NewCelX Management to Attend Breakthrough T1D Congress in Philadelphia, Advancing Its Mission to Develop a Cure for Type 1 Diabetes

Following successful FDA Pre-IND meeting, NewcelX advances IND-enabling activities for NCEL-101

ZURICH, Sept. 28, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (Nasdaq: NCEL), a regenerative medicine company developing stem-cell-derived therapies for Type 1 Diabetes (T1D), today announced that members of its senior management team will attend the Breakthrough T1D Clinical & Research Congress, taking place October 9–11, 2026, in Philadelphia, Pennsylvania.

During the congress, NewcelX management will be available to meet with researchers, clinicians, investors and potential strategic partners to discuss the Company’s lead program, NCEL-101, and preparations for its planned Phase 1/2a clinical trial in T1D.

The Company’s attendance follows its successful Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA), announced in July 2026. The meeting provided constructive FDA feedback and alignment on the proposed development strategy, including chemistry, manufacturing and controls (CMC) and the preclinical program, and clarified the regulatory pathway toward clinical development of NCEL-101.

Following the Pre-IND meeting, NewcelX has a clear path forward on the remaining IND-enabling work required to support its planned Investigational New Drug (IND) submission. The Company is advancing the necessary preclinical, manufacturing and regulatory activities in preparation for its planned Phase 1/2a clinical trial, subject to applicable regulatory requirements.

NCEL-101 combines NewcelX’s enriched stem-cell-derived pancreatic islet cells with Eledon Pharmaceuticals’ investigational anti-CD40L antibody, tegoprubart, as part of a proposed immunomodulatory regimen intended to support transplanted cell survival and function.

Researchers, investors and potential strategic partners interested in learning more about NCEL-101 and the Company’s planned clinical development program are encouraged to contact NewcelX to arrange a meeting at InvestorRelations@newcelx.com

About NewcelX

NewcelX Ltd. (Nasdaq: NCEL) 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 anticipated participation in the Breakthrough T1D Clinical & Research Congress; the expected presentation of NCEL-101 development updates; the potential therapeutic benefits, safety profile, scalability and clinical utility of NCEL-101; the planned development of NCEL-101 in combination with tegoprubart; the advancement and timing of preclinical, manufacturing, regulatory and IND-enabling activities; the planned submission of an Investigational New Drug application; the planned initiation, timing, design and objectives of future clinical trials; the ability of NCEL-101 to support functional insulin production, achieve durable graft survival and function, or provide outcomes comparable to donor islet transplantation; and the Company's future development plans, strategy, regulatory progress and growth 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 Contact
KCSA Strategic Communications
Valter Pinto, Managing Director
PH: (212) 896-1254
NewCelX@kcsa.com

Company Contact
Sarah Bazak
InvestorRelations@newcelx.com