Welcome to our dedicated page for NewcelX SEC filings (Ticker: NCEL), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The NewcelX Ltd. (Nasdaq: NCEL) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as a foreign private issuer. NewcelX reports under the Exchange Act on Form 20-F and furnishes current reports on Form 6-K, offering investors structured insight into its operations as a Swiss clinical-stage biopharmaceutical and biotechnology company focused on neurodegenerative and metabolic diseases.
Through these filings, readers can follow key corporate events connected to the merger between NLS Pharmaceutics Ltd. and Kadimastem Ltd., which established NewcelX as a combined entity integrating cell-therapy platforms with neuroscience and small-molecule expertise. For example, a Form 6-K details the post-merger appointment of Kost Forrer Gabbay & Kasierer, a member of Ernst & Young, as the independent registered public accounting firm for the fiscal year ending December 31, 2025, and describes the prior engagement and dismissal of CBIZ CPAs, P.C., along with references to previously disclosed material weaknesses.
On Stock Titan, NewcelX filings such as annual reports on Form 20-F, interim and event-driven Form 6-K submissions, and related exhibits can be viewed alongside AI-powered summaries. These summaries are designed to highlight essential elements of lengthy documents, helping users quickly identify information on topics like accounting firm changes, internal control disclosures, merger-related details, and other governance matters discussed in the filings.
Investors researching NCEL can use this page to monitor how NewcelX describes its business, risk factors, financial reporting framework, and post-merger integration steps over time. Real-time updates from EDGAR combined with AI-assisted overviews aim to make complex regulatory content more accessible without replacing the need to review the full original filings.
NewcelX Ltd. reports that the Brazilian Patent and Trademark Office has issued Patent Number 112018010946-0, protecting the manufacturing process for its lead stem-cell-derived therapy candidate NCEL-101 for type 1 diabetes through November 2036. This Brazil patent complements the existing U.S. patent portfolio and is described as strengthening NewcelX’s global intellectual property position and potential partnering opportunities.
The company highlights Brazil as a major type 1 diabetes market, with about 500,000 people living with the disease and prevalence growing at an estimated 4.4% annually. NewcelX also notes a recently completed FDA Type B Pre-IND meeting for NCEL-101 in combination with Eledon’s anti-CD40L antibody, tegoprubart, which it says provides a regulatory pathway toward initiating clinical trials, while risk disclosures reiterate that its financial position raises substantial doubt about its ability to continue as a going concern.
NewcelX Ltd., a clinical-stage biotechnology company focused on regenerative cell therapies for type 1 diabetes, reported the appointment of world‑renowned diabetes researcher Dr. Camillo Ricordi to its Scientific Advisory Board.
The company links this hire to its recently completed FDA Type B Pre‑IND meeting for its lead program, NCEL‑101, which it says provided a clear regulatory pathway toward starting clinical trials. Dr. Ricordi brings extensive experience in islet transplantation, stem cell–derived islet replacement and immune modulation, and will advise on NewcelX’s biologic replacement strategy, regenerative medicine platform and collaboration with Eledon Pharmaceuticals.
The press release reiterates standard forward‑looking statement cautions and highlights risks such as regulatory uncertainty, clinical trial timing, technology adoption, intellectual property protection, Nasdaq listing compliance and the company’s financial position, which it states raises substantial doubt about its ability to continue as a going concern.
NewcelX Ltd. reports a successful Type B Pre-IND meeting with the U.S. FDA for its lead cell therapy candidate NCEL-101, aimed at treating type 1 diabetes in combination with Eledon Pharmaceuticals’ anti-CD40L antibody, tegoprubart. FDA feedback aligned with NewcelX’s proposed development strategy, including its Chemistry, Manufacturing, and Controls processes and preclinical program, allowing the company to move toward IND-enabling activities and planning a first clinical trial. NCEL-101 is built on a human pluripotent stem cell platform and is designed as a scalable, off-the-shelf islet cell replacement therapy, supported by existing clinical experience with tegoprubart in transplant patients.
NewcelX Ltd. reported that it held its Annual General Shareholders’ Meeting on June 30, 2026. Shareholders approved all proposals presented at the meeting, each receiving the required majority. The proposals were previously detailed in the notice and invitation furnished on June 5, 2026 as an exhibit to an earlier report.
The company also stated that this report is incorporated by reference into its existing shelf registration statements on Form F-3, meaning those registration statements now include the information from this update.
NewcelX Ltd. reported that a peer-reviewed study in Stem Cell Reports highlights the therapeutic potential of its AstroRx® stem-cell-derived astrocyte therapy. The work, done with academic collaborators, shows pro‑repair effects in experimental multiple sclerosis models, supporting broader use in chronic demyelinating diseases.
The company frames the results as further validation of its stem cell technology platform, which is intended to generate scalable therapies across multiple indications while it advances lead candidate NCEL‑101 for Type 1 Diabetes. NewcelX also reiterates substantial risks, including going concern doubts, regulatory and clinical uncertainties, and Nasdaq listing and geopolitical risks.
NewcelX Ltd.: registers an offering to sell up to $75,000,000 of common shares, warrants or units on a shelf, from time to time after effectiveness.
The prospectus states 5,383,871 Common Shares are issued and outstanding as of the date of this prospectus. The document discloses a Nasdaq last reported sale price of $3.17 per share on June 9, 2026. Financial tables show cash and cash equivalents of $2,201 (U.S. dollars in thousands) as of December 31, 2025. The registration contemplates multiple distribution methods (including at-the-market offerings, underwritten offerings and equity lines); exact terms, pricing and proceeds allocation will be provided in prospectus supplements.
NewcelX Ltd. has called its ordinary shareholders’ meeting for June 30, 2026 in Zurich and circulated the full agenda and proxy card. Shareholders of record as of June 5, 2026 may vote in person, by independent proxy or via electronic instructions.
The Board asks shareholders to approve the 2025 statutory financial statements and compensation report, carry forward a net loss of CHF 38,642,417 to a new accumulated loss of CHF 90,869,091, grant discharge to directors and executives, and re-elect all current board, committee members and the auditor. Proposals also seek approval of maximum fixed, variable and equity compensation totals for the Board and Executive Management for 2027.
A key set of items would authorize up to six ordinary capital increases, each up to CHF 50,000 in nominal share capital, through issuances of up to 1,000,000 new registered shares per tranche with shareholder subscription rights excluded for specified “good cause.” Additional proposals would amend the Company’s capital band and conditional share capital provisions in the articles of association to provide greater flexibility for future equity financings.
NewcelX Ltd. submitted a Pre-IND briefing package to the U.S. FDA for NCEL-101, its stem-cell-derived islet product candidate for Type 1 Diabetes, in combination with Eledon’s investigational anti-CD40L antibody, tegoprubart. This is intended to support a proposed first-in-human clinical trial.
The planned regimen is calcineurin inhibitor-free and aims to achieve durable graft survival and insulin-producing function, building on a 12-patient University of Chicago islet transplant study where tegoprubart-based immunosuppression preserved transplanted islet function. Tegoprubart has been used in more than 100 transplant recipients across multiple FDA-cleared INDs.
A Type B pre-IND meeting with the FDA is scheduled for the last week of June to discuss NCEL-101 manufacturing, the preclinical safety and toxicology plan, and first-in-human trial design. The company also reiterates that its financial position raises substantial doubt about its ability to continue as a going concern and highlights risks including regulatory uncertainty, Nasdaq listing compliance, clinical development challenges, intellectual property protection, and geopolitical and economic conditions.