Blog

• Aspire’s sublingual aspirin formulation significantly inhibited serum thromboxane B2 (TxB2) within the first two minutes after dosing

• TxB2 is a biomarker indicating aspirin’s effect on platelet aggregation, the clumping of platelets that leads to dangerous blood clots

• This rapid inhibition is critical during suspected heart attacks, when clots blocking heart arteries can cause permanent muscle damage

• Lab results showed Aspire’s product acted approximately twice as fast as the current recommendation for chewed aspirin tablet treatment

• These clinical trial results enable a potential regulatory submission for accelerated approval on track for Q3 2025

ESTERO, FLORIDA / ACCESS Newswire / September 3, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (“Aspire” or the “Company”), developer of a multi-faceted patent-pending drug delivery technology, today announced positive final results from its randomized, crossover bioavailability trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Aspire’s investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets in healthy adults. The final results demonstrated that Aspire’s sublingual aspirin product produced higher and more rapid mean plasma concentrations of acetylsalicylic acid (ASA, the active antiplatelet form of aspirin) compared to chewed aspirin tablets (p0.05), as detailed in Aspire’s previous press release. The product was also safe and well-tolerated by patients, and no adverse events were reported. However, even more clinically significant results were discovered since the press release announcing top-line results was issued on August 18, 2025.

Important New Findings

Aspire’s OTASA BA2039 sublingual formulation also significantly inhibited serum thromboxane B₂ (TxB₂) within the first two minutes after dosing compared to the chewed oral aspirin tablets (p0.02). TxB₂ is a biomarker for the effect of aspirin on platelet aggregation. This has significant and important positive implications for its role in the inhibition of blood clotting and its role in heart attacks.

These important results underscore the potential of Aspire’s sublingual aspirin product to be the market-leading treatment for suspected acute myocardial infarction (AMI, blockage of blood flow to heart muscle causing damage or death of heart tissue – commonly known as a “heart attack”). There are an estimated 18 million Americans living with coronary artery disease with approximately 800,000 per year experiencing an AMI leading to 300,000 deaths.

According to a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines dated April 1, 2025, “Aspirin has long been considered an integral part of anti-platelet therapy to prevent recurrent atherothrombotic events among patients with Acute Coronary Syndromes (ACS). Aspirin reduces the incidence of vascular death after AMI, and in secondary prevention trials (that include patients after MI), it re-duces the occurrence of vascular and coronary events, including MI and stroke.

Aspirin should be initiated with a loading dose (162-325 mg) in patients with ACS without an absolute contraindication as soon as possible on presentation irrespective of final management strategy (invasive or noninvasive).” Aspire’s sublingual product rapidly delivers 162.5 mg of aspirin, precisely in the range suggested by this study, and Aspire’s product begins to show TxB2 inhibition in two minutes or less.”

Kraig Higginson, Interim Chief Executive Officer of Aspire, commented, “The final results from our recent clinical trial confirm our belief that our high dose sublingual aspirin has to the potential to be a life-changing, market-leading treatment for patients experiencing a suspected heart attack. Patients in our study experienced a significantly improved time of inhibition of TxB₂, a biomarker for platelet aggregation, the process where activated platelets stick to each other to block the flow of blood to heart muscle. We believe our new sublingually delivered aspirin has the potential to save lives. We look forward to presenting these data to the FDA as we move down the development pathway towards potential commercialization of our safe, novel and effective sublingual form of high dose aspirin. We hope the day will soon come that every EMT, emergency service provider, and hospital will have our sublingual aspirin on hand for those suffering from heart attacks.”

* TxB₂ is a stable metabolite of thromboxane A₂ (TxA₂), a potent chemical that promotes platelet clumping and vasoconstriction. Measuring low levels of TxB₂ confirms that aspirin is working as intended.

The results of Aspire’s clinical study suggest that sublingual administration of aspirin provides earlier drug exposure and platelet inhibition than the current standard-of-care, which is chewing and swallowing uncoated aspirin tablets. Numerous published studies indicate that an even more rapid pharmacodynamic effect would be desirable during the early phase of thrombus evolution in the setting of myocardial infarction or ischemic stroke (i.e., the sooner TxB2 concentration can be reduced, the better for the patient). Reducing mean serum TxB₂ concentration after aspirin dosing-which the clinical study demonstrates that Aspire’s sublingual aspirin product does rapidly, starting in 2 minutes or less–indicates successful inhibition of platelet aggregation, which may reduce the risk of vascular death and other major adverse cardiovascular events.

Advancing Aspire’s Sublingual Aspirin

Aspire plans to review its clinical trial results with the U.S. Food and Drug Administration (FDA) to enable a potential regulatory submission for accelerated approval in the third quarter of 2025.

About Aspire’s Clinical trial AB-101

Clinical trial AB-101 was a randomized crossover bioavailability study of Aspire’s investigational new sublingual aspirin product compared to chewed uncoated aspirin tablets. Six otherwise healthy 40 to 65-year-old subjects were administered 162 mg aspirin as a single dose in each of three treatment periods separated by two 14-day washout periods. Two different investigational sublingual powder and granule formulations (Aspire Biopharma) and chewed uncoated oral aspirin tablets (Bayer) were studied. The primary objective of the clinical trial was to evaluate the bioavailability of ASA in plasma over eight hours after dosing. An additional objective was to evaluate the potentially life-saving effect of each treatment on serum TxB₂.

Aspire’s sublingual aspirin is an investigational new drug and has not been approved for marketing by FDA or any other government regulatory authority.

About Oral Aspirin

Oral aspirin is FDA-approved for treatment of suspected AMI with the initial dose of 160-162.5 mg is administered as soon as an AMI is suspected.ⁱ In a large, multicenter study of aspirin, streptokinase, and the combination of aspirin and streptokinase in 17,187 patients with suspected AMI, aspirin treatment produced a 23 percent reduction in the risk of death from cardiovascular diseases within five weeks.ⁱⁱ Clinical practice guidelines recommend that aspirin be initiated as soon as possible with the initial dose chewed, when possible, to achieve faster onset of antiplatelet action.ⁱⁱⁱ

About Aspire Biopharma Holdings, Inc.

Aspire Biopharma has developed a patent-pending sublingual delivery technology that can deliver drugs to the body rapidly and precisely. This technology offers the potential to improve effectiveness and reduce side effects by going directly to the bloodstream and avoiding the gastrointestinal tract. Aspire Biopharma’s delivery technology can be applied to many different active pharmaceutical ingredients (APIs) and other bioactive substances, spanning both small and large molecule therapeutics, nutraceuticals and supplements.

For more information, please visit www.aspirebiolabs.com

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Aspire’s forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include general market conditions, whether clinical trials demonstrate the efficacy and safety of our drug candidates to the satisfaction of regulatory authorities, or do not otherwise produce positive results which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete the development and commercialization of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.

View the original press release on ACCESS Newswire

An inspiring day of connection, learning, and impact.

CHARLOTTE, NORTH CAROLINA / ACCESS Newswire / September 3, 2025 / Mental Health America of Central Carolinas (MHACC) is proud to announce that Nora McInerny, bestselling author, award-winning podcast host, and internationally recognized speaker, will deliver the keynote address at the Southeast Regional Conference on Mental Health, taking place Thursday, October 30, 2025, at the UNC Charlotte Marriott Hotel & Conference Center.

McInerny is best known for her celebrated books (It’s Okay to Laugh, No Happy Endings, Bad Vibes Only) and as the host of the widely acclaimed podcast Terrible, Thanks for Asking, which blends humor, honesty, and hope to explore some of life’s most difficult topics. Her keynote will inspire attendees with her trademark mix of vulnerability and levity, encouraging open conversations about grief, resilience, and mental wellness.

“Having Nora McInerny join us as our keynote speaker is an incredible honor,” said Ayo Johnson, Executive Director of MHACC. “Her ability to connect with audiences, break down stigma, and make space for the full spectrum of human experiences aligns perfectly with the vision for this inaugural conference.”

About the Conference

The Southeast Regional Conference on Mental Health will bring together mental health professionals, advocates, and community leaders for a day of learning and connection. Sessions will focus on three core areas:

• Advocacy: Policies and practices shaping mental health equity.

• Education: Clinical insights, community learning, and public awareness.

• Access: Strategies to expand access to care across diverse populations.

Event Details

• What: Southeast Regional Conference on Mental Health

• When: Thursday, October 30, 2025

• Where: UNC Charlotte Marriott Hotel & Conference Center

• Registration: mhaofcc.org/conference

About Mental Health America of Central Carolinas

Mental Health America of Central Carolinas has served the region for over 90 years, providing education, advocacy, and direct support services to families and individuals. Programs include family support for parents of children with behavioral and mental health needs, peer support for adults, free counseling for those who cannot afford care, and mental health education for the broader community. Learn more at mhaofcc.org.

Contact Information

J. Hill
Public Relations Manager
jhill@branduscriptpr.com
704-287-6998

SOURCE: The Branduscript Agency

View the original press release on ACCESS Newswire

Modules utilize a new 51Ah cell format both of which received UN38.8 certification

Further demand for the new battery module expected in the Japanese market for other OEM opportunities with sales through Sumitomo Corporation Power and Mobility

Further strengthens the Company’s leadership position in the market for industrial and heavy-duty vehicles

TORONTO, ON / ACCESS Newswire / September 3, 2025 / Electrovaya Inc. (“Electrovaya” or the “Company”) (NASDAQ:ELVA)(TSX:ELVA), a leading lithium-ion battery technology and manufacturing company, is pleased to announce that it has successfully completed shipment of its first battery modules to Japan from its Canadian manufacturing facility. These modules were custom designed for a global construction equipment OEM and feature a new NMC based 51Ah cell format that features Electrovaya’s proprietary Infinity technologies which significantly enhance safety and cycle life performance. Prior to the shipment, the new 1.5 kWh modules passed third party UN38.3 testing at TÜV SÜD.

SOURCE: Electrovaya, Inc.

View the original press release on ACCESS Newswire

MIAMI, FL / ACCESS Newswire / September 2, 2025 / Diveroli Investment Group (“DIG”) announced today that it has accumulated a 9.48% position in Wheeler Real Estate Investment Trust, Inc. (NASDAQ:WHLR) and filed a Schedule 13D with the SEC.

Together with its affiliates, DIG has substantial interests in commercial real estate, and its interest was piqued by WHLR’s portfolio of retail properties and blue chip tenants. The group believes Wheeler is deeply undervalued considering it controls more than $600 million in total assets and the majority of its debt does not come due until 2031 or later.

As further validation of the Company’s underlying value, DIG highlights that while Wheeler’s current market capitalization is approximately $3 million, its most recent balance sheet shows total assets exceeding liabilities by more than $90 million – almost 30 times greater than its public market valuation. At the same time, WHLR controls a ~7.5 million square foot portfolio of grocery-anchored retail centers across the Mid-Atlantic, Southeast, and Northeast, which remains more than 90% leased and continues to generate durable cash flows with meaningful growth potential.

“WHLR trades like a penny stock but controls more than half a billion in real estate,” said Aharon Diveroli, CIO at DIG. “With fundamentals improving and strong political tailwinds suggesting rate cuts, we see significant upside as a real potential.”

The White House has pushed for monetary easing, with many top analysts now expecting the Federal Reserve to begin rate cuts in September – which, in DIG’s opinion, creates a strong tailwind for REITs like WHLR.

Among the multiple catalysts for rerating: capital structure simplification; portfolio resilience due in part to blue chip tenants with long-term leases like Food Lion, Kroger, Aldi, and Dollar Tree; and the aforementioned Federal Reserve rate cuts, which could drive lower financing costs and higher property valuations.

About Diveroli Investment Group
Diveroli Investment Group (or “DIG”) is a Miami-based, family-run investment firm that pursues value creation through opportunities in public and private companies. The firm focuses on sectors where technological change, operational inflection points, or strategic under-appreciation create significant upside potential.

To learn more about Diveroli Investment Group’s investment philosophy and current areas of focus, please visit: www.investdig.com

Investor & Media Relations
Avigail Diveroli, Communications Director
Diveroli Investment Group
Email: avigail@investdig.com
Website: www.investdig.com

Important Additional Information and Where to Find It
The views expressed in this press release reflect the personal opinions of the authors or speakers and are based solely on publicly available information believed to be reliable at the time of publication. This communication is not a recommendation to buy, sell or exchange any securities, and it does not constitute an offer to sell or buy or the solicitation of an offer to buy or sell any securities. Information about Wheeler Real Estate Investment Trust, Inc. is available at the SEC’s website at www.sec.gov. We are not broker-dealers or registered investment advisors. Although we possess WHLR shares, we may buy or sell shares at any time without notice.

Any statements about valuation, performance, or outlook are personal opinions and should not be construed as facts. Always conduct your own due diligence and consult a licensed financial advisor before making investment decisions. Compensation may have been provided to third parties involved in the creation or promotion of this content. All material is for informational and educational purposes only.

SOURCE: Diveroli Investment Group

View the original press release on ACCESS Newswire

One Art Space Gallery, in Tribeca, NY premiere “The Authenticity,” an exhibition curated by graffiti writer Cope2 featuring Shepard Fairey, Danny Cortes, Stash and Many more…

NEW YORK CITY, NEW YORK / ACCESS Newswire / September 2, 2025 / In the Heart of Tribeca, New York, One Art Space is proud to announce, “The Authenticity,” a group exhibition featuring 17 artists and curated by renowned graffiti writer Cope2. Participating artists include Shepard Fairey, Danny Cortes, Mark Bode, Scien and Klor / 123KLAN, Mqizm, Stash, Cope2, Valeri Larko, Joe Iurato, Eye sticker, Delta2, Dain, CortesNYC, Claytonles, Rebecca Marley, Wane One, and Indie184.

This exhibition, “The Authenticity,” balances Cope2’s international connections and decades-long career in the graffiti and fine arts world, including local street artists like Eye Sticker and graffiti writers like Indie184. “I feel that what they do is authentic. Every artist is inspired by every other artist. Even me, I learned from graffiti writers in the ‘70s, but what these artists do that I like is they draw from other sources, but they’re still authentic,” says Cope2. Every artist in the show is inspired both by their individual experiences and the wider art community.

Visually, the work is tied together by bright colors and striking images such as Shepard Fairey’s iconic OBEY giant, Eye Sticker’s neon pink figurative abstractions that border on the absurd, or Mqizm’s mesmerizing graffiti mailboxes. Cope2’s taste emerges as bold colors and strong visions on both canvas and found materials.

Co-owners Mei Fung and MaryAnn Giella McCulloh (Co-Owner, Gallerist, and Curator) are looking forward to welcoming Shepard Fairey back to One Art Space after ten years. Original works by Shepard Fairey will be on view. Shepard Fairey stated that he is excited for his work to appear at One Art Space again and share the exhibit with this incredible lineup of New York artists. When there is so much inauthenticity in the world, this show promises to offer real, raw, and unedited experiences. “The Authenticity” will show how we celebrate our authentic selves, that’s when true connection emerges.

Bio: Cope2, born Carlo Jr. in New York City, is a graffiti artist whose work has appeared in exhibitions across the U.S. and internationally. Starting in the South Bronx in 1978, he gained fame for being one of New York City’s most prolific graffiti artists on subways and city walls, contributing over 35 years to street art culture and recognition for his distinctive raw style.

One Art Space, 23 Warren St., Tribeca, NY 10007

EXHIBITION: September 5 – September 18, 2025

VIP RECEPTION: September 4, 2025, 6pm-9pm

OPENING RECEPTION: September 5, 2025, 6-9pm

www.oneartspace.com • Instagram: @oneartspace • facebook.com/OneArtSpaceNYC • TikTok: @one.art.space • YouTube: @oneartspace

SOURCE: One Art Space

View the original press release on ACCESS Newswire