NewcelX Granted Patent in Brazil for NCEL-101 in Type 1 Diabetes, Expanding Global IP Portfolio
Rhea-AI Summary
NewcelX (Nasdaq: NCEL) announced that the Brazilian Patent and Trademark Office has granted Patent BR 112018010946-0, covering its cell selection and enrichment manufacturing process for lead candidate NCEL-101 for type 1 diabetes. The patent runs until November 2036 and complements the existing U.S. portfolio.
According to NewcelX, Brazil has about 500,000 people with type 1 diabetes, with prevalence growing 4.4% annually. NCEL-101 has shown favorable preclinical data, including ~60% beta cells co-expressing insulin and NKX6.1/MAFA, 99.98% endocrine lineage, and over 96% non-proliferative cells. The company recently completed a Type B Pre-IND meeting with the FDA for NCEL-101 in combination with Eledon's tegoprubart, supporting plans to initiate clinical activities.
Positive
- Brazil patent for NCEL-101 protects manufacturing process until November 2036
- Strategic market coverage in Brazil with approximately 500,000 type 1 diabetes patients
- High endocrine purity of NCEL-101 with 99.98% endocrine lineage cells in preclinical work
- Low proliferative risk with more than 96% of NCEL-101 cells non-proliferative
- Regulatory milestone with successful FDA Type B Pre-IND meeting for NCEL-101 and tegoprubart
Negative
- NCEL-101 remains at the preclinical stage with clinical trials yet to begin
News Market Reaction – NCEL
In the Jul 15 session, NCEL declined 1.26%, reflecting a mild negative market reaction. Argus tracked a trough of -3.7% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 08 | Advisory board change | Positive | +5.5% | Added diabetes pioneer to Scientific Advisory Board after positive FDA feedback. |
| Jul 01 | Regulatory update | Positive | +5.2% | Announced successful FDA Type B Pre-IND meeting for NCEL-101 in T1D. |
| May 27 | Regulatory update | Positive | +9.5% | Submitted Pre-IND package to FDA for NCEL-101 in type 1 diabetes. |
| Apr 30 | Earnings and financing | Positive | +28.9% | Reported 2025 results and highlighted funding and NCEL-101 acceleration plans. |
| Apr 20 | Partnership update | Positive | +6.4% | Updated corporate presentation to emphasize NCEL-101 and Eledon collaboration. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent NCEL-101 and financing-related headlines have typically been followed by double-digit or mid-single-digit gains over the next session.
Key Terms
type b pre-ind regulatory
monoclonal antibody medical
endocrine lineage medical
non-proliferative medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Brazil patent complements U.S. patent portfolio for NCEL-101, strengthening global position in the type 1 diabetes market
ZURICH, July 15, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced that the Brazilian Patent and Trademark Office has issued Patent Number BR 112018010946-0 covering its innovative cell selection and enrichment technology. The patent protects the manufacturing process of its lead clinical compound, NCEL-101, until November 2036.
“The patent grant follows our recently announced successful FDA Type B Pre-IND meeting for NCEL-101, in combination with Eledon’s anti-CD40L monoclonal antibody, tegoprubart, for the treatment of type 1 diabetes, providing a clear regulatory pathway toward initiating clinical trials,” stated Ronen Twito, CEO & Executive Chairman of NewcelX. “Brazil is one of the largest type 1 diabetes markets in Latin America, with approximately 500,000 people living with T1D and prevalence growing at an estimated annual rate of
NCEL-101 leverages a differentiated enrichment process and has demonstrated favorable results in preclinical studies and a supportive safety profile with the following qualities:
- ~
60% Beta cells co express insulin and NKX6.1 - MAFA expression, a transcription factor critical for Beta cells maturation and glucose dependent insulin secretion
99.98% endocrine lineage, implying minimal, if any, off target non-endocrine population- More than
96% of cells are non-proliferative, as donor human islets
The Company's technology is unique with its ability to select and enrich the functional and clinically relevant islet cells from the population of differentiated islet-like cells which enables the optimal therapeutic effect with minimal dose.
Recently, the Company successfully completed a Type B Pre-IND meeting with the U.S. Food and Drug Administration (“FDA”), paving the way for the initiation of clinical activities for NCEL-101 in combination with Eledon’s anti-CD40L monoclonal antibody, tegoprubart, for the treatment of type 1 diabetes.
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 clinical development of an innovative treatment intended for a potential cure for type 1 diabetes, advancing NCEL-101 into clinical studies with Eledon’s investigational anti-CD40L monoclonal antibody, the planned advancement of NCEL-101, the Company’s expectations concerning its interactions with the U.S. Food and Drug Administration (the “FDA”), the timing, scope and outcome of any FDA feedback, the potential initiation, timing, design and progress of future preclinical studies or clinical trials, the advancement of the Company’s development programs and the regulatory pathway for its product candidate. 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 NewcelX may elect to utilize in seeking European Medicines Agency, the FDA, and other regulatory approvals; its ability to drive revenue growth, enhance research and development capabilities, and improve financial performance is subject to uncertainties; that its financial position raises substantial doubt about its ability to continue as a going concern; its 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 its 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 its product candidates or whether such trials will be conducted at all; competitive companies, technologies and its industry; the development and commercialization, if any, of any other product candidates that it 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 it is able to establish and maintain for intellectual property rights covering its product candidates and its ability to operate its 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; its 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 its 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
1 https://www.t1dindex.org/countries/brazil/
