Author: Ravi Shankar

–  First-Ever Fast Track Designation Granted for a Peeling Skin Syndrome Therapy

–  Second Fast Track Designation Granted to QRX003, in Addition to Netherton Syndrome

–  Fast Track Designation Facilitates Development and Expedites Regulatory Review of Therapies Addressing Serious Conditions with Significant Unmet Medical Need

–  Follows July 2026 FDA Clearance of the First-Ever IND Submitted for Peeling Skin Syndrome

–  Phase 2/3 Study Expected to Initiate in 2H 2026, Enrolling up to 12 Pediatric and Adult Patients in the U.S. and Europe

–  Peeling Skin Syndrome Currently Has No Approved Treatment

ASHBURN, Va., Sept. 22, 2026 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 for the treatment of Peeling Skin Syndrome (PSS). QRX003 is an investigational topical serine protease inhibitor lotion. Peeling Skin Syndrome is a rare genetic skin disease for which there is currently no approved treatment.

Key Facts

• Fast Track Designation applies to QRX003 for the treatment of Peeling Skin Syndrome.

• This is the first ever Fast Track Designation granted for a Peeling Skin Syndrome therapy.

• Peeling Skin Syndrome is the second indication for which QRX003 has received Fast Track Designation. The FDA granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome on March 11, 2026.

• The designation follows FDA clearance in July 2026 of Quoin’s Investigational New Drug (IND) application for QRX003 in Peeling Skin Syndrome. Quoin submitted that IND on June 2, 2026, and it was the first IND ever submitted to the FDA for the disease.

• Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026.

• The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study in a single subject. Significant improvements in skin appearance along with positive changes in pruritus and a number of quality-of-life measures have been recorded. Treatment is ongoing and has continued for more than 15 months, with no adverse events reported.

• There is currently no approved treatment for Peeling Skin Syndrome.

“This is an important regulatory milestone for QRX003 and for a community that today has no approved treatment,” said Dr. Michael Myers, CEO and Co-Founder of Quoin Pharmaceuticals. “Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome, that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease. We expect to initiate our Phase 2/3 study in the second half of 2026, and we believe Fast Track status will allow us to work closely with the agency as we advance the first company-sponsored clinical study in this disease.”

Peeling Skin Syndrome Development Program

The planned Phase 2/3 study is expected to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome in the United States and Europe. In the study, QRX003 will be applied twice-daily to greater than 80% of patients’ body surface area (BSA) over a 48-week period, with an interim data review at 24 weeks. Quoin is targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028.

The IND submission was supported by clinical observations from an ongoing investigator-led pediatric study. The subject has achieved improvements across key objective severity endpoints, including the Modified Ichthyosis Area Severity Index (M-IASI), Investigator’s Global Assessment (IGA) as well as pruritus and a pediatric dermatology-specific quality-of-life measure (CDLQI). Treatment is ongoing, and after continued dosing with QRX003 for over 15 months, no adverse events have been reported.

About Fast Track Designation

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. A therapy granted Fast Track Designation may benefit from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.

About Peeling Skin Syndrome (PSS)

Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS.

About QRX003

QRX003 is an investigational topical serine protease inhibitor lotion in late-stage development for Netherton Syndrome and other orphan skin diseases. QRX003 has been granted Orphan Drug, Rare Pediatric Disease, and Fast Track designations by the U.S. Food and Drug Administration, and Orphan Drug Designation in the European Union and Japan for Netherton Syndrome. QRX003 has also been granted Rare Pediatric Disease and Fast Track Designation by the FDA for Peeling Skin Syndrome. QRX003 lotion (4%) is currently being evaluated in Phase 2/3 whole-body clinical trials in patients with Netherton Syndrome. Quoin expects to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026.

About Quoin Pharmaceuticals Ltd.

Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin’s innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Forward-Looking Statements

The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “potential,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. This press release contains forward-looking statements. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: Fast Track Designation facilitating development and expediting regulatory review of therapies addressing serious conditions with significant unmet medical need; plans to initiate a Phase 2/3 clinical study of QRX003 in Peeling Skin Syndrome in the second half of 2026; Fast Track status allowing Quoin to work closely with the FDA to advance the first company-sponsored clinical study in Peeling Skin Syndrome; the study expecting to enroll up to 12 pediatric and adult patients with Peeling Skin Syndrome in the United States and Europe; QRX003 expected to be applied twice-daily to greater than 80% of a patients’ body surface area over a 48-week period, with an interim data review at 24 weeks; targeting approval of QRX003 as a potential treatment for Peeling Skin Syndrome in 2028; therapies granted Fast Track Designation benefiting from more frequent interactions with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met; and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome, Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibroma and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

For further information, contact:

Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
mmyers@quoinpharma.com

Investor Relations
PCG Advisory
Jeff Ramson
jramson@pcgadvisory.com
(646) 863-6341

• The FDA recommended that Compass conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig.
• Compass does not believe that a new trial is warranted prior to submitting a BLA based on the data from the Phase 2/3 COMPANION-002 study and the urgent unmet medical need for patients with BTC.
• Compass intends to further engage with the FDA as we continue to prepare a BLA submission for tovecimig.
• Compass remains confident in tovecimig based on the positive results from COMPANION-002, including the statistically significant improvements in ORR and PFS.

BOSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) — Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced that the U.S. Food and Drug Administration (FDA) recommended that Compass conduct a trial demonstrating a survival benefit before proceeding with a Biologics License Application (BLA) submission for tovecimig in patients with previously treated, advanced biliary tract cancer (BTC).

BTC is an aggressive, life-threatening cancer with poor survival outcomes, and effective options remain limited for patients who have received prior treatment, underscoring the urgent need for new approaches.

As previously disclosed, in the positive Phase 2/3 COMPANION-002 study, tovecimig plus paclitaxel demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) of 18.0% vs. 5.3% with paclitaxel alone (p=0.0228) and a highly significant improvement in progression-free survival (PFS) in patients with BTC who had received prior treatment. Median PFS was 4.7 vs. 2.6 months with a hazard ratio of 0.44 (p<0.0001), representing a compelling 56% reduction in the risk of disease progression. Overall survival (OS) analyses were confounded by both high crossover and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance. The safety profile was generally consistent with previously reported data from prior tovecimig studies.

“While this is not the response we expected, we respect the FDA’s feedback and our priority is to work with the Agency to determine the best path forward to support our planned BLA submission and address this pressing unmet need,” said Thomas Schuetz, M.D., Ph.D., Chief Executive Officer of Compass. “We remain confident that the COMPANION-002 findings, including the statistically significant improvements in PFS and ORR combined with subset analyses on survival, demonstrate clinically meaningful activity in patients with previously treated, advanced BTC.”

About Tovecimig
Tovecimig is an investigational DLL4 x VEGF-A bispecific antibody designed to block two angiogenic pathways simultaneously, representing a first-in-class approach to disrupting tumor angiogenesis. In COMPANION-002, tovecimig was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. Tovecimig has received Fast Track and Orphan Drug Designation from the U.S. Food and Drug Administration.

About Compass Therapeutics
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company dedicated to transforming the standard of care for patients with cancer through the discovery and development of innovative antibody-based therapeutics. The company leverages deep expertise in tumor biology and proprietary antibody engineering technologies to develop differentiated therapies that target the intersection of angiogenesis, immune activation, and tumor-driven immunosuppression. Compass has a robust pipeline of novel product candidates designed to address significant unmet needs and improve outcomes for patients with cancer. The Company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding tovecimig, the results of the COMPANION-002 study, and the associated regulatory feedback, plans, and timelines, and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com

Media Contact
Anna Gifford, Chief of Staff
media@compasstherapeutics.com
617-500-8099

Acquisition expands Superstar’s fintech portfolio with a digital-first platform designed to modernize the traditionally storefront-based vehicle title lending industry

ATLANTA, Sept. 22, 2026 (GLOBE NEWSWIRE) — Superstar Platforms, Inc. (OTCID: SPST) (“Superstar,” “we,” “us,” “our” or the “Company”), a technology-focused holding company building and acquiring businesses across financial technology, automotive and technology-enabled commerce, today announced that it has entered into an agreement to acquire TitlePal, Inc. (“TitlePal”) in an all-stock transaction.

TitlePal is a financial technology company that has developed a web- and mobile-based platform designed to modernize the traditional vehicle title lending and title pawn transaction by moving much of the customer experience from a physical storefront to a consumer’s Smartphone or computer.

The acquisition is expected to expand Superstar’s financial technology platform while providing the Company with exposure to an established consumer finance category that historically has operated primarily through brick-and-mortar locations.

Transforming a Traditionally Storefront-Based Industry

For decades, the vehicle title lending industry has largely operated through physical storefronts. A consumer seeking a title loan or title pawn typically travels to a lending location, presents a vehicle and clear title, completes an application, allows the lender to evaluate the vehicle and collateral, executes the required transaction documents and receives funds while retaining possession and use of the vehicle. TitlePal was developed around the premise that technology can significantly change that process.

Rather than requiring the customer to begin the transaction inside a traditional title lending location, TitlePal is designed to allow eligible consumers with qualifying vehicle titles to initiate and complete the process remotely through a computer or mobile device at their convenience.

The TitlePal platform incorporates digital applications, identity verification, vehicle and title verification, underwriting, third-party data integrations, document processing and electronic funding into a streamlined technology platform. TitlePal’s technology utilizes smartphone capabilities and third-party verification resources to facilitate vehicle inspection and transaction verification without requiring the consumer to enter a traditional storefront. TitlePal provides consumers with a complete digital environment encompassing the application, inspection, approval and funding process, designed to improve convenience and the overall customer experience.

“We believe TitlePal represents the type of technology driven transformation that Superstar Platforms was built to pursue,” said Michael Farr, Chief Executive Officer. “The underlying vehicle title lending business has existed for decades, but the customer experience continues to rely heavily on physical locations. Consumers today bank from their phones, purchase automobiles from their phones, buy groceries from their phones and manage much of their financial lives from their phones. We believe the title lending customer should have the same opportunity.”

The Digital Transformation of Title Lending

TitlePal’s strategy is not based on changing the underlying collateral based nature of the product. Instead, the Company’s strategy is focused on changing how the loan is originated. Today, most title lending transactions continue to depend heavily upon face-to-face interaction and physical locations. TitlePal moves loan origination, verification, underwriting and funding into a digital environment.

Traditional title lenders have historically required substantial physical infrastructure to originate transactions across multiple geographic markets. A technology based model is designed to allow TitlePal to acquire and serve customers digitally while centralizing significant portions of underwriting, verification, servicing and collections. This provides an opportunity to scale receivables and customer relationships without requiring a corresponding expansion of physical storefront infrastructure.

A Large Existing Industry Positioned for Technology Adoption

TitlePal is entering an established consumer finance market rather than attempting to create a new lending category. More than 2 million Americans used auto title loans annually, with more than 8,000 title lending storefronts operating across 25 states. Consumers pay almost $4 billion annually in title loan fees, with an average loan size of approximately $1,000. (PEW Report)

The historical economics of the industry also demonstrate why the market is positioned for digital transformation. Pew reported that the largest title lender it analyzed historically spent approximately 66% of revenue on overhead, compared with approximately 18% on credit losses. TitlePal believes a technology driven model can reduce dependence on the extensive physical infrastructure traditionally required to originate title loans by centralizing underwriting, verification, servicing and collections while acquiring and serving customers digitally.

For TitlePal, the opportunity is therefore not dependent upon creating consumer demand for a new financial product. The opportunity is to capture a portion of an already established lending market by providing consumers with a technology enabled alternative to the traditional storefront experience.

TitlePal is already a revenue generating business with interest income over the last 2 years of almost $700,000 with the potential to expand materially as the Company gains access to additional lending capital and enters additional markets.

A State-by-State Expansion Strategy

Vehicle title lending and title pawn transactions are governed by state-specific laws and regulations. TitlePal therefore expects its geographic expansion to occur on a state-by-state basis based upon applicable lending and pawn laws, licensing requirements and the technological infrastructure available within each jurisdiction. TitlePal’s expansion strategy places particular emphasis on states where electronic title and lien-processing capabilities can support a digital transaction.

Strategic Fit Within Superstar Platforms

The acquisition of TitlePal is expected to become an important component of Superstar Platforms’ broader strategy of acquiring and developing businesses operating at the intersection of technology, financial services and traditional industries undergoing digital transformation.

TitlePal will complement Superstar’s existing portfolio, including PawnTrust, Superstar’s technology-enabled marketplace developed specifically for the pawn industry.

While PawnTrust is designed to expand the digital reach of independent pawn retailers and their inventory, TitlePal is designed to address another segment of the collateral-based financial services market by digitizing the customer acquisition and lending experience. The two platforms reflect a common Superstar investment thesis: Large, established and fragmented industries can create significant opportunities when technology is applied to longstanding business models.

“Superstar Platforms is being built around businesses where technology can change the economics and customer experience of an established industry,” Farr said. “TitlePal fits directly into that strategy. We are acquiring a revenue-generating technology platform, operating experience and a business model that can be expanded over time as capital, licensing and market conditions permit.”

Transaction

Superstar Platforms has agreed to acquire TitlePal in an all-stock transaction. The transaction is expected to be structured with provisions designed to manage the timing and extent of potential dilution to Superstar’s existing common shareholders.

The acquisition remains subject to completion of definitive documentation, customary closing conditions and any corporate, regulatory or other approvals that may be applicable.

The Company expects to provide additional information regarding the transaction and its terms through its appropriate public disclosures following completion of definitive documentation.

About TitlePal, Inc.

TitlePal, Inc. is a financial technology company focused on modernizing the vehicle title lending and title pawn transaction.

TitlePal has developed a web- and mobile-based platform designed to allow eligible consumers with qualifying vehicle titles to initiate a collateral-based lending transaction remotely. The platform is designed to integrate customer application processing, identity verification, vehicle and title verification, underwriting, document processing and electronic funding into a technology enabled customer experience. TitlePal’s strategy is centered on applying technology, third-party data integrations and automation to an industry that has traditionally relied heavily upon physical storefront locations. TITLEPAL® and the company’s marketing slogan GRAB YOUR PHONE, GET YOUR LOAN® are federally registered U.S. trademarks.
www.titlepal.com 

     TITLEPAL®—U.S. Trademark Registration No. 7,475,665
     GRAB YOUR PHONE, GET YOUR LOAN® — U.S. Trademark Registration No. 8,264,738

About Superstar Platforms, Inc.

Superstar Platforms, Inc. (SPST) is a national conglomerate pursuing the acquisition, development and scaling of businesses across financial technology, automotive and technology-enabled commerce. Superstar seeks to identify established industries in which technology, centralized infrastructure, access to capital and strategic management can create new opportunities for growth.

The Company’s portfolio includes PawnTrust, a technology-enabled marketplace developed specifically for the pawn industry, and other operating businesses and strategic investments across its targeted sectors. Superstar’s growth strategy is centered on a combination of strategic acquisitions, technology development and the expansion of its operating platforms.
www.superstarplatforms.com 

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and is intended to qualify for the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the Company’s plans, objectives, expectations, intentions, strategies and future performance, including statements regarding the acquisition of TitlePal, Inc., the anticipated benefits of the transaction, the integration and expansion of TitlePal’s technology and operations, the development and adoption of its digital lending platform, geographic expansion, regulatory approvals and licensing, access to capital, customer acquisition, market opportunities and future financial and operating performance.

Forward-looking statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “plan,” “may,” “will,” “could,” “should,” “estimate,” “project,” “potential,” “continue,” “target,” “seek” and similar expressions. These statements are based upon management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements.

Such risks and uncertainties include, among others, the Company’s ability to complete and successfully integrate acquisitions; the ability to realize anticipated benefits from the TitlePal transaction; changes in federal, state or local laws and regulations applicable to title lending, pawn transactions and consumer finance; licensing and regulatory requirements; the availability of lending and operating capital; credit and collection risks; cybersecurity and data privacy risks; reliance on third-party technology and service providers; competition; market acceptance of the Company’s products and services; general economic and market conditions; and other risks and uncertainties described in Superstar Platforms, Inc.’s filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this press release. Readers are cautioned not to place undue reliance on these statements. Except as required by applicable law, Superstar Platforms, Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information:

Investor Relations
(650)228-0680
invest@superstarplatforms.com

Fasedienol nasal spray was well-tolerated in patients with social anxiety disorder with no new drug-related safety findings after as-needed use for up to 12 months 

Clinically relevant improvement in social anxiety over time was observed on both clinician-administered and patient-reported scales over four months

PALISADE-4 OLE data add to growing body of evidence supporting fasedienol’s potential to address social anxiety disorder in anxiety-provoking social and performance situations in everyday life

SOUTH SAN FRANCISCO, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) — Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company leveraging nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today announced preliminary positive data from the open-label extension (OLE) portion of its PALISADE-4 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder.

In a recent analysis of subjects who elected to participate in the OLE portion of PALISADE-4 (safety population: N=322), administration of 3.2 µg of fasedienol, taken as needed up to six times per day in anxiety-provoking social and performance situations in everyday life for up to 12 months, was well-tolerated with no new drug-related safety findings. Exploratory efficacy data over the first four months of as-needed treatment demonstrated improvement over time on both the Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN).

“These preliminary PALISADE-4 OLE results are important because they reflect the potential impact of repeated, as-needed use of fasedienol in everyday life settings where social anxiety symptoms occur,” said Angel S. Angelov, M.D., Chief Medical Officer of Vistagen. “These findings contribute to the deep clinical dataset informing our understanding of fasedienol’s potential clinical utility to help patients experience less fear, anxiety, and avoidance in social and performance situations over time.”

Preliminary Safety Data

In the OLE portion of PALISADE-4, as of a July 24, 2026 data cut-off¹, fasedienol nasal spray, taken as needed up to six times per day, was well-tolerated in adults with social anxiety disorder.

• The rate of discontinuation due to adverse events was 1.6% (5/322), with no discontinuations attributed to fasedienol.
• More than 95% of treatment-emergent adverse events (TEAEs) were mild or moderate in severity.
• The TEAEs occurring in more than 5% of subjects were headache (18.0%; 58/322), upper respiratory tract infection (9.9%; 32/322), rhinorrhoea (7.1%; 23/322), and oropharyngeal pain (5.3%; 17/322).
• There were no serious adverse events related to fasedienol.
• No safety signals of concern were identified related to laboratory values, ECGs, physical examinations, and vital sign assessments following exposure to fasedienol.

Preliminary Exploratory Efficacy Data

Liebowitz Social Anxiety Scale (LSAS)

The OLE portion of PALISADE-4 explored the change from baseline (study entry) on the LSAS, a clinician-administered scale (range 0-144) which assesses both fear or anxiety and avoidance across 24 standardized anxiety-provoking social-interaction and performance situations, with the goal of capturing not only how distressing situations are, but also whether patients entered, tolerated, remained in, or avoided them. Preliminary analysis of the data cut (July 24, 2026) from the initial four-month period in the OLE portion of PALISADE-4 demonstrated a clinically relevant improvement from repeated as-needed use of fasedienol over time on the LSAS for subjects participating in the OLE¹:

• At study entry, the mean baseline LSAS score (99.3, n=320) indicated very severe social anxiety (≥95).
• At Month 1, mean improvement on the LSAS was 20.2 points (n=298, 44% had a ≥ 20 point-improvement).
• At Month 2, mean improvement on the LSAS was 24.6 points (n=273, 54% had a ≥ 20 point-improvement).
• At Month 3, mean improvement on the LSAS was 29.1 points (n=240, 60% had a ≥ 20 point-improvement).
• At Month 4, mean improvement on the LSAS was 31.4 points (n=197, 65% had ≥ 20 point-improvement).

Continued improvements were observed through each month on both the fear or anxiety and avoidance subscales of the LSAS, suggesting that participants engaging in everyday life experienced less fear or anxiety and avoidance of anxiety-provoking situations. The mean change in LSAS achieved by month 2 showed a clinically meaningful improvement of two social anxiety disorder severity categories, which was maintained through month 4. The percentage of participants who improved by two social anxiety disorder severity categories also increased steadily over 4 months. Social anxiety disorder severity categories based on the LSAS are defined as: 0-29 minimal (remission, patient does not suffer social anxiety disorder); 30-49 (mild); 50-64 (moderate); 65-79 (marked); 80-94 (severe); ≥95 (very severe)².

Social Phobia Inventory (SPIN)

The OLE portion of PALISADE-4 also explored the change from baseline on the SPIN, a 17-item patient-reported scale (range 0-64) which measures fear, avoidance, and physiological components of social phobia over time. The recent preliminary analysis of the initial four-month data cut from the OLE portion of PALISADE-4 demonstrated consistent improvement over time on the SPIN for subjects participating in the OLE:

• At study entry, the mean baseline SPIN score (48.5, n=321) indicated severe social anxiety (≥41).
• At Month 1, mean improvement on the SPIN was 10.5 points (n=299, 45% had a ≥ 10-point improvement).
• At Month 4, mean improvement on the SPIN was 14.9 points (n=199, 59% had a ≥ 10-point improvement).

The Company believes that results from a placebo-controlled Phase 2 crossover study of fasedienol and the open-label extensions of the PALISADE Phase 3 studies conducted to date in everyday life settings suggest that acute treatment with fasedienol, administered as-needed at the patient’s discretion, was accompanied by a persistent change in the overall severity of social anxiety disorder, including observed reductions in fear, anxiety, and avoidance as measured by the LSAS over the course of fasedienol usage. The Company is preparing to meet with the FDA during the current quarter to consider a proposed new registrational Phase 3 clinical trial of fasedienol in social anxiety disorder.

About the OLE Portion of PALISADE-4
The OLE portion of PALISADE-4 was a voluntary extension of the randomized, double-blind, placebo-controlled portion of the PALISADE-4 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder, available to participants who chose to continue in the study per the study protocol¹. It was designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (up to six times daily, maximum daily dose of 19.2 µg fasedienol) in adults with social anxiety disorder over time in an everyday life setting. Monthly safety and tolerability assessments included change in adverse events, laboratory values, 12-lead electrocardiograms, physical examinations, and vital sign assessments. The study evaluated change from baseline over time in standard clinical measurements, including the LSAS and SPIN, as participants used fasedienol in anxiety-provoking social and performance situations in their everyday lives. Endpoints of the OLE portion of PALISADE-4 included monthly evaluation of change from baseline at study entry on the LSAS and Month 1 and Month 4 evaluation of change from baseline at study entry on the SPIN patient self-report questionnaire. Both scales provide validated psychological assessments of the severity of social anxiety disorder, with a focus on fear, avoidance, and physiological discomfort in social and performance situations.

About PALISADE-4
PALISADE-4 was a U.S. multi-center, randomized, double-blind, placebo-controlled Phase 3 public speaking challenge study designed to evaluate the efficacy and safety of fasedienol in reducing anxiety symptoms during a simulated single-dose, clinic-based public speaking challenge using the Subjective Units of Distress Scale (SUDS). PALISADE-4 subjects who chose to continue with the OLE portion of the study could use fasedienol as needed in their daily lives up to six times per day for up to 12 months¹.

In June 2026, Vistagen announced topline results from the randomized portion of PALISADE-4. The single-dose randomized portion of the study did not achieve its primary endpoint in the overall study population, as measured by the least squares mean change from baseline on the SUDS for fasedienol compared with placebo. The favorable safety results observed for fasedienol were consistent with those observed in previously completed clinical trials. In a post-hoc analysis of a subpopulation of patients with very severe social anxiety defined by a baseline score at screening of 95 or greater on the Liebowitz Social Anxiety Scale (LSAS) (n=123), fasedienol was nominally statistically significant as measured by the LS mean change from baseline on the SUDS score for fasedienol (-12.8+/-3.4 SE) compared with placebo (-3.7 +/-3.4 SE), with a difference in the LS means of -9.1 (p=0.036).

About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a new class of rapid-onset neurocircuitry-focused intranasal product candidates called pherines. Vistagen’s pherine product candidates are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options, if successfully developed and approved. Vistagen’s most advanced intranasal pherine product candidates are fasedienol for the acute treatment of social anxiety disorder, itruvone for treatment of major depressive disorder, and refisolone for treatment of vasomotor symptoms (hot flashes) due to menopause. Connect at www.vistagen.com

Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements regarding indications of improvements observed over time by patients in the OLE portion of PALISADE-4; the ability of preliminary findings from the OLE portion of PALISADE-4 to support potential clinical meaningfulness; indications of safety data from the OLE portion of PALISADE-4; the Company’s belief that the results of the PALISADE-4 OLE are consistent with, supportive of, or complementary to previously reported fasedienol clinical data; Vistagen’s other beliefs about the understandings drawn from the preliminary OLE data and other fasedienol clinical studies; Vistagen’s plans to meet with FDA and the potential regulatory path forward for fasedienol; and Vistagen’s belief that its fasedienol development program could support a potential New Drug Application submission to the FDA for the acute treatment of social anxiety disorder. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would,” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen’s product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval, or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing and future clinical trials, Vistagen’s ability to secure adequate financing or collaborative support for continued clinical development of its product candidates, Vistagen’s dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, the scope and enforceability of Vistagen’s patents, including patents related to its pherine product candidates, and other technical and unexpected hurdles in the development, manufacture and/or potential commercialization of Vistagen’s product candidates. These risks and others are more fully discussed in the section entitled “Risk Factors” in Vistagen’s most recent Quarterly Report on Form 10-Q for the period ended June 30, 2026, as well as discussions of potential risks, uncertainties, and other important factors in Vistagen’s other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen’s SEC filings are available on the SEC’s website at www.sec.gov. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.

_{¹ As previously reported, the Company believes its clinical program for fasedienol nasal spray for the acute treatment of social anxiety disorder has achieved the minimum patient exposures as recommended under ICH E1, the international regulatory standard governing safety database exposure recommendations for drugs intended for long-term treatment (chronic or repeated intermittent use for longer than 6 months) of non-life-threatening conditions. As a result, for business reasons, the Company closed the OLE portion of PALISADE-4 in July 2026, prior to the data cut. Accordingly, at the time of study closure, not all participants in the study had the opportunity to reach the four-month observation point.}

_{² Liebowitz MR. Social Phobia. In Klein DF, (Ed). Anxiety: S.Karger AG 1987:141–173.}

Investor Inquiries:
IR@vistagen.com

Media Inquiries:
media@vistagen.com

Partnership Targets Surging AI and Data-Center Power Demand Through Rapidly Deployable Off-Grid Microgrids, Bypassing Traditional Grid Connection Timelines

NEW PORT RICHEY, Fla., Sept. 22, 2026 (GLOBE NEWSWIRE) — Zeo Energy Corp. (Nasdaq: ZEO) (“Zeo” or the “Company”), a provider of residential solar and commercial long-duration energy-storage solutions, today announced that it has entered into an agreement (the “Agreement”) with Ewyze Corp. (“Ewyze”) to collaborate on the development of integrated off-grid power and data-center infrastructure. The cooperation is intended to focus on opportunities in the United States and include selected international markets where conditions are favourable.

SURGING DEMAND FOR AI-READY POWER INFRASTRUCTURE
The rapid expansion of artificial intelligence compute loads— driven by GPU-intensive model training, real-time inference, and cloud computing — is creating unprecedented massive demands for high-density, reliable power capacity. Data centers supporting these workloads require high-density, reliable power. Industry analysts project global data-center power consumption will more than double by the end of the decade.

Traditional grid infrastructure is struggling to keep pace. In the United States, interconnection wait times can stretch five to ten years in many regions, making grid-connected power inaccessible for new data-center developments on commercially relevant timelines. This structural bottleneck is creating a significant market opportunity for operators capable of delivering scalable, off-grid power solutions alongside compute infrastructure.

THE EWYZE INTEGRATED INFRASTRUCTURE MODEL
Ewyze is an energy and digital infrastructure platform with more than 18 years of experience in renewable energy development. The Ewyze team has developed approximately 1.7 GW of renewable power solutions across international markets and is now focused on developing, owning and operating integrated off-grid power and data-center infrastructure.

Ewyze’s differentiated model addresses gridlock directly by co-developing data-center infrastructure alongside dedicated off-grid microgrids. Each microgrid is engineered to combine solar photovoltaic generation with battery energy storage systems and an additional dispatchable power source — which may include a grid connection, natural gas, or geothermal power — to deliver reliable, 24/7 power capacity at the scale required by modern AI and cloud workloads.

This integrated approach — where the power infrastructure and the data-center infrastructure are developed together — is designed to materially reduce dependency on traditional utility timelines and enable data-center capacity to be brought online within approximately two to three years from project initiation, where market, land, permitting, financing and technical conditions allow.

THE COOPERATION AGREEMENT
Under the Agreement, Zeo and Ewyze intend to cooperate primarily on identifying, developing, financing and commercialising integrated off-grid power and data-center projects in the United States, while also considering selected opportunities in other markets. The Agreement is intended to combine Zeo’s public market platform and strategic relationships with Ewyze’s proven development track record and integrated infrastructure capabilities.

The parties will work collaboratively across the project development lifecycle, including site identification and land acquisition, permitting and regulatory approvals, engineering and construction, financing structuring and project commercialisation with data-centre operators and hyperscale customers.

MANAGEMENT COMMENTARY
Timothy Bridgewater, Chief Executive Officer of Zeo Energy, commented: “Entering into this cooperation with Ewyze represents an important and strategic step in Zeo’s evolution toward larger-scale renewable energy and power infrastructure opportunities. The demand for AI-capable compute infrastructure — and the power required to run it — is growing faster than traditional grid systems can accommodate. We believe Ewyze’s integrated model, combining off-grid microgrids with data-center development, positions the partnership to address one of the most significant infrastructure bottlenecks of our time. We look forward to developing these opportunities together.”

Svante Kumlin, Chief Executive Officer of Ewyze, added: “The artificial intelligence revolution is fundamentally a power challenge. AI workloads demand vast amounts of reliable, cost-effective energy, and the existing grid simply cannot deliver it at the speed or scale the market requires. Ewyze was built to solve exactly that problem — by developing the full infrastructure stack from the ground up, integrating renewable generation, battery storage and data-center assets into a single, coherent platform. This cooperation with Zeo provides the market access and strategic framework to bring these projects to scale, with a strong focus on the United States, where the opportunity is most immediate.”

About Zeo Energy Corp.
Zeo Energy Corp. (Nasdaq: ZEO) is a diversified clean energy company providing residential, commercial, industrial, and utility-scale solutions that cut costs and carbon emissions. Zeo operates Sunergy, a residential solar, distributed energy, and efficiency solutions business. It also operates Heliogen, LLC, a long-duration energy generation and storage business designed to deliver renewable power for high-demand applications such as data centers and other energy-intensive industries. With its vertically integrated approach, Zeo helps customers secure cost-effective, 24/7 clean energy.

About Ewyze Corp.
Ewyze Corp. is an energy and digital infrastructure platform focused on developing, owning and operating integrated off-grid power and data-centre infrastructure. With more than 18 years of renewable energy development experience and approximately 1.7 GW of solutions developed across international markets, Ewyze combines solar generation, battery energy storage and dispatchable power sources to create dedicated 24/7 microgrids alongside data-center assets. Ewyze’s integrated model is designed to reduce dependency on traditional grid connection timelines and support faster deployment of AI-ready compute capacity.

Cautionary Note Regarding Forward-Looking Statements
This press release and statements of Zeo’s and Ewyze’s management in connection with this press release contain or may contain “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Exchange Act of 1934, as amended, that are based on beliefs and assumptions and on information currently available to the Company, including regarding the Company’s potential involvement in projects described herein.. Such statements may include, but are not limited to, statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions. The words “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “explore,” “develop,” “development,” “deploy,” “deployment,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about the development of projects, future financial performance of the Company; the ability to effectively consolidate the assets of acquired companies and produce expected results; changes in the Company’s strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects, the ability to raise additional funds, and plans and objectives of management. These forward-looking statements are based on information available as of the date of this press release, and current expectations, forecasts, and assumptions, and involve a number of significant judgments, risks, and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing the Company’s views as of any subsequent date, and the Company does not undertake any obligation to update such 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. You should not place undue reliance on these forward-looking statements. As a result of a number of known and unknown risks and uncertainties, the Company’s actual results or performance may be materially and adversely different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include: (i) planned pipelines and projects may not be developed in the timelines anticipated, if at all; (ii) the outcome of any legal proceedings that may be instituted against the Company or others; (iii) the Company’s success in retaining or recruiting, or changes required in, its officers, key employees, or directors; (iv) the Company’s ability to raise additional capital and maintain the listing of its common stock and warrants on Nasdaq; (v) limited liquidity and trading of the Company’s securities; (vi) geopolitical risk and changes in applicable laws or regulations, including tariffs or trade restrictions; (vii) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (viii) operational risks, including risks associated with Zeo’s expanding business model; (ix) litigation and regulatory enforcement risks, including the diversion of management time and attention and the additional costs and demands on the Company’s resources; (x) the Company’s ability to effectively consolidate the assets of acquired companies and produce the expected results; and (xi) other risks and uncertainties, including those included under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) for the year ended December 31, 2025 and in its subsequent periodic reports and other filings with the SEC.

In light of the significant risks and uncertainties associated with forward-looking statements, you should not regard these statements as a representation or warranty by the Company, its respective directors, officers or employees or any other person that the Company will achieve its objectives and plans in any specified time frame, or at all. The forward-looking statements in this news release represent the views of the Company as of the date of this news release. Subsequent events and developments may cause that view to change. However, while the Company may elect to update these forward-looking statements at some point in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of the Company as of any date subsequent to the date of this news release.

Zeo Energy Corp. Contacts

For Investors:
Tom Colton and Greg Bradbury
Gateway Group
ZEO@gateway-grp.com

For Media:
Zach Kadletz
Gateway Group
ZEO@gateway-grp.com

DOYLESTOWN, Pa., Sept. 22, 2026 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, today announced that an abstract featuring updated interim results from the ongoing Phase 1 ACESOT-1051 study of its WEE1 inhibitor APR-1051 in patients with advanced solid tumors has been accepted for oral presentation at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), to take place November 18-20, 2026, in Barcelona, Spain.

“We look forward to presenting an update from our ongoing Phase 1 ACESOT-1051 trial at the EORTC-NCI-AACR Symposium and sharing these data with the international oncology community,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “This meeting brings together leading investigators, clinicians and researchers focused on advancing new approaches in cancer treatment, and we welcome the opportunity to discuss our program with the broader oncology community in Barcelona.”

Presentation Details:

Title:	Interim results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)
Presenting Author:	Timothy A. Yap, MBBS, PhD, FRCP Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and Investigator in the ACESOT-1051 study
Session:	Plenary Session (Oral Presentation)
Date and Time:	Friday, November 20, 2026, 3:00 PM – 3:10 PM CET
Location:	Room 111 + 112, CCIB, Barcelona.

For more information on the ACESOT-1051 trial, refer to ClinicalTrials.gov NCT06260514.

About Aprea Therapeutics

Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.

The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

Forward-Looking Statement

Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from our clinical development programs, and our ability to predict clinical outcomes based on such preclinical and early clinical results, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.

Investor Contact:

Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com

Media Contact:

Sean Naughton Ph.D.
Russo Partners, LLC
sean.naughton@russopartnersllc.com
(858) 717-2310

The expanded collaboration brings fans refreshed licensed product, broader shopping access and new activations with the Dallas Cowboys and Dallas Cowboys Cheerleaders

NEW ALBANY, Ohio, Sept. 22, 2026 (GLOBE NEWSWIRE) — Abercrombie & Fitch (Abercrombie), a division of Abercrombie & Fitch Co. (NYSE: ANF), is expanding its relationship with the Dallas Cowboys, as it returns for a second year as the Official Fashion Partner of the team and the Dallas Cowboys Cheerleaders (DCC). Through the expanded collaboration, Abercrombie will bring fans new product and year-round activations that extend the partnership beyond the football season. The announcement comes as Abercrombie enters the second year of its partnership with the NFL as the league’s Official Fashion Partner.

Building on the success of the 2025 season, Abercrombie will bring fashion and sport together through refreshed assortments, broader distribution, in-stadium brand experiences and athlete collaborations. Throughout the season, the brand will show up through an Abercrombie-branded pregame player tunnel walk, fan activations at AT&T Stadium, and host creator moments and ticket giveaways for A&F Creator Suite members. Abercrombie will also team up with athletes CeeDee Lamb, Caleb Downs and Malachi Lawrence throughout the season, providing personalized style concierge services and curated game-day arrival looks.

The Abercrombie x Cowboys collection continues to be available through Abercrombie’s online channels and stores, with expanded distribution at NFLShop.com and at AT&T Stadium in Dallas through Abercrombie’s recently announced partnership with Fanatics, giving fans even more ways to shop the assortment.

As the Official Fashion Partner of the Dallas Cowboys Cheerleaders, Abercrombie is unveiling a branded closet, shoppable by the DCC throughout the season. Located in their locker room at The Star in Frisco, Texas, the Abercrombie x DCC closet gives the Dallas Cowboys Cheerleaders ongoing access to new Abercrombie product, with assortments refreshed each month and curated for their off-field wardrobes.

“We’re proud to deepen our relationship with the Dallas Cowboys and the Dallas Cowboys Cheerleaders as we enter this next chapter of our partnership,” said Corey Robinson, brand president of Abercrombie & Fitch. “Together, we’re bringing Abercrombie’s effortless, elevated style to one of the most passionate fandoms in sports, creating new ways for fans to show up for their team well beyond game day.”

“Abercrombie has been a strong partner in helping us connect with fans through style, self-expression and unique experiences that extend far beyond the field,” said Dallas Cowboys Chief Brand Officer and Co-Owner Charlotte Jones. “We’re excited to build on that momentum this season and bring fans even more ways to show their Cowboys pride through this collaboration.”

Fans can shop the A&F x Dallas Cowboys collection, which includes products for adults, kids, toddler and baby, at abercrombie.com, select Abercrombie stores, NFLShop.com and at AT&T Stadium in Arlington, Texas.

About Abercrombie & Fitch:
Abercrombie & Fitch is an effortless, elevated American lifestyle brand, blending heritage and modern style through quality apparel, accessories and fragrance crafted for all of life’s moments. Abercrombie & Fitch is the namesake brand of Abercrombie & Fitch Co. and is sold in more than 300 stores worldwide (including abercrombie kids) and on abercrombie.com globally.
http://abercrombie.com/

Abercrombie Media Contact:
public_relations@anfcorp.com

Photos accompanying this release are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/ea8e8585-bf3b-4b47-b543-2be178bbbfab

https://www.globenewswire.com/NewsRoom/AttachmentNg/72adc0bb-e287-45c7-af18-5a89e7ad72f0

Agreement provides dedicated commercial channel for REZENOPY^™ across approximately 2,000 OTP (Opioid Treatment Program) Clinics and other Addiction Treatment Center Networks in the United States

According to IQVIA data (MAT July 2026), the U.S. naloxone market generated approximately $140 million in annual sales across 9.8 million units

COMMACK, NY, Sept. 22, 2026 (GLOBE NEWSWIRE) — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today announced that its wholly owned subsidiary, Scienture, LLC, has entered into an exclusive Sales, Marketing and Distribution Agreement with a distribution partner to provide opioid and substance-use disorder treatment centers nationwide with REZENOPY^™ (naloxone hydrochloride nasal spray 10 mg/0.11 mL) within the U.S. addiction treatment center market.

Under the agreement, REZENOPY^™ will be available exclusively through the distribution partner’s established customer network of approximately 2,000 OTP (Opioid Treatment Program) clinics and other Addiction Treatment Centers across the United States, expanding the product’s reach within the substance use disorder treatment market.

The agreement complements Scienture’s commercialization strategy and provides access to REZENOPY^™ within the defined addiction treatment center field. Scienture will continue to commercialize REZENOPY^™ outside this field through multiple concurrent commercial channels, including its existing and future wholesaler agreements, group purchasing organizations (“GPOs”), other distributors and customer relationships.

“This agreement represents an important expansion of our commercialization strategy for REZENOPY^™ and provides us with a dedicated channel into approximately 2,000 OTP Clinics and addiction treatment centers across the United States,” said Narasimhan Mani, President and Co-Chief Executive Officer of Scienture Holdings. “This strategic collaboration allows us to leverage established experience and relationships within the substance use disorder treatment market, making this relationship complementary to our broader commercialization efforts and provides an additional pathway to expand product availability while we continue building access through our wholesale, GPO, distributor and other institutional channels. As adoption expands across the OTP Clinic and Addiction Treatment Center networks, we believe this relationship has the potential to become a meaningful contributor to REZENOPY^™ revenue and support the continued growth of the franchise.”

“Expanding access to REZENOPY^™ among addiction treatment providers is an important component of our commercial strategy,” Shankar Hariharan, Executive Chairman and Co-Chief Executive Officer of Scienture. “We believe our distribution partner’s established presence in this market can help us efficiently reach treatment centers where naloxone availability is particularly relevant. As adoption develops, we believe this channel has the potential to contribute meaningfully to REZENOPY^™’s overall commercial growth alongside our other distribution initiatives.”

REZENOPY^™ is the highest-dose FDA-approved naloxone hydrochloride nasal spray available in the United States, delivering 10 mg of naloxone hydrochloride in a single-use nasal spray device for the emergency treatment of known or suspected opioid overdose. Built on the proven naloxone molecule and a familiar nasal spray delivery platform, REZENOPY^™ is designed to provide an important treatment option for overdoses involving highly potent synthetic opioids. According to IQVIA data (MAT July 2026), the U.S. naloxone market generated approximately $140 million in annual sales across 9.8 million units, highlighting a substantial commercial opportunity for REZENOPY^™.

As previously disclosed, Scienture, LLC, a wholly-owned subsidiary of Scienture Holdings, Inc., entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, for the exclusive U.S. commercialization rights to REZENOPY^™ (naloxone hydrochloride) Nasal Spray 10 mg, which received FDA approval on April 19, 2024.

About REZENOPY^™

REZENOPY^™ (naloxone hydrochloride) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.

REZENOPY^™ nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device.

IMPORTANT SAFETY INFORMATION

• Administration: REZENOPY^™ nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
• Contraindications: REZENOPY^™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.
  Warnings and Precautions:
  • Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.
  • Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.
  • Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.
  • Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.
• Adverse Reactions: The following adverse reactions were observed in a REZENOPY^™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.
• Storage and Handling: Store REZENOPY^™ nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY^™ nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY^™ nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away.

  For more detailed information, please refer to the full prescribing information provided by the FDA.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the success those products may have in the marketplace, such as REZENOPY™, and our strategies related to those products. 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on The Nasdaq Stock Market LLC; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K, as amended, and subsequent reports filed with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

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SCIENTURE HOLDINGS, INC.
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Pluxee releases a global study uncovering three paradoxes shaping employee engagement in the era of inflation and AI

Paris, September 22, 2026

Pluxee, a global player in employee benefits and engagement, today publishes its second international employee engagement study, surveying 11,000 respondents across 14 countries. The study highlights three paradoxes that offer a vivid snapshot of employee engagement today:

• While work plays a less central role in employees’ lives, their connection to their company grows stronger;

• Despite persistent financial pressure, employees are prepared to leave a job that no longer interests them;
• Although artificial intelligence is poised to profoundly transform employees’ jobs, it inspires more enthusiasm than fear.

 Aurélien Sonet, Chief Executive Officer of Pluxee, commented, “This second global study reveals a workforce that is far more optimistic than many might expect. In the context of economic uncertainty and pressure on purchasing power, employees are strongly connected to their companies, which they increasingly see as a source of stability in a challenging environment. The research also questions common perceptions about AI: while employees recognize its transformative potential for their jobs, most see it as an opportunity rather than a threat, expecting it to make work simpler and more interesting. As the world of work evolves rapidly and new skills become essential, the support we, as employers, provide our employees is crucial to driving their engagement.”

Key figures from the study   Inflation and purchasing power are employees’ number one concern, cited by 70% of employees globally (74% in France), including 25% who say they ‘can’t stop thinking about it’ (27% in France). Job satisfaction is higher than overall life satisfaction, with an average score of 7.6/10 vs. 7.3/10 globally (7.2/10 vs. 6.9/10 in France). Employees remain strongly connected to their organizations, with 87% saying they ‘love’ or ‘like’ their company, +4 points vs. 2025 (83% in France). More employees are adopting “Measured Engagement”, with 38% of employees globally engaging with work more intentionally to protect their boundaries, values and work-life balance, up 5 points since 2025. In France, this figure reaches 45%, up 9 points since 2025. Loyalty is becoming more conditional, with 33% of employees globally intending to stay with their company as long as their job remains interesting, +6 points since 2025. In France, this figure reaches 40%, +10 points vs. 2025. Well-being, recognition and benefits top employees’ HR priorities. Globally, well-being and working conditions rank first (35%), followed by recognition (33%) and employee benefits that complement compensation (29%). In France, the ranking follows a similar trend: well-being and working conditions (35%), recognition (34%) and employee benefits (21%). Employees are surprisingly optimistic about AI, with 65% expressing a positive attitude towards its use at work (51% in France), including 40% who say they “love” it (27% in France). Employees see AI as more of an opportunity than a threat: 40% are confident their job will not disappear as a result of AI (44% in France), while 42% believe AI will positively transform the content of their job (36% in France) Find the full research paper on the Pluxee website:  www.pluxeegroup.com/work-a-refuge-in-turbulent-times

An international study in 14 countries

Pluxee’s global employee engagement study explores how employees worldwide are experiencing work amid economic pressure and the rise of artificial intelligence. Conducted by Ipsos in May 2026 with 11,000 employees across 14 countries, the study tracks changes observed since the first edition in 2025. The countries surveyed include Belgium, Brazil, Chile, Colombia, France, Germany, Indiaⁱ, Italy, Mexico, Romania, Spain, Turkey, the UK and the USA.

The findings are analyzed by Jean-Baptiste Barféty, a public policy expert specializing in work, digital transition and the common good, and former advisor to the French Ministry of Labor, together with Antoine Solom, Senior Consultant at FOCUS, specializing in research, advisory and strategy for engaging transformations.

Three paradoxes shaping employee engagement

Despite mounting pressure on household budgets and the rapid transformation of work driven by AI, employees continue to demonstrate a surprising capacity to adapt and move forward with confidence. Contrary to many assumptions, the findings reveal a workforce that remains engaged, strongly connected to employers and broadly positive about work.

Yet beneath this resilience lie three striking paradoxes that capture the changing reality of employee engagement today.

While work is becoming less central to people’s lives, employees feel increasingly connected to their company

As reduced purchasing power and lower life satisfaction prompt employees to make bigger trade-offs at work to better focus on their personal lives, work is becoming less central to their lives. The share of employees who say work is the center of their lives has fallen from 19% to 13%, while “Measured Engagement”ⁱⁱ has increased from 34% to 38%, reflecting a growing tendency to engage with work more deliberately to protect boundaries, values and work-life balance.

This shift should not be mistaken for disengagement. On the contrary, employees’ connection to their organizations continues to grow: professional satisfaction remains high (above 7 in all countries), and 87% report they either ‘love’ or ‘like” their company, up four percentage points.

According to Jean-Baptiste Barféty, the workplace has become a reliable ‘refuge’ for employees, serving as a place of connection and “a shock absorber protecting them from some of the discomforts they might be experiencing because of inflation and global uncertainty”. 

Despite financial pressures, employees are prepared to leave jobs they no longer find interesting

Financial difficulties are having a tangible impact on workers’ lives, with 70% citing inflation and cost-of-living as their top worry and 25% saying they ‘cannot stop thinking about it’. In most of the countries studied, more than half of employees struggle to make ends meet, sometimes running out of money by the tenth day of the month.

However, despite a challenging context, employee loyalty is increasingly conditional: the percentage of employees who want to stay with their company ‘for as long as I can’ has fallen by 5 points compared to 2025. Meanwhile, the percentage of employees who ‘intend to stay as long as my job remains interesting’ is on the rise, increasing by 6 points globally.

Interesting work, the variety of tasks and recognition are driving employee engagement. This development reinforces a trend highlighted in the first edition of the study: employees expect reciprocity from their company in exchange for their engagement. Globally, when asked what their company’s HR priorities should be in the coming months, beyond higher salaries, employees’ top priorities are well-being and working conditions (35%), recognition of their commitment and achievements (33%), and employee benefits that complement compensation (29%).

Employees also expressed a need for growth, with 25% wishing to be ‘provided with better individual support and career development opportunities’ and 21% calling for their company’s HR to put developing ‘people’s skills through more training, particularly in AI’ at the top of their agenda.

AI is transforming jobs, yet employees see more opportunity than threat

While workers across the globe recognize that AI will be a major force in transforming the world of work, they are unexpectedly optimistic about its potential: 65% welcome the AI revolution, and 40% described AI as ‘great’ and say they ‘love’ using it.

This confidence is reflected in perceptions of AI’s impact on employment: 40% of employees are confident that their jobs will not disappear as a result of AI, and 42% concede that the content of their jobs will most likely change, ‘but in a positive way’, making work ‘less routine and more interesting’.

Employees are increasingly embracing AI and adapting to its growing role in the workplace. Among regular AI users, 39% say they learn to use the technology on their own, compared with just 9% who rely on managers and 9% on colleagues. With 31% of employees identifying improving efficiency as a key challenge for their organization in the years ahead, many employees view AI as a tool to save time, simplify work and reduce complexity.

The study also highlights a clear link between employee engagement and openness to AI. Using the Engagement Spectrum introduced in Pluxee’s 2025 global study The New Rules of Engagement, researchers found that the more engaged and outwardly curious employees are, the more likely they are to embrace AI. While 64% of “All Parts Engaged” employees say they love AI and use it frequently, this falls to 39% among “Work Centrists” and 27% among “Outsiders”.

Companies now face the challenge of ensuring that AI becomes the game-changer employees expect for efficiency and well-being, so that their current enthusiasm for the technology endures.

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About Pluxee 

Pluxee is a global player in Employee Benefits and Engagement that operates in 28 countries. Pluxee helps companies attract, engage, and retain talent thanks to a broad range of solutions across Meal & Food, Well-being, Lifestyle, Reward & Recognition, and Public Benefits. Powered by leading technology and more than 5,600 engaged team members, Pluxee acts as a trusted partner within a highly interconnected B2B2C ecosystem made up of more than 500,000 clients, 37 million+ consumers and 1.7 million+ merchants. Conducting business for 50 years, Pluxee is committed to creating a positive impact on local communities, supporting well-being at work for employees and protecting the planet. 

For more information: www.pluxeegroup.com

Contact 
Cecilia de Pierrebourg  
+33 6 03 30 46 98  
cecilia.depierrebourg@pluxeegroup.com 

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iTo ensure the comparability of results across markets, responses from India were excluded from the consolidated global analysis due to distinct response patterns observed within the dataset.

ii Pluxee’s global study published in 2025, The New Rules of Engagement was the first research paper to identify Measured Engagement, a trend in which employees engage with work deliberately to protect their boundaries, values, and work-life balance — a pragmatic response to a world of work that often expects people to overextend themselves.

Attachment

• Pluxee_PR_Work a refuge in turbulent times

Lille, Sept. 22, 2026 (GLOBE NEWSWIRE) — Top Wealth Group Holding Limited (NASDAQ: TWG)(“Top Wealth” or the “Company”), a distinguished purveyor of high-quality caviar and fine wines, today announced the relocation of its corporate headquarters from Hong Kong, China to Lille, France. This strategic move marks a pivotal step in the Company’s evolution from a regional Asian leader to a globally focused luxury food and beverage house.

The new Lille headquarters will serve as the command center for the Company’s international expansion, placing it at the heart of Europe’s luxury market and closer to key markets in the Americas, the Middle East, and the broader European continent. The relocation underscores the Company’s commitment to enhancing its global distribution capabilities and strengthening its presence in key international markets.

“Moving our head office to Lille is a natural progression for our Company as we pivot our operational focus from Asia to the world,” said Mr. Carp Lee, CEO of the Company. “France is the global capital of luxury, gastronomy, and fine wine, making it the ideal base for our next chapter. This move positions us to better serve our growing international clientele, forge deeper relationships with premier distributors, and elevate our brands to a new echelon of global prestige.”

The decision comes as the Company accelerates its global expansion, following a recent series of distributorship agreements covering key markets, including locations in Europe, the Middle-east, and Asia . The Company’s management forecasts that total revenue for the current financial year will increase by more than 30% compared to the previous year, driven by strong demand in these new markets.

“Our vision has always been to bring the world’s finest caviar and wine to discerning customers everywhere,” added Carp Lee. “This headquarters relocation is not just a change of address; it is a declaration of our global ambitions. We are excited to build on our Hong Kong heritage while embracing the opportunities that France and the global market offer.”

The Company will maintain a significant operational presence in Hong Kong, continuing to serve its valued Asian clientele as it expands its footprint worldwide.

About Top Wealth Group Holding Limited

The Company is a leading supplier of premium-class sturgeon caviar and light luxury wines. The Company sources and distributes products with the highest standards of quality and authenticity, holding permits and certifications that underscore its commitment to sustainability and excellence. The Company supplies caviar under private labels and through its own luxury brand, renowned for its exceptional quality and taste. With a heritage rooted in Asia and a new home in France, the Company is dedicated to providing unforgettable epicurean experiences to the global market.

Safe Harbor Statement

This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission, in its annual report to shareholders, in press releases and other written materials and in verbal statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including but not limited to statements about the Company’s beliefs and expectations, are forward-looking statements. Forward looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement. Further information regarding these and other risks is included in the Company’s filings with the Securities and Exchange Commission. All information provided in this press release is as of the date of the press release, and the Company undertakes no duty to update such information, except as required under applicable law.

For more information, please contact:

Top Wealth Group Holding Limited
Investor Relations
Email: ir@topwealth.cc