and now services thousands of dealers nationwide. The program offers specialized financing for manufacturers, including floor plans and retail installment loans for tractors (up to 75hp), trailers, boats, powersports, motorcycles, lawn equipment, and farm equipment.

About First Community Bank

First Community Bank, which is locally owned and managed, opened August 4, 1997, in Batesville, Arkansas, and currently operates in 34 locations across Arkansas and Missouri. First Community Bank employs 600 professional bankers, and reports assets of $3.09 billion as of March 31, 2025.

SOURCE: Volcon, Inc.

View the original press release on ACCESS Newswire

• Sublingual nano technology delivers caffeine rapidly to the blood stream, bringing its unique disruptive benefits to the Pre-workout market

• Initial production has commenced with six flavor options

• Expanded pre-launch consumer testing planned for Q2 2025

• Aspire to launch BUZZ BOMB™ at two major upcoming fitness conventions

• Marketing plan focused on cost-effective multi-channel digital strategy targeting primary influencers, direct response sales and traditional retail sales channels

• Global pre-workout supplements market size is expected to reach $27.97 billion by 2030, registering a CAGR of 5.9% from 2025 to 2030

HUMACO, PUERTO RICO and NEW YORK, NY / ACCESS Newswire / May 28, 2025 / Aspire Biopharma Holdings, Inc. (Nasdaq:ASBP) (“Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology, today announced the brand name BUZZ BOMB™ and anticipated market launch for its novel sublingual pre-workout supplement. BUZZ BOMB™ features 50mg of caffeine and is designed to support sustained energy and mental focus, helping athletes and fitness enthusiasts maximize their performance potential.

Aspire has commenced initial production of BUZZ BOMB™, its single serving pre-workout caffeine supplement utilizing Aspire’s patent-pending and proprietary sublingual delivery technology.The pre-workout formula is conveniently packaged in a single serving packet for easy on-the-go use. Consumers will have a choice of six BUZZ BOMB™ flavors, including Tropical Fruit, Mixed Berry, Watermelon, Lemon Lime, Peach Mango, and Mocha Coffee.

Fitness Convention Booth and Sponsor Events for BUZZ BOMB™ Launch

The Company expects to begin expanded pre-launch consumer testing of this supplement product during the second quarter of 2025. In August, the Company will have a booth and be an event sponsor at two of the largest fitness conferences in the nation where over 50,000 people interested in health, fitness, optimization, nutrition, and overall wellbeing will be able to taste, sample, and experience the BUZZ BOMB™ pre-workout supplement.

FITCON Expo
https://fitcon.com/

August 1-2, 2025
Mountain America Expo Center, Salt Lake City, Utah

The Fit Expo™
https://thefitexpo.com/cities/anaheim/
August 2-3
The Anaheim Convention Center, Anaheim, CA

Management Commentary

“The introduction of Aspire’s caffeine-based “Buzz Bomb™” Sublingual Pre-Workout energy supplement has the ideal unique characteristics to disrupt the fast-growing, multi-billion-dollar Sports Nutrition and Fitness market,” said Kraig Higginson, Chief Executive Officer of Aspire. “We are excited about the early feedback from fitness trainers and athletes-who love how clean and simple our product is–and we look forward to the implementation of our phased marketing plan as we prepare for our market launch in the early third quarter. Initial production, performed by Desert Stream, a leading private label manufacturer in the health and wellness industry, has proceeded as planned and we expect to have ample product available for consumer testing and launch.

While we are initially focused on the fitness pre-workout market, we believe the product also has tremendous broad market appeal in the Cognitive Focus and Energy Boost markets for professionals seeking a safe, healthy way to meet energy demands at work. We believe it may also appeal to a growing Health and Nutrition market as a weight loss enhancement, and as a coffee alternative, providing the taste, energy, and cognitive boost of coffee, while on the go, without the adverse effects of disrupting the gut micro biome and the liver, that is associated with long term coffee consumption.”

Higginson added, “As part of our commercial and revenue strategy, BUZZ BOMB™, is expected to provide Aspire with the opportunity for rapid, cost-effective market entry, and early revenue and cash flow while we complete our FDA clinical trials and application process for our high-dose aspirin product.”

BUZZ BOMB™: Disruptive Characteristics

The Pre-Workout supplement market segment is flooded with many options for energy boosting and hydration products. Many, if not most, of these products today are based on a powdered “mix + water” combination that take 20-30 minutes to digest and begin to provide performance benefits. This disadvantage complicates use, response management, caffeine control, and effectiveness. In contrast, Buzz Bomb™ provides nearly instant energy, in easy-to-use small sublingual packets, which can be taken right before and during work out as needed.

Market research shows that immediacy, ease of use and time management (take as needed, when needed) ranks highest in consumer preferences. Buzz Bomb™ offers potentially disruptive benefits and product characteristics that is expected to drive market penetration with significant differentiation, leading to rapid customer conversion, acquisition, and brand identity in this market.

Aspire’s sublingual nano technology is designed to deliver caffeine directly to the blood stream, bringing its unique disruptive benefits to the Pre-Workout market. These unique benefits provide significant product differentiation from powder mix beverage products that currently dominate the market segment.

BUZZ BOMB™ Disruptive Features:

• Speed – works nearly immediately vs. 20-30 minutes

• Convenience – easy to use small packets vs. mix beverages

• Energy management – use as needed, when needed to manage energy

• Single Safe Ingredients – well known benefits and use of caffeine

• Low manufacturing & packaging costs – competitive pricing with high margin potential

• Easy powerful product demonstration – enabling low-cost sample kits

Pre-workout Supplements Market & Growth Drivers

According to Research and Market Reports recent report, “The global pre-workout supplements market size is expected to reach $27.97 billion by 2030, registering a CAGR of 5.9% from 2025 to 2030.”

Growth Drivers

• Rising fitness culture and gym memberships

• Consumer focus on performance and recovery

• Expanding demographics (women, Gen Z, casual exercisers)

• Growth of RTD (“Ready To Drink”- no mixing) formats & natural formulations

• Digital fitness and influencer-led marketing

About the Aspire Targeted Oral Delivery Platform

Aspire’s technology delivers a soluble, fast acting granular or powder formulation which has been developed by using our patent-pending methodology, and “trade secret” process. The technology’s new mechanism of action allows for rapid sublingual absorption and entry into the bloodstream of supplements and other substances. The benefits of “rapid absorption” are to provide rapid impact in more precise quantities.

About Aspire Biopharma, Inc.

Headquartered in Humacao, Puerto Rico, Aspire Biopharma has developed a disruptive technology through a Novel Soluble Formulation which can deliver supplements and drugs rapidly and precisely. For more information, please visit www.aspirebiolabs.com.

Safe Harbor Statement

Certain statements made in this communication are “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of words such as “estimate,” “projects,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “would,” “should,” “future,” “propose,” “potential,” “target,” “goal,” “objective,” “outlook” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the financial position, business strategy and the plans and objectives of management for future operations. These statements are based on various assumptions, whether or not identified in this communication, and on the current expectations of Aspire’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as a guarantee, an assurance, a prediction or a definitive statement of fact or probability. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the parties, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Aspire Biopharma Holdings, Inc.

Contact

TraDigital IR
Kevin McGrath
+1-646-418-7002
kevin@tradigitalir.com

SOURCE: Aspire Biopharma Holdings, Inc.

View the original press release on ACCESS Newswire

The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition.

MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) (“MIRA” or the “Company”), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it will participate in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities.

The Company’s lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management.

In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. (“SKNY”), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY’s primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors.

“Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders,” said Erez Aminov, Chief Executive Officer of MIRA. “As we move closer to initiating Phase IIa and completing the SKNY transaction, we’re actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed.”

Dr. Angel, Chief Scientific Advisor at MIRA, added:
“We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we’ve generated with potential partners and investors.”

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 other SEC filings, which are on file with the SEC at www.sec.gov and 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 Information
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

TAMPA, FLORIDA / ACCESS Newswire / May 28, 2025 / Wellgistics Health, Inc. (NASDAQ:WGRX), a healthcare infrastructure company transforming the prescription drug ecosystem, today announced key additions to its executive leadership team and Board of Directors. These strategic appointments reflect the Company’s commitment to executing on its growth strategy, enhancing operational scale, and delivering long-term shareholder value.

Key Leadership Appointments

Wellgistics has appointed a diverse and deeply experienced group of executives to drive execution across the Company’s operations:

Tony Madsen, Chief Operating Officer (COO) – A seasoned executive with over a decade of regulatory compliance, cybersecurity, and healthcare operations scaling experience. Mr. Madsen will oversee execution across Wellgistics’ platform and ensure cross-functional alignment and operational excellence. Since 2020, he served as Managing Partner at Nomad Capital, an investment firm dedicated to reshaping capital structures and fine-tuning operational efficiencies. For the six years prior, he was Director of Cybersecurity at Cingo Solutions, an SOC2-certified managed detection and response cybersecurity provider. He holds a degree in Economics from Brigham State University.

Shelley Bailey, Chief Revenue Officer (CRO) – A proven growth strategist, Ms. Bailey brings deep industry knowledge and leadership in scaling healthcare sales teams and revenue operations across multiple verticals. Most recently, she served as Chief Strategy Officer at Wellgistics, where she combined her specialty pharmacy, government affairs, and supply chain experience to create tailored employer solutions. For the three years prior, she was the Chair of the Oregon Prescription Drug Affordability Board, a branch of that state’s largest consumer protection and business regulatory​ agency. Between 2020 and 2025 she served as founder and CEO of Famlee Health, which provided clinical assessment, diagnosis and step-therapy treatment for fertility from home. For the seven years prior, Ms. Bailey was a Specialty Pharmacy Consultant to legislators, pharmaceutical, and healthcare companies with a focus on specialty pharmacy and 340B programs. Between 2000 and 2017 she was CEO and co-owner of Central Drugs Specialty Pharmacy in Oregon. She earned an MBA from Babson F.W. Olin Graduate School of Business.

Srini Kalla, Chief Information Officer (CIO) – Mr. Kalla will lead the modernization of Wellgistics’ digital and data infrastructure, driving the Company’s AI integration strategy, compliance frameworks, and platform interoperability. Prior to joining Wellgistics, he worked with Optum Workers’ Comp and Auto No-Fault, a Minnesota-based insurance company, where he first served as Executive Director and then Vice President IT. Previously, he was employed in Analyst-Security Operations and Specialist-Operations Support by Verizon Data Services. He holds MS and MIS degrees from the University of Florida.

Vasudev Patel, Product Owner – Mr. Patel will spearhead product development across the Company’s AI-driven prescription routing tools, pharmacy technology platforms, and digital patient engagement solutions. Prior to joining Wellgistics, Mr. Patel held the position of Agile Product Owner with Evernorth Health Services. From 2012 to 2022 he served as Senior Business Analyst at UnitedHealth Group. He previously held Business Analyst positions with both Express Scripts and Merrill Lynch/Bank of America. He holds an MBA, Finance, from Brain Wells University in London.

Ari Aichbhaumik, Senior Vice President of Supply Chain – Mr. Aichbhaumik brings a strong track record of optimizing pharmaceutical supply chain networks at scale, with expertise in distribution, logistics, and global procurement. Before joining Wellgistics, Ari held a number of pharmacy operations management positions including Senior Vice President with Bayvrio, VP, Pharmacy Practice and Specialty Solution at Eversana, and Director of Pharmacy Operations at WellDyne, Inc. He holds degrees in Pharmacy from Temple University and Pharmaceutical Economics from University of Florida, as well as an MS, Computer Information and Business Management from the University of Phoenix.

Kim Dresser, Director of Human Resources – Ms. Dresser will drive talent acquisition, culture transformation, and HR infrastructure as Wellgistics continues to scale nationally.

Most recently, Kim served as Human Resources Director for Leonard Buildings & Truck Accessories, a 150-store, 18-state manufacturer and distributor. Previously, she was Human Resources Manager for MVP Group International, one of the world’s largest manufacturers of private label scented candles. From 2016 through 2021 she served as Production Manager at World Wide Protective Products, a maker of custom hand and body protection products. She holds an Associate degree in Business Management from Surry Community college in North Carolina.

Board Appointment

Michael Peterson, Member, Board of Directors – A veteran public company executive and capital markets strategist bringing significant governance and financial experience, Mr. Peterson will help guide Wellgistics’ strategic expansion and shareholder engagement.

Since 2022 Michael has served as CEO, Director, and Founder of Lafayette Energy, a Utah based oil and gas exploration company. He also presently serves as Director with both the biopharma company, Ocean Biomedical, and with the energy exploration company, Indonesia Energy Corporation. Michael also served as Director and CEO with Trio Petroleum Corp and as Director with TRxADE Health, Inc. (Nasdaq: MEDS), a wholesale drug selling platform. He holds an MBA, Finance, from Brigham Young University Mariott School of Business.

“This is more than just leadership expansion-it’s the strategic assembly of a world-class team capable of executing on our national vision to fundamentally shift the way prescription drugs move across the supply chain in America,” commented Brian Norton, CEO of Wellgistics Health. “We’re not just optimizing logistics-we’re rebuilding the infrastructure of healthcare medicine delivery to create lasting value for employer groups, patients, pharmacies, and the entire healthcare ecosystem.”

About Wellgistics Health

Wellgistics Health, Inc. is a publicly traded healthcare infrastructure company redefining how medications move, are priced, and reach patients. The company operates across pharmaceutical distribution, prescription technology, and clinical fulfillment-connecting over 150 direct manufacturer contracts to a nationwide network of over 6,000 independent pharmacies.

Wellgistics Health provides real-time prescription hub services, compliance-driven logistics, and patient-first fulfillment solutions, while equipping pharmacies with integrated financial, clinical, and digital tools. Its end-to-end platform supports a broad range of therapeutic areas from specialty-lite to chronic maintenance medications by eliminating friction, accelerating reimbursements, and enabling direct, transparent connections between manufacturers, providers, pharmacies, and patients.

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, Wellgistics Health’s statements regarding Wellgistics Health’s strategy and descriptions of its future operations, prospects, and plans, including without limitation its plan in connection with certain financings and cryptocurrencies and outlook and actions with respect to incurring future expenses. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from Wellgistics Health’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other risks detailed in our reports and statements filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in Wellgistics Health’s filings with the SEC, which are available for review at www.sec.gov.

For more information, please contact:

Media Contact: media@wellgisticshealth.com
Investor Relations: investors@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.

View the original press release on ACCESS Newswire