Author: Ravi Shankar

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.

Contact:

SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Email: IR@Scienture.com

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.

 ***

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 

---

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

Independent Data Monitoring Committee recommends the ongoing Phase 2 MRD study continue without modification following its review of all safety data to date

No cytokine release syndrome, systemic toxicities or serious immune-related adverse events observed to date, reinforcing IMNN-001’s differentiated safety profile as an IL-12-based immunotherapy

MRD study has now demonstrated the safety and tolerability of IMNN-001 both in combination with bevacizumab and in the maintenance setting

Recommendation follows encouraging preliminary Phase 2 MRD data reported in July demonstrating evidence of deeper anti-tumor activity and immune activation

LAWRENCEVILLE, N.J., Sept. 22, 2026 (GLOBE NEWSWIRE) — IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage biotechnology company developing DNA-mediated immunotherapies, today announced that the Independent Data Monitoring Committee (IDMC) overseeing its ongoing Phase 2 minimal residual disease (MRD) translational study of IMNN-001 has reviewed all safety data to date and recommended that the study continue without modification after identifying no new safety signals and confirming comparable safety across both treatment arms.

The IDMC is comprised of independent medical experts in gynecologic cancers. The Phase 2 MRD study is a randomized, controlled translational study assessing minimal residual disease following treatment with standard-of-care chemotherapy and bevacizumab, with or without IMNN-001, in women with newly diagnosed advanced ovarian cancer. The multi-site study is being conducted in collaboration with Break Through Cancer and is led by investigators at The University of Texas MD Anderson Cancer Center.

“The IDMC’s recommendation to continue our Phase 2 MRD study without modification provides important independent validation of the favorable safety profile we have consistently observed across our clinical development program,” said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. “Across our completed and ongoing clinical studies, we have observed no cytokine release syndrome, no systemic toxicities and no serious immune-related adverse events—an important distinction for an IL-12-based immunotherapy. Combined with the encouraging biological and clinical activity reported from this study in July, these findings further strengthen our confidence as we continue advancing our pivotal Phase 3 OVATION 3 trial.”

Consistent with this experience, the latest IDMC review identified no new safety concerns in the ongoing pivotal Phase 3 OVATION 3 trial. The MRD study has also achieved two important safety objectives by demonstrating the safety and tolerability of IMNN-001 both in combination with bevacizumab and in the maintenance setting.

In July 2026, the Company reported encouraging preliminary data from the MRD study, which is designed both to evaluate clinical activity and to better understand how IMNN-001 remodels the tumor immune microenvironment following frontline treatment. Among patients who reached the study’s primary assessment at second-look laparoscopy, treatment with IMNN-001 was associated with:

• A lower rate of MRD positivity compared with the control arm (44% versus 67%);
• Higher clearance of circulating tumor DNA (ctDNA) (87.5% versus 62.5%); and
• A higher proportion of patients achieving “no evidence of disease” following frontline therapy (100% versus 56%).

While preliminary and based on a limited number of patients, these findings provide encouraging evidence that IMNN-001 may drive deeper anti-tumor responses while maintaining the highly favorable safety profile consistently observed across the Company’s clinical development program. These clinical findings are supported by translational analyses that demonstrated robust IL-12 expression within macrophages, activation of downstream cytokines including interferon-gamma, and evidence of both macrophage and T-cell activation, consistent with remodeling the tumor immune microenvironment from an immunologically “cold” state to one that is immunologically active, or “hot.”

About the Translational Phase 2 MRD Study

The Phase 2 MRD study (NCT05739981) is evaluating IMNN-001 in combination with standard-of-care neoadjuvant and adjuvant chemotherapy plus bevacizumab in women with newly diagnosed advanced ovarian cancer, conducted through the Break Through Cancer Targeting Minimal Residual Disease in Ovarian Cancer TeamLab. Patients in the experimental arm receive IMNN-001, administered intraperitoneally, in combination with N/ACT plus bevacizumab, followed by interval cytoreductive surgery and additional cycles of adjuvant chemotherapy plus IMNN-001. Patients then undergo second-look laparoscopy (SLL) to assess for minimal residual disease, followed by maintenance therapy assigned according to homologous recombination deficiency (HRD) status. The primary endpoint of the study is MRD-positive rate at SLL; the secondary endpoint is progression-free survival (PFS). The study also includes serial translational analyses of tumor tissue, circulating tumor DNA (ctDNA), microbiome, and intraperitoneal fluid, to further characterize IMNN-001’s impact on the tumor immune microenvironment.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas^® platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity, acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer, and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

About IMUNON

IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA-based gene therapy technology across its modalities. The first modality, TheraPlas^®, is developed for the gene-based delivery of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising.

The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy being developed for the localized treatment of advanced ovarian cancer. IMNN-001 has been evaluated in multiple clinical trials including one Phase 2 clinical trial (OVATION 2) and is currently being studied in the ongoing Phase 3 clinical trial (OVATION 3). IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has completed dosing in a first-in-human study of its COVID-19 booster vaccine (IMNN-101). The Company will continue to leverage these modalities and to advance, either directly or through partnership, the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information, please visit www.imunon.com.

About Break Through Cancer

Founded in 2021, Break Through Cancer empowers outstanding researchers and physicians to both intercept and find cures for several of the deadliest cancers by stimulating radical collaboration among outstanding cancer research institutions, including its founding partners: Dana-Farber Cancer Institute, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Memorial Sloan Kettering Cancer Center, MIT’s Koch Institute for Integrative Cancer Research, and The University of Texas MD Anderson Cancer Center.

The Foundation is supported by a Board of Directors from the five partner institutions and a Scientific Advisory Board of U.S. cancer experts. The Foundation was launched with an extraordinary challenge pledge of $250 million from Mr. and Mrs. William H. Goodwin, Jr. and their family, and the estate of William Hunter Goodwin III.

For further information, please visit the Foundation’s website at www.breakthroughcancer.org.

Forward-Looking Statements

IMUNON wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure in conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

Investor Contact:
Valter Pinto
KCSA Strategic Communications
212-896-1254
imunon@kcsa.com

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	NextEnergy Solar Fund Ltd
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	21/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	Ordinary NPV
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	5,812,009	1.01%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	5,812,009	1.01%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
Ordinary NPV	Sale	10,000	49.23p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
Ordinary NPV

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	22/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.

8.3

PUBLIC OPENING POSITION DISCLOSURE/DEALING DISCLOSURE BY
A PERSON WITH INTERESTS IN RELEVANT SECURITIES REPRESENTING 1% OR MORE
Rule 8.3 of the Takeover Code (the “Code”)

1.        KEY INFORMATION

(a)   Full name of discloser:	Rathbones Group Plc
(b)   Owner or controller of interests and short positions disclosed, if different from 1(a):         The naming of nominee or vehicle companies is insufficient. For a trust, the trustee(s), settlor and beneficiaries must be named.
(c)   Name of offeror/offeree in relation to whose relevant securities this form relates:         Use a separate form for each offeror/offeree	Eleco Plc
(d)   If an exempt fund manager connected with an offeror/offeree, state this and specify identity of offeror/offeree:
(e)   Date position held/dealing undertaken:         For an opening position disclosure, state the latest practicable date prior to the disclosure	21/09/2026
(f)   In addition to the company in 1(c) above, is the discloser making disclosures in respect of any other party to the offer?         If it is a cash offer or possible cash offer, state “N/A”	No

2.        POSITIONS OF THE PERSON MAKING THE DISCLOSURE

If there are positions or rights to subscribe to disclose in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 2(a) or (b) (as appropriate) for each additional class of relevant security.

(a)      Interests and short positions in the relevant securities of the offeror or offeree to which the disclosure relates following the dealing (if any)

Class of relevant security:	1p Ordinary Shares
	Interests		Short positions
	Number	%	Number	%
(1)   Relevant securities owned and/or controlled:	1,157,410	1.37%
(2)   Cash-settled derivatives:
(3)   Stock-settled derivatives (including options) and agreements to purchase/sell:
TOTAL:	1,157,410	1.37%

All interests and all short positions should be disclosed.

Details of any open stock-settled derivative positions (including traded options), or agreements to purchase or sell relevant securities, should be given on a Supplemental Form 8 (Open Positions).

(b)      Rights to subscribe for new securities (including directors’ and other employee options)

Class of relevant security in relation to which subscription right exists:
Details, including nature of the rights concerned and relevant percentages:

3.        DEALINGS (IF ANY) BY THE PERSON MAKING THE DISCLOSURE

Where there have been dealings in more than one class of relevant securities of the offeror or offeree named in 1(c), copy table 3(a), (b), (c) or (d) (as appropriate) for each additional class of relevant security dealt in.

The currency of all prices and other monetary amounts should be stated.

(a)        Purchases and sales

Class of relevant security	Purchase/sale	Number of securities	Price per unit
1p Ordinary Shares	Sale	210	229.36p

(b)        Cash-settled derivative transactions

Class of relevant security	Product description e.g. CFD	Nature of dealing e.g. opening/closing a long/short position, increasing/reducing a long/short position	Number of reference securities	Price per unit

(c)        Stock-settled derivative transactions (including options)

(i)        Writing, selling, purchasing or varying

Class of relevant security	Product description e.g. call option	Writing, purchasing, selling, varying etc.	Number of securities to which option relates	Exercise price per unit	Type e.g. American, European etc.	Expiry date	Option money paid/ received per unit

(ii)        Exercise

Class of relevant security	Product description e.g. call option	Exercising/ exercised against	Number of securities	Exercise price per unit

(d)        Other dealings (including subscribing for new securities)

Class of relevant security	Nature of dealing e.g. subscription, conversion	Details	Price per unit (if applicable)
1p Ordinary Shares

4.        OTHER INFORMATION

(a)        Indemnity and other dealing arrangements

Details of any indemnity or option arrangement, or any agreement or understanding, formal or informal, relating to relevant securities which may be an inducement to deal or refrain from dealing entered into by the person making the disclosure and any party to the offer or any person acting in concert with a party to the offer: Irrevocable commitments and letters of intent should not be included. If there are no such agreements, arrangements or understandings, state “none”

None

(b)        Agreements, arrangements or understandings relating to options or derivatives

Details of any agreement, arrangement or understanding, formal or informal, between the person making the disclosure and any other person relating to: (i)   the voting rights of any relevant securities under any option; or (ii)   the voting rights or future acquisition or disposal of any relevant securities to which any derivative is referenced: If there are no such agreements, arrangements or understandings, state “none”

None

(c)        Attachments

Is a Supplemental Form 8 (Open Positions) attached?

No

Date of disclosure:	22/09/2026
Contact name:	Lydia Cotterill – Compliance Department
Telephone number:	0151 237 1176

Public disclosures under Rule 8 of the Code must be made to a Regulatory Information Service.

The Panel’s Market Surveillance Unit is available for consultation in relation to the Code’s disclosure requirements on +44 (0)20 7638 0129.

The Code can be viewed on the Panel’s website at.