NewcelX Reports Peer-Reviewed Publication Supporting Mazindol IR/SR and Advances CVR Monetization Strategy
MWN-AI** Summary
NewcelX Ltd., a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders, has announced a significant milestone with the publication of a peer-reviewed article titled "Mazindol Immediate-Release/Sustained-Release (IR/SR): A 50-Year Legacy of Multifaceted Mechanisms and Emerging Therapeutic Potential." Published in Clinical Drug Investigation, this comprehensive review strengthens the scientific positioning of Mazindol ER, a key asset under NewcelX's Contingent Value Right (CVR) framework.
This independent validation of Mazindol ER's clinical and mechanistic profile is expected to enhance buyer confidence as the company engages in advanced discussions with multiple parties regarding potential licensing and acquisition transactions. NewcelX is operating within a structured competitive framework to optimize transaction terms while maximizing CVR value realization. The management emphasizes its goal of executing a strategic transaction that reflects the intrinsic value of Mazindol ER, aiming to provide measurable returns to CVR holders and shareholders.
The article highlights over 20 years of dedicated research supporting Mazindol ER's development, positioning it as a differentiated CNS asset targeting underserved markets such as narcolepsy and ADHD. Dr. Eric Konofal, Head of NewcelX's DOXA Program, underscored that this publication reflects the company's scientific commitment to advancing Mazindol ER as a novel therapeutic option.
Ronen Twito, Executive Chairman & CEO of NewcelX, stated that the publication reinforces their negotiating position as they move forward with discussions on unlocking the commercial potential of Mazindol ER. This step is seen as pivotal in bolstering NewcelX's CNS pipeline and overall strategic positioning in the biopharmaceutical landscape.
MWN-AI** Analysis
NewcelX Ltd. (NASDAQ: NCEL) is rapidly gaining traction within the biopharmaceutical sector, particularly with its latest announcement regarding the peer-reviewed publication of "Mazindol Immediate-Release/Sustained-Release (IR/SR)." This publication could serve as a crucial catalyst for the company's growth and market positioning.
The validation of Mazindol ER's clinical profile through an independent review significantly enhances its attractiveness to potential investors and partners. The presence of recognized, peer-reviewed research in a respected journal strengthens buyer confidence as NewcelX engages in advanced negotiations with multiple counterparties for potential licensing and acquisition of this asset. As seen in similar cases within the biopharma industry, peer-reviewed validation can often lead to more favorable deal terms, which is also indicative of the strength of NewcelX's negotiating position.
Investors should keep a close eye on the ongoing discussions surrounding the Contingent Value Right (CVR) framework, which ties payments to the successful monetization of legacy assets like Mazindol ER. With management actively working to optimize these transaction terms, the realization of CVR value may lead to substantial returns for shareholders.
Given that Mazindol targets underserved markets—including narcolepsy, ADHD, and substance use disorders—the scope for commercial success is considerable. The company's efforts to convert scientific findings into strategic business outcomes solidify its long-term growth potential.
In summary, NewcelX presents a compelling investment opportunity backed by strong scientific validation and active commercial negotiations. Investors should monitor the ongoing developments closely, as successful monetization of Mazindol ER could significantly enhance shareholder value.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
Publication strengthens scientific positioning as Company progresses strategic discussions related to CVR-linked asset
ZURICH, Feb. 12, 2026 /PRNewswire/ -- NewcelX Ltd. ("NewcelX" or the "Company") (Nasdaq: NCEL), a clinical-stage biopharmaceutical company advancing stem-cell-derived therapies for Type 1 Diabetes and advancing innovative therapies for central nervous system (CNS) today announced the publication of a comprehensive peer-reviewed scientific review entitled, "Mazindol Immediate-Release/Sustained-Release (IR/SR): A 50-Year Legacy of Multifaceted Mechanisms and Emerging Therapeutic Potential," in Clinical Drug Investigation, a Springer Nature journal. The article is available at: https://doi.org/10.1007/s40261-025-01510-2.
The peer-reviewed publication represents a significant inflection point in the strategic positioning of Mazindol ER under NewcelX's Contingent Value Right (CVR) framework pursuant to which CVR holders have the right to additional payments based on the proceeds received by NewcelX in the event of the disposition of certain legacy assets.
The publication in a leading scientific journal provides independent third-party validation of the asset's clinical and mechanistic profile, materially strengthening its positioning in active licensing and acquisition discussions. Management believes this external validation meaningfully enhances buyer confidence, accelerates diligence processes, and supports value recognition in ongoing negotiations.
NewcelX confirmed that it is currently engaged in advanced discussions with multiple counterparties evaluating potential licensing and acquisition transactions for Mazindol ER. These discussions are being conducted within a structured competitive framework designed to optimize transaction terms and maximize CVR value realization.
The Company's objective remains clear: to execute a strategic transaction that crystallizes the intrinsic value of Mazindol ER and delivers measurable returns to CVR holders and shareholders.
This milestone publication reinforces the strong scientific foundation behind Mazindol ER and highlights more than 20 years of dedicated research supporting its development. With intellectual property dating back to 2006, Mazindol ER represents a differentiated, de-risked CNS asset targeting large and underserved markets, including narcolepsy, ADHD, and substance use disorders.
NewcelX believes that the peer-reviewed publication by an international group of experts significantly enhances the visibility, credibility, and long-term commercial potential of the program, further strengthening NewcelX's CNS pipeline and strategic positioning.
"This milestone publication marks the culmination of over two decades of research," said Dr. Eric Konofal, Head of NewcelX's DOXA Program. "It reflects the sustained scientific commitment to advancing Mazindol ER as a novel therapeutic option in CNS disorders."
"Our priority is to convert the scientific strength of Mazindol ER into strategic and financial outcomes," said Ronen Twito, Executive Chairman & CEO of NewcelX. "We believe that the peer-reviewed publication materially strengthens our negotiating position as we advance structured discussions with interested parties focused on unlocking the full commercial potential of this asset".
About NewcelX
NewcelX is an innovative biopharmaceutical company focused on developing transformative stem-cell-derived therapies for Type 1 Diabetes. Built on a validated human pluripotent stem cell (hPSC) platform, the company's lead program, IsletRx, is designed to restore functional insulin production through scalable, off-the-shelf cell replacement. NewcelX is advancing a comprehensive therapeutic approach for Type 1 Diabetes that integrates cell therapy, immune protection, and translational science to address critical unmet medical needs.
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Website: www.newcelx.com
Forward-Looking Statements
This press release contains expressed or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. For example, NewcelX is using forward-looking statements when it discusses how it is currently engaged in advanced discussions with multiple counterparties evaluating potential licensing and acquisition transactions for Mazindol ER, maximizing CVR value realization, executing a strategic transaction that crystallizes the intrinsic value of Mazindol ER and delivers measurable returns to CVR holders and shareholders, the visibility, credibility, and long-term commercial potential of the program, further strengthening NewcelX's CNS pipeline and strategic positioning, converting the scientific strength of Mazindol ER into strategic and financial outcomes and its belief that the peer-reviewed publication materially strengthens its negotiating position as it advances structured discussions with interested parties focused on unlocking the full commercial potential of Mazindol ER. These forward-looking statements and their implications are based on the current expectations of the management of NewcelX and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; potential delays or obstacles in launching or completing clinical trials; products that may not be approved by regulatory agencies; technologies that may not be validated or accepted by the scientific community; the inability to retain or attract key employees; unforeseen scientific difficulties with products in development; higher-than-expected product costs; results in the laboratory that do not translate to clinical success; insufficient patent protection; possible adverse safety outcomes; legislative changes; delays in developing or introducing new technologies, products, or applications; and competitive pressures that could reduce market share or pricing. Except as otherwise required by law, NewcelX does not undertake any obligation to publicly release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in its Annual Report on Form 20-F for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission ("SEC") and available at www.sec.gov, as well as in subsequent filings made by NewcelX, including under the heading "Risk Factors" in its proxy statement/prospectus filed with the SEC on November 6, 2025.
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Investor & Media Contacts
Sarah Bazak, Investors relations
InvestorRelations@newcelx.com
SOURCE NewcelX Ltd.
FAQ**
How does the recent peer-reviewed publication strengthen NewcelX Ltd. NCEL’s position in the market and attract potential partners for licensing or acquisition of Mazindol IR/SR?
What specific aspects of the peer-reviewed publication validate the clinical and mechanistic profile of Mazindol IR/SR, and how might that impact negotiations for potential transactions involving NewcelX Ltd. NCEL?
Can NewcelX Ltd. NCEL provide insights into the timeline and process for the ongoing discussions with multiple counterparties regarding Mazindol IR/SR’s licensing or acquisition?
How does NewcelX Ltd. NCEL plan to leverage the scientific validation from the recent publication to maximize the value of the Contingent Value Rights (CVR) associated with Mazindol IR/SR?
**MWN-AI FAQ is based on asking OpenAI questions about NewcelX Ltd. (NASDAQ: NCEL).
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