NCEL

NewcelX and Eledon Pharmaceuticals are collaborating to advance one of the few scalable approaches to a potential functional cure in Type 1 Diabetes, NCEL-101, as the flagship program and key long-term value driver toward IND-enabling milestones Substantially debt free, NewcelX recently closed a financing of up to approximately $3.4 million, including $1.35 million in cash and approximately $2 million of potential additional proceeds from the exercise of warrants, and has access to up to a $25 million Equity Line of Credit Strengthened scientific leadership with appointment of Julien Boisdron, MD, Chief Medical Officer of a Swiss Big Pharma, to Scientific Advisory Board Aims to significantly accelerate development progress of NCEL-101 and rest of clinical pipeline in 2026 ZURICH, Switzerland, April 30, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (Nasdaq: NCEL),– NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced reporting its financial results for the period ended December 31, 2025 and corporate highlights. “2025 was a transformative year for NewcelX, marked by completion of the merger, strengthening of our balance sheet and advancement of NCEL-101 together with our partner Eledon Pharmaceuticals (Nasdaq: ELDN) as our flagship program and key long-term shareholder value driver,” said Ronen Twito, Executive Chairman and Chief Executive Officer of NewcelX. “We believe our scalable stem cell-derived islet platform, combined with targeted immune protection, represents one of the few differentiated approaches aimed at a potential functional cure for Type 1 Diabetes. With our first post-merger annual results, strengthened capital structure and growing scientific validation, we expect 2026 to be a year of significantly accelerated execution.” Corporate and Program Highlights Advanced development of NCEL-101, Company’s flagship stem cell-derived islet therapy for Type 1 Diabetes. Continued IND-enabling development activities, including regulatory preparation and preclinical planning. Progress in manufacturing readiness, including clinical batches manufacturing preparations with CDMO, Pluri Inc., supporting continued development. Further development of clinical pipeline with advancement of a differentiated approach combining stem cell-derived islets with tegoprubart for targeted immune protection. Strengthened scientific advisory board with appointment of Julien Boisdron, MD, Chief Medical Officer of a Swiss Big Pharma, whose experience in diabetes innovation and translational medicine is expected to support advancement of NCEL-101. Clinical Pipeline Development and Platform Value Beyond NCEL-101, the Company continued advancing its broader pipeline, including AstroRx® for ALS and DOXA for narcolepsy and additional CNS indications, while exploring strategic development and collaboration opportunities for these programs. The Company believes prior development work in AstroRx®, including GMP cell manufacturing development, translational activities and regulatory interactions with the U.S. Food and Drug Administration, has provided foundational validation of the Company’s ability to develop, manufacture and advance cell therapies toward the clinic, and contributed important know-how now supporting advancement of NCEL-101 in Type 1 Diabetes. This accumulated experience in cell therapy development, manufacturing and regulatory execution supports NewcelX’s multi-asset strategy and may also create potential non-dilutive partnering opportunities across the broader portfolio. Strengthened Balance Sheet In April 2026, the Company completed a $1.35 million private placement, with approximately $2.0 million in additional potential proceeds from future exercise of warrants, representing a financing transaction totaling up to approximately $3.4 million. The Company also maintains access to its $25 million Equity Line of Credit. As of year-end, the Company’s balance sheet was substantially free of debt and financial liabilities other than ordinary working capital obligations. Financial Highlights for the Period Ended December 31, 2025 Cash and cash equivalents as of December 31, 2025 were $2.2 million. Net loss for 2025 was $8.3 million, including $5.7 million in non-cash accounting-related finance expenses, primarily associated with fair value remeasurement of derivative liabilities related to convertible instruments converted prior to merger completion and not expected to recur. Net cash used in operating activities was $2.8 million, reflecting increased investment in NCEL-101 development activities, including manufacturing, as well as payments to service providers related to merger obligations. Outlook for 2026 The Company expects 2026 to be a year of accelerated execution, including: Advancing NCEL-101 toward key IND-enabling milestones Expanding strategic development collaborations Pursuing additional financing and partnership opportunities Accelerating development activities following establishment of an integrated post-merger operating platform “With a strengthened capital structure, clean balance sheet and expected acceleration in development, we believe our scalable stem cell-derived islet platform, combined with targeted immune protection, represents one of the few differentiated approaches aimed at a potential functional cure for Type 1 Diabetes. At the same time, capabilities built through AstroRx® and our broader pipeline strengthen our platform and our ability to execute across multiple programs,” added Ronen Twito NewcelX Chief Executive Officer. A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2025 has been filed with the U.S. Securities and Exchange Commission https://www.sec.gov/ and posted on the Company’s investor relations website at https://newcelx.com/investors/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected]. 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, NCEL-101, 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 integrating cell therapy, immune protection, and translational science to address critical unmet medical needs. Social Media: LinkedIn, Facebook, X, Instagram 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 its business strategy and product pipeline including the development of a potential functional cure for Type 1 Diabetes, expectations regarding accelerated execution and the potential for non-dilutive partnering opportunities. 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: the regulatory pathways that we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; our ability to drive revenue growth, enhance research and development capabilities, and improve financial performance is subject to uncertainties; that our financial position raises substantial doubt about our ability to continue as a going concern; our ability to maintain listing and effectively comply with the listing requirements of the Nasdaq; changes in technology and market requirements; potential delays or obstacles in launching or completing clinical trials, including our expectations regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and the order of such trials with each of our product candidates or whether such trials will be conducted at all; competitive companies, technologies and our industry; the development and commercialization, if any, of any other product candidates that we may seek to develop; 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; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; higher-than-expected product costs; results in the laboratory that do not translate to clinical success; insufficient patent protection; possible adverse safety outcomes; our ability to establish and maintain strategic partnerships and other corporate collaborations; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; delays in developing or introducing new technologies, products, or applications; competitive pressures that could reduce market share or pricing; the overall global political and economic environment in the countries in which we operate; and security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel.. 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, 2025, 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. Investor & Media Contacts Sarah Bazak, Investors relations [email protected]

ZURICH, Jan. 12, 2026 /PRNewswire/ -- NewcelX Ltd. (Nasdaq: NCEL) ("NewcelX" or the "Company"), a clinical-stage biotechnology company advancing regenerative medicine solutions, today reported the results of an international collaborative research study investigating advanced biomaterial strategies to support the delivery and function of stem cell–derived islets for the treatment of Type 1 Diabetes. The peer reviewed study, published in Diabetology, a journal dedicated to diabetes research, conducted in collaboration with research groups from the University of Technology Sydney, the University of Wisconsin–Madison, Monash University, the Queensland University of Technology, and the Australian Foundation for Diabetes Research (AFDR), examined the use of engineered scaffolds incorporating extracellular matrix (ECM) derived from a decellularized human pancreas. The work evaluated whether ECM integration could support the function of encapsulated pluripotent stem cell–derived islets within a removable delivery system. The study results demonstrated that when ECM was incorporated into the scaffold, implanted islets exhibited functional performance comparable to encapsulated islets delivered without a scaffold. These findings suggest that biomaterial design and tissue microenvironment play a critical role in supporting islet function and may enable safer, retrievable delivery configurations for future therapeutic development. The research was supported through a Type 1 Diabetes research initiative led by the Australian Foundation for Diabetes Research, which had received donor matched funding for the published study from the National Stem Cell Foundation of Australia. Moreover, it has received dedicated funding from Breakthrough T1D (formerly JDRF), the leading global type 1 diabetes research and advocacy organization, to further develop the underlying model based on the study results. "This research contributes to our understanding of how advanced biomaterials and tissue microenvironments can support engineered islet function," said Prof. Michel Revel, Chief Scientific Officer of NewcelX. "The findings are consistent with the scientific principles underlying our diabetes program, which aims to combine scalable stem cell–derived islets with strategies to enhance engraftment and retrievability intended to eliminate the need for chronic immunosuppression medications." "We are delighted that it has been possible to progress our goal of developing a realistic cell therapy for type 1 diabetes," said Professor Bernard Tuch, Chief Scientific Officer of AFDR, "with the continuing support of our international and national partners". Type 1 Diabetes represents NewcelX's primary therapeutic focus, and the Company is directing significant scientific and development resources toward advancing cell-based solutions in this area. The study aligns with NewcelX's scientific focus on combining stem cell biology with delivery and protection strategies to support functional insulin-producing cell therapies. IsletRx is NewcelX's investigational stem cell–derived islet therapy designed to restore insulin production in individuals with insulin-dependent diabetes. The program integrates proprietary cell differentiation protocols with immune-protective and delivery-oriented design features, with the goal of achieving functional insulin secretion without the need for systemic immunosuppression. "Type 1 diabetes is a central focus of NewCelX's development strategy," said Ronen Twito, Executive Chairman and CEO of NewCelX. "The positive results from this international collaborative study contribute to the continued advancement of our technologies and help guide our ongoing development efforts as we move toward the clinical trial." About NewcelX Ltd. NewcelX Ltd. (Nasdaq: NCEL) is a biotechnology company developing cell-based and small-molecule therapies for neurodegenerative and metabolic diseases. The Company's integrated platform combines advanced stem-cell technologies, biomaterials, and neuroscience expertise to support scalable therapeutic solutions for conditions such as Amyotrophic Lateral Sclerosis (ALS) and Type 1 Diabetes. NewcelX is headquartered in Zurich, Switzerland, with research and development operations in Ness Ziona, Israel. Social Media: LinkedIn, Facebook, X, Instagram Website: www.newcelx.com Investor & Media Contacts Sarah Bazak, Investors relations [email protected] About Australian Foundation for Diabetes Research (AFDR) AFDR is a not-for-profit company established to develop a cell therapy suitable for most people with type 1 diabetes. To this end it is championing a bioengineered approach to deliver insulin-producing cells without recipients having to take anti-rejection drugs. 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 the continued advancement of its technologies and its ongoing development efforts as its move toward the clinical trial. 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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