Market Newsdesk

PRINCETON, N.J., June 23, 2026 (GLOBE NEWSWIRE) — Integra LifeSciences Corporation Holdings (Nasdaq: IART), a global leader in medical technology, today announced several leadership appointments within its commercial organization. These changes are designed to strengthen customer focus, accelerate execution, and support the company’s long-term growth strategy.

Following the recent appointment of Mike McBreen as executive vice president and chief commercial officer, Robert T. Davis Jr. has been appointed executive vice president, Tissue Reconstruction and Distributed Technologies, where he will lead the wound reconstruction and soft tissue segments, as well as private label. Christopher Kilburn-Peterson has been promoted to corporate vice president and president for the Tissue Reconstruction division, reporting to Davis. He will be responsible for the division’s strategic direction, including commercial and portfolio priorities. Kilburn-Peterson most recently served as senior vice president and general manager of Acclarent, where he led the successful integration of the company’s ENT business.

Harvinder Singh, who previously led the international business, succeeds McBreen as executive vice president and president of the Specialty Surgery division, leading its commercial and portfolio strategy and business performance, and will report to him. With the international business aligned under McBreen’s commercial organization, the regional international leaders will now report directly to McBreen.

“These changes reflect our continued focus on commercial excellence, while developing internal talent and strengthening our leadership bench,” said Mike McBreen, executive vice president and chief commercial officer, Integra LifeSciences. “We are building strong management capabilities across the organization and positioning experienced leaders at the forefront of our market-facing activities. Bob, Chris, and Harvinder bring deep expertise, proven leadership, and a strong track record of execution that will help us deliver for customers and patients.”

About Integra LifeSciences

Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com.

Investor Relations:

Chris Ward
(609) 772-7736
[email protected]

Media Contact:

Laurene Isip
(609) 208-8121
[email protected]

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/daeb707f-cfa7-4617-beee-f00f28194901
https://www.globenewswire.com/NewsRoom/AttachmentNg/2a8e48ad-f79e-4610-ab74-287ac135fcbb
https://www.globenewswire.com/NewsRoom/AttachmentNg/1fb9e02a-375d-4a92-9208-657bee9ce339

• Galectin has reached agreement with the FDA on the primary endpoint and regulatory path forward for the potential full approval of belapectin
• Company intends to file the Phase 3 protocol in Q3 2026 and is actively exploring strategic and financial partnership opportunities to support the continued development and commercialization of belapectin

NORCROSS, Ga., June 23, 2026 (GLOBE NEWSWIRE) — Galectin Therapeutics Inc. (NASDAQ: GALT), a biotechnology company focused on developing therapies for patients with advanced liver disease, today announced positive feedback from its recent in person Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of belapectin for the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.

Joel Lewis, Chief Executive Officer of Galectin Therapeutics, said, “We are pleased to have reached agreement with FDA on the key elements of our planned Phase 3 program for belapectin. Alignment on the study design, primary endpoint, and regulatory framework provides important clarity, as we advance the program with renewed confidence. We are initiating preparations for the Phase 3 trial and in parallel are evaluating development pathways alongside potential strategic partnership opportunities. We remain committed to patients with MASH cirrhosis and portal hypertension facing the highest risk of life-threatening decompensation events, who currently are excluded from enrolling in other ongoing drug development efforts. Additionally, FDA acknowledged the substantial unmet medical need in this patient population during our meeting, which strengthened our dedication to continuing the development of belapectin and our Phase 3 trial. We look forward to submitting the final Phase 3 protocol in the third quarter of 2026.”

The Phase 3 trial will assess the safety and efficacy of belapectin for the prevention of disease progression in a randomized, double-blind, placebo-controlled design in patients with metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension. Alignment was reached on the following:

Primary Endpoint: Alignment was reached on a composite liver outcome as the primary endpoint, including prevention of development of large esophageal varices (>5 mm), a clinically meaningful manifestation of worsening portal hypertension and disease progression in patients with compensated MASH cirrhosis. Importantly, the Company plans to incorporate the development of large esophageal varices as one component of composite clinical outcome endpoints in the planned Phase 3 study.

Central Endoscopy Review Methodology: FDA accepted the Company’s proposed blinded central review process for endoscopic assessment of esophageal varices. This methodology builds upon the approach successfully implemented in the global Phase 2b/3 NAVIGATE trial and is designed to ensure standardized, objective, and consistent assessment of endoscopic outcomes across study sites.

Galectin recently published details of the central review methodology and operational framework developed for NAVIGATE, highlighting the rigor and reproducibility of the process in a large multinational clinical trial.

Planned registration trial to evaluate single dose: Based on the robust efficacy observed with the 2 mg dose across prior clinical studies, the Company plans to evaluate a single 2 mg dose of belapectin in its planned Phase 3 trial. The Company believes that the planned Phase 3 study, together with the totality of existing clinical data, has the potential to support a full approval application for belapectin in patients with MASH cirrhosis and portal hypertension.

Given the similarity of the intended study population to the NAVIGATE trial, including patients with MASH cirrhosis and portal hypertension, and the evaluation of a single belapectin dose, the Company currently expects the planned Phase 3 trial to be of a size generally comparable to the NAVIGATE trial.

Regulatory Pathway: Consistent with FDA guidance, the Company understands that approval in the MASH cirrhosis population will require a traditional pathway, unlike earlier-stage MASH populations where accelerated approval based on histologic endpoints may be available. The FDA confirmed that the proposed composite outcome endpoints, including the development of large varices, and study framework are appropriate for a full approval pathway. Based on FDA’s recent communication regarding use of a single, adequate and well-controlled confirmatory trial for marketing approval, the Company believes the planned phase 3 trial provides a clear regulatory path toward a broad indication focused on preventing progression of MASH cirrhosis.

Khurram Jamil, M.D., Chief Medical Officer of Galectin Therapeutics, commented “FDA’s acceptance of our centralized endoscopy review process underscores the scientific rigor and operational robustness of the methodology that Galectin pioneered, and successfully implemented in the NAVIGATE trial. Standardized, blinded assessment of esophageal varices is critical to ensuring reliable and reproducible endpoint evaluation in global studies. Importantly, the Agency’s feedback supports the advancement of belapectin towards full approval, which we believe offers the opportunity to pursue a broad indication focused on preventing disease progression in patients with MASH cirrhosis.”

Galectin is advancing Phase 3 planning and is actively pursuing potential strategic and financial partners. Phase 3 protocol submission is anticipated in the third quarter of 2026.

About Galectin Therapeutics

Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which belapectin has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH, formerly known as nonalcoholic steatohepatitis, or NASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH, formerly known as NASH, with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.

Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
[email protected]

Investors Relations Contact:
Kevin Gardner
[email protected]

Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.

YUBA CITY, Calif., June 23, 2026 (GLOBE NEWSWIRE) — LGI Homes, Inc. (NASDAQ: LGIH) proudly announces the Grand Opening of Chima Ranch, a brand-new community offering spacious homes, exceptional value, and a desirable location in the heart of Yuba City. Surrounded by scenic orchards and established neighborhoods, Chima Ranch provides residents with a peaceful setting while remaining just minutes from everyday conveniences, major employers, outdoor recreation, and the Feather River.

At full build-out, Chima Ranch will feature 82 homesites with a collection of thoughtfully designed three-, four-, and five-bedroom homes. Each home showcases LGI Homes’ CompleteHome™ package, which includes a host of sought-after upgrades at no additional cost. Homeowners will enjoy energy-efficient Whirlpool® stainless steel kitchen appliances, premium hard-surface countertops, designer plank flooring, modern fixtures, and other carefully selected finishes. Spacious layouts, open-concept living spaces, and attached two-car garages provide both functionality and comfort for today’s homebuyers.

Five thoughtfully designed floor plans will be available at Chima Ranch, starting in the $490s:

• Baker – 3 beds, 2 baths, 2-car garage, 1,335 sq. ft.
• Carmel – 3 beds, 2 baths, 2-car garage, 1,505 sq. ft.
  • An Accessory Dwelling Unit (ADU) is available with select Carmel floor plans
• Eureka – 4 beds, 2 baths, 2-car garage, 1,708 sq. ft.
• Newport – 4 beds, 2.5 baths, 2-car garage, 1,943 sq. ft.
• Stallion – 5 beds, 3 baths, 2-car garage, 2,492 sq. ft.

“Our spacious lot sizes at Chima Ranch will allow homebuyers the opportunity to purchase an ADU on many of our home sites. These ADU’s can become the perfect guest house, multi-generational suite, or even an income producing opportunity for our homeowners,” stated Chris Kelly, Regional President.

Located just north of Sacramento, Chima Ranch places homeowners close to the shopping, dining, and entertainment options found at Yuba Sutter Mall and Yuba City Marketplace. Residents can also take advantage of the area’s abundant recreational opportunities, including local parks, walking trails, and the nearby Feather River, where fishing, boating, and waterfront relaxation await. Families will also appreciate easy access to Gauche Aquatic Park, a popular summer hotspot featuring pools, a splash pad, and waterslides for all ages.

To celebrate the community’s Grand Opening, LGI Homes will host a special event on June 20, 2026, featuring limited-time savings available exclusively during the event weekend. Interested homebuyers are encouraged to call (866) 460-3472 ext 792 to schedule a tour or visit the Chima Ranch Information Center, located at 1669 Sanborn Road in Yuba City. The Information Center is open daily from 10:00 a.m. to 6:00 p.m.

About LGI Homes

Headquartered in The Woodlands, Texas, LGI Homes, Inc. is a pioneer in the homebuilding industry, successfully applying an innovative and systematic approach to the design, construction and sale of homes across 36 markets in 21 states. LGI Homes has closed over 80,000 homes since its founding in 2003 and has delivered profitable financial results every year. Nationally recognized for its quality construction and exceptional customer service, LGI Homes was named to Newsweek’s list of the World’s Most Trustworthy Companies. LGI Homes’ commitment to excellence extends to its more than 1,000 employees, earning the Company numerous workplace awards at the local, state, and national level, including the Top Workplaces USA 2025 Award. For more information about LGI Homes and its unique operating model focused on making the dream of homeownership a reality for families across the nation, please visit the Company’s website at https://www.lgihomes.com.

MEDIA CONTACT:

Rachel Eaton
(281) 362-8998 ext. 2560

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c10c9f33-3ce8-4325-933d-3add766ab3bb

 

KALISPELL, Mont., June 23, 2026 (GLOBE NEWSWIRE) — ClassOne Technology, a leading global provider of advanced electroplating and wet processing tools for microelectronics manufacturing, today announced record follow-on orders from Applied Optoelectronics, Inc. (NASDAQ: AAOI) for multiple Solstice^® S8 advanced single-wafer wet processing systems to support the company’s expanding production of optical devices in Houston.

Marking the largest customer order in ClassOne’s history, these orders reflect a pivotal inflection point in the semiconductor industry: the rapid transition from electrical to optical interconnects within artificial intelligence (AI)-driven datacenter architectures. Industry analysts such as Yole Group project that photonics will become a foundational technology in AI datacenters over the next decade, with silicon photonics markets growing at approximately 30% CAGR through 2030, while AI-driven optical interconnect infrastructure expands at more than 20% CAGR as hyperscalers transition from pluggable optics to co-packaged architectures.

“The continued growth of AI datacenter infrastructure is placing new demands on both scale and process consistency in optical device manufacturing,” said Stephen Hu, Deputy Director of Wafer and Chip Production at AOI. “These additional Solstice systems will support our expansion in Texas, and having ClassOne’s world-class wafer processing technologies in house will help us speed our production ramp.”

This order further strengthens ClassOne’s move into high-volume manufacturing (HVM) to meet accelerating global demand for high-speed optical interconnect devices driven by AI infrastructure buildout. With the addition of these systems, AOI is expanding both capacity and process capability, including its transition to 6-inch InP wafer production.

“This milestone order is not only a validation of the performance and scalability of our Solstice platform, but also a clear signal of where the industry is heading,” said Byron Exarcos, CEO of ClassOne Technology. “We are in the early stages of a major architectural shift in AI datacenters toward optical interconnects. From transceivers today to co-packaged optics tomorrow, photonics will play a central role in enabling the next decade of AI growth.”

ClassOne has established an early leadership position in this transition, with Solstice systems deployed at leading photonics manufacturers such as AOI. This latest order builds on AOI’s adoption of the Solstice S8 platform last year, while ClassOne continues to expand its footprint among leading photonics manufacturers, with Solstice systems now deployed across the world’s top five photonics device makers to support their transition to volume 6-inch InP production. With its differentiated approach to precision single-wafer wet processing, ClassOne is ideally positioned to support both current production needs and future technology transitions.

About ClassOne Technology

ClassOne Technology is a leading provider of advanced electroplating and wet processing systems for semiconductor and microelectronic device manufacturing around the world. Its advanced IP portfolio comprises highly customized, cost-effective processing solutions for critical wafer processes used to manufacture devices for photonics, power, 5G, microLED, and MEMS and sensor markets. With tools installed in leading fabs and research organizations worldwide, ClassOne’s flagship Solstice^® platform is highly configurable, comprising fully automated wet processing applications with the industry’s most competitive ROI. For more information, visit classone.com. Stay in touch on LinkedIn and X.

For more information, contact:

Sales Inquiries	Media Inquiries
Byron Exarcos	Lisa Gillette-Martin
ClassOne Technology	Bodewell Group
tel: +1 678.772.9086	tel: +1 408.205.4732
email: [email protected]	email: [email protected]

Solstice
is a registered trademark of ClassOne Technology.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6f1b5ad5-f298-44e3-8778-3b7809f16e23

BERKELEY HEIGHTS, N.J., June 23, 2026 (GLOBE NEWSWIRE) — Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced an upcoming presentation of Phase 1a data at the American Society of Retina Specialists (ASRS) 2026 Annual Meeting.

ASRS Presentation Details:

• Title: First-in-Human Evaluation of TH103, a Novel Dual-Targeting VEGF/HSPG Biologic: Phase 1 Single Ascending Dose Study in Treatment-Naïve Neovascular AMD
• Speaker: Joel Pearlman, MD, PhD, Retinal Consultants Medical Group
• Date: Friday, July 17, 2026
• Time: 8:00 am EDT
• Session: AMD – Neovascular Symposium 2. Innovations in nAMD: New Targets, New Therapies, Early Results
• Location: Palais des congrès de Montréal, Montréal, Quebec

Kalaris also confirms that its Phase 1b/2 multiple ascending dose study of TH103 for neovascular Age-related Macular Degeneration is actively enrolling and dosing patients.  The company remains on-track to share initial data from the study in 1H 2027 which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development.

About TH103

TH103 is an investigational dual-targeting biologic engineered by VEGF scientific discoverer Dr. Napoleone Ferrara to achieve extended intraocular retention with enhanced VEGF inhibition through optimized binding to VEGF receptor 1 ligands and concurrent heparan sulfate proteoglycan (HSPG) anchoring. It is a fully humanized, recombinant fusion protein designed for intravitreal delivery, with potential applications as a treatment for exudative and/or neovascular retinal diseases, such as wet AMD, diabetic eye disease and retinal vein occlusion. TH103 is currently being investigated in a Phase 1b/2 clinical trial in patients with neovascular Age-related Macular Degeneration (nAMD).

About Kalaris

Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. Founded by renowned scientist Dr. Napoleone Ferrara, whose pioneering research led to the development of anti-VEGF therapy, the company is committed to advancing novel therapeutic approaches for patients with sight-threatening retinal conditions with major unmet medical needs.

For more information, visit www.kalaristx.com.

Kalaris Therapeutics Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors, LLC
+1 212 915 2577
[email protected]
[email protected]

PHILADELPHIA, PA, June 23, 2026 (GLOBE NEWSWIRE) — Exyn Technologies (“Exyn” or the “Company”) (NASDAQ: EXYN, EXYNW), a leader in autonomous mapping and perception-driven navigation for complex, GPS-denied environments, today announced that Range, its wholly owned defense-focused subsidiary, has been rebranded as Exyn Defense, Inc.,  with the goal of delivering ExynAI-powered autonomy and mapping software for government, national-security, and allied mission applications.

The rebranding of Range to Exyn Defense aligns the Company’s defense operations under the Exyn brand and aims to strengthen its positioning in government, defense, and national-security markets.

Exyn Defense provides a dedicated platform for delivering ExynAI-powered autonomy to government and allied customers operating in GPS-denied, communications-contested, and high-risk environments. Leveraging technology proven across some of the world’s most demanding commercial applications, the subsidiary will support autonomous aerial, ground, and hybrid robotic systems in mission-critical settings.

The rebrand comes as demand for autonomous defense systems continues to accelerate.

“Rebranding Range as Exyn Defense represents the next step in the evolution of our defense business. The Exyn name is increasingly recognized for autonomy in complex environments, and aligning our defense activities under a single brand strengthens our ability to begin to engage with government agencies, defense organizations, and strategic partners worldwide,” said Brandon Torres Declet, CEO of Exyn Technologies. “We believe our software-first, platform-agnostic approach positions Exyn to participate in a significant and expanding market opportunity while building on the investments we have already made in ExynAI.”

The Company’s ExynAI Autonomy & Mapping Stack has already been deployed in underground mines, industrial facilities, construction sites, and critical infrastructure environments where GPS, communications, and prior maps cannot be relied upon. The goal of Exyn Defense will be to extend those capabilities to government and defense customers seeking autonomous solutions that can operate effectively in contested, denied, and mission-critical environments.

As a dedicated defense-focused organization operating under the unified Exyn brand, Exyn Defense will seek to engage with defense agencies, prime contractors, systems integrators, and allied partners to support platform integrations, operational evaluations, and mission-specific autonomy applications. The Company’s platform-agnostic architecture is designed to enable integration across multiple robotic systems, expanding potential deployment opportunities while reducing dependence on any single hardware platform.

Potential mission applications include intelligence, surveillance and reconnaissance, subterranean and indoor mapping, EOD/UXO and CBRN reconnaissance, battle damage assessment, contested infrastructure inspection, tactical logistics, GPS-denied navigation, and defense-oriented digital twins.

“Many of the challenges we have already tackled with our commercial customers mirror the operational challenges currently facing defense organizations today,” added Mr. Declet. “Whether operating underground, indoors, in damaged infrastructure, or in contested environments, autonomous systems need to perceive, navigate, map, and complete missions with limited external infrastructure and reduced operator burden. Exyn Defense is focused on bringing those capabilities to government and allied customers worldwide.”

About Exyn Technologies

Exyn Technologies (NASDAQ: EXYN, EXYNW) is a leader in autonomous mapping and perception-driven navigation for complex, GPS-denied environments. The Company’s technology enables teams to capture accurate 3D data in environments that are dark, disconnected, hazardous, or difficult to access. Exyn’s solutions support customers across mining, construction, infrastructure, geospatial, industrial, government, and defense applications.

For more information, visit www.exyn.com.

About Exyn Defense Inc.

Exyn Defense Inc. is a wholly owned subsidiary of Exyn Technologies focused on autonomy software for defense, government, and allied mission applications. Built on ExynAI, Exyn Defense Inc. enables uncrewed systems to localize, map, navigate, avoid obstacles, and execute missions in GPS-denied, comms-degraded, and high-risk environments without external infrastructure or continuous operator control.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding Exyn Defense; the expected focus, strategy, capabilities, applications, customer opportunities, and potential benefits of Exyn Defense; the Company’s ability to address government, defense, national-security, and allied markets; the expected demand for autonomous systems, military drones, military robotics, and related defense technology; the Company’s ability to leverage its ExynAI Autonomy & Mapping Stack and software-first, platform-agnostic approach in defense and government applications; potential integrations with uncrewed aerial, ground, and hybrid robotic systems; potential engagement with defense agencies, prime contractors, systems integrators, and allied partners; and the Company’s expectations regarding market growth, deployment opportunities, operational evaluations, mission-specific autonomy applications, and future commercial or strategic opportunities.

These forward-looking statements are based on current expectations, estimates, projections, assumptions, and beliefs of the Company’s management, including assumptions regarding market demand, customer adoption, technology performance, procurement activity, defense and government spending, competitive conditions, third-party market forecasts, and the Company’s ability to execute its strategy. Forward-looking statements are inherently subject to known and unknown risks, uncertainties, and other important factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the Company’s ability to successfully launch, operate, and grow Exyn Defense; the ability of the Company’s technology to meet the requirements of defense, government, and allied customers; delays or failures in customer adoption, procurement processes, platform integrations, operational evaluations, or contract awards; changes in defense budgets, government priorities, regulations, export controls, or procurement requirements; reliance on third-party platforms, partners, systems integrators, or suppliers; competitive developments; the accuracy of third-party market research and growth forecasts; and the other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission.

Forward-looking statements can generally be identified by words such as “anticipates,” “believes,” “designed,” “expects,” “forecasts,” “intends,” “may,” “plans,” “potential,” “projects,” “seeks,” “should,” “targets,” “will,” “would,” and similar expressions, although not all forward-looking statements contain these identifying words. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law.

Media Contact
Vanessa Varian
Exyn
[email protected] 

Investor Contact
Crescendo Communications, LLC
[email protected]
(212) 671-1020

• MHRA minutes from May 12 pre-MAA Scientific Advice meeting confirm agreement across all questions covering CMC, non-clinical and clinical evidence packages
  
   
• MHRA pediatric feedback recognizes MissionEB Phase 2 data as demonstrating clinically meaningful symptomatic benefit, particularity pain and pruritis, and states the data could support positioning as chronic or intermittent supportive therapy for RDEB

BOCA RATON, Fla, June 23, 2026 (GLOBE NEWSWIRE) — INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has received official, accepted meeting minutes from its recent face-to-face pre-Marketing Authorization Application (pre-MAA) Scientific Advice meeting with the UK Medicines & Healthcare products Regulatory Agency (MHRA) for CORDStrom™ (Ebstrocel™) in Recessive Dystrophic Epidermolysis Bullosa (RDEB).

The May 12, 2026, meeting resulted in written alignment across all questions submitted by the Company and provides a clear regulatory path for INmune Bio’s planned 2026 UK Marketing Authorization Application (MAA) seeking Conditional Marketing Authorization for Ebstrocel™ in RDEB. Ebstrocel™ is the name of the RDEB-specific investigational formulation derived from INmune Bio’s proprietary CORDStrom™ off-the-shelf, pooled, human umbilical cord-derived mesenchymal stromal cell platform.

“Definitive MHRA alignment across CMC, non-clinical and clinical strategy is an important regulatory de-risking milestone for Ebstrocel™ and for the broader CORDStrom™ platform,” said David Moss, Chief Executive Officer of INmune Bio. “The minutes give us a practical roadmap to completing the MAA package for potential conditional authorization in the UK.”

In addition, the Company received written comments on its pediatric investigation plan (PIP). In those comments, MHRA recognized MissionEB Phase 2 data as demonstrating “clinically meaningful symptomatic benefit, particularly in pain and pruritus. While MissionEB demonstrated improvements in wound quality, inflammation, and granulation during treatment periods, it did not show durable wound closure or sustained reduction in total wound burden after treatment cessation, which is a significant limitation of the study. Nevertheless, these data could support the positioning as chronic or intermittent supportive therapy for RDEB.” INmune Bio is incorporating the Agency’s endpoint recommendations into its confirmatory Phase 3 program to better capture patient-relevant benefits in this ultra-rare disease.

“MHRA’s comments recognize the patient-relevant symptomatic benefits observed in MissionEB and provide specific guidance on the evidence package, manufacturing transition and confirmatory trial design needed to support review,” stated David Moss. “We remain on track for our planned 2026 UK MAA submission, with the EU and US submissions to follow.”

“RDEB studies require a development framework that reflects small patient populations, caregiver-reported outcomes and clinically meaningful symptom changes,” said Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio. “The MHRA feedback has been very valuable, constructive and highly specific. We are implementing MHRA’s recommendations, including refinements to the primary and secondary endpoints, which move away from a focus on wound closure, and broadening the planned pediatric age range to 0 to 18 years, before submitting the clinical trial application. The Agency’s openness to Bayesian analyses and patient/parent-reported evidence is consistent with the realities of rare-disease development and will inform both our conditional-approval package and our confirmatory Phase 3 strategy.”

Key outcomes from the MHRA written advice:

1. CMC and Commercial Manufacturing Framework Validated

The MHRA affirmed that INmune Bio’s proprietary pooled-donor approach is acceptable, provided it is supported by the Company’s data-characterization package and donor-contribution controls. The agency also concurred with INmune Bio’s analytical and comparability plans to transition manufacturing to commercial platforms, including standard microcarrier clearance controls and stability protocols. Importantly, the Company expects to submit certain real-time manufacturing and stability updates during the formal MAA assessment period.

2. Capital-Efficient Non-Clinical Safety Package Accepted

Regulators agreed with INmune Bio’s strategy to use a focused, literature-supported non-clinical safety package, supplemented by in vitro safety and pharmacology data. This approach is designed to satisfy non-clinical safety requirements while avoiding redundant, capital-intensive animal testing that is unlikely to add decision-relevant information for this cell-therapy product candidate.

3. Rare-Disease Clinical Evidence Framework Clarified

The MHRA provided constructive guidance on the statistical and clinical evidence challenges inherent in ultra-rare diseases such as RDEB. Regulators noted that traditional frequentist statistical analyses may be less informative in small orphan populations and invited INmune Bio to incorporate alternative approaches, including Bayesian statistical models and qualitative patient and parent interview data describing improvements in systemic symptoms such as chronic pain, intractable itch and sleep quality, to support the Ebstrocel™ MAA.  The Agency also gave clear advice about strengthening our analysis of the qualitative data from the MISSION EB phase II trial for submission, emphasizing the importance of this data. We have taken on board their advice regarding data analyses for the phase III trial required for substantive approval, which is expected to open in 2026.

INmune Bio is advancing final commercial manufacturing validation activities and dossier compilation to support the planned UK submission. The Company also intends to use the MHRA feedback to inform future interactions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) with additional filings planned in late 2026 or early 2027, subject to regulatory alignment and completion of required submissions.

About CORDStrom™

CORDStrom™ is a patent-pending cell medicine platform comprising aseptic, allogeneic, pooled human umbilical cord-derived mesenchymal stromal cells in suspension for injection or infusion. The CORDStrom™ platform leverages proprietary screening, pooling and expansion techniques to create off-the-shelf, allogeneic, pooled hucMSCs as medicines to treat complex inflammatory and autoimmune diseases. CORDStrom™ products are designed to provide high-quality, off-the-shelf, batch-to-batch consistent, scalable, cGMP-manufactured and potent cellular medicines that can be produced affordably and with repeatable specifications. Ebstrocel™ is the indication-specific formulation derived from the CORDStrom™ platform, optimized with anti-inflammatory, immunomodulatory and wound-healing effector functions to treat the severe systemic effects of RDEB in pediatric patients.

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.

INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:

1. CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission.

2. XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to eliminate neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.

To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.

Forward Looking Statements

Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contacts:

David Moss
Chief Executive Officer
(561) 710-0512
[email protected]

Daniel Carlson
Head of Investor Relations
(415) 509-4590
[email protected]

NEW YORK and HONG KONG, June 23, 2026 (GLOBE NEWSWIRE) — Veea Inc. (“Veea”) (NASDAQ: VEEA), a first-to-market leader in edge-native hyperconverged networking and AI-powered cybersecurity, enabling distributed “micro AI factories,” and TROLLEE Holdings Limited (“THL”), the global innovator behind the TROLLEE^® smart shopping cart product line, today announced the extension of their a strategic partnership, initially commenced in 2018 and extended with a licensing agreement in May 2023 between Veea and a predecessor to THL, to accelerate the global smart retail revolution.

This alliance represents the culmination of years of collaboration between the parties, resulting in a unified platform that combines Veea’s AI-powered, cybersecure hybrid edge-cloud computing and AdEdge™ contextual advertising engine with TROLLEE’s next-generation Smart Retail platform incorporating smart shopping carts and emerging retail robotics capabilities. THL, established in 2025 to focus exclusively on the commercial expansion of the TROLLEE ecosystem, brings a proven track record of successful deployments across Japan, Korea, China, Singapore, Malaysia, Thailand, South Africa, and the Middle East. Critically, by joining forces with Veea, TROLLEE gains immediate access to Veea’s established enterprise relationships across the Americas and Europe. This strategic alignment significantly expands TROLLEE’s global footprint, positioning the combined Veea-Trollee platform as a globally scalable smart retail solution.

A New Era in Smart Retail — From Smart Carts to Autonomous Stores

This partnership expands the role of the smart cart beyond shopper assistance, positioning TROLLEE as a key interface within an intelligent retail operating environment and redefining TROLLEE as the digital nervous system of the fully autonomous, AI-driven store. While others offer fragmented solutions—disjointed IoT sensors, disparate video analytics, and standalone carts—TROLLEE and Veea deliver a single, hyperconverged operating system for the retail floor with large scale orchestration of digital intelligence across all retailer’s locations, powered by federated learning.

The consolidated solution leverages VeeaONE’s robust edge-AI capabilities to transform TROLLEE into a fully autonomous retail assistant. Key revolutionary features include:

• AI-Powered Inventory Robotics & Replenishment: As shoppers navigate the aisles, TROLLEE utilizes integrated high-definition cameras and real-time planogram data to scan shelf inventory. When the system detects low stock, misplaced items, or spills, it autonomously triggers robotics workflows. Through integration with retail-optimized humanoid robots, the platform initiates instant restocking, cleaning, or spill prevention, closing the inventory management loop with ultra-low latency and minimal human intervention.
• Advanced Patrolling & Security: Extending beyond the shopping cart, the TROLLEE platform serves as a mobile surveillance and patrolling unit. Equipped with Veea’s edge-AI, these robotic units can navigate store floors autonomously, identifying slip-and-fall hazards, monitoring for loss prevention, and ensuring safety compliance, effectively serving as an autonomous digital security and safety assistant.
• Unmanned Store Capability: The integration of Veea’s resilient in-store networking and edge execution allows TROLLEE to scale beyond a single cart into a chain-wide, supply-chain-aware operating layer. This enables a seamless, checkout-free experience, allowing retailers to operate 24/7 unmanned stores with high confidence in inventory accuracy and transaction security.

Unlocking Commercial Retail Robotics with Physical AI

The strategic partnership between Veea and THL opens a vast frontier extending far beyond the grocery aisle. By integrating Veea’s versatile edge-AI solutions with TROLLEE’s ruggedized hardware, the companies are positioned to pioneer a new category of “Commercial AI Robotics.”

This synergy allows for the deployment of continually “trained” autonomous robots not just for retail, but for logistics and warehouses, hospitality, and public spaces, capable of performing complex tasks such as floor cleaning, disinfection, and concierge services—all managed through the unified VeeaONE cloud interface.

“VeeaONE has simplified the deployment of comprehensive AI-powered solutions, unifying multi-access connectivity, edge computing, and cybersecurity in a single platform,” said Allen Salmasi, CEO of Veea Inc. “This partnership with TROLLEE is a natural evolution of our vision for the future of retail and autonomous infrastructure. We are uniting the physical interface of the shopping experience with large-scale orchestration of digital intelligence across retail environments. TROLLEE’s advancements in robotics and inventory management make them the ideal partner to showcase the full potential of edge AI.”

A Seamless Ecosystem: Digital Twins, Tokenization, and Targeted Advertising

The combined stack creates an AI-powered hyper-connected environment featuring a real-time digital twin, facilitated by IoT and camera endpoints, of the retail store. This enables:

• Transforming Retail Space Efficiency: Optionally, equipped with a containerized version of Honeywell Tridium’s Niagara^®, VeeaONE enables seamless data collection, continuous monitoring and management across all building functions, from HVAC systems to lighting, refrigeration, air quality management and security services. Real-time data analytics combined with edge AI facilitates proactive, predictive maintenance and faster response times, enhancing overall operational efficiency.
• Farm-to-Store Transparency: The platform supports tokenized product provenance, verification, and smart-contract-enabled workflows, enabling transparent provenance tracking, food safety monitoring, and secure transactions—establishing a verifiable digital passport for retail goods.
• Hyper-Contextual Retail Media: Together, they form a digital concierge for the shoppers, integrated with an AdEdge-based proximal marketing engine that delivers highly contextualized, targeted and privacy-compliant advertising directly from Consumer Packaged Goods companies (CPGs), programmatic networks, Demand-Side Platforms (DSPs), local service providers, and others to shoppers at the critical moment of decision-making — creating new revenue streams for retailers while elevating the shoppers’ experience.

“THL and its predecessor have spent over a decade perfecting the TROLLEE platform as both a consumer assistant and an enterprise data powerhouse, while deploying our Smart Retail solutions across three continents,” said Thim S Chiew, CEO of THL. “By joining forces with Veea, we are embedding our groundbreaking hardware and global market experience into the ultimate edge-AI operating system for the store of the future. More importantly, Veea’s strong presence in the Americas and Europe opens the door for our solutions to achieve true global scale—uniting markets across Asia, Africa, the Middle East, the Americas, and Europe under one unified platform. This strategic partnership allows us to combine Veea’s unparalleled edge infrastructure with our leading-edge retail robotic capabilities to deliver the most advanced smart retail and commercial AI solutions offered today. We are not just changing how people shop; we are redefining the economics, security, and global reach of physical retail. “

For more information about Veea’s Smart Retail Edge Intelligence solution with TROLLEE, visit https://www.veea.com/solutions/trollee.

About Veea Inc.

Veea Inc. (NASDAQ: VEEA) is a global leader in AI-driven edge infrastructure. Founded in 2014 and headquartered in New York City, Veea enables enterprises, service providers, and public sector organizations to deploy AI-powered applications and services at the edge. Built on Veea-developed and third-party devices, the VeeaONE platform integrates connectivity, computing, cybersecurity, and storage into a unified, hyperconverged network solution, delivered through a full software stack spanning edge to cloud — bringing AI to deployments that range from SMBs to enterprise campuses, smart industries, and remote communities. With more than 123 patents across related technology domains, Veea has been recognized by Gartner for its innovations in edge computing.

About TROLLEE Holdings Limited

TROLLEE Holdings Limited is the developer of the TROLLEE smart shopping cart solution—an AI-powered retail platform that transforms traditional shopping carts into connected, interactive robotic devices. With a strong R&D foundation and one of the largest commercial deployment footprints in the smart retail sector, TROLLEE Holdings Limited is a globally recognized innovator in intelligent hardware, real-time retail data intelligence, and autonomous commercial robotics.

Media Contacts:

Thomas Latiolais
Email: [email protected]

THL Media Relations
Email: [email protected]

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995, including statements regarding, among other things, the plans, strategies and prospects, both business and financial, of Veea. These statements are based on the beliefs and assumptions, whether or not identified in this press release, of the management of Veea. Although Veea believes that its plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, Veea cannot assure you that it will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events or results of operations, and any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements may be preceded by, followed by or include the words “anticipate,” “believe,” “could,” “continue,” “estimate,” “expect,” “forecast,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “project,” “scheduled,” “seek,” “should,” “will” or similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements contained in this press release include, but are not limited to, statements about (i) Veea’s ability to maintain adequate operational and financial resources, including the ability to raise sufficient capital and/or generate sufficient cash flows; (ii) Veea’s ability achieve its current growth strategy and its ability to generate revenue and become profitable; (iii) Veea’s ability to successfully maintain its strategic relationship with THL,(iv) the market acceptance of Veea’s platform and products; (v) Veea’s reliance on distribution and partnering arrangements; and (vi) Veea’s ability to compete against industry competitors.

You are cautioned not to place undue reliance on these forward-looking statements, which only speak as of the date made, are not a guarantee of future performance and are subject to a number of uncertainties, risks, assumptions and other factors, many of which are outside the control of Veea. Veea expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the expectations of Veea with respect thereto or any change in events, conditions or circumstances on which any statement is based.

ISELIN, N.J., June 23, 2026 (GLOBE NEWSWIRE) — Provident Bank, a leading New Jersey-based financial institution, announced today the appointment of Adriano Duarte to Executive Vice President and Chief Financial Officer of Provident Bank and Provident Financial Services, Inc. (NYSE: PFS), effective July 1, 2026.

In his new role, Mr. Duarte will lead all aspects of the Finance organization, including accounting, financial planning and analysis, treasury, investor relations, corporate strategy, financial reporting, tax, facilities, and financial risk management. He will serve as a key advisor to the Executive Leadership Team and Board of Directors, helping guide the company’s financial performance, growth strategy, capital management, and long-term value creation. Mr. Duarte will also help identify strategic opportunities and partner across the organization to support continued growth and strong financial performance.

Mr. Duarte will report directly to Anthony Labozzetta, President and Chief Executive Officer of Provident Bank, and will serve as a member of the bank’s Executive Leadership Team.

“Adriano is a highly respected and trusted leader whose deep financial expertise, strategic perspective, and collaborative leadership style have made a significant impact across our organization,” said Mr. Labozzetta. “Since joining Provident through the acquisition of SB One Bank, Adriano has played an instrumental role in strengthening our financial management capabilities and advancing many of the bank’s key priorities. He embodies our culture and Guiding Principles, and I am confident he will continue to provide the strong financial leadership and strategic insight necessary to help shape Provident’s future.”

Mr. Duarte joined Provident in 2020 through the acquisition of SB One Bank and most recently served as Executive Vice President and Chief Accounting Officer. In that role, he led the bank’s accounting, financial reporting, financial planning and analysis, tax, facilities, and investor relations functions while helping advance several strategic initiatives designed to enhance performance and support long-term growth.

With more than 30 years of banking and financial services experience, Mr. Duarte has built a distinguished career in financial leadership, balance sheet management, mergers and acquisitions, financial planning and analysis, regulatory and SEC reporting, and investor relations. Prior to joining Provident, he served as Chief Financial Officer of SB One Bank and held several senior finance leadership positions at both SB One Bank and Investors Bank.

“I am honored to assume this role and grateful for the confidence Tony, the Board of Directors, and my colleagues have placed in me,” said Mr. Duarte. “Provident has a long history of financial strength, a strong culture, and a clear vision for the future. I look forward to continuing to work alongside our talented teams across the organization to support our strategic priorities, deliver long-term value for our shareholders, and help our customers and communities succeed.”

Mr. Duarte earned a Bachelor of Science degree in Accounting and an MBA with a concentration in Finance from Rutgers University and is a Certified Public Accountant.

Mr. Duarte succeeds Thomas Lyons, who retired after a distinguished career spanning more than two decades with Provident.

About Provident Bank

Founded in Jersey City in 1839, Provident Bank is the oldest community-focused financial institution based in New Jersey and is the wholly owned subsidiary of Provident Financial Services, Inc. (NYSE:PFS). With assets of $25.20 billion as of March 31, 2026, Provident Bank offers a wide range of customized financial solutions for businesses and consumers with an exceptional customer experience delivered through its convenient network of more than 140 branches across New Jersey and parts of New York and Pennsylvania, via mobile and online banking, and from its customer contact center. The bank also provides fiduciary and wealth management services through its wholly owned subsidiary, Beacon Trust Company, and insurance services through its wholly owned subsidiary, Provident Protection Plus, Inc. To learn more about Provident Bank, go to www.provident.bank or call our customer contact center at 800.448.7768.

Media Contact:
Keith Buscio
Director of Public Relations & Communications
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/097ab7be-fc2e-4a76-82cf-405278a4b240