Lifeward Appoints Bob Marshall as Chairman of the Board




Lifeward Appoints Bob Marshall as Chairman of the Board

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) — Lifeward Ltd., (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global leader in innovative medical technology designed to transform the lives of people with physical limitations or disabilities, announced today that its Board of Directors has appointed Bob Marshall as Chairman of the Board, effective January 1, 2026. He replaces Joseph Turk, who will transition off the Board in connection with his new position at Fresenius Medical Care.

“On behalf of the Board and entire Lifeward team, I congratulate Joe on his appointment as Chief Executive Officer of Care Enablement at Fresenius Medical Care, a global leader in renal care,” said Lifeward’s CEO, Mark Grant. “We are grateful for Joe’s leadership and dedicated service to Lifeward, including his stewardship as Chairman, and we wish him tremendous success in his new role.”

Mr. Grant continued, “I’m also pleased to welcome Bob Marshall as our new Chairman. Bob has been a valuable member of our Board and Chair of our Audit Committee since joining in 2024. His financial leadership, healthcare public company expertise, and strategic perspective will be instrumental as we continue to execute on our strategic growth plans and deliver improved care and outcomes for patients.”

Mr. Marshall is Chief Financial Officer and Treasurer of Lantheus Holdings, a publicly traded radiopharmaceutical company, and has served in these roles since 2018. Previously, he spent 16 years at Zimmer Biomet Holdings, in positions including Vice President, Investor Relations and Corporate Treasurer, and most recently Vice President, Americas Finance for the U.S., Canadian, and Latin American commercial markets. Earlier in his career, he held roles of increasing responsibility at Brown & Williamson Tobacco, a subsidiary of British American Tobacco.

About Lifeward

Lifeward designs, develops, and commercializes life-changing solutions spanning the continuum of care in physical rehabilitation and recovery, delivering proven functional and health benefits in clinical settings, as well as in the home and community. Our mission at Lifeward is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities. We are committed to delivering groundbreaking solutions that empower individuals to do what they love. The Lifeward portfolio features innovative products, including the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System. Founded in 2001, Lifeward has operations in the United States, Israel, and Germany.

Lifeward^®, ReWalk^®, ReStore^®, and Alter G^® are registered trademarks of Lifeward Ltd. and/or its affiliates.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward looking statements may include projections regarding the Company’s future performance and other statements that are not statements of historical fact and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Important factors that could cause the Company’s actual results to differ materially from those indicated in the forward looking statements include, among others: the acceptance of the ReWalk 7 Personal Exoskeleton by healthcare professionals and patients; uncertainties associated with future clinical trials and the clinical development process, the product development process and FDA regulatory submission review and approval process; the Company’s ability to have sufficient funds to meet certain future capital requirements, which could impair the Company’s efforts to develop and commercialize existing and new products; the Company’s ability to maintain and grow its reputation and the market acceptance of its products; the Company’s ability to achieve reimbursement from third-party payors, including CMS, for its products; the Company’s limited operating history and its ability to leverage its sales, marketing and training infrastructure; the Company’s expectations as to its clinical research program and clinical results; the Company’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; the Company’s ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; the Company’s ability to navigate any difficulties associated with moving production of its AlterG Anti-Gravity Systems to a contract manufacturer and transitioning the manufacturing of its ReWalk products to its in-house manufacturer; the Company’s ability to improve its products and develop new products; the Company’s compliance with medical device reporting regulations to report adverse events involving the Company’s products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on the Company’s ability to market and sell its products; the Company’s ability to gain and maintain regulatory approvals; the Company’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company’s IT systems significantly disrupting its business operations; the Company’s ability to use effectively the proceeds of its offerings of securities; and other factors discussed under the heading “Risk Factors” in the Company’s annual report on Form 10-K, as amended, for the year ended December 31, 2024 filed with the SEC and other documents subsequently filed with or furnished to the SEC. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause the Company’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for the Company to predict all of them. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Contact:

Almog Adar
Chief Financial Officer
E: media@golifeward.com

E: ir@golifeward.com

NurExone Reports Anti-Inflammatory Activity of Its Exosomes in Lab Analysis




NurExone Reports Anti-Inflammatory Activity of Its Exosomes in Lab Analysis

Reducing inflammation helps create a regenerative environment in the Central Nervous System

TORONTO and HAIFA, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) — NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially available exosome product.

“Inflammation and regeneration are conflicting biological processes, and this is particularly relevant in the Central Nervous System,” said Dr. Tali Kizhner, Director of Research & Development at NurExone. “These laboratory results show that our exosomes suppress inflammation more effectively than untreated cells and commercial alternatives, even at low concentrations, with stronger effects as the doses increase. This anti-inflammatory action is a part of our ExoPTEN approach, where exosomes and therapeutic cargo work synergistically to support regenerative pathways.”

Building analytical depth and platform strength

These findings build on NurExone’s December 12, 2025 news release, reporting analytical data demonstrating that its exosomes, produced from human bone marrow–derived mesenchymal stem cells (“MSC”), exhibit significantly higher biological activity compared with a commercially available MSC derived exosome as a control.

“We are building an analytical framework to understand and quantify the true biological complexity of exosome-based therapeutics,” said Dr. Lior Shaltiel, Chief Executive Officer of NurExone. “This will help ensure consistency from batch to batch, support quality and regulatory readiness, and clearly explain the benefits of our exosomes relative to commercial alternatives. This is essential not only for advancing our own drug programs, such as ExoPTEN, but also for establishing a reliable, scalable platform for exosome-based drug delivery.”

In the Company’s laboratory analysis, immune cells were stimulated to produce a strong inflammatory response, creating a controlled inflammatory environment. These untreated inflamed cells served as the controlled baseline. Inflammatory signaling following treatment with NurExone-produced exosomes or commercially available exosomes across a range of increasing concentrations were evaluated, and statistical significance was assessed using one-way analysis of variance (“ANOVA”).

The results showed that NurExone’s exosomes consistently reduced inflammatory signals relative to the untreated inflamed control and outperformed commercial exosome product at comparable concentrations. Importantly, meaningful reductions were observed even at lower concentrations, with greater reductions seen as concentrations increased, demonstrating a clear concentration-dependent biological effect.

NurExone’s exosomes reduced levels of IL-6, a key inflammatory signaling molecule, by more than 86% compared to untreated inflamed cells, including at the lowest concentration tested (see Figure 1A). This reduction remained consistent across all tested concentrations, indicating strong intrinsic anti-inflammatory activity.

For TNF-alpha, another central inflammatory signal, NurExone’s exosomes demonstrated a clear concentration-dependent response, as concentration increased, inflammatory signaling decreased further, reaching reductions of over 60% compared to the untreated inflamed control at the highest concentration tested (see Figure 1B).

In contrast, commercially available exosome product showed little to no meaningful reduction in either inflammatory signal in the concentration analysed (see Figures 1A and 1B).

Figure 1: NurExone BM-MSC EVs reduce pro-inflammatory cytokines IL-6 and TNF-α in LPS-stimulated RAW 264.7 cells

RAW 264.7 macrophages were stimulated with LPS (Lipopolysaccharide) to induced inflammation and treated with NurExone BM-MSC extracellular vesicles (“EVs“) or commercial BM-MSC EVs at the indicated concentrations. Pro-inflammatory cytokine levels in culture supernatants were measured and are presented as a percentage relative to LPS-stimulated control (mean ± SEM).

(A) NurExone BM-MSC EVs robustly reduced IL-6 levels by more than 86% at all concentrations tested, whereas commercial BM-MSC EVs did not lead to a decrease in IL-6.

(B) NurExone BM-MSC EVs reduced TNF-α levels in a dose-dependent manner, reaching a reduction of over 62% at the highest concentration tested, while commercial EVs did not induce a significant reduction in the same concentration.

Statistical analysis was performed using one-way ANOVA with Tukey’s multiple comparisons test. Statistical significance is indicated as: P < 0.01 (**), P < 0.0001 (****); ns, not significant.

About NurExone

NurExone Biologic Inc. is a TSX Venture Exchange (“TSXV”), OTCQB, and Frankfurt-listed biotech company focused on developing regenerative exosome-based therapies for central nervous system injuries. Its lead product, ExoPTEN, has demonstrated strong preclinical data supporting clinical potential in treating acute spinal cord and optic nerve injury, both multi-billion-dollar marketsⁱ . Regulatory milestones, including obtaining the Orphan Drug Designation, facilitates the roadmap towards clinical trials in the U.S. and Europe. Commercially, the Company is expected to offer solutions to companies interested in quality exosomes and minimally invasive targeted delivery systems for other indications. NurExone has established Exo-Top Inc., a U.S. subsidiary, to anchor its North American activity and growth strategy.

For additional information and a brief interview, please watch Who is NurExone?, visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.

For more information, please contact:

Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Email: info@nurexone.com

Dr. Eva Reuter
Investor Relations – Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu

Allele Capital Partners
Investor Relations – U.S.
Phone: +1 978-857-5075
Email: aeriksen@allelecapital.com

FORWARD-LOOKING STATEMENTS

This press release contains certain “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to: the Company advancing the optimization of ExoPTEN’s analytical methods; the Company continuing to build an analytical framework to quantify exosome biological activity, support batch-to-batch consistency, quality and regulatory readiness, and to establish a reliable, scalable platform for exosome-based drug delivery; expectations that the Company’s exosomes demonstrate superior biological activity compared with commercial alternatives; the Company preparing regulatory submissions; the belief that anti‑inflammatory activity observed in laboratory analyses supports regenerative pathways and may translate into therapeutic benefits; the Company’s aims to launch clinical trials; and the NurExone platform technology offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including: the Company will have the ability to advance the optimization of ExoPTEN’s analytical methods; the Company will establish a reliable, scalable platform for exosome-based drug delivery; the Company’s laboratory observations of anti‑inflammatory activity and concentration‑dependent biological effects will be reproducible and will translate into clinically meaningful outcomes; the Company has the ability to prepare regulatory submissions; the Company has the ability to launch clinical trials; and the NurExone platform technology has the ability to offer novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications.

Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to: the Company’s early stage of development; lack of revenues to date; the inherent uncertainty of preclinical drug development, including the risk that product candidates may not advance to clinical trials or receive regulatory approval; the possibility that results from preclinical studies and early-stage trials may not predict later outcomes; the uncertain timing, cost, and outcome of preclinical and clinical development activities; risks related to the clinical trial process, including potential delays or failure to achieve effective trial design or positive results; the inability to obtain or maintain required regulatory approvals; limited market acceptance of the Company’s products, even if approved; the Company will not establish a reliable scalable platform for exosome-based drug delivery; the Company’s laboratory observations of anti‑inflammatory activity and concentration‑dependent biological effects will not be reproducible and will not translate into clinically meaningful outcomes; the potential emergence of competing therapies that are safer, more effective, or more affordable; rapid technological change that may impact the relevance of the Company’s technologies; the Company’s dependence on key personnel and strategic partners; the inability to obtain adequate financing; risks related to the Company’s ability to protect its intellectual property; the possibility that the Company’s technologies, including its exosome-based platforms, may not achieve their intended therapeutic impact; the inability to produce or scale exosome-based products for clinical use; limited adoption in regenerative medicine or cell therapy applications; lack of growing clinical demand in targeted indications such as spinal cord injury, optic nerve repair, or other therapeutic areas; failure to meet planned development milestones or achieve commercial breakthroughs; the Company will not advance the optimization of ExoPTEN’s analytical methods; the Company will not prepare regulatory submissions; the Company will not launch clinical trials; the NurExone platform technology not offering novel solutions to drug companies interested in minimally invasive targeted drug delivery for other indications; and the risks discussed under the heading “Risk Factors” on pages 44 to 51 of the Company’s Annual Information Form dated August 27, 2024, a copy of which is available under the Company’s SEDAR+ profile at www.sedarplus.ca . These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.

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

ⁱ Spinal cord injury, Glaucoma

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7620f75b-e94c-4579-9a9e-9aa5cfc858cd

Aclaris Therapeutics Added to the NASDAQ Biotechnology Index (NBI)




Aclaris Therapeutics Added to the NASDAQ Biotechnology Index (NBI)

WAYNE, Pa., Dec. 19, 2025 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced it has been added to the Nasdaq Biotechnology Index (NASDAQ: NBI), effective at the close of trading today, December 19, 2025.

The NBI is designed to track the performance of a set of securities listed on The Nasdaq Stock Market^® that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark. Companies in the NBI must meet eligibility requirements, including minimum market capitalization, average daily trading volume and seasoning as a public company, among other criteria. The NBI is evaluated annually in December and is calculated under a modified capitalization-weighted methodology.

For more information about the Nasdaq Biotechnology Index, please visit this link.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.

Aclaris Therapeutics Contact:

Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
wroberts@aclaristx.com

Salarius Pharmaceuticals Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting




Salarius Pharmaceuticals Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting

HOUSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) (“Salarius” or the “Company”) today announced that its 2025 Annual Meeting of Stockholders (the “Annual Meeting”) scheduled for and convened on December 19, 2025 has been adjourned for the purpose of soliciting additional votes with respect to the proposals described in the Company’s definitive proxy statement for the Annual Meeting filed with the Securities and Exchange Commission (the “SEC”) on November 7, 2025.

The required quorum for the transaction of business at the Annual Meeting is 34% of the outstanding shares entitled to vote. There was less than the required voting power represented in person or by proxy at the meeting. The Annual Meeting will be reconvened on December 31, 2025 at 10.00 a.m. Central Time and will continue to be held virtually via live webcast at www.virtualshareholdermeeting.com/SLRX2025.

The record date for determination of stockholders entitled to vote at the reconvened Annual Meeting remains the close of business on October 24, 2025. At the time the Annual Meeting was adjourned, proxies had been submitted by stockholders representing approximately 30% of the shares of the Company’s common stock issued and outstanding as of the record date.

Stockholders as of close of business on October 24, 2025, the record date for the Annual Meeting, are encouraged to vote as soon as possible via the Internet at www.proxyvote.com or by phone at 1-800-690-6903 (have proxy card available). Eligible stockholders may also vote by contacting the Company’s proxy solicitor, Alliance Advisors, at SLRX@allianceadvisors.com.

Important Information

This material may be deemed to be solicitation material in respect of the Annual Meeting to be reconvened and held December 31, 2025. In connection with the Annual Meeting, the Company filed a definitive proxy statement and a proxy card with the SEC on November 7, 2025. BEFORE MAKING ANY VOTING DECISIONS, STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, THE ACCOMPANYING PROXY CARD, AND ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. The proxy materials have been made available to stockholders who are entitled to vote at the Annual Meeting. The Company’s definitive proxy statement and any other materials filed by the Company with the SEC can be obtained free of charge at the SEC’s website at sec.gov or the Company’s website https://investors.salariuspharma.com/sec-filings.

Participant Information

The Company, its directors, certain of its officers, and other employees are or will be “participants” (as defined in Section 14(a) of the U.S. Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company’s stockholders in connection with the matters to be considered at the Annual Meeting. The identity, their direct or indirect interests (by security holdings or otherwise), and other information relating to the participants is available in the definitive proxy statement filed with the SEC on November 7, 2025, including in the section titled “Security Ownership of Certain Beneficial Owners and Management” (beginning on page 32). To the extent the holdings by the “participants” in the solicitation reported in the definitive proxy statement have changed, such changes have been or will be reflected on “Statements of Change in Ownership” on Forms 3, 4 or 5 filed with the SEC (where applicable). All these documents are or will be available free of charge at the SEC’s website at www.sec.gov.

About Decoy Therapeutics Inc.

Salarius’ subsidiary Decoy is a preclinical-stage biotechnology company that is leveraging ML and AI tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The Company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant capital from the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program among other sources. The company has also received QuickFire Challenge award funding provided by the BARDA through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and BARDA within the Administration for Strategic Preparedness and Response.

About Salarius Pharmaceuticals, Inc.

Salarius is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas. For more information, please visit www.salariuspharma.com.

Contact:
Salarius Pharmaceuticals
Rick Pierce, CEO
Pierce@decoytx.com
617-447-8299

Business Development
Peter Marschel, CBO
Peter@Decoytx.com
617-943-6305

Investors and Media
Alliance Advisors IR
Jody Cain
jcain@allianceadvisors.com
310-691-7100

Salarius Pharmaceuticals Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting




Salarius Pharmaceuticals Announces Adjournment of Annual Meeting, Information for Reconvened Annual Meeting

HOUSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) (“Salarius” or the “Company”) today announced that its 2025 Annual Meeting of Stockholders (the “Annual Meeting”) scheduled for and convened on December 19, 2025 has been adjourned for the purpose of soliciting additional votes with respect to the proposals described in the Company’s definitive proxy statement for the Annual Meeting filed with the Securities and Exchange Commission (the “SEC”) on November 7, 2025.

The required quorum for the transaction of business at the Annual Meeting is 34% of the outstanding shares entitled to vote. There was less than the required voting power represented in person or by proxy at the meeting. The Annual Meeting will be reconvened on December 31, 2025 at 10.00 a.m. Central Time and will continue to be held virtually via live webcast at www.virtualshareholdermeeting.com/SLRX2025.

The record date for determination of stockholders entitled to vote at the reconvened Annual Meeting remains the close of business on October 24, 2025. At the time the Annual Meeting was adjourned, proxies had been submitted by stockholders representing approximately 30% of the shares of the Company’s common stock issued and outstanding as of the record date.

Stockholders as of close of business on October 24, 2025, the record date for the Annual Meeting, are encouraged to vote as soon as possible via the Internet at www.proxyvote.com or by phone at 1-800-690-6903 (have proxy card available). Eligible stockholders may also vote by contacting the Company’s proxy solicitor, Alliance Advisors, at SLRX@allianceadvisors.com.

Important Information

This material may be deemed to be solicitation material in respect of the Annual Meeting to be reconvened and held December 31, 2025. In connection with the Annual Meeting, the Company filed a definitive proxy statement and a proxy card with the SEC on November 7, 2025. BEFORE MAKING ANY VOTING DECISIONS, STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT, THE ACCOMPANYING PROXY CARD, AND ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. The proxy materials have been made available to stockholders who are entitled to vote at the Annual Meeting. The Company’s definitive proxy statement and any other materials filed by the Company with the SEC can be obtained free of charge at the SEC’s website at sec.gov or the Company’s website https://investors.salariuspharma.com/sec-filings.

Participant Information

The Company, its directors, certain of its officers, and other employees are or will be “participants” (as defined in Section 14(a) of the U.S. Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company’s stockholders in connection with the matters to be considered at the Annual Meeting. The identity, their direct or indirect interests (by security holdings or otherwise), and other information relating to the participants is available in the definitive proxy statement filed with the SEC on November 7, 2025, including in the section titled “Security Ownership of Certain Beneficial Owners and Management” (beginning on page 32). To the extent the holdings by the “participants” in the solicitation reported in the definitive proxy statement have changed, such changes have been or will be reflected on “Statements of Change in Ownership” on Forms 3, 4 or 5 filed with the SEC (where applicable). All these documents are or will be available free of charge at the SEC’s website at www.sec.gov.

About Decoy Therapeutics Inc.

Salarius’ subsidiary Decoy is a preclinical-stage biotechnology company that is leveraging ML and AI tools alongside high-speed synthesis techniques to rapidly design, engineer and manufacture peptide conjugate drug candidates that target serious unmet medical needs. The Company’s initial pipeline is focused on respiratory viruses and GI cancers. Decoy has attracted financing from institutional investors as well as significant capital from the Massachusetts Life Sciences Seed Fund, the Google AI startup program and the NVIDIA Inception program among other sources. The company has also received QuickFire Challenge award funding provided by the BARDA through BLUE KNIGHT™, a collaboration between Johnson & Johnson Innovation – JLABS and BARDA within the Administration for Strategic Preparedness and Response.

About Salarius Pharmaceuticals, Inc.

Salarius is a clinical-stage biopharmaceutical company with two drug candidates for patients with cancer in need of new treatment options. Salarius’ product portfolio includes seclidemstat, the company’s lead candidate, which is being studied in an investigator-initiated Phase 1/2 clinical study in hematologic cancers underway at MD Anderson Cancer Center as a potential treatment for myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML) in patients with limited treatment options. SP-3164, the company’s IND-stage second asset, is an oral small molecule protein degrader. Salarius previously received financial support for seclidemstat for the treatment of Ewing sarcoma from the National Pediatric Cancer Foundation and was a recipient of a Product Development Award from the Cancer Prevention and Research Institute of Texas. For more information, please visit www.salariuspharma.com.

Contact:
Salarius Pharmaceuticals
Rick Pierce, CEO
Pierce@decoytx.com
617-447-8299

Business Development
Peter Marschel, CBO
Peter@Decoytx.com
617-943-6305

Investors and Media
Alliance Advisors IR
Jody Cain
jcain@allianceadvisors.com
310-691-7100

Tevogen CEO Donates Personal Shares to Support Local Fire Department




Tevogen CEO Donates Personal Shares to Support Local Fire Department

WARREN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced that its Founder and CEO, Dr. Ryan Saadi has donated 50,000 shares of his personal holdings of Tevogen common stock to the Mt. Bethel Fire Company, supporting the organization’s mission to protect the Warren Township community. The donations reflect Dr. Saadi’s continued commitment to supporting first responders and the Warren Township community.

“On behalf of the Mt. Bethel Fire Company, we’re sincerely grateful to Dr. Saadi for this generous donation. This support will help strengthen our readiness and enhance the equipment and resources our members rely on to serve the Warren Township community safely and effectively,” commented Assistant Chief, Derek Reedman, Mt. Bethel Fire Company.

“I’m pleased to be able to directly support the Warren Township community and the first responders who serve it every day. Building Tevogen here has always been intentional, not only to advance important science, but to create meaningful jobs and long-term economic impact locally,” added Ryan Saadi, Founder and CEO, Tevogen. “What began as a concept has evolved into a company with an estimated $10 billion asset valuation and a secured cash runway through commercialization. More importantly, it is a platform with the potential to deliver solutions for diseases that remain largely untreatable today. Supporting the community where this work is being built is both a responsibility and a privilege.”

The contributed shares are intended to support Mt. Bethel Fire Company initiatives that enhance safety, readiness, and emergency response capabilities. The donation was conducted in accordance with SEC Rule 144 and Dr. Saadi will not receive any proceeds from the disposal of the securities.

About Tevogen

Tevogen is a next-generation, socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages industry-leading artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and strategic engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA–restricted, genetically unmodified allogeneic T cells. The Tevogen Bio pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3a118701-a82b-4462-a7d1-4b20bf0854b7

Tevogen CEO Donates Personal Shares to Support Local Fire Department




Tevogen CEO Donates Personal Shares to Support Local Fire Department

WARREN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced that its Founder and CEO, Dr. Ryan Saadi has donated 50,000 shares of his personal holdings of Tevogen common stock to the Mt. Bethel Fire Company, supporting the organization’s mission to protect the Warren Township community. The donations reflect Dr. Saadi’s continued commitment to supporting first responders and the Warren Township community.

“On behalf of the Mt. Bethel Fire Company, we’re sincerely grateful to Dr. Saadi for this generous donation. This support will help strengthen our readiness and enhance the equipment and resources our members rely on to serve the Warren Township community safely and effectively,” commented Assistant Chief, Derek Reedman, Mt. Bethel Fire Company.

“I’m pleased to be able to directly support the Warren Township community and the first responders who serve it every day. Building Tevogen here has always been intentional, not only to advance important science, but to create meaningful jobs and long-term economic impact locally,” added Ryan Saadi, Founder and CEO, Tevogen. “What began as a concept has evolved into a company with an estimated $10 billion asset valuation and a secured cash runway through commercialization. More importantly, it is a platform with the potential to deliver solutions for diseases that remain largely untreatable today. Supporting the community where this work is being built is both a responsibility and a privilege.”

The contributed shares are intended to support Mt. Bethel Fire Company initiatives that enhance safety, readiness, and emergency response capabilities. The donation was conducted in accordance with SEC Rule 144 and Dr. Saadi will not receive any proceeds from the disposal of the securities.

About Tevogen

Tevogen is a next-generation, socially integrated healthcare enterprise built on the principles of affordability, efficiency, and scientific rigor. The company leverages industry-leading artificial intelligence and precision T cell therapy platforms, a patient-first and cost-disciplined operating model, and strategic engagements with global technology leaders to support the development of advanced, life-saving therapies across multiple therapeutic areas and scalable solutions for the broader healthcare system.

Tevogen Bio, the company’s lead initiative, has completed a proof-of-concept clinical trial demonstrating the potential of its single-HLA–restricted, genetically unmodified allogeneic T cells. The Tevogen Bio pipeline spans virology, oncology, and neurology, with programs built on the company’s proprietary ExacTcell™ platform.

Tevogen.AI is designed to transform drug development by accelerating target detection, helping reduce failure rates, and supporting optimized clinical trial design through proprietary predictive technologies. The platform utilizes cloud and data services from leading technology providers, including Microsoft and Databricks, to advance its long-term ambition to predict the proteome for any given protein–HLA combination, enabling rapid and cost-efficient therapeutic discovery.

Tevogen is exploring future strategic initiatives that may include domestic generics, biosimilars, medical devices, and innovative insurance solutions for healthcare providers. Together, these programs reflect Tevogen’s mission to advance sustainable innovation and broaden patient access through a faster, more efficient, and more equitable healthcare model.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; that Tevogen will need to raise additional capital to fully realize its business plans; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3a118701-a82b-4462-a7d1-4b20bf0854b7

Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman




Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that its Executive Chairman and Founder, Mr. Gabriele Cerrone, has purchased 97,687 common shares, bringing his total holding to 43,374,830 common shares, which is 36.08% of issued share capital.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

___________________
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman




Tiziana Life Sciences Announces Acquisition of Shares by Executive Chairman

BOSTON, Dec. 19, 2025 (GLOBE NEWSWIRE) — Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announces that its Executive Chairman and Founder, Mr. Gabriele Cerrone, has purchased 97,687 common shares, bringing his total holding to 43,374,830 common shares, which is 36.08% of issued share capital.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

For further inquiries:

Tiziana Life Sciences Ltd
Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

___________________
[1] https://www.pnas.org/doi/10.1073/pnas.2220272120
[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America




OncoInv and MaxBloch Partner to Expand Early Cancer Detection Across Central America

OncoInv has signed a distribution partnership with MaxBloch Clinical Laboratories to introduce the OncoSeek® multi-cancer early detection blood test in El Salvador, expanding access to affordable early cancer detection.

HOUTEN, The Netherlands, Dec. 19, 2025 (GLOBE NEWSWIRE) — OncoInv, a Netherlands-based company focused on multi-cancer early detection, has signed a distribution agreement with MaxBloch Clinical Laboratories to introduce OncoSeek^®, its multi-cancer early detection blood test, in El Salvador. The agreement marks the official start of the collaboration and expands access to early cancer detection in Central America.

Through the partnership, OncoSeek^® will be made available via MaxBloch’s nationwide laboratory network, allowing healthcare providers across El Salvador to offer the test using existing laboratory infrastructure. The collaboration is designed to improve access to affordable, early multi-cancer detection in a healthcare system where early diagnosis remains uneven.

Access to early detection solutions

“This partnership is part of our ongoing mission to bridge global health inequalities,” said Jesper Verhey, Chief Commercial Officer at OncoInv. “The cancer burden is growing, but so is our ability to act. By joining forces with MaxBloch Clinical Laboratories, we bring OncoSeek^® closer to the people who need it most.”

“At MaxBloch, we believe early multi-cancer detection is one of the strongest tools to improve patient outcomes,” said Lisette Bloch, Chief Executive Officer of MaxBloch Clinical Laboratories. “Introducing OncoSeek^® in El Salvador allows us to offer a scientifically robust and accessible solution aligned with our long-standing commitment to high-quality, ethical diagnostics.”

The partnership reflects a shared commitment to reducing cancer-related health inequalities by expanding access to early detection solutions across Central America.

Detects nine high-mortality cancer types

The cancer burden in Latin America is expected to continue rising sharply. Estimates based on demographic trends project a 67% increase in new cancer cases by 2040, reaching around 2.4 million new cases annually if current rates persist.

OncoSeek^® is a low-cost, scalable blood test capable of detecting nine high-mortality cancer types from a single blood sample. The test analyses six Protein Tumour Markers, with results processed through cloud-based software applying machine learning and big data analytics. The algorithm is operated by OncoInv, a wholly owned subsidiary of the non-profit foundation Inspire2Live. It is fully GDPR compliant, and CE-marked. In low- and middle-income countries, OncoSeek^® is offered on a not-for-profit basis in the public sector, supporting global health equity.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2891f79d-95bf-4600-b1ba-36f4f4442a2c/en

CONTACT: Contact:
Jesper Verhey
jesper.verhey@oncoinv.org