The Company remains materially unaffected by recently announced U.S. tariffs and procurement restrictions

MONTREAL, Sept. 14, 2026 (GLOBE NEWSWIRE) — PyroGenesis Inc. (“PyroGenesis” or the “Company”) (TSX: PYR) (OTCQX: PYRGF) (FRA: 8PY1), a leader in ultra-high temperature processes and engineering innovation, and a plasma-based technology provider to heavy industry & defense, confirms that, based on the information currently available and the Company’s assessment to date, recently announced U.S. tariffs and procurement restrictions are not expected to have a materially adverse impact on the Company’s operations or financial results. This update responds to investor questions concerning recent Canada-U.S. trade policy developments and the resulting tariffs and regulatory restrictions affecting certain Canadian products.

The Company continues to closely monitor the tariff environment which has changed substantially in the last few weeks after Canada suspended negotiations with respect to a potential U.S. trade agreement. Subsequent counter-tariffs were implemented by both countries. Most recently, on September 8, the U.S. government directed the General Services Administration, working with the U.S. Trade Representative, to take steps to remove Canadian-origin products from the General Services Administration’s Multiple Award Schedules (GSA MAS). GSA MAS is a procurement program through which federal agencies and other eligible government buyers may acquire commercial products and services.

Based on the Company’s assessment to date, none of these developments have materially affected PyroGenesis’ goods or operations.

Certain machinery exported by PyroGenesis to the U.S has, for several years, been subject to a 10% tariff. Based on the company’s review of the applicable tariff classifications and measures announced to date, the tariff rate applicable to that machinery has not changed

With respect to the announced U.S. federal procurement changes, PyroGenesis does not currently supply goods directly to U.S. federal agencies other than in connection with certain U.S. Department of Defense activities. Based on the information currently available to the Company, the universities and university research facilities supplied by PyroGenesis are not expected to be materially affected. Although GSA MAS is principally used by federal agencies, state and local governments and certain other eligible entities (such as public universities, that are governed at the state level) may acquire specified products and services through the program; accordingly, the effect on any institution should be assessed based on its eligibility, funding source and procurement requirements.

Additionally, it is understood by the Company that defense-related clients, especially those connected to U.S. federal funding agencies, operate under specific regulatory exceptions and statutory carve-outs that legally allow or require contracting officers to deviate from or look outside of GSA Schedules, in the interest of national security.

Finally, it is important to note that the Company maintains the capability to manufacture and assemble its systems in Canada, the United States, and other jurisdictions worldwide. This flexibility reduces reliance on any single geographic location and enables the Company to respond efficiently to changing market conditions, customer requirements, and supply chain considerations. In the event of changes to U.S. tariff policies or other trade measures, the Company’s diversified supply chain and global manufacturing capabilities provide the flexibility to adjust sourcing, manufacturing, and assembly activities as appropriate to mitigate potential impacts and continue serving customers efficiently.

“Based on the information currently available, I am confident that the recently imposed tariffs and procurement restrictions will have little to no direct negative impact on PyroGenesis,” said Mr. P. Peter Pascali, President and CEO of PyroGenesis. “We will continue to closely monitor the situation, but for now, we can safely say that PyroGenesis has positioned itself in such a way that these recent announcements will not change our situation.”

About PyroGenesis Inc.

PyroGenesis leverages 35 years of plasma technology leadership to deliver advanced engineering solutions to energy, propulsion, destruction, process heating, emissions, and materials development challenges across heavy industry and defense. Its customers include global leaders in aluminum, aerospace, steel, iron ore, utilities, environmental services, military, and government. From its Montreal headquarters and local manufacturing facilities, PyroGenesis’ engineers, scientists, and technicians drive innovation and commercialization of energy transition and ultra-high temperature technology. PyroGenesis’ operations are ISO 9001:2015 and AS9100D certified, with ISO certification maintained since 1997. PyroGenesis’ shares trade on the TSX (PYR), OTCQX (PYRGF), and Frankfurt (8PY1) stock exchanges.

Cautionary and Forward-Looking Statements

This press release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking statements. Forward-looking statements are not historical facts, nor guarantees or assurances of future performance but instead represent management’s current beliefs, expectations, estimates and projections regarding future events and operating performance. Forward-looking statements are necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by PyroGenesis as of the date of this release, are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Important factors that could cause actual results to differ, possibly materially, from those indicated by the forward-looking statements include, but are not limited to, the risk factors identified under “Risk Factors” in PyroGenesis’ latest annual information form, and in other periodic filings that it has made and may make in the future with the securities commissions or similar regulatory authorities, all of which are available under PyroGenesis’ profile on SEDAR+ at www.sedarplus.ca. These factors are not intended to represent a complete list of the factors that could affect PyroGenesis. However, such risk factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. You should not place undue reliance on forward-looking statements, which speak only as of the date of this release. PyroGenesis undertakes no obligation to publicly update or revise any forward-looking statement, except as required by applicable securities laws. Neither the Toronto Stock Exchange, its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) nor the OTCQX Best Market accepts responsibility for the adequacy or accuracy of this press release.

For further information contact ir@pyrogenesis.com or visit http://www.pyrogenesis.com

  • Invention is based on the discovery that ALS may be caused by reactivation of Human Endogenous Retrovirus K (HERV K) Envelope protein (K Env), already coded in the “dark genome” of all people.
  • K Env is found in the spinal fluid of more than 75% of people with ALS and has been shown to produce the neurodegenerative findings of ALS in experimental animals and human neuron cells.
  • The patent (EP 3 570 878 B1) covers a novel monoclonal antibody (GNK-301) developed by GeNeuro and scientists at the US National Institute of Neurological Disorders and Stroke (NINDS) under a Cooperative Research and Development Agreement and co-owned under a subsequent patent agreement. Two US patents (10,723,787 and 10,981,977) have previously been granted for this invention.
  • As described in the patents, GNK-301 has been shown to prevent the neurotoxic effects of K Env in nonclinical subjects and in human motor neuron cells – the cells that are damaged by ALS.
  • GeNeuro has instituted GMP manufacture of GNK-301 and anticipates initiating human Phase I trials in patients with ALS in the second half of 2027 in the US and Europe.
  • GeNeuro was selected in the first round of the Congressionally Directed Medical Research Program for two potential awards and is finalizing its submission.
  • GeNeuro will participate in a conference this weekend on “HERVs and Humanity” bringing together leading clinicians and molecular biologists to focus on the understanding and treatment of HERV-induced diseases, including ALS, Multiple Sclerosis, Optic Neuritis, and Schizophrenia.

MIAMI, Sept. 14, 2026 (GLOBE NEWSWIRE) — GeNeuro, Inc., (“GeNeuro” or the “Company”), a subsidiary of NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), today announced the award of a European Patent (EP 3 570 878 B1) entitled “Anti HERV K Envelope Antibody and Uses Thereof.” The patent, together with two previously-issued US patents (10,723,787 and 10,981,977) describes in detail the discovery that the envelope protein (K Env) of Human Endogenous Retrovirus K (HERV K) is found in the spinal fluid of more than 75% of people with Amyotrophic Lateral Sclerosis (ALS), is shown to be highly neurotoxic, and to produce the neurodegenerative findings of ALS in laboratory animals and in human motor neuron cell culture.

HERVs are the remnants of viruses that infected primates between 2 and 5 million years ago and are now thought to have played a role in human disease. A monoclonal antibody against K Env (GNK-301) has been shown to block those neurotoxic effects in the same models. The discovery was made by a team comprised of scientists from Geneuro SA (Lyon, France) and the US National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health (NIH) under a Cooperative Research and Development Agreement (CRADA) and subsequent patent agreement. The patents are jointly owned by GeNeuro and the US Dept. of Health and Human Services.

The assets of the former Geneuro SA were awarded to GeNeuro, Inc. (Miami, FL) by the Courts of Switzerland in June 2026 and GeNeuro initiated manufacture of GNK-301 under Good Manufacturing Practices (cGMP) with the plan to initiate human Phase 1 trials of GNK-301 in the US and Europe in the latter half of 2027.

Geneuro SA previously conducted five human trials of a related antibody (Temelimab®) which targets the envelope protein of HERV W in more than 400 human participants who had Multiple Sclerosis, Type 1 Diabetes, or symptoms of Long Covid, with no Serious Adverse Events. Temelimab was shown to cross the blood brain barrier and to achieve a statistically significant reduction in neurodegeneration, as measured by “Black Holes” on Magnetic Resonance Imaging (MRI) and a corresponding reduction in brain shrinkage. The Company believes these results support the potential for anti-HERV Envelope antibodies to achieve clinically meaningful effects in patients with HERV-mediated neurodegenerative diseases.

The recently-issued patent adds to a portfolio of more than 25 issued and pending patents owned by GeNeuro related to the effects of HERVs and to methods of diagnosing and mitigating those effects. A more comprehensive list can be found on www.geneuro.us.

In August 2026, GeNeuro, in partnership with NINDS was selected in the first round of the ALS grant competition of the Congressionally Directed Medical Research Program (CDMRP) for potential awards in Therapeutic Development and Biomarker Development and is currently preparing its final bid submission. This weekend, the first annual conference on “HERVs and Humanity” will be held at the Princeton Institute for Advanced Study to bring together an international group of clinicians and molecular biologists to prioritize research objectives and clinical priorities in this dramatic new area of science. Portions of the conference will be simulcast.

“ALS is possibly the most devastating diseases one can contract, with a life expectancy of two to five years. The opportunity to partner with the NIH and leading experts across the globe around a biomarker-targeted, potentially disease-modifying drug has the potential to forever change the course of this terrible disease,” said Dr. Jonathan Javitt, the Company’s CEO.

About GeNeuro, Inc.

GeNeuro, Inc. (www.geneuro.us) is a newly-formed US Company organized around the assets of the former Geneuro SA. Those assets include the products of more than $180 million in funded research on Human Endogenous Retrovirus-targeted drugs for ALS, Multiple Sclerosis, Type 1 Diabetes, and Schizophrenia. Temelimab, targeting the HERV W Envelope protein has reached Phase 2 in Europe with completed clinical trials demonstrating statistically-significant reductions in neurodegeneration in multiple sclerosis and decreased Islet cell destruction in Type 1 diabetes. GNK-301, targeting ALS was developed and patented worldwide under a Cooperative Research and Development Agreement with the US National Institutes of Health and is now in production and anticipated to enter Phase 1 human trials in the second half of 2026.

About NRx Pharmaceuticals, Inc.

NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression.

Notice Regarding Forward-Looking Statements

The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in NRx Pharmaceuticals, Inc.’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

For further information:

Brian Korb Matthew Duffy
Managing Partner, astr partners Chief Business Officer
(917) 653-5122 +1 (646) 335-5923
brian.korb@astrpartners.com mduffy@geneuro.us

FREEHOLD, NJ, Sept. 14, 2026 (GLOBE NEWSWIRE) — UMH Properties, Inc. (NYSE: UMH) (TASE: UMH), a real estate investment trust (REIT) specializing in the ownership and operation of manufactured home communities, today announced that the Company will attend the U.S. Department of Housing and Urban Development’s (HUD) annual Innovative Housing Showcase for the 6th consecutive year. The event kicks off with the Showcase Opening Ceremony on Tuesday, September 22, 2026, on the National Mall in Washington, D.C. and runs through Thursday, September 24, 2026.

Samuel A. Landy, President and Chief Executive Officer, commented, “At this year’s Innovative Housing Showcase, UMH is proud to present two ground-breaking manufactured homes in partnership with Champion Homes and Cavco Industries. Making its debut on the National Mall is the first-ever HUD-code two-story manufactured home built by Champion Homes. This three-bedroom, two-bath home showcases the evolution of modern manufactured housing through this innovative design. UMH will also feature an off-frame, two-bedroom, two-bath multi-section home built by Cavco Industries, demonstrating the removal of the traditional chassis and highlighting the construction advancements shaping the future of manufactured housing. Together, these homes expand the possibilities of high-quality affordable housing. This event provides policymakers and the public with an opportunity to experience these homes firsthand, and we invite everyone to attend it.”

UMH Properties, Inc., which was organized in 1968, is a public equity REIT that currently owns and operates 145 manufactured home communities, containing approximately 27,100 developed homesites, of which 11,200 contain rental homes, and over 1,000 self-storage units. These communities are located in New Jersey, New York, Ohio, Pennsylvania, Tennessee, Indiana, Maryland, Michigan, Alabama, South Carolina, Florida and Georgia. Included in the 145 communities are two communities in Florida, containing 363 sites, and one community in Pennsylvania, containing 113 sites, that UMH has an ownership interest in and operates through its joint ventures with Nuveen Real Estate.

Contact: Nelli Madden

732-577-4062

Wilmington, Del., Sept. 14, 2026 (GLOBE NEWSWIRE) — Ashland Inc. (NYSE: ASH) will host an Innovation Day webcast on September 17, 2026. The event will begin promptly at 9:00 am ET and conclude by 11:00 am ET. Ashland leadership will provide an updated overview of the company’s innovative Technology Platforms, highlighting their commercial progress and scalability.  Registration is required, and participants are encouraged to join early. Registration can be accessed from the following link:  https://innovationday26.ashland.com

During the event, participants will hear from Ashland executives and senior technology leaders as they provide an in-depth review of the latest innovations and expanding commercial opportunities. The presentations will detail how these advancements are poised to impact key markets and drive organic growth.

Following the formal remarks, participants will have the opportunity to engage directly in a moderated question-and-answer (Q&A) session.

Ashland leaders presenting at the event include:

  • Guillermo Novo, chair, and chief executive officer
  • Osama Musa, senior vice president and chief technology officer
  • Jim Minicucci, senior vice president and general manager, personal care
  • Alessandra Faccin, senior vice president and general manager, life sciences and intermediates
  • Dago Caceres, senior vice president and general manager, specialty additives
  • William Whitaker, senior vice president and chief financial officer
  • Sandy Klugman, director, investor relations

Registration information and further event details can be found on Ashland’s investor website at http://investor.ashland.com

A webcast of the event will be available live and can be accessed, along with supporting materials, through the Ashland website. A replay will be available within 24 hours of the live event and will be archived, along with supporting materials, on the Ashland website for 12 months. Copies of the presentation may also be requested by sending an email to investor_relations@ashland.com

About Ashland 
Ashland Inc. (NYSE: ASH) is a global additives and specialty ingredients company with a conscious and proactive mindset for environmental, social and governance (ESG). The company serves customers in a wide range of consumer and industrial markets, including architectural coatings, construction, energy, food and beverage, personal care and pharmaceutical. Approximately 2,900 passionate, tenacious solvers – from renowned scientists and research chemists to talented engineers and plant operators – thrive on developing practical, innovative and elegant solutions to complex problems for customers in more than 100 countries. Visit ashland.com and ashland.com/ESG to learn more.  

™ Trademark, Ashland or its subsidiaries, registered in various countries.

FOR FURTHER INFORMATION:

Investor Relations: Media Relations:
Sandy Klugman Carolmarie C. Brown
+1 (302) 594-7777 +1 (302) 995-3158
sandy.klugman@ashland.com ccbrown@ashland.com

Attachment

SOUTH SAN FRANCISCO, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that members of its senior management team will participate in the Baird 2026 Global Healthcare Conference on Tuesday, September 15, 2026, in New York with a fireside chat scheduled for 2:00 pm Eastern Time.

A live webcast of the fireside chat can be accessed through the Investors section of the Company’s website at www.lyell.com. A replay of the webcast will be available on the Company’s website following the event.

About Lyell Immunopharma, Inc.

Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. Lyell’s proprietary LyFE Manufacturing Center™ has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year. To learn more, please visit www.lyell.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell management’s planned participation at an investor conference; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; and the sufficiency of the capacity of LyFE to manufacture drug supply through potential commercial launch. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the Securities and Exchange Commission on August 6, 2026. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.

Contact:

Lyell Investor Relations
IR@lyell.com

Texas-based company is designed to coordinate U.S. development, pharmaceutical-grade supply and potential clinical sponsorship activities through a dedicated Psyence BioMed entity

HIGHLIGHTS

  • Texas-based company established as dedicated U.S. vehicle for regulated ibogaine development
  • Positioned to hold U.S. rights to PsyLabs’ pharmaceutical-grade ibogaine, subject to completion of definitive licensing arrangements
  • Designed to coordinate supply, manufacturing, regulatory and potential clinical development activities through a single U.S. entity with U.S.-based partners

NEW YORK, Sept. 14, 2026 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company developing nature-derived neuroplastogen therapeutics, today announced the formation of Texas Ibogaine Research Corporation (“TIRC”), a Texas-based company established to coordinate the Company’s U.S. ibogaine development activities, including pharmaceutical-grade supply, regulatory engagement and potential clinical development.

TIRC has been established as the Company’s dedicated U.S. vehicle for the regulated development of ibogaine. Subject to completion of definitive licensing arrangements, TIRC is positioned to hold U.S. rights to pharmaceutical-grade ibogaine developed by PsyLabs, a neuroplastogen active pharmaceutical ingredient development company in which Psyence BioMed holds an ownership interest.

The Company intends for TIRC to coordinate the applicable rights, manufacturing arrangements, regulatory documentation and any future investigational new drug application within a single U.S. entity financed by Psyence BioMed. TIRC is also intended to serve as the Company’s counterparty of record in engagements with federal agencies, state programs and potential clinical partners in the United States.

Jody Aufrichtig, Chief Executive Officer of Psyence BioMed, will also serve as Chief Executive Officer of TIRC. Dr. John Thorne has been appointed project lead. Psyence BioMed expects to provide technical, legal, administrative and financial support through existing internal resources, with corporate oversight that includes Chief Financial Officer Warwick Corden-Lloyd and the Company’s in-house legal function.

“The United States is creating new momentum around rigorous, regulated ibogaine research. We established TIRC in Texas to contribute to that effort by bringing the rights, pharmaceutical-grade supply and development strategy together within a dedicated U.S. company advancing this research for U.S. patients.”

— Jody Aufrichtig, Chief Executive Officer, Psyence BioMed and Texas Ibogaine Research Corporation

“TIRC gives us a focused structure through which to coordinate the material, regulatory documentation, manufacturing pathway and clinical development plan. This positions us to engage efficiently with government agencies and potential research partners as opportunities advance.”

— Dr. John Thorne, Project Lead, Texas Ibogaine Research Corporation

The formation of TIRC follows a series of U.S. policy and research developments involving neuroplastogens, including ibogaine. These include the Executive Order signed on April 18, 2026, directing federal agencies to accelerate relevant research; the coordinated federal implementation announced in July 2026; and the subsequent provision to the U.S. Department of Health and Human Services of the University of Miami’s original 1994 ibogaine investigational new drug application.

Psyence BioMed intends to provide further updates as TIRC advances its licensing, manufacturing, regulatory and potential clinical development activities. Expected next steps include completing definitive licensing arrangements, progressing regulatory engagement and developing the manufacturing and clinical plans required to support a potential U.S. development program. These activities remain subject to applicable laws, regulatory requirements and the availability of appropriate development pathways.

ABOUT PSYENCE BIOMED

Psyence Biomedical Ltd. (Nasdaq: PBM) is a life sciences biotechnology company developing nature-derived neuroplastogen therapeutics. Through its multi-asset development platform and supply capabilities, the Company is advancing pharmaceutical-grade psilocybin- and ibogaine-based development programs using an evidence-based approach. Psyence BioMed is focused on addressing unmet needs in mental health and substance-use disorders through the development of safe, effective and regulator-approved treatments. Its U.S. subsidiary, Texas Ibogaine Research Corporation, is headquartered in Texas.

ABOUT PSYLABS

PsyLabs is an international neuroplastogen active pharmaceutical ingredient development company federally licensed in its operating jurisdiction to cultivate, extract and export psilocybin mushrooms and other neuroplastogen compounds, including psilocybin, psilocin, mescaline, ibogaine and dimethyltryptamine, to lawful medical and research markets. PsyLabs operates from an ISO 22000 and GMP-compliant facility, with a focus on natural compound purification, regulatory support and global distribution. www.psylabs.life

CONTACTS

Psyence Biomedical Ltd. · ir@psyencebiomed.com · media@psyencebiomed.com · info@psyencebiomed.com · +1 416-477-1708

Investor contact: Michael Kydd, Investor Relations Advisor — michael@psyencebiomed.com 

FORWARD-LOOKING STATEMENTS

This communication contains “forward-looking statements” within the meaning of applicable securities laws, including the U.S. Private Securities Litigation Reform Act of 1995. These include statements regarding the intended role, financing and activities of TIRC; the execution, scope and duration of definitive licensing arrangements with PsyLabs; TIRC’s expected ownership of U.S. rights to pharmaceutical-grade ibogaine; the Company’s ability to obtain and maintain required registrations, permits, quotas and licenses; its ability to participate in federal or state ibogaine programs; and its expected role in future research, development and commercialization activities relating to ibogaine. Forward-looking statements may be identified by words such as “will,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates” and similar expressions.

These statements are based on assumptions regarding government policy, continued interest in regulated neuroplastogen research, the availability of lawful development pathways, and the Company’s ability to maintain licenses, permits, supply arrangements and third-party relationships. These assumptions may prove incorrect. Risks and uncertainties that could cause actual results to differ materially include the possibility that the contemplated licensing or corporate arrangements are not completed on the terms or timetable expected; changes in law, regulation or enforcement priorities in the United States, Southern Africa or elsewhere; the continuing status of ibogaine as a controlled substance; clinical, regulatory and approval risks; competition and market adoption risks; financing risks; and the Company’s ability to maintain compliance with Nasdaq continued listing standards. This list is not exhaustive. These risks should be considered together with the risk factors described in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the fiscal year ended March 31, 2026 and in the Company’s other filings with the U.S. Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Readers should not place undue reliance on forward-looking statements, which speak only as of the date made. Except as required by law, the Company undertakes no obligation to update such statements.

The Company makes no medical, treatment or health-benefit claims regarding its proposed products. The U.S. Food and Drug Administration, Health Canada and other regulatory authorities have not approved ibogaine or the Company’s other neuroplastogen compounds for therapeutic use, and their safety and efficacy have not been established through authorized clinical research. Rigorous scientific research and clinical trials are required. References to “GMP-compliant” mean production in a facility designed, operated and controlled in accordance with applicable Good Manufacturing Practice standards and do not, by themselves, represent formal certification or approval by any regulatory authority unless expressly stated.

Learn more about the company at www.psyencebiomed.com and on LinkedIn.

Contact Information for Psyence Biomedical Ltd.

Email: ir@psyencebiomed.com

Media Inquiries: media@psyencebiomed.com

General Information: info@psyencebiomed.com

Phone: +1 416-477-1708

Investor Contact:

Michael Kydd

Investor Relations Advisor

michael@psyencebiomed.com

Application describes a proposed architecture integrating space-based sensing, artificial intelligence, resilient HF communications, secure command and control, and coordinated multi-effector defense against drones and autonomous aerial threats; ARGUS remains in development, and no patent has been issued

WEST HOLLYWOOD, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) — VisionWave Holdings, Inc. (Nasdaq: VWAV) (“VisionWave” or the “Company”), an advanced defense technology company specializing in artificial intelligence, autonomous systems, RF sensing, and next-generation defense technologies, today announced that it has filed a U.S. non-provisional patent application with the U.S. Patent and Trademark Office (the “USPTO”) describing ARGUS™, a proposed space-enabled, AI-driven counter-unmanned aircraft system (C-UAS) architecture that the Company is developing.

The U.S. patent application, Serial No. 19/797,497, filed on September 4, 2026, 2026, is titled “Systems and Methods of Detecting and Countering Drone Attacks by Space-Enabled, AI-Driven Counter-UAS Architecture.” The application claims priority to U.S. provisional patent application Serial No. 63/940,940, filed on December 15, 2025, and describes an integrated architecture intended to detect, classify, track, evaluate, and respond to hostile drones and other low-altitude aerial threats over wide geographic areas. The application has not yet been examined by the USPTO. Patent applications are frequently rejected or allowed only with claims narrower than those originally filed, and there can be no assurance that any patent will issue from the application, that the scope of any issued claims will be the same as the claims as filed, or that any patent that issues will provide VisionWave with a competitive advantage or withstand challenge.

As described in the application, ARGUS is intended to combine space-based surveillance, artificial intelligence, ground-based sensing, resilient communications, cybersecurity, command and control, and multiple types of defensive effectors into a coordinated counter-UAS system.

ARGUS is an architecture described in a pending patent application and remains in development. ARGUS has not been built, integrated or tested as a system, and no prototype of the complete architecture exists. VisionWave does not own or operate any satellites and has no agreement with any satellite operator, launch provider, government agency or other party for the space segment or any other element of ARGUS. The capabilities described in this press release are those set out in the application; they have not been demonstrated or independently validated. Developing, testing and fielding ARGUS would require substantial additional capital, third-party participation and government authorizations, none of which is assured, and ARGUS has not generated any revenue.

The patent application describes a space segment incorporating satellites equipped with electro-optical and infrared sensors, with optional synthetic aperture radar and RF sensing capabilities, intended to provide wide-area surveillance and early detection. Under the described architecture, information collected from space would be combined with information from ground-based radar, RF, and EO/IR sensors to form a unified recognized air picture.

A central element of the described architecture is an AI-based object-recognition methodology designed to analyze the structural geometry of airborne objects. Rather than relying solely on conventional image classification, the methodology described in the application is designed to identify structural key points such as rotor hubs, arms, fuselage features, wings, and payload attachment points and to use multi-view information to generate virtual three-dimensional representations of potential targets. This approach is intended to improve classification where a target is partially obscured or observed from difficult viewing angles; its performance has not been validated through testing

The application also describes multi-sensor fusion and AI-based threat assessment, combining information from satellites, radar, RF detectors, EO/IR sensors, and other sources. The described system is designed to update target tracks and threat scores continuously as additional evidence becomes available and to use those assessments within command-and-control logic to determine whether an object should be monitored, generate a warning, or be considered for engagement, with any engagement subject to authorization by a human operator.

Another component of the disclosed architecture is SkyWeave™, an AI-controlled high-frequency (HF) communications backbone, also in development, designed to provide resilient beyond-line-of-sight command and control. As described in the application, the HF network would dynamically evaluate ionospheric conditions, interference, link quality, mission requirements, and other factors to select frequencies, transmission power, antenna configurations, relay nodes, and communications routes. The architecture is intended to maintain command connectivity when SATCOM, cellular, microwave, or terrestrial communications are degraded, jammed, or unavailable.

The application also describes a security architecture for protecting command, communications, and navigation information, including authentication, encryption, session security, key establishment, and synchronous or asynchronous key-exchange techniques designed for constrained and intermittently available communications environments.

The described system is designed to coordinate a layered mix of defensive responses rather than depend upon a single interceptor technology. Depending upon mission conditions, threat assessment, communications availability, rules of engagement, and collateral-risk considerations, the architecture described in the application would coordinate interceptor drones, RF jammers, deceptive navigation techniques, kinetic systems, directed-energy systems, high-power microwave systems, and other effectors. In the United States, the use of RF jamming, navigation spoofing and certain other counter-UAS mitigation technologies is restricted by federal law and is generally limited to specifically authorized government agencies, and similar restrictions apply in many other jurisdictions. These restrictions may limit the potential customers for, and permitted uses of, ARGUS.

“ARGUS represents our vision for moving counter-drone defense toward an intelligent, distributed defense architecture,” said Danny Rittman, Chief Technology Officer of VisionWave. “The objective is to connect detection, artificial intelligence, resilient communications, cybersecurity, command and control, and multiple defensive technologies into a single coordinated system. By combining space-based awareness with terrestrial sensors and resilient HF communications, ARGUS is being designed for the increasingly contested environments in which we believe future counter-UAS systems will need to operate.”

The patent application additionally describes predictive trajectory modeling and defensive swarm concepts. Under the described approach, AI models would forecast likely target positions and behavior, allowing defensive assets to be positioned along predicted ingress corridors, and the architecture would coordinate defensive drones using global sensor information, resilient HF communications, encrypted navigation information, and local autonomous control.

VisionWave believes the filing is a step in the development of ARGUS and is consistent with the Company’s broader strategy of developing AI-enabled, resilient, and distributed defense technologies intended to operate across space, RF, cyber, autonomous, and physical domains.

About ARGUS™

ARGUS™ is a proposed space-enabled counter-UAS architecture, in development by VisionWave and described in a pending U.S. patent application, that is designed to integrate wide-area sensing, artificial intelligence, multi-sensor fusion, resilient communications, secure command and control, and layered countermeasure technologies. The architecture is intended to support defense against small unmanned aircraft, autonomous aerial systems, loitering munitions, and coordinated drone threats across geographically distributed operating environments. ARGUS has not been commercialized, is not available for sale and has not generated any revenue.

About VisionWave Holdings, Inc.

VisionWave Holdings, Inc. (Nasdaq: VWAV) is a defense and advanced sensing technology company developing AI-driven, RF-based sensing, autonomy, and computational acceleration technologies for defense, homeland security, and commercial infrastructure applications. VisionWave’s mission is to connect defense innovation with civilian progress through shared core technologies deployed across air, land, and fixed-site environments. The Company’s website is https://www.vwav.inc. Information contained on, or accessible through, the Company’s website is not incorporated by reference into, and does not form a part of, this press release or any filing of the Company with the Securities and Exchange Commission.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and such statements are intended to be covered by the safe harbor provisions of those laws. All statements other than statements of historical fact are forward-looking statements, including statements regarding the prosecution of U.S. Patent Application Serial No. 19/797,497 and the scope of any patent that may issue from it; the design, development, capabilities, testing, performance, potential applications, commercialization and future deployment of ARGUS, SkyWeave and other VisionWave technologies; the Company’s ability to obtain the satellite, communications, effector and other capabilities, third-party participation and government authorizations that the ARGUS architecture contemplates; and the Company’s business strategy. Forward-looking statements are generally identified by words such as “anticipate,” “believe,” “continue,” “could,” “designed to,” “estimate,” “expect,” “intend,” “intended to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “vision,” “will,” “would” and similar expressions, although not all forward-looking statements contain these identifying words.

Forward-looking statements are based on management’s current expectations and assumptions and are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied, including, among others: the risk that the USPTO rejects the application or allows only claims narrower than those sought, that any patent that issues is challenged, invalidated or circumvented, or that third parties hold patents that the ARGUS architecture would infringe; the early stage of development of ARGUS and SkyWeave, which have not been built or tested as integrated systems and may never be successfully developed; the Company’s need for substantial additional capital to develop ARGUS and its other technologies, which may not be available on acceptable terms or at all, and the dilution that may result from equity financings, including sales under the Company’s at-the-market offering programs, conversions of outstanding convertible debentures and exercises of outstanding warrants; the Company’s dependence on third parties for satellites, launch services, space-based data, effectors and other elements that it does not own or produce; legal restrictions on the use of RF jamming, navigation spoofing, directed-energy and other counter-UAS mitigation technologies, and the need for spectrum, export and other governmental authorizations; U.S. export control laws and regulations, including the International Traffic in Arms Regulations and the Export Administration Regulations, and any secrecy order that may be imposed with respect to the application; the lengthy, uncertain and budget-dependent nature of government procurement, and the absence of any contract or award for ARGUS; competition from larger, better-capitalized defense contractors; the performance and reliability of artificial-intelligence models; cybersecurity risks; the Company’s limited operating history and revenue, history of losses and the substantial doubt about its ability to continue as a going concern; the Company’s ability to maintain compliance with The Nasdaq Stock Market’s continued listing requirements, including the minimum bid price requirement; and the other risks described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, its subsequent Quarterly Reports on Form 10-Q and its other filings with the Securities and Exchange Commission, available at www.sec.gov.

Forward-looking statements speak only as of the date of this press release and are expressly qualified in their entirety by these cautionary statements. Readers should not place undue reliance on forward-looking statements. VisionWave undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.

Contact for Investors: investors@vwav.inc

CALGARY, Alberta, Sept. 14, 2026 (GLOBE NEWSWIRE) — Canadian Premium Sand Inc. (“CPS” or the “Company”) (TSXV: CPS) is pleased to announce that it is participating in the inaugural Canada Investment Summit (the “Summit”) hosted by Prime Minster Mark Carney on September 14th and 15th in Toronto, Ontario, providing the Company with an exceptional opportunity to engage with leading institutional investors from around the world and to demonstrate how CPS can contribute to long-term economic growth while delivering value to shareholders, stakeholders, partners and the communities in which we operate.

The Company’s proposed vertically integrated 600 tonne per day float glass manufacturing facility in Selkirk, Manitoba utilizing its wholly owned low-iron silica sand resource (the “Project”) will be included in the Summit prospectus for distribution to all Summit participants.

“We are honoured to be included in the prospectus for the inaugural Canada Investment Summit,” said Glenn Leroux, President & CEO of CPS. “Canada is currently 100% reliant on imported float glass to support 30,000 jobs and a $2 billion industry. Our Project can reduce this dependency by providing Canada with a secure domestic supply of high-quality glass and set a foundation to build a more diversified glass industry in Canada. With established Indigenous and local community partnerships, a wholly owned unique silica resource and permitted projects, the CPS Project represents an important nation-building opportunity for Canada.”

The Company’s project is also included in the Manitoba Deal Book promoted at the Summit by Premier Wab Kinew. Participants at the Summit include large international investors and sovereign wealth funds, along with private equity firms and sources of public capital.

On September 15th, the Company is also participating in a roundtable on critical minerals hosted by Dentons and Invest in Alberta, in association with the Province of Manitoba. The roundtable will focus on a range of topics structured to drive discussion on how critical minerals projects can attract financing.

As part of the Company’s ongoing strategic review announced earlier this year, one of the development options the Company has advanced through the process is the manufacturing of float glass for use in residential and commercial buildings. With no current manufacturing of float glass in Canada, the Project is critical in enabling the domestic industry to secure independence from US imports. The Company is working to secure offtakes with the Canadian customer base sufficient to support financing the Project.

About Canada Investment Summit

The Summit is hosted by Prime Minister Mark Carney in partnership with Canada Pension Plan Investment Board and Public Sector Pension Investment Board, two of Canada’s largest institutional investors. The Summit is part of the Government of Canada’s broader objective to catalyze $1 trillion of total investment in Canada over the next five years, including investment that expands domestic manufacturing, creates good, long-term jobs and strengthens Canadian supply chains.

Structured as a practical forum, the Summit is focused on long-horizon capital, commercial opportunity and productive assets that strengthen growth and resilience. To help advance projects like the Project, the Summit aims to mobilize long term capital, create high-quality jobs, strengthen global supply-chain integration and enhance Canada’s competitiveness and economic resilience.

About Canadian Premium Sand Inc.

Canadian Premium Sand Inc. is developing its Wanipigow silica sand resource in Manitoba to supply high specification, high purity, low iron silica sand for vertically integrated manufacturing of float glass and solar glass, fracture proppant for the Western Canada Sedimentary Basin, and a range of other industrial and manufacturing applications. The Company is a reporting issuer in Ontario, Alberta and British Columbia. Its shares trade on the TSX Venture Exchange under the symbol “CPS”.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

 
CONTACT INFORMATION:
 
Canadian Premium Sand Inc. 
Glenn Leroux
President and Chief Executive Officer
glenn.leroux@cpsmail.com
 
Investor Relations
IR@cpsmail.com
587.355.3714
https://cpsglass.com  
 

Forward-Looking Information

Certain statements contained in this press release constitute forward-looking statements relating to, without limitation, expectations, intentions, plans and beliefs, including information as to the future events, results of operations and the Company’s future performance (both operational and financial) and business prospects. In certain cases, forward-looking statements can be identified by the use of words such as “expects”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes”, “plans”, “seeks”, “projects” or variations of such words and phrases, or state that certain actions, events or results “may” or “will” be taken, occur or be achieved. Such forward-looking statements reflect the Company’s beliefs, estimates and opinions regarding its future growth, results of operations, future performance (both operational and financial), and business prospects and opportunities at the time such statements are made, and the Company undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or circumstances should change. Forward-looking statements are necessarily based upon a number of estimates and assumptions made by the Company that are inherently subject to significant business, economic, competitive, political, geopolitical and social risks, uncertainties and contingencies and the other risk factors outlined in CPS’s most recent Management’s Discussion and Analysis which is available on SEDAR+ at www.sedarplus.ca. Forward-looking statements are not guarantees of future performance. In particular, this press release contains forward-looking statements pertaining, but not limited, to: the purpose and goal of CPS attending the Summit and the potential benefits to be derived therefrom including the ability to engage with investors to demonstrate to attendees how CPS can contribute to long-term economic growth while delivering value to shareholders, stakeholders, partners and the communities in which we operate; the ability to finance the Project including obtaining offtake agreements for this purpose; and the Company’s objectives, strategies and competitive strengths. By their nature, forward-looking statements involve numerous current assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from those anticipated by the Company and described in the forward-looking statements. The forward-looking information and statements contained in this document speak only as of the date hereof and the Company does not assume any obligation to publicly update or revise them to reflect new events or circumstances, except as may be required pursuant to applicable laws.

Hop Valley opens its new pub Sept. 17, giving Ducks fans a new place to rally, celebrate, and raise a pint on game day

Hop Valley Eugene Bar

EUGENE, Ore., Sept. 14, 2026 (GLOBE NEWSWIRE) — Hop Valley Brewing Co, a trailblazer in the craft brewing industry and a brand by Tilray Brands, Inc. (NASDAQ: TLRY and TSX: TLRY), today announced it will open a new pub at 5th Street Public Market in downtown Eugene, pouring its first pint at 5:30 p.m. on Thursday, Sept. 17.

The sports-forward brewpub returns Hop Valley to Eugene, serving the brewery’s award-winning beers alongside a full food menu and screens for every Ducks game. The tap list features fan favorites including Dang Green IPA, the first officially licensed, co-branded craft beer of the Oregon Ducks.

To mark the opening, Hop Valley will host a pre-game rally on Thursday, Sept. 17 ahead of the Ducks’ home game against Portland State. The celebration will include appearances by the Oregon Ducks mascot and cheer squad, merchandise and ticket giveaways, and a live DJ. The first 100 guests, 21 and over, will receive custom Oregon Ducks x Hop Valley glassware. A group Dang Green toast at 6 p.m. will lead into a celebration that runs until the pub closes at 9 p.m.

“We’re thrilled to welcome the Eugene community back to raise a pint with us in the heart of downtown,” said Brian Hughes, Senior Director, Brands West at Tilray Beverages. “Hop Valley was built here, and this space was designed to feel like a true local hangout, somewhere fans, friends and neighbors can gather all year long. With our longstanding partnership with the Ducks, there’s no better way to open our doors.”

Founded in Springfield in 2009, Hop Valley has been part of the Eugene-Springfield community for more than 15 years. The 5th Street pub joins Hop Valley’s Springfield location and gives the brewery a downtown Eugene home base for Ducks fans, craft beer lovers and community events year-round.

Event Details

  • What: Grand opening of Hop Valley Brewing Co.’s new Eugene pub
  • When: Ducks pre-game rally Sept. 17, 4:30–9 p.m., with a group Dang Green toast at 6 p.m.
  • Where: 5th Street Public Market, 550 Pearl St Suite 150, Eugene, OR 97401

Follow @hopvalleybrewing on Instagram and visit hopvalleybrewing.com for opening updates, events, and tap list details.

About Hop Valley Brewing

Founded in 2009 in the most free-spirited city in a state known for innovation and high-quality hops, Hop Valley Brewing proudly embraces the influences of our counter-culture surroundings in the crafting of refreshingly different beers.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms.

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian and U.S. securities laws and 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, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities law.

For further information, please contact:

Tilray Brands Media: news@tilray.com

Tilray Brands Investors: investors@tilray.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/517c2566-aec2-4f15-87d3-d53065f86ec0

Independent DSMB Recommends MediWound’s EscharEx® Phase III VALUE Study Continue Without Modification

DSMB did not identify safety concerns in pre-specified review; interim assessment and enrollment completion remain on track for end of the first quarter of 2027

YAVNE, Israel, September 14, 2026 (GLOBE NEWSWIRE) — MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the independent Data and Safety Monitoring Board (DSMB) completed its pre-specified periodic safety review of the ongoing Phase III VALUE study evaluating the safety and efficacy of EscharEx® in patients with venous leg ulcers (VLU). Following its review, the DSMB did not identify any safety concerns and recommended that the study continue as planned without modification. MediWound also continues to expect the study’s pre-specified interim sample-size reassessment and completion of patient enrollment by the end of the first quarter of 2027.

“We are encouraged by the DSMB’s recommendation to continue the VALUE study as planned and without modification,” said Ofer Gonen, Chief Executive Officer of MediWound. “The DSMB’s findings are consistent with the favorable safety profile observed across the EscharEx clinical program and support our continued execution of this pivotal Phase III study.”

About the VALUE Trial

VALUE (NCT06568627) is a global, multicenter, randomized, double-blind, placebo-controlled Phase III pivotal trial evaluating the efficacy and safety of EscharEx® in patients with venous leg ulcers (VLU). The study is designed to enroll 216 patients across approximately 40 sites in the U.S., Europe, and Israel, randomized in a 1:1 ratio to receive EscharEx or placebo. The co-primary endpoints are the incidence of complete debridement and the facilitation of wound closure. The study includes a pre-specified interim sample-size reassessment after 65% of patients have completed the 12-week wound-management period. The interim reassessment and completion of enrollment are expected by the end of the first quarter of 2027. An independent DSMB separately conducts pre-specified periodic reviews that address safety only.

About EscharEx®

EscharEx is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds. Designed for topical, once-daily use, EscharEx has demonstrated effective wound bed preparation and a favorable safety profile in multiple Phase II studies. It enables rapid removal of non-viable tissue while promoting granulation tissue formation and reducing bioburden and biofilm. The global Phase III VALUE trial in venous leg ulcers (VLU) is underway, with additional clinical studies planned in diabetic foot ulcers (DFU) and pressure ulcers (PU). EscharEx has demonstrated advantages over standard-of-care treatments, including the leading enzymatic debridement agent, and targets a substantial global market opportunity.

About MediWound Ltd.

MediWound Ltd. (Nasdaq: MDWD) is a global leader in next-generation enzymatic therapeutics for tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the United States, the European Union, Japan, and additional international markets. MediWound’s late-stage development candidate, EscharEx®, is an investigational therapy for the debridement of chronic wounds, with the potential to become a new standard of care in wound management.

For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter).

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives, anticipated timelines, outcome of future periodic DSMB’s reviews, expectations and commercial potential of our products and product candidates, including EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; our contracts with governmental agencies; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; geopolitical risks, including armed conflict, the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future. These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2026 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound does not undertake, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

MediWound Contacts:      
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
  Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
 

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